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+At least 1 but not more than 5 prior systemic therapies for advanced/recurrent or progressing disease.
+1-2 prior regimens (including primary therapy); hormonal therapies (e.g., tamoxifen, aromatase inhibitors) will not count toward the prior regimen limit
+Patients must have previously received at least one line of therapy for their advanced lung cancer; there are no restrictions on the maximum number of prior therapies allowed
+No more than 3 prior regimens for large cell component (e.g. one induction and two salvage therapies); monoclonal antibody alone or involved field/involved site radiotherapy do not count as lines of therapy
+Patients must not have had systemic chemotherapy or immunotherapy, including, but not limited to interferon alfa-2b, high dose interleukin 2 (IL-2), pegylated interferon (PEG-IFN), anti-programmed cell death protein 1 (PD-1), anti-PD-L1, intra-tumoral, or vaccine therapies within 6 weeks prior to cycle 1, day 1; patients must not have received or be planning to receive any of the prohibited therapies during protocol treatment; prior intravesical interferon therapy is allowed
+No concurrent treatment with other cytotoxic drugs or targeted therapies
+Prior experimental (non-Food and Drug Administration [FDA] approved) therapies and immunotherapies are allowed; patients must not have received these therapies for 4 weeks prior to the initiation of study treatment and must have recovery =< grade 1 from any adverse events of these therapies (other than alopecia); prior treatment with any PARP inhibitor or any anti-PD-1/anti-PD-L1 antibody is NOT allowed
+Patient has persistent toxicities from prior MDS therapies which are determined to be relevant by the Investigator.
+Able to discontinue all anticancer therapies 2 weeks prior to study start
+Patients may have had 0-4 prior therapies\r\n* Prior chemoembolization or local ablative therapies are permitted if completed >= 6 weeks prior to study enrollment\r\n* Prior temozolomide is permitted
+Receipt of treatment with immunotherapy, biological therapies, targeted small molecules, hormonal therapies within 3 weeks of scheduled C1D1 dosing.
+Patients currently receiving anticancer therapies or who have received anticancer therapies within 2 weeks of the start of study drug (including chemotherapy, radiation therapy, and biologics). Patients who have received prior endocrine therapy for fertility purposes will be eligible
+Has receiving immunosuppressive or other contraindicated therapies within the excluded time frame from entry
+No limit on number of prior therapies
+Co-administration of anti-cancer therapies other than those administered in the study
+Radiotherapy - 2 weeks NOTE: Duration of any other anticancer therapies must be discussed with the Sponsor Study Physician
+Patients must be willing to forego other cytotoxic and non-cytotoxic therapies against the tumor while being treated on this protocol
+Patients who have received prior cytotoxic, non-cytotoxic or experimental drug therapies for brain tumor are excluded
+Must have been treated with at least 2 prior systemic therapies.
+Patients must not have received any of the specified therapies as stated in the protocol in the time period prior to registration
+Participants are permitted to have any number of prior therapies prior to enrollment
+Patients currently receiving investigational or commercial anti-cancer agents or anti-cancer therapies other than BCG, ALT-803 and supportive care therapies.
+Participants in all monotherapy arms must have an advanced solid tumor that has progressed on standard therapies known to provide clinical benefit or the participants are intolerant to such therapies.
+Participants must have an advanced solid tumor that has progressed on standard therapies known to provide clinical benefit or the participants are intolerant to such therapies.
+Recovery from significant toxicities from previous therapies and sufficient time since last dose of previous therapy
+Patients are eligible for available approved standard therapies
+Concomitant therapy with valproic acid/valproate-containing therapies
+Patient have received anti-cancer therapies within defined time frames prior to the first dose of study treatment
+Requirement of active receipt of systemic therapies concurrent with SBRT (concurrent hormonal therapies are allowed)
+Subjects previously treated with investigational anticancer therapies less than 6 weeks prior to the first dose of Nivolumab
+Not amenable to approved therapies
+Have discontinued all previous therapies for cancer.
+More than two prior systemic treatments for MDS. Prior systemic therapies are those that have been received at standard doses for at least one full treatment cycle.
+Chemotherapy within 2 weeks of initiating study treatment; there is no maximum allowable number of previous therapies
+Any number of prior chemotherapies and targeted therapies are allowed
+Participants who have a history of non-compliance to medical therapies
+Melanoma after failure of available therapies
+Any number of prior systemic therapies.
+Diagnosis of relapsed or refractory lymphoid malignancy for which there are no available therapies.
+Discontinuation of previous cancer therapies at least four (4) weeks prior to treatment in this study.
+Other therapies: Prior experimental (non-Federal Drug Administration [FDA] approved) therapies (other than drugs that share the same target) and immunotherapies are allowed; patients must not have received these therapies for 30 days or five half-lives of the drug (whichever is less) prior to the initiation of study treatment and must have full recovery from any acute effects of these therapies
+Patients currently receiving anticancer therapies or who have received anticancer therapies within 2 weeks of the start of study drug (including chemotherapy, radiation therapy, and biologics)
+Active residual toxicity from prior therapies.
+Prior ablative, radiation, resection, or transplant therapies less than 4 weeks before study registration
+Subjects may not be on other therapies that affect hormone levels, such as estrogens, testosterones, ketoconazole during this study; however, megestrol for hot flashes is permitted
+Treatment with any of the following prior therapies:
+Prior chemoembolization of local ablative therapies are allowed, provided there is measurable disease outside of the area treated, or documented evidence of progression at the site of prior treatment
+All subjects' cancer must have progressed after treatment with standard therapies or have no appropriate available therapies.
+Subjects currently receiving other anticancer therapies.
+At least one line of prior systemic therapy for metastatic or recurrent breast cancer (there is no limit to the number of prior therapies)
+Prior anti-cancer therapies for current malignancy
+Patients with known oncogenic mutations for which there are approved therapies must have documented intolerance or disease progression for the approved therapies for their mutation. For Other Indications
+Allowable prior therapies:\r\n* Subjects must have had clinical or radiographic progression on imatinib; those who were taken off of imatinib for intolerance must have progressed on at least one other tyrosine kinase inhibitor (TKI)\r\n* Subjects must have received >= 1 prior systemic therapy (including imatinib); a maximum of 4 prior therapies for metastatic disease are allowed
+Female or male subjects whose advanced HER2 expressing cancer has failed standard of care treatments, or for whom such therapy is not acceptable to the subject. Subjects with advanced breast and gastric cancer who test positive for HER2 by ASCO/CAP criteria (either IHC or FISH) must have received prior treatment with a trastuzumab containing therapy. Subjects who have been previously treated with pertuzumab, TDM-1, lapatinib, or other available and accessible HER2-directed therapies or investigational therapies are eligible.
+two prior hormonal therapies;
+ENROLLMENT TO THE DOSE ESCALATION, EXPANSION AND PART II: Participants are permitted to have any number of prior therapies prior to enrollment
+Received any previously systemic therapy (including investigational agents) targeting VEGF or the VEGFR signaling pathways; other previous targeted therapies are permitted if stopped at least 28 days prior to start of treatment
+No limit to number of prior therapies
+Patients may have received prior radiation, chemoembolization, radioembolization or other local ablative therapies or hepatic resection if completed >= 4 weeks prior to registration AND if patient has recovered to =< grade 1 toxicity
+There is no limit to number of prior therapies
+Men and Women > 18 years of age with Eastern Cooperative Oncology Group (ECOG) performance status < 2; 2a. Eligibility: U.S. Sites Includes subjects with loco-regional disease that have relapsed/recurred within 6 months of chemo-radiation and who have no standard of care. Includes patients (subjects) with metastatic disease having injections into only superficial lesions that have failed (includes progression, relapse or intolerance) or not be a candidate for approved therapies. Note, patients (subjects) that have approved therapies available, which might confer clinical benefit, may be enrolled as long as the physician properly explains the nature of the treatment, and obtains consent \. Includes patients (subjects) with metastatic disease having at least one deep tumor injection who have failed (includes progression, relapse or intolerance) all approved lines of therapy prior to enrollment unless they are not an appropriate candidate for a particular approved therapy or no approved therapy exists. Note: There is no limit on the number of prior therapies that a patient (subject) may have received prior to enrollment in any cohort. 2b. Eligibility: Canadian Sites Subjects with advanced or metastatic solid tumors that have disease progression after treatment with approved, available therapies (in site's country) for the cancer type or for whom available therapies have limited benefit and the subject refuses the available therapy. Includes subjects with locoregional disease that have relapsed/recurred within 6 months of chemo-radiation; or who have no standard of care or beneficial options. No limit on the number of prior treatments;
+Patients who have received other cell therapies
+Prior treatment with cluster of differentiation 137 (CD137) agonists or immune checkpoint blockade therapies
+Part E only: Patients with biopsy-proven DLBCL who are intolerant to, or have disease that is relapsed/refractory after, at least two prior therapies, including any anti-CD20 monoclonal antibody and chemotherapy with curative intent
+Part C) Triple-negative disease and received 2-4 prior non-hormonally-directed therapies in the MBC setting (not enrolling new patients);
+Progression of tumor or intolerance to therapies known to provide clinical benefit. There is no limit to the number of prior treatment regimens
+Experienced disease progression after having received at least 1 but no more than 2 prior next-generation androgen receptor-targeted therapies, and 1 prior taxane-based chemotherapy, for castration-resistant disease
+At least 2 weeks post any treatments/therapies at the time of first dose.
