Patients with uncontrolled inter-current illnesses which in the opinion of the investigator will interfere with the ability to undergo therapy including chemotherapy are excludedXx_NEWLINE_xXSubjects who have any other disease, either metabolic or psychological, which as per Investigator assessment may affect the subject's compliance or place the subject at higher risk of potential treatment complicationsXx_NEWLINE_xXPsychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirementsXx_NEWLINE_xXPatients must have progressed (in the opinion of the treating investigator) following the most recent line of therapyXx_NEWLINE_xXPsychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirementsXx_NEWLINE_xXAny medical condition for which prednisone (corticosteroid) is contraindicatedXx_NEWLINE_xXPatients with medical history or conditions not otherwise previously specified which in the opinion of the investigator should exclude participation in this study; the investigator can consult the study chair or study co-chairs for uncertainty in this regardXx_NEWLINE_xXMedical, psychological, or social condition that, in the opinion of the investigator, may increase the patient’s risk or limit the patient’s adherence with study requirementsXx_NEWLINE_xXAny medical or other condition which, in the opinion of the investigator, would preclude participation in a clinical trialXx_NEWLINE_xXPatient has any other medical, psychiatric, or social condition, including substance abuse, that in the opinion of the investigator would preclude compliance with the requirements of this studyXx_NEWLINE_xXA serious uncontrolled medical disorder that in the opinion of the investigator would impair the ability of the subject to receive protocol therapyXx_NEWLINE_xXAny other medical condition, which in the opinion of the Investigator, places the subject at an unacceptably high risk for toxicities.Xx_NEWLINE_xXPatients who have any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator’s opinion, could compromise the subject’s safety, interfere with the absorption or metabolism of ibrutinib capsules, or put the study outcomes at risk are not eligibleXx_NEWLINE_xXPresence of concomitant intercurrent illness, or any condition which in the opinion of the Investigator, would compromise safe participation in the study, e.g. active severe infection, unstable angina pectoris, new onset of exacerbation of a cardiac arrhythmia.Xx_NEWLINE_xXPatient receiving concomitant therapy, which in the opinion of the Investigator is considered relevant for the evaluation of the efficacy or safety of the trial drug.Xx_NEWLINE_xXPatients with any other medical condition or laboratory value that would, at the discretion of the investigator, preclude the patient from participation in this clinical studyXx_NEWLINE_xXHas signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:Xx_NEWLINE_xXParticipants must, in the opinion of the investigator, be capable of complying with the protocolXx_NEWLINE_xXPatients with any significant medical illnesses that in the investigator’s opinion cannot be adequately controlled with appropriate therapy or would compromise the patient’s ability to tolerate this therapyXx_NEWLINE_xXAny other active malignancy other than melanoma that, in the opinion of the investigator, would interfere with study participation (for treatment phase)Xx_NEWLINE_xXHave any underlying medical condition, psychiatric condition, or social situation that, in the opinion of the Investigator, would compromise study administration as per protocol or compromise the assessment of AEs.Xx_NEWLINE_xXActive infection or an unexplained fever > 38.5 degrees Celsius (C) during screening visits or on the first scheduled day of dosing (at the discretion of the investigator, patients with tumor fever may be enrolled), which in the investigator’s opinion might compromise the patient’s participation in the trial or affect the study outcomeXx_NEWLINE_xXHistory or presence of an abnormal electrocardiogram (ECG) that, in the Investigator's opinion, is clinically meaningful.Xx_NEWLINE_xXKnown significant mental illness or other condition, such as active alcohol or other substance abuse or addiction, that in the opinion of the investigator predisposes the subject to high risk of noncompliance with the protocol.Xx_NEWLINE_xXLife-threatening illness or severe organ system dysfunction, such as uncontrolled congestive heart failure or chronic obstructive pulmonary disease, or other reasons including laboratory abnormalities, which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of ASTX727, or compromise completion of the study or integrity of the study outcomes.Xx_NEWLINE_xXAny uncontrolled medical condition (for example, inflammatory bowel disease, uncontrolled asthma), which, in the opinion of the Investigator, might impair the subject's tolerance of trial treatment or confound interpretation of study assessments.Xx_NEWLINE_xXAny serious concurrent condition that could, in the investigator’s opinion, significantly interfere with completion of study procedures or protocol complianceXx_NEWLINE_xXAny medical conditions that, in the Investigator's opinion, would impose excessive risk to the patient or would adversely affect his/her participating in this study.Xx_NEWLINE_xXPatients that have any significant medical illnesses that in the investigator’s opinion cannot be adequately controlled with appropriate therapy or would compromise the patient’s ability to tolerate this therapy are excludedXx_NEWLINE_xXSerious nonmalignant disease (e.g., hydronephrosis, liver failure, or other conditions) that could compromise protocol objectives in the opinion of the investigator and/or the sponsorXx_NEWLINE_xXPresence of an active infection or with an unexplained fever > 38.5°C during screening visits or on the first scheduled day of dosing, which in the investigator's opinion might compromise the patient's participation in the trial or affect the study outcome. At the discretion of the investigator, patients with tumor fever may be enrolledXx_NEWLINE_xXConcomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the Investigator, pose an unacceptable risk to the Subject in this study.Xx_NEWLINE_xXExpected survival of ? 12 weeks, in the opinion of the investigator.Xx_NEWLINE_xXTherapy with clinically significant systemic anticoagulant or antithrombotic agents within 7 days prior to randomization that may prevent blood clotting and, in the investigator's opinion, could place the subject at risk.Xx_NEWLINE_xXMedical or psychiatric illnesses that, in the investigator's opinion, may impact the safety of the subject or the objectives of the study.Xx_NEWLINE_xXHistory of severe adverse events, in the investigator's opinion, related to ramucirumab.Xx_NEWLINE_xXHistory of other significant cardiovascular diseases or vascular diseases within the last 6 months prior to randomization that, in the investigator's opinion, may pose a risk to the patient on VEGF inhibitor therapy.Xx_NEWLINE_xXAny medical or other condition which, in the opinion of the investigator, would preclude participation in a clinical trialXx_NEWLINE_xXAny other condition which the Investigator believes would make participation in the study not acceptableXx_NEWLINE_xXSevere and/or uncontrolled medical conditions that in the investigator's opinion could affect the safety of individual or impair the assessment of study result.Xx_NEWLINE_xXAny other condition which, in the opinion of the investigator, would preclude participation in this trialXx_NEWLINE_xXHigh likelihood of protocol non-compliance (in opinion of investigator)Xx_NEWLINE_xXConcomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study.Xx_NEWLINE_xXAny significant medical illnesses or infection that, in the investigator’s opinion, cannot be adequately controlled with appropriate therapy or would compromise the patient’s ability to tolerate this therapy are not eligible for participationXx_NEWLINE_xXMedical condition such as uncontrolled infection or cardiac disease that, in the opinion of the physician, would make this protocol unreasonably hazardous for the patient (see Section 4.4-4.10).Xx_NEWLINE_xXAny physical or psychological condition that, in the opinion of the investigator, would pose unacceptable risk to the patient or raise concern that the patient would not comply with protocol proceduresXx_NEWLINE_xXUnderlying medical conditions that, in the investigator's opinion, will make the administration of study drug hazardous or obscure the interpretation of toxicity determination or adverse events (AEs).Xx_NEWLINE_xXAny clinically significant medical disease or condition that, in the investigator’s opinion, may interfere with protocol adherence or a subject’s ability to give informed consentXx_NEWLINE_xXAny condition which, in the investigator’s opinion, makes the subject unsuitable for trial participationXx_NEWLINE_xXResearch participants with any concomitant significant medical illness that in the investigator’s opinion cannot be adequately controlled with appropriate therapy, or that would impair the evaluation of side effects related to this treatment, alter drug metabolism or the tolerance to this treatmentXx_NEWLINE_xXAny serious medical condition that interferes with adherence to study procedures.Xx_NEWLINE_xXPatient must not have a co-morbid condition(s) that, in the opinion of the investigator, prevent safe treatmentXx_NEWLINE_xXIf the patient is otherwise not deemed a good study candidate by sole discretion of the principal investigatorXx_NEWLINE_xXAny history of a medical condition or a concomitant medical condition that, in the opinion of the investigator, would compromise the subject's ability to safely complete the studyXx_NEWLINE_xXConcurrent condition that in the investigator’s opinion would jeopardize compliance with the protocolXx_NEWLINE_xXAny condition or illness that, in the opinion of the investigator, would compromise patient safety or interfere with the evaluation of the drugXx_NEWLINE_xXAny other medical or psychiatric condition that in the opinion of the investigator would make the study therapy unsafe for the patientXx_NEWLINE_xXHas any other reason(s) for the investigator to consider that the subject should not participate in the study.Xx_NEWLINE_xXUncontrolled or progressive systemic disease or other concurrent condition which in the Investigator’s opinion makes HD-MTX an undesirable treatment option for the patient or would jeopardize complianceXx_NEWLINE_xXHistory or presence of a medical condition or disease or substance abuse that in the investigator's assessment would place the patient at an unacceptable risk for study participationXx_NEWLINE_xXAny other concomitant serious illness or organ system dysfunction in opinion of Investigator would either compromise subject safety or interfere with test drug safety evaluationXx_NEWLINE_xXAny other clinically significant medical disease or condition that, in the investigator’s opinion, may interfere with protocol adherence or a subject’s ability to give informed consentXx_NEWLINE_xX•A life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of acalabrutinib, or put the study outcomes at undue riskXx_NEWLINE_xXAny condition, in the opinion of the investigator, that compromises compliance with study requirementsXx_NEWLINE_xXHas a concomitant medical condition that would increase the risk of toxicity, in the opinion of the Investigator or Sponsor.Xx_NEWLINE_xXHistory of or ongoing alcohol abuse that, in the opinion of the investigator, would compromise compliance or impart excess risks associated with study participationXx_NEWLINE_xXAny condition or illness that, in the opinion of the investigator, would compromise patient safety or interfere with the evaluation of the drugXx_NEWLINE_xXAny other serious concomitant medical condition that, in the opinion of the investigator, would compromise the safety of the participant or compromise the participant's ability to participate in the studyXx_NEWLINE_xXAny clinically significant medical disease or condition that, in the investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consentXx_NEWLINE_xXAny other concomitant serious illness or organ system dysfunction which in the opinion of the investigator would either compromise patient safety or interfere with the evaluation of the safety of the study drugXx_NEWLINE_xXAny screening laboratory, electrocardiogram (ECG), or other findings that, in the opinion of the investigator or the sponsor, indicate an unacceptable risk for the subject's participation in the study.Xx_NEWLINE_xXIn the judgment of the investigator, participation in the protocol offers an acceptable benefit-to-risk ratio when considering current disease status, medical condition, and the potential benefits and risks of alternative treatments for the subject's cancer.Xx_NEWLINE_xXSubject has other conditions that in the opinion of the investigator would place the subject at increased risk for toxicity by participation in the study.Xx_NEWLINE_xXHave any other medical or psychological condition deemed by the Investigator to likely interfere with the subject's ability to give informed consent or participate in the study.Xx_NEWLINE_xXHistory of any major disease that might interfere with safe protocol participation, as determined by the investigatorXx_NEWLINE_xXOther unspecified reasons that, in the opinion of the investigator, make the patient unsuitable for enrollmentXx_NEWLINE_xXSignificant allergy to a pharmaceutical therapy that, in the opinion of the Investigator, poses an increased risk to the patientXx_NEWLINE_xXActive bleeding diatheses, which in the investigator’s opinion makes it undesirable for the patient to participate in the trial or which would jeopardize compliance with the protocolXx_NEWLINE_xXAny evidence of severe or uncontrolled systemic diseases, including active bleeding diatheses, which in the investigator’s opinion makes it undesirable for the patient to participate in the trial or which would jeopardize compliance with the protocolXx_NEWLINE_xXAny serious medical condition that interferes with adherence to study procedures.Xx_NEWLINE_xXAny other medical condition that in the investigator’s opinion would not make the patient a good candidate for the studyXx_NEWLINE_xXPHASE II EXCLUSION CRITERIA: Any other medical condition that in the investigator’s opinion would not make the patient a good candidate for the studyXx_NEWLINE_xXAny significant medical condition including any suggested by Screening laboratory findings that, in the opinion of the Investigator or Sponsor, may place the subject at undue risk from the study.Xx_NEWLINE_xXAny other factors, including psychiatric or social, that in the opinion of the treating physician makes the patient an inappropriate candidate for a studyXx_NEWLINE_xXAny electrocardiogram (ECG) abnormality, which in the opinion of the Investigator would preclude safe participation in the study.Xx_NEWLINE_xXSerious non-malignant disease that could compromise protocol objectives in the opinion of the Investigator and/or the Sponsor.Xx_NEWLINE_xXSignificant allergy to a biological pharmaceutical therapy that, in the opinion of the Investigator, poses an increased risk to the participant.Xx_NEWLINE_xXAny medical condition that in the judgement of the principal investigator is likely to interfere with assessment of safety or efficacy of study treatmentXx_NEWLINE_xXSubject is known or suspected of not being able to comply with the study protocol (eg, because of alcoholism, drug dependency, or psychological disorder); subject has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessmentsXx_NEWLINE_xXWomen with skin conditions such as psoriasis, fungal infections, keloids etc., or tattoos and/or piercings, which in the opinion of the Investigator, would interfere with absorption of the IP.Xx_NEWLINE_xXWomen with a concurrent illness, disease or condition that, in the opinion of the Investigator, would limit their compliance with study requirements or place them at additional risk.Xx_NEWLINE_xXAny medical or other condition that in the opinion of the investigator(s) would preclude the participant's participation in a clinical studyXx_NEWLINE_xXOther medical or psychiatric illness or organ dysfunction which, in the opinion of the Investigator, would either compromise the subject's safety or interfere with the evaluation of the safety of the study agent.Xx_NEWLINE_xXAny other condition that would, in the investigator's judgement, contraindicate the patient's participation in the clinical studyXx_NEWLINE_xXSigns or symptoms of organ failure, major chronic illnesses other than cancer, or any concomitant medical or social conditions which, in the opinion of the investigator, make it undesirable for the patient to participate in the study, or which could jeopardize compliance with the protocolXx_NEWLINE_xXAny other medical or social condition that, in the opinion of the investigator, would not permit the patient to complete the study or sign informed consentXx_NEWLINE_xXPROCUREMENT EXCLUSION CRITERIA: Patients with a chronic uncontrolled medical condition that, in the opinion of the principal investigator, precludes them from participationXx_NEWLINE_xXPatients with a chronic uncontrolled medical condition that, in the opinion of the principal investigator, precludes them from participationXx_NEWLINE_xXAny condition that in the opinion of the investigator, would preclude participation in this studyXx_NEWLINE_xXAny condition which in the investigator’s opinion deems the participant an unsuitable candidate to receive study drugXx_NEWLINE_xXPresence of any severe or uncontrolled concurrent medical condition felt in the opinion of the investigator to increase the risk of serious toxicity from the study therapyXx_NEWLINE_xXUnderlying medical condition that, in the Principal Investigator's opinion, will make the administration of study drug hazardous or obscure the interpretation of toxicity determination or adverse events;Xx_NEWLINE_xXAny other serious or uncontrolled medical disorder, active infection, physical exam finding, laboratory finding, altered mental status, or psychiatric condition that, in the opinion of the investigator, would limit a subject’s ability to comply with the study requirements, substantially increase risk to the subject, or impact the interpretability of study resultsXx_NEWLINE_xXUnderlying medical conditions that, in the investigator’s opinion, will make the administration of study drug hazardous or obscure the interpretation of toxicity or adverse eventsXx_NEWLINE_xXActive infection or serious underlying medical condition that would impair the ability of the patient to received protocol therapyXx_NEWLINE_xXParticipants must in the opinion of the investigator be capable of complying with this protocolXx_NEWLINE_xXPatients with any condition that in the judgment of the investigator would jeopardize safety or patient compliance with the protocolXx_NEWLINE_xXAny disease or condition that, in the opinion of the Investigator, would compromise the safety of the patient or interfere with study assessments.Xx_NEWLINE_xXActive infection or serious underlying medical condition that would impair the ability of the patient to received protocol therapyXx_NEWLINE_xXAny life-threatening illness, medical condition, or organ system dysfunction that, in the investigator’s opinion, could compromise the subject’s safety or put the study outcomes at undue riskXx_NEWLINE_xXAny other medical condition that in the Investigator’s opinion would not make the patient a good candidate for the studyXx_NEWLINE_xXSevere pre-existing ototoxicity or neuropathy that would, in the opinion of the investigator, preclude the use of cisplatin chemotherapyXx_NEWLINE_xXIn the opinion of the treating investigator, the patient must be a candidate to receive gemcitabine/cisplatin treatmentXx_NEWLINE_xXSerious co-morbid medical conditions, or a clinically significant laboratory finding(s) or any finding(s) on history and/or examination that, in the opinion of the Investigator, could interfere with the conduct of the study or could put the patient at unacceptable risk;Xx_NEWLINE_xXHistory or other evidence of severe illness or any other conditions that would make the subject, in the opinion of the investigator, unsuitable for the study (such as poorly controlled psychiatric disease or coronary artery disease).Xx_NEWLINE_xXAny life-threatening illness, medical condition, or organ system dysfunction that, in the investigator’s opinion, could compromise the subject’s safety or put the study outcomes at undue riskXx_NEWLINE_xXAny significant psychiatric disease, medical or other condition, which in the opinion of the principal investigator could prevent adequate informed consent or compromise participation in the clinical trialXx_NEWLINE_xXConcomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study.Xx_NEWLINE_xXAny medical condition which, in the opinion of the clinical investigator, would interfere with the evaluation of the patient; subjects with a clinically significant or unstable medical or surgical condition or any other condition that cannot be well-controlled by the allowed medications permitted in the study protocol that would preclude safe and complete study participation, as determined by medical history, physical examinations, laboratory tests, and according to the investigator’s judgmentXx_NEWLINE_xXAny medical conditions that, in the opinion of the investigator, would preclude use of AGEN1884, including AGEN1884 hypersensitivity.Xx_NEWLINE_xXThe patient has any medical condition which in the opinion of the Investigator places the patient at an unacceptably high risk for toxicities.Xx_NEWLINE_xXAny history of or concomitant condition that, in the opinion of the investigator, would compromise the patient’s ability to comply with the study or interfere with the evaluation of the efficacy and safety of the test drugXx_NEWLINE_xXHistory or evidence of any other clinically significant disorder, condition or disease that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completionXx_NEWLINE_xXSubject requires any medical intervention(s) or has any other condition(s) that, in the Investigator’s opinion, will 1) make the administration of PROSTVAC or ipilimumab hazardous, 2) obscure the interpretation of adverse events (AEs), 3) compromise adherence with study requirements, or 4) otherwise compromise the study’s objectivesXx_NEWLINE_xXAny condition which makes the subject unsuitable for trial participationXx_NEWLINE_xXSpinal cord compression, imminent long bone fracture, or any other condition that, in the opinion of the investigator, is likely to require radiation therapy and/or steroids for pain control during the active phaseXx_NEWLINE_xXAny medical intervention, any other condition, or any other circumstance which, in the opinion of the investigator, could compromise adherence with study requirements or otherwise compromise the study’s objectivesXx_NEWLINE_xXAny condition which, in the investigator’s opinion, makes the subject unsuitable for trial participationXx_NEWLINE_xXAny condition or illness that, in the investigator’s opinion, would place the subject at unacceptable risk if he/she were to participateXx_NEWLINE_xXAny history of or concomitant condition that, in the opinion of the investigator, would compromise the patient’s ability to comply with the study or interfere with the evaluation of the efficacy and safety of the test drugXx_NEWLINE_xXUncontrolled cystitis, significant bladder pain or spasms, or gross hematuria that in the opinion of the treating investigator, should preclude study entryXx_NEWLINE_xXAny condition which, in the investigator’s opinion, makes the subject unsuitable for trial participationXx_NEWLINE_xXA history of serious allergic reactions, which in the opinion of the investigator pose an increased risk of serious infusion reactions.Xx_NEWLINE_xXOther cardiac or pulmonary disease that, at the investigator’s discretion, can impair treatment safetyXx_NEWLINE_xXAny other pathology or condition which the principal investigator may deem to negatively impact treatment safetyXx_NEWLINE_xXPatients with a known history of drug abuse or any chronic neurologic, psychiatric, endocrine, metabolic, immunologic, hepatic or renal disease (including a history of hemolytic uremic syndrome) that in the opinion of the Investigator would adversely affect study participation.Xx_NEWLINE_xXAny underlying medical or psychiatric condition, which in the opinion of the investigator will make the administration of study agents hazardous or obscure the interpretation of adverse events (AEs)Xx_NEWLINE_xXA life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of study drugs, or put the study outcomes at undue risk.Xx_NEWLINE_xXSerious non-malignant disease such as active infection or other condition which in the opinion of the investigator would compromise other protocol objectivesXx_NEWLINE_xXAny life-threatening illness, medical condition, or organ system dysfunction that, in the opinion of the investigator, could compromise the subject’s safety or put the study outcomes at undue riskXx_NEWLINE_xXPatients whose comorbid medical condition, in the investigator’s opinion, would make participation in this trial and adherence to the protocol guidelines difficult should be excludedXx_NEWLINE_xXAny underlying medical or psychiatric condition, which in the opinion of the investigator will make the administration of ipilimumab hazardous or obscure the interpretation of adverse events (AEs), such as a condition associated with frequent diarrheaXx_NEWLINE_xXChronic or acute renal or hepatic disorder or any other condition, medical or psychological that, in the opinion of the investigator, could jeopardize the subject’s safe participationXx_NEWLINE_xXAny subject who, in the opinion of the principal investigator (PI) is at risk for thromboembolic eventsXx_NEWLINE_xXEvidence of current drug or alcohol abuse or psychiatric impairment, which in the investigator’s opinion will prevent completion of the protocol therapy or follow-upXx_NEWLINE_xXAny condition which in the investigator’s opinion deems the patient an unsuitable candidate to receive study drug (i.e., any significant medical illness or abnormal laboratory finding that would, in the investigator’s judgment, increase the patient’s risk by participating in this study)Xx_NEWLINE_xXAny other serious medical condition which in the Investigator's opinion would preclude safe participation in the study.Xx_NEWLINE_xXSubjects, in the opinion of the Investigator, who are unsuitable to participate in the study.Xx_NEWLINE_xXPatients that have any significant medical illnesses that in the investigator’s opinion cannot be adequately controlled with appropriate therapy or would compromise the patient’s ability to tolerate this therapy are excludedXx_NEWLINE_xXPatients in whom there is a medical contraindication or potential problem in complying with the requirements of the protocol, in the opinion of the investigator.Xx_NEWLINE_xXPatients with a \currently active\ second malignancy that, in the opinion of the principal investigator, will interfere with patient participation, increase patient risk, shorten survival to < 1 year, or confound data interpretationXx_NEWLINE_xXConcurrent use of complementary or alternative medicines that in the opinion of the principal investigator would confound the interpretation of toxicities and/or antitumor activity of the study drugXx_NEWLINE_xXAny co-morbidity or condition of sufficient severity to limit full compliance with the protocol per assessment by the investigatorXx_NEWLINE_xXPatients must NOT have any concurrent medical condition that, in the opinion of the PI or designee, would prevent the patient from undergoing protocol-based therapy; patients with a primary immunodeficiency/ bone marrow failure syndrome are excluded from this trialXx_NEWLINE_xXAny condition which in the investigator’s opinion deems the patient an unsuitable candidateXx_NEWLINE_xXOther serious uncontrolled medical conditions that the investigator feels might compromise study participationXx_NEWLINE_xXAny underlying medical or psychiatric condition, which in the opinion of the investigator will make the administration of ipilimumab hazardous or obscure the interpretation of adverse events (AEs), such as a condition associated with frequent diarrheaXx_NEWLINE_xXSignificant history of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, cardiovascular or hepatic disease, within the last 6 months that, in the opinion of the investigator, would adversely affect his/her participation in the study.Xx_NEWLINE_xXPsychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements.Xx_NEWLINE_xXPatients with rapidly progressing disease in the opinion of the principal investigatorXx_NEWLINE_xXAny condition which in the investigator's opinion deems the subject an unsuitable candidate to receive study drugXx_NEWLINE_xXPresence of any concurrent illness or condition that, in the opinion of the investigator, would jeopardize the safety of the subject or impact the validity of the study results.Xx_NEWLINE_xXAny significant disease that, in the opinion of the investigator, may impair the patient's tolerance of study treatmentXx_NEWLINE_xXNo evidence of severe or uncontrolled other systemic disease or any concurrent condition which in the investigator’s opinion makes it undesirable for the subject to participate in the trial or which would jeopardize compliance with the protocolXx_NEWLINE_xXAny condition or set of circumstances that the principal investigator (PI) or lead associate investigator (LAI) interprets as creating undue risk to the patient by participating on this study or would make the patient unlikely to comply with the studyXx_NEWLINE_xXAny condition or set of circumstances that in the opinion of the investigators would make participation in this study unsafe or otherwise inappropriate for a given individualXx_NEWLINE_xXKnown psychiatric condition, social circumstance, or other medical condition reasonably judged by the investigator to unacceptably increase the risk of study participation; or to prohibit the understanding or rendering of informed consent or anticipated compliance with and interpretation of scheduled visits, treatment schedule, laboratory tests and other study requirements.Xx_NEWLINE_xXAny serious or uncontrolled medical disorder or active infection that, in the opinion of the Investigator, may increase the risk associated with study participation, study drug administration, or would impair the ability of the patient to receive protocol therapyXx_NEWLINE_xXClinically relevant diseases (for example, inflammatory bowel disease) and /or uncontrolled medical conditions, which, in the opinion of the investigator, might impair the subject’s tolerance or ability to participate in the trial.Xx_NEWLINE_xXPatient with concurrent severe and/or uncontrolled medical conditions that, in the opinion of the investigator, may impair participation in the study or the evaluation of safety and/or efficacyXx_NEWLINE_xXSubject has an abnormal electrocardiogram (ECG) that, in the Investigator's opinion, is clinically significant and would preclude study participation.Xx_NEWLINE_xXThe recipient has another medical problem or neurologic/psychiatric dysfunction which would impair his/her ability to be compliant with the medical regimen and to tolerate transplantation or would prolong hematologic recovery in which the opinion of the principal investigator would place the recipient at unacceptable riskXx_NEWLINE_xXIn the opinion of the principal investigator (PI), the participant has a condition that will preclude them from complying with study treatmentXx_NEWLINE_xXAny condition which, in the opinion of the investigator, would prevent full participation in this trial (including the long-term follow-up), or would interfere with the evaluation of the trial endpointsXx_NEWLINE_xXAny medical conditions that, in the investigator’s opinion, would impose excessive risk to the subject, e.g., any uncontrolled disease, such as pulmonary disease, infection, seizure disorder, uncontrolled hyperglycemiaXx_NEWLINE_xXAny medical conditions that, in the Investigator's opinion, would impose excessive risk to the patient or would adversely affect his/her participating in this study. Examples of such conditions are: a significant history of cardiovascular disease (e.g., myocardial infarction, significant conduction system abnormalities, uncontrolled hypertension, ? Grade 3 thromboembolic event in the last 6 months)Xx_NEWLINE_xXAny condition which in the investigator’s opinion deems the participant an unsuitable candidate to receive study drugXx_NEWLINE_xXAny condition that would jeopardize the safety of the subject or compliance with the protocolXx_NEWLINE_xXOther medical or psychiatric illness or organ dysfunction, which in the opinion of the investigator, would either compromise the subject's safety or interfere with the evaluation of the safety of the study agentXx_NEWLINE_xXAny condition which in the investigator’s opinion deems the participant an unsuitable candidate to receive study drugXx_NEWLINE_xXHave any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study or prevent the subject from meeting or performing study requirementsXx_NEWLINE_xXCurrent or recent (within 10 days of study enrollment) use of anticoagulants that, in the opinion of the investigator, would place the subject at significant risk for bleeding. Prophylactic use of anticoagulants is allowed.Xx_NEWLINE_xXClinically relevant diseases (for example, inflammatory bowel disease) and/or uncontrolled medical conditions, which, in the opinion of the Investigator, might impair the subject’s tolerance or ability to participate in the trialXx_NEWLINE_xXPresence of a significant psychiatric disease, which in the opinion of the principal investigator or his/her designee, would prevent adequate informed consent.Xx_NEWLINE_xXAny other condition that in the investigator’s judgement would significantly increase the risks of participation.Xx_NEWLINE_xXAny life-threatening illness, medical condition, or organ system dysfunction which, in the investigator’s opinion, could compromise the subject’s safety, interfere with the absorption or metabolism of ibrutinib capsules, or put the study outcomes at undue riskXx_NEWLINE_xXPhysical or psychological condition which would impair study participation; orXx_NEWLINE_xXAny life-threatening illness, medical condition, or organ system dysfunction that, in the investigator's opinion, could compromise the subject's safety or put the study outcomes at undue riskXx_NEWLINE_xXAny condition which, in the investigator’s opinion, makes the subject unsuitable for trial participationXx_NEWLINE_xXAny concurrent uncontrolled illness, including mental illness or substance abuse, which in the opinion of the Investigator, would make the subject unable to cooperate or participate in the trial.Xx_NEWLINE_xXAny clinically significant uncontrolled condition that may increase the risk to the study patient or that the Investigator considers places the patient at unacceptable riskXx_NEWLINE_xXAny condition which, in the opinion of the investigator, would preclude participation in this trialXx_NEWLINE_xXClinically relevant diseases (for example, inflammatory bowel disease) and / or uncontrolled medical conditions, which, in the opinion of the Investigator, might impair the subject’s tolerance or ability to participate in the trial.Xx_NEWLINE_xXAny severe, uncontrolled disease or condition which in the investigator's opinion, may put the subject at significant risk, may confound the study results, or impact the subject's participation in the studyXx_NEWLINE_xXSignificant medical conditions (including widely disseminated metastatic disease) or laboratory results that, in the opinion of the investigator, indicate an increased vulnerability to study drugs and procedures.Xx_NEWLINE_xXPresence of a concomitant medical condition that (in the judgement of the investigator) interferes with the ability of the subject to participate in the study.Xx_NEWLINE_xXThe presence of a medical or psychiatric condition that, in the opinion of the principal investigator, makes the patient inappropriate for inclusion in this studyXx_NEWLINE_xXAny clinically important abnormalities in rhythm, conduction or morphology of a resting ECG, e.g., complete left bundle branch block, third degree heart block, that in the opinion of the Investigator render the patient unsuitable for participation in the studyXx_NEWLINE_xXIn the judgment of the investigator, participation in the protocol offers an acceptable benefit-to-risk ratio when considering current disease status, medical condition, and the potential benefits and risks of alternative treatments for the subject's cancer.Xx_NEWLINE_xXAny illness, medical condition or organ system dysfunction which, in the investigator’s opinion, could compromise the subject’s safety, interfere with the absorption or metabolism of lenalidomide, or put the study outcomes at undue riskXx_NEWLINE_xXOther unspecified reasons that, in the opinion of the Investigator, make the subject unsuitable for enrollment.Xx_NEWLINE_xXAny other medical, psychological, or social condition that may interfere with study participation or compliance, or compromise patient safety in the opinion of the investigatorXx_NEWLINE_xXAny additional condition which in the investigator’s opinion deems the participant an unsuitable candidate to