Patients with uncontrolled inter-current illnesses which in the opinion of the investigator will interfere with the ability to undergo therapy including chemotherapy are excluded

Any active disease condition which would render the protocol treatment dangerous or impair the ability of the patient to receive protocol therapy.

Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements

Patients must have progressed (in the opinion of the treating investigator) following the most recent line of therapy

Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements

Any medical condition for which prednisone (corticosteroid) is contraindicated

Patients 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 regard

Medical, 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 requirements

Any medical or other condition which, in the opinion of the investigator, would preclude participation in a clinical trial

Patient 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 study

A serious uncontrolled medical disorder that in the opinion of the investigator would impair the ability of the subject to receive protocol therapy

Serious underlying medical or psychiatric illnesses that would, in the opinion of the treating physician, substantially increase the risk for complications related to treatment

Any malabsorption problem that, in the investigator's opinion, would prevent adequate absorption of the study drug

Any other medical condition, which in the opinion of the Investigator, places the subject at an unacceptably high risk for toxicities.

Patients 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 eligible

Presence 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.

Patient 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.

Patients 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

Has signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:

Participants must, in the opinion of the investigator, be capable of complying with the protocol

Patients 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 therapy

Any other active malignancy other than melanoma that, in the opinion of the investigator, would interfere with study participation (for treatment phase)

Have 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.

Active 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 outcome

Has a medical condition that requires immunosuppression

History or presence of an abnormal electrocardiogram (ECG) that, in the Investigator's opinion, is clinically meaningful.

Life-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.

Any 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.

Any 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.

Patients 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 excluded

Serious 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

Presence 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 enrolled

Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

Concomitant 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.

Expected survival of ? 12 weeks, in the opinion of the investigator.

Therapy 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.

Medical or psychiatric illnesses that, in the investigator's opinion, may impact the safety of the subject or the objectives of the study.

History 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.

Any medical or other condition which, in the opinion of the investigator, would preclude participation in a clinical trial

Any other condition which the Investigator believes would make participation in the study not acceptable

Severe and/or uncontrolled medical conditions that in the investigator's opinion could affect the safety of individual or impair the assessment of study result.

Any other condition which, in the opinion of the investigator, would preclude participation in this trial

High likelihood of protocol non-compliance (in opinion of investigator)

Concomitant 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.

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 participation

Medical 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).

Any 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 procedures

Underlying 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).

Any 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

Any malabsorption condition

Any condition which, in the investigator’s opinion, makes the subject unsuitable for trial participation

Any condition that, in the clinical judgment of the treating physician, is likely to prevent the subject from complying with any aspect of the protocol or that may put the subject at unacceptable risk.

Any other medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent

Any serious medical condition that interferes with adherence to study procedures.

Patient must not have a co-morbid condition(s) that, in the opinion of the investigator, prevent safe treatment

Any 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 study

Concurrent condition that in the investigator’s opinion would jeopardize compliance with the protocol

Any condition or illness that, in the opinion of the investigator, would compromise patient safety or interfere with the evaluation of the drug

Any other medical or psychiatric condition that in the opinion of the investigator would make the study therapy unsafe for the patient

Has any other reason(s) for the investigator to consider that the subject should not participate in the study.

Uncontrolled 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 compliance

History 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 participation

Any other concomitant serious illness or organ system dysfunction in opinion of Investigator would either compromise subject safety or interfere with test drug safety evaluation

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

Any medical condition or laboratory abnormalities, which – in the opinion of the investigator – places the subject at unacceptable risk, or confounds the ability to interpret data if he/she were to participate in the study

•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 risk

Any condition, in the opinion of the investigator, that compromises compliance with study requirements

Has a concomitant medical condition that would increase the risk of toxicity, in the opinion of the Investigator or Sponsor.

Any condition or illness that, in the opinion of the investigator, would compromise patient safety or interfere with the evaluation of the drug

Any 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 study

Any other intercurrent medical/psychological problem deemed exclusionary by the treating physician or investigators/principal investigator (PI)

Any 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

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 drug

Any 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.

In 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.

Subject has other conditions that in the opinion of the investigator would place the subject at increased risk for toxicity by participation in the study.

Other unspecified reasons that, in the opinion of the investigator, make the patient unsuitable for enrollment

Significant allergy to a pharmaceutical therapy that, in the opinion of the Investigator, poses an increased risk to the patient

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

Any serious medical condition that interferes with adherence to study procedures.

Any other medical condition that in the investigator’s opinion would not make the patient a good candidate for the study

PHASE II EXCLUSION CRITERIA: Any other medical condition that in the investigator’s opinion would not make the patient a good candidate for the study

Any 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.

Subject has any condition that confounds the ability to interpret data from the study.

Any other factors, including psychiatric or social, that in the opinion of the treating physician makes the patient an inappropriate candidate for a study

Any electrocardiogram (ECG) abnormality, which in the opinion of the Investigator would preclude safe participation in the study.

Serious non-malignant disease that could compromise protocol objectives in the opinion of the Investigator and/or the Sponsor.

Any medical condition that in the judgement of the principal investigator is likely to interfere with assessment of safety or efficacy of study treatment

Subject 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 assessments

Women 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.

Women 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.

Any medical or other condition that in the opinion of the investigator(s) would preclude the participant's participation in a clinical study

Other 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.

Serious cardiopulmonary medical condition

Any other condition that would, in the investigator's judgement, contraindicate the patient's participation in the clinical study

Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

Signs 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 protocol

Any other medical or social condition that, in the opinion of the investigator, would not permit the patient to complete the study or sign informed consent

PROCUREMENT EXCLUSION CRITERIA: Patients with a chronic uncontrolled medical condition that, in the opinion of the principal investigator, precludes them from participation

Patients with a chronic uncontrolled medical condition that, in the opinion of the principal investigator, precludes them from participation

Any condition that in the opinion of the investigator, would preclude participation in this study

Any condition which in the investigator’s opinion deems the participant an unsuitable candidate to receive study drug

Presence 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 therapy

Underlying 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;

Any 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

Underlying medical conditions that, in the investigator’s opinion, will make the administration of study drug hazardous or obscure the interpretation of toxicity or adverse events

Active infection or serious underlying medical condition that would impair the ability of the patient to received protocol therapy

Participants must in the opinion of the investigator be capable of complying with this protocol

Serious medical risk factors involving any of the major organ systems, or serious psychiatric disorders that could compromise the patient's safety or the study data integrity.

Any active disease condition which would render the protocol treatment dangerous or impair the ability of the patient to receive protocol therapy.

Patients who, in the opinion of the investigator, are unable or unlikely to comply with the dosing schedule and study evaluations

Any disease or condition that, in the opinion of the Investigator, would compromise the safety of the patient or interfere with study assessments.

Active infection or serious underlying medical condition that would impair the ability of the patient to received protocol therapy

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 risk

Any other medical condition that in the Investigator’s opinion would not make the patient a good candidate for the study

In the opinion of the treating investigator, the patient must be a candidate to receive gemcitabine/cisplatin treatment

Serious 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;

Have other concurrent severe and/or uncontrolled medical condition that would, in the site Investigator's judgment contraindicate the patient's participation in the clinical study

History 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).

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 risk

Any 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 trial

Concomitant 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.

Any 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 judgment

Any medical conditions that, in the opinion of the investigator, would preclude use of AGEN1884, including AGEN1884 hypersensitivity.

The patient has any medical condition which in the opinion of the Investigator places the patient at an unacceptably high risk for toxicities.

Any 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 drug

History 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 completion

Any condition that confounds the ability to interpret data from the study

Subject 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 objectives

Any malabsorption condition

Any condition which makes the subject unsuitable for trial participation

Any 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 objectives

Any malabsorption condition

Any condition which, in the investigator’s opinion, makes the subject unsuitable for trial participation

Any condition or illness that, in the investigator’s opinion, would place the subject at unacceptable risk if he/she were to participate

Any 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 drug

Uncontrolled cystitis, significant bladder pain or spasms, or gross hematuria that in the opinion of the treating investigator, should preclude study entry

Clinical judgment by the investigator that the patient should not participate in the study

Any malabsorption condition

Any condition which, in the investigator’s opinion, makes the subject unsuitable for trial participation

Any other pathology or condition which the principal investigator may deem to negatively impact treatment safety

Patients who, in the opinion of the principal investigator, have significant medical or psychosocial problems that warrant exclusion including:\r\n* Other serious non-malignancy-associated medical conditions that may be expected to limit life expectancy to less than 2 years\r\n* Any condition, medical, psychiatric or otherwise, that would preclude informed consent, consistent follow-up, or compliance with any aspect of the study

Any 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)

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 study drugs, or put the study outcomes at undue risk.

Serious non-malignant disease such as active infection or other condition which in the opinion of the investigator would compromise other protocol objectives

Any condition, including laboratory abnormalities, that in the opinion of the investigator places the subject at an unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study

Any 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 risk

Patients whose comorbid medical condition, in the investigator’s opinion, would make participation in this trial and adherence to the protocol guidelines difficult should be excluded

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 diarrhea

Chronic 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 participation

Any subject who, in the opinion of the principal investigator (PI) is at risk for thromboembolic events

Any 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)

Any other serious medical condition which in the Investigator's opinion would preclude safe participation in the study.

Subjects, in the opinion of the Investigator, who are unsuitable to participate in the study.