+More than 5 lines of previous cytotoxic therapies. For patients of CTCL who failed romidepsin, more than 4 lines of previous therapies
+Prior anti-CD19-directed therapies
+Naive to prior systemic anti-cancer therapy for melanoma (example: chemotherapy, hormonal therapy, targeted therapy, immunotherapy, or other biologic therapies) except adjuvant treatment with interferon (IFN), interleukin (IL)-2, or vaccine therapies or herbal therapies
+Experimental therapies within 4 weeks before first ZW25 dosing
+Off biologic therapies including hematopoietic growth factors >= 1 week
+Patients with solid tumors: Have received anticancer therapies, including radiation therapy, cytotoxic agents, targeted agents or endocrine therapy within 2 weeks prior to dose assignment
+Patients may not receive any other anti-cancer therapies, within 28 days prior to registration and throughout the duration of this trial
+Up to 3 prior cytotoxic chemotherapeutics regimens or myelosuppressive therapies in the advanced setting.
+Patients with prior ? Grade 3, serious, or life threatening immune-mediated reactions following prior anti-PD-1 or other immune-oncology therapies
+Patients will have recovered from toxicities from prior systemic anticancer treatment or local therapies
+The patient should have received all established therapies where there is a clear, superior available regimen available for the patient and the patient should have demonstrated progressive disease on or since completion of the last treatment regimen
+At least 3 weeks must have passed since any prior anti-tumor therapies including chemotherapy, radiation therapy or any other anti-cancer treatments
+Patients must have recovered from toxicities from prior systemic anticancer treatment or local therapies
+PHASE I: No limit on the number of prior systemic therapies for metastatic disease
+EXCLUDED THERAPIES AND MEDICATIONS, PREVIOUS AND CONCOMITANT
+Previously treated with anti-pCAD biologic therapies.
+Received anti-cancer therapies within the following time frames prior to the first dose of study treatment:
+Patients are not eligible if they are using any other approved or investigational anti-neoplastic therapies or any other investigational therapies for any other reason.
+Must have failed or be unable to tolerate or refused other available Food and Drug Administration (FDA) approved effective therapies; NOTE: patients should not have other treatment options considered curative
+Other concurrent experimental therapies
+Failed to recover from the reversible effects of prior anticancer therapies with the exception of alopecia
+Not amenable to approved therapies
+There is no limit on the number of prior therapies
+AML relapsed or refractory to prior therapy, or ? 60 years of age and not a candidate for other therapies Phase 2a:
+Patients must be willing to forego other cytotoxic and non-cytotoxic therapies against the tumor while being treated on this protocol
+Patients who have received prior cytotoxic, non-cytotoxic or experimental drug therapies for brain tumor are excluded
+Patients currently receiving medical anticancer therapies or who have received medical anticancer therapies within 4 weeks of the start of study drug (including chemotherapy, antibody based therapy, etc.)
+Must have received first line chemotherapy; no upper limit to number of prior therapies
+Patients currently receiving anticancer therapies or who have received anticancer therapies within 30 days of the start of study drug (including chemotherapy, radiation therapy, antibody based therapy, etc.); steroids for symptom palliation are allowed, but must be either discontinued or on stable doses at the time of initiation of protocol therapy
+Patients cannot have received any other immunomodulatory therapies (including vaccines) as treatment for this or any other cancer.
+PART I: Recurrent or progressive disease on prior standard therapies with known clinical benefit with the exception of adjuvant bladder cancer population
+PART II: Recurrent or progressive metastatic disease after standard of care HER2-targeted therapies i.e. trastuzumab (Herceptin), pertuzumab (Perjeta), lapatinib (Tykerb), ado-trastuzumab emtansine (TDM1) (Kadcyla) or other HER2-directed therapies
+There is no limit on prior systemic or IT therapies
+Received any other investigational therapeutic agents or other anticancer therapies within 4 weeks prior to randomization
+For the dose escalation portion of the trial, patients with available therapies known to confer clinical benefit (platinum sensitive ovarian cancer) must be excluded
+Patients with available therapies known to confer clinical benefit (platinum sensitive\r\nrecurrent ovarian cancer) must be excluded from the dose escalation portion
+Must have relapsed or refractory disease after treatments including three therapies: proteasome inhibitors, immunomodulatory imide drugs (IMiDs), and anti-CD38 antibody
+Prior treatment with CD137 agonists or immune checkpoint blockade therapies;
+Insufficient recovery from all active toxicities of prior therapies
+Patients with metastatic bone sarcomas who have failed all available therapies that have demonstrated clinical benefit. Available therapies include but not limited to methotrexate, adriamycin and cisplatin for osteosarcoma and vincristine, adriamycin and cytoxan, ifosfamide, etoposide (VAC/IE) for Ewing’s sarcoma
+Patients who received imatinib and 1 or 2 other TKIs as prior treatment regimens. Patients who experienced intolerance to prior therapies must have objective disease progression prior to enrollment onto BLU-285-1303 study.
+Patients with a history of prior adoptive cell therapies.
+Patients may not have received chemotherapy, targeted therapies, biologic response modifiers and/or hormonal therapy within the last 14 days
+Received chemotherapy, radiotherapy, immunotherapy, or any investigational cancer therapies within 28 days prior to the first dose of enzalutamide and/or CORT125281, or treatment with such therapies is planned during protocol treatment
+Previously treated with enzalutamide or experimental therapies directed against androgen receptor (ie, apalutamide).
+Four weeks must have elapsed since any prior antibody therapies to allow antibody levels to decline
+The participant may have no more than 2 prior lines of systemic therapies (neoadjuvant and adjuvant therapies will not be considered as a prior line of therapy) for advanced or metastatic disease and is suitable to receive gemcitabine and docetaxel therapy. All previous therapies must have completed ? 3 weeks (21 days) prior to first dose of study drug.
+Patients demonstrating disease progression after treatment with available therapies that are known to confer clinical benefit, or who are intolerant to treatment,
+Any number of prior therapies are allowed
+Administration of other prior anticancer therapies within 4 weeks of enrollment, except ongoing administration of a bisphosphonate drug or denosumab as treatment for bone metastasis
+Patients must have exhausted all available therapies known to provide clinical benefit and has progressed, relapsed or is refractory to last line of treatment
+EXCLUDED THERAPIES AND MEDICATIONS FOR CANCER
+Triple Negative tumors: Must have exhausted other available therapies including prior treatment with a taxane and carboplatin. Patients with new or progressive breast cancer metastatic to brain will be eligible provided:
+There are no specific restrictions for therapies to treat cGVHD
+No concomitant therapy with any of the following: IL2, interferon, or other non-study immunotherapy regimens; cytotoxic chemotherapy; immunosuppressive agents; or other investigational therapies; all such therapies must have been discontinued > 4 weeks prior to registration
+Patients can have any number of prior therapies and any amount of time period from the last therapy as long as they have complete response as seen in PET/CT at the time of enrolment
+Subjects who received non-oncology vaccine therapies for prevention of infectious disease within 4 weeks of study drug administration
+Patients can have had any number of prior therapies, however must have had previous therapy with at least radiotherapy; patients with oligodendroglioma must have also received chemotherapy in addition to radiation therapy
+Patients must have received no more than 3 prior therapies for recurrent high grade glioma (rHGG)
+Received daratumumab or other anti-CD38 therapies previously
+Patients currently receiving anticancer therapies or who have received anticancer therapies (including chemotherapy and targeted therapy) within 2 weeks (14 days) prior to study day are excluded. Patients who have completed palliative radiation therapy more than 14 days prior to the first dose of the combination ipilimumab plus nivolumab are eligible.
+Relapsed and/or refractory myeloma; there is no minimum or maximum number of previous therapies that a patient may have received previously before being put on the current trial
+Prior systemic, regional and radiation anticancer therapies must have been completed at least three months prior to enrollment; prior therapies (including anti-PD-1 inhibitors) is allowed provided three months have elapsed from last dose
+Phase 1: Participants must be diagnosed with histologically confirmed solid tumors (excluding CNS tumors), which is relapsed or refractory, and for which there are no currently available therapies.
+Phase 2: Received prior therapies with eribulin mesilate or irinotecan.
+Subjects not seeking or receiving potentially curative therapies for cancer.
+Any number of prior therapies is allowed
+Unlimited prior therapies allowed
+CHEMOTHERAPY/CELL INFUSION ELIGIBILITY: Patients must have adequate TIL available as per Moffitt Cell Therapies current standard operating procedures (SOP)
+Patients may have received an unlimited number of prior therapies
+Relapse following first line immunotherapy or chemoimmunotherapy; there is no upper limit to the number of therapies received prior to study entry; prior therapies may include high-dose therapy with autologous stem cell rescue
+Patients who are currently undergoing other anti-tumor therapies or have concurrent active cancer
+Previous treatment with 1 or 2 chemotherapy regimens including at least 1 taxane-based regimen for metastatic (non castrate or castrate) prostate cancer. Patients may have received radium-223 and/or cabazitaxel, or were deemed unsuitable, declined, or did not have access to these therapies.
+Bisphosphonate or denosumab dosage must have been stable for at least 4 weeks before day 1 for patients receiving these therapies.