receive the study drugsXx_NEWLINE_xXHas a concomitant medical condition that would increase the risk of toxicity, in the opinion of the InvestigatorXx_NEWLINE_xXHistory or evidence of any other clinically significant disorder, condition or disease that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completionXx_NEWLINE_xXSubjects with any coexisting medical or psychiatric condition which, in the opinion of the investigator likely to interfere with study procedures and/or resultsXx_NEWLINE_xXAny other medical or psychological condition deemed by the Investigator to be likely to interfere with a subject's ability to give informed consent or participate in the studyXx_NEWLINE_xXParticipant has chronic respiratory disease that requires continuous oxygen, or significant history of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, hepatic, cardiovascular disease, any other medical condition or known hypersensitivity to any of the study medications including excipients of azacitidine that in the opinion of the investigator would adversely affect his/her participating in this study.Xx_NEWLINE_xXPatients with any significant medical illnesses that in the investigator’s opinion cannot be adequately controlled with appropriate therapy or would compromise the patient’s ability to tolerate this therapyXx_NEWLINE_xXParticipants must, in the opinion of the Investigator, be capable of complying with the requirements of this protocol including self-administration of study treatmentXx_NEWLINE_xXConcurrent condition that in the investigator's opinion would jeopardize compliance with the protocol or would impart excessive risk associated with study participation that would make it inappropriate for the patient to be enrolled.Xx_NEWLINE_xXAny condition which in the investigator’s opinion deems the participant an unsuitable candidate to receive study drugXx_NEWLINE_xXAny medical or psychiatric illness, which, in the opinion of the principal investigator, would compromise the patient's ability to tolerate this treatmentXx_NEWLINE_xXAny co-morbid medical condition that may put the patient at significant risk for toxicityXx_NEWLINE_xXSubjects with life-threatening illnesses other than MDS, uncontrolled medical conditions or organ system dysfunction which, in the investigator’s opinion, could compromise the subject’s safety, or put the study outcomes at riskXx_NEWLINE_xXAny condition which in the investigator’s opinion deems the participant an unsuitable candidate to receive study drugXx_NEWLINE_xXAny concurrent disease, infection, or comorbid condition that interferes with the ability of the patient to participate in the trial; places the patient at undue risk; or complicates the interpretation of the data, in the opinion of the investigator or medical monitorXx_NEWLINE_xXIn the opinion of the Investigator would benefit from continued treatment.Xx_NEWLINE_xXMedical condition including but not limited to ongoing or active infection or connective tissue disease (e.g. systemic sclerosis or other collagen vascular diseases) that would, in the opinion of the treating physician, make this protocol unreasonably hazardous to the patientXx_NEWLINE_xXPatient has a serious active disease or co-morbid medical condition, as judged by the investigator, which would interfere with the conduct of this study.Xx_NEWLINE_xXAny other condition that would cause a risk to the patient if he/she participated in the trial.Xx_NEWLINE_xXAny condition which in the investigator’s opinion deems the participant an unsuitable candidate to receive study drugXx_NEWLINE_xXSubjects must NOT have any concurrent medical condition that, in the opinion of the protocol PI or designee, would prevent the patient from undergoing protocol-based therapy; subjects with a primary immunodeficiency/bone marrow failure syndrome are excluded from this trialXx_NEWLINE_xXAny medical intervention or other condition which, in the opinion of the principal investigator, could compromise adherence with study requirements or otherwise compromise the study’s objectivesXx_NEWLINE_xXMedical or psychological conditions present within 30 days prior to enrollment that would make the patient unsuitable candidate for cell therapy at the discretion of the principal investigator (PI)Xx_NEWLINE_xXHistory or presence of an abnormal electrocardiogram (ECG) that, in the Investigator's opinion, is clinically meaningful.Xx_NEWLINE_xXUncontrolled concomitant disease that in the opinion of the investigator would interfere with the patient’s safety or compliance on trialXx_NEWLINE_xXHistory of severe autoimmune disease that in the opinion of the investigator would interfere with patient safety or compliance on trialXx_NEWLINE_xXAny condition or history of illness or surgery that in the opinion of the investigator might affect the conduct and results of the study or pose additional risks to the subject (e.g., cardiac or respiratory disease precluding general anesthesia; anticoagulant treatment which cannot be temporarily withdrawn for the procedure).Xx_NEWLINE_xXLife expectancy < 6 months due to any condition other than BOS that, in the opinion of the investigator, is likely to result in the death of the patientXx_NEWLINE_xXConcurrent medical condition or disease (e.g., autoimmune disease, active systemic infection) that is likely to interfere with study procedures or results, or that in the opinion of the investigator would constitute a hazard for participating in the studyXx_NEWLINE_xXAny condition which, in the investigator’s opinion, makes the subject unsuitable for trial participationXx_NEWLINE_xXPresence of any other medical, psychological, familial, sociological, or geographic condition potentially hampering compliance with the study protocol or would interfere with the study endpoints or the subject's ability to participate in the study in the judgement of the investigatorXx_NEWLINE_xXAny underlying medical condition, which in the opinion of the investigator, will make the administration of study drug hazardous or obscure the interpretation of adverse events, such as a condition associated with frequent diarrhea, uncontrolled nausea or vomiting.Xx_NEWLINE_xXPatient (Pt) may be excluded if, in the opinion of the principal investigator (PI) and investigator team, the pt is not capable of being compliantXx_NEWLINE_xXA serious uncontrolled medical disorder that in the opinion of the investigator may be jeopardized by the treatment with protocol therapyXx_NEWLINE_xXPt may be excluded if, in the opinion of the principal investigator (PI) and investigator team, the pt is not capable of being compliantXx_NEWLINE_xXAny other cardiac condition that, in the opinion of the investigator, could pose an additional risk for participation in the study (example, pericardial effusion or restrictive cardiomyopathy).Xx_NEWLINE_xXAny other medical or psychiatric disorders, or social situation, that would, in the investigator's opinion, place the subject at unacceptable risk if he/she participates in the study.Xx_NEWLINE_xXAny other serious or uncontrolled medical disorder, active infection, physical exam finding, laboratory finding, altered mental status, or psychiatric condition that, in the opinion of the investigator, would limit a subject’s ability to comply with the study requirements, substantially increase risk to the subject, or impact the interpretability of study results.Xx_NEWLINE_xXOther medical conditions deemed by the principal investigator (or associates) to make the subject unsafe or ineligible for protocol proceduresXx_NEWLINE_xXAny medical conditions that, in the investigator’s opinion, would impose excessive risk to the patient or would adversely affect his/her participating in this study, including:Xx_NEWLINE_xXPatients with any condition that in the judgment of the investigator would jeopardize safety or patient compliance with the protocolXx_NEWLINE_xXHas any serious concomitant illness that in the opinion of the investigator(s) could affect the participant's safety or interfere with the study assessments.Xx_NEWLINE_xXSubjects must NOT have any concurrent medical condition that, in the opinion of the protocol PI or designee, would prevent the patient from undergoing protocol-based therapy; subjects with a primary immunodeficiency/bone marrow failure syndrome are excluded from this trialXx_NEWLINE_xXSubject has any condition which makes the subject unsuitable for study participation.Xx_NEWLINE_xXAny medical condition that in the judgement of the investigator is likely to interfere with assessment of safety or efficacy of study treatmentXx_NEWLINE_xXSubjects with medical condition that could adversely impact the study participation or assessments.Xx_NEWLINE_xXAny other clinically significant medical disease or condition that, in the investigator’s opinion, may interfere with protocol adherence or a subject’s ability to give informed consentXx_NEWLINE_xXAny underlying medical condition, which in the opinion of the Investigator, will make the administration of study drug hazardous or obscure the interpretation of adverse events, such as a condition associated with frequent diarrheaXx_NEWLINE_xXMedical, psychological, or social condition that, in the opinion of the investigator, may increase the patient’s risk or limit the patient’s adherence with study requirementsXx_NEWLINE_xXSubject has any other significant medical or psychiatric history that in the opinion of the investigator would adversely affect participation in this studyXx_NEWLINE_xXAny condition which in the investigator’s opinion deems the participant an unsuitable candidate to receive study drugXx_NEWLINE_xXAny mental or physical condition, in the opinion of the PI (or PI designee), which could interfere with the ability of the subject (or the only parent or legal guardian available to care for the subject) to understand or adhere to the requirements of the studyXx_NEWLINE_xXAny other severe concurrent disease, or history of serious organ dysfunction or disease involving the heart, kidney, liver or other organ system that, in the investigator’s opinion, may place the patient at undue risk to undergo therapy with ibrutinib.Xx_NEWLINE_xXOngoing severe inflammatory skin condition (as determined by the Investigator) requiring medical treatmentXx_NEWLINE_xXNormal organ function since eligibility screening, and no new clinical or laboratory findings that, in the opinion of the investigator, might jeopardize the patient's safetyXx_NEWLINE_xXIndividuals in whom the ability to observe possible local reactions at the eligible injection sites (deltoid region) is, in the opinion of the investigator, unacceptably obscured due to a physical condition or permanent body artXx_NEWLINE_xXAny life-threatening illness, medical condition, or organ system dysfunction that, in the investigator’s opinion, could compromise the subject’s safety or put the study outcomes at undue riskXx_NEWLINE_xXAny severe, uncontrolled disease or condition, which in the investigator's opinion, may put the subject at significant risk, may confound the study results, or impact the subject's participation in the studyXx_NEWLINE_xXNormal organ function since eligibility screening, and no new clinical or laboratory findings that, in the opinion of the investigator, might jeopardize the patient's safetyXx_NEWLINE_xXAny medical, psychological or social condition that in the opinion of the investigator, would preclude participation in this study.Xx_NEWLINE_xXSerious concomitant systemic disorders (e.g., active uncontrolled infection or uncontrolled diabetes) or psychiatric disorders that, in the opinion of the investigator, would compromise the safety of the patient or compromise the patient's ability to complete the study.Xx_NEWLINE_xXSevere active co-morbidity as determined by the investigator or principal investigatorXx_NEWLINE_xXAny clinically significant psychiatric, social, or medical condition that, in the opinion of the investigator, could increase subject’s risk, interfere with protocol adherence, or affect a subject’s ability to give informed consentXx_NEWLINE_xXThe patient must be a suitable candidate for surgery, in the opinion of the treating physicianXx_NEWLINE_xXThe presence of any medical condition that the Investigator deems incompatible with participation in the trialXx_NEWLINE_xXAny other medical or psychiatric comorbidities, including decompensated heart failure, unstable angina or coronary artery disease or severe pulmonary disease, that, in the opinion of the study investigator, would make the patient a poor candidate for the studyXx_NEWLINE_xXHas any severe concurrent disease, infection, or comorbid condition that renders the patient inappropriate for enrollment in the opinion of the investigatorXx_NEWLINE_xXIndividuals in whom the ability to observe possible local reactions at the eligible injection sites (deltoid region) is, in the opinion of the investigator, unacceptably obscured due to a physical condition or permanent body artXx_NEWLINE_xXHistory or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined) that, in the opinion of the principal investigator would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.Xx_NEWLINE_xXAny other serious or uncontrolled medical disorder, active infection, physical exam finding, laboratory finding, altered mental status, or psychiatric condition that, in the opinion of the investigator, would limit a subject’s ability to comply with the study requirements, substantially increase risk to the subject, or impact the interpretability of study resultsXx_NEWLINE_xXAny other pathology or condition that the principal investigator deems to negatively impact treatment safetyXx_NEWLINE_xXOne of the two following populations:\r\n* High risk for recurrence of RCC after nephrectomy, in the opinion of the investigator, OR\r\n* Locally advanced, unresectable or metastatic disease, in the opinion of the investigator, and good or intermediate risk by Clinical Trial Independent Data Monitoring Committee (IDMC) Heng CriteriaXx_NEWLINE_xXOsseous metastatic disease with unacceptable risk of impending fracture due to study assessments, in the opinion of the investigatorXx_NEWLINE_xXAny condition which, in the investigator’s opinion, makes the subject unsuitable for trial participationXx_NEWLINE_xXAny underlying medical or psychiatric condition, which in the opinion of the Investigator, will make the administration of study drug hazardous or obscure the interpretation of AEs: e.g. a condition associated with frequent diarrhea or chronic skin conditions, recent surgery or colonic biopsy from which the patient has not recovered, or partial endocrine organ deficiencies.Xx_NEWLINE_xXAny life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the patient’s safetyXx_NEWLINE_xXPatients are excluded for any underlying medical or psychiatric condition, which in the opinion of the investigator, will make treatment hazardous or obscure the interpretation of adverse events, such as a condition associated with frequent rashes or diarrheaXx_NEWLINE_xXKnown significant mental illness or other conditions such as active alcohol or other substance abuse/addiction that, in the opinion of the investigator, predisposes the subject to high risk of noncompliance with the protocolXx_NEWLINE_xXAny other issue which, in the opinion of the treating physician, would make the patient ineligible for the studyXx_NEWLINE_xXSignificant acute or chronic medical or psychiatric illness that, in the judgment of the Investigator, could compromise subject safety, limit the subject's ability to complete the trial, and/or compromise the objectives of the trialXx_NEWLINE_xXAny other condition (e.g. psychiatric disorder) that, in the opinion of the Investigator, may interfere with the patient's ability to comply with the study requirements or visit scheduleXx_NEWLINE_xXAny other health condition that would preclude participation in the study in the judgment of the principal investigatorXx_NEWLINE_xXAll other significant diseases (for example, inflammatory bowel disease, uncontrolled asthma), which, in the opinion of the investigator, might impair the subject’s tolerance of trial treatmentXx_NEWLINE_xXAny serious or uncontrolled medical disorder or active infection that, in the opinion of the investigator, may increase the risk associated with study participation, study drug administration, or would impair the ability of the subject to receive protocol therapyXx_NEWLINE_xXAny other issue which, in the opinion of the treating physician, would make the patient ineligible for the studyXx_NEWLINE_xXParticipant has chronic respiratory disease that requires continuous oxygen, or significant history of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, hepatic, cardiovascular disease, any other medical condition or known hypersensitivity to any of the study medications including excipients of LDAC that in the opinion of the investigator would adversely affect his/her participating in this study.Xx_NEWLINE_xXHave any condition or illness that, in the opinion of the investigator, might compromise patient safety or interfere with the evaluation of the safety of the drugXx_NEWLINE_xXAny concurrent condition which in the investigator’s opinion makes it undesirable for the subject to participate in this trial or which would jeopardize compliance with the protocolXx_NEWLINE_xXAny other condition which, in the opinion of the investigator, may compromise the subject's ability to follow study procedures and safely complete the studyXx_NEWLINE_xXAny significant disease that, in the opinion of the investigator, may impair the patient’s tolerance of study treatmentXx_NEWLINE_xXAny life threatening illness, medical condition, or organ system dysfunction that, in the investigator’s opinion, could compromise the subject’s safety or put the study outcomes at undue riskXx_NEWLINE_xXSubjects with any concurrent condition that, in the investigator's opinion, would jeopardize the safety of the subject or compliance with the protocolXx_NEWLINE_xXOther medical or psychiatric conditions that in the opinion of the investigator would preclude safe participation in the protocolXx_NEWLINE_xXPatients must not have any significant medical illnesses that in the investigator’s opinion cannot be adequately controlled with appropriate therapy or would compromise the patient’s ability to tolerate this therapy.Xx_NEWLINE_xXSerious active infection at the time of enrolment, or another serious underlying medical condition that would impair the ability of the patient to receive study treatmentXx_NEWLINE_xXPatients must not have any significant infections or medical illnesses that in the investigator’s opinion cannot be adequately controlled with appropriate therapy or would compromise the patient’s ability to tolerate NU-0129Xx_NEWLINE_xXNo other condition which, in the opinion of the Investigator, would preclude participation in this trialXx_NEWLINE_xXAny life-threatening illness, medical condition, or organ system dysfunction that, in the investigator's opinion, could compromise the subject's safety or put the study outcomes at undue riskXx_NEWLINE_xXAny life-threatening illness, medical condition, or organ system dysfunction that, in the investigator's opinion, could compromise the subject's safety or put the study outcomes at undue riskXx_NEWLINE_xXA concomitant medical condition that in the opinion of the treating physician would pose unreasonable additional risk to therapeutic injection of ONCOS-102.Xx_NEWLINE_xXAny reason, at the investigator’s discretion, that the participation of the patient in this protocol would not be in patient’s best interest, or where the patient would be unable to adhere to the study requirementsXx_NEWLINE_xXAny illness, medical condition or organ system dysfunction which, in the investigator’s opinion, could compromise the subject’s safety, interfere with the absorption or metabolism of venetoclax and lenalidomide, or put the study outcomes at undue riskXx_NEWLINE_xXSerious nonmalignant disease that could compromise protocol objectives in the opinion of the investigator and/or the sponsorXx_NEWLINE_xXAny condition which, in the investigator’s opinion, makes the subject unsuitable for trial participationXx_NEWLINE_xXPresence of underlying medical condition that in the opinion of the investigator or sponsor could adversely affect the ability of the subject to comply with or tolerate study procedures and/or study therapy, or confound the ability to interpret the tolerability of combined administration of DS-8273A and nivolumab in treated subjectsXx_NEWLINE_xXSubjects must not have a history of other serious underlying medical or psychiatric condition that, in the opinion of the investigator, would impair the ability to receive, tolerate and or comply with the planned treatment and follow-upXx_NEWLINE_xXHistory of intercurrent illness (cardiovascular, renal, hepatic, etc.) or laboratory abnormality that, in the investigator’s opinion would increase the risk of participating in the study or limit compliance with study requirementsXx_NEWLINE_xXAny history of or concomitant condition that, in the opinion of the investigator, would compromise the patient’s ability to comply with the study or interfere with the evaluation of the efficacy and safety of the test drugXx_NEWLINE_xXSevere and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise adherence to the protocol (e.g. uncontrolled diabetes, uncontrolled infection, etc.)Xx_NEWLINE_xXAny clinically significant medical disease or condition that, in the treating investigator’s opinion, may interfere with protocol adherence or a subject’s ability to give informed consentXx_NEWLINE_xXAny condition which, in the opinion of the investigator, would preclude participation in this trialXx_NEWLINE_xXHistory or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation procedures or completion.Xx_NEWLINE_xXMedical, psychological, or social condition that, in the opinion of the investigator, may increase the patient’s risk or limit the patient’s adherence with study requirementsXx_NEWLINE_xXAny condition which in the investigator’s opinion deems the participant an unsuitable candidate to receive study drugXx_NEWLINE_xXAny other medical, psychological, or social condition that may interfere with study participation or compliance, or compromise patient safety in the opinion of the investigatorXx_NEWLINE_xXAll other significant diseases (for example, inflammatory bowel disease, uncontrolled asthma), which, in the opinion of the investigator, might impair the subject’s tolerance of trial treatmentXx_NEWLINE_xXChronic alcohol or drug abuse or any condition that, in the Investigator's opinion, makes him/her an unreliable trial subject, unlikely to complete the trial, or unable to comply with the protocol procedures.Xx_NEWLINE_xXAny condition which in the Investigator’s opinion deems the participant an unsuitable candidate to receive study drugXx_NEWLINE_xXHave a serious preexisting medical condition that, in the opinion of the investigator would preclude participation in the study (for example a GI disorder causing clinically significant symptoms such as nausea, vomiting, and diarrhea, or malabsorption syndrome) or that would result in a life expectancy of less than 1 yearXx_NEWLINE_xXAny life-threatening illness, medical condition, or organ system dysfunction that, in the investigators’ opinion, could compromise the subject’s safety or put the study outcomes at undue riskXx_NEWLINE_xXA life-threatening illness, medical condition or organ system dysfunction which, in the investigator’s opinion, could compromise the subject’s safety, interfere with the absorption or metabolism of ibrutinib, or put the study outcomes at undue riskXx_NEWLINE_xXSerious nonmalignant disease (e.g., hydronephrosis, liver failure, or other conditions) that could compromise protocol objectives in the opinion of the investigatorXx_NEWLINE_xXIn the opinion of the investigator and confirmed by the Millennium medical monitor, the participant may continue to benefit from treatment with ixazomib (eg, response to therapy or stable disease without evidence of disease progression).Xx_NEWLINE_xXSubjects should be in otherwise satisfactory health in the opinion of the Investigator;Xx_NEWLINE_xXPatients are excluded for any underlying medical or psychiatric condition which, in the opinion of the investigator, will make treatment hazardous or obscure the interpretation of adverse events, such as a condition associated with frequent diarrhea.Xx_NEWLINE_xXAny other medical condition or laboratory evaluation that, in the treating physician's or principal investigator's opinion, makes the patient unsuitable to participate in this clinical trialXx_NEWLINE_xXAny life-threatening illness, known autoimmune disease, medical condition, or organ system dysfunction that, in the investigator’s opinion, could compromise the subject’s safety or put the study outcomes at undue riskXx_NEWLINE_xXNo serious disease or condition that, in the opinion of the investigator, would compromise the patient’s ability to participate in the studyXx_NEWLINE_xXAny condition that in the opinion of the investigator, would preclude participation in this studyXx_NEWLINE_xXPatients positive for hepatitis C are permitted if controlled with medication, in the opinion of the investigatorXx_NEWLINE_xXAny condition that, in the opinion of the investigator, would impair the subject's ability to comply with study procedures.Xx_NEWLINE_xXMedical, psychological, or social condition that, in the opinion of the investigator, may increase the patient’s risk or limit the patient’s adherence with study requirementsXx_NEWLINE_xXHas had major surgery (other than definitive lung cancer surgery) within two weeks of study or other serious concomitant disorders that in the opinion of the investigator would compromise the safety of the patient or compromise the patient’s ability to complete the studyXx_NEWLINE_xXUnderlying medical conditions that, in the investigator’s opinion, will make the administration of study drug hazardous or obscure the interpretation of toxicity determination or adverse eventsXx_NEWLINE_xXSerious underlying medical conditions that, per the Investigator's discretion, could impair the ability of the patient to participate in the trialXx_NEWLINE_xXAny condition or organ toxicity deemed by the principal investigator (PI) or the attending physician to place the patient at unacceptable risk for treatment on the protocolXx_NEWLINE_xXHave any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study or prevent the subject from meeting or performing study requirementsXx_NEWLINE_xXAny evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, which in the investigator’s opinion makes it undesirable for the patient to participate in the trial or which would jeopardize compliance with the protocol; screening for chronic conditions is not requiredXx_NEWLINE_xXAny other clinically significant medical or psychiatric disease or condition or social situation that, in the investigator’s opinion, may interfere with protocol adherence or a subject’s ability to give informed consentXx_NEWLINE_xXPatients with medical history or conditions not otherwise previously specified which in the opinion of the investigator should exclude participation in this studyXx_NEWLINE_xXAny life-threatening illness, medical condition, or organ system dysfunction that, in the investigator's opinion, could compromise the subject's safety or put the study outcomes at undue riskXx_NEWLINE_xXAny life-threatening illness, medical condition, or organ system dysfunction which, in the investigator’s opinion, could compromise the subject’s safety, interfere with the absorption or metabolism of ibrutinib capsules, or put the study outcomes at undue riskXx_NEWLINE_xXEligible for therapy for the lymphoid malignancy which has a high likelihood of a curative result in the opinion of the investigatorXx_NEWLINE_xXHave any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study or prevent the subject from meeting or performing study requirementsXx_NEWLINE_xXCurrent evidence of any of the following:\r\n* Uncontrolled hypertension \r\n* Gastrointestinal disorder affecting absorption\r\n* Active infection (e.g. human immunodeficiency virus [HIV] or viral hepatitis) or other medical condition that would make prednisone/prednisolone (corticosteroid) use contraindicated\r\n* Any condition that in the opinion of the investigator, would preclude participation in this studyXx_NEWLINE_xXAny medical or psychological condition that, in the opinion of the investigator, might interfere with the subject’s participation in the trial, poses any additional risk for the subject, or confounds the assessment of the subjectXx_NEWLINE_xXAny underlying medical or psychiatric condition, which in the opinion of the investigator, will make the administration of study drug hazardous or obscure the interpretation of adverse eventsXx_NEWLINE_xXSubject has any medical or psychiatric condition that, in the opinion of the Investigator, may compromise the subject's ability to participate in this studyXx_NEWLINE_xXPatient has serious medical risk factors involving any of the major organ systems such that the investigator considers it unsafe for the patient to receive an experimental research drugXx_NEWLINE_xXAny underlying medical or psychiatric condition, which in the opinion of the investigator, will make the administration of study drug hazardous or obscure the interpretation of adverse events (AEs): e.g. a condition associated with frequent diarrhea or chronic skin conditions, recent surgery or colonic biopsy from which the patient has not recovered, or partial endocrine organ deficienciesXx_NEWLINE_xXAny serious underlying medical condition that, in the opinion of the enrolling physician, would impair the ability of the patient to receive protocol treatmentXx_NEWLINE_xXAny other condition that, according to the investigator, may forbid the administration of the idarubicin + cytarabine regimenXx_NEWLINE_xXAny other medical intervention or other condition which, in the opinion of the Principal Investigator, could compromise adherence to study requirements or confound the interpretation of study resultsXx_NEWLINE_xXOther serious, ongoing, non-malignant disease or infection that would in the opinion of the site investigator compromise other protocol objectivesXx_NEWLINE_xXhepatic, renal neurological or metabolic conditions - which in the opinion of the investigator would compromise the protocol objectives.Xx_NEWLINE_xXPatients with a significant psychiatric disease, who in the opinion of the principal investigator or his designee, would prevent adequate informed consent or render immunotherapy unsafe will be excludedXx_NEWLINE_xXAny concomitant condition that in the opinion of the investigator could compromise the objectives of this study and the patient's compliance.Xx_NEWLINE_xXAny medical condition which, in the opinion of the clinical investigator, would interfere with the evaluation of the patient; subjects with a clinically significant or unstable medical or surgical condition or any other condition that cannot be well-controlled by the allowed medications permitted in the study protocol that would preclude safe and complete study participation, as determined by medical history, physical examinations, electrocardiogram (ECG), laboratory tests, or chest-X-ray and according to the investigator’s judgmentXx_NEWLINE_xXMedical, psychological, or social condition that, in the opinion of the investigator, may increase the patient’s risk or limit the patient’s adherence with study requirementsXx_NEWLINE_xXInvestigator does not believe study participation, for any reason, is in the best interest of the patientXx_NEWLINE_xXIn the investigator’s judgment, any comorbid disease or condition that would place the patient at undue risk and preclude safe use of radioembolization or TAS-102Xx_NEWLINE_xXAny other serious illness or medical condition that would, in the opinion of the investigator, make this protocol unreasonably hazardous, including, but not limited to:\r\n* Any uncontrolled infection\r\n* Cardiac failure NYHA (New York Heart Association) III or IV\r\n* Crohn’s disease or ulcerative colitis\r\n* Bone marrow dysplasia\r\n* Known allergy to any of the compounds under investigation\r\n* Unmanageable fecal incontinenceXx_NEWLINE_xXAny medical conditions, which, in the opinion of the investigators, would jeopardize either the patient or the integrity of the data obtained are not eligibleXx_NEWLINE_xXMedical, psychological, or social condition that, in the opinion of the investigator, may increase the patient’s risk or limit the patient’s adherence with study requirementsXx_NEWLINE_xXAny condition or organ toxicity that is deemed by the principal investigator (PI) or the attending physician to place the patient at unacceptable risk for treatment on the protocolXx_NEWLINE_xXNo uncontrolled, inter-current or recent illness that in the investigator’s opinion precludes participation in the study, including those undergoing therapy for a separate invasive malignancyXx_NEWLINE_xXAny other disease, either metabolic or psychological, that as per Investigator assessment may affect the patient's compliance or place the patient at an increased risk of potential treatment complications.Xx_NEWLINE_xXAny condition or reason that in the opinion of the investigator, interferes with the ability of the patient to participate in the trialXx_NEWLINE_xXPatients with medical conditions, which, in the opinion of the investigators, would jeopardize either the patient or the integrity of the data obtained will not be eligibleXx_NEWLINE_xXAny condition which, in the opinion of the investigator, would preclude participation in this trialXx_NEWLINE_xXMajor medical conditions that might affect study participation (uncontrolled pulmonary, renal, or hepatic dysfunction, uncontrolled infection) are not eligible; other significant comorbid condition which the investigator feels might compromise effective and safe participation in the studyXx_NEWLINE_xXAny other current or previous malignancy within the past three years that, in the opinion of the Principal Investigator, will interfere with study-specific objectives.Xx_NEWLINE_xXAny medical condition, which in the investigator's opinion, could compromise the patient's safetyXx_NEWLINE_xXAny other conditions or circumstances that would, in the opinion of the investigator, make the patient unsuitable for participation in the studyXx_NEWLINE_xXAny clinically significant concomitant disease or condition that could interfere with, or for which the treatment might interfere with, the conduct of the study or the absorption of oral medications or that would, in the opinion of the principal investigator, pose an unacceptable risk to the patient in this studyXx_NEWLINE_xXAny co-morbidity or condition of sufficient severity to limit full compliance with the protocol per assessment by the principal investigatorXx_NEWLINE_xXA serious uncontrolled medical disorder or active infection that in the investigator’s opinion would impair the patient’s ability to receive study treatmentXx_NEWLINE_xXPatients with severe and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocolXx_NEWLINE_xXAny condition which, in the investigator's opinion, makes the subject unsuitable for trial participationXx_NEWLINE_xXCurrent evidence of any of the following:\r\n* Uncontrolled hypertension\r\n* Gastrointestinal disorder affecting absorption\r\n* Active infection (e.g., human immunodeficiency virus [HIV] or viral hepatitis)\r\n* Any chronic medical condition requiring a dose of corticosteroid higher than 10 mg prednisone/prednisolone once daily\r\n* Any condition that, in the opinion of the site investigator, would preclude participation in this study\r\n* Moderate or severe hepatic impairment (Child Pugh class B or C)Xx_NEWLINE_xXHave any medical or social condition that, in the opinion of the Investigator, might place a subject at increased risk, affect compliance, or confound safety or other clinical trial data interpretationXx_NEWLINE_xXAny severe concurrent disease, infection or comorbid condition that renders the patient inappropriate for enrollment in the opinion of the investigator or interferes with the patient's ability to participate in the study requirementsXx_NEWLINE_xXOther significant medical conditions must be well-controlled and stable in the opinion of the investigator for at least 30 days prior to RandomizationXx_NEWLINE_xXAny medical or other condition that, in the opinion of the investigator, would preclude the subject's participation in a clinical studyXx_NEWLINE_xXSubjects may not receive ABBV-399 in combination with erlotinib or nivolumab if they have any medical condition which in the opinion of the Investigator places the subject at an unacceptably high risk for toxicities from the combination.Xx_NEWLINE_xXAny electrocardiogram (ECG) abnormality that in the opinion of the principal investigator would preclude safe participation in the studyXx_NEWLINE_xXAny condition or medical problem in addition to the underlying malignancy and organ dysfunction which the investigator feels would pose unacceptable riskXx_NEWLINE_xXHas any other medical or personal condition that, in the opinion of the site investigator, may potentially compromise the safety or compliance of the patient, or may preclude the patient’s successful completion of the clinical trialXx_NEWLINE_xXClinically significant medical disease