Patients 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 excluded

Patients 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 interpretation

Concurrent 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 drug

Patients 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 trial

Any condition which in the investigator’s opinion deems the patient an unsuitable candidate

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 diarrhea

Significant 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.

Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements.

Patients with rapidly progressing disease in the opinion of the principal investigator

Any condition which in the investigator's opinion deems the subject an unsuitable candidate to receive study drug

Presence 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.

Any other intercurrent medical/psychological problem deemed exclusionary by the treating physician or investigators/principal investigator (PI)

Any significant disease that, in the opinion of the investigator, may impair the patient's tolerance of study treatment

No 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 protocol

Any 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 study

Any 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 individual

Known history of allergy or intolerance which, in the opinion of the investigator, was an unacceptable adverse reaction attributed by the investigator to any prior anti-neoplastic therapy specifically targeting T-cell costimulation or immune checkpoint pathways – i.e. nivolumab (Opdivo), pembrolizumab (Keytruda), atezolizumab (Tecentriq), ipilimumab (Yervoy), etc.

Known 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.

Any 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

Clinically 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.

Patient 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 efficacy

Subject has any surgical or medical condition (active or chronic) that may interfere with drug absorption, distribution, metabolism, or excretion of the study drug, or any other condition that may place the subject at risk for such interference (for example, short bowel syndrome or inflammatory bowel disease).

The 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 risk

In the opinion of the principal investigator (PI), the participant has a condition that will preclude them from complying with study treatment

Any 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 endpoints

Any 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)

Any condition which in the investigator’s opinion deems the participant an unsuitable candidate to receive study drug

Other 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

Any condition which in the investigator’s opinion deems the participant an unsuitable candidate to receive study drug

Have 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 requirements

Clinically 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

Presence of a significant psychiatric disease, which in the opinion of the principal investigator or his/her designee, would prevent adequate informed consent.

Any other condition that in the investigator’s judgement would significantly increase the risks of participation.

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 undue risk

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 risk

Any other condition that would, in the investigator's judgement, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures

Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

Any condition which, in the investigator’s opinion, makes the subject unsuitable for trial participation

Any 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.

Any clinically significant uncontrolled condition that may increase the risk to the study patient or that the Investigator considers places the patient at unacceptable risk

Any condition which, in the opinion of the investigator, would preclude participation in this trial

Clinically 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.

Any 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 study

Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the investigator, could interfere with study assessments or compliance.

Significant 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.

Presence of a concomitant medical condition that (in the judgement of the investigator) interferes with the ability of the subject to participate in the study.

The presence of a medical or psychiatric condition that, in the opinion of the principal investigator, makes the patient inappropriate for inclusion in this study

In 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.

Any 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 risk

Other unspecified reasons that, in the opinion of the Investigator, make the subject unsuitable for enrollment.

Any additional condition which in the investigator’s opinion deems the participant an unsuitable candidate to receive the study drugs

Has a concomitant medical condition that would increase the risk of toxicity, in the opinion of the Investigator

Any coexistent medical condition interfering with drug absorption

History 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 completion

Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study Cancer-Related Exclusion Criteria

Participant 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.

Patients 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 therapy

Participants must, in the opinion of the Investigator, be capable of complying with the requirements of this protocol including self-administration of study treatment

Concurrent 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.

Any condition which in the investigator’s opinion deems the participant an unsuitable candidate to receive study drug

Any prior or coexisting medical condition that in the investigator’s judgment will substantially increase the risk associated with the subject’s participation in the study

Any co-morbid medical condition that may put the patient at significant risk for toxicity

Any other condition that would, in the investigator's judgement, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures

Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

Subjects 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 risk

Any condition which in the investigator’s opinion deems the participant an unsuitable candidate to receive study drug

Any 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 monitor

In the opinion of the Investigator would benefit from continued treatment.

Medical 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 patient

Patient has a serious active disease or co-morbid medical condition, as judged by the investigator, which would interfere with the conduct of this study.

Uncontrolled diabetes mellitus, cardiovascular disease, active serious infection or other condition which, in the opinion of treating physician, would make this protocol unreasonably hazardous for the patient

Any condition which in the investigator’s opinion deems the participant an unsuitable candidate to receive study drug

Subjects 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 trial

Any 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 objectives

Medical 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)

History or presence of an abnormal electrocardiogram (ECG) that, in the Investigator's opinion, is clinically meaningful.

Uncontrolled concomitant disease that in the opinion of the investigator would interfere with the patient’s safety or compliance on trial

History of severe autoimmune disease that in the opinion of the investigator would interfere with patient safety or compliance on trial

Any 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).

Life 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 patient

Any condition which, in the opinion of the Investigator, places the subject at unacceptable risk if he/she were to participate in the study.

Any condition which, in the investigator’s opinion, makes the subject unsuitable for trial participation

Subjects with any concomitant disease or condition that, in the clinical judgment of the treating physician, is likely to prevent the subject from complying with any aspect of the protocol or that may put the subject at unacceptable risk.

Active infection or other medical condition that would make prednisone/prednisolone (corticosteroid) use contraindicated.

Any 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.

Patient (Pt) may be excluded if, in the opinion of the principal investigator (PI) and investigator team, the pt is not capable of being compliant

A serious uncontrolled medical disorder that in the opinion of the investigator may be jeopardized by the treatment with protocol therapy

Pt may be excluded if, in the opinion of the principal investigator (PI) and investigator team, the pt is not capable of being compliant

Any 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).

Any 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.

Any 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.

Subject has any condition including the presence of laboratory abnormalities which, in the opinion of the Investigator, places the subject at unacceptable risk if he/she were to participate in the study.

Subject has any condition that confounds the ability to interpret data from the study.

Other medical conditions deemed by the principal investigator (or associates) to make the subject unsafe or ineligible for protocol procedures

Any 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:

Patients who, in the opinion of the investigator, are unable or unlikely to comply with the dosing schedule and study evaluations

Has any serious concomitant illness that in the opinion of the investigator(s) could affect the participant's safety or interfere with the study assessments.

Subjects 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 trial

Subject has any condition which makes the subject unsuitable for study participation.

Subjects with medical condition that could adversely impact the study participation or assessments.

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

Any 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

Medical, 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 requirements

Subject has any other significant medical or psychiatric history that in the opinion of the investigator would adversely affect participation in this study

Any condition that will put the patient at undue risk or discomfort as a result of adherence to study procedures

Any condition which in the investigator’s opinion deems the participant an unsuitable candidate to receive study drug

Any 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 study

Ongoing severe inflammatory skin condition (as determined by the Investigator) requiring medical treatment

Normal organ function since eligibility screening, and no new clinical or laboratory findings that, in the opinion of the investigator, might jeopardize the patient's safety

Individuals 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 art

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 risk

Any 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 study

Normal organ function since eligibility screening, and no new clinical or laboratory findings that, in the opinion of the investigator, might jeopardize the patient's safety

Any medical, psychological or social condition that in the opinion of the investigator, would preclude participation in this study.

Any other major medical illnesses or psychiatric impairments that in the investigator's opinion will prevent administration or completion of protocol therapy

Any 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 consent

The presence of any medical condition that the Investigator deems incompatible with participation in the trial

Any 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 study

Has any severe concurrent disease, infection, or comorbid condition that renders the patient inappropriate for enrollment in the opinion of the investigator

Individuals 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 art

History 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.

Any 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

Any other pathology or condition that the principal investigator deems to negatively impact treatment safety

Osseous metastatic disease with unacceptable risk of impending fracture due to study assessments, in the opinion of the investigator

Investigator's opinion of subject's probable noncompliance or inability to understand the trial and/or give adequate informed consent;

Any malabsorption condition

Any condition which, in the investigator’s opinion, makes the subject unsuitable for trial participation

Any 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.

Current or relevant previous history of serious, severe or unstable (acute or progressive) physical or psychiatric illness, including any medical disorder that may require treatment or make the subject unlikely to fully complete the study, or any condition that presents undue risk from the IP or procedures.

Any life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the patient’s safety

Patients 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 diarrhea

Any other issue which, in the opinion of the treating physician, would make the patient ineligible for the study

Significant 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 trial

Any other health condition that would preclude participation in the study in the judgment of the principal investigator

All 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 treatment

Any 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 therapy

Any other issue which, in the opinion of the treating physician, would make the patient ineligible for the study

Participant 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.

Have 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

Any 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 protocol

Any other condition which, in the opinion of the investigator, may compromise the subject's ability to follow study procedures and safely complete the study

Any significant disease that, in the opinion of the investigator, may impair the patient’s tolerance of study treatment

Any prior or coexisting medical condition that in the investigator’s judgment will substantially increase the risk associated with the subject’s participation in the study

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 risk

Any malabsorption condition

Subjects with any concurrent condition that, in the investigator's opinion, would jeopardize the safety of the subject or compliance with the protocol

Subjects with major medical, neurologic or psychiatric condition who are judged as unable to fully comply with study therapy or assessments should not be enrolled

Other medical or psychiatric conditions that in the opinion of the investigator would preclude safe participation in the protocol

Patients 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.