+Patients may or may not have received prior therapy for their recurrent/metastatic disease\r\n* NOTE: There is no limit to the number of prior therapies for stage IV disease\r\n* NOTE: Patients should not be a candidate for curative surgical treatment or radiation (palliative radiotherapy is permitted)
+Patients on bisphosphonates or RANK-L inhibitors may continue receiving these therapies during study treatment; there is no washout period required between the last dose of these therapies and the start of abemaciclib
+Ongoing or planned administration of anti-cancer therapies other than nivolumab
+Subjects must have received no more than 2 prior therapies for metastatic triple-negative breast cancer
+Fewer than 28 days from prior anticancer therapy including chemotherapy, hormonal, investigational, and/or biological therapies and irradiation except for:
+Any other previous antitumor therapies for the current cancer event; this exclusion does not apply to phase Ib part of cohort 1
+Concomitant therapy with any of the following: IL-2, interferon or other non-study immunotherapy regimens; cytotoxic chemotherapy; immunosuppressive agents; or other investigational therapies.
+Must have received at least one prior systemic therapy, and must have relapsed or progressed after, or failed to respond to any/all available effective therapy or therapies.
+Subject has received daratumumab or other anti-CD38 therapies previously
+Is not a candidate for local therapies, including liver transplantation, tumor ablation, transarterial embolization, or resection
+There is no limit on number of prior therapies
+Hormonal tumor therapies should not be administered within 14 days of registration; exceptions may be discussed with the PI
+SY-1425 and daratumumab combination only - Prior or concurrent exposure to daratumumab or other CD38 therapies5.
+Previously untreated or treated subjects with no limit on prior lines of systemic therapies are allowed
+MCL requiring treatment and for which no prior systemic anticancer therapies have been received.
+Patients currently receiving anticancer therapies or who have received anticancer therapies within 2 weeks (14 days) from enrollment into this study (including chemotherapy and targeted therapy) are excluded; also, patients who have completed palliative radiation therapy more than 14 days prior to the first dose of MGCD516 are eligible
+Failed >= 2 prior systemic therapies\r\n* NOTE: For systemic anaplastic large cell lymphoma (ALCL) prior systemic therapy must also include progression on brentuximab vedotin
+Immunotherapy with immune checkpoint inhibitors, cell-based therapies, or cancer vaccines
+PCSPES or PCx products; other herbal therapies or supplements will be considered by the principle investigator on a case-by-case basis based on their potential for hormonal or anticancer therapies
+Subjects must have received no prior therapies for this disease
+The number of prior therapies is restricted as follows:\r\n* Zero or one prior therapies during the preceding one year; this serves to limit the treatment cohort to patients with either only slowly progressive disease, or up to one prior therapy\r\n* No prior PD-1 or PD-L1 antibody therapies are allowed\r\n* Prior IL-2 is allowed, if it finished more than 1 year prior
+The following are not counted as medical therapies: nephrectomy, radiation therapy, other energy-ablative techniques, or metastasectomy
+Symptomatic subjects who accept treatment with approved palliative or life-prolonging systemic therapies, including docetaxel and cabazitaxel chemotherapy; (Note: subjects who refuse chemotherapy or are not symptomatic or in immediate need for standard systemic therapies may be included)
+Subjects who have received anti-CD 19 targeted therapies, chimeric antigen receptor T-cell or other cellular therapies for the treatment of their lymphoma .
+Any prior number of prior therapies, including prior immunotherapy, is allowed
+Metastatic renal cell cancer patients (any histologic subtype) with measurable and/or evaluable disease who have completed at least one line of prior systemic therapy are potentially eligible for this trial; any number of prior systemic therapies are allowed, including prior nivolumab
+Patients who had received at least 2 prior therapies for advanced or metastatic disease condition, including platinum doublet and pemetrexed, docetaxel, or immunotherapy, and were refractory to or unable to tolerate their last prior therapy
+Any number of prior therapies (including none) is permitted; the last dose of systemic therapy (include targeted therapies) must have been given at least 4 weeks prior to initiation of therapy; patients receiving carmustine (BCNU) or mitomycin C must have received their last dose of such therapy at least 6 weeks prior to initiation of therapy
+Patients may be treatment naive or have received any number of prior therapies\r\n* NOTE: Prior immunotherapy is contraindicated and not permitted
+Patients may not have received prior HER2 directed therapies
+Histologically confirmed metastatic castrate resistant cancer (mCRPC) who progressed after both hormonal therapy (abiraterone or enzalutamide) and chemotherapy (docetaxel, for example); or cannot tolerate either or both of these classes of therapies.
+Treatment with trastuzumab, bevacizumab or other targeted therapies within the past 4 weeks
+No ongoing anti-coagulation and/or anti-platelet therapies allowed
+Receipt of therapies or procedures prior to first dose including:
+Prior use of other retinoid therapies in the 3 months prior to enrollment in the study
+Subjects that have received experimental vaccines or other immune therapies should be discussed with the principal investigator to confirm eligibility
+Patients who have received any other previous antitumor therapies (other than anthracycline-based neoadjuvant chemotherapy for the current cancer event)
+Histiocytic disorder must be (a) multi-system disease or (b) disease that is recurrent or refractory to standard therapies, or (c) single-system disease that is unlikely to benefit from conventional and less toxic therapies, based on the best available evidence (for example, central nervous system [CNS] or cardiac infiltration, retroperitoneal fibrosis, prior chemotherapy, or other medical history or co-morbidities, etc)
+Male or female subjects with AML with no available curative treatment options using currently available therapies
+May have received at least 1 prior therapy for recurrent or metastatic disease, up to 2 prior systemic therapies.
+Patient has not received available therapies that confer clinical benefit
+Subject who received any therapies intended to treat malignancy within 21 days of first receipt of DS-3032b
+Patients who have received alemtuzumab or antithymocyte globulin within 8 weeks of the transplant admission; the absence of these therapies in the medical record will serve as documentation that they were not given
+Required washout period for prior therapies Topical therapy: 2 weeks
+Co-administration of anti-cancer therapies other than those administered in this study
+Patients currently receiving anticancer therapies or who have received anticancer therapies within 4 weeks of the start of the investigational therapy (including chemotherapy, radiation therapy, antibody based therapy)
+Patients must have had =< 3 prior therapies in the metastatic setting (not including chemotherapy given as maintenance therapy)
+For which there are no standard therapies available (Cohorts 1, 3, 4 and 5)
+Evidence of residual disease after surgery and SoC adjuvant therapies
+Any non-oncology vaccine therapies used for the prevention of infectious disease within 28 days prior to enrollment and during treatment period
+Patients on or requiring immunosuppressive therapies
+Have received any anti-pancreatic cancer therapy (symptomatic therapies are allowed)
+Failed 2 or more prior standard MM therapies, and >100 days post autologous bone marrow transplant prior to first dose for transplanted subjects. Prior lenalidomide is permitted.
+There is no restriction on the number of prior therapies allowed for this disease and prior radiation and chemotherapy is allowed, provided the subject has recovered from all grade 2 or greater toxicity prior to enrollment
+Concomitant therapies for treatment or control of leukemia.
+Relapsed/refractory disease that has failed conventional therapy and other therapies of higher priority
+Greater than 2 prior therapies in metastatic CRPC (including single-agent docetaxel, abiraterone); abiraterone can only be taken pre-chemotherapy
+Patients currently receiving anticancer therapies or who have received anticancer therapies within 4 weeks including chemotherapy, radiation therapy, antibody based therapy, etc.
+Received any therapies intended to treat malignancy within 14 days of first receipt of DS-3032b (except for hydroxyurea, which must be discontinued at least 48 hours prior to study treatment).
+Patients who have had chemotherapy or radiotherapy within 2 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study; for investigational targeted therapies, patients will need to clear for 5 half-lives (not applicable to standard of care therapies)
+Subjects have received two or more standard available therapies known to prolong survival and for which they would be considered eligible; at a minimum, such therapies should include regimens containing oxaliplatin and irinotecan in combination with a fluoropyrimidine (e.g., leucovorin calcium-fluorouracil-oxaliplatin [FOLFOX] and leucovorin calcium-fluorouracil-irinotecan hydrochloride [FOLFIRI] or their variants)
+Current disease state must be one for which there is currently no known curative therapy or no additional therapies proven to prolong survival with an acceptable quality of life.