or condition that, in the investigator’s opinion, may interfere with protocol adherence or the patient’s ability to give informed consentXx_NEWLINE_xXAny mental or physical condition, in the opinion of the Principal Investigator (PI) (or PI designee), which could interfere with the ability of the subject (or the only parent or legal guardian available to care for the subject) to understand or adhere to the requirements of the studyXx_NEWLINE_xXPresence of a significant psychiatric disease, which in the opinion of the principal investigator or his designee, would prevent adequate informed consentXx_NEWLINE_xXPatient, in the opinion of the investigator, is likely to be poorly compliantXx_NEWLINE_xXAny other medical intervention or condition, which, in the opinion of the PI or treating physician, could compromise patient safety or adherence with the study requirements over the primary 3-6 month treatment periodXx_NEWLINE_xXAdequate pulmonary and cardiac function: no clinical evidence of cardiopulmonary disease, which, in the opinion of the investigator, precludes enrollmentXx_NEWLINE_xXAny other issue which, in the opinion of the treating physician, would make the patient ineligible for the studyXx_NEWLINE_xXEvidence of severe or uncontrolled systemic disease or any concurrent condition which in the Investigator’s opinion makes it undesirable for the patient to participate in the trial or which would jeopardize compliance with the protocolXx_NEWLINE_xXAny concomitant medications that are known to be associated with Torsades de Pointes, that in the investigator’s opinion cannot be discontinued, are allowed however, must be monitored closelyXx_NEWLINE_xXActive, uncontrolled infection, any other concurrent disease, or medical condition that is deemed to interfere with the conduct of the study as judged by the investigatorXx_NEWLINE_xXAny life-threatening illness, medical condition, or organ system dysfunction which, in the investigator’s opinion, could compromise the subject’s safety, interfere with the absorption or metabolism of enzalutamide, or put the study outcomes at undue riskXx_NEWLINE_xXAny condition or abnormality which may, in the opinion of the investigator, compromise the safety of patientsXx_NEWLINE_xXAny medical condition which in the opinion of the study investigator places the subject at an unacceptably high risk for toxicitiesXx_NEWLINE_xXMedical, psychological, or social condition that, in the opinion of the investigator, may increase the patient’s risk or limit the patient’s adherence with study requirementsXx_NEWLINE_xXA co-morbid condition that, in the Investigator's opinion, renders the subject at high risk for treatment complications.Xx_NEWLINE_xXAny other medical intervention or other condition which, in the opinion of the Principal Investigator, could compromise adherence with study requirements or confound the interpretation of study resultsXx_NEWLINE_xXThe recipient has a medical problem or neurologic/psychiatric dysfunction which would impair his/her ability to be compliant with the medical regimen and to tolerate transplantation or would prolong hematologic recovery which in the opinion of the principal investigator would place the recipient at unacceptable riskXx_NEWLINE_xXAny medical or other condition that in the opinion of the investigator(s) would preclude the participant's participation in a clinical study.Xx_NEWLINE_xXSerious uncontrolled medical disorder or active infection that in the investigator's opinion would impair the patient's ability to receive study treatment.Xx_NEWLINE_xXUnstable coronary artery disease or other medical condition (such as type 1 diabetes) that, in the Investigator's opinion, might increase the risk to the patientXx_NEWLINE_xXHistory or evidence on physical examination or screening laboratory tests of any systemic disease or any acute or chronic illness that, in the opinion of the investigator, may interfere with the evaluation of the safety or immunogenicity of the study drugXx_NEWLINE_xXIn the investigator’s opinion, the patient has the ability to communicate satisfactorily with the investigator, to participate fully in the study, and comply with all its requirementsXx_NEWLINE_xXAny other medical, psychological, or social condition that may interfere with study participation or compliance, or compromise patient safety in the opinion of the investigatorXx_NEWLINE_xXAny significant disease that, in the opinion of the investigator, may impair the patient’s tolerance of study treatmentXx_NEWLINE_xXAny medical or psychological condition or situation deemed by the principal investigator (PI) to put the patient at increased risk of complications or noncomplianceXx_NEWLINE_xXAny other medical condition for which the treating physicians deem might lead to unacceptable toxicity or morbidity for that treatment plan for the patient e.g., allergy to a component of therapy or a medical condition that might be aggravated by the therapy and increases potential risk of toxicity in the opinion of the treating physiciansXx_NEWLINE_xXHistory of psychiatric disorder or any other condition which may compromise compliance with transplant protocol or expose patient to unnecessary risk as determined by principal investigator or lead associate investigatorXx_NEWLINE_xXHas any condition that, in the opinion of the investigator, might jeopardize the safety of the patient or interfere with protocol complianceXx_NEWLINE_xXIndividuals in whom the ability to observe possible local reactions at the eligible injection sites (deltoid region) is, in the opinion of the investigator, unacceptably obscured due to a physical condition or permanent body artXx_NEWLINE_xXAny condition which, in the investigator’s opinion, makes the subject unsuitable for trial participationXx_NEWLINE_xXAny concurrent or past medical condition that, in the opinion of the investigator, would exclude the subject from participationXx_NEWLINE_xXRequirement for treatment in the opinion of the investigator.Xx_NEWLINE_xXSignificant active renal, neurologic, psychiatric, hepatic or endocrinologic disease that in the investigator's opinion would adversely impact on his/her participating in the study.Xx_NEWLINE_xXNo condition or abnormality which may, in the opinion of the investigator, compromise the safety of the patientXx_NEWLINE_xXAny condition or abnormality which may, in the opinion of the investigator, compromise the safety of patientsXx_NEWLINE_xXLife expectancy is not severely limited by concomitant illness in the opinion of the treating investigatorXx_NEWLINE_xXAny physical or psychological condition that, in the opinion of the investigator, would pose unacceptable risk to the patientXx_NEWLINE_xXPatient has any condition or laboratory abnormality which, in the opinion of the investigator, would pose additional risk in administering the study drug to the patientXx_NEWLINE_xXSerious concomitant systemic disorders (including active infections) that would compromise the safety of the patient or compromise the patient’s ability to complete the study, at the discretion of the investigatorXx_NEWLINE_xXHas a concomitant medical condition that would in the opinion of the Investigator increase the risk of toxicity.Xx_NEWLINE_xXAny illness or condition that in the opinion of the investigator may affect safety of treatment or evaluation of any the study’s endpointsXx_NEWLINE_xXPatient does NOT have any concurrent medical condition that, in the opinion of the protocol PI or designee, would prevent the patient from undergoing protocol-based therapy; patients with a primary immunodeficiency/bone marrow failure syndrome are excluded from this trialXx_NEWLINE_xXConcurrent severe or uncontrolled medical disease (i.e., active systemic infection, diabetes, coronary artery disease, congestive heart failure) that, in the opinion of the investigator, would compromise the safety of the patient or compromise the ability of the patient to complete the studyXx_NEWLINE_xXSignificant cardiac, pulmonary, metabolic, renal, hepatic, gastrointestinal or autoimmune conditions that in the opinion of the investigator places the subject at an unacceptable risk as participant in this trialXx_NEWLINE_xXLaboratory evaluations (kidney and liver) outside normal limits and of potential clinical significance in the opinion of the investigatorXx_NEWLINE_xXSubject considered by the investigator as unsuitable candidate for receipt of an investigational drug, or unstable to be followed up throughout the entire duration of the studyXx_NEWLINE_xXUnderlying medical conditions that, in the investigator’s opinion, will make the administration of study drug hazardous or obscure the interpretation of toxicity or adverse eventsXx_NEWLINE_xXSignificant acute or chronic medical, neurologic, or psychiatric illness in the subject that, in the judgment of the principal investigator, could compromise subject safety, limit the subject’s ability to complete the study, and/or compromise the objectives of the studyXx_NEWLINE_xXAny underlying medical or psychiatric condition, which in the opinion of the investigator, will make the administration of study drug hazardous or obscure the interpretation of adverse events: (AE's) e.g. a condition associated with frequent diarrhea or chronic skin conditions, recent surgery or colonic biopsy from which the patient has not recovered, or partial endocrine organ deficienciesXx_NEWLINE_xXThe investigator should assess the patient to determine if she has any psychiatric or addictive disorder or other condition that, in the opinion of the investigator, would preclude her from meeting the study requirements.Xx_NEWLINE_xXAny condition or abnormality which may, in the opinion of the investigator, compromise the safety of patientsXx_NEWLINE_xXAny condition or abnormality which may, in the opinion of the investigator, compromise the safety of the patientXx_NEWLINE_xXHistory of alcoholism, drug addiction, or any psychiatric or psychological condition which, in the opinion of the investigator, would impair study complianceXx_NEWLINE_xXAny underlying medical condition, which in the opinion of the investigator, will make the administration of study drug hazardous or obscure the interpretation of adverse events, such as a condition associated with frequent diarrheaXx_NEWLINE_xXAny life-threatening illness, medical condition, or organ system dysfunction which, in the investigator’s opinion, could compromise the subject’s safety, interfere with the absorption or metabolism of ibrutinib capsules, or put the study outcomes at undue riskXx_NEWLINE_xXIndividuals in whom the ability to observe possible local reactions at the eligible injection sites (deltoid region) is, in the opinion of the investigator, unacceptably obscured due to a physical condition or permanent body artXx_NEWLINE_xXAny condition that is unstable and could jeopardize the subject's participation in the study.Xx_NEWLINE_xXPsychiatric of addictive disorders or other condition that in the opinion of the investigator would preclude the patient from meeting the study requirementsXx_NEWLINE_xXAny concomitant condition that in the opinion of the Investigator could compromise the objectives of this study and the patient's compliance.Xx_NEWLINE_xXAny condition or abnormality which may, in the opinion of the investigator, compromise the safety of patientsXx_NEWLINE_xXPatients with a medical condition or social situation that at the discretion of the Principal Investigator (PI) would preclude them from completion of the trialXx_NEWLINE_xXPatients unable to receive cisplatin in the opinion of the medical oncologistXx_NEWLINE_xXComorbid conditions that, in the opinion of the investigator, would complicate safety or compliance such as known human immunodeficiency virus (HIV) or current substance abuseXx_NEWLINE_xXPatients, who in the opinion of the investigator and another independent party, may not be able to adhere to the safety monitoring requirements of the studyXx_NEWLINE_xXAny other pathology or condition where the principle investigator may deem to negatively impact treatment safetyXx_NEWLINE_xXAny other medical condition(s) that, at the discretion of the principal investigator (PI), would make the patient inappropriate for this studyXx_NEWLINE_xXPatients with medical conditions which, in the opinion of the investigators, would pose undue risk to the patientXx_NEWLINE_xXNo other medical condition or reason that, in the opinion of the investigator, would preclude study participationXx_NEWLINE_xXPatients must not have any significant medical illnesses that in the investigator’s opinion cannot be adequately controlled with appropriate therapy or would compromise the patient’s ability to tolerate this therapyXx_NEWLINE_xXConcomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the patient in this studyXx_NEWLINE_xXAny other clinically significant medical disease or condition that, in the investigator’s opinion, may interfere with protocol adherence or a subject’s ability to give informed consentXx_NEWLINE_xXAny underlying medical or psychiatric condition, which in the opinion of the investigator will make the administration of ipilimumab hazardous or obscure the interpretation of adverse events (AEs), such as a condition associated with frequent diarrheaXx_NEWLINE_xXPatients who exhibit any significant concurrent, uncontrolled medical or psychiatric condition that in the opinion of the investigator would compromise the patient's ability to tolerate this treatment are NOT eligible for participationXx_NEWLINE_xXPresence of a significant psychiatric disease, which in the opinion of the principal investigator or his designee, would prevent adequate informed consent (Turnstile I)Xx_NEWLINE_xXPresence of a significant psychiatric disease, which in the opinion of the principal investigator or his designee, would prevent adequate informed consent or render immunotherapy unsafe or contraindicated (Turnstile II)Xx_NEWLINE_xXConcomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the patient in this studyXx_NEWLINE_xXMust not have any other clinically significant medical disease or condition that, in the Investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent.Xx_NEWLINE_xXAny condition or abnormality which may, in the opinion of the investigator, compromise his or her safetyXx_NEWLINE_xXRelapsed/refractory MCL: The patient has a prior or concurrent malignancy that in the opinion of the investigator, presents a greater risk to the patient’s health and survival, than of the MCL, within the subsequent 6 months at the time of consentXx_NEWLINE_xXNewly diagnosed MCL: The patient has a prior or concurrent malignancy that in the opinion of the investigator, presents a greater risk to the patient’s health and survival, than of the MCL, within the subsequent 6 months at the time of consentXx_NEWLINE_xXUncontrolled significant intercurrent illness that would preclude the patient from study participation per investigator assessmentXx_NEWLINE_xXAny condition which in the Investigator’s opinion deems the subject an unsuitable candidate to receive study drugXx_NEWLINE_xXPsychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirementsXx_NEWLINE_xXSignificant psychiatric disorder and any other reason in the Investigator’s opinion that would jeopardize protocol compliance or compromise the patient’s ability to give informed consentXx_NEWLINE_xXA serious uncontrolled medical disorder that is in the opinion of the Investigator would impair the ability of the subject to receive protocol therapyXx_NEWLINE_xXOther condition(s) that in the opinion of the investigator might compromise the objectives of the studyXx_NEWLINE_xXPatient has demonstrated compliance, as assessed by the investigator, with the parent study requirementsXx_NEWLINE_xXAny condition or abnormality which may, in the opinion of the investigator, compromise the safety of patientsXx_NEWLINE_xXAny condition or abnormality which may, in the opinion of the investigator, compromise the safety of the patientXx_NEWLINE_xXPatients with other medical conditions or concomitant medications that in the opinion of the principal investigator may interfere with the therapeutic treatment.Xx_NEWLINE_xXAny condition which in the investigator’s opinion deems the patient an unsuitable candidate to receive study drugXx_NEWLINE_xXPresence of a significant psychiatric disease, which in the opinion of the principal investigator or his designee, would prevent adequate informed consent or render immunotherapy unsafe or contraindicated (Turnstile II)Xx_NEWLINE_xXAny underlying medical or psychiatric condition, which in the opinion of the Investigator, will make the administration of study drug hazardous or obscure the interpretation of Adverse Events (AEs): e.g. a condition associated with frequent diarrhea or chronic skin conditions, recent surgery or colonic biopsy from which the patient has not recovered, or partial endocrine organ deficiencies.Xx_NEWLINE_xXPatients with substance abuse or other medical or psychiatric conditions that, in the opinion of the investigator, would confound study interpretation or affect the patient's ability to tolerate or complete the study.Xx_NEWLINE_xXConcomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this studyXx_NEWLINE_xXSerious nonmalignant disease which, in the opinion of the investigator would compromise protocol objectivesXx_NEWLINE_xXSignificant psychiatric disorder and any other reason in the Investigator’s opinion that would jeopardize protocol compliance or compromise the patient’s ability to give informed consentXx_NEWLINE_xXMedical or psychological conditions that would make the patient unsuitable candidate for cell therapy at the discretion of the principal investigator (PI)Xx_NEWLINE_xXAny medical or psychiatric illness which in the opinion of the principal investigator would compromise the patient’s ability to tolerate this treatmentXx_NEWLINE_xXPatients with any significant medical illnesses that in the investigator’s opinion cannot be adequately controlled with appropriate therapy or would compromise the patient’s ability to tolerate this therapyXx_NEWLINE_xXAny underlying medical or psychiatric condition, which in the opinion of the investigator will make the administration of ipilimumab hazardous or obscure the interpretation of adverse events (AEs), such as a condition associated with frequent diarrheaXx_NEWLINE_xXPatients with other significant disease or disorders that, in the investigator's opinion, would exclude the patient from the studyXx_NEWLINE_xXPatients has any significant medical illnesses that in the investigator’s opinion cannot be adequately controlled with appropriate therapy or would compromise the patient’s ability to tolerate this therapyXx_NEWLINE_xXAny condition which, in the opinion of the investigator, would preclude participation in this trialXx_NEWLINE_xXKnown significant mental illness or other condition such as active alcohol or other substance abuse or addiction that, in the opinion of the investigator, predisposes the subject to high risk of noncompliance with the protocol.Xx_NEWLINE_xXHave any condition or illness that, in the opinion of the investigator, might compromise patient safety or interfere with the evaluation of the safety of the drug.Xx_NEWLINE_xXOngoing severe inflammatory skin condition (as determined by the Investigator) requiring medical treatmentXx_NEWLINE_xXAny life-threatening illness, medical condition, or organ system dysfunction that, in the investigator’s opinion, could compromise the subject’s safety or put the study outcomes at undue riskXx_NEWLINE_xXMedical illness unrelated to Hodgkin lymphoma, which, in the opinion of the attending physician and/or Memorial Sloan Kettering (MSK) principal investigator, makes participation in this study inappropriateXx_NEWLINE_xXPatients with any significant medical illnesses that, in the investigator’s opinion, cannot be adequately controlled with appropriate therapy or would compromise the patient’s ability to tolerate this therapyXx_NEWLINE_xXPatients with any infectious process that, in the opinion of the investigator, could worsen or its outcome be affected as a result of the investigational therapyXx_NEWLINE_xXAny co-morbidity or condition of sufficient severity to limit full compliance with the protocol per assessment by the investigatorXx_NEWLINE_xXIn the judgment of the investigator, participation in the protocol offers acceptable risk/benefit ratio when considering current NF2 disease status, medical condition, and the potential benefits of and risks of surgery or irradiationXx_NEWLINE_xXNo other medical and or psychosocial problems, which in the opinion of the primary physician or principal investigator would place the patient at unacceptable risk from this regimenXx_NEWLINE_xXInfection or any other severe systemic disease or medical or surgical condition deemed significant by the principal investigatorXx_NEWLINE_xXAny co morbidity or condition which, in the opinion of the investigator, may interfere with the assessments and procedures of this protocolXx_NEWLINE_xXPatient who is otherwise considered unsuitable for transplant at the discretion of the principal investigatorXx_NEWLINE_xXPresence of a significant psychiatric disease, which in the opinion of the principal investigator or his designee, would prevent adequate informed consent or render immunotherapy unsafe or contraindicated (Turnstile II - Chemotherapy/Cell Infusion Exclusion Criteria)Xx_NEWLINE_xXPatients who in the opinion of the principal investigator are poor psychiatric or medical risks are not eligibleXx_NEWLINE_xXAny evidence of severe or uncontrolled systemic or psychiatric diseases, including uncontrolled hypertension and active bleeding diatheses, which in the Investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardize compliance with the protocolXx_NEWLINE_xXHas any serious concomitant illness that in the opinion of the investigator(s) could affect the participant's safety or interfere with the study assessmentsXx_NEWLINE_xXHas any concurrent medical condition that, in the opinion of the Investigator, would complicate or compromise compliance with the study or the well-being of the subject. Additional Exclusion Criteria for Cohort 1:Xx_NEWLINE_xXAny other condition that might place the patient at undue risk.Xx_NEWLINE_xXAny condition that would jeopardize the safety of the subject or compliance with the protocolXx_NEWLINE_xXAny condition which in the investigator’s opinion deems the participant ineligibleXx_NEWLINE_xXIntensive care unit (ICU) care, life expectancy of less than 28 days, ongoing or unresolved hepatic sinusoidal obstruction syndrome, unstable hemodynamics, or evidence of current or previous clinically significant disease, medical condition or finding (including vital signs and ECG) that in the opinion of the Investigator, would compromise the safety of the patient or the quality of the dataXx_NEWLINE_xXClinically significant abnormalities or co-morbidities, other than HCV infection that in opinion of the investigator makes subject unsuitable for this study or drug regimenXx_NEWLINE_xXRecent history of drug or alcohol abuse that could, in the opinion of the investigator, affect adherence to the study protocolXx_NEWLINE_xXAny other diseases that, in the opinion of the investigator and Sponsor's medical monitor would pose a risk to the subject safetyXx_NEWLINE_xXAll other significant diseases, which in the opinion of the investigator, may impair the subject’s tolerance of trial treatmentXx_NEWLINE_xXAny other clinical condition, psychiatric condition or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable or to comply with follow-up visitsXx_NEWLINE_xXNo other illness that in the opinion of the investigator would exclude the subject from participating in the studyXx_NEWLINE_xXAny other condition or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with the protocolXx_NEWLINE_xXany condition that as judged by the Investigator would place the subject at increased risk of harm if he/she participated in the study.Xx_NEWLINE_xXPeripheral oedema at Screening that in the opinion of the Prinicpal Investigator (PI) or designee might prevent adequate absorption of subcutaneously administered CPHPCXx_NEWLINE_xXPresence of any co-morbid or an uncontrolled medical condition (e.g. diabetes mellitus), which in the opinion of the investigator would increase the potential risk to the subject. Investigator should liaise with the Medical Monitor where there is uncertainty as to the eligibility of a patientXx_NEWLINE_xXHistory of sensitivity to any of the study medications, or metabolite thereof or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation CARDIAC MAGNETIC RESONANCE (CMR) SCANNINGXx_NEWLINE_xXActive infection or any serious underlying medical condition, which would impair the ability of the patient to receive protocol treatment.Xx_NEWLINE_xXPresence of a comorbid disease or medical condition that would impair the ability of the patient to receive or comply with the study protocolXx_NEWLINE_xXAny condition or reason that, in the opinion of the investigator, interferes with the ability of the patient to participate in the trial, which places the patient at undue risk, or complicates the interpretation of safety dataXx_NEWLINE_xXAny other clinical condition that, in the Investigator's judgement, would potentially compromise study compliance or the ability to evaluate safety/efficacyXx_NEWLINE_xXPatient has demonstrated compliance, as assessed by the investigator, with the parent study protocol requirements.Xx_NEWLINE_xXSubject has any clinically significant medical or psychiatric disease or condition that, in the Investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent.Xx_NEWLINE_xXPatients who have any other life threatening illness or organ system dysfunction, which in the opinion of the investigator, would either compromise patient safety or interfere with the evaluation of the safety of the study drugXx_NEWLINE_xXAny condition that is unstable and could jeopardize the patient's participation in the study.Xx_NEWLINE_xXHas significant renal or hepatic disease, uncontrolled or severe cardiovascular or pulmonary diseases, or other uncontrolled medical condition that, based on the Investigator's assessment, would compromise the patient's ability to tolerate study treatment or the assessment of treatment response.Xx_NEWLINE_xXSerious concomitant systemic disorders (for example, active infection or abnormal electrocardiogram (ECG) indicative of cardiac disease) that, in the opinion of the investigator, would compromise the safety of the patient and his/her ability to complete the studyXx_NEWLINE_xXNo underlying medical or psychiatric condition, which in the opinion of the investigator will make the administration of ipilimumab hazardous or obscure the interpretation of adverse events (AEs), such as a condition associated with frequent diarrheaXx_NEWLINE_xXPatients with serious concurrent illness or psychological, familial, sociological, geographical, or other concomitant conditions that, in the opinion of the investigator, would not permit adequate follow-up and compliance with the study protocol.Xx_NEWLINE_xXPatients with significant concurrent, uncontrolled medical condition including, but not limited to, cardiovascular, renal, hepatic, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease which in the opinion of the investigator may represent a risk for the patient, are NOT eligibleXx_NEWLINE_xXOther uncontrolled serious chronic disease or conditions that in the investigator's opinion could render compliance or follow-up in the protocol problematicXx_NEWLINE_xXAny condition that is unstable or which could jeopardize the safety of the patient (please refer to the Investigator Brochure and product labeling safety sections).Xx_NEWLINE_xXAny condition which could jeopardise the safety of the patient and his/her compliance in the study Excluded therapies and medications, previous and concomitant:Xx_NEWLINE_xXAny significant medical illnesses or toxicities that in the investigator’s opinion cannot be adequately controlled with appropriate therapy or would compromise the subjects’ ability to tolerate this therapy. Subjects must not have any disease that will obscure toxicity or dangerously alter drug metabolism, e.g. congestive heart failure, moderate to severe liver and renal disease, other cancers.Xx_NEWLINE_xXHave at least stable disease, as determined by the investigator.Xx_NEWLINE_xXHas demonstrated compliance, as assessed by the investigator, with the parent study protocol requirements.Xx_NEWLINE_xXHave completed a patisiran study (i.e., completed the last efficacy visit in the parent study) and, in the opinion of the investigator, tolerated study drugXx_NEWLINE_xXAny new or uncontrolled condition that could make the patient unsuitable for participationXx_NEWLINE_xXPatients should be in such a health condition in the opinion of the attending physician that with the administration of mifepristone benefits may outweigh risksXx_NEWLINE_xXOther condition or prior therapy that, in the opinion of the Investigator, compromises the subject's welfare or may confound study results;Xx_NEWLINE_xXA life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of PCI-32765 PO, or put the study outcomes at undue riskXx_NEWLINE_xXPresence of active renal condition (infection, requirement for dialysis or any other condition that could affect subject's safety). Subjects with isolated proteinuria resulting from MM are eligible.Xx_NEWLINE_xX224 History or evidence of any other clinically-relevant concurrent disorder, condition or disease (eg, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrythmia requiring therapy at time of screening) with the exception of those outlined above that, in the opinion of the investigator or Amgen medical monitor, if consulted, would not pose a risk to subject safety or interfere with the study evaluation, procedures or completion.Xx_NEWLINE_xXParticipant has any medical condition which in the opinion of the investigator places the participant at an unacceptably high risk for toxicities.Xx_NEWLINE_xXSerious active infection at the time of study entry, or another serious underlying medical condition that would impair the ability of the patient to receive study treatmentXx_NEWLINE_xXSubjects who, in the opinion of the Investigator, have a high probability of death within 3 months of randomization due to a disease process other than the CRBSI/CLABSIXx_NEWLINE_xXPsychological, familial, sociological or geographical or other condition which in the opinion of the investigator would not permit study follow-up or other compliance with the study protocol.Xx_NEWLINE_xXHas any history or medical condition, metastatic condition, drug/medication use or other condition that might, per protocol or in the opinion of the investigator, compromise:Xx_NEWLINE_xXHistory or presence of an ECG that, in the investigator's opinion, is clinically meaningful as per protocol-defined criteria.Xx_NEWLINE_xXIn the judgment of the investigator, participation in the protocol offers an acceptable benefit-to-risk ratio when considering current disease status, medical condition, and the potential benefits and risks of alternative treatments for the subject’s ALLXx_NEWLINE_xXA life threatening illness, medical condition or organ system dysfunction which, in the investigators’ opinion, could compromise the subject’s safety or interfere with the absorption or metabolism of pembrolizumabXx_NEWLINE_xXHistory of clinically significant medical condition that, in the opinion of the investigator, would adversely affect participation in this study.Xx_NEWLINE_xXAny condition(s), medical or otherwise, which, in the opinion of the investigators, would jeopardize either the patient or the integrity of the data obtainedXx_NEWLINE_xXIn the investigator's judgment, any other condition that jeopardizes the patient's participation in the treatment phaseXx_NEWLINE_xXAny condition that may, in the opinion of the investigator, compromise the safety of the patientXx_NEWLINE_xXAny condition medical or psychosocial that in the opinion of the investigator would hinder complianceXx_NEWLINE_xXAny other condition that would, in the opinion of the investigator's judgement, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study proceduresXx_NEWLINE_xXAny other medical intervention or other condition which, in the opinion of the Principal Investigator, could compromise adherence to study requirements or confound the interpretation of study resultsXx_NEWLINE_xXCurrent life-threatening illness, medical condition, or organ-system dysfunction that could compromise patient safety or put the study at riskXx_NEWLINE_xXConcurrent medical condition that precludes safe participation in this studyXx_NEWLINE_xXPresence of any psychological, familial, sociological or geographical condition that in the opinion of the investigator would hamper compliance with the study protocol and follow-up schedule, including alcohol dependence or drug abuseXx_NEWLINE_xXSerious active infection at the time of study entry, or another serious underlying medical condition that would impair the ability of the patient to receive study treatment.Xx_NEWLINE_xXAny medical condition that, in the opinion of the investigator, would exclude the patient from participating in this study and treatment plan.Xx_NEWLINE_xXHistory of previous malignancy that in the principal investigator (PI)’s opinion has a reasonable chance of recurrence during the study period or otherwise confounding this clinical trialXx_NEWLINE_xXAny other illness or condition that in the investigator’s opinion would adversely affect the safety of checkpoint inhibitor therapyXx_NEWLINE_xXAny other condition that, in the opinion of the Investigator, would impair the patient’s ability to comply with study proceduresXx_NEWLINE_xXAny condition that would make the patient, in the opinion of the investigator, unsuitable for the study (eg, would place a patient at risk or compromise the quality of the dataXx_NEWLINE_xXRENAL & BLADDER: Any condition that in the opinion of the investigator, would preclude participation in this studyXx_NEWLINE_xXAny serious medical condition that interferes with adherence to study procedures.Xx_NEWLINE_xXPatient has a foreign body which in the opinion of the treating investigator could be difficult to manage in case of infectionXx_NEWLINE_xXEstimated life expectancy < 28 days in the opinion of the enrolling investigatorXx_NEWLINE_xXAny condition or abnormality which may, in the opinion of the investigator, compromise the safety of patientsXx_NEWLINE_xXAny condition or abnormality which may, in the opinion of the investigator, compromise the safety of the patientXx_NEWLINE_xXAny underlying medical or psychiatric condition, which in the opinion of the investigator, will make the administration of study drug hazardous or obscure the interpretation of adverse events.Xx_NEWLINE_xXAny other illness or condition that the treating investigator feels would interfere with study compliance or would compromise the patient’s safety or study endpointsXx_NEWLINE_xXAny serious medical condition that, in the investigator opinion, places the patient at unacceptable risk and/or would prevent the subject from signing the informed consent form. Examples include but are not limited to, uncontrolled hypertension, uncontrolled diabetes mellitus, active/symptomatic coronary artery disease, active infection requiring treatment with intravenous (IV) antibiotics, antiviral or antifungal agents, active hemorrhage, or psychiatric illness in the investigator’s opinion places the patient at unacceptable risk and would prevent the subject from signing the informed consent form.Xx_NEWLINE_xXThe patient has a prior or concurrent malignancy that in the opinion of the investigator, presents a greater risk to the patient’s health and survival, than of the MCL, within the subsequent 6 months at the time of consent.Xx_NEWLINE_xXThe patient has a prior or concurrent malignancy that in the opinion of the investigator, presents a greater risk to the patient’s health and survival, than of the MCL with a life expectancy < 2 years.Xx_NEWLINE_xXTHE PATIENT IS INELIGIBLE TO PARTICIPATE IN PART 2 IF ANY OF THE FOLLOWING OCCUR: Part 1 data contradict clinical judgment. The investigator should discuss with the principal investigator (PI) and use the best discretion.Xx_NEWLINE_xXSubject has any concurrent medical condition or disease (e.g., active systemic infection) that is likely to interfere with study procedures or results, or that in the opinion of the investigator would constitute a hazard for participating in this studyXx_NEWLINE_xXAny underlying medical or psychiatric condition, which in the opinion of the investigator, will make the administration of study drug hazardous or obscure the interpretation of adverse events, such as a condition associated with frequent diarrheaXx_NEWLINE_xXIn the opinion of the investigator, the participant is an unsuitable candidate for this studyXx_NEWLINE_xXOther medical or psychiatric conditions that in the opinion of the investigator would preclude safe participation in the protocolXx_NEWLINE_xXAny condition which, in the investigator’s opinion, makes the subject unsuitable for trial participationXx_NEWLINE_xXPatients who have post-obstructive pneumonia or other serious infection at the time of registration or other serious underlying medical condition that would impair the ability of the patient to