Serious active infection at the time of enrolment, or another serious underlying medical condition that would impair the ability of the patient to receive study treatment

Patients 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-0129

Comorbid condition(s) which, in the opinion of the attending physician and/or MSK Cancer Center (CC) principal investigator, will preclude stem cell mobilization and/or high-dose therapy with autologous stem cell rescue

No other condition which, in the opinion of the Investigator, would preclude participation in this trial

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 risk

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 risk

Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures

Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

In the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

A concomitant medical condition that in the opinion of the treating physician would pose unreasonable additional risk to therapeutic injection of ONCOS-102.

Any 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 risk

Serious nonmalignant disease that could compromise protocol objectives in the opinion of the investigator and/or the sponsor

Any condition which, in the investigator’s opinion, makes the subject unsuitable for trial participation

Any other medical or surgical condition or disease that, in the judgment of the treating physician, renders subject ineligible for high dose interleukin-2 therapy

Presence 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 subjects

Subjects 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-up

Any 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 drug

Any other major medical illnesses or psychiatric impairments that in the investigator's opinion will prevent administration or completion of protocol therapy

Any 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 consent

Any condition which, in the opinion of the investigator, would preclude participation in this trial

History 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.

Medical, 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 requirements

Any condition which in the investigator’s opinion deems the participant an unsuitable candidate to receive study drug

All 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 treatment

Chronic 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.

Any condition which in the Investigator’s opinion deems the participant an unsuitable candidate to receive study drug

Have 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 year

Any 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 risk

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 ibrutinib, or put the study outcomes at undue risk

Serious nonmalignant disease (e.g., hydronephrosis, liver failure, or other conditions) that could compromise protocol objectives in the opinion of the investigator

Subjects should be in otherwise satisfactory health in the opinion of the Investigator;

Patients 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.

Any condition, including laboratory abnormalities, which in the opinion of the principal investigator or lead associate investigator, would prohibit administration of planned chemotherapeutic intervention, places the subject at unacceptable risk if they were to participate in the study or confounds the ability to interpret data from the study

Any 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 trial

Any 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 risk

Any concomitant disease or condition that, in the clinical judgment of the treating physician, is likely to prevent the subject from complying with any aspect of the protocol or that may put the subject at unacceptable risk

Other known other significant medical or psychiatric condition that would make assessment of toxicity or efficacy difficult

No serious disease or condition that, in the opinion of the investigator, would compromise the patient’s ability to participate in the study

Any condition that in the opinion of the investigator, would preclude participation in this study

Clinical judgment by the investigator that the patient should not participate in the study

Patients positive for hepatitis C are permitted if controlled with medication, in the opinion of the investigator

Any condition that, in the opinion of the investigator, would impair the subject's ability to comply with study procedures.

Medical, 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 requirements

Active infection requiring antibiotics, antifungal or antiviral agents, that in the opinion of the investigator would compromise the patient’s ability to tolerate therapy

Underlying 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

Serious underlying medical conditions that, per the Investigator's discretion, could impair the ability of the patient to participate in the trial

Any 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 protocol

Have 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 requirements

Patients with medical history or conditions not otherwise previously specified which in the opinion of the investigator should exclude participation in this study

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 risk

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 undue risk

Active infection or other serious underlying medical condition which would impair the ability of the patient to receive the planned treatment

Eligible for therapy for the lymphoid malignancy which has a high likelihood of a curative result in the opinion of the investigator

Have 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 requirements

Current 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 study

Any 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 subject

Any 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

Either a concurrent condition (including medical illness, such as active infection requiring treatment with intravenous antibiotics or the presence of laboratory abnormalities) or history of a prior condition that places the patient at unacceptable risk if he/she were treated with the study drug or a medical condition that confounds the ability to interpret data from the study

Subject has any medical or psychiatric condition that, in the opinion of the Investigator, may compromise the subject's ability to participate in this study

Patient 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 drug

Any 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

Any serious underlying medical condition that, in the opinion of the enrolling physician, would impair the ability of the patient to receive protocol treatment

Any other condition that, according to the investigator, may forbid the administration of the idarubicin + cytarabine regimen

Other serious, ongoing, non-malignant disease or infection that would in the opinion of the site investigator compromise other protocol objectives

hepatic, renal neurological or metabolic conditions - which in the opinion of the investigator would compromise the protocol objectives.

Any medical conditions that, in the investigator’s opinion, would impose excessive risk to the subject\r\n* Examples of such conditions include:\r\n** Any uncontrolled disease, such as pulmonary disease, infection, seizure disorder\r\n** Any altered mental status or any psychiatric condition that would interfere with the understanding of the informed consent\r\n** Active infection that requires parenteral anti-microbial or anti-parasitic treatment

Patients 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 excluded

Any concomitant condition that in the opinion of the investigator could compromise the objectives of this study and the patient's compliance.

Any 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 judgment

Medical, 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 requirements

In 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-102

Any 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 incontinence

Any medical conditions, which, in the opinion of the investigators, would jeopardize either the patient or the integrity of the data obtained are not eligible

Medical, 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 requirements

Any 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 protocol

No 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 malignancy

Serious illness or medical condition that could affect the safety or tolerability of study treatments

Any condition or reason that in the opinion of the investigator, interferes with the ability of the patient to participate in the trial

Patients 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 eligible

Any condition which, in the opinion of the investigator, would preclude participation in this trial

Any other current or previous malignancy within the past three years that, in the opinion of the Principal Investigator, will interfere with study-specific objectives.

Any medical condition, which in the investigator's opinion, could compromise the patient's safety

Any other conditions or circumstances that would, in the opinion of the investigator, make the patient unsuitable for participation in the study

Any 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 study

Any malabsorption condition.

Any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation

Current 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)

Have 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 interpretation

Any 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 requirements

Other significant medical conditions must be well-controlled and stable in the opinion of the investigator for at least 30 days prior to Randomization

Any medical or other condition that, in the opinion of the investigator, would preclude the subject's participation in a clinical study

Subjects 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.

Any electrocardiogram (ECG) abnormality that in the opinion of the principal investigator would preclude safe participation in the study

Any condition or medical problem in addition to the underlying malignancy and organ dysfunction which the investigator feels would pose unacceptable risk

Has 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 trial

Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

Clinically significant medical disease or condition that, in the investigator’s opinion, may interfere with protocol adherence or the patient’s ability to give informed consent

NONCOMPLIANCE: Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

Any 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 study

Presence of a significant psychiatric disease, which in the opinion of the principal investigator or his designee, would prevent adequate informed consent

Patient, in the opinion of the investigator, is likely to be poorly compliant

Any 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 period

Any other issue which, in the opinion of the treating physician, would make the patient ineligible for the study

Evidence 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 protocol

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 enzalutamide, or put the study outcomes at undue risk

Any condition or abnormality which may, in the opinion of the investigator, compromise the safety of patients

Any medical condition which in the opinion of the study investigator places the subject at an unacceptably high risk for toxicities

Medical, 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 requirements

Life expectancy of ? 2 months. 6. 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, ECG, laboratory tests or chest X-ray. Such conditions may include: • Unstable cardiovascular conditions at Baseline including but not limited to:

A co-morbid condition that, in the Investigator's opinion, renders the subject at high risk for treatment complications.

The 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 risk

Any medical or other condition that in the opinion of the investigator(s) would preclude the participant's participation in a clinical study.

Have a psychiatric disorder(s) or psychosocial circumstance(s) which in the opinion of the primary physician would place the patient at an unacceptable risk from transplant

Serious uncontrolled medical disorder or active infection that in the investigator's opinion would impair the patient's ability to receive study treatment.

Unstable coronary artery disease or other medical condition (such as type 1 diabetes) that, in the Investigator's opinion, might increase the risk to the patient

In 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 requirements

Any significant disease that, in the opinion of the investigator, may impair the patient’s tolerance of study treatment

Any medical or psychological condition or situation deemed by the principal investigator (PI) to put the patient at increased risk of complications or noncompliance

Any 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 physicians

History 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 investigator

Has any condition that, in the opinion of the investigator, might jeopardize the safety of the patient or interfere with protocol compliance

Individuals 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 art

Any condition which, in the investigator’s opinion, makes the subject unsuitable for trial participation

Any concurrent or past medical condition that, in the opinion of the investigator, would exclude the subject from participation

Requirement for treatment in the opinion of the investigator.

Significant active renal, neurologic, psychiatric, hepatic or endocrinologic disease that in the investigator's opinion would adversely impact on his/her participating in the study.

No condition or abnormality which may, in the opinion of the investigator, compromise the safety of the patient

Any condition or abnormality which may, in the opinion of the investigator, compromise the safety of patients

Life expectancy is not severely limited by concomitant illness in the opinion of the treating investigator

Any physical or psychological condition that, in the opinion of the investigator, would pose unacceptable risk to the patient

Patient has any condition or laboratory abnormality which, in the opinion of the investigator, would pose additional risk in administering the study drug to the patient

Has a concomitant medical condition that would in the opinion of the Investigator increase the risk of toxicity.

Any illness or condition that in the opinion of the investigator may affect safety of treatment or evaluation of any the study’s endpoints

Patient 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 trial

Any malabsorption condition

Significant 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 trial

Any medical or psychiatric condition, illness, disorder, or concomitant medication that could compromise participant safety or treatment, as determined by the principal investigator and/or study physician

Underlying medical conditions that, in the investigator’s opinion, will make the administration of study drug hazardous or obscure the interpretation of toxicity or adverse events

Significant 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 study

Any 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 deficiencies

The 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.