+Patients may be previously untreated or have received up to 3 prior systemic therapies for metastatic disease; prior radiation therapy (any number) and interferon use in the adjuvant or metastatic disease settings is permitted (in this trial interferon is mainly used to enhance or initiate immune responses to MK-3475); vaccine therapy will not be counted as systemic therapy; all prior therapies must have been discontinued for at least 4 weeks; a 2 week washout for kinase inhibitors is acceptable
+Previously untreated AML patients, except those who have received prior therapy with hydroxyurea, single agent chemotherapy (e.g. decitabine), hematopoietic growth factors, biological or targeted therapies are allowed
+For Cohort A (enzalutamide) and Cohort B (abiraterone acetate): prior treatment with up to 2 additional second line hormone therapies, including ketoconazole is allowed
+a. Have advanced solid tumors that are refractory to established therapies known to provide clinical benefit for the malignancy in question, OR
+b. Be intolerant of established therapies known to provide clinical benefit for the malignancy in question
+Patients may have had any number of prior systemic therapies; patients need not have exhausted standard therapy for their disease, but must be stable and must not have actively progressing
+Circulating blast count >= 30,000/uL by morphology or flow cytometry (cytoreductive therapies including leukapheresis or hydroxyurea are allowed)
+Patients with previously untreated AML (by the World Health Organization [WHO] criteria, i.e. >= 20% blasts); prior biologic therapies (such as growth factors) and targeted therapies administered for the treatment of prior myelodysplastic syndrome are allowed, with the exception of hypomethylating agents 5-azacytidine or decitabine; patients must have been off such therapy for 1 week prior to entering this study and recovered from the toxic effects of that therapy, unless there is evidence of rapidly progressive disease; hydroxyurea, and a single dose of cytarabine up to 3 g/m^2, is permitted for control of counts prior to treatment
+Prohibited treatments and or therapies
+Any number of prior therapies is allowed
+Prior therapies:\r\n* For patients stratified to the untreated arm:\r\n** Untreated patients should have received zero prior therapies for metastatic disease\r\n** They may have received prior adjuvant chemotherapy and/or radiation therapy, but not within 6 months prior to treatment\r\n** They may have received prior palliative radiation therapy for unresectable disease, but without any systemic chemotherapy, even as a radiosensitizer\r\n* For patients in the previously treated arm:\r\n** Previously treated patients may have received any number of prior therapies\r\n** Patients who received prior adjuvant chemotherapy and/or radiation therapy within 6 months of treatment will be considered previously treated\r\n*** Patients may have received any prior therapies EXCEPT prior therapy with a PARP inhibitor\r\n** Timing of prior therapies:\r\n*** At least 14 days must have passed since all prior anti-cancer therapy, including chemotherapy, biological therapy, or radiation therapy\r\n*** However, at least 28 days must have passed since any prior antibody-based therapies (such as, but not limited to cetuximab or bevacizumab)\r\n*** Additionally, at least 28 days must have passed since any prior investigational agent\r\n*** All patients must have completely recovered from all transient side effects related to prior therapies\r\n**** However, any side effects that are expected to be more durable or even permanent (e.g., neurotoxicity or ototoxicity) must have resolved to at least grade 1
+Patients must have recovered from the toxic effects of prior therapy: > 3 weeks for biologic therapies or non-cytotoxic therapies, > 4 weeks for cytotoxic therapies, and > 6 weeks for nitrosoureas; any questions related to the definition of non-cytotoxic agents should be directed to the study chair\r\n* NOTE: 13 cis-retinoic acid (Accutane) as biologic therapy has a washout period of 14 days
+No limitations on prior therapies
+Has undergone ?3 previous regimens (depending on treatment arm) of cytoreductive therapies including, but not limited to, platinum-based compounds, taxanes, or 5-fluorouracil. for B7, no prior systemic treatments should have been received for RM SCCHN
+Arms B1-B6: Has undergone 1-3 previous regimens of cytoreductive chemo-therapies Arm B7: with no prior exposure to anti-PD-(L)1 therapies and have received no prior systemic treatment for RM SCCHN
+Patients currently receiving anticancer therapies or who have received anticancer therapies within 4 weeks of the start of study drug (including chemotherapy, antibody based therapy, e.g. lapatinib, bevacizumab, erlotinib, imatinib, that are sometimes offered on a compassionate-use basis to NF2 patients)
+Insufficient recovery from all active toxicities of prior therapies
+During phase I: all patients with relapsed disease will be eligible if they have received at least 1 prior standard CLL therapy and no more than 4 prior therapies (one of which must be a purine analog and/or an alkylating agent)
+MDS at any stage; prior therapies allowed
+Have received prior ixazomib at any time or daratumumab or other anti-CD38 therapies, except as part of initial therapy if this was stopped to move on to SCT and the participants did not progress on anti-CD38 treatment.
+Patients must have had at least 2 lines of anti-HER2 directed therapies either in the metastatic or early-stage disease setting
+Patients must be refractory to, or intolerant of, existing therapies known to provide clinical benefit for their condition (i.e., cancer diagnosis).
+First or later relapse AND has received at least 2 prior therapies (one of which can be frontline therapy) or
+Receipt of all standard therapies for the tumor type:
+Must have had all standard approved and unapproved therapies as deemed appropriate by the treating physician.
+Patients receiving other investigational drugs for GVHD. Co-enrollment in other clinical trials that do not include experimental GVHD therapies is allowed
+Refractory disease, having failed available therapies
+Arm 1: Subjects must have received at least one prior therapy and a maximum of three prior therapies
+Arm 2: Subjects must have received at least one prior therapy and a maximum of three prior therapies. No prior treatment with 5-Azacitidine is allowed in this arm.
+Patients must have discontinued systemic antineoplastic therapy (including endocrine and biological agents, as well as systemic corticosteroids) at least three (3) to four (4) weeks prior to enrollment. Toxicities from previous therapies must be grade 1 or less.
+Prior Therapies: Systemic treatments: must have discontinued previous systemic treatments for cancer and recovered from the acute effects of therapy. Participants must have discontinued mitomycin-C or nitrosourea therapy at least 42 days and have discontinued any cytotoxic therapies at least 28 days prior to study enrollment. Radiation therapy and surgery: must be completed at least 4 weeks before study enrollment
+Patients who have metastatic or recurrent disease after previous surgery, radiation therapy, and/or chemotherapy are eligible. In Stage 1, no restriction is placed on the number of prior therapies. In Stage 2, patients may have 0 or 1 prior chemotherapy treatments for adjuvant or metastatic disease and no prior endocrine therapies.
+Patients with MF/SS must have failed at least 1 prior topical therapy (including steroids, nitrogen mustard, retinoids, phototherapy, photochemotherapy, radiation, and total skin electron beam); there is no upper limit for prior therapies
+Prior cytotoxic therapies are NOT allowed; the only exception is prior corticosteroid therapy (prednisone up to 1 mg/kg for =< 3 months) which must be stopped at least 1 week prior to study enrollment
+Failed available therapies (pancreatic cancer may be treated without previous therapies)
+Recovered from all acute toxicities caused by prior cancer therapies, except for alopecia.
+Eligible subjects must have completed appropriate treatment for their primary disease and be off cytotoxic chemotherapy and any immunosuppressive agents such as systemic steroids for at least 30 days prior to enrollment; patients should continue trastuzumab monotherapy throughout the course of this protocol; concurrent hormonal and biphosphonate therapies are allowed
+203 Prior anti-CD19-directed therapies.
+Prior toxicity to anti-FGFR-directed or anti-PI3K-directed therapies leading to treatment discontinuation (previous exposure is allowed in other circumstances).
+Any previous antitumor therapies for the current cancer event
+Previous or concomitant systemic anti cancer therapies used for the treatment of cancer in the last 3 years.
+Prior treatment with less than 4 prior endocrine therapies for metastatic breast cancer
+Patients must not have received any of the specified therapies as stated in the protocol in the time period prior to registration
+Concomitant therapy with any of the following: interleukin-2 (IL-2), interferon, or other non-study immunotherapy regimens; cytotoxic chemotherapy; immunosuppressive agents; other investigational therapies; all such therapies must have been discontinued > 4 weeks
+Failed >= 2 prior systemic therapies
+For dose-escalation portion of study, patients must be refractory to or intolerant of existing therapies known to provide clinical benefit for their condition.
+Patient has any prior use of anti-androgen therapies.
+No concomitant therapy with any of the following: IL2, interferon, or other non-study immunotherapy regimens; cytotoxic chemotherapy; immunosuppressive agents; or other investigational therapies; all such therapies must have been discontinued >= 4 weeks prior to registration
+Participants requiring the use of anti-tumor necrosis factor (anti-TNF) therapies, such as infliximab, or has received treatment with anti-TNF therapies within 5 half-lives of the drug
+Any number of prior endocrine therapies is allowed and must be discontinued prior to randomization
+Any number of biologic therapies (e.g., bevacizumab) or immunotherapies is allowed in the absence of co-administered chemotherapy and must have been completed >= 28 days prior to randomization
+No more than two (2) prior anti-cancer therapies for aBC
+For the dose escalation cohort, patients may have received any number of prior therapies
+Plan to receive anti-myeloma therapies
+Prior anti-tumor therapies must have been completed within time periods specified in the protocol prior to DNX-2401 injection
+Not eligible for cytotoxic therapies
+All patients must have received, and be relapsed/refractory to at least one line of systemic therapy\r\n* NOTE: This does not include surgery or radiation alone; patients may have received any number of systemic therapies\r\n* NOTE: For patients with aggressive lymphoma, there should be no other standard therapies that would confer survival benefit
+Subjects must have progressive cancer at the time of study entry; prior experimental (non-Food and Drug Administration [FDA] approved) therapies (other than drugs that share the same target) and immunotherapies are allowed; patients must not have received these therapies for 30 days or five half-lives of the drug (whichever is less) prior to the initiation of study treatment; toxicities from these therapies should have recovered to =< grade 1, with the exception of stable chronic grade 2 that is not overlapping with presumed toxicities of olaparib
+Participants unwilling or unable to discontinue use of prohibited therapies, including any cytotoxic chemotherapy, radiotherapy, immunotherapy or biologic agent (approved or investigational) for the treatment of TCC are ineligible
+Concomitant therapy with any anticancer agents, immunosuppressive agents, other investigational anticancer therapies
+Patients currently receiving anticancer therapies or who have received anticancer therapies within 4 weeks of the start of study drug (including chemotherapy, radiation therapy, antibody based therapy, etc.)