receive protocol treatmentXx_NEWLINE_xXHave any other medical or psychological condition deemed by the Investigator to be likely to interfere with the subject's ability to give informed consent or participate in the study.Xx_NEWLINE_xXCurrent or prior disease or treatment that could compromise protocol objectives in the opinion of the Investigator and/or the SponsorXx_NEWLINE_xXHistory of intratumoral or peritumoral hemorrhage if deemed significant by the treating investigator; if there are questions, the treating investigator should contact the study overall principal investigator (P.I.), Eudocia Quant Lee, medical doctor (MD), at 617-632-2166 or eqlee@partners.orgXx_NEWLINE_xXOther unspecified reasons that, in the opinion of the investigator, make the subject unsuitable for the studyXx_NEWLINE_xXKnown significant mental illness or other condition such as active alcohol or other substance abuse or addiction that, in the opinion of the investigator, predisposes the subject to high risk of noncompliance with the protocol.Xx_NEWLINE_xXAny condition that in the opinion of the investigator, would preclude participation in this studyXx_NEWLINE_xXPatients must not have other significant medical, surgical, or psychiatric conditions or require any medication or treatment that in the opinion of the investigator may interfere with compliance, make the administration of the study drugs hazardous or obscure the interpretation of adverse events (AEs), such as a condition associated with frequent diarrhea; patients must not have an active infection requiring current treatment with parenteral antibioticsXx_NEWLINE_xXEvidence of current drug or alcohol abuse or psychiatric impairment, which in the investigator’s opinion will prevent completion of protocol therapy or follow-upXx_NEWLINE_xXAny condition which in the investigator’s opinion deems the participant an unsuitable candidate to receive study drug. (i.e., any significant medical illness or abnormal laboratory finding that would increase the patient’s risk by participating in this study)Xx_NEWLINE_xXMedical, psychological, or social condition that, in the opinion of the investigator, may increase the patient’s risk or limit the patient’s adherence with study requirementsXx_NEWLINE_xXPatients for whom it is not in the best interest to participate in the study, in the opinion of the treating investigatorXx_NEWLINE_xXAny other therapy or serious medical condition, as specified in the protocol, or abnormality in clinical laboratory tests that, in the investigator's judgement, precludes the participant's safe participation in and completion of the studyXx_NEWLINE_xXSubjects with a life-threatening illness, medical condition or organ system dysfunction, or other reasons which, in the investigator’s opinion, could compromise the subject’s safety, interfere with or compromise the integrity of the study outcomes including incomplete recovery from the acute effects from any prior anti-neoplastic therapyXx_NEWLINE_xXARM A: Any condition, which in the opinion of the investigator would render the patient unsuitable to participate in the studyXx_NEWLINE_xXARM B: Any condition, which in the opinion of the investigator would render the patient unsuitable to participate in the studyXx_NEWLINE_xXPresence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the study participant or the quality of the study dataXx_NEWLINE_xXAny condition or medical problem in addition to the underlying malignancy and organ dysfunction that the investigator feels would pose unacceptable riskXx_NEWLINE_xXAny medical or psychological condition that in the opinion of the principal investigator would interfere with safe completion of the trialXx_NEWLINE_xXAny underlying medical condition which, in the opinion of the principal investigator, will make the administration of study drug hazardous or obscure the interpretation of adverse eventsXx_NEWLINE_xXAny other medical, psychological, or social condition that may interfere with study participation or compliance, or compromise patient safety in the opinion of the investigator or medical monitorXx_NEWLINE_xXA serious uncontrolled medical disorder that in the opinion of the investigator may be jeopardized by the treatment with protocol therapyXx_NEWLINE_xXPatient (Pt) may be excluded if, in the opinion of the principal investigator (PI) and investigator team, the pt is not capable of being compliantXx_NEWLINE_xXCurrent life-threatening illness, medical condition, or organ system dysfunction, which, in the investigator’s opinion, could compromise the patient’s safety, or put the study at riskXx_NEWLINE_xXPatients with malabsorption or any other condition that in the opinion of the principal investigator could cause difficulty in absorption of drugXx_NEWLINE_xXAny concurrent or past medical condition that, in the opinion of the Investigator, would exclude the subject from participation or any psychosocial conditions that would hinder study compliance or follow-up, at the discretion of the InvestigatorXx_NEWLINE_xXIn the opinion of the investigator, patient must be medically fit to undergo surgical procedureXx_NEWLINE_xXAny underlying medical condition, psychiatric condition or social situation that in the opinion of the investigator would compromise study administration as per protocol or compromise the assessment of adverse events (AEs)Xx_NEWLINE_xXAny active or chronic illness that, in the opinion of the investigators, would make the study unsafe or limit compliance with study proceduresXx_NEWLINE_xXSerious concomitant systemic disorders (including active infections) that would compromise the safety of the patient or compromise the patient’s ability to complete the study, at the discretion of the investigator; this includes sclerodermaXx_NEWLINE_xXAny underlying medical condition, psychiatric condition or social situation that in the opinion of the investigator would compromise study administration as per protocol or compromise the assessment of adverse events (AEs)Xx_NEWLINE_xXAny severe and/or uncontrolled medical conditions or other conditions that, in the treating physician's opinion, could adversely impact their ability to participate in the studyXx_NEWLINE_xXParticipants in whom there is a medical contraindication or potential problem in complying with the requirements of the protocol, in the opinion of the investigatorXx_NEWLINE_xXAny other clinically significant medical disease or condition that, in the Investigator’s opinion, may interfere with protocol adherence or a subject’s ability to give informed consentXx_NEWLINE_xXAny physical or mental condition that, in the opinion of the PI, would cause the risk/benefit ratio of participation to be unacceptableXx_NEWLINE_xXAny life-threatening illness, medical condition, or organ system dysfunction that, in the investigator’s opinion, could compromise the patient’s safety, or put the study at undue risk; patients with suspicious radiologic evidence of aspergillosis infection (i.e., chest computed tomography [CT] and/or brain magnetic resonance imaging [MRI]) will not be eligible unless confirmatory laboratory testing of beta-D glucan and aspergillus antigen are negativeXx_NEWLINE_xXAny other reason the investigator considers the patient should not participate in the\n             studyXx_NEWLINE_xXAny underlying medical or psychiatric condition, which in the opinion of the investigator will make the administration of CYT107 hazardous or obscure the interpretation of adverse events (AEs), such as a condition associated with frequent diarrheaXx_NEWLINE_xXPatients must not have other significant medical, surgical, or psychiatric conditions or require any medication or treatment that in the opinion of the investigator may interfere with compliance, make the administration of ipilimumab or HDI hazardous or obscure the interpretation of adverse events (AEs), such as a condition associated with frequent diarrhea; patients with a baseline of frequent diarrhea (e.g. irritable bowel syndrome) are not eligibleXx_NEWLINE_xXClinically significant medical disease or condition that, in the investigator's opinion, may interfere with protocol adherence or the patient's ability to give informed consentXx_NEWLINE_xXAny condition which, in the investigator’s opinion, makes the subject unsuitable for trial participationXx_NEWLINE_xXSubjects with any clinical condition that is considered unstable or might jeopardize the safety of the subject and/or influence the subject’s compliance in the studyXx_NEWLINE_xXNo presence of uncontrolled systemic disease or tumor related complication which, in opinion of the investigator, might restrict life expectancy to less than 3 monthsXx_NEWLINE_xXAny medical condition which, in the investigator's opinion, could compromise the patient's safetyXx_NEWLINE_xXPatients with significant medical illness that in the investigator’s opinion cannot be adequately controlled with appropriate therapy or would compromise the patient’s ability to tolerate this therapyXx_NEWLINE_xXAny condition or medical problem in addition to the underlying malignancy and organ dysfunction which the investigator feels would pose unacceptable riskXx_NEWLINE_xXAny medical condition that would compromise the subject’s ability to safely participate in the studyXx_NEWLINE_xXOther condition(s) that in the opinion of the investigator might compromise the objectives of the study or increase patient riskXx_NEWLINE_xXPatients are excluded for any underlying medical or psychiatric condition, which in the opinion of the investigator, will make treatment hazardous or obscure the interpretation of adverse events, such as a condition associated with frequent rashes or diarrheaXx_NEWLINE_xXAny other clinically significant medical or psychiatric disease or condition that, in the investigator’s opinion, may interfere with protocol adherence or a subject’s ability to give informed consentXx_NEWLINE_xXActive uncontrolled infection or major concurrent illness which in the opinion of the investigator would render the patient unsafe to proceed with the studyXx_NEWLINE_xXNo gastro-intestinal condition, that in the opinion of the treating physician or the principal investigator significantly limits oral absorptionXx_NEWLINE_xXAny underlying medical or psychiatric condition, which in the opinion of the investigator, will make the administration of INCB024360 hazardous or obscure the interpretation of adverse eventsXx_NEWLINE_xXSubjects with any concurrent condition that, in the investigator’s opinion, would jeopardize the safety of the subject or compliance with the protocolXx_NEWLINE_xXMedical conditions which, in the opinion of the investigators, would jeopardize the patient or the integrity of the data obtainedXx_NEWLINE_xXPsychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirementsXx_NEWLINE_xXAny condition which in the investigator’s opinion makes the subject unsuitable for study participationXx_NEWLINE_xXAny serious active disease or co-morbid condition, which in the opinion of the principal investigator, will interfere with the safety or compliance of the trialXx_NEWLINE_xXPrevious medical history or evidence of an intercurrent illness that may, in the opinion of the investigator, compromise the safety of the patient in the studyXx_NEWLINE_xXAny significant disease that, in the opinion of the investigator, may impair the patient's tolerance of study treatmentXx_NEWLINE_xXAny uncontrolled concurrent illness that would, in the opinion of the investigator, limit compliance with study requirementsXx_NEWLINE_xXAny medical intervention or other condition which, in the opinion of the principal investigator could compromise adherence with study requirements or otherwise compromise the study's objectivesXx_NEWLINE_xXAny condition which the investigator's opinion deems the patient ineligibleXx_NEWLINE_xXAny condition or abnormality which may, in the opinion of the investigator, compromise the safety of patientsXx_NEWLINE_xXAny medical condition which in the opinion of the investigator puts the patient at risk of potentially serious complications while on this therapyXx_NEWLINE_xXPatients must not have other significant medical, surgical, or psychiatric conditions or require any medication or treatment that in the opinion of the investigator may interfere with compliance, make the administration of ipilimumab or HDI hazardous or obscure the interpretation of adverse events (AEs), such as a condition associated with frequent diarrhea; patients must not have an active infection requiring current treatment with parenteral antibioticsXx_NEWLINE_xXPresence of a significant psychiatric disease, which in the opinion of the principal investigator or his designee, would prevent adequate informed consent or render immunotherapy unsafe or contraindicatedXx_NEWLINE_xXAny medical or psychiatric illness, which in the opinion of the principal investigator, would compromise the patient's ability to tolerate this treatment or limit compliance with study requirementsXx_NEWLINE_xXPresence of a significant psychiatric disease, which in the opinion of the principal investigator or his designee, would prevent adequate informed consent or render immunotherapy unsafe or contraindicatedXx_NEWLINE_xXSubstance abuse or other concurrent medical or psychiatric conditions that, in the\n             Investigator's opinion, could confound study interpretation or affect the patient's\n             ability to tolerate or complete the studyXx_NEWLINE_xXPatients must not have a history of any condition (social or medical) that, in the opinion of the investigator, might interfere with the patient’s ability to comply with the protocol or pose additional or unacceptable risk to the patientXx_NEWLINE_xXPatients with other significant diseases or disorders that, in the investigator’s opinion, would exclude them from the studyXx_NEWLINE_xXSerious concomitant systemic disorders (including active infections) that would compromise the safety of the patient or compromise the patient’s ability to complete the study, at the discretion of the investigatorXx_NEWLINE_xXUnderlying medical condition (e.g., a condition associated with diarrhea) that, in the investigator's opinion, would make the administration of either study drug or both study drugs hazardous to the subject or obscure the interpretation of toxicity determination or adverse eventsXx_NEWLINE_xXUnderlying medical condition (eg, a condition associated with diarrhea) that, in the Investigator’s opinion, would make the administration of either study drug or both study drugs hazardous to the subject or obscure the interpretation of toxicity determination or adverse eventsXx_NEWLINE_xXAny condition (psychological, physical or use/abuse of substances) which, in the opinion of the principal investigator (PI) or a sub-investigator (sub-I), would possibly endanger the subject during their participation in the study, or allow for non-compliance with the investigational drug and treatment under studyXx_NEWLINE_xXAny medical or psychiatric illness, which, in the opinion of the principal investigator, would compromise the patient’s ability to tolerate this treatmentXx_NEWLINE_xXSubjects with any other medical condition, which in the opinion of the investigator would compromise the results of the study by deleterious effects of treatmentXx_NEWLINE_xXPatients must not have any other concomitant serious illness or organ system dysfunction which in the opinion of the investigator would either compromise patient safety or interfere with the evaluation of the safety of the study drugXx_NEWLINE_xXAny other concurrent illness which in investigator’s opinion puts the patient at excessive risk of treatment related toxicitiesXx_NEWLINE_xXSubjects with any other medical condition, which in the opinion of the investigator would compromise the results of the study by deleterious effects of treatmentXx_NEWLINE_xXAny other significant disease or other clinical findings which in the opinion of the investigator would prevent study entryXx_NEWLINE_xXSubject has any condition which makes the subject unsuitable for study participation.Xx_NEWLINE_xXAny condition which, in the investigator’s opinion, makes the patient unsuitable for trial participationXx_NEWLINE_xXMedical condition, serious intercurrent illness, or other circumstance that, in the Investigator's judgment, could jeopardize the candidate's safety as a study subject, or that could interfere with study objectives.Xx_NEWLINE_xXAny serious or uncontrolled concomitant disorder that, in the opinion of the investigator, would compromise the patient’s ability to complete the studyXx_NEWLINE_xXSubjects who, in the opinion of the Investigator, cannot tolerate intravesical administration or intravesical surgical manipulation (cystoscopy, biopsy) due to the presence of serious comorbid condition(s) (e.g., uncontrolled cardiac or respiratory disorders).Xx_NEWLINE_xXSubject with any other condition which in the opinion of the investigator would preclude participation in the study.Xx_NEWLINE_xXHistory or presence of abnormal electrocardiogram (ECG) that, in the investigator's opinion, is clinically meaningfulXx_NEWLINE_xXInability to comply with protocol and /or not willing or not available for follow-up assessments or any condition which in the investigator's opinion makes the patient unsuitable for the study participationXx_NEWLINE_xXc) History of other malignancy that in the Investigator's opinion would not affect the determination of study treatment effectXx_NEWLINE_xXAny other medical condition or laboratory evaluation that, in the treating physician’s or principal investigator’s opinion, makes the patient unsuitable to participate in this clinical trialXx_NEWLINE_xXPatients may not have any other medical condition or reason, in that investigator's opinion, makes the patient unstable to participate in a clinical trialXx_NEWLINE_xXActive infection or serious underlying medical condition that would impair the patient's ability to receive protocol treatmentXx_NEWLINE_xXPresence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the subject or the quality of the data.Xx_NEWLINE_xXSubject with concurrent severe and/or uncontrolled medical conditions that in the opinion of the investigator may impair the participation in the study or the evaluation of safety and/or efficacyXx_NEWLINE_xXLife-threatening illness, significant organ system dysfunction, or other condition that, in the investigator's opinion, could compromise subject safety or the integrity of the study outcomes, or interfere with the absorption or metabolism of ASTX660.Xx_NEWLINE_xXKnown significant mental illness or other conditions such as active alcohol or other substance abuse that, in the opinion of the investigator, predisposes the subject to high risk of noncompliance with the protocol treatment or assessments.Xx_NEWLINE_xXThe patient has any medical condition which in the opinion of the investigator places the patient at an unacceptably high risk for toxicities.Xx_NEWLINE_xXSubjects with a condition which may interfere with the subjects' ability to understand the requirements of the studyXx_NEWLINE_xXCo-morbid disease or condition that would place the patient at undue risk and preclude safe use of TheraSphere treatment, in the Investigator's judgmentXx_NEWLINE_xXSerious nonmalignant disease (e.g., hydronephrosis, liver failure, or other conditions) that could compromise protocol objectives in the opinion of the investigator and/or the sponsor.Xx_NEWLINE_xXHas history of any disease, metastatic condition, drug/medication use or other condition that might, per protocol or in the opinion of the investigator, compromise:Xx_NEWLINE_xXHistory or presence of an abnormal ECG that, in the investigator's opinion, is clinically meaningful.Xx_NEWLINE_xXAny other medical condition that, in the opinion of the Investigator, would adversely affect the subject's participation in the study.Xx_NEWLINE_xXAny medical or other condition that in the opinion of the investigator(s) would preclude the participant's participation in a clinical study.Xx_NEWLINE_xXAny condition that, in the opinion of the investigator or sponsor, would interfere with evaluation of the investigational product.Xx_NEWLINE_xXSubject has a concomitant medical condition that precludes adequate study treatment compliance or assessment, or increases subject risk, in the opinion of the Investigator, such as but not limited to:Xx_NEWLINE_xXA life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of study drugs, or put the study outcomes at undue risk.Xx_NEWLINE_xXConcomitant medical condition that would increase the risk of toxicity, in the opinion of the Investigator or SponsorXx_NEWLINE_xXHas any condition that, in the opinion of the investigator, would compromise the well-being of the participant or the study or prevent the participant from meeting or performing study requirementsXx_NEWLINE_xXPatients with concurrent medical, psychological or social conditions of such severity that the investigator deems it unwise to enter the patient on protocolXx_NEWLINE_xXHave any medical condition that, in the opinion of the investigator, may interfere with the study results or place the subject at undue riskXx_NEWLINE_xXPatients must be, in the opinion of the Investigator, available and compliant for treatment and follow-up.Xx_NEWLINE_xXAny condition which in the Investigator’s opinion deems the participant an unsuitable candidate to receive study drugXx_NEWLINE_xXAll other significant diseases (for example, inflammatory bowel disease), which, in the opinion of the Investigator, might impair the subject's tolerance of trial treatmentXx_NEWLINE_xXAny concurrent disease, infection, or comorbid condition that interferes with the ability of the patient to participate in the trial, which places the patient at undue risk, or complicates the interpretation of data, in the opinion of the investigator or medical monitor.Xx_NEWLINE_xXPatients are ineligible if they have a history of any underlying medical or psychiatric conditions or require any medications or treatment that in the opinion of the principal investigator may interfere with compliance, make the administration of study drug hazardous or obscure the interpretation of adverse events, such as a condition associated with frequent diarrheaXx_NEWLINE_xXSignificant concurrent medical condition that would make prednisone/prednisolone use contraindicated or would interfere with the patient’s ability to participate in the trialXx_NEWLINE_xXAny condition that in the opinion of the principal investigator, would compromise the well-being of the subject or the study or prevent the subject from meeting or performing the study requirementsXx_NEWLINE_xXHistory of or ongoing major cardiac, pulmonary, renal, endocrine, or hepatic disease that, in the opinion of the investigator or sponsor, would preclude participation.Xx_NEWLINE_xXHistory/evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.Xx_NEWLINE_xXHas an Underlying medical condition that would preclude study participation.Xx_NEWLINE_xXHave any condition or illness that, in the opinion of the investigator, would compromise patient safety or interfere with the evaluation of the study drug.Xx_NEWLINE_xXAny underlying medical condition that, in the Investigator's opinion, will make the administration of study treatment hazardous to the patient, or would obscure the interpretation of adverse events.Xx_NEWLINE_xXUncontrolled concurrent illness, or any underlying medical condition, which in the principal investigator’s opinion will make the administration of ibrutinib hazardous or obscure the interpretation of adverse eventsXx_NEWLINE_xXNo other illness that in the opinion of the investigator would exclude the subject from participating in the studyXx_NEWLINE_xXOther uncontrolled serious chronic disease or conditions that in the investigator's opinion could affect compliance or follow-up in the protocolXx_NEWLINE_xXAny condition which in the investigator’s opinion deems the participant an unsuitable candidate to receive study drugXx_NEWLINE_xXIn the opinion of the investigator the patients must:Xx_NEWLINE_xXhistory or evidence of clinically significant cardiovascular, CNS and/or other systemic disease that would in the investigator's opinion preclude participation in the study or compromise the patient's ability to give informed consent.Xx_NEWLINE_xXAny medical condition that, in the opinion of the Investigator, may pose a safety risk to a subject in this trial, may confound the assessment of safety and efficacy, or may interfere with study participation.Xx_NEWLINE_xXAny life-threatening illness, medical condition, or organ system dysfunction that, in the investigator’s opinion, could compromise the patient’s safety, or put the study at undue riskXx_NEWLINE_xXSubject has serious medical risk factors involving any of the major organ systems such that the investigator considers it unsafe for the subject to receive an experimental research drugXx_NEWLINE_xXAny condition which, in the investigator’s opinion, makes the subject unsuitable for trial participationXx_NEWLINE_xXAny medical conditions that, in the Investigator's opinion, would impose excessive risk to the patient or would adversely affect his/her participation in this studyXx_NEWLINE_xXEvidence of severe or uncontrolled systemic disease or any concurrent condition which in the investigator’s opinion makes it undesirable for the patient to participate in the trial or which could jeopardize compliance with the protocolXx_NEWLINE_xXSerious concomitant systemic disorders (e.g., active infection) that, in the opinion of the investigator, would compromise the safety of the patient or compromise the patient’s ability to complete the studyXx_NEWLINE_xXHistory or presence of an abnormal electrocardiogram (ECG) that, in the investigator's opinion, is clinically meaningful.Xx_NEWLINE_xXHistory or presence of an abnormal electrocardiogram (ECG) that, in the investigator's opinion, is clinically meaningful.Xx_NEWLINE_xXHistory or presence of an abnormal electrocardiogram that, in the investigator's opinion, is clinically meaningful.Xx_NEWLINE_xXHistory or evidence of clinically significant disorder, condition, or disease that, in the opinion of the investigator or the Gilead medical monitor would pose a risk to individual safety or interfere with the study evaluations, procedures, or completionXx_NEWLINE_xXUnderlying medical condition (eg, a condition associated with diarrhea) that, in the investigator’s opinion, would make the administration of either study drug or both study drugs hazardous to the subject or obscure the interpretation of toxicity determination or adverse eventsXx_NEWLINE_xXHistory of or ongoing major cardiac, pulmonary, renal, endocrine, or hepatic disease that, in the opinion of the investigator or sponsor, would preclude participation.Xx_NEWLINE_xXAny life-threatening illness, medical condition, or organ system dysfunction which, in the investigator’s opinion, could compromise the subject’s safety, interfere with the absorption or metabolism of lenalidomide capsules, or put the study outcomes at undue riskXx_NEWLINE_xXActive infection or any serious underlying medical condition, which would impair the ability of the patient to receive protocol treatmentXx_NEWLINE_xXAny underlying medical or psychiatric condition, which in the opinion of the investigator, will make the administration of study drug hazardous or obscure the interpretation of adverse events (AEs), such as a condition associated with frequent diarrheaXx_NEWLINE_xXMedical condition or organ system dysfunction which, in the investigator opinion, could interfere with absorption or metabolism of ibrutinibXx_NEWLINE_xXAny life-threatening illness, medical condition, or organ system dysfunction that, in the investigator’s opinion, could compromise the subject’s safety or put the study outcomes at undue riskXx_NEWLINE_xXAny reason that, in the opinion of the Investigator, contraindicates that the patient participates in the studyXx_NEWLINE_xXAny condition which, in the investigator's opinion, makes the subject unsuitable for trial participation.Xx_NEWLINE_xXPresence of any condition which makes the patient unsuitableXx_NEWLINE_xXAny life-threatening illness, medical condition, or organ system dysfunction that, in the investigator’s opinion, could compromise the subject’s safety or put the study outcomes at undue riskXx_NEWLINE_xXAny other medical, psychological, or social condition that may interfere with study participation or compliance, or compromise patient safety in the opinion of the investigatorXx_NEWLINE_xXAny underlying medical condition that, in the Investigator's opinion, will make the administration of study vector hazardous to the patient, would obscure the interpretation of adverse events, or not permit adequate surgical resection.Xx_NEWLINE_xXHave other significant medical conditions well-controlled and stable in the opinion of the investigator for at least 30 days prior to Day 1Xx_NEWLINE_xXHave evidence of any other serious systemic disease, including active bacterial or fungal infection, or any medical condition that, in the opinion of the investigator(s) could affect the participant's safety or interfere with the study assessmentsXx_NEWLINE_xXHave any medical or other condition that in the opinion of the investigator(s) would preclude the participant's participation in a clinical studyXx_NEWLINE_xXSubject has serious medical risk factors involving any of the major organ systems such that the investigator considers it unsafe for the subject to receive an experimental research drugXx_NEWLINE_xXAny concurrent medical or psychiatric condition or disease (eg, autoimmune disease, active systemic disease, myelodysplasia) that is likely to interfere with the study procedures or results, or that in the opinion of the investigator, would constitute a hazard for participating in this studyXx_NEWLINE_xXAny underlying medical or psychiatric condition, which in the opinion of the Investigator, will make the administration of study drug hazardous or obscure the interpretation of Adverse Events, such as a condition associated with frequent diarrhoeaXx_NEWLINE_xXHistory of another malignancy that in the opinion of the investigator may compromise the outcome of the studyXx_NEWLINE_xXAny reason why, in the opinion of the investigator, the patient should not participate.Xx_NEWLINE_xXThe patient must be a suitable candidate for surgery, in the opinion of the treating physicianXx_NEWLINE_xXPatients who have any current or prior medical condition that can interfere with the conduct of the study or the evaluation of its results in the opinion of the investigator or the sponsor's medical monitor.Xx_NEWLINE_xXSubjects must be stable and, in the opinion of the investigator, be expected to complete 4 week treatment period.Xx_NEWLINE_xXAny other concomitant serious illness or organ system dysfunction as per investigator assessmentXx_NEWLINE_xXAny clinically significant disease or condition (or history of) that could interfere with, or for which the treatment might interfere with, the conduct of the study or the absorption of oral medications or that would, in the opinion of the principal investigator, pose an unacceptable risk to the participant in this studyXx_NEWLINE_xXAny other condition, including concurrent medical condition, social circumstance or drug dependency, which in the opinion of the investigator could compromise patient safety and/or compliance with study requirementsXx_NEWLINE_xXPresence of underlying medical condition that in the opinion of the investigator or sponsor could adversely affect the ability of the subject to comply with or tolerate study procedures and/or study therapy, or confound the ability to interpret the tolerability of combined administration of panobinostat and ipilimumab in treated subjectsXx_NEWLINE_xXRequires myelofibrosis therapy, in the opinion of the investigatorXx_NEWLINE_xXUncontrolled undercurrent illness that in the opinion of the treating physician would contraindicate the use of the drugXx_NEWLINE_xXPatients with psychiatric or addictive disorders or other conditions that, in the opinion of the investigators, would preclude them from meeting the study requirements are not eligibleXx_NEWLINE_xXKnown or suspected hypersensitivity to ofatumumab or SB-485232 that in the opinion of the investigator is a contraindication to their participation in the studyXx_NEWLINE_xXAny medical or other condition that in the opinion of the investigator would preclude the subject's participation in a clinical studyXx_NEWLINE_xXUnstable or clinically significant concurrent medical condition that would, in the opinion of the investigator, jeopardize the safety of a subject and/or compliance with the protocol.Xx_NEWLINE_xXAny significant medical illnesses that in the investigator's opinion cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate this therapyXx_NEWLINE_xXAny other medical condition that in the opinion of the investigator may interfere with a subject participation in, or compliance with, the studyXx_NEWLINE_xXHave any clinical condition that is considered unstable or might jeopardize the safety of the subject and/or influence the subject's compliance in the study.Xx_NEWLINE_xXAny life-threatening illness, medical condition, organ system dysfunction, need for profound anticoagulation, or bleeding disorder, which, in the investigator's opinion, could compromise the subject's safetyXx_NEWLINE_xXThe patient has any medical condition which, in the opinion of the Investigator, places the patient at an unacceptably high risk for toxicities.Xx_NEWLINE_xXHave any underlying medical condition, psychiatric condition, or social situation that, in the opinion of the Investigator, would compromise study administration as per protocol or compromise the assessment of AEs.Xx_NEWLINE_xXSubject has any condition which makes the subject unsuitable for study participation, including any contraindications of azacitidine.Xx_NEWLINE_xXA serious uncontrolled medical disorder that in the opinion of the Investigator would impair the ability of the subject to receive protocol therapyXx_NEWLINE_xXAny underlying medical or psychiatric condition, which in the opinion of the investigator, will make the administration of study drug hazardous or obscure the interpretation of adverse events, such as a condition associated with frequent diarrhea.Xx_NEWLINE_xXParticipation in any other immunotherapy treatment, that in the opinion of the principal investigator would be unsafe to receive further checkpoint blockade immunotherapy.Xx_NEWLINE_xXOther uncontrolled serious chronic disease or conditions that in the investigator's opinion could affect compliance or follow-up in the protocolXx_NEWLINE_xXActive and uncontrolled disease/infection that in the opinion of the treating physician and principal investigator may affect the ability to participate in the trial or put the patient at unduly high riskXx_NEWLINE_xXJudgment by the investigator that the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions and requirements; Note: Patients who are likely to require surgery or radiation for NF2-related tumors during the first year of treatment in the investigator’s opinion should not be enrolled on this clinical trialXx_NEWLINE_xXSubject has a known psychiatric disorder, which in the opinion of the Principal Investigator, would preclude the subject from completing this clinical study;Xx_NEWLINE_xXSubject is not appropriate for inclusion in the clinical trial, per the medical opinion of the Principal Investigator. Intraoperative Eligibility Criteria:Xx_NEWLINE_xXAny condition which, in the investigator's opinion, makes the subject unsuitable for trial participationXx_NEWLINE_xXPatients with any life threatening illness, medical condition or organ system dysfunction that in the opinion of the investigator could compromise the subject’s safety, interfere with absorption of metabolism of study drugs or put the study outcomes at undue riskXx_NEWLINE_xXAny other illness or condition that the treating investigator feels would interfere with study compliance or would compromise the patient’s safety or study endpointsXx_NEWLINE_xXEvidence of severe or uncontrolled systemic disease or any concurrent condition that, in the opinion of the Investigator or Medical Monitor, makes it undesirable for the subject to participate in the study or that would jeopardize compliance with the protocol. Subjects with pre-existing well-controlled diabetes are not excluded.Xx_NEWLINE_xXNo other active malignancies within the past 36 months (with the exception of nonmelanoma skin cancers or carcinoma in situ of the bladder) or life-threatening illnesses, in the opinion of the investigatorXx_NEWLINE_xXUnfit for chemotherapy based on investigator assessment or patient not willing to receive intensive induction as advised by investigatorXx_NEWLINE_xXInclusion Criteria:\n\n        A subject will be eligible for inclusion in this study only if all of the following\n        criteria are met:\n\n          1. Male or female subject is between 18 and 65 years of age at the time of signing the\n             Informed Consent Form (ICF).\n\n          2. Subject has definitive histologically or cytologically confirmed metastatic pancreatic\n             adenocarcinoma.\n\n          3. Subject has an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1.