Any condition or abnormality which may, in the opinion of the investigator, compromise the safety of patients

Any condition or abnormality which may, in the opinion of the investigator, compromise the safety of the patient

History of alcoholism, drug addiction, or any psychiatric or psychological condition which, in the opinion of the investigator, would impair study compliance

Any 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

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 undue risk

Individuals 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 art

Any condition that is unstable and could jeopardize the subject's participation in the study.

Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

Psychiatric of addictive disorders or other condition that in the opinion of the investigator would preclude the patient from meeting the study requirements

Any concomitant condition that in the opinion of the Investigator could compromise the objectives of this study and the patient's compliance.

Any condition or abnormality which may, in the opinion of the investigator, compromise the safety of patients

Patients with a medical condition or social situation that at the discretion of the Principal Investigator (PI) would preclude them from completion of the trial

Patients unable to receive cisplatin in the opinion of the medical oncologist

Active second malignancy that in the opinion of the principal investigator (PI) may interfere with or be adversely affected by this treatment

Either a concurrent condition (including medical illness, such as active infection requiring treatment with intravenous antibiotics or the presence of laboratory abnormalities) or history of a prior condition that places the patient at unacceptable risk if he/she were treated with the study drug or a medical condition that confounds the ability to interpret data from the study

Any other pathology or condition where the principle investigator may deem to negatively impact treatment safety

Patients with medical conditions which, in the opinion of the investigators, would pose undue risk to the patient

No other medical condition or reason that, in the opinion of the investigator, would preclude study participation

Patients 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

Concomitant 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 study

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

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 diarrhea

Patients 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 participation

Presence of a significant psychiatric disease, which in the opinion of the principal investigator or his designee, would prevent adequate informed consent (Turnstile I)

Presence 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)

Concomitant 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 study

Must 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.

Any condition or abnormality which may, in the opinion of the investigator, compromise his or her safety

Uncontrolled significant intercurrent illness that would preclude the patient from study participation per investigator assessment

Any condition which in the Investigator’s opinion deems the subject an unsuitable candidate to receive study drug

Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements

A serious uncontrolled medical disorder that is in the opinion of the Investigator would impair the ability of the subject to receive protocol therapy

Other condition(s) that in the opinion of the investigator might compromise the objectives of the study

Any condition which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study

Any condition or abnormality which may, in the opinion of the investigator, compromise the safety of patients

Any condition or abnormality which may, in the opinion of the investigator, compromise the safety of the patient

Patients with other medical conditions or concomitant medications that in the opinion of the principal investigator may interfere with the therapeutic treatment.

Any condition which in the investigator’s opinion deems the patient an unsuitable candidate to receive study drug

Presence 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)

Any 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.

Concomitant 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

Serious nonmalignant disease which, in the opinion of the investigator would compromise protocol objectives

Medical or psychological conditions that would make the patient unsuitable candidate for cell therapy at the discretion of the principal investigator (PI)

Patients 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 therapy

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 diarrhea

Patients with other significant disease or disorders that, in the investigator's opinion, would exclude the patient from the study

History of venous or arterial thromboembolism, unless:\r\n* Line-related thrombosis without embolus occurring >= 1 year prior to screening\r\n* Complications resulting from atherosclerotic coronary artery disease, peripheral vascular disease, or cerebrovascular disease (including infarction) are not considered exclusion criteria unless in the opinion of the principal investigator or lead associate investigator their clinical consequences in a particular subject places the subject at unacceptable risk if they were to participate in the study or confounds the ability to interpret data from the study

Any condition, including the presence of laboratory abnormalities, which in the opinion of the principal investigator or lead associate investigator places the subject at unacceptable risk if they were to participate in the study or confounds the ability to interpret data from the study

Patients 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 therapy

Active infection or other medical condition that would make prednisone/prednisolone (corticosteroid) use contraindicated

Any condition which, in the opinion of the investigator, would preclude participation in this trial

Have 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.

Ongoing severe inflammatory skin condition (as determined by the Investigator) requiring medical treatment

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 risk

Significant co-morbid condition or disease which in the judgment of the principal investigator would place the patient at undue risk or interfere with the study

Medical 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 inappropriate

Patients 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 therapy

In 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 irradiation

No 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 regimen

Infection or any other severe systemic disease or medical or surgical condition deemed significant by the principal investigator

Subjects who have other conditions which in the opinion of the investigator contraindicate the receipt of HSV1716 or indicate subject’s inability to follow protocol requirements

Any co morbidity or condition which, in the opinion of the investigator, may interfere with the assessments and procedures of this protocol

Patients should have uncontrolled intercurrent illness, which in the opinion of the attending medical oncologist, would render the patient unsuitable for the study (i.e., preclude safe administration of the prescribed chemotherapy treatment).

Patient who is otherwise considered unsuitable for transplant at the discretion of the principal investigator

Presence 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)

Patients who in the opinion of the principal investigator are poor psychiatric or medical risks are not eligible

Subject has any concurrent disease, infection or comorbid condition that interferes with the ability of the subject to participate in the study, which places the subject at undue risk or complicates the interpretation of data.

Has any serious concomitant illness that in the opinion of the investigator(s) could affect the participant's safety or interfere with the study assessments

Intolerance to the investigational product or its excipients, or any condition that would significantly impair and/or prohibit the patient's participation in the study, as per the Investigator's judgment.

Has 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:

Any other condition that might place the patient at undue risk.

Any condition which in the investigator’s opinion deems the participant ineligible

Intensive 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 data

Clinically significant abnormalities or co-morbidities, other than HCV infection that in opinion of the investigator makes subject unsuitable for this study or drug regimen

Any other diseases that, in the opinion of the investigator and Sponsor's medical monitor would pose a risk to the subject safety

All other significant diseases, which in the opinion of the investigator, may impair the subject’s tolerance of trial treatment

Any 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 visits

No other illness that in the opinion of the investigator would exclude the subject from participating in the study

Any 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 protocol

any condition that as judged by the Investigator would place the subject at increased risk of harm if he/she participated in the study.

Peripheral oedema at Screening that in the opinion of the Prinicpal Investigator (PI) or designee might prevent adequate absorption of subcutaneously administered CPHPC

Presence 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 patient

Active infection or any serious underlying medical condition, which would impair the ability of the patient to receive protocol treatment.

Presence of a comorbid disease or medical condition that would impair the ability of the patient to receive or comply with the study protocol

Any 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 data

Any condition that, in the clinical judgment of the treating physician, is likely to prevent the subject from complying with any aspect of the protocol or that may put the subject at unacceptable risk.

Patients with any serious underlying medical condition that would impair their ability to receive or tolerate the planned treatment.

Subject 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.

Has a serious illness or medical condition(s) that would affect safety or tolerability of the study treatments

Patients 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 drug

Any condition that is unstable and could jeopardize the patient's participation in the study.

Serious 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 study

No 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 diarrhea

Patients 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 eligible

Patients with life-threatening condition or complication other than their basic condition

Any condition that is unstable or which could jeopardize the safety of the patient (please refer to the Investigator Brochure and product labeling safety sections).

Any condition which in the opinion of the investigator, places the subject at unacceptable risk if he/she were to participate in the study.

Patients who, in the opinion of the principal investigator, have significant medical or psychosocial problems that warrant exclusion including:\r\n* Other serious non-malignancy-associated medical conditions that may be expected to limit life expectancy to less than 2 years\r\n* Any condition- medical, psychiatric or otherwise, that would preclude informed consent, consistent follow-up or compliance with any aspect of the study

Unstable or severe uncontrolled medical condition (eg, unstable cardiac function, unstable pulmonary condition), or any important medical illness or abnormal laboratory finding that would, in the Investigator's judgment, increase the subject's risk while participating in this study

Any new or uncontrolled condition that could make the patient unsuitable for participation

Patients should be in such a health condition in the opinion of the attending physician that with the administration of mifepristone benefits may outweigh risks

Other condition or prior therapy that, in the opinion of the Investigator, compromises the subject's welfare or may confound study results;

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 PCI-32765 PO, or put the study outcomes at undue risk

Presence 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.

224 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.

Serious 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

Subjects 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/CLABSI

Has 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:

Comorbid disease or a medical or psychiatric condition that would impair the ability of the patient to receive or comply with the study protocol.

Presence 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, provided they fulfill criteria.

Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

History or presence of an ECG that, in the investigator's opinion, is clinically meaningful as per protocol-defined criteria.

In 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 ALL

A 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 pembrolizumab

History of clinically significant medical condition that, in the opinion of the investigator, would adversely affect participation in this study.

Any condition(s), medical or otherwise, which, in the opinion of the investigators, would jeopardize either the patient or the integrity of the data obtained

In the investigator's judgment, any other condition that jeopardizes the patient's participation in the treatment phase

Any condition that may, in the opinion of the investigator, compromise the safety of the patient

Any condition medical or psychosocial that in the opinion of the investigator would hinder compliance

Any 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 procedures

Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

Current life-threatening illness, medical condition, or organ-system dysfunction that could compromise patient safety or put the study at risk

Concurrent medical condition that precludes safe participation in this study

Serious 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.

Any condition that confounds the ability to interpret data from the study

Any medical condition that, in the opinion of the investigator, would exclude the patient from participating in this study and treatment plan.