+No more than two prior therapies for metastatic disease
+Disease specific therapies within 1 week of starting conditioning regimen
+There is no limit to number of prior therapies
+Discontinuation of other therapies (except corticosteroids) for the treatment of NF2\n             and resolution of any acute toxic effects of prior therapies
+Received at least 2 prior therapies (regimens) for CLL
+Progression on, or intolerance of, or ineligibility for all standard therapies
+There is no limit to the number of prior therapies
+Previous therapy with anthracycline, taxanes, carboplatin, trastuzumab, or other HER2 targeted therapies for any malignancy
+Prior chemoembolization, local ablative therapies, or hepatic resection permitted if completed >= 4 weeks prior to study enrollment if patient has recovered with =< grade 1 toxicity and if measurable disease is present
+Any number of prior systemic therapies for metastatic/recurrent disease are permitted in both the phase I and II portions of the study; patients need not have received a prior cetuximab-based chemotherapy regimen to be eligible for this trial
+Patients treated with other secondary hormonal therapies
+Patients with prior investigational therapies within 4 weeks before treatment with\n             APC-100
+Unlimited prior therapies are permitted for patients enrolled in the dose escalation phase of the study; patients in the expansion cohort of the study may not have any prior therapy with riluzole or sorafenib and must have biopsiable tumor
+No concomitant use of alternative complimentary therapies or over the counter (OTC) agents allowed without prior approval of the principal investigator (PI)
+Patients randomized to either arm may also co-enroll in phase III trials that compare local therapies, or compare systemic therapies (such as chemotherapy, if randomized to Arm I of S1007)
+Relapsed, refractory, or progressive disease following at least 2 prior systemic therapies
+1c. Colorectal Cancer -Enrollment Completed Metastatic or recurrent; prior treatment progression during, after, or intolerant following the last administration of approved standard therapies (required therapies apply).
+Must have received 1 or 2 prior anti-angiogenic therapies.
+Use of any monoclonal based therapies within 2-4 weeks prior to the first dose of study treatment.
+Disease progression after 2 prior ALK inhibitor therapies. Patients may have had any number of prior chemotherapy regimens in any disease setting.
+Disease progression after 3 prior ALK inhibitor therapies. Patients may have had any number of prior chemotherapy regimens in any disease setting. ROS1-positive NSCLC patients may be:
+Any number of prior therapies (ie, chemotherapy and/or ROS inhibitor therapies).
+Patients currently receiving non-hormonal anticancer therapies or who have received non-hormonal anticancer therapies within 4 weeks from day 1 of study drug (including investigational agents, chemotherapy, radiation therapy, antibody based therapy, etc.); if radiation was received exclusively for bony metastases and the interval between completion of radiation treatments and the first infusion of study drug is less than 7 days; hormonal therapies are not excluded
+at least 2 HER2-directed therapies for advanced disease
+Inadequate response, relapse, and/or unacceptable toxicity with ? 1 prior systemic, surgical, or radiation cancer therapies.
+Use of certain investigational therapies within 21 days prior to enrollment
+Patients must not have received neoadjuvant treatment for their melanoma; patients must not have had prior immunotherapy including, but not limited to ipilimumab, interferon alfa-2b, high dose IL-2, pegylated (PEG)-IFN, anti-PD-1, anti-PD-L1 intra-tumoral, or vaccine therapies; patients must not be planning to receive any of the prohibited therapies during the screening or treatment phases of the study
+Participants in Stage 1 (Safety Evaluation) receiving erlotinib: No limit to the number of prior therapies (except for EGFR TKIs).
+Prior treatment with CD137 agonists or immune checkpoint blockade therapies.
+Has received prior treatment with daratumumab or other anti-CD38 therapies previously
+Must have received ? 1 prior therapies for CLL.
+Antiproliferative therapies other than lymphodepleting chemotherapy within two weeks of infusion
+Inadequate response, relapse, and/or unacceptable toxicity with one or more prior systemic, surgical, or radiation cancer therapies, and for whom curative standard therapy is not an option (except patients with NSCLC who must have experienced either an inadequate response, relapse, and/or unacceptable toxicity with two or more prior systemic, surgical, or radiation cancer therapies)
+Prior anticancer treatments or therapies within the indicated time window prior to first dose of study treatment (ASTX660), as follows:
+Any number of prior therapies is allowed
+Recovery from significant toxicities from previous therapies and sufficient time since last dose of previous therapy
+Prior treatment with other anti-cancer therapies including cytokines, monoclonal antibodies, immunotherapies, and cytotoxic chemotherapy is allowed
+Phase 1: Subjects who have disease progression after treatment with available therapies.
+Have discontinued previous experimental therapies and checkpoint inhibitor antibodies at least 28 days prior to the Randomization Visit
+Prior systemic, regional and radiation anticancer therapies for melanoma must have been completed at least 3 months prior to randomization.
+Had more than 2 prior lines of systemic therapy. Maintenance therapies and hormonal therapies are not considered additional lines of therapy
+Participants previously treated in the recurrent/metastatic setting with any 1 of the 3 SOC therapies in this study (i.e., docetaxel, capecitabine, or gemcitabine) may not receive the same therapy if randomized to the SOC arm. Additionally, participants previously treated in the recurrent/metastatic setting with all 3 SOC therapies are excluded from this study.
+Histologically confirmed advanced hepatocellular carcinoma, not eligible for surgical and/or locoregional therapies; or progressive disease after surgical and /or locoregional therapies
+Treatment with investigational therapy (with the exception of cancer therapies as described above) within 4 weeks prior to initiation of study drug
+Current treatment with any systemic anti-cancer therapies for advanced disease or any systemic experimental treatment on another clinical trial
+Previously received daratumumab or other anti-CD38 therapies
+Subjects of 18 years or older (men and women) with histologically confirmed advanced hepatocellular carcinoma, not eligible for surgical and/or locoregional therapies; or progressive disease after surgical and /or locoregional therapies
+Prior experimental (non-Food and Drug Administration [FDA] approved) therapies and immunotherapies are allowed; patients must not have received these therapies for 4 weeks prior to the initiation of study treatment and must have full recovery from any acute effects of these therapies
+Prior anti-CD19 therapies
+For RCC, at least two prior anticancer regimens (one must be a VEGF-targeted TKI), or are otherwise inappropriate candidates for all approved therapies. For OCCC, at least one line of prior therapy with a platinum and taxane regimen.
+SUB-PROTOCOL AIM A: Previously treated patients who have failed, unable to tolerate, or refused other available active therapies
+Any prior use of hormonal therapy, including:\r\n* Gonadotrophin releasing hormone (GNRH) agonists or GNRH antagonists (e.g., leuprorelin, degarelix)\r\n* Antiandrogens (e.g., bicalutamide, flutamide, nilutamide)\r\n* Novel androgen-directed therapies (e.g., abiraterone, enzalutamide)\r\n* Any estrogen containing compounds\r\n* 5-alpha reductase inhibitors (e.g., finasteride, dutasteride)\r\n* PC-SPES or PC-x products; other herbal therapies or supplements will be considered by the principle investigator on a case by case basis based on their potential for hormonal or anti-cancer therapies
+Current analgesic therapies have failed, the subject is not a candidate for, OR the subject is not experiencing adequate pain relief from current pain therapies (e.g. radiation, analgesics)
+Allowed prior treatments for localized prostate cancer (all treatments must have been completed >= 1 year prior to randomization) a) <= 3 years total of ADT; b) All other forms of prior therapies including radiation therapy, prostatectomy,lymph node dissection, and systemic therapies
+More than 3 prior systemic anti-cancer therapies (e.g. cytotoxic agents, biologic agents) regimens for metastatic disease
+No concomitant approved anti-cancer therapies or any investigational agents
+Patients must have received at least 2 prior therapies.
+Nasopharyngeal carcinoma basket\r\n* Metastatic or locally recurrent disease not amenable to curative intent treatment\r\n* Any number of prior therapies, including 0
+Merkel cell carcinoma basket \r\n* Metastatic or locally recurrent disease not amenable to curative intent treatment\r\n* Any number of prior therapies, including 0
+Peritoneal mesothelioma basket \r\n* Refractory or intolerant to platinum and pemetrexed systemic therapy\r\n* Any number of prior therapies
+Pleural mesothelioma basket\r\n* Metastatic or locally recurrent disease not amenable to curative intent treatment\r\n* Refractory to platinum and pemetrexed systemic therapy\r\n* Any number of prior therapies
+Patients with any number of prior therapies with anti-angiogenic agents or immunotherapy with the exception of any previous anti-CTLA-4 directed agents are allowed; a 2 week washout period is required for all agents, except for bevacizumab where a 4 week washout is required
+Other investigational therapies
+Participant has received daratumumab or other anti-cluster of differentiation 38 (anti-CD38) therapies previously
+Patients previously treated with herbal supplements, or other potential or experimental therapies for prostate cancer (apart from LHRH agonists and antiandrogens), must have been discontinued these treatments and completed at least a one-month washout prior to first vaccination
+Patients must have received at least two or more prior courses of intravesical therapy per recommended schedules. BCG must have been one of the prior therapies administered.
+More than two previous treatment lines of systemic antineoplastic therapies in the advanced setting
+More than 2 prior lines of systemic antineoplastic therapies in the advanced setting
+Patients with follicular lymphoma must have received at least two prior therapies
+Any other previous antitumor therapies for the current cancer event
+Have mCRC that has been treated with currently approved standard therapies
+Current or recent treatment with biologic anticancer therapies
+Ongoing AEs from prior anticancer therapies
+Failure, ineligible or intolerant of approved therapies; any number of prior systemic therapeutic regimens for unresectable stage III or stage IV melanoma; this includes chemotherapy, immunotherapy, pathway inhibitors, biochemotherapy, or investigational treatments; patients may also have received therapies in the adjuvant setting
+Has received daratumumab or other anti-CD38 therapies previously
+For Part A (abemaciclib + pemetrexed): Non-squamous subtypes only. The participant must have received at least one but no more than three prior therapies for advanced/metastatic NSCLC.