\n\n          4. Subject has one or more tumors measurable by CT scan (or (MRI), if allergic to CT\n             contrast media) as defined by Response Evaluation Criteria In Solid Tumors (RECIST)\n             1.1.\n\n          5. Subject has the following blood counts / Hemoglobin (Hgb) at screening:\n\n               -  Absolute neutrophil count (ANC) ? 1.5 × 10^9/L;\n\n               -  Platelet count ? 100,000/mm3 (100 × 10^9/L);\n\n               -  Hgb ? LLN or 10 g/dL.\n\n          6. Subject has the following blood chemistry levels at screening:\n\n               -  AST (SGOT), ALT (SGPT) ? 2.5 x upper limit of normal range (ULN); if hepatic\n                  metastases present ? 5.0 x ULN\n\n               -  Total bilirubin ? 1.5 X ULN\n\n               -  Creatinine clearance ? 60 mL/min (by Cockroft-Gault)\n\n               -  Albumin ? 3.5 grams/dL7.\n\n          7. Females of childbearing potential (FOCBP) [defined as a sexually mature woman who (1)\n             have not undergone hysterectomy (the surgical removal of the uterus) or bilateral\n             oophorectomy (the surgical removal of both ovaries) or (2) have not been naturally\n             postmenopausal for at least 24 consecutive months (ie, has had menses at any time\n             during the preceding 24 consecutive months)] must:\n\n               -  Have a negative pregnancy test (?-human chorionic gonadotropin [? -hCG]) as\n                  verified by the study doctor within 72 hours prior to starting study therapy\n\n               -  Commit to complete abstinence from heterosexual contact, or agree to use medical\n                  doctor-approved contraception throughout the study without interruption; while\n                  receiving study medication and for at least 6 months following last dose of study\n                  IP.\n\n          8. Males must practice complete abstinence or agree to use a condom (even if he has\n             undergone a successful vasectomy) during sexual contact with a pregnant female or a\n             female of childbearing potential while participating in the study, during dose\n             interruptions and for at least 6 months following last dose of study IP.\n\n          9. Subject has no clinically significant abnormalities in urinalysis results at baseline.\n\n         10. Subject is able to adhere to the study visit schedule and other protocol requirements.\n\n         11. Subject understands the nature of the study, and has agreed to participate in the\n             study, and has voluntarily signed the ICF prior to participation in any study-related\n             activities.\n\n         12. Subject must consent to provide protocol-mandated tumor and blood samples for\n             molecular analysis.\n\n         13. Subject is willing and able to adhere to the study visit schedule and other protocol\n             requirements\n\n        Exclusion Criteria:\n\n        A subject will not be eligible for inclusion in this study if any of the following criteria\n        apply:\n\n          1. Subject has received previous systemic chemotherapy or investigational therapy (other\n             than that as a radiosensitizer concomitant with radiotherapy) for the treatment of\n             pancreatic adenocarcinoma, including neo-adjuvant or adjuvant therapy.\n\n          2. Subject has known brain metastases unless previously treated and controlled for a\n             minimum of 2 weeks prior to enrollment. Subject is not receiving corticosteroids with\n             no evidence of cerebral edema.\n\n          3. Pre-existing peripheral neuropathy > Grade 1\n\n          4. Subject with unstable stent.\n\n          5. History of malignancy in the last 3 years. Subjects with prior history of in situ\n             cancer or basal or squamous cell skin cancer are eligible. Subjects with other\n             malignancies are eligible if they were cured by surgery alone or surgery plus\n             radiotherapy and have been continuously disease-free for at least 3 years.\n\n          6. Subject has active, uncontrolled bacterial, viral, or fungal infection(s) requiring\n             systemic therapy , defined as ongoing signs/symptoms related to the infection without\n             improvement despite appropriate antibiotics, antiviral therapy, and/or other\n             treatment.\n\n          7. Subject has known historical or active infection with human immunodeficiency virus\n             (HIV), hepatitis B, or hepatitis C or subject receiving immunosuppressive or\n             myelosuppressive medications that would, in the opinion of the Investigator, increase\n             the risk of serious neutropenic complications.\n\n          8. Subject has undergone major surgery, other than diagnostic surgery (ie, surgery done\n             to obtain a biopsy for diagnosis without removal of an organ), within 4 weeks prior to\n             Day 1 of treatment in this study or surgical wound has not fully healed.\n\n          9. Subject has a history of allergy or hypersensitivity to any of the IP or any of their\n             excipients, or the subject exhibits any of the events outlined in the\n             Contraindications or Special Warnings and Precautions sections for and of the\n             products' Summary of Product Characteristics or Prescribing Information.\n\n         10. History of connective tissue disorders (eg, lupus, scleroderma, arteritis nodosa).\n\n         11. Subject with a history of interstitial lung disease, history of slowly progressive\n             dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis,\n             pulmonary hypersensitivity pneumonitis or multiple allergies that in the opinion of\n             the Investigator may put them at increased risk of interstitial pneumonitis.\n\n         12. Subject with high cardiovascular risk, including, but not limited to:\n\n               -  uncontrolled hypertension\n\n               -  unstable angina\n\n               -  diagnosis of ischemic heart disease\n\n               -  heart disease of New York Heart Association functional classification ? 3 (see\n                  Appendix C)\n\n               -  prior history of hemorrhagic or thrombolytic stroke\n\n               -  prior exposure to anthracycline\n\n               -  history of peripheral artery disease (eg, claudication, Leo Buerger's disease)\n\n               -  any of the following within the prior 6 months\n\n               -  coronary stenting\n\n               -  myocardial infarction\n\n               -  coronary bypass surgery\n\n         13. Recent history of clinically significant hemoptysis.\n\n         14. Pregnant and nursing (lactating) women.\n\n         15. Any significant medical condition, laboratory abnormality, or psychiatric illness that\n             would prevent the subject from participating in the study.\n\n         16. Subject has any condition including the presence of laboratory abnormalities, which\n             places the subject at unacceptable risk if he/she were to participate in the study.\n\n         17. Subject has any condition that confounds the ability to interpret data from the study.Xx_NEWLINE_xXAny life-threatening illness, medical condition, or organ system dysfunction which, in the investigator’s opinion could interfere with the absorption or metabolism of ibrutinibXx_NEWLINE_xXAny medical condition or organ system dysfunction which, in the investigator’s opinion, could compromise the patient’s safety, interfere with the absorption or metabolism of ibrutinibXx_NEWLINE_xXPatient has any unstable medical condition that would make it unsafe to undergo TURBT.Xx_NEWLINE_xXNo serious disease or condition that, in the opinion of the investigator, would compromise the patient’s ability to participate in the studyXx_NEWLINE_xXAny condition, psychiatric, substance abuse, or otherwise, that, in the opinion of the Investigator, would preclude informed consent, consistent follow-up, or compliance with any aspect of the studyXx_NEWLINE_xXIn the opinion of the investigator would benefit from systemic therapyXx_NEWLINE_xXAny life-threatening illness, medical condition, or organ system dysfunction which, in the investigator’s opinion, could compromise the subject’s safety, interfere with the absorption or metabolism of ibrutinib capsules, or put the study outcomes at undue risk, including but not limited to:\r\n* Moderate to severe hepatic impairment (Child-Pugh classes B and C)Xx_NEWLINE_xXSubject has any other condition or reason that, in the opinion of the investigator, interferes with the ability of the subject to participate in the trial, places the subject at undue risk or complicates the interpretation of safety data.Xx_NEWLINE_xXOther uncontrolled serious chronic disease or conditions that in the investigator's opinion could affect compliance or follow-up in the protocolXx_NEWLINE_xXAny other clinically significant medical or psychological disease or condition that, in the investigator’s opinion, may interfere with protocol adherence or a subject’s ability to give informed consentXx_NEWLINE_xXIn the opinion of the investigator, the patient is an unsuitable candidate to receive HM61713Xx_NEWLINE_xXAny medical condition which, in the investigator's opinion, could compromise the patient's safetyXx_NEWLINE_xXHas any condition that, in the opinion of the investigator, might jeopardize the safety of the subject or interfere with protocol compliance.Xx_NEWLINE_xXPatients with serious concurrent infection or medical illness, which in the treating physician's opinion would jeopardize the ability of the patient to receive the treatment outlined in this protocol with reasonable safetyXx_NEWLINE_xXAny condition which in the investigator’s opinion deems the participant an unsuitable candidate to receive study drugXx_NEWLINE_xXA life-threatening illness, medical condition (including psychiatric conditions) or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safetyXx_NEWLINE_xXAny medical condition which, in the investigator's opinion, makes the patient unsuitable for participationXx_NEWLINE_xXPending visceral crisis, in the opinion of the treating investigatorXx_NEWLINE_xXThe participant has any condition (for example, psychological, geographical, or medical) that does not permit compliance with the study and follow-up procedures or suggests that the participant is, in the investigator's opinion, not an appropriate candidate for the study.Xx_NEWLINE_xXPrior or ongoing clinically significant illness, medical condition, surgical history, physical finding, electrocardiography (ECG) finding, or laboratory abnormality that, in the investigator's opinion, could affect the safety of the patient; alter the absorption, distribution, metabolism or excretion of idelalisib; or impair the assessment of study resultsXx_NEWLINE_xXAny other serious or uncontrolled medical disorder, active infection, physical exam finding, laboratory finding, altered mental status, or psychiatric condition that, in the opinion of the investigator, would limit a subject’s ability to comply with the study requirements, substantially increase risk to the subject, or impact the interpretability of study resultsXx_NEWLINE_xXThe patient has a prior or concurrent malignancy that in the opinion of the investigator, presents a greater risk to the patient’s health and survival, than of the MCL, within the subsequent 6 months at the time of consent; investigator discretion is allowedXx_NEWLINE_xXSerious concomitant systemic disorder that would compromise the safety of the patient or compromise the patient’s ability to complete the study, at the discretion of the investigatorXx_NEWLINE_xXAny medical condition which, in the investigator's opinion, could compromise the patient's safetyXx_NEWLINE_xXAny condition or organ toxicity deemed by the principal investigator (PI) or the attending physician to place the patient at unacceptable risk for treatment on the protocolXx_NEWLINE_xXAny condition which, in the investigator’s opinion, makes the subject unsuitable for trial participationXx_NEWLINE_xXAny condition which, in the investigator’s opinion, makes the subject unsuitable for trial participationXx_NEWLINE_xXAny condition that, in the opinion of the treating physician, would exclude the subject from receiving bevacizumab. Examples may include but are not limited to:Xx_NEWLINE_xXAny condition that, in the opinion of the investigator, might jeopardize the safety of the subject or interfere with protocol compliance.Xx_NEWLINE_xXHistory or presence of any medical condition or disease which, in the opinion of the investigator, may place the subject at unacceptable risk for study participationXx_NEWLINE_xXPatient has an important medical illness or abnormal laboratory finding that, in the Investigator's opinion, would increase the risk of participating in this study.Xx_NEWLINE_xXActive infection or serious underlying medical condition that would impair the patient's ability to receive protocol treatmentXx_NEWLINE_xXThe investigator should assess the patient to determine if she has any psychiatric or addictive disorder or other condition that, in the opinion of the investigator, would preclude her from meeting the study requirements.Xx_NEWLINE_xXParticipant has a significant history of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, hepatic, cardiovascular disease, or any other medical condition that in the opinion of the investigator would adversely affect his/her participating in this study.Xx_NEWLINE_xXPatient, in the opinion of the investigator, is likely to be poorly compliantXx_NEWLINE_xXWillingness to undergo core biopsies at baseline and mid-cycle 1 unless contraindicated by medical risk in the opinion of the treating physician and discussed with the principal investigatorXx_NEWLINE_xXPatients with a history of pulmonary disease or findings present on baseline high-resolution chest CT scan that, in the opinion of the treating investigator, would put the patient at risk of complications of pneumonitis will be excludedXx_NEWLINE_xXAny life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety or put the study outcomes at undue riskXx_NEWLINE_xXThe patient has a prior or concurrent malignancy that in the opinion of the investigator, presents a greater risk to the patient’s health and survival, than of the MCL, within the subsequent 6 months at the time of consent; investigator discretion is allowedXx_NEWLINE_xXMedical conditions that, in the investigator’s opinion, would impose excessive risk to the subjectXx_NEWLINE_xXAny illness or condition that in the opinion of the investigator may affect safety of treatment or evaluation of any the study’s endpointsXx_NEWLINE_xXA life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of ACP-196 (acalabrutinib), or put the study outcomes at undue riskXx_NEWLINE_xXAny medical intervention or other condition which, in the opinion of the principal investigator could compromise adherence with study requirements or otherwise compromise the study’s objectivesXx_NEWLINE_xXParticipant has any concurrent medical or psychiatric condition or disease (example active systemic infection, uncontrolled diabetes, acute diffuse infiltrative pulmonary disease) that is likely to interfere with the study procedures or results, or that in the opinion of the investigator, would constitute a hazard for participating in this studyXx_NEWLINE_xXA life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of acalabrutinib, or put the study outcomes at undue risk.Xx_NEWLINE_xXAny life-threatening illness, medical condition, or organ system dysfunction that, in the investigator's opinion, could compromise the subject's safety or put the study outcomes at undue risk.Xx_NEWLINE_xXIn the opinion of the investigator, subject has rapidly progressing disease, OR has life expectancy of less than 6 months, OR would be unable to receive at least one cycle of therapy.Xx_NEWLINE_xXA life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of acalabrutinib and/or ACP-319, or put the study outcomes at undue risk.Xx_NEWLINE_xXA serious uncontrolled medical disorder that, in the opinion of the Investigator, would impair the ability of the patient to receive protocol therapyXx_NEWLINE_xXSignificant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease which in the opinion of the investigator may represent a risk for the participantXx_NEWLINE_xXIn the opinion of the investigator, patient must be able to receive at least 2 cycles of treatmentXx_NEWLINE_xXIn the opinion of the investigator, patients who are significantly below their ideal body weightXx_NEWLINE_xXAny condition which, in the investigator’s opinion, makes the subject unsuitable for trial participationXx_NEWLINE_xXAny underlying medical or psychiatric condition, which in the opinion of the investigator, will make the administration of study drug hazardous or obscure the interpretation of adverse events (AEs), such as a condition associated with frequent diarrheaXx_NEWLINE_xXA life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of ACP-196, or put the study outcomes at undue riskXx_NEWLINE_xXAny underlying medical or psychiatric condition, which in the opinion of the investigator will make the administration of ipilimumab hazardous or obscure the interpretation of adverse events (AEs), such as a condition associated with frequent diarrheaXx_NEWLINE_xXAny condition which, in the investigator’s opinion, makes the subject unsuitable for trial participationXx_NEWLINE_xXAny medical condition which, in the opinion of the investigator, puts the patient at risk of potentially serious complications while on study treatmentXx_NEWLINE_xXAny other clinically significant medical disease or condition that, in the investigator’s opinion, may interfere with protocol adherence or a subject’s ability to give informed consentXx_NEWLINE_xXHave any condition or illness that, in the opinion of the investigator, would compromise participants safety or interfere with evaluation of the drug study.Xx_NEWLINE_xXAny other condition that, in the opinion of the investigator, would impair the patient's ability to comply with study proceduresXx_NEWLINE_xXSubjects with any other medical or psychological condition, deemed by the Investigator to be likely to interfere with a subject's ability to sign informed consent, cooperate, or participate in the study.Xx_NEWLINE_xXAny condition which in the investigator's opinion deems the subject an unsuitable candidate to receive study drugXx_NEWLINE_xXConcurrent serious illness which, in the opinion of the investigator, would place the patient at unreasonable risk from study therapy;Xx_NEWLINE_xXAny condition or reason that, in the opinion of the investigator, interferes with the ability of the patient to participate in the trial, which place the patient at undue risk, or complicates the interpretation of safety dataXx_NEWLINE_xXMedical condition that would make prednisone (corticosteroid) use contraindicatedXx_NEWLINE_xXAny other medical condition that in opinion of investigator would place patient at increased risk for toxicity during pomalidomide treatment (i.e. history of recurrent or serious thromboembolic events)Xx_NEWLINE_xXA life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of acalabrutinib, or put the study outcomes at undue risk.Xx_NEWLINE_xXAny condition or reason that, in the opinion of the investigator, interferes with the ability of the patient to participate in the trial, places the patient at undue risk, or complicates the interpretation of safety dataXx_NEWLINE_xXAny underlying medical or psychiatric condition, which in the opinion of the investigator, will make the administration of study drug hazardous or obscure the interpretation of adverse events, such as a condition associated with frequent diarrheaXx_NEWLINE_xXAny other clinically significant medical disease or condition that, in the Investigator’s opinion, may interfere with protocol adherence or a subject’s ability to give informed consentXx_NEWLINE_xXCOHORT A: Any underlying medical or psychiatric condition, which in the opinion of the investigator will make the administration of ipilimumab hazardous or obscure the interpretation of adverse events (AEs), such as a condition associated with frequent diarrheaXx_NEWLINE_xXCOHORT B: Any underlying medical or psychiatric condition, which in the opinion of the investigator will make the administration of ipilimumab hazardous or obscure the interpretation of adverse events (AEs), such as a condition associated with frequent diarrheaXx_NEWLINE_xXHave any past or current, acute or chronic concurrent medical condition/illness or therapy that, in the opinion of the investigator, would make the subject unsuitable for the clinical trial or unable to comply with follow up visitsXx_NEWLINE_xXMedical, social, or psychosocial factors that, in the opinion of the Investigator, could impact safety or compliance with study procedures.Xx_NEWLINE_xXAny life-threatening illness, medical condition, or organ system dysfunction which, in the Investigator's opinion, could compromise the participant's safety, interfere with the absorption or metabolism of ibrutinib capsules, or put the study outcomes at undue riskXx_NEWLINE_xXHave any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study or prevent the subject from meeting or performing study requirementsXx_NEWLINE_xXPsychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements.Xx_NEWLINE_xXPatients with severe and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol.Xx_NEWLINE_xXSubject has any condition which makes the subject unsuitable for study participation (e.g. ophthalmic conditions such as advanced cataracts).Xx_NEWLINE_xXHigh likelihood or protocol non-compliance (in opinion of investigator)Xx_NEWLINE_xXStudy team (PI, co-investigator [I], and/or research nurse) may deny enrollment if in the study team’s opinion, the candidate may not be adherent to the treatment protocol including scheduled follow-upsXx_NEWLINE_xXSubjects with acute hepatitis B are not eligible; subjects with chronic hepatitis are eligible if their condition is stable and, in the opinion of the investigator, if consulted, would not pose a risk to subject safetyXx_NEWLINE_xXAny life-threatening illness, medical condition, or organ system dysfunction that, in the opinion of the investigator, could compromise the subject's safety or put the study outcomes at undue riskXx_NEWLINE_xXHas any disease or condition that, per protocol or in the opinion of the investigator, might affect:Xx_NEWLINE_xXAny other clinically significant medical disease or condition that, in the investigator’s opinion, may interfere with protocol adherence or a subject’s ability to give informed consentXx_NEWLINE_xXAll other significant diseases (for example, inflammatory bowel disease), which, in the opinion of the investigator, might impair the subject's tolerance of trial treatmentXx_NEWLINE_xXAny condition which, in the opinion of the investigator, would preclude participation in this trialXx_NEWLINE_xXAny condition or abnormality which may, in the opinion of the investigator, compromise his or her safetyXx_NEWLINE_xXPatients must not have any significant medical illnesses that in the investigator’s opinion cannot be adequately controlled with appropriate therapy or would compromise the patient’s ability to tolerate this therapyXx_NEWLINE_xXSerious underlying medical condition which would impair the ability of the patient to receive protocol treatment, in the opinion of the treating physicianXx_NEWLINE_xXAny condition or reason that, in the opinion of the investigator, interferes with the ability of the patient to participate in the trial, which places the patient at undue risk, or complicates the interpretation of safety dataXx_NEWLINE_xXSubjects with any other medical or psychological condition, deemed by the Investigator to be likely to interfere with a subject's ability to sign informed consent, cooperate, or participate in the study.Xx_NEWLINE_xXAny condition or medical problem in addition to the underlying malignancy and organ dysfunction which the investigator feels would pose unacceptable riskXx_NEWLINE_xXPatients with any significant medical illnesses or infection that, in the investigator’s opinion, cannot be adequately controlled with appropriate therapy or would compromise the patient’s ability to tolerate this therapy are not eligible for participationXx_NEWLINE_xXAny other medical, psychological, or social condition that may interfere with study participation or compliance, or compromise patient safety in the opinion of the investigator or medical monitorXx_NEWLINE_xXCurrent life-threatening illness, medical condition, or organ system dysfunction which, in the investigator’s opinion, could compromise the patient’s safety, or put the study at riskXx_NEWLINE_xXOther laboratory abnormalities that, in the opinion of the investigator, would compromise the patient’s safety or interfere with data interpretationXx_NEWLINE_xXPresence of any severe or uncontrolled concurrent medical condition which, in the opinion of the investigator, would increase the risk of serious toxicity from the study drugsXx_NEWLINE_xXCandidate for potentially curative therapies in the opinion of the investigator.Xx_NEWLINE_xXAny medical or other condition that in the opinion of the investigator(s) would preclude the subject's participation in a clinical study or would preclude them from completing the study.Xx_NEWLINE_xXActive infection or serious underlying medical condition that would impair the patient's ability to receive protocol treatmentXx_NEWLINE_xXAny condition which, in the opinion of the investigator, would prevent full participation in this trial (including the long-term follow-up), or would interfere with the evaluation of the trial endpointsXx_NEWLINE_xXAny life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's opinion, could compromise the patient's safety, interfere with the absorption or metabolism of ibrutinib capsules, or put the study outcomes at undue riskXx_NEWLINE_xXthe patient is less than 65 years of age but has significant comorbid condition(s) that are, in the opinion of the investigator, likely to have a negative impact on tolerability of HDT-SCTXx_NEWLINE_xXAny condition which, in the investigator’s opinion, makes the subject unsuitable for trial participationXx_NEWLINE_xXOther past or current malignancy unless in the opinion of the investigator it does not contraindicate participation in the studyXx_NEWLINE_xXAny condition or abnormality which may, in the opinion of the investigator, compromise the safety of patientsXx_NEWLINE_xXAny significant concurrent illness that would, in the judgment of the treating physician/principal investigator, compromise patient safety or compliance, or study participationXx_NEWLINE_xXAny condition or abnormality which may, in the opinion of the investigator, compromise the safety of patientsXx_NEWLINE_xXAny condition or abnormality which may, in the opinion of the investigator, compromise the safety of the patientXx_NEWLINE_xXAny condition which, in the investigator's opinion, makes the subject unsuitable for trial participation.Xx_NEWLINE_xXSocial or psychological conditions that the investigator judges may compromise study complianceXx_NEWLINE_xXAny underlying medical or psychiatric condition, which in the opinion of the investigator will make the administration of BPX-201 and AP1903 hazardous or obscure the interpretation of AEs, such as a condition associated with frequent diarrhea.Xx_NEWLINE_xXOther serious uncontrolled medical conditions that the investigator feels might compromise study participationXx_NEWLINE_xXMajor surgery (other than definitive lung cancer surgery) within two weeks of study or other serious concomitant systemic disorders that, in the opinion of the investigator, would compromise the safety of the patient or compromise the patient’s ability to complete the studyXx_NEWLINE_xXPresence of any severe or uncontrolled concurrent medical condition which, in the opinion of the investigator, would increase the risk of serious toxicity from the study drugsXx_NEWLINE_xXAny clinically significant medical disease or condition that, in the treating investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consentXx_NEWLINE_xXSignificant history of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, cardiovascular, pulmonary or hepatic disease, that in the opinion of the investigator, would adversely affect his/her participation in the study.Xx_NEWLINE_xXExpected survival time of >= 3 months in the opinion of the investigatorXx_NEWLINE_xXAny condition which, in the opinion of the investigator, would preclude participation in this trialXx_NEWLINE_xXAny laboratory abnormalities, which in the opinion of the investigator, may put the subject at risk if participating in the study; for example:Xx_NEWLINE_xXOther medical or psychiatric illness or organ dysfunction that, in the opinion of the investigator, would either compromise the patient’s safety or interfere with the evaluation of the safety of bevacizumabXx_NEWLINE_xXUncontrolled intercurrent illness or any concurrent condition that, in the Investigator's opinion, would jeopardize the safety of the patient or compliance with the protocolXx_NEWLINE_xXSignificant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease which in the opinion of the investigator may represent a risk for the patientXx_NEWLINE_xXAny physical or mental condition or social situation that in the opinion of the Investigator may interfere with the patient's ability to comply with the trial proceduresXx_NEWLINE_xXAny other condition or prior therapy, which in the opinion of the PI, would make the subject unsuitable for the study.Xx_NEWLINE_xXAny other medical intervention or condition, which, in the opinion of the PI could compromise patient safety or adherence with the study requirementsXx_NEWLINE_xXAny other concurrent condition that in the investigator’s opinion would jeopardize compliance with the protocolXx_NEWLINE_xXAny concomitant condition that in the opinion of the investigator could compromise the objectives of this study and the patient's compliance.Xx_NEWLINE_xXSevere and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol (e.g. uncontrolled diabetes (defined as HbA1c > 9%), uncontrolled infection)Xx_NEWLINE_xXIn the opinion of the investigator, the patient is felt not to be appropriate for the studyXx_NEWLINE_xXSystemic diseases (cardiovascular, renal, hepatic, etc) that would prevent study treatment in the investigator's opinion.Xx_NEWLINE_xXHave any clinically significant medical conditions that are unstable, progressive, or inadequately controlled in the opinion of the investigator, that would pose a potential risk for the subject, result in poor compliance with the study requirements, or require treatment with an excluded medication or treatment during the studyXx_NEWLINE_xXExpected survival time of >= 3 months in the opinion of the investigatorXx_NEWLINE_xXOther unspecified reasons that, in the opinion of the investigator or sponsor, make the subject unsuitable for enrollmentXx_NEWLINE_xXAny condition which in the investigator's opinion makes the subject unsuitable for study participationXx_NEWLINE_xXPatient with concurrent severe and/or uncontrolled medical conditions that in the opinion of the investigator may impair the participation in the study or the evaluation of safety and/or efficacyXx_NEWLINE_xXPatients with other systemic illness, or have not recovered adequately from their primary treatment or who have evidence of progression of their current cancer prior to therapy that, in the investigator’s opinion, would preclude their inclusionXx_NEWLINE_xXPatients must not have a history of any condition (social or medical) that, in the opinion of the Investigator, might interfere with the patient’s compliance with the protocol or pose additional or unacceptable risk to the patientXx_NEWLINE_xXSerious concomitant systemic disorders (including active infections) or psychiatric illness/social situations that would compromise the safety of the patient or compromise the patient’s ability to complete the study, at the discretion of the investigatorXx_NEWLINE_xXAny uncontrolled active systemic infection or any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's opinion, could compromise the patient's safety, interfere with the absorption or metabolism of ibrutinib capsules, or put the study outcomes at undue riskXx_NEWLINE_xXAny underlying medical or psychiatric condition, which in the opinion of the investigator/sub-investigator will make the administration of ipilimumab or HDI hazardous or obscure the interpretation of adverse events (AEs), such as a condition associated with frequent diarrheaXx_NEWLINE_xXSubject has a significant history of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, or hepatic disease that in the opinion of the Investigator would adversely affect his/her participating in this study.Xx_NEWLINE_xXOther serious uncontrolled medical conditions that the investigator feels might compromise study participationXx_NEWLINE_xXMedical or other condition that would represent an inappropriate risk to the patient or would likely compromise achievement of the primary study objectiveXx_NEWLINE_xXAny other concurrent condition that in the investigator's opinion would jeopardize compliance with the protocolXx_NEWLINE_xXPending visceral crisis, in the opinion of the treating investigatorXx_NEWLINE_xXSignificant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease which in the opinion of the investigator may represent a risk for the patientXx_NEWLINE_xXPatients with a significant systemic illness that is not well-controlled in the opinion of the treating physician are not eligibleXx_NEWLINE_xXAny condition which in the investigator’s opinion deems the patient an unsuitable candidate to receive study drugXx_NEWLINE_xXThe patient has any condition that will place the patient at undue risk or discomfort as a result of adherence to study proceduresXx_NEWLINE_xXAny underlying medical or psychiatric condition, which in the opinion of the investigator will make the administration of ipilimumab hazardous or obscure the interpretation of adverse events (AEs), such as a condition associated with frequent diarrheaXx_NEWLINE_xXSignificant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease which in the option of the investigator may represent a risk for the patientXx_NEWLINE_xXOther serious uncontrolled medical conditions that the investigator feels might compromise study participationXx_NEWLINE_xXSerious nonmalignant or malignant disease or psychiatric illness, which, in the opinion of the investigator would compromise protocol objectives or interfere with participationXx_NEWLINE_xXAny underlying medical or psychiatric condition, which in the opinion of the investigator will make the administration of ipilimumab hazardous or obscure the interpretation of adverse events (AEs), such as a condition associated with frequent diarrheaXx_NEWLINE_xXAny underlying medical or psychiatric condition that, in the opinion of the investigator, could make the administration of ipilimumab hazardous or could obscure the interpretation of adverse eventsXx_NEWLINE_xXIn the opinion of the treating investigator, patients must have adequate cognitive abilities to complete the neurocognitive components of the study.Xx_NEWLINE_xXPatients must not have any significant medical or psychiatric illnesses that in the investigator's opinion cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate this therapy.Xx_NEWLINE_xXPatients must not have any significant medical illnesses that, in the investigator's opinion, cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate this therapyXx_NEWLINE_xXExpected survival time of at least 3 months in the opinion of the investigatorXx_NEWLINE_xXOther unspecified reasons that, in the opinion of the investigator or Millennium, make the patient unsuitable for enrollmentXx_NEWLINE_xXPatient may be excluded if, in the opinion of the principal investigator (PI) and investigator team, the patient is not capable of being compliantXx_NEWLINE_xXGeneral medical condition: fit for the proposed surgery and/or radiation treatment as determined by the treating investigatorXx_NEWLINE_xXSubject has a significant history of renal, neurologic, psychiatric, pulmonary, endocrinologic, metabolic, immunologic, cardiovascular, or hepatic disease that in the opinion of the Investigator would adversely affect his/her participating in this study.Xx_NEWLINE_xXAny other cardiac condition, which in the opinion of the treating physician would make this protocol unreasonably hazardous for the patientXx_NEWLINE_xXInclusion Criteria:\n\n        Participants will be required to meet all of the following criteria to be considered\n        eligible for the study:\n\n          -  Have a confirmed diagnosis of HCC. Biopsy is preferred but is not required.\n\n          -  Male and female participants who are ?18 years of age.\n\n          -  In the opinion of the investigator, the participants have a life expectancy of at\n             least 12 weeks.\n\n          -  Able to take food or nutritional support orally.\n\n          -  On sorafenib for at least 4 weeks prior to randomization. Dose adjustments are allowed\n             prior to randomization.\n\n          -  Have a Karnofsky Performance Score (KPS) equal to or greater than 50.\n\n          -  Have a cirrhotic status of Child-Pugh Class A or B7.