History 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 trial

Any other illness or condition that in the investigator’s opinion would adversely affect the safety of checkpoint inhibitor therapy

Any other condition that, in the opinion of the Investigator, would impair the patient’s ability to comply with study procedures

Any 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 data

RENAL & BLADDER: Any condition that in the opinion of the investigator, would preclude participation in this study

Any serious medical condition that interferes with adherence to study procedures.

Psychiatric, other medical illness or other condition that in the opinion of the principal investigator (PI) prevents compliance with study procedures or ability to provide valid informed consent.

Patient has a foreign body which in the opinion of the treating investigator could be difficult to manage in case of infection

Any condition or abnormality which may, in the opinion of the investigator, compromise the safety of patients

Any condition or abnormality which may, in the opinion of the investigator, compromise the safety of the patient

Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

Any 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.

Any 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.

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 with a life expectancy < 2 years.

THE 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.

Any 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

In the opinion of the investigator, the participant is an unsuitable candidate for this study

Other medical or psychiatric conditions that in the opinion of the investigator would preclude safe participation in the protocol

Any malabsorption condition

Any condition which, in the investigator’s opinion, makes the subject unsuitable for trial participation

Patients 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 treatment

Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

Current or prior disease or treatment that could compromise protocol objectives in the opinion of the Investigator and/or the Sponsor

History 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.org

Other unspecified reasons that, in the opinion of the investigator, make the subject unsuitable for the study

Active infection or other medical condition that would make prednisone use contraindicated

Any condition that in the opinion of the investigator, would preclude participation in this study

Patients 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 antibiotics

Any 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)

Medical, 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 requirements

Patients for whom it is not in the best interest to participate in the study, in the opinion of the treating investigator

Any 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 study

Subjects 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 therapy

ARM A: Any condition, which in the opinion of the investigator would render the patient unsuitable to participate in the study

ARM B: Any condition, which in the opinion of the investigator would render the patient unsuitable to participate in the study

Presence 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 data

Any condition or medical problem in addition to the underlying malignancy and organ dysfunction that the investigator feels would pose unacceptable risk

Any medical or psychological condition that in the opinion of the principal investigator would interfere with safe completion of the trial

Patients currently receiving any medication known to induce central serous chorioretinopathy which in the opinion of the principal investigator, would make the administration of study drug hazardous

Any 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 events

A serious uncontrolled medical disorder that in the opinion of the investigator may be jeopardized by the treatment with protocol therapy

Patient (Pt) may be excluded if, in the opinion of the principal investigator (PI) and investigator team, the pt is not capable of being compliant

Current 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

Patients with malabsorption or any other condition that in the opinion of the principal investigator could cause difficulty in absorption of drug

Any 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 Investigator

Any condition or behavior that in the judgment of the investigator, would compromise the patient’s ability to participate in the study and/or comply with study procedures

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 adverse events (AEs)

Any active or chronic illness that, in the opinion of the investigators, would make the study unsafe or limit compliance with study procedures

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 adverse events (AEs)

Subjects must not 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 subjects to receive protocol treatment

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

Any physical or mental condition that, in the opinion of the PI, would cause the risk/benefit ratio of participation to be unacceptable

Any other reason the investigator considers the patient should not participate in the\n             study

Any 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 diarrhea

Patients 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 eligible

Clinically significant medical disease or condition that, in the investigator's opinion, may interfere with protocol adherence or the patient's ability to give informed consent

Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

Any malabsorption condition

Any condition which, in the investigator’s opinion, makes the subject unsuitable for trial participation

Any concurrent health condition that in the view of the treating physician would pose excessive risk to the patient if enrolled in the study

No presence of uncontrolled systemic disease or tumor related complication which, in opinion of the investigator, might restrict life expectancy to less than 3 months

Any medical condition which, in the investigator's opinion, could compromise the patient's safety

Patients 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 therapy

Any condition or medical problem in addition to the underlying malignancy and organ dysfunction which the investigator feels would pose unacceptable risk

Subject has any other medical or psychiatric disorder that, in the opinion of the treating physician, would contraindicate the use of drugs in this protocol or place the subject at undue risk for treatment complications

Any medical condition that would compromise the subject’s ability to safely participate in the study

Other condition(s) that in the opinion of the investigator might compromise the objectives of the study or increase patient risk

Patients 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 diarrhea

Active uncontrolled infection or major concurrent illness which in the opinion of the investigator would render the patient unsafe to proceed with the study

No gastro-intestinal condition, that in the opinion of the treating physician or the principal investigator significantly limits oral absorption

Any 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 events

Subjects with any concurrent condition that, in the investigator’s opinion, would jeopardize the safety of the subject or compliance with the protocol

Medical conditions which, in the opinion of the investigators, would jeopardize the patient or the integrity of the data obtained

Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements

Any condition which in the investigator’s opinion makes the subject unsuitable for study participation

Any serious active disease or co-morbid condition, which in the opinion of the principal investigator, will interfere with the safety or compliance of the trial

Previous medical history or evidence of an intercurrent illness that may, in the opinion of the investigator, compromise the safety of the patient in the study

Any significant disease that, in the opinion of the investigator, may impair the patient's tolerance of study treatment

Any 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 objectives

Any condition which the investigator's opinion deems the patient ineligible

Any condition or abnormality which may, in the opinion of the investigator, compromise the safety of patients

Any medical condition which in the opinion of the investigator puts the patient at risk of potentially serious complications while on this therapy

Patients 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 antibiotics

Presence 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

Any 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 requirements

Presence 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

Patients 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 patient

Patients with other significant diseases or disorders that, in the investigator’s opinion, would exclude them from the study

Serious psychiatric condition or addictive disorder

Patients may be excluded at the discretion of the principal investigator (PI) or if it is deemed that allowing participation would represent an unacceptable medical or psychiatric risk

Underlying 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 events

Underlying 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 events

Any 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 study

Subjects with any other medical condition, which in the opinion of the investigator would compromise the results of the study by deleterious effects of treatment

Patients 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 drug

Any other concurrent illness which in investigator’s opinion puts the patient at excessive risk of treatment related toxicities

Subjects with any other medical condition, which in the opinion of the investigator would compromise the results of the study by deleterious effects of treatment

Any other significant disease or other clinical findings which in the opinion of the investigator would prevent study entry

Subject has any condition which makes the subject unsuitable for study participation.

Any malabsorption condition

Any condition which, in the investigator’s opinion, makes the patient unsuitable for trial participation

Medical 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.

Any serious or uncontrolled concomitant disorder that, in the opinion of the investigator, would compromise the patient’s ability to complete the study

Significant co-morbid condition or disease which in the judgment of the Investigator would place the subject at undue risk or interfere with the study; examples include, but are not limited to, cirrhotic liver disease, sepsis, recent significant traumatic injury, and other conditions

Subject has any condition that confounds the ability to interpret data from the study.

Subjects 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).

Subject with any other condition which in the opinion of the investigator would preclude participation in the study.

History or presence of abnormal electrocardiogram (ECG) that, in the investigator's opinion, is clinically meaningful

Inability 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 participation

c) History of other malignancy that in the Investigator's opinion would not affect the determination of study treatment effect

Any 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 trial

Patients may not have any other medical condition or reason, in that investigator's opinion, makes the patient unstable to participate in a clinical trial

have serious preexisting medical conditions that, in the judgment of the investigator, would preclude participation in this study

Active infection or serious underlying medical condition that would impair the patient's ability to receive protocol treatment

Presence 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.

Subject has any condition that confounds the ability to interpret data from the study.

Subject 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 efficacy

Life-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.

The presence of any other medical or psychiatric disorder that, in the opinion of the treating physician, would contraindicate the use of drugs in this protocol or place the subject at undue risk for treatment complications

The patient has any medical condition which in the opinion of the investigator places the patient at an unacceptably high risk for toxicities.

Subjects with a condition which may interfere with the subjects' ability to understand the requirements of the study

Co-morbid disease or condition that would place the patient at undue risk and preclude safe use of TheraSphere treatment, in the Investigator's judgment

Serious 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.

Has history of any disease, metastatic condition, drug/medication use or other condition that might, per protocol or in the opinion of the investigator, compromise:

Either a concurrent condition or history of a prior condition that places the patient at unacceptable risk if he/she were treated with the study drug or confounds the ability to interpret data from the study

History or presence of an abnormal ECG that, in the investigator's opinion, is clinically meaningful.

Any other medical condition that, in the opinion of the Investigator, would adversely affect the subject's participation in the study.

Any condition that confounds the ability to interpret data from the study

Any medical or other condition that in the opinion of the investigator(s) would preclude the participant's participation in a clinical study.

Any condition that, in the opinion of the investigator or sponsor, would interfere with evaluation of the investigational product.

Subject 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:

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 study drugs, or put the study outcomes at undue risk.

Concomitant medical condition that would increase the risk of toxicity, in the opinion of the Investigator or Sponsor

Any other condition which, in the opinion of the Investigator, might impair the subject's tolerance of trial treatment, the safety of the individual subject or the outcome of the trial. (including but not limited to: history of major depressive episode, bipolar disorder, obsessive-compulsive disorder, schizophrenia, suicidal attempt or ideation, homicidal ideation, or >= Common Terminology Criteria for Adverse Events [CTCAE] Grade 3 anxiety)

Serious infection, immunosuppression or concurrent medical condition (chronic or acute in nature) that may prevent safe participation or ability to meet follow-up requirements

Patients must be, in the opinion of the Investigator, available and compliant for treatment and follow-up.