+For Part B (abemaciclib + gemcitabine): Any subtype. The participant must have received at least one but not more than three prior therapies for advanced/metastatic NSCLC.
+For Part C (abemaciclib + ramucirumab): Any subtype. The participant must have received at least two but not more than three prior therapies for advanced/metastatic NSCLC.
+For Part E (abemaciclib + pembrolizumab): Any subtype. The participant must have received at least one but no more than three prior therapies for advanced/metastatic NSCLC.
+Co-administration of anti-cancer therapies other than those administered in this study
+Experimental therapies when given as separate regimen are considered as separate line of therapy
+Prohibited Treatments and/or Restricted Therapies
+Ongoing or planned administration of anti-cancer therapies other than those specified in this study
+Circulating blast count >= 10,000/uL by morphology or flow cytometry (cytoreductive therapies including leukapheresis or hydroxyurea are allowed)
+May have received prior therapies for advanced or metastatic disease
+Commercially available, molecularly targeted therapies (e.g., dabrafenib, trametinib, vemurafenib, imatinib) taken within 7 days prior to lymphodepletion
+Chemotherapy, radiotherapy or immunotherapy must have stopped more than 14 days prior to receiving study drug; however, small field palliative radiotherapy, tyrosine-kinase inhibitor (TKI) therapies, and hormonal therapies are allowed
+Phase 2: Prior talimogene laherparepvec, other oncolytic virus therapies, or tumor vaccines
+Patients with known immunodeficiency or receiving immunosuppressive therapies
+AR targeted agents (including GTx-024, enzalutamide or other AR targeted therapies)
+Hormone replacement therapies (estrogens, megestrol acetate) within 14 days prior to day 1 of protocol therapy
+Relapsed or are refractory following at least 2 prior systemic therapeutic attempts (1 prior systemic attempt for PTCL). For CTCL, extracorporal photochemotherapy (ECP) will be considered a systemic therapy. Local radiation and topical agents are not systemic therapies.
+Received any of the following prescribed medications or therapies in the past:
+Received any subsequent anti-cancer therapies from the time between the last dose of atezolizumab prior to the first administration of study drug after crossing over
+Patients must be off all other anti-tumor therapies (including immunologic agents) for at least four weeks prior to study registration. Patients on hormonal agents require a washout for 10 days.
+Patients currently receiving anticancer therapies or who have received anticancer therapies within 4 weeks of the start of study drug (including chemotherapy, radiation therapy, antibody based therapy, etc.)
+Participants must have received no more than 3 prior chemotherapy or cytotoxic regimens; there is no limit to the number of prior hormonal therapies
+Must have received at least 2 prior approved therapies
+Prior treatment with greater than (>) 1 cytotoxic chemotherapy regimen or >2 endocrine therapies for advanced or metastatic disease
+Any number of prior therapies other than oxaliplatin is allowed
+Any cancer directed therapies between completion of induction chemotherapy and treatment on protocol
+Herbal therapies, with an antitumor effect.
+The participant may have had any number of prior systemic cytotoxic therapies for advanced/metastatic disease and are considered appropriate candidates for anthracycline therapy. All previous anticancer treatments must be completed ? 3 weeks (21 days) prior to first dose of study drug.
+Subjects have received two or more standard available therapies known to prolong survival and for which they would be considered eligible; such therapies should include regimens containing oxaliplatin and irinotecan in combination with a fluoropyrimidine if appropriate (e.g., FOLFOX and FOLFIRI or their variants)
+Ongoing or planned administration of anti-cancer therapies other than those specified in this study
+Expansion Cohort only: Patients with high grade glioma (grade 3 and 4) that are refractory to standard therapies, and who have progressive disease following radiation therapy. Patients with any number of prior treatments are allowed.
+Participants who have received previous CLL therapy, including investigational therapies
+Patients currently receiving anticancer therapies or who have received anticancer therapies =< 4 weeks prior to registration (including chemotherapy, radiation therapy, antibody based therapy, etc.)
+Patients currently receiving anticancer therapies or who have received anticancer therapies within 2 weeks of the start of everolimus (including chemotherapy, radiation therapy, antibody based therapy)
+Insufficient recovery from all side effects of previous anticancer therapies
+Progression on at least 2 lines of anti-HER2-targeted therapies for metastatic breast cancer (MBC)
+Patient must have received at least one, and no more than two prior systemic therapies for metastatic cancer
+Patients currently receiving anticancer therapies or who have received anticancer therapies within 4 weeks of the start of everolimus and LDE225 (including chemotherapy, radiation therapy, antibody based therapy, etc.)
+Concomitant therapy with any of the following: interleukin (IL)-2, interferon, other non-study immunotherapy regimens, cytotoxic chemotherapy, other investigation therapies
+Must be off prior systemic therapies for 2 weeks prior to enrollment; patients that have been previously treated with systemic therapy adjuvantly or for metastatic disease remain eligible as long as they continue to meet all other eligibility criteria (oligometastatic, no visceral metastasis > 5 cm, eligible for SABR)
+Has received any of the following therapies: daratumumab or other anti-CD38 therapies
+Other concurrent anticancer therapies.
+Patients who have received previous systemic therapies including TKI inhibitors are eligible.
+Participants may have had any number of previous hormonal therapies (antiandrogens including enzalutamide, estrogens, finasteride, dutasteride, ketoconazole) provided these were discontinued >= 4 weeks before starting the trial; prior therapy with steroids is allowed though these must be discontinued >= 2 weeks before starting the trial; inhaled, topical, and intra-articular steroids are allowed
+Participants are permitted to have any number of prior therapies prior to enrollment
+Advanced solid tumor for which no other higher priority therapies are available
+Other available therapies have failed to cure the cancer
+Treatment with any of the following anti-cancer therapies:\r\n* Radiation therapy, surgery or tumor embolization within 14 days prior to the first dose of study treatment
+Patients may have received 1-3 prior systemic therapies in the metastatic setting.
+Taking investigational or commercial agents or therapies with the intent to treat the subject's malignancy other than those therapies permitted
+RESTRICTED THERAPIES:
+At least 1 prior treatment (no restriction to number of prior therapies)
+Patients currently receiving anticancer therapies or who have received anticancer therapies within 3 weeks of the start of study drug including chemotherapy, biologics, targeted therapies, or immunologics
+Is taking or has taken any medications or therapies outside of protocol-defined parameters
+Participants may have received any number of prior therapies as long as they have adequate performance status and meet all other eligibility criteria
+Patients may have received any number of prior CNS directed therapies - there are no limitations
+Candidate for potentially curative therapies in the opinion of the investigator.
+Patients must have received at least one prior line of therapy for their advanced lung cancer but there is no restrictions on the maximum number of prior therapies allowed
+EXCLUDED THERAPIES AND MEDICATIONS, PREVIOUS AND CONCOMITANT
+Patients who have had systemic chemotherapies or targeted therapies within 3 weeks or radiotherapy within 2 weeks prior to entering the study or those patients whose adverse events from prior therapies have not recovered to =< grade 1 (other than grade 2 neuropathy, lymphopenia and alopecia which are permitted)
+Patients must be off all other anti-tumor therapies (including immunologic or hormonal agents) for at least four weeks prior to study registration
+Patients currently receiving anticancer therapies or who have received anticancer therapies within 4 weeks of the start of study drug (including chemotherapy, radiation therapy, antibody based therapy, etc.)
+Participants may not be receiving any other investigational or commercial agents or therapies other than those described in this protocol to treat their malignancy
+Prior treatment with embolization of ablative therapies is allowed if measurable disease remains outside of the treated area or if there is definite progression of the treated lesions; there is no limit on the number of prior procedures
+Excluded therapies and medications, previous and concomitant:
+Treatment with a single course of gefitinib(Iressa®) or erlotinib (Tarceva®), or other small molecule or targeted therapies, or monoclonal antibody therapy (excluding docetaxel) will be considered and count as prior chemotherapy.
+More than 4 prior chemotherapy regimens; note: repeat use of regimens count as 1 prior regimen; switching front-line therapy regimens (for example, from intraperitoneal to intravenous therapy) for reasons other than progression will count as 1 prior therapy; bevacizumab and other ‘targeted’ agents will count in the total number of prior regimens; vaccine therapies will not count in the total of prior therapies
+Patients with antecedent MDS/MPN, defined by WHO criteria, without any prior therapy for AML, regardless of the number of therapies for MDS/ MPN
+Must have received first line chemotherapy; no upper limit for the number of prior therapies
+Participants may have received up to 2 prior cytotoxic chemotherapies; there is no limit to the number of lines of prior biologic or hormonal therapies they may have had; patients must be platinum resistant
+Participants may have received any number of prior cytotoxic chemotherapies; there is no limit to the number of lines of prior biologic or hormonal therapies they may have had; patients may be platinum-sensitive or resistant or refractory
+Concomitant antineoplastic therapies including chemotherapy, radiotherapy, or biological agents during the study
+Treatment with trastuzumab, bevacizumab or other targeted therapies within the past 2 weeks
+Received any of the following antitumor therapies
+Investigational or biologic therapies within 3 weeks of C1D1
+Prior therapies:
+Participants who were refractory to all lines of previous treatment(s) (ie, participants who had never responded to any therapies received).
+Patients currently receiving anticancer therapies or who have received anticancer therapies within 4 weeks of the start of study drug (including chemotherapy, radiation therapy, antibody based therapy, etc.)
+Phase Ia: Patients may have de novo metastatic disease, or documented progression despite any number of prior therapies; patients must have no curative or other effective therapeutic options available
+Patient is not a candidate for, or has not demonstrated a significant local response to chemotherapy, biologic, hormonal ,or other therapies
+Plan for chemotherapy or targeted therapies during WBRT or over the subsequent 7 days
+Patients previously treated with herbal supplements, or other potential or experimental therapies for prostate cancer must have discontinued these treatments and completed at least a one-month washout prior to beginning treatment
+Prior experimental systemic therapies must have been completed greater than 2 weeks prior to study entry
+Received other therapies as follows:
+Patients are allowed to receive, but are not required to receive, three additional cytotoxic regimen for management of recurrent or persistent disease; hormonal therapies will not count toward the prior regimen limit
+Must have received at least 2 prior therapies approved for CRPC; including a prior AR inhibitor (e.g., enzalutamide or apalutamide). (Part 1 only)
+Must have received enzalutamide or apalutamide. (Note: additional therapies approved for CRPC prior to enzalutamide or apalutamide are allowed.) (Part 2 only)
+Had a prior anti-cancer monoclonal antibody (except immune CPI in the case of melanoma subjects) within 30 days prior to start of study treatment, or failure to recover to CTCAE Grade 1 or better from the adverse events of prior therapies
+For Arm C, patients may have had an unlimited number of prior therapies for GBM, however must be at first recurrence from a therapeutic regimen containing bevacizumab
+Recovered from all clinically relevant toxicities related to prior therapies
+Failed to recover from the reversible effects of prior anticancer therapies
+Patients who have received more than two prior therapies
+Receipt of any biological or immunological-based therapies (including experimental therapies) for leukemia, lymphoma, or myeloma (including, but not limited to, MAb therapy such as rituximab, or cancer vaccine therapies) within 28 days or 5 half-lives, whichever is shorter, prior to the first dose of MEDI-551
+Patients may have received any number of prior therapies, including monotherapy with liposomal doxorubicin or bevacizumab
+Receipt of anti-CTLA-4 targeted therapies or other checkpoint or co-stimulatory therapy within 3 months prior to start of study treatment.
+Patients with rapidly progressive disease who are candidates for other approved therapies such as docetaxel, abiraterone, and enzalutamide.
+Daratumumab or other anti-CD38 therapies
+At least 3 weeks post any treatments/therapies at the time of first dose.
+GVHD therapies: Any drug used for GVHD within 4 weeks prior to leukapheresis
+Patient have received anti-cancer therapies within the following time frames prior to the first dose of study treatment:
+14 days for non-cytotoxic cancer therapies and radiotherapy
+At least three weeks from any non-anti-EGFR therapy prior to start of study treatment; any number of prior therapies is permitted
+Patients currently receiving anticancer therapies (including chemotherapy, radiation therapy, antibody based therapy, etc.)
+Herceptin: women who have been previously treated with Herceptin or other monoclonal antibody therapies are eligible for the trial
+Immunosuppressant therapies other than allowed background therapy
+Patients with CNS refractory small cell lung cancer having received standard recommended dosing for either of the two therapies:\r\n* Whole brain radiation therapy (WBRT)\r\n* Prophylactic cranial irradiation (PCI)
+Most prior therapies and prior targeted therapy are allowed and these specific therapies are detailed in the protocol.
+Prior allogeneic or autologous HCT or adoptive cellular therapies, including T-cell chimeric antigen receptor (CAR) therapy
+Patient must have received at least one line but less than three lines of prior systemic therapies and have either progressed or intolerant to prior therapies; patients who have received adjuvant/neoadjuvant therapy within last one year will be eligible as well
+Patients currently receiving anticancer therapies or who have received anticancer therapies within 4 weeks of the start of everolimus (including chemotherapy, radiation therapy, antibody based therapy, etc., but not including somatostatin analogues, e.g., octreotide)
+Must have received at least 4 prior therapies, including an alkylating agent (unless not clinically indicated), proteasome inhibitor, an immunomodulatory (IMiD) and CD38 targeted therapy. At least 3 prior therapies where CD38 targeted therapies are not approved, not commercially accessible, contraindicated or refused by subject. DLBCL Dose Expansion Arm:
+1 to 2 prior therapies
+For Phase I: Locally advanced or metastatic B-Raf proto-oncogene, serine/threonine kinase (BRAF) V600E/K positive melanoma that is either treatment-naïve or treatment-experienced; for the latter, progression, or stable as best response, or intolerance to the last treatment is required; previous treatments can be local or systemic therapies; there are no limits to the number of prior therapies; for all patients, disease does not have to be measurable but must be evaluable, which is defined as one or more lesions which are known to be present, but which cannot be measured; e.g.: bony lesions, pleural effusion, ascites
+Excluded previous therapies and medications:
+Being treated with anti-TNF therapies or has been treated with an anti-TNF therapy within 5 half-lives of randomization.
+Chemotherapy and other investigational therapies (targeted or immunotherapy) will require a 3-week washout period before treatment initiation
+Prior treatment with any investigational or targeted therapies
+At least 14 days between ibrutinib initiation and last cancer therapy; any number of prior cancer therapies is permitted; patients otherwise fit for blood or marrow transplantation (BMT) should receive second-line chemotherapy before considering enrollment
+Patients who have had any chemotherapy regimens, biologic, or targeted therapies within the 2 weeks prior to Cycle 1 Day 1
+Relapsed/refractory disease failing >= 2 prior therapies; an exception is patients with KS, where patients can be previously untreated, relapsed/refractory to one or more prior therapies, or intolerant of a prior therapy
+Mandatory tumor biopsy at study entry (pre-randomization, unless already collected after sorafenib progression but within 3 months of enrollment and no systemic anticancer therapies received)
+Prior treatment with any number of immunotherapies (e.g., IL2, ipilimumab), targeted therapies (e.g., vemurafenib) are permitted but no more than one 1 prior chemotherapy
+Anticancer treatment with radiation therapy, targeted therapies, chemotherapy, immunotherapy, hormones or other antitumour therapies within 28 days prior to first dose of TH-302.
+For Phase Ib, there is no restriction on the number of prior therapies for recurrent or metastatic disease
+Anticipated or ongoing administration of anti-cancer therapies other than those administered in this study
+All subjects must have advanced solid tumors that have returned after treatment with established approved therapies or be intolerant of established therapies
+Prior treatment with cluster of differentiation 137 (CD137) agonists or immune checkpoint blockade therapies
+For investigational anti-cancer therapies, the interval will be determined in consultation with the Medical Monitor.
+History of the following therapies in the post-transplant period:
+CD19 CAR-T cells based therapies
+< 28 days for any antibodies or biological therapies
+Relapsed, refractory, or progressive disease following at least 2 prior systemic therapies
+Disease progression despite standard therapies
+Progressive disease without any standard therapies established
+Standard therapies are considered intolerable
+Patient has persistent toxicities from prior anti-leukemic therapies which are determined to be relevant by the Investigator.
+Use of antineoplastic therapies within 21 days before day 1.
+Receipt of treatment with immunotherapy (including interferons, interleukins, immunoconjugates), biological therapies (including monoclonal antibodies or other engineered proteins), targeted small molecules (including but not limited to kinase inhibitors), hormonal therapies (except for gonadotropin releasing hormone agonists/antagonists for prostate cancer which may be continued while on study) within 3 weeks of scheduled dosing day 1.
+Being treated with other anti-cancer therapies (approved or investigational).
+Patients must have no available approved therapies that confer clinical benefit
+Concurrent administration of any anti-cancer therapies other than those administered in this study
+Discontinuation of all other therapies for treatment of iNHL ? 3 weeks before Visit 2
+Subjects must have received one or more prior systemic therapies for this disease, with disease progression or intolerable toxicity precluding further therapy with prior regimen(s)
+No limitations on prior systemic or intrathecal therapies
+Patient has been treated with all FDA approved endocrine therapies or has been treated with all FDA approved endocrine therapies except for tamoxifen (tamoxifen is excluded from the trial)
+Subject has not discontinued all previous systemic therapies for cancer including chemotherapy, immunotherapy, or biological therapies for at least 14 days prior to the initiation of ASP4132.
+Has received other anti-cancer therapies other than IMO-8400 since enrolling in Protocol 8400-401.
+Being treated with other anti-cancer therapies (approved or investigational)
+Treatments in this category include chemotherapy and targeted therapies not targeting VEGF; 14 days must have elapsed since discontinuation of prior chemotherapeutic treatments for glioma and study treatment
+Must have received or may still be receiving one or more therapies including octreotide or serotonin synthesis inhibitor (SSI) or other somatostatin analogues
+Ongoing adverse events from surgery or prior anti-cancer therapies, including radiation, targeted, or cytotoxic therapies
+Candidate for potential curative therapies (i.e., resection or transplantation).
+Patients must have experienced disease recurrence or progression during or after prior treatment with one or more prior standard systemic therapies;
+Prior treatment with sorafenib or other RAF/VEGF targeted therapies.
+Systemic cytotoxic therapies or radiotherapy ?14 days prior to day 1 cycle 1
+No concomitant therapy with any of the following: aldesleukin (IL2), interferon, or other non-study immunotherapy regimens; cytotoxic chemotherapy; immunosuppressive agents; other investigational therapies; or chronic use of systemic corticosteroids; all such therapies must have been discontinued >= 4 weeks
+Patients may not have received prior systemic or hepatic directed infusional/embolization therapies for advanced uveal melanoma; local therapies such as radiofrequency ablation or cryotherapy for metastatic disease are permitted but must have been performed at least 21 days prior to initiation of study therapy; lesions treated with local modalities such as radiofrequency ablation or cryotherapy may not be used as target lesions unless they demonstrate growth over a minimum of 3 months on subsequent imaging studies
+Histologically or cytologically confirmed gastrointestinal (GI) carcinoma, which has progressed on standard therapies (surgery, radiotherapy, endocrine therapy, chemotherapy), for which effective therapy is not available or for which patients are not a candidate for or intolerant of such therapies.
+Co-administration of anti-cancer therapies other than those administered in this study
+Treatment less than two weeks prior to enrollment with other systemic experimental therapies or antineoplastic agents, with the exception of hydroxyurea and intrathecal chemotherapeutic agents
+Adequate residual organ function per treating physician discretion; Note: there is no limit with regard to the number of prior therapies
+Received and failed all known effective therapies for their disease;
+Patients must not have received the therapies indicated below for the specified time period prior to the first day of administration of protocol therapy on this study:
+Anticipated or ongoing administration of anti-cancer therapies other than those administrated in this study
+No limit to prior therapies with last anti-cancer treatment >= 2 weeks from initiation of WBRT; please note: there is no washout period required for trastuzumab and pertuzumab
+Parts A,B: The presence of a solid, malignant tumour, excluding lymphoma, that is resistance to standard therapies or for which no standard therapies exist.
+GIST subjects must have previously received all FDA-approved therapies (imatinib mesylate, sunitinib malate, and regorafenib) for which they are eligible
+Subjects currently receiving anti-cancer therapies (other than SSAs, which may continue).
+Subjects who have received anti-cancer therapies within 2 weeks of the start of study drug (including chemotherapy, radiation therapy, immunotherapy, etc.).
+Must not be receiving other anti-cancer therapies (except somatostatin analogues, which may be allowed)
+Phase 1: Subjects who have disease progression after treatment with available therapies.
+Patients must have histologically confirmed solid malignancy (excluding lymphoma) that is metastatic or unresectable and for which standard curative or palliative systemic therapies (such as chemotherapy, targeted therapies or immunotherapy) do not exist or are no longer effective
+Patients currently receiving anticancer therapies or who have received anticancer therapies within 2 weeks of the start of study drug (including chemotherapy, radiation therapy, antibody based therapy, etc.)
+Some prior cancer therapies are not consistent with eligibility; specifically:
+Prohibited Treatments and/or Therapies
+The systemic use of the following therapies are prohibited within 28 days of first dose of study medication, or longer where indicated:
+Failed to recover from the reversible effects of prior anticancer therapies;
+Prior treatment with greater than (>) one cytotoxic chemotherapy regimens or experienced recurrent or progressive disease on > two endocrine therapies for MBC
+May have up to three biological therapies
+No known contraindications to intended therapies
+Patients planning on receiving other anti-cancer therapies while on this study
+Patient has received any of the following therapies:
+Part B: Candidate for experimental therapy after standard therapies used or non-eligible for standard therapies. Histological or cytological evidence of 1 of the 5 tumor types:
+No previous systemic anti-cancer therapy permitted (2 prior systemic anti-cancer regimen are allowed in Phase Ib). Previous chemoembolization, radioembolization, radiofrequency ablation, or other local ablative therapies are permitted if greater than 6 weeks of first day of study-defined treatment;
+Received prior therapies including:
+Concurrent use of alternative cancer therapies
+Patients who are receiving other biologic therapies including cytokines or growth factors not specified by the protocol; herbal supplements will not result in exclusion but should be noted and reviewed with the PI
+For phase I, any solid tumors, including lymphoma, that progressed or were stable as best response on at least one previous therapy but no more than two previous cytotoxic therapies and are evaluable
+Prior treatment with CD137 agonists or immune checkpoint blockade therapies
+Prior warfarin-based therapies within 7 days of capecitabine treatment
+Patients with a histologically and/or cytologically confirmed solid tumor who are resistant / refractory to approved therapies or for whom no curative therapies are available
+All previous therapies must have been discontinued at least 4 weeks prior to initiation of the administration of this study’s drugs
+Less than 4 prior systemic cancer therapies (with the exception of hormonal agents), including experimental agents, prior HER-family TKI therapies, and prior docetaxel and other taxane therapy; there are no limits to the number of prior therapies for Part 1
+6-60 months post-treatment (surgery, chemotherapy, radiation therapy, and/or maintenance therapies) for cancer; time frame applies to most recent completion of treatment if participant had a cancer recurrence; it is acceptable to be on hormonal therapies
+Ongoing treatment with radiotherapy to thorax, cytotoxic or biological therapies for this malignancy (Note: hormonal therapy is allowed)
+Patients with metastatic cancers who are considering or pursuing additional palliative therapy after progressing on at least two prior lines of chemotherapy, immunotherapy, biological or targeted therapies
+COHORT A SPECIFIC INCLUSION: Histologically confirmed IDHwt, retinoblastoma (RB) intact, grade II or III glioma that has recurred after first line therapy (consisting of at least maximum feasible surgical resection and radiation therapy); there is no limit on the number of prior therapies or types of therapies patients can have received
+No limit on number of prior therapies
+Patients currently receiving any other anticancer therapies;
+Have received more than 2 prior therapies for ED-SCLC (including immunotherapy, targeted therapies, or chemotherapy)
+Patients may have received any of the following therapies: surgery, chemotherapy, hormones, biologics, or radiation
+Patient must be on a stable dose of adjuvant pain therapies for one week prior to screening or after 4-5 half-lives of adjuvant pain therapies (i.e., glucocorticoids, nonsteroidal antiinflammatory drug [NSAIDs], anticonvulsants, pharmaceutical cannabinoids, tricyclic antidepressants)
+Continuation of over-the-counter therapies for nausea and/or vomiting during the study
+Patients on anti-hormonal therapies (e.g., anti-estrogens for breast cancer) or other maintenance therapies will be eligible.
+Hormonal (e.g., tamoxifen or arimidex, etc.) and targeted (tarceva and avastin, etc.) therapies allowed as long as they will be continued during the course of the study.
+Not recovered from toxicity due to all prior therapies.
+For the dose escalation cohorts, any prior number of MDS therapies, including hypomethylating agents, are permitted; for the dose expansion cohort, subjects must be azacitidine naïve, but otherwise any prior number of MDS therapies are permitted; treatment naïve patients are eligible for both the dose escalation and expansion cohorts if they are unfit for or refuse intense therapy
+Any number of prior therapies are allowed
+Currently receiving immune-modulating therapies
+Patients receiving other investigational drugs for GVHD; co-enrollment in other clinical trials that do not include experimental GVHD therapies is allowed
+Patients must have a diagnosis of colorectal or lung cancer and be planning to receive one of the following human epidermal growth factor receptor (HER1)/epidermal growth factor receptor (EGFR) inhibitor therapies listed below for at least 6 weeks:\r\n* Cetuximab 400 mg/m^2 loading dose, 250 mg/m^2 weekly\r\n* Cetuximab 500 mg/m^2 every 2 weeks\r\n* Panitumumab 6 mg/kg every 2 weeks\r\n* Erlotinib 100-150 mg daily\r\n* Other HER1/EGFR inhibitor therapies, schedules, or doses of the above listed agents are not allowed\r\n* NOTE: concurrent chemotherapy and other anti-cancer therapies (such as carboplatin, paclitaxel, and bevacizumab) are allowed EXCEPT for the following chemotherapeutic agents which are known to cause skin rash that could interfere with EGFRI-induced skin toxicity assessment: gemcitabine, capecitabine, and topical fluorouracil (Efudex, Fluoroplex, Carac)
+Plan to receive or is receiving primary frontline anti-myeloma therapies
+There must be no prior second-line or third line therapies for aGVHD (with exception of mycophenolate mofetil [MMF]) or second or third line therapies for cGVHD (other than extracorporeal photopheresis, rituximab or MMF); second and third line therapies for aGVHD and cGVHD are as defined by the British Committee on Standards in Hematology and reproduced in the GVHD Policy of the Blood and Marrow Transplant program (version 1-13); all prior therapies other than corticosteroids, tacrolimus, sirolimus or cyclosporine must be completed and discontinued; patients with breakpoint cluster region (bcr)-ABL proto-oncogene 1 (abl) associated malignancies may be on a tyrosine kinase inhibitor as malignant disease therapy or prophylaxis
+if they are currently using or planning on using other complementary alternative medicine (CAM) therapies prior to or after surgery.
+Concomitant trastuzumab and anti-endocrine therapies are permitted; if taking anti-endocrine therapy must have been taking for at least 3 months prior to enrollment
+Are not within 12 months of completing treatment for breast cancer (except hormonal therapies) at the time of recruitment;
+Current analgesic therapies have failed OR the subject is experiencing intolerable side effects
+Failure of previous HCV therapies
+Patients with steroid refractory cGVHD cannot have history of the following therapies at any time in the post-transplant period: B-cell depleting biologic agents within the past 18 months, BTK/SYK/JAK/PI3K inhibitors within the past 2 weeks, CD19 chimeric antigen receptor (CAR) T-cell therapies at any time post-transplant
+History of serious side effects from nicotine or from any nicotine replacement therapies
+Prior treatment with CD137 agonists or other immune checkpoint blockade therapies, including