\n\n          -  Have the following laboratory parameters:\n\n               -  a. Platelet count ?50 x 10E9/L.\n\n               -  b. Total bilirubin ?1.5 mg/dL (?1.0 mg/dL for primary biliary cirrhosis). If\n                  total bilirubin >1.5 mg/dL but <3.0 mg/dL, a patient could be enrolled after\n                  consultation with the Medical Monitor. If total bilirubin is >3.0 mg/dL, but the\n                  value has been constant for a period of greater than 3 months, a patient could be\n                  enrolled after consultation with the Medical Monitor.\n\n               -  c. Serum creatinine ?1.5 x upper limit of normal (ULN) or creatinine clearance\n                  >60 mL/min calculated using Cockcroft-Gault.\n\n               -  d. Serum albumin ?3.5 g/dL and/or C-reactive protein (CRP) ?3 mg/L\n\n          -  Able to provide written informed consent prior to any study specific screening\n             procedures with the understanding that the patient has the right to withdraw from the\n             study at any time, for any reason without prejudice.\n\n        Exclusion Criteria:\n\n        Participants must not have any of the following criteria to be considered eligible for\n        inclusion in the study:\n\n          -  The patient has a history of another primary cancer, with the exception of: a)\n             curatively resected non-melanomatous skin cancer; b) curatively treated cervical\n             carcinoma in-situ; or c) other primary solid tumor with no known active disease\n             present that in the opinion of the investigator will not affect patient outcome in the\n             setting of current HCC diagnosis.\n\n          -  Contraindication to sorafenib, propranolol, etodolac, or placebo.\n\n          -  Patient currently on beta-blockers for the treatment of portal hypertension or\n             arrhythmia. [Patients on beta blockers for the treatment of hypertension are allowed\n             if they change to a different drug class, e.g. some classes of angiotensin-converting\n             enzyme (ACE) inhibitors, for controlling hypertension at least one week before\n             randomization].\n\n          -  Body mass index (BMI) <17.5 kg/m2.\n\n          -  History or evidence of cardiac disease: congestive heart failure; New York Heart\n             Association class 2 or greater; active coronary artery disease; unstable angina,\n             cardiac arrhythmias requiring anti-arrhythmic therapy, atrioventricular block of\n             second or third degree, or uncontrolled hypertension. Patients with recent (less than\n             6 months) myocardial infarction (MI) or coronary revascularization.\n\n          -  Hypotension at the time of screening (i.e., systolic blood pressure <90 mmHg,\n             diastolic blood pressure <60 mmHg).\n\n          -  Resting heart rate <60 bpm at time of screening.\n\n          -  Participants with a recent diagnosis of bleeding varices that has not been resolved\n             for a minimum period of 4 weeks.\n\n          -  Any uncontrolled intercurrent illness that, in the opinion of the Investigator, may\n             interfere with study evaluation.\n\n          -  On chronotropic drugs (acetylcholine, digoxin, diltiazem, verapamil, atropine,\n             dopamine, dobutamine, epinephrine, isoproterenol).\n\n          -  Active clinically serious infections [>Grade 2 National Cancer Institute (NCI)-Common\n             Terminology Criteria for Adverse Events (CTCAE) version 4.0].\n\n          -  Known history of human immunodeficiency virus (HIV) infection.\n\n          -  Known central nervous system tumors including metastatic brain disease.\n\n          -  Clinically significant gastrointestinal (GI) bleeding within 30 days prior to\n             Screening.\n\n          -  Substance abuse, medical, psychological or social conditions that may, in the in the\n             opinion of the investigator, interfere with the patient's participation in the study\n             or evaluation of the study results.\n\n          -  Known or suspected allergy to the investigational agents or any agent given in\n             association with this trial (hypersensitivity reaction, hives, rash, difficulty\n             breathing swelling of face, lips, tongue, or throat).\n\n          -  Inability to swallow oral medications.\n\n          -  Any condition that is unstable or which in the opinion of the Investigator could\n             jeopardize the safety of the patient and his/her compliance in the study.\n\n          -  Pregnant or breastfeeding participants. Women of childbearing potential\n             (non-childbearing potential is defined as menopausal for at least 2 years,\n             post-bilateral tubal ligation for at least 1 year, post-bilateral oophorectomy or\n             post-hysterectomy) must have a negative urine pregnancy test performed within 10 days\n             prior to the start of study drug. Both men and women enrolled in this trial must use\n             adequate double-barrier birth control measures [2 types of an acceptable form of\n             FDA-approved contraception (e.g., barrier method, Depo-Provera™, Norplant™, Ortho\n             Evra® [birth control patch], oral contraceptives)] during the course of the trial.\n\n          -  Participation in any other investigational trial in which receipt of investigational\n             drug or device occurred within 30 days prior to screening for this study.Xx_NEWLINE_xXInfectious process, which, in the opinion of the investigator, could worsen or its outcome be affected, as a result of the investigational therapyXx_NEWLINE_xXAny other medical condition that in the opinion of the principal investigator would compromise the ability to deliver or evaluate study drugXx_NEWLINE_xXHave serious preexisting medical conditions that, in the opinion of the investigator, that cannot be adequately controlled with appropriate therapy or would preclude participation in this studyXx_NEWLINE_xXSerious concurrent illness, which in the opinion of the investigator or an authorized physician sub-investigator would interfere with participation in this clinical studyXx_NEWLINE_xXAny medical or psychiatric condition that in the opinion of the principal investigator would compromise the patient's ability to tolerate this treatmentXx_NEWLINE_xXSuffer from any other condition or illness that would compromise safety or interfere with evaluation of the drugXx_NEWLINE_xXPatients must not have any significant medical illnesses that in the investigator's opinion cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate this therapyXx_NEWLINE_xXAny condition that is unstable or which could jeopardize the safety of the subject and his/her compliance in the studyXx_NEWLINE_xXA serious uncontrolled medical disorder/condition that in the opinion of the Investigator would impair the ability of the subject to receive protocol therapyXx_NEWLINE_xXin the opinion of the Investigator, the subject does not have progressive diseaseXx_NEWLINE_xXPatients must not have any significant medical illnesses that in the investigator's opinion cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate this therapyXx_NEWLINE_xXAny medical or other condition which, in the opinion of the investigator, would preclude participation in a clinical trial or the investigator’s belief that the subject is medically unfit to receive eribulin mesylate and atezolizumab or unsuitable for any other reasonXx_NEWLINE_xXAny uncontrolled active systemic infection or any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of entinostat capsules, or put the study outcomes at undue riskXx_NEWLINE_xXThe participant has serious preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study.Xx_NEWLINE_xXLife-threatening illnesses other than AML, uncontrolled medical conditions or organ system dysfunction that, in the Investigator's opinion, could compromise the patient's safety or put the study outcomes at riskXx_NEWLINE_xXAll other significant diseases (e.g., inflammatory bowel disease) that, in the opinion of the investigator, might impair the subject's tolerance of trial treatment.Xx_NEWLINE_xXPatients with severe and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocolXx_NEWLINE_xXAny other condition that, in the opinion of the investigator, may compromise the safety, compliance of the patient, or would preclude the patient from successful completion of the studyXx_NEWLINE_xXAny medical intervention, condition or any other circumstance which in the opinion of the investigator or the sponsor's medical monitor, could compromise adherence to study procedures or study objectives.Xx_NEWLINE_xXAny serious underlying medical or psychiatric condition (e.g., alcohol or drug abuse), dementia or altered mental status or any issue that would impair the ability of the patient to receive or tolerate the planned treatment, to understand informed consent or that in the opinion of the investigator would contraindicate the patient's participation in the study or that would confound the results of the study.Xx_NEWLINE_xXAny life-threatening illness, medical condition, including uncontrolled diabetes mellitus (DM), or organ system dysfunction that, in the opinion of the investigator, could compromise the subject's safety or put the study outcomes at undue riskXx_NEWLINE_xXAny clinically significant condition or situation, other than the condition being studied that, in the opinion of the investigator, would impair with their ability to receive or tolerate the planned treatment, or interfere with the study evaluations or optimal participation in the study.Xx_NEWLINE_xXThe patient is, in the investigator's opinion, adequately recovered from the effects of surgery and chemoradiotherapy to participate in this study.Xx_NEWLINE_xXAny medical condition which would, in the investigator's opinion, compromise the patient's ability to mount an immune response, renders the patient a poor candidate for this trial or could confound the results of the studyXx_NEWLINE_xXAny other condition or circumstance that would, in the opinion of the investigator, make the patient unsuitable for participation in the studyXx_NEWLINE_xXPatients with medical history or conditions not otherwise previously specified which in the opinion of the investigator should exclude participation in this study.Xx_NEWLINE_xXSerious underlying medical condition which would impair the ability of the patient to receive protocol treatment, in the opinion of the treating physicianXx_NEWLINE_xXAny medical condition that would preclude adequate evaluation of the safety and toxicity of the study combinationXx_NEWLINE_xXNo serious disease or condition that, in the opinion of the investigator, would compromise the subject's ability to participate in the studyXx_NEWLINE_xXPrevious medical history, or evidence, of an intercurrent illness that at the discretion of the principal investigator may compromise the safety of the subject in the studyXx_NEWLINE_xXAny other medical condition or laboratory evaluation that, in the treating physician’s or principal investigator's opinion, makes the patient unsuitable to participate in this clinical trialXx_NEWLINE_xXMedical or psychiatric condition which in the opinion of the protocol chairman would compromise the patient's ability to tolerate this protocolXx_NEWLINE_xXPatients with any other medical condition or reason, in that investigator’s opinion, makes the patient unstable to participate in a clinical trialXx_NEWLINE_xXAny condition that is unstable or could jeopardize the safety or compliance of the patient in the studyXx_NEWLINE_xXSubject has concurrent corneal disorder or any ophthalmologic condition which, in the investigator's opinion, makes the subject unsuitable for study participation (i.e., advanced cataracts, glaucoma).Xx_NEWLINE_xXSubject has any condition which, in the investigator's opinion, makes the subject unsuitable for study participation.Xx_NEWLINE_xXUncontrolled intercurrent illness (i.e., active infection) or concurrent condition that, in the opinion of the Investigator, would interfere with the study endpoints or the patient's ability to participateXx_NEWLINE_xXThe presence of a medical or psychiatric condition that, in the opinion of the Principal Investigator, makes the patient inappropriate for inclusion in this studyXx_NEWLINE_xXSymptomatic orthostatic hypotension that in the medical judgment of the Investigator would interfere with subject's ability to safely receive treatment or complete study assessmentsXx_NEWLINE_xXAny condition which could interfere with, or the treatment for which might interfere with, the conduct of the study or which would, in the opinion of the Investigator, unacceptably increase the subject's risk by participating in the studyXx_NEWLINE_xXHas, in the Investigator's opinion, any medical condition that makes the subject a poor candidate for the investigational procedure, or interferes with the interpretation of study results.Xx_NEWLINE_xXIs actively participating in another investigational clinical study which, in the Investigator's or Sponsor's opinion, would interfere in this study.Xx_NEWLINE_xXHave, in the judgment of the Investigator, a clinically significant concurrent illness or psychological, familial, sociological, geographical, or other concomitant condition that would not permit adequate follow-up and compliance with the study protocolXx_NEWLINE_xXSubject has a concomitant medical condition that precludes adequate study treatment compliance or assessment, or increases subject risk, in the opinion of the Investigator, such as but not limited to:Xx_NEWLINE_xXAny medical condition which in the opinion of the investigator places the participant at an unacceptably high risk for toxicities.Xx_NEWLINE_xXAny significant medical condition that, in the opinion of the investigator or sponsor, may place the participant at undue risk from the study.Xx_NEWLINE_xXAny condition, which, in the site investigator's opinion, makes the subject unsuitable for trial participation.Xx_NEWLINE_xXConsidered by the investigator to be an appropriate candidate for a Phase 1 clinical study;Xx_NEWLINE_xXAny condition deemed by the investigator to be likely to interfere with a subject's ability to participate in the clinical trial.Xx_NEWLINE_xXAny other reason the investigator considers the patient should not participate in the studyXx_NEWLINE_xXUncontrolled intercurrent illness involving any other organ system or a social situation that would, in investigator's opinion, place the subject at unacceptable risk, limit compliance, or confound interpretation of safety or other results.Xx_NEWLINE_xXNo other medical, or psychosocial problems, which in the opinion of the primary physician or principal investigator would place the patient at unacceptably high risk from this treatment regimenXx_NEWLINE_xXAny serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administrationXx_NEWLINE_xXAny life-threatening illness, medical condition, or organ system dysfunction which, in the investigator’s opinion, could compromise the subject’s safety, interfere with the absorption or metabolism of ibrutinib capsules, or put the study outcomes at undue riskXx_NEWLINE_xXThe presence of any medical condition that the Investigator deems incompatible with participation in the trialXx_NEWLINE_xXDONOR: The presence of any medical condition that the investigator deems incompatible with participation in the trialXx_NEWLINE_xXAny other condition which, in the opinion of the Investigator, would preclude participation in this trialXx_NEWLINE_xXUncontrolled intercurrent illness (i.e., active infection ? Grade 2) or concurrent condition that, in the opinion of the Investigator, would interfere with the study endpoints or the subject's ability to participate.Xx_NEWLINE_xXThe presence of a medical or psychiatric condition that, in the opinion of the Principal Investigator, makes the subject inappropriate for inclusion in this study.Xx_NEWLINE_xXClinically significant abnormalities, other than HCV infection, in a participant with HCC based upon the medical history, physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram (ECG) that make the participant an unsuitable candidate for this study in the opinion of the investigator.Xx_NEWLINE_xXSubject has any condition which makes the subject unsuitable for study participation.Xx_NEWLINE_xXAny other circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocolXx_NEWLINE_xXSubject is a family member or employee of the investigatorXx_NEWLINE_xXIn the opinion of the investigator, the participant or legal guardian is capable of understanding and complying with protocol requirements for the duration of the study.Xx_NEWLINE_xXConcurrent clinically significant illness, medical condition, surgical history, physical finding, electrocardiogram or laboratory finding that, in the opinion of the investigator, could adversely affect the safety of the subject or impair the assessment of the study results.Xx_NEWLINE_xXAny condition that is unstable or could jeopardize the safety of the patient and his/her compliance in the studyXx_NEWLINE_xXAny life-threatening illness, medical condition, or organ system dysfunction that, in the investigator's opinion, could compromise the subject's safety or put the study outcomes at undue risk.Xx_NEWLINE_xXIn opinion of Investigator, make subject unsuitable for study.Xx_NEWLINE_xXSerious concomitant systemic disorders (including active infections) that would compromise the safety of the patient or compromise the patient’s ability to complete the study, at the discretion of the investigator; this includes sclerodermaXx_NEWLINE_xXAny condition which, in the investigator’s opinion, makes the subject unsuitable for trial participationXx_NEWLINE_xXAny life-threatening condition that could affect protocol compliance.Xx_NEWLINE_xXAny malabsorption condition that in the opinion of the investigator would significantly impact drug absorptionXx_NEWLINE_xXAny condition which, in the investigator’s opinion, makes the subject unsuitable for trial participationXx_NEWLINE_xXAny serious or uncontrolled medical disorder or active infection that, in the opinion of the investigator, may increase the risk associated with study participation, study drug administration, or would impair the ability of the subject to receive protocol therapyXx_NEWLINE_xXAny reason why, in the opinion of the investigator, the patient should not participateXx_NEWLINE_xXAny malabsorption condition that in the opinion of the investigator would significantly impact drug absorptionXx_NEWLINE_xXAny condition which, in the investigator’s opinion, makes the subject unsuitable for trial participationXx_NEWLINE_xXAny condition which in the investigator’s opinion deems the patient an unsuitable candidate to receive treatment (i.e., any significant medical illness or abnormal laboratory finding that would, in the investigator’s judgment, increase the subject’s risk by participating in this study)Xx_NEWLINE_xXAny condition or abnormality which may, in the opinion of the investigator, compromise the safety of patientsXx_NEWLINE_xXAny condition that was unstable or which could jeopardize the safety of the patient and his/her compliance in the study.Xx_NEWLINE_xXAny medical condition that would preclude adequate evaluation of the safety and toxicity of the study combinationXx_NEWLINE_xXAny condition which in the investigator’s opinion deems the patient an unsuitable candidate to receive study drugXx_NEWLINE_xXAny concurrent disease and/or medical condition that, in the opinion of the Investigator, would prevent the subject's participation.Xx_NEWLINE_xXParticipants must, in the opinion of the investigator, be capable of complying with the protocolXx_NEWLINE_xXCurrent life-threatening illness, medical condition, or organ system dysfunction which, in the Investigator’s opinion, could compromise the patient’s safety, or put the study at risk; any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver or other organ system that may place the subject at undue risk to undergo therapy with ibrutinibXx_NEWLINE_xXAny other condition which, in the opinion of the investigator, would preclude participation in this trialXx_NEWLINE_xXSignificant, concurrent, uncontrolled medical condition which, in the opinion of the investigator, may interfere with patient participation in the study.Xx_NEWLINE_xXMust in the opinion of the investigator be capable of complying with this protocolXx_NEWLINE_xXAny serious, active underlying medical condition that would impair the ability of the subjects to receive study treatmentXx_NEWLINE_xXAny condition which in the Investigators' opinion deems the subject an unsuitable candidate to receive study drug and therapyXx_NEWLINE_xXThe patient has a prior or concurrent malignancy that in the opinion of the investigator, presents a greater risk to the patient’s health and survival, than of the MCL, within the subsequent 6 months at the time of consent; investigator discretion is allowedXx_NEWLINE_xXAny condition which in the investigator’s opinion deems the subject an unsuitable candidate to receive study drugXx_NEWLINE_xXAcute Hepatitis B. Chronic Hepatitis B eligible if condition is stable and, in the opinion of the investigator or Amgen physician, if consulted, would not pose a risk to subject safetyXx_NEWLINE_xXConcomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this studyXx_NEWLINE_xXAny uncontrolled, intercurrent illness that in the opinion of the Investigator may interfere with study evaluation. Participants with uncontrolled diabetes will be excluded from the study.Xx_NEWLINE_xXAny condition that is unstable or which in the opinion of the Investigator could jeopardize the safety of the patient and his/her compliance in the studyXx_NEWLINE_xXConcomitant disease or condition that would interfere with the conduct of the study or that would, in the opinion of the Investigator, pose an unacceptable risk to the patient in this study.Xx_NEWLINE_xXAny serious underlying medical condition that, in the opinion of the investigator or medical monitor, would impair the ability to receive or tolerate the planned treatmentXx_NEWLINE_xXAny other condition that is unstable or which could jeopardize the safety of the patient and his/her protocol complianceXx_NEWLINE_xXSuffer from any condition or illness that, in the opinion of the investigator, would compromise patient safety or interfere with the evaluation of the safety of the study drugXx_NEWLINE_xXSerious nonmalignant disease (e.g., hydronephrosis, liver failure, heart failure, or other conditions) that could compromise protocol objectives in the opinion of the investigator and/or the sponsor.Xx_NEWLINE_xXPatient has serious medical risk factors involving any of the major organ systems such that the investigator considers it unsafe for the patient to receive chemotherapy and/or radiation therapyXx_NEWLINE_xXAny condition or organ toxicity that is deemed by the principal investigator (PI) or the attending physician to place the patient at unacceptable risk for treatment on the protocolXx_NEWLINE_xXSerious underlying medical or psychiatric illnesses that would, in the opinion of the treating physician, substantially increase the risk for complications related to treatment; similarly, any unstable medical condition that in the opinion of the treating physician or study investigators, would interfere with determination of the study objectivesXx_NEWLINE_xXPatient has serious medical risk factors involving any of the major organ systems such that the investigator considers it unsafe for the patient to receive chemotherapy and/or radiation therapyXx_NEWLINE_xXUse of any medical conditions that, in the Investigator's opinion, would impose excessive risk to the patient.Xx_NEWLINE_xXMedical, psychological or surgical condition which the investigator feels might compromise study participationXx_NEWLINE_xXAny serious medical condition considered by the investigator to constitute an unwarranted high risk for investigational treatmentXx_NEWLINE_xXNo patient may be entered onto the study without consultation with the principal investigator or his designeeXx_NEWLINE_xXSignificant concurrent, uncontrolled medical condition including, but not limited to, renal, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease which in the opinion of the investigator may represent a risk for the patientXx_NEWLINE_xXParticipants must, in the opinion of the investigator, be capable of complying with the protocolXx_NEWLINE_xXAny other medical condition that, in the opinion of the principal investigator (PI), may interfere with a subject's participation in or compliance with the studyXx_NEWLINE_xXHas any other medical or personal condition that, in the opinion of the Investigator, may potentially compromise the safety or compliance of the patient, or may preclude the patient's successful completion of the clinical trial.Xx_NEWLINE_xXHistory of concomitant medical conditions or infectious diseases that, in the opinion of the investigator, would compromise the participant's ability to safely complete the study.Xx_NEWLINE_xXAny other medical condition that, in the opinion of the PI, may interfere with a subject's participation in or compliance with the studyXx_NEWLINE_xXPsychiatric or addictive disorders or other conditions that in the opinion of the investigators would preclude the patient from complying with the study protocolXx_NEWLINE_xXAny condition which in the investigator's opinion deems the patient an unsuitable candidate to receive study drugXx_NEWLINE_xXAny illness or condition that in the opinion of the Investigator may affect safety of treatment or evaluation of any the study’s endpointsXx_NEWLINE_xXPatients who have serious intercurrent medical illness which in the opinion of the investigator would compromise the patient's ability to tolerate this therapyXx_NEWLINE_xXKey Inclusion Criteria:\n\n          -  Received an autologous or allogeneic HCT using any conditioning regimen\n\n          -  Evidence of new abnormalities on chest X-ray obtained < 48 hours prior to screening,\n             determined to be consistent with LRTI by the local radiologist, relative to the most\n             recent previous chest X-ray. If chest X-ray is not available, a chest X-ray must be\n             obtained for screening.\n\n          -  Documented RSV in both the upper (eg, nasal swab, nasopharyngeal swab, nasal wash) and\n             lower (eg, induced sputum, bronchoalveolar lavage, lung biopsy, but not spontaneous\n             sputum) respiratory tract as determined by local testing (eg, polymerase chain\n             reaction, direct fluorescence antibody, respiratory viral panel assay, or culture).\n             All samples must have been collected ? 6 days prior to Day 1, or as determined at\n             screening as per protocol.\n\n          -  An informed consent document signed and dated by the participant or a legal guardian\n             of the participant and investigator or his/her designee.\n\n          -  A negative urine or serum pregnancy test is required for female participants (unless\n             surgically sterile or greater than two years post-menopausal)\n\n          -  Male and female participants of childbearing potential must agree to contraceptive\n             requirements as described in the study protocol\n\n          -  Willingness to complete necessary study procedures and have available a working\n             telephone or email\n\n        Key Exclusion Criteria:\n\n        Related to concomitant or previous medication use:\n\n          -  Use of non-marketed (according to region) investigational agents within 30 days, OR\n             use of any monoclonal anti-RSV antibodies within 4 months or 5 half-lives of\n             screening, whichever is longer, OR use of any investigational RSV vaccines after HCT\n\n          -  Use of a moderate or strong cytochrome P450 enzyme inducer including but not limited\n             to rifampin, St. John's Wort, carbamazepine, phenytoin, efavirenz, bosentan,\n             etravirine, modafinil, and nafcillin, within 2 weeks prior to the first dose of study\n             drug\n\n        Related to medical history:\n\n          -  Pregnant, breastfeeding, or lactating females\n\n          -  Unable to tolerate nasal sampling required for this study, as determined by the\n             investigator\n\n          -  Known history of HIV/AIDS with a CD4 count <200 cells/?L within the last month\n\n          -  History of drug and/or alcohol abuse that, in the opinion of the investigator, may\n             prevent adherence to study activities\n\n        Related to medical conditions:\n\n          -  Requiring invasive mechanical ventilation at the time of randomization\n\n          -  Documented to be positive for other respiratory viruses (limited to influenza,\n             parainfluenza, human rhinovirus, adenovirus, human metapneumovirus, or coronavirus),\n             from the lower respiratory tract sample as determined by local testing\n\n          -  Clinically significant bacteremia or fungemia within 7 days prior to screening that\n             has not been adequately treated, as determined by the investigator\n\n          -  Clinically significant bacterial, fungal, or viral pneumonia within 2 weeks prior to\n             screening that has not been adequately treated, as determined by the investigator\n\n          -  Excessive nausea/vomiting at screening, as determined by the investigator, or an\n             inability to swallow pills that precludes oral administration of the investigational\n             medical product (for individuals without an NG tube in place)\n\n          -  Any condition which, in the opinion of the investigator, would prevent full\n             participation in this trial or would interfere with the evaluation of the trial\n             endpoints\n\n        Related to laboratory results:\n\n          -  Creatinine clearance < 30 mL/min (calculated using the Cockcroft-Gault method)\n\n          -  Clinically significant aspartate aminotransferase/alanine aminotransferase, as\n             determined by the investigator\n\n          -  Clinically significant total bilirubin, as determined by the investigator\n\n        Note: Other protocol defined Inclusion/Exclusion criteria may apply.Xx_NEWLINE_xXInclusion Criteria:\n\n          -  Received an autologous or allogeneic HCT using any conditioning regimen\n\n          -  Documented to be RSV-positive as determined by local testing (eg, polymerase chain\n             reaction, direct fluorescence antibody, respiratory viral panel assay, or culture)\n             using an upper respiratory tract sample collected ? 6 days prior to Day 1\n\n          -  New onset of at least 1 of the following respiratory symptoms for ? 7 days prior to\n             Day 1: nasal congestion, runny nose, cough, or sore throat, or worsening of one of\n             these chronic (associated with a previously existing diagnosis, eg, chronic\n             rhinorrhea, seasonal allergies, chronic lung disease) respiratory symptoms ? 7 days\n             prior to Day 1\n\n          -  No evidence of new abnormalities consistent with LRTI on a chest X-ray relative to the\n             most recent chest X-ray, as determined by the local radiologist. If a chest X-ray is\n             not available or was not obtained during standard care < 48 hours prior to screening,\n             a chest X-ray must be obtained for screening\n\n          -  O2 saturation ? 92% on room air\n\n          -  An informed consent document signed and dated by the participant or a legal guardian\n             of the participant and the investigator or his/her designee\n\n          -  A negative urine or serum pregnancy test is required for female participants (unless\n             surgically sterile or greater than two years post-menopausal)\n\n          -  Male and female participants of childbearing potential must agree to contraceptive\n             requirements as described in the study protocol\n\n          -  Willingness to complete necessary study procedures and have available a working\n             telephone or email\n\n        Exclusion Criteria:\n\n        Related to concomitant or previous medication use:\n\n          -  Use of non-marketed (according to region) investigational agents within 30 days, OR\n             use of any monoclonal anti-RSV antibodies within 4 months or 5 half-lives of\n             screening, whichever is longer, OR use of any investigational RSV vaccines after HCT\n\n        Related to medical history:\n\n          -  Pregnant, breastfeeding, or lactating females\n\n          -  Unable to tolerate nasal sampling required for this study, as determined by the\n             investigator\n\n          -  Known history of HIV/AIDS with a CD4 count <200 cells/?L within the last month\n\n          -  History of drug and/or alcohol abuse that, in the opinion of the investigator, may\n             prevent adherence to study activities\n\n        Related to medical condition at screening:\n\n          -  Documented to be positive for other respiratory viruses (limited to influenza,\n             parainfluenza, human rhinovirus, adenovirus, or human metapneumovirus, or coronavirus)\n             within 7 days prior to the screening visit, as determined by local testing (additional\n             testing is not required)\n\n          -  Clinically significant bacteremia or fungemia within 7 days prior to screening that\n             has not been adequately treated, as determined by the investigator\n\n          -  Clinically significant bacterial, fungal, or viral pneumonia within 2 weeks prior to\n             screening that has not been adequately treated, as determined by the investigator\n\n          -  Excessive nausea/vomiting at screening, as determined by the investigator, or an\n             inability to swallow pills that precludes oral administration of the investigational\n             medical product (for participants without an nasogastric tube in place)\n\n          -  Any condition which, in the opinion of the investigator, would prevent full\n             participation in this trial or would interfere with the evaluation of the trial\n             endpoints\n\n        Related to laboratory results:\n\n          -  Creatinine clearance < 30 mL/min (calculated using the Cockcroft-Gault method)\n\n          -  Clinically significant aspertate aminotransferase/alanine aminotransferase, as\n             determined by the investigator\n\n          -  Clinically significant total bilirubin, as determined by the investigatorXx_NEWLINE_xXA medical condition that precludes adequate study treatment or increases patient riskXx_NEWLINE_xXPsychiatric conditions or diminished capacity that could compromise the giving of informed consent, or interfere with study compliance; any underlying medical or psychiatric condition, which in the opinion of the investigator will make the administration of nivolumab and ipilimumab hazardous or obscure the interpretation of adverse events (AEs)Xx_NEWLINE_xXRequires myelofibrosis therapy, in the opinion of the investigatorXx_NEWLINE_xXHave any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study or prevent the subject from meeting or performing study requirementsXx_NEWLINE_xXPatient has any underlying or current medical or psychiatric condition that, in the opinion of the Investigator, would interfere with the evaluation of the subject including but not limited to uncontrolled infection, heart failure, pulmonary hypertension, etc.Xx_NEWLINE_xXAny condition that, in the opinion of the investigator or sponsor, would interfere with evaluation of the investigational product.Xx_NEWLINE_xXPatient has a foreign body which in the opinion of the treating investigator could be difficult to manage in case of infection (e.g. prosthetic hip).Xx_NEWLINE_xXAny underlying medical or psychiatric condition, which in the opinion of the investigator/sub-investigator will make the administration of ipilimumab or nivolumab hazardous or obscure the interpretation of adverse events (AE)s, such as a condition associated with frequent diarrheaXx_NEWLINE_xXConcomitant intercurrent illness, or any condition which in the opinion of the Investigator, would compromise safe participation in the study, e.g. active severe infection, unstable angina pectoris, new onset of exacerbation of a cardiac arrhythmiaXx_NEWLINE_xXAny condition (concurrent disease, infection, or comorbidity) that interferes with ability to participate in the study, causes undue risk, or complicates the interpretation of safety data, in the opinion of the investigator or medical monitor.Xx_NEWLINE_xXKnown inability to undergo neoadjuvant gemcitabine and cisplatin combination treatment due to pre-existing medical conditions in the opinion of the treating physician or investigatorXx_NEWLINE_xXAny concurrent medical condition that, in the opinion of the Investigator, would complicate or compromise compliance with the study or the well-being of the subjectXx_NEWLINE_xXAny other condition that in the investigator's opinion would not make the subject a good candidate for the clinical study,Xx_NEWLINE_xXHave serious preexisting medical conditions (left to the discretion of the investigator).Xx_NEWLINE_xXAny other clinically significant medical disease or condition that, in the Investigator’s opinion, may interfere with protocol adherence or a subject’s ability to give informed consentXx_NEWLINE_xXOther serious uncontrolled medical conditions that the investigator feels might compromise study participationXx_NEWLINE_xXSubjects who, in the Investigator's opinion, have any medical condition that makes the subject a poor candidate for the investigational procedure, or interferes with the interpretation of study results.Xx_NEWLINE_xXHistory of prior therapy or a serious, uncontrolled medical disorder that in the Investigator's opinion would impair participation in the study.Xx_NEWLINE_xXPatient has any other medical, psychiatric, or social condition, including substance abuse that in the opinion of the investigator would preclude participation in the study.Xx_NEWLINE_xXThe presence of a medical or psychiatric condition that, in the opinion of the Principal Investigator, makes the patient inappropriate for inclusion in this study.Xx_NEWLINE_xXOther severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that would, in the investigator's opinion, contraindicate participation in this studyXx_NEWLINE_xXPrior or ongoing clinically significant illness, medical condition, surgical history, physical finding, ECG finding, or laboratory abnormality that, in the investigator's opinion, could affect the safety of the patient, alter the absorption, distribution, metabolism or excretion of the study drug, or impair the assessment of study resultsXx_NEWLINE_xXAny condition that in the opinion of the investigator would cause the subject to be unable to participate or tolerate the protocol regimenXx_NEWLINE_xXOngoing or recent history of any other uncontrolled and/or clinically significant systemic disease or condition which, in the Investigator's medical opinion, should exclude participation in the studyXx_NEWLINE_xXUnstable or clinically significant concurrent medical condition that would, in the opinion of the investigator, jeopardize the safety of a subject and/or compliance with the protocolXx_NEWLINE_xXConcurrent use of complementary or alternative medicines that in the opinion of the principal investigator would confound the interpretation of toxicities and/or antitumor activity of the study drugXx_NEWLINE_xXAny serious or uncontrolled medical disorder or active infection that, in the opinion of the Investigator, may increase the risk associated with study participation, study drug administration, or would impair the ability of the patient to receive protocol therapy.Xx_NEWLINE_xXPhysical or psychological condition which would impair study participation; orXx_NEWLINE_xXThe subject is judged unsuitable for study participation by the Investigator for any other reason.Xx_NEWLINE_xXAny concurrent condition which in the investigator’s opinion makes it undesirable for the subject to participate in this trial or which would jeopardize compliance with the protocolXx_NEWLINE_xXSubject with concurrent severe and/or uncontrolled medical or psychiatric conditions that in the opinion of the investigator may impair the participation in the study or the evaluation of safety and/or efficacyXx_NEWLINE_xXIn the judgment of the investigator, participation in the protocol offers an acceptable benefit-to-risk ratio when considering current disease status, medical condition, and the potential benefits and risks of alternative treatments for the individual's NHLXx_NEWLINE_xXA life threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the individual's safety or interfere with the absorption or metabolism of ENTOXx_NEWLINE_xXAny condition that, in the opinion of the investigator or the Sponsor, makes the patients unsuitable for the study.Xx_NEWLINE_xXAny significant disease that, in the opinion of the investigator, may impair the patient's tolerance of study treatment.Xx_NEWLINE_xXHave any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study or prevent the subject from meeting or performing study requirementsXx_NEWLINE_xXAny underlying medical condition that in the principal investigator’s opinion will make the administration of study drug hazardous to the patient or would obscure the interpretation of adverse eventsXx_NEWLINE_xXSubject with significant or uncontrolled cardiac, renal, hepatic or other systemic disorders; or significant psychological conditions at baseline that in the investigator's opinion, makes the subject unsuitable for study participation.Xx_NEWLINE_xXDisease that requires treatment based on the Investigator's opinion (e.g., meets GELF criteria)Xx_NEWLINE_xXSubject has concurrent severe or uncontrolled medical disease or organ system dysfunction which, in the opinion of the Investigators, would limit life expectancy to < 3 months.Xx_NEWLINE_xXIn the opinion of the investigator, subjects who have a life expectancy fewer than 30 days.Xx_NEWLINE_xXImpending or actual fracture at any other location that, in the Investigator's opinion, would preclude ability to assess pain and/or function in the target humerus.Xx_NEWLINE_xXAny medical condition, which in the opinion of the study Investigator, places the participant at an unacceptably high risk for toxicitiesXx_NEWLINE_xXAny other medical or psychological condition, deemed by the Investigator to be likely to interfere with a subject's ability to sign informed consent, cooperate, or participate in the studyXx_NEWLINE_xXPatient with concurrent severe and/or uncontrolled medical conditions that, in the opinion of the investigator, may impair participation in the study or the evaluation of safety and/or efficacyXx_NEWLINE_xXHas medical, social, or psychological factors that, in the opinion of the Investigator, could impact safety or compliance with study proceduresXx_NEWLINE_xXUnstable or clinically significant concurrent medical condition that would, in the opinion of the investigator, jeopardize the safety of a patient and/or their compliance with the protocol.Xx_NEWLINE_xXCurrent life-threatening illness, medical condition, or organ system dysfunction which, in the Investigator’s opinion, could compromise the patient’s safety, or put the study at riskXx_NEWLINE_xXAny condition, which in the opinion of the investigator, would preclude participation in this trialXx_NEWLINE_xXPatient whose disease progressed on insufficient dose of EGFR TKI immediately prior to study in the opinion of the investigatorXx_NEWLINE_xXAny history of or concomitant condition that, in the opinion of the investigator not to comply with the study or interfere with the evaluation of the efficacy and safety of the test drugXx_NEWLINE_xXAny significant disease that, in the opinion of the investigator, may impair the patient’s tolerance of study treatmentXx_NEWLINE_xXIllness or any other circumstances (as defined by the investigator), which would preclude safe performance of study procedures or compromise the ability of the patient to consent to studyXx_NEWLINE_xXAny condition that is unstable or that could jeopardize the safety of the subject and the subject's protocol compliance, including known infection with human immunodeficiency virusXx_NEWLINE_xXSignificant gastrointestinal disorders, in the opinion of the InvestigatorXx_NEWLINE_xXSerious concomitant disease or medical condition affecting compliance with trial requirements or which are considered relevant for the evaluation of the efficacy or safety of the trial drug,Xx_NEWLINE_xXPatients with any clinically significant medical condition which, in the opinion of the investigator, makes it undesirable for the patient to participate in the study or which could jeopardize compliance with protocol requirements including, but not limited to: ongoing or active infection, significant uncontrolled hypertension, or severe psychiatric illness/social situationsXx_NEWLINE_xXPatients with a co-morbid condition(s) that, in the opinion of the investigator, prevents safe surgery/biopsy procedureXx_NEWLINE_xXSubjects who in the opinion of the subject and investigator would benefit more from regorafenib treatment (except where regorafenib is not reimbursed in the country)Xx_NEWLINE_xXAny condition which in the investigator's opinion makes the patient unsuitable for study participation.Xx_NEWLINE_xXHas a concomitant medical condition that would increase the risk of toxicity, in the opinion of the Investigator or Sponsor.Xx_NEWLINE_xXAny condition that is unstable and could jeopardize the subject's participation in the study.Xx_NEWLINE_xXThe presence of any medical condition that the Investigator deems incompatible with participation in the trialXx_NEWLINE_xXDONOR: The presence of any medical condition that the Investigator deems incompatible with participation in the trialXx_NEWLINE_xXAny condition that is unstable and could jeopardize the subject's participation in the study.Xx_NEWLINE_xXHave a history of thrombocytopenia with complications including hemorrhage or bleeding >= grade 2 using NCI CTCAE v4.03, 14 June 2010 that required medical intervention or any hemolytic condition or coagulation disorders that would make participation unsafe in the opinion of the investigatorXx_NEWLINE_xXHave signs or symptoms of end organ failure, major chronic illnesses other than cancer, or any severe concomitant conditions which, in the opinion of the investigator, make it undesirable for the patient to participate in the study, or which could jeopardize compliance with the protocolXx_NEWLINE_xXAny circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocolXx_NEWLINE_xXHas medical, social, or psychosocial factors that, in the opinion of the investigator, could impact safety or compliance with study proceduresXx_NEWLINE_xXActive infection or antibiotics within one-week prior to study, including unexplained fever; any significant psychiatric disease, medical intervention, or other condition, which in the opinion of the principal investigator, could prevent adequate informed consent or compromise participation in the clinical trialXx_NEWLINE_xXPatients with medical conditions, which, in the opinion of the investigators, would jeopardize either the patient or the integrity of the data obtained will not be eligibleXx_NEWLINE_xXAny condition which, in the opinion of the investigator, would preclude participation in this trialXx_NEWLINE_xXSerious nonmalignant disease (e.g., hydronephrosis, liver failure, or other conditions) that could compromise protocol objectives in the opinion of the investigator and/or the sponsor.Xx_NEWLINE_xXAny other condition including but not limited to major co-morbidities, which in the opinion of the investigator would render the patient ineligible.Xx_NEWLINE_xXAny other clinically significant medical disease or psychiatric condition that, in the Investigator's opinion, may interfere with protocol complianceXx_NEWLINE_xXPatients with any other life-threatening illness, significant organ system dysfunction, or clinically significant laboratory abnormality, which, in the opinion of the Investigator, would either compromise the patient's safety or interfere with evaluation of the safety of the study drug.Xx_NEWLINE_xXIn the opinion of the investigator, patients who are significantly below their ideal body weightXx_NEWLINE_xXAny condition which in the Investigator’s opinion deems the patient an unsuitable candidate to receive treatmentXx_NEWLINE_xXHistory of prior therapy or a serious, uncontrolled medical disorder that in the Investigator's opinion would impair participation in the studyXx_NEWLINE_xXAny medical condition, which in the opinion of the study investigator, places the subject at an unacceptably high risk for toxicities;Xx_NEWLINE_xXHave any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study or prevent the subject from meeting or performing study requirementsXx_NEWLINE_xXSubject has a significant history of cardiovascular disease (e.g., myocardial infarction [MI], thrombotic or thromboembolic event in the last 6 months), renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, or hepatic disease that in the opinion of the Investigator would adversely affect his/her participating in this studyXx_NEWLINE_xXPatients must not have any coexisting medical condition that is likely to interfere with study procedures or results, and must be reasonable candidates for intensive chemotherapy, in the opinion of their treating physiciansXx_NEWLINE_xXAny clinically significant concomitant disease or condition that could interfere with, or for which treatment might interfere with, the conduct of the study, or absorption of oral medications, or that would, in the opinion of the principal investigator, pose an unacceptable risk to the subject in the studyXx_NEWLINE_xXThe risk of rapidly fatal illness and death within 72 hrs, or any concomitant condition not related to ventilator-associated pneumonia that, in the opinion of the investigator, precludes completion of study evaluations and the course of therapyXx_NEWLINE_xXHistory of any condition or uncontrolled intercurrent illness that in the opinion of the local investigator might interfere with or limit the patient's ability to comply with the protocol or pose additional or unacceptable risk to the patient.Xx_NEWLINE_xXAny other clinically significant medical disease or condition that, in the Investigator’s opinion, may interfere with protocol adherence or a subject’s ability to give informed consentXx_NEWLINE_xXPatients with any other life-threatening illness, significant organ system dysfunction, or clinically significant laboratory abnormality, which, in the opinion of the Investigator, would either compromise the patient's safety or interfere with evaluation of the safety of the study drugXx_NEWLINE_xXAny other evidence of severe iron overload that, in the Investigator's opinion, warrants exclusion.Xx_NEWLINE_xXSubject is hospitalized for a condition other than VOCXx_NEWLINE_xXPatients with medical conditions, which, in the opinion of the investigators, would jeopardize either the patient or the integrity of the data obtained will not be eligibleXx_NEWLINE_xXKnown concomitant disease(s) known to influence calcium metabolism including hyperparathyroidism, hyperthyroidism, Paget's disease of bone, or any other concurrent severe or uncontrolled concomitant medical condition that, in the opinion of the Investigator, would preclude participation in this studyXx_NEWLINE_xXHistory of significant disease that in the Investigator's opinion would put the patient at high risk on the trialXx_NEWLINE_xXPatients who in the opinion of the Investigator would not be able to provide reliable study data or be available for study follow-upXx_NEWLINE_xXAny medical or psychiatric illness which, in the opinion of the principal investigator, would compromise the patient's ability to tolerate this treatment regimenXx_NEWLINE_xXPsychiatric or cognitive illness or recreational drug/alcohol use that, in the opinion of the principal investigator, would affect patient safety and/or compliance.Xx_NEWLINE_xXAny significant finding in the patient's medical history or physical examination that, in the opinion of the investigator, would affect patient safety or compliance with the dosing schedule.Xx_NEWLINE_xXIn the opinion of the Investigator, subjects with a low chance of survival during the first 5 days of treatment.Xx_NEWLINE_xXSubjects may not have an underlying medical condition that in the opinion of the investigator could adversely affect the ability of the subject to comply with or tolerate study procedures and/or study therapy, or confound the ability to interpret the tolerability of combined administration of dasatinib and ipilimumab in treated subjectsXx_NEWLINE_xXThe patient has any medical condition which in the opinion of the Investigator places the patient at an unacceptably high risk for toxicities.Xx_NEWLINE_xXAny condition that is unstable or could jeopardize the safety of the subject and his / her compliance to the study.Xx_NEWLINE_xXAny condition which, in the investigator’s opinion, makes the subject unsuitable for trial participationXx_NEWLINE_xXAny condition which in the investigator's opinion makes the patient unsuitable for the study participationXx_NEWLINE_xXClinical judgement by the investigator that the patient should not participate in the studyXx_NEWLINE_xXAny medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the participant's safe participation in and completion of the study Cancer-Specific Exclusion CriteriaXx_NEWLINE_xXIn the opinion of the investigator, patients who are significantly below their ideal body weight.Xx_NEWLINE_xXIn the opinion of the investigator the protocol treatment is appropriate for the participantXx_NEWLINE_xXKnown or suspected hypersensitivity to ofatumumab or bendamustine that in the opinion of the investigator is a contraindication to their participation in the present study.Xx_NEWLINE_xXSubjects can participate in the study if in the opinion of the investigator it is thought not to affect the subject's safety, the conduct of the study or the interpretation of the data.Xx_NEWLINE_xXSerious concurrent medical illness that in the opinion of the investigator would compromise patient safety or preclude accurate assessment of outcome.Xx_NEWLINE_xXSerious concurrent psychiatric disorder that in the opinion of the investigator would compromise patient safety or preclude accurate assessment of outcome.Xx_NEWLINE_xXPatients with any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study or prevent the subject from meeting or performing study requirementsXx_NEWLINE_xXSystemic cardiac disease that would, in the opinion of the investigator or medical monitor, interfere with assessment of efficacy or safety of the drugXx_NEWLINE_xXAny serious underlying medical condition that, in the opinion of the investigator or medical monitor, would impair their ability to receive or tolerate the planned treatmentXx_NEWLINE_xXDonor must not have any medical condition, which, in the opinion of the clinical investigator, would interfere with his/her evaluation.Xx_NEWLINE_xXSubject has any medical condition which in the opinion of the investigator places the subject at an unacceptably high risk for toxicities.Xx_NEWLINE_xXAny condition that, in the opinion of the investigator, would compromise the well-being of the participant or the study or prevent the participant from meeting or performing study requirements OEP phase:Xx_NEWLINE_xXAny medical or other condition which, in the opinion of the PI or designee, will preclude participation in a clinical trial.Xx_NEWLINE_xXAny underlying medical or psychiatric condition, which in the opinion of the investigator will make the administration of ipilimumab hazardous or obscure the interpretation of adverse events (AEs), such as a condition associated with frequent diarrheaXx_NEWLINE_xXOther significant concurrent, uncontrolled medical conditions including, but not limited to, renal, hepatic, autoimmune, hematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease which, in the Investigator's opinion, will impact study participation.Xx_NEWLINE_xXAny co-morbid condition that in the judgment of the investigator renders the subject at high risk of treatment complications or reduces the possibility of assessing clinical effect.Xx_NEWLINE_xXAny co-morbid medical disorder that may increase the risk of toxicity, in the opinion of the investigator or sponsorXx_NEWLINE_xXSubjects must in the opinion of the Investigator be capable of complying with this protocolXx_NEWLINE_xXA serious underlying medical condition that would impair the ability of the patient to receive protocol treatmentXx_NEWLINE_xXSubjects who, in the opinion of the investigator, are not likely to survive beyond 48 hours from Baseline.Xx_NEWLINE_xXConcurrent severe or uncontrolled medical disease that would compromise the safety or compromise the ability of the patient to complete the studyXx_NEWLINE_xXConcurrent severe or uncontrolled medical disease that would compromise the safety or compromise the ability of the patient to complete the studyXx_NEWLINE_xXConcurrent severe or uncontrolled medical disease that would compromise the safety or compromise the ability of the patient to complete studyXx_NEWLINE_xXOther significant concurrent, uncontrolled medical conditions including, but not limited to, renal, hepatic, autoimmune, hematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease which, in the investigator's opinion, will impact study participation.Xx_NEWLINE_xXMedical, psychological or surgical condition which the investigator feels might compromise study participationXx_NEWLINE_xXAny other condition that, in the opinion of the investigator, would make the subject unsuitable for enrollment or could interfere with the subject participating in and completing the protocol.Xx_NEWLINE_xXPatients with medical history or conditions not otherwise previously specified which in the opinion of the investigator should exclude participation in this study; the investigator should consult the study chairXx_NEWLINE_xXAny reason why, in the opinion of the investigator, the patient should not participateXx_NEWLINE_xXAny other clinically significant medical disease or condition that, in the Investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consentXx_NEWLINE_xXSerious concomitant systemic disorders (including active infections) that would compromise the safety of the patient or compromise the patient’s ability to complete the study, at the discretion of the investigatorXx_NEWLINE_xXSubjects with a condition which may interfere with the subjects' ability to understand the requirements of the study.Xx_NEWLINE_xXAny significant psychiatric disease, medical intervention, or other condition, which in the opinion of the principal investigator or co-investigators, could prevent adequate informed consent or compromise participation in the clinical trialXx_NEWLINE_xXNo medical, psychological or surgical condition which the investigator feels might compromise study participationXx_NEWLINE_xXPatients must not have any significant medical illnesses that in the investigator's opinion cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate this therapyXx_NEWLINE_xXPatients must not have any significant medical illnesses that in the investigator’s opinion cannot be adequately controlled with appropriate therapy or would compromise the patient’s ability to tolerate this therapyXx_NEWLINE_xXAny concurrent condition which in the investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardize compliance with the protocol.Xx_NEWLINE_xXAny reason why, in the opinion of the investigator, the patient should not participateXx_NEWLINE_xXPatients who have completed preceding gefitinib therapy from either the 1839IL/0709 (250mg dosing) study or 1839IL/0710 (250mg dosing) study and in the opinion of the investigator may benefit from further gefitinib treatment.Xx_NEWLINE_xXIn the opinion of the investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease).Xx_NEWLINE_xXHas any other clinically important abnormalities such that risk to patient of participation outweighs the potential benefit of therapy as determined by the investigatorXx_NEWLINE_xXUncontrolled cystitis, gross hematuria, bladder pain, or bladder spasms, other uncontrolled concurrent illness, or any underlying medical condition, including any underlying conditions resulting in chronic immunosuppression which in the Investigator’s opinion will make the administration of talimogene laherparepvec hazardous, or obscure the interpretation of adverse eventsXx_NEWLINE_xXPresence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient or the quality of the dataXx_NEWLINE_xXAny life-threatening illness, medical condition, or organ system dysfunction which, in the investigator’s opinion, could compromise the subject’s safety, interfere with the absorption or metabolism of ibrutinib capsules, or put the study outcomes at undue riskXx_NEWLINE_xXSubject has any condition which may require treatment during the study and may make the subject unsuitable for study participation.Xx_NEWLINE_xXAny condition that in the opinion of the investigator, would preclude participation in this studyXx_NEWLINE_xXAny life-threatening illness, medical condition, or organ system dysfunction which, in the investigator’s opinion, could compromise the subject’s safety, interfere with the absorption or metabolism of ibrutinib capsules, or put the study outcomes at undue riskXx_NEWLINE_xXHistory of alcoholism, drug addiction, or any psychiatric or psychological condition which, in the opinion of the Investigator, would impair study complianceXx_NEWLINE_xXEvidence of current drug or alcohol abuse or psychiatric impairment, which in the Investigator’s opinion will prevent completion of the protocol therapy or follow-upXx_NEWLINE_xXAny condition which in the investigator’s opinion deems the patient an unsuitable candidate to receive study drug (i.e., any significant medical illness or abnormal laboratory finding that would, in the investigator’s judgment, increase the subject’s risk by participating in this study)Xx_NEWLINE_xXAny other medical, psychological, or social condition that may interfere with study participation or compliance, or compromise patient safety in the opinion of the investigatorXx_NEWLINE_xXSubject has concurrent corneal disorder or any ophthalmologic condition which, in the Investigator's opinion, makes the subject unsuitable for study participation (e.g., advanced cataracts, glaucoma, or subject is unable to undergo a comprehensive ophthalmologic exam).Xx_NEWLINE_xXHas any condition(s), which seriously compromises the subject's ability to participate in this study, sign consent, or has a known history of poor adherence with medical treatmentXx_NEWLINE_xXIn the opinion of the principal investigator (PI), has a history of drug or alcohol abuse within last 12 monthsXx_NEWLINE_xXAny condition which in the Investigator’s opinion deems the participant an unsuitable candidate to receive study drugXx_NEWLINE_xXAny condition or medical problem in addition to the underlying malignancy and organ dysfunction that the investigator feels would pose unacceptable riskXx_NEWLINE_xXPatients who are severely underweight in the opinion of the investigatorXx_NEWLINE_xXAny condition which in the investigator’s opinion deems the patient an unsuitable candidate to receive study drugXx_NEWLINE_xXAny condition which in the Investigator's opinion deems the patient an unsuitable candidate to receive study drugXx_NEWLINE_xXAny condition or history of illness or surgery that, in the opinion of the investigator, might confound the results of the study or pose additional risk to the patient (e.g. significant cardiovascular conditions)Xx_NEWLINE_xXPatients with a condition that, in the opinion of the investigator, would interfere with the absorption of oral medication will be excluded from the studyXx_NEWLINE_xXNo known history of any condition or factor judged by the investigator to preclude participation in the study or which might hinder study adherenceXx_NEWLINE_xXPatient has any other condition that, in the opinion of the investigator, may impact the absorption of oral medicationsXx_NEWLINE_xXPATIENT EXCLUSION: Current radiation therapy that in the opinion of the investigator is significantly affecting painXx_NEWLINE_xXAny other condition which, in the opinion of the investigator, would make the subject unsuitable for trial participationXx_NEWLINE_xXAcute or chronic medical disorder that, in the opinion of the investigator, would impair the ability of the subject to receive protocol treatmentXx_NEWLINE_xXHave any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study or prevent the subject from meeting or performing study requirementsXx_NEWLINE_xXAny co-morbid condition which, in the view of the principal investigator, renders the patient at high risk from treatment complicationsXx_NEWLINE_xXPATIENTS: Existence of co-morbid disease, which in the opinion of the investigator prohibits participation in the protocolXx_NEWLINE_xXAny condition or situation which, in the opinion of the treating physician, may interfere significantly with a subject's participation in the protocol.Xx_NEWLINE_xXAny other medical condition or laboratory evaluation that, in the treating physician‘s or principal investigator's opinion, makes the patient unsuitable to participate in this clinical trialXx_NEWLINE_xXHave a history of thrombocytopenia with complications including hemorrhage or bleeding of ?Grade 2 per NCI CTCAE v4.03 that required medical intervention or have any hemolytic condition or coagulation disorder that would make participation unsafe in the opinion of the investigator.Xx_NEWLINE_xXHave signs or symptoms of organ failure, major chronic illnesses other than cancer, or any concomitant medical or social condition that, in the opinion of the investigator, make it undesirable for the patient to participate in the study or that could jeopardize compliance with the protocol.Xx_NEWLINE_xXAny serious or unstable medical condition that interferes with ability to tolerate treatment or assessments associated with the protocol.Xx_NEWLINE_xXAny condition or reason that interferes with ability to participate in the study, tolerate treatment or assessments associated with the protocol, causes undue risk, or complicates the interpretation of safety data, in the opinion of the Investigator or Medical MonitorXx_NEWLINE_xXAny serious or unstable medical condition that interferes with ability to tolerate treatment or assessments associated with the protocol.Xx_NEWLINE_xXAny condition or reason that interferes with ability to participate in the study, tolerate treatment or assessments associated with the protocol, causes undue risk, or complicates the interpretation of safety data, in the opinion of the Investigator or Medical Monitor.Xx_NEWLINE_xXLife-threatening illness unrelated to cancer that could, in the investigator's opinion, make the participant not appropriate for this study.Xx_NEWLINE_xXHas a clinically significant cardiovascular, dermatologic, endocrine, gastrointestinal, hematologic, infectious, metabolic, neurologic, psychologic, or pulmonary disorder or any other condition, including excessive alcohol or drug abuse, or secondary malignancy, that may interfere with study participation in the opinion of the investigator.Xx_NEWLINE_xXAny medical or other condition that in the opinion of the investigator(s) would preclude the participant's participation in a clinical studyXx_NEWLINE_xXAll other significant diseases (for example, inflammatory bowel disease, uncontrolled asthma), which, in the opinion of the investigator, might impair the subject’s tolerance of trial treatmentXx_NEWLINE_xXAny condition that in the opinion of the investigator would preclude participation in this studyXx_NEWLINE_xXAny life-threatening illness, medical condition, or organ system dysfunction which, in the investigator’s opinion, could compromise the subject’s safety, interfere with the absorption or metabolism of ibrutinib capsules, or put the study outcomes at undue riskXx_NEWLINE_xXPossesses any condition, or is under treatment for any condition which, in the opinion of the investigator and/or consulting physicians(s), may constitute an unwarranted surgical riskXx_NEWLINE_xXMedical exclusions include: patients with a history of myocardial infarction or ischemic heart disease within the past six months; patients with history of epilepsy, brain damage, or symptomatic brain metastases; skin conditions such as open sores that would prevent proper application of the electrodes; or other medical or other condition(s) that in the opinion of the investigators might compromise the objectives of the studyXx_NEWLINE_xXOther medical or other condition(s) that in the opinion of the investigators might compromise the objectives of the studyXx_NEWLINE_xXAny condition that, in the opinion of the enrolling investigator, would interfere with the subject’s ability to comply with the study requirementsXx_NEWLINE_xXAny condition which in the investigator’s opinion deems the subject an unsuitable candidate to undergo observational study (may also include preoperative testing results including electrocardiography [EKG], chest x-ray, or pulmonary function tests that preclude a wide excision in the operating room)Xx_NEWLINE_xXAny other condition that, in the opinion of the investigator, may impact the absorption of oral medicationsXx_NEWLINE_xXAny condition which in the investigator’s opinion deems the participant an unsuitable candidate for study participationXx_NEWLINE_xXAny concurrent co-morbid illness and/or infection which in the opinion of the investigators could make the patient an inappropriate subject for the above trialXx_NEWLINE_xXIn the opinion of the surgeon, the subject has no medical contraindications to pancreatectomyXx_NEWLINE_xXIn the opinion of the surgeon, the subject has medical contraindications to pancreatectomyXx_NEWLINE_xXAny current treatment, medical history, or uncontrolled condition, other than malignancy, (e.g., alcoholism or signs of alcohol abuse, seizure disorder, medical or psychiatric condition) that, in the opinion of the investigator, would confound the results of the study or pose any unwarranted risk in administering study drug to the subjectXx_NEWLINE_xXHas been diagnosed with/exhibits any mental neurological disorder/disease/condition that would prevent participation in the study in the opinion of the investigatorXx_NEWLINE_xXAny condition, in the principal investigator’s opinion, that would compromise patient safety or study outcomesXx_NEWLINE_xXIn the opinion of the principal investigator (PI) or an associate investigator (AI), the subject has significant cognitive or emotional difficulties that would prevent them from being able to understand and/or participate fully in the intervention or the measuresXx_NEWLINE_xXClinically evident cognitive and/or behavioral impairment that in the opinion of the study investigator would impair the ability of the patient to adhere to the study procedures, specifically completing home activity monitoringXx_NEWLINE_xXPost-operative complications that in the opinion of the study investigator would impair the ability of the patient to adhere to the study procedures, specifically completing home activity monitoringXx_NEWLINE_xXPresence of medical co-morbidities, which, in the opinion of the investigator complicates the surgical procedure or would require additional hospital stayXx_NEWLINE_xXSignificant acute or chronic medical, neurologic, or psychiatric illness in the subject that, in the judgment of the principal investigator, could compromise subject safety, limit the subject’s ability to complete the study, and/or compromise the objectives of the studyXx_NEWLINE_xXAny other condition or intercurrent illness that, in the opinion of the investigator, makes the participant a poor candidate for the trialXx_NEWLINE_xXA serious uncontrolled medical disorder that is in the opinion of the investigator would impair the ability of the subject to receive protocol therapyXx_NEWLINE_xXOther medical or other condition(s) that in the opinion of the investigators might compromise the objectives of the studyXx_NEWLINE_xXAny other condition or intercurrent illness that, in the opinion of the investigator, makes the participant a poor candidate for the trialXx_NEWLINE_xXSubject has evidence, in the opinion of the PI, of either ongoing systemic or pleural infectionXx_NEWLINE_xXIn the opinion of the principal investigator (PI), the participant has a condition that will preclude them from complying with study treatmentXx_NEWLINE_xXEither the child or the parent has a mental health or medical condition that, in the opinion of investigators or the treating oncologist, would make it difficult to participate in the studyXx_NEWLINE_xXPatients with medical history or conditions not otherwise previously specified which in the opinion of the investigator should exclude participation in this study; examples of this would be hearing loss or neuropathy which would prevent tolerance to cisplatin, and paclitaxel administration; the investigator should feel free to consult the Study Chair or Study Co-Chairs for uncertainty in this regardXx_NEWLINE_xXPatients who, in the opinion of the treating physician, have a medical condition, or currently take medications, which are felt to contraindicate safe or effective administration of the standard three drug anti-emetic regimen used in this studyXx_NEWLINE_xXAny condition which in the investigator’s opinion deems the patient an unsuitable candidate to receive study drugXx_NEWLINE_xXOther medical or other condition(s) that in the opinion of the investigators might compromise the objectives of the studyXx_NEWLINE_xXNo orthopedic restrictions or neurologic deficits that would limit ability to complete the Power Protocol (based on the opinion of the investigator)Xx_NEWLINE_xXNo conditions that would be exacerbated by dehydration in the opinion of the investigatorXx_NEWLINE_xXSubjects with any concurrent condition that, in the investigator’s opinion, would jeopardize the safety of the subject or compliance with the protocolXx_NEWLINE_xXOther medical or other condition(s) that in the opinion of the investigators might compromise the objectives of the studyXx_NEWLINE_xXMust not have any other clinically significant medical disease or condition that, in the investigator’s opinion, may interfere with protocol adherence or a participant’s ability to give informed consentXx_NEWLINE_xXPleural effusion or ascites that causes respiratory compromise (>= NCI-CTCAE version 4.0 grade 2 dyspnea); a) history of organ allograft (including corneal transplant); b) known or suspected allergy or hypersensitivity to any of the study drugs, study drug classes, or excipients of the formulations given during the course of this trial; c) any malabsorption condition; d) any condition which, in the investigator’s opinion, makes the subject unsuitable for trial participation; e) substance abuse, medical, psychological or social conditions that may interfere with the subject’s participation in the study or evaluation of the study resultsXx_NEWLINE_xXMedical, psychiatric condition which in the investigators opinion will affect the successful completion of studyXx_NEWLINE_xXAny condition which in the investigator's opinion deems the patient an unsuitable candidate to receive ALTENSXx_NEWLINE_xXKnown previous or concomitant serious illness (other than advanced cancer with metastatic bone disease) or medical condition, such as, HIV, significant gastrointestinal disease, or cardiovascular event that in the opinion of the investigator may worsen and/or interfere with participation in the studyXx_NEWLINE_xXOther unspecified reasons that, in the opinion of the investigator or TARIS, make the subject unsuitable for enrollment.Xx_NEWLINE_xXNot a candidate for enzalutamide treatment, in the opinion of the InvestigatorXx_NEWLINE_xXPrior or ongoing clinically significant illness, medical condition, surgical history, physical finding, electrocardiography (ECG) finding, or laboratory abnormality that, in the investigator's opinion, could affect the safety of the patient, including symptomatic hyperviscosity; alter the absorption, distribution, metabolism or excretion of ABT-199; or impair the assessment of study resultsXx_NEWLINE_xXSubject has evidence, in the opinion of the Investigator, of either on-going systemic or pleural infection.Xx_NEWLINE_xXSubject has any clinical condition, diagnosis, or social circumstance that, in the opinion of the Investigator, would mean participation in the study would be contraindicated.Xx_NEWLINE_xXAny life-threatening illness, medical condition, or organ system dysfunction which, in the investigator’s opinion, could compromise the subject’s safety or put the study outcomes at undue riskXx_NEWLINE_xXAny life-threatening illness, medical condition, or organ system dysfunction that, in the investigator’s opinion, could compromise the subject’s safety or put the study outcomes at undue riskXx_NEWLINE_xXAny life-threatening illness, medical condition, or organ system dysfunction that, in the investigator’s opinion, could compromise the subject’s safety or put the study outcomes at undue riskXx_NEWLINE_xXAny condition that, in the opinion of the investigator, would impair the subject's ability to comply with study procedures;Xx_NEWLINE_xXParticipants must, in the opinion of the investigator, be capable of complying with the requirements of this protocolXx_NEWLINE_xXPatient has a life-threatening illness, medical condition, or organ system dysfunction that, in the opinion of the investigator, could compromise the subject’s safety or put the study outcomes at undue riskXx_NEWLINE_xXSerious or unstable medical or psychological conditions that, in the opinion of the investigator would compromise the subject’s safety or successful participation in the studyXx_NEWLINE_xXAny condition that, in the opinion of the investigator, would preclude safe and adequate test performanceXx_NEWLINE_xXNo prior renal disease that in the opinion of the attending physician would make the patient ineligible to receive the study drugXx_NEWLINE_xXAny other condition or intercurrent illness that, in the opinion of the investigator, makes the participant a poor candidate for the trialXx_NEWLINE_xXPatients must not have a history of illness that, in the opinion of the investigator, might confound the results of the study or pose additional risk to the patientXx_NEWLINE_xXAny medical or psychological condition or any reason that, according to the investigator’s judgment, makes the patient unsuitable for participation in the studyXx_NEWLINE_xXAny condition which in the investigator’s opinion makes the subject unsuitable for study participationXx_NEWLINE_xXSubjects with current alcohol use, illicit drug use, or any other condition (e.g., psychiatric disorder) that, in the opinion of the Investigator, may interfere with the subject's ability to comply with the study requirements or visit scheduleXx_NEWLINE_xXAny mental or physical condition, in the opinion of the principal investigator (PI) or PI designee, which could interfere with the ability of the subject to understand or adhere to the requirements of the studyXx_NEWLINE_xXSerious or unstable medical condition that could likely lead to hospitalization during the course of the study or compromise study participationXx_NEWLINE_xXPatients with a clinically significant abnormality on screening electrocardiogram (ECG) (taken within 12 weeks) that in the opinion of the investigator/co-investigator may increase the patient’s cardiovascular risk in this studyXx_NEWLINE_xXPatients must not have any concurrent condition which in the Investigator’s opinion makes it inappropriate for the patient to participate in the trial or which would jeopardize compliance with the protocolXx_NEWLINE_xXSerious underlying medical condition that would impair the ability of the patient to receive protocol treatment, specifically cardiac diseases, uncontrolled hypertension or renal diseasesXx_NEWLINE_xXAny condition which, in the investigator's opinion, deems the patient an unsuitable candidate to receive study drugXx_NEWLINE_xXAcute or chronic medical disorder that, in the opinion of the investigator or medical monitor, may prevent the subject from completing participation in the studyXx_NEWLINE_xXHas any other condition or prior therapy that in the opinion of the Investigator would make the patient unsuitable for the study and/or unable to comply with requirements for follow-up visits.Xx_NEWLINE_xXAny physical or psychological condition that, in the opinion of the investigator, would pose unacceptable risk to the patient or raise concern that the patient would not comply with protocol proceduresXx_NEWLINE_xXThe investigator determines that participation in the study may jeopardize the safety or welfare of the subject.Xx_NEWLINE_xXAny uncontrolled medical condition which may place the patient at increased risk during study participation (at the discretion of the clinical investigator)Xx_NEWLINE_xXA medical condition, movement or neurological disorder, or medication use that contraindicates participation in moderate intensity exercise (confirmed by self-report on the Health History Questionnaire, and by physician clearance; if in the professional opinion of the Principal Investigator, Dr. Kerri Winters-Stone, contraindications other than those identified by the patient or physician are present, she may consider the participant ineligible)Xx_NEWLINE_xXIn the opinion of the surgeon, the subject has no medical contraindications to distal pancreatectomyXx_NEWLINE_xXIn the opinion of the surgeon, the subject has medical contraindications to distal pancreatectomyXx_NEWLINE_xXConditions unsuitable for participation in the trial in the investigator's opinionXx_NEWLINE_xXSignificant co-morbidities (e.g., diabetes, cardiac disease, or other condition that in the opinion of the primary physician or investigators would limit participation in the intervention groups) that would preclude study participationXx_NEWLINE_xXAny medical condition or other circumstances that in the opinion of the investigators compromise obtaining reliable data or achieving the study objectivesXx_NEWLINE_xXHave any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study or prevent the subject from meeting or performing study requirementsXx_NEWLINE_xXPatient has a serious active disease or co-morbid medical condition, as judged by the investigator, which would interfere with the conduct of this study.Xx_NEWLINE_xXAny condition or therapy, which, in the opinion of the Investigator, might pose a risk to the patient or make participation in the study not in the best interest of the patient.Xx_NEWLINE_xXAny condition that, in the clinical judgement of the investigator, would place a participant at unreasonably increased riskXx_NEWLINE_xXAny condition which in the Investigator’s opinion deems the subject an unsuitable candidate to receive study drugXx_NEWLINE_xXAny autoimmune disease or other medical condition that, in the opinion of the investigator, would compromise the subject's safetyXx_NEWLINE_xXConcurrent illness which in the opinion of the investigators would compromise either the patient or the integrity of the dataXx_NEWLINE_xXOther illness that in the opinion of the investigator would exclude the patient from participating in this studyXx_NEWLINE_xXCurrent use of any drug (except metformin) or anticipated change in concomitant medication, which the investigator’s opinion could interfere with the glucose metabolism (e.g. systemic corticosteroids).Xx_NEWLINE_xXHave any medical disease or condition that, in the opinion of the site principal investigator is a contraindication to study participation; this includes any chronic medical condition, defined as persisting 3 months (defined as 90 days) or longer, that would place the subject at an unacceptable risk of injury, render the subject unable to meet the requirements of the protocol, or may interfere with the evaluation of responses or the subject’s successful completion of this studyXx_NEWLINE_xXAny other condition or intercurrent illness that in the opinion of the investigator makes the subject a poor candidate for participation in the trial such as recent cardiac eventXx_NEWLINE_xXEXCLUSION CRITERIA (PRIOR TO IBRUTINIB ADMINISTRATION): Any life threatening illness, medical condition, or organ system dysfunction that, in the investigator’s opinion, could compromise the subject’s safety or put the study outcomes at undue riskXx_NEWLINE_xXFor patient aged 2 years with known mild to moderate hepatic impairment: in the Investigator's opinion the impairment does not jeopardize patient's safety during the study.Xx_NEWLINE_xXFor patient aged 2 years with known mild to moderate renal impairment: in the Investigator's opinion the impairment should not jeopardize patient's safety during the study.Xx_NEWLINE_xXFor patient with known history or predisposition to cardiac abnormalities: in the Investigator's opinion the history/predisposition should not jeopardize patient's safety during the study.Xx_NEWLINE_xXPatient with clinically relevant abnormal laboratory values that in the Investigator's opinion jeopardize the patient's safety during the study.Xx_NEWLINE_xXAny condition which in the Investigator’s opinion deems the participant an unsuitable candidate to receive study drugXx_NEWLINE_xXIndividuals with a history of photosensitive diseases including, but not limited to, lupus erythematosus, pseudoporphyria, or other diseases that in the opinion of the study physician would pose a risk to the subject or interfere with the studyXx_NEWLINE_xXAny current treatment, medical history, or uncontrolled condition, other than malignancy, (e.g., alcoholism or signs of alcohol abuse, seizure disorder, medical or psychiatric condition) that, in the opinion of the investigator, would confound the results of the study or pose any unwarranted risk in administering study drug to the subjectXx_NEWLINE_xXAny other condition or intercurrent illness that in the opinion of the investigator makes the subject a poor candidate for participation in the trial such as recent cardiac eventXx_NEWLINE_xXPresence of any major medical condition which, in the opinion of the investigator, precludes participation in the studyXx_NEWLINE_xXAny condition which, in the opinion of the investigator, would prevent full participation in this trial (including follow-up), or would interfere with the evaluation of the trial endpointsXx_NEWLINE_xXAny physical or psychological condition that, in the opinion of the investigator, would post unacceptable risk to the patient or raise concern that the patient would not comply with protocol proceduresXx_NEWLINE_xXAny other significant acute or chronic diseases that in the investigator's opinion would exclude the subject from the trialXx_NEWLINE_xXAny other condition or intercurrent illness that, in the opinion of the investigator, makes the subject a poor candidate for core biopsy or the trialXx_NEWLINE_xXLaboratory evaluations (kidney and liver) outside normal limits and of potential clinical significance in the opinion of the investigatorXx_NEWLINE_xXSubject considered by the investigator as unsuitable candidate for receipt of an investigational drug, or unstable to be followed up throughout the entire duration of the studyXx_NEWLINE_xXConcurrent illness which in the opinion of the investigators would compromise either the patient or the integrity of the dataXx_NEWLINE_xXAny other condition that, in the opinion of the investigator, makes the patient or donor ineligible for the studyXx_NEWLINE_xXAny condition that in the opinion of the investigator raises concerns about protocol complianceXx_NEWLINE_xXAny condition which in the investigator’s opinion deems the participant an unsuitable candidate to receive study interventionXx_NEWLINE_xXHigh risk medical condition (e.g. kidney disease)Xx_NEWLINE_xXAny other condition or intercurrent illness that in the opinion of the investigator makes the subject a poor candidate for RPFNA or the trialXx_NEWLINE_xXAny condition which would make the subject, in the opinion of the investigator, unsuitable for the studyXx_NEWLINE_xXSignificant medical or psychiatric problems which would make the subject a poor protocol candidate, in the opinion of the treating physicianXx_NEWLINE_xXRecent extended history of constant-recurrent substance abuse or another medical condition that might compromise safety or the successful completion of the studyXx_NEWLINE_xXActive drug or alcohol use or dependence that, in the opinion of the Site Investigator, would interfere with adherence to study protocolXx_NEWLINE_xXAny other condition which, in the opinion of the investigator, makes the patient ineligible for the study Inclusion Criteria Donor:Xx_NEWLINE_xXAny other serious medical condition that would make PA unsafeXx_NEWLINE_xXSubjects with any significant psychological disturbance that, in the opinion of the Investigator, could impair the consent process or ability to complete self-assessment questionnaires.Xx_NEWLINE_xXSubjects with any other condition that would contraindicate participation, as determined by the Investigator.Xx_NEWLINE_xXPatients with severe medical condition(s) that in the view of the investigator prohibits participation in the studyXx_NEWLINE_xXParticipants who in the opinion of the principal investigator (PI) will be at higher risk of acetylsalicylic acid (ASA)-related complicationsXx_NEWLINE_xXUnstable or clinically significant concurrent medical condition that would, in the opinion of the investigator or medical monitor, jeopardize the safety of a subject and/or their compliance with the protocol.Xx_NEWLINE_xXMedical comorbidities that in the opinion of the investigator limits the patient’s ability to complete this studyXx_NEWLINE_xXSubject has significant uncontrolled medical condition within 6 months prior to enrollment, as determined by the investigator.Xx_NEWLINE_xXSubject has an active ocular condition that in the opinion of the investigator may alter visual acuity during the course of the study (i.e., ocular inflammatory disease etc.) or a history or anticipation of major ocular surgery (including cataract extraction, intraocular surgery, etc.) during the study.Xx_NEWLINE_xXMedical or psychiatric condition or disease (for example, active systemic disease, uncontrolled diabetes) that is likely to interfere with the study procedures or results, or that in the opinion of the investigator, would constitute a hazard for participating in this studyXx_NEWLINE_xXSignificant medical or psychiatric history which would make the participant a poor protocol candidate, in the opinion of the principal investigator, for any aspect of study participation including metformin, unsupervised exercise program or dietary behavior changeXx_NEWLINE_xXEvidence of severe or uncontrolled systemic disease or any concurrent condition which in the investigator’s opinion makes it undesirable for the patient to participate in the trial or which would jeopardize compliance with the protocolXx_NEWLINE_xXAny concurrent medication with a known risk of inducing Torsades de Pointes, that in the investigator’s opinion cannot be discontinuedXx_NEWLINE_xXAny condition which in the Investigator’s opinion deems the subject an unsuitable candidate to receive study drugXx_NEWLINE_xXHave any condition that in the opinion of the investigator would confound the efficacy, safety and tolerability assessments, such as oral thrush.Xx_NEWLINE_xXAny medical condition judged by the investigator to constitute a risk to safe participationXx_NEWLINE_xXAny dermatological condition that in the opinion of the investigator will affect the absorption of the study medication, e.g. Atopic Dermatitis, etc.Xx_NEWLINE_xXActive drug or alcohol use or dependence that, in the opinion of the site Investigator, would interfere with adherence to study requirementsXx_NEWLINE_xXSubjects with any medical condition or other circumstance that, in the opinion of the investigator, compromise obtaining reliable data, achieving study objectives, or completion. Cohort A Only:Xx_NEWLINE_xXAny condition which in the investigator’s opinion makes the patient unsuitable for the study participationXx_NEWLINE_xXMedical history and concurrent disease:\r\n* Prior history of treated breast cancer\r\n* Any underlying medical or psychiatric conditions, which in the opinion of the investigator, will make performing the study intervention hazardous or obscure the interpretation of the resultsXx_NEWLINE_xXA medical condition such as uncontrolled infection or cardiac disease that, in the opinion of the treating surgeon, makes resection unreasonably hazardous for the patientXx_NEWLINE_xXPatients must not have any significant medical illnesses that in the investigator’s opinion cannot be adequately controlled with appropriate therapy, would compromise the patient’s ability to tolerate the imaging examination or any disease that will obscure toxicity or dangerously alter response to the imaging agentXx_NEWLINE_xXAny medical condition that in the opinion of the investigators could potentially jeopardize the safety of the patientXx_NEWLINE_xXSubjects with other medical conditions deemed by the principal investigator (or associates) to make the subject ineligible for protocol proceduresXx_NEWLINE_xXAny other significant co morbid conditions that in the opinion of the investigator would impair study participation or cooperationXx_NEWLINE_xXHave a medical condition or other circumstances that, in the opinion of the investigator would significantly decrease the chances of obtaining reliable data, achieving the study objectives, or completing the trial.Xx_NEWLINE_xXPatient/participant has a medical condition which in the judgment of the investigator might make supine positioning for the duration of the scan unsafe, such as (but not limited to) congestive heart failure or significant pulmonary\r\ndiseaseXx_NEWLINE_xXAny condition, medical or psychosocial, that in the opinion of the principal investigator would hinder complianceXx_NEWLINE_xXAny condition which in the investigator’s opinion deems the subject an unsuitable candidate to undergo observational study (may also include preoperative testing results including electrocardiography [EKG], chest x-ray, or pulmonary function tests that preclude a wide excision in the operating room)Xx_NEWLINE_xXOther medical conditions deemed by the principal investigator (or associates) to make the subject unsafe/ineligible for protocol proceduresXx_NEWLINE_xXOther medical conditions deemed by the principal investigator (or associates) to make the subject unsafe/ineligible for protocol proceduresXx_NEWLINE_xXAny additional medical condition, serious concurrent illness, or other extenuating circumstance that, in the opinion of the investigator may significantly interfere with study compliance.Xx_NEWLINE_xXSubject is in acute unstable conditionXx_NEWLINE_xXAny additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study complianceXx_NEWLINE_xXSerious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject’s safety or successful participation in the studyXx_NEWLINE_xXSerious or unstable medical or psychological conditions that, in the opinion of the investigator would compromise the subject’s safety or successful participation in the studyXx_NEWLINE_xXSerious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject’s safety or successful participation in the studyXx_NEWLINE_xXHave any medical condition or other circumstances that, in the opinion of the investigator, would significantly decrease obtaining reliable data, achieving study objectives or completing the studyXx_NEWLINE_xXAny condition that, in the opinion of the principal investigator, would impair the patient’s ability to comply with study proceduresXx_NEWLINE_xXAny condition that, in the opinion of the principal investigator, would impair the patient’s ability to comply with study proceduresXx_NEWLINE_xXAny condition which, in the opinion of the investigator precludes the patient from completion of the study procedureXx_NEWLINE_xXAny condition which in the investigator’s opinion deems the participant an unsuitable candidate to undergo observational study (may also include preoperative testing results including electrocardiogram [EKG], chest x-ray, or pulmonary function tests)Xx_NEWLINE_xXSerious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject’s safety or successful participation in the studyXx_NEWLINE_xXSerious or unstable medical or psychological conditions that, in the opinion of the investigator would compromise the subject’s safety or successful participation in the studyXx_NEWLINE_xXSerious or unstable medical or psychological comorbidities that, in the opinion of the investigator, would compromise the subject’s safety or successful participation in the studyXx_NEWLINE_xXHEALTHY VOLUNTEER: Subject has a history of any illness that, in the opinion of the study investigator, might confound the results of the study or poses an additional risk to the subject by his participation in the studyXx_NEWLINE_xXHEALTHY VOLUNTEER: Any other condition precluding subject participation as per investigator judgmentXx_NEWLINE_xXAny additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the investigator, may significantly interfere with study complianceXx_NEWLINE_xXMedical or psychological conditions which, in the opinion of the investigator, might create undue risk to the subject or interfere with the subject’s ability to comply with the protocol requirementsXx_NEWLINE_xXPatients with vertebral lesions that, in the opinion of the principal investigator and the treating medical oncologist, pose an imminent risk for cord compressionXx_NEWLINE_xXAny additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the investigator, may significantly interfere with study complianceXx_NEWLINE_xXOther medical condition or laboratory value that would, at the discretion of the investigator, preclude the patient from participation in this clinical studyXx_NEWLINE_xXSerious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject’s safety or successful participation in the studyXx_NEWLINE_xXAny condition which, in the opinion of the investigator, might interfere with study objectiveXx_NEWLINE_xXAny reason which, in the opinion of the investigator, adds additional risk to the patientXx_NEWLINE_xXDONOR: Any condition which, in the opinion of the investigator, might interfere with study objectiveXx_NEWLINE_xXUncontrolled illness or comorbidity that in the judgment of the principal investigator (PI) would preclude participation in the studyXx_NEWLINE_xXIt is determined by the investigator that the subject is clinically unsuitable for the studyXx_NEWLINE_xXUncontrolled intercurrent illness that, in the opinion of the investigator, would limit the participant’s compliance with study requirementsXx_NEWLINE_xXPatient has any other condition or personal circumstance that, in the judgment of the investigator, might interfere with the collection of complete good quality dataXx_NEWLINE_xXOther condition that, in the opinion of the Investigator, might jeopardize the safety of the patient, or the adequate evaluation of study results.Xx_NEWLINE_xXAcute major illness (e.g., unstable angina, etc.) or other condition that makes participation unsafe, per the investigator’s judgementXx_NEWLINE_xXPatients with other poorly controlled medical conditions that in the opinion of the surgeon, make them not a candidate for primary cytoreductive surgeryXx_NEWLINE_xXAny additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the investigator, may significantly interfere with study complianceXx_NEWLINE_xXPatient not a candidate for surgery (neck dissection) because of an underlying medical conditionXx_NEWLINE_xXAny condition which in the Investigator’s opinion deems the subject an unsuitable candidate to undergo observational study (may also include preoperative testing results including electrocardiogram [EKG], chest x-ray, or pulmonary function tests that preclude a wide excision in the operating room)Xx_NEWLINE_xXSerious underlying medical condition that would impair patient's ability to tolerate the imaging procedureXx_NEWLINE_xXAny condition, or history of illness or surgery that, in the opinion of the Investigator, might confound the results of the study or pose additional risks to the patient (e.g., significant cardiovascular conditions or allergies)Xx_NEWLINE_xXAny medical condition that in the opinion of the investigators could potentially jeopardize the safety of the patient, limit the patient’s ability to complete the study, and/or compromise the objectives of the studyXx_NEWLINE_xXAny additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study complianceXx_NEWLINE_xXPresence of any other co-existing condition which, in the judgment of the investigator, might increase the risk to the subjectXx_NEWLINE_xXAny additional medical condition, serious intercurrent illness or other extenuating circumstance that, in the opinion of the investigator, may significantly interfere with study performance or interpretationXx_NEWLINE_xXAny additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the investigator, may significantly interfere with study complianceXx_NEWLINE_xXAny other concurrent condition that in the investigator's opinion would jeopardize compliance with the protocolXx_NEWLINE_xXClinically relevant hepatic, neurological, pulmonary, ophthalmological, endocrine, renal, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult, or that would put the subject at risk by participating in the study in the opinion of the Investigator.Xx_NEWLINE_xXSubjects who have any clinically significant psychiatric, social, or medical condition that, in the opinion of the investigator, could increase the subject's risk, interfere with protocol adherence, or affect the subject's ability to give informed consent are ineligible to participate in the study.Xx_NEWLINE_xXHistory or presence of an abnormal ECG that in the investigator's opinion is clinically meaningful.Xx_NEWLINE_xXHas a concomitant medical condition that would increase the risk of toxicity, in the opinion of the Investigator or SponsorXx_NEWLINE_xXAny concurrent uncontrolled illness, including mental illness or substance abuse, which in the opinion of the Investigator, would make the subject unable to cooperate or participate in the trial.Xx_NEWLINE_xXHistory or current evidence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, hematological, endocrinological, metabolic, neurological, psychiatric, or other diseases, which, in the opinion of the investigator, may affect the subject's safety or interfere with the trial.Xx_NEWLINE_xXAny other condition which in the opinion of the investigator would interfere with successful completion of this clinical trial.Xx_NEWLINE_xXAny other local condition including bacterial superinfection which in the opinion of the investigator would interfere with the efficacy evaluation.Xx_NEWLINE_xXAny medical conditions that, in the Investigator's opinion, would impose excessive risk to the patient or would adversely affect his/her participating in this studyXx_NEWLINE_xXSubject has any condition which makes the subject unsuitable for study participation.Xx_NEWLINE_xXDoes the subject have any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study complianceXx_NEWLINE_xXMedical, psychological, or social condition that, in the opinion of the investigator, may increase the patient’s risk or limit the patient’s adherence with study requirementsXx_NEWLINE_xXInvestigator precludes participation for scientific reasons, for reasons of compliance (e.g., concurrent disease which could compromise the subject's study completion), or for reasons of the patient's safetyXx_NEWLINE_xXAny additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study complianceXx_NEWLINE_xXPresence of any other co-existing condition which, in the judgment of the investigator, might increase the risk to the subjectXx_NEWLINE_xXAny condition or abnormality which may, in the opinion of the investigator, compromise the safety of patientsXx_NEWLINE_xXany other concomitant serious illness or organ system dysfunction which in the opinion of the investigator would either compromise subject safety or interfere with the evaluation of the safety of the test drugXx_NEWLINE_xXOther medical conditions deemed by the principal investigator (or associates) to make the subject unsafe/ineligible for protocol proceduresXx_NEWLINE_xXHave a medical condition or other circumstances which, in the opinion of the investigator would significantly decrease the chances of obtaining reliable data, achieving the study objectives, or completing the study.Xx_NEWLINE_xXPatient presenting with any condition which, based on the investigator's clinical judgment, would prevent the patient from completing all trial assessments and visitsXx_NEWLINE_xXSubjects with other medical conditions deemed by the principal investigator (or associates) to make the subject ineligible for protocol proceduresXx_NEWLINE_xXHave a medical condition or other circumstances that, in the opinion of the investigator would significantly decrease the chances of obtaining reliable data, achieving the study objectives, or completing the trial.Xx_NEWLINE_xXAny additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study complianceXx_NEWLINE_xXPresence of any additional medical condition such as inter-current illness, or other extenuating circumstance that, in the opinion of the investigator, may significantly interfere with study complianceXx_NEWLINE_xXDetermined by investigator to be clinically unsuitable for the studyXx_NEWLINE_xXAny other condition or personal circumstance that, in the judgment of the investigator, might interfere with the collection of complete good quality dataXx_NEWLINE_xXA serious uncontrolled medical disorder that in the opinion of the Investigator would impair the ability of the subject to receive protocol therapyXx_NEWLINE_xXAny additional medical condition, serious concurrent illness, or other extenuating circumstance that, in the opinion of the investigator, may significantly interfere with study complianceXx_NEWLINE_xXSubject has another active medical condition(s) or organ disease(s) that may either compromise subject safety or interfere with the safety and/or outcome evaluation of the study drugXx_NEWLINE_xXAny condition that is unstable or could jeopardize the safety of the patient and his or her compliance in the study, in the investigator’s judgmentXx_NEWLINE_xXA serious underlying medical condition that would otherwise impair the patient’s ability to receive treatment and imaging studiesXx_NEWLINE_xXAny condition which, in the opinion of the investigator, would preclude participation in this trialXx_NEWLINE_xXIn the opinion of the investigator, the patient is felt not to be appropriate for the studyXx_NEWLINE_xXBIODISTRIBUTION COHORT: Any current medical condition, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the studyXx_NEWLINE_xXDYNAMIC COHORT: Any current medical condition, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the studyXx_NEWLINE_xXAny condition or abnormality which may, in the opinion of the investigator, compromise the safety of patientsXx_NEWLINE_xXAny condition which in the investigator’s opinion deems the patient an unsuitable candidate to receive B-WARMXx_NEWLINE_xXSerious underlying medical (including acute decompensated congestive heart failure) or psychiatric illnesses that would, in the opinion of the treating physician, substantially increase the risk for complications related to treatment; similarly, any unstable medical condition that, in the opinion of the treating physician or study investigators, would interfere with the study objectivesXx_NEWLINE_xXAny condition which in the investigator's opinion deems the participant an unsuitable candidate to receive flaxseedXx_NEWLINE_xXPresence of a comorbid disease or medical condition that would impair the ability of the patient to receive or comply with the study protocolXx_NEWLINE_xXAny condition or reason that, in the opinion of the Investigator, interferes with the ability of the patient to participate in the trial, which places the patient at undue risk, or complicates the interpretation of safety dataXx_NEWLINE_xXSignificant acute or chronic medical, neurologic, or psychiatric illness in the subject that, in the judgment of the investigator, could compromise subject safety, limit the subject’s ability to complete the study, and/or compromise the objectives of the studyXx_NEWLINE_xXA concomitant medical condition that would increase the risk of toxicity, in the opinion of the Investigator or Sponsor.Xx_NEWLINE_xXHas signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:Xx_NEWLINE_xXHave serious preexisting medical conditions (left to the discretion of the investigator).Xx_NEWLINE_xXAny other concurrent condition that in the investigator's opinion would jeopardize compliance with the protocolXx_NEWLINE_xXConcurrent disease or condition that interferes with participation or safetyXx_NEWLINE_xXAny other criteria, in the opinion of the investigator that would make the subject unsuitable for study participation.Xx_NEWLINE_xXAny condition, or history of illness or surgery that, in the opinion of the Investigator, might confound the results of the study or pose additional risks to the patient (e.g. significant cardiovascular conditions or allergies)Xx_NEWLINE_xXAny condition or set of circumstances that in the opinion of the investigators would make participation in this study unsafe or otherwise inappropriate for a given individualXx_NEWLINE_xXInvestigator feels participation is not in the best interest of the subject.Xx_NEWLINE_xXLife-threatening illnesses other than AML or MDS, uncontrolled medical conditions or organ system dysfunction which, in the investigator's opinion, could compromise the patient's safety, or put the study outcomes at risk.Xx_NEWLINE_xXAny condition that would in the Investigator's judgment prevents compliance with the requirements of the protocol.Xx_NEWLINE_xXAny subject for whom the investigator feels participation is not in the best interest of the subject.Xx_NEWLINE_xXAny concurrent condition, including psychological and social situations, which, in the opinion of the investigator, would adversely impact the subject or the interpretation of the study data.Xx_NEWLINE_xXAny medical condition that in the opinion of the investigators could potentially jeopardize the safety of the patientXx_NEWLINE_xXPatients with any other medical condition or laboratory value that would, at the discretion of the investigator, preclude the patient from participation in this clinical study.Xx_NEWLINE_xXAny subject for whom the investigator feels participation is not in the best interest of the subject.Xx_NEWLINE_xXHistory or evidence of a clinically unstable/uncontrollable disorder, condition or disease other than primary malignancy, that in the opinion of the Investigator would pose a risk to the patient safety or interfere with the study evaluation, procedures or completionXx_NEWLINE_xXAny significant medical condition, that, in the opinion of the investigator or sponsor, may place the subject at undue risk from the study.Xx_NEWLINE_xXConcurrent condition that in the investigator's opinion would jeopardize compliance with the protocol or would impart excessive risk associated with study participation that would make it inappropriate for the patient to be enrolled.Xx_NEWLINE_xXHistory or evidence of a clinically unstable/uncontrollable disorder, condition or disease other than primary malignancy, that in the opinion of the Investigator would pose a risk to the patient safety or interfere with the study evaluationXx_NEWLINE_xXAny medical or other condition that in the opinion of the investigator(s) would preclude the participant's participation in a clinical study.Xx_NEWLINE_xXPatients with psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirementsXx_NEWLINE_xX