Any condition which in the Investigator’s opinion deems the participant an unsuitable candidate to receive study drug

Any condition that in the opinion of the investigator would impair the patients' ability to comply with the study procedures.

All other significant diseases (for example, inflammatory bowel disease), which, in the opinion of the Investigator, might impair the subject's tolerance of trial treatment

Any 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.

Patients 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 diarrhea

Significant concurrent medical condition that would make prednisone/prednisolone use contraindicated or would interfere with the patient’s ability to participate in the trial

Any 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 requirements

Subjects who, in the opinion of the investigator, are unable or unlikely to comply with the dosing schedule and study evaluations

History of or ongoing major cardiac, pulmonary, renal, endocrine, or hepatic disease that, in the opinion of the investigator or sponsor, would preclude participation.

History/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.

Has an Underlying medical condition that would preclude study participation.

Have any condition or illness that, in the opinion of the investigator, would compromise patient safety or interfere with the evaluation of the study drug.

Any 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.

Any malabsorption condition.

Uncontrolled 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 events

No other illness that in the opinion of the investigator would exclude the subject from participating in the study

Any condition which in the investigator’s opinion deems the participant an unsuitable candidate to receive study drug

In the opinion of the investigator the patients must:

history 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.

Any condition that confounds the ability to interpret data from the study.

Any condition that confounds the ability to interpret data from the study

Any condition that confounds the ability to interpret data from the study

Any 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.

Any 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

Subject 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 drug

Any malabsorption condition

Any condition which, in the investigator’s opinion, makes the subject unsuitable for trial participation

Any serious, unstable medical or psychiatric condition that would prevent, (as judged by the Investigator) the subject from signing the informed consent form or any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study;

Any medical conditions that, in the Investigator's opinion, would impose excessive risk to the patient or would adversely affect his/her participation in this study

Evidence 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 protocol

Any condition that confounds the ability to interpret data from the study.

Serious 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 study

History or presence of an abnormal electrocardiogram (ECG) that, in the investigator's opinion, is clinically meaningful.

History or presence of an abnormal electrocardiogram (ECG) that, in the investigator's opinion, is clinically meaningful.

History or presence of an abnormal electrocardiogram that, in the investigator's opinion, is clinically meaningful.

History 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 completion

Underlying 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 events

History of or ongoing major cardiac, pulmonary, renal, endocrine, or hepatic disease that, in the opinion of the investigator or sponsor, would preclude participation.

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 lenalidomide capsules, or put the study outcomes at undue risk

Any condition that, in the clinical judgment of the treating physician, is likely to prevent the subject from complying with any aspect of the protocol or that may put the subject at unacceptable risk.

Active infection or any serious underlying medical condition, which would impair the ability of the patient to receive protocol treatment

Any 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 diarrhea

Clinically significant infections as judged by the treating investigator. Subjects must not have been diagnosed with human immunodeficiency virus (HIV) infection, active chronic hepatitis B or C, life-threatening illness unrelated to cancer, or any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with participation in this study. Subjects should be tested for hepatitis B or C or HIV infection during screening only if they are considered by the investigator to be at high risk for these infections.

Medical condition or organ system dysfunction which, in the investigator opinion, could interfere with absorption or metabolism of ibrutinib

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 risk

Any reason that, in the opinion of the Investigator, contraindicates that the patient participates in the study

Any malabsorption condition.

Any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation.

Presence of any condition which makes the patient unsuitable

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 risk

Patients with unstable or severe intercurrent medical conditions or laboratory abnormalities that would impart, in the judgment of the protocol principal investigator, excess risk associated with study participation or study agent administration

Any condition that confounds the ability to interpret data from the study

Any 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.

Have other significant medical conditions well-controlled and stable in the opinion of the investigator for at least 30 days prior to Day 1

Have 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 assessments

Have any medical or other condition that in the opinion of the investigator(s) would preclude the participant's participation in a clinical study

Subjects with pre-existing medical illnesses or medications which might interfere with the study as determined by principal investigator (PI)

Serious underlying medical or psychiatric illnesses that would, in the opinion of the treating physician, substantially increase the risk for complications related to treatment

Subject 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 drug

Any other major medical illnesses or psychiatric impairments that in the investigator's opinion will prevent administration or completion of protocol therapy

Any 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 diarrhoea

History of another malignancy that in the opinion of the investigator may compromise the outcome of the study

Any reason why, in the opinion of the investigator, the patient should not participate.

Subjects must be stable and, in the opinion of the investigator, be expected to complete 4 week treatment period.

Any new condition or worsening of existing condition that could make the patient unsuitable for participation, or interfere with the patient participating in and/or completing the study

Any other concomitant serious illness or organ system dysfunction as per investigator assessment

Diagnosis of a coexisting medical condition which limits life expectancy to < 2 years

Any 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 study

Any 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 requirements

Subjects with pre-existing medical illnesses or medications which might interfere with the study as determined by principal investigator (PI)

Presence 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 subjects

Requires myelofibrosis therapy, in the opinion of the investigator

Any condition that places the subject at unacceptable risk if he/she were to participate in the study or that confounds the ability to interpret data from the study.

Patients 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 eligible

Any medical or other condition that in the opinion of the investigator would preclude the subject's participation in a clinical study

Unstable 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.

Subject is diagnosed with a known medical condition associated with a hypercoagulable state.

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

Any other medical condition that in the opinion of the investigator may interfere with a subject participation in, or compliance with, the study

Any condition that, in the clinical judgment of the treating physician, is likely to prevent the subject from complying with any aspect of the protocol or that may put the subject at unacceptable risk

Any 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 safety

Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

The patient has any medical condition which, in the opinion of the Investigator, places the patient at an unacceptably high risk for toxicities.

Have 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.

Subject has any condition which makes the subject unsuitable for study participation, including any contraindications of azacitidine.

A serious uncontrolled medical disorder that in the opinion of the Investigator would impair the ability of the subject to receive protocol therapy

Any 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.

Participation in any other immunotherapy treatment, that in the opinion of the principal investigator would be unsafe to receive further checkpoint blockade immunotherapy.

Active 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 risk

Judgment 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 trial

Subject has a known psychiatric disorder, which in the opinion of the Principal Investigator, would preclude the subject from completing this clinical study;

Subject is not appropriate for inclusion in the clinical trial, per the medical opinion of the Principal Investigator. Intraoperative Eligibility Criteria:

Any malabsorption condition

Any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation

Patients 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 risk

Evidence 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.

Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator’s opinion could interfere with the absorption or metabolism of ibrutinib

Any 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

Patient has any unstable medical condition that would make it unsafe to undergo TURBT.

No serious disease or condition that, in the opinion of the investigator, would compromise the patient’s ability to participate in the study

Patients who, in the opinion of the Investigator, have significant medical or psychosocial problems that warrant exclusion. Examples of significant problems include, but are not limited to:

Any 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 study

In the opinion of the investigator would benefit from systemic therapy

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 undue risk, including but not limited to:\r\n* Moderate to severe hepatic impairment (Child-Pugh classes B and C)

Subject 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.

Any 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 consent

In the opinion of the investigator, the patient is an unsuitable candidate to receive HM61713

Any medical condition which, in the investigator's opinion, could compromise the patient's safety

Has any condition that, in the opinion of the investigator, might jeopardize the safety of the subject or interfere with protocol compliance.

Patients 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 safety

Any condition which in the investigator’s opinion deems the participant an unsuitable candidate to receive study drug

A life-threatening illness, medical condition (including psychiatric conditions) or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety

Active collagen-vascular disease that, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient

Any medical condition which, in the investigator's opinion, makes the patient unsuitable for participation

Pending visceral crisis, in the opinion of the treating investigator

Any serious co-morbid condition, including laboratory abnormalities, that in the opinion of the investigator places the subject at unacceptable risk if he/she were to participate in the study

Prior 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 results

Any condition that, in the clinical judgment of the treating physician, is likely to prevent the subject from complying with any aspect of the protocol or that may put the subject at unacceptable risk.

Any 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

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 consent; investigator discretion is allowed

Serious 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 investigator

Any medical condition which, in the investigator's opinion, could compromise the patient's safety

Any 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 protocol

Any malabsorption condition

Any condition which, in the investigator’s opinion, makes the subject unsuitable for trial participation

Any condition, including laboratory abnormalities, that in the opinion of the investigator places the subject at unacceptable risk if he/she were to participate in the study

Any malabsorption condition

Any condition which, in the investigator’s opinion, makes the subject unsuitable for trial participation

Any condition that confounds the ability to interpret data from the study

Any condition that, in the opinion of the treating physician, would exclude the subject from receiving bevacizumab. Examples may include but are not limited to:

Any condition that, in the opinion of the investigator, might jeopardize the safety of the subject or interfere with protocol compliance.

History or presence of any medical condition or disease which, in the opinion of the investigator, may place the subject at unacceptable risk for study participation

Patient has an important medical illness or abnormal laboratory finding that, in the Investigator's opinion, would increase the risk of participating in this study.

Active infection or serious underlying medical condition that would impair the patient's ability to receive protocol treatment

The 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.

Participant 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.

Patient, in the opinion of the investigator, is likely to be poorly compliant

Willingness 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 investigator

Other major medical illnesses or psychiatric impairments that in the investigator's opinion will prevent administration or completion of protocol therapy

Any 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 risk

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 consent; investigator discretion is allowed

Medical conditions that, in the investigator’s opinion, would impose excessive risk to the subject

Any illness or condition that in the opinion of the investigator may affect safety of treatment or evaluation of any the study’s endpoints

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 ACP-196 (acalabrutinib), or put the study outcomes at undue risk

Any 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 objectives

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 risk.

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 risk.

In 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.

Significant co-morbid condition or disease which in the judgment of the investigator would place the patient at undue risk or interfere with the study; examples include, but are not limited to cirrhotic liver disease, sepsis, or recent significant traumatic injury

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 and/or ACP-319, or put the study outcomes at undue risk.

A serious uncontrolled medical disorder that, in the opinion of the Investigator, would impair the ability of the patient to receive protocol therapy

Having a history or presence of a significant psychiatric disorder or any other condition that, in the investigator’s judgment, would interfere with participation in the trial

Significant 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 participant

In the opinion of the investigator, patient must be able to receive at least 2 cycles of treatment

Serious active infection at the time of treatment, or another serious underlying medical condition that would impair the ability of the patient to receive protocol treatment.

Any serious ongoing condition, such as an untreated infection or organ dysfunction

Any malabsorption condition

Any condition which, in the investigator’s opinion, makes the subject unsuitable for trial participation

Any 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 diarrhea

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 ACP-196, or put the study outcomes at undue risk

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 diarrhea

Any malabsorption condition

Any condition which, in the investigator’s opinion, makes the subject unsuitable for trial participation

Any medical condition which, in the opinion of the investigator, puts the patient at risk of potentially serious complications while on study treatment

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

Have any condition or illness that, in the opinion of the investigator, would compromise participants safety or interfere with evaluation of the drug study.

Any other condition that, in the opinion of the investigator, would impair the patient's ability to comply with study procedures

Any condition which in the investigator's opinion deems the subject an unsuitable candidate to receive study drug

Concurrent serious illness which, in the opinion of the investigator, would place the patient at unreasonable risk from study therapy;

Willingness to swallow pills and no medical condition that would interfere with this

Any 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 data

Medical condition that would make prednisone (corticosteroid) use contraindicated

Any 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)

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 risk.

Any 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 data

Any 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

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

COHORT 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 diarrhea

COHORT 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 diarrhea

Any prior or co-existing medical condition that in the investigator’s judgment will substantially increase the risk associated with the subject’s participation in the study

Unstable or severe uncontrolled medical condition (eg, unstable cardiac function, unstable pulmonary condition), or any important medical illness or abnormal laboratory finding that would, in the investigator's judgment, increase the subject's risk while participating in this study

Have 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 visits

Any condition that, in the clinical judgment of the treating physician, is likely to prevent the subject from complying with any aspect of the protocol or that may put the subject at unacceptable risk.

Any 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 risk

Any condition, including laboratory abnormalities, that in the opinion of the investigator places the subject at unacceptable risk if he/she were to participate in the study

The patient has any condition that confounds the ability to interpret data from the study.

Active infection or other medical condition that would make prednisone/prednisolone (corticosteroid) use contraindicated

Have 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 requirements

Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements.

Subject has any condition which makes the subject unsuitable for study participation (e.g. ophthalmic conditions such as advanced cataracts).

High likelihood or protocol non-compliance (in opinion of investigator)

Study 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-ups

Subjects 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 safety

Any 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 risk

Has any disease or condition that, per protocol or in the opinion of the investigator, might affect:

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

All other significant diseases (for example, inflammatory bowel disease), which, in the opinion of the investigator, might impair the subject's tolerance of trial treatment

Active infection or other medical condition that would make prednisone/prednisolone (corticosteroid) use contraindicated

Any condition which, in the opinion of the investigator, would preclude participation in this trial

Any condition or abnormality which may, in the opinion of the investigator, compromise his or her safety

Patients 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

Serious underlying medical condition which would impair the ability of the patient to receive protocol treatment, in the opinion of the treating physician

Any 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 data

Any condition or medical problem in addition to the underlying malignancy and organ dysfunction which the investigator feels would pose unacceptable risk

Any malabsorption condition

Patients 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 participation

Any prior or co-existing medical condition that in the investigator's judgment will substantially increase the risk associated with the subject's participation in the study

Current 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

Presence 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 drugs

Any 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.

Active infection or serious underlying medical condition that would impair the patient's ability to receive protocol treatment

Any 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 endpoints

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 risk

the 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-SCT

Any malabsorption condition

Any condition which, in the investigator’s opinion, makes the subject unsuitable for trial participation

Other past or current malignancy unless in the opinion of the investigator it does not contraindicate participation in the study

Any condition or abnormality which may, in the opinion of the investigator, compromise the safety of patients

Any significant concurrent illness that would, in the judgment of the treating physician/principal investigator, compromise patient safety or compliance, or study participation

Any condition or abnormality which may, in the opinion of the investigator, compromise the safety of patients

Any condition or abnormality which may, in the opinion of the investigator, compromise the safety of the patient

Any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation.

Any 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.

Active infection requiring IV antibiotics, antifungal or antiviral agents, that in the opinion of the investigator would compromise the patient’s ability to tolerate therapy

Presence 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 drugs

Participation in another clinical trial unless approved by the lead principal investigator

Any 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 consent

Significant 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.

Active infection or other medical condition that would make prednisone/prednisolone (corticosteroid) use contraindicated

Significant gastrointestinal disorder(s), in the opinion of the Principal Investigator, (e.g., Crohn's disease, ulcerative colitis, extensive gastric and small intestine resection)

Any malabsorption condition

The patient has a medical or psychiatric condition that constitutes an unacceptable risk for participation in this trial, in the judgment of the treating physician

Any condition which, in the opinion of the investigator, would preclude participation in this trial

Psychiatric or medical conditions which, in the opinion of the treating physician, would not allow the patient to undergo the proposed treatments safely

Any laboratory abnormalities, which in the opinion of the investigator, may put the subject at risk if participating in the study; for example:

Other 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 bevacizumab

Uncontrolled intercurrent illness or any concurrent condition that, in the Investigator's opinion, would jeopardize the safety of the patient or compliance with the protocol

Significant 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 patient

Any 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 procedures

Any other condition or prior therapy, which in the opinion of the PI, would make the subject unsuitable for the study.

Any other medical intervention or condition, which, in the opinion of the PI could compromise patient safety or adherence with the study requirements

Any other concurrent condition that in the investigator’s opinion would jeopardize compliance with the protocol

Any concomitant condition that in the opinion of the investigator could compromise the objectives of this study and the patient's compliance.

In the opinion of the investigator, the patient is felt not to be appropriate for the study

Systemic diseases (cardiovascular, renal, hepatic, etc) that would prevent study treatment in the investigator's opinion.

Any condition, including laboratory abnormalities, that in the opinion of the investigator places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study

Significant 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 patient\r\n* Those patients with medical conditions that are controlled with medical therapy are eligible

Have 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 study

Other unspecified reasons that, in the opinion of the investigator or sponsor, make the subject unsuitable for enrollment

Any condition which in the investigator's opinion makes the subject unsuitable for study participation

Patient 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 efficacy

Patients 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 patient

Serious underlying medical or psychiatric illnesses that would, in the opinion of the treating physician, substantially increase the risk for complications related to treatment

Any 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 risk

Any 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 diarrhea

Subject 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.

Medical or other condition that would represent an inappropriate risk to the patient or would likely compromise achievement of the primary study objective

Any other concurrent condition that in the investigator's opinion would jeopardize compliance with the protocol

Patients must have no fever or evidence of infection or other coexisting medical condition that would preclude protocol therapy

Pending visceral crisis, in the opinion of the treating investigator

Significant 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 patient

Any condition which in the investigator’s opinion deems the patient an unsuitable candidate to receive study drug

The patient has any condition that will place the patient at undue risk or discomfort as a result of adherence to study procedures

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 diarrhea

Significant 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 patient

Serious nonmalignant or malignant disease or psychiatric illness, which, in the opinion of the investigator would compromise protocol objectives or interfere with participation

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 diarrhea

Any 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 events

In the opinion of the treating investigator, patients must have adequate cognitive abilities to complete the neurocognitive components of the study.

Patients 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.

Patients 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

Other unspecified reasons that, in the opinion of the investigator or Millennium, make the patient unsuitable for enrollment

Patient may be excluded if, in the opinion of the principal investigator (PI) and investigator team, the patient is not capable of being compliant

Patients with any serious underlying medical condition that would impair their ability to receive or tolerate the planned treatment

General medical condition: fit for the proposed surgery and/or radiation treatment as determined by the treating investigator

History of medical or psychiatric disease which, in the view of the principal investigator, would preclude safe treatment

Subject 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.

Any malabsorption condition

Any other cardiac condition, which in the opinion of the treating physician would make this protocol unreasonably hazardous for the patient

Inclusion 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.

Infectious process, which, in the opinion of the investigator, could worsen or its outcome be affected, as a result of the investigational therapy

Any other medical condition that in the opinion of the principal investigator would compromise the ability to deliver or evaluate study drug

Have 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 study

Serious concurrent illness, which in the opinion of the investigator or an authorized physician sub-investigator would interfere with participation in this clinical study

Any medical or psychiatric condition that in the opinion of the principal investigator would compromise the patient's ability to tolerate this treatment

Suffer from any other condition or illness that would compromise safety or interfere with evaluation of the drug

Patients 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

A serious uncontrolled medical disorder/condition that in the opinion of the Investigator would impair the ability of the subject to receive protocol therapy

in the opinion of the Investigator, the subject does not have progressive disease

Patients with psychiatric or addictive disorders that, in the opinion of the investigator, would preclude obtaining informed consent

Patients 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

Any 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 reason

Any 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 risk

The participant has serious preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study.

Life-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 risk

All other significant diseases (e.g., inflammatory bowel disease) that, in the opinion of the investigator, might impair the subject's tolerance of trial treatment.

Patients with grade 2 or greater diarrhea prior to study initiation despite maximal medical management due to medications or a medical condition such as Crohn's disease or malabsorption

Any 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 study

Any 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.

Any 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.

Any 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 risk

Any 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.

Any 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 study

Any other condition or circumstance that would, in the opinion of the investigator, make the patient unsuitable for participation in the study

Patients with medical history or conditions not otherwise previously specified which in the opinion of the investigator should exclude participation in this study.

Serious underlying medical condition which would impair the ability of the patient to receive protocol treatment, in the opinion of the treating physician

Any medical condition that would preclude adequate evaluation of the safety and toxicity of the study combination

Patient with other significant medical or psychiatric condition that would make assessment of toxicity or efficacy difficult

No serious disease or condition that, in the opinion of the investigator, would compromise the subject's ability to participate in the study

Previous 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 study

Any condition, including the presence of laboratory abnormalities, which in the opinion of the principal investigator or lead associate investigator places the subject at unacceptable risk if they were to participate in the study or confounds the ability to interpret data from the study

Any 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 trial

Medical or psychiatric condition which in the opinion of the protocol chairman would compromise the patient's ability to tolerate this protocol

Patients with any other medical condition or reason, in that investigator’s opinion, makes the patient unstable to participate in a clinical trial

Subject 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).

Subject has any condition which, in the investigator's opinion, makes the subject unsuitable for study participation.

Uncontrolled 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 participate

The presence of a medical or psychiatric condition that, in the opinion of the Principal Investigator, makes the patient inappropriate for inclusion in this study

Symptomatic orthostatic hypotension that in the medical judgment of the Investigator would interfere with subject's ability to safely receive treatment or complete study assessments

Has, 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.

Is actively participating in another investigational clinical study which, in the Investigator's or Sponsor's opinion, would interfere in this study.

Subject 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:

Any medical condition which in the opinion of the investigator places the participant at an unacceptably high risk for toxicities.

Any significant medical condition that, in the opinion of the investigator or sponsor, may place the participant at undue risk from the study.

Any malabsorption condition which, in the opinion of the treating physician, will affect the absorption of any of the agents used in this study.

Any condition, which, in the site investigator's opinion, makes the subject unsuitable for trial participation.

Any condition deemed by the investigator to be likely to interfere with a subject's ability to participate in the clinical trial.

Subject is a female who is pregnant or is breast feeding 24. Subject is unwilling or unable to comply with the protocol, in the opinion of the investigator 25. Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study 26. Subject has any condition that confounds the ability to interpret data from the study

Any other reason the investigator considers the patient should not participate in the study

Uncontrolled 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.

Significant gastrointestinal disorder(s), in the opinion of the principal investigator (e.g., Crohn’s disease, ulcerative colitis, extensive gastric resection)

No 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 regimen

Subject has concurrent corneal disorder or any ophthalmologic condition that makes the subject unsuitable for study participation (e.g., advanced cataracts, glaucoma).

Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration

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 undue risk

The presence of any medical condition that the Investigator deems incompatible with participation in the trial

DONOR: The presence of any medical condition that the investigator deems incompatible with participation in the trial

Any other condition which, in the opinion of the Investigator, would preclude participation in this trial

Uncontrolled 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.

The presence of a medical or psychiatric condition that, in the opinion of the Principal Investigator, makes the subject inappropriate for inclusion in this study.

Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

Subject has concurrent corneal disorder or any ophthalmologic condition which makes the subject unsuitable for study participation .

Subject has any condition which makes the subject unsuitable for study participation.

Any prior or coexisting medical condition that in the investigator’s judgment will substantially increase the risk associated with the subject’s participation in the study

Any other circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol

Any disorder or disease, or clinically significant abnormality on laboratory or other clinical test(s) (eg, blood tests, ECG), that in medical judgment of the investigator may impede the subject's participation in the study, pose increased risk to the subject, and/or confound the results of the study

Subject is a family member or employee of the investigator

Concurrent 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.

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 risk.

In opinion of Investigator, make subject unsuitable for study.

Any condition which, in the investigator’s opinion, makes the subject unsuitable for trial participation

Any condition that confounds the ability to interpret data from the study.

Any malabsorption condition that in the opinion of the investigator would significantly impact drug absorption

Any condition which, in the investigator’s opinion, makes the subject unsuitable for trial participation

Any 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 therapy

The presence of any other medical or psychiatric disorder that, in the opinion of the treating physician, would contraindicate the use of the drugs in this protocol or place the subject at undue risk for treatment complications

Any reason why, in the opinion of the investigator, the patient should not participate

Any malabsorption condition that in the opinion of the investigator would significantly impact drug absorption

Any condition which, in the investigator’s opinion, makes the subject unsuitable for trial participation

Any 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)

Any condition or abnormality which may, in the opinion of the investigator, compromise the safety of patients

Any medical condition that would preclude adequate evaluation of the safety and toxicity of the study combination

Any condition which in the investigator’s opinion deems the patient an unsuitable candidate to receive study drug

Any concurrent disease and/or medical condition that, in the opinion of the Investigator, would prevent the subject's participation.

Participants must, in the opinion of the investigator, be capable of complying with the protocol

Current 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 ibrutinib

Any other condition which, in the opinion of the investigator, would preclude participation in this trial

Significant, concurrent, uncontrolled medical condition which, in the opinion of the investigator, may interfere with patient participation in the study.

Must in the opinion of the investigator be capable of complying with this protocol

Any serious, active underlying medical condition that would impair the ability of the subjects to receive study treatment

Any condition which in the Investigators' opinion deems the subject an unsuitable candidate to receive study drug and therapy

Other medical or psychiatric illness or organ dysfunction or laboratory abnormality which in the opinion of the investigator would compromise the patient’s safety or interfere with data interpretation, e.g., infection/inflammation, intestinal obstruction, unable to swallow medication, social/ psychological issues, etc.

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 consent; investigator discretion is allowed

have any coexisting medical condition that will substantially increase the risk associated with the subject's participation in the study.

Any condition which in the investigator’s opinion deems the subject an unsuitable candidate to receive study drug

Acute 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 safety

Subject has an existing medical condition that is likely to require the use of diathermy in the future

Concomitant 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

Any 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 study

Concomitant 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.

Any serious underlying medical condition that, in the opinion of the investigator or medical monitor, would impair the ability to receive or tolerate the planned treatment

Suffer 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 drug

Serious 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.

Any condition that, in the clinical judgment of the treating physician, is likely to prevent the patient from complying with any aspect of the protocol or that may put the patient at unacceptable risk.

Patient 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 therapy

Any 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 protocol

Serious 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 objectives

Patient 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 therapy

Use of any medical conditions that, in the Investigator's opinion, would impose excessive risk to the patient.

Medical, psychological or surgical condition which the investigator feels might compromise study participation

Significant 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 patient

Participants must, in the opinion of the investigator, be capable of complying with the protocol

Any other medical condition that, in the opinion of the principal investigator (PI), may interfere with a subject's participation in or compliance with the study

Has 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.

History 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.

Any other medical condition that, in the opinion of the PI, may interfere with a subject's participation in or compliance with the study

Have serious pre-existing medical conditions (at the discretion of the investigator).

Any condition that confounds the ability to interpret data from the study.

Psychiatric or addictive disorders or other conditions that in the opinion of the investigators would preclude the patient from complying with the study protocol

Any condition which in the investigator's opinion deems the patient an unsuitable candidate to receive study drug

Any illness or condition that in the opinion of the Investigator may affect safety of treatment or evaluation of any the study’s endpoints

Patients who have serious intercurrent medical illness which in the opinion of the investigator would compromise the patient's ability to tolerate this therapy

Key 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.

Inclusion 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 investigator

A medical condition that precludes adequate study treatment or increases patient risk

Psychiatric 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)

Requires myelofibrosis therapy, in the opinion of the investigator

Have 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 requirements

Active infection or other medical condition that would make corticosteroids (i.e. dexamethasone) use contraindicated

Patient 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.

Any condition that, in the opinion of the investigator or sponsor, would interfere with evaluation of the investigational product.

Patient 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).

Any 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 diarrhea

Have serious pre-existing medical conditions (at the discretion of the investigator, such as severe acute or chronic medical condition or laboratory abnormality that may increase the risk associated with study participation).

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

Any 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.

Known inability to undergo neoadjuvant gemcitabine and cisplatin combination treatment due to pre-existing medical conditions in the opinion of the treating physician or investigator

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

Any other condition that in the investigator's opinion would not make the subject a good candidate for the clinical study,

A subject who, in the opinion of the sponsor-investigator will be uncooperative or unable to comply with study procedures

Have serious preexisting medical conditions (left to the discretion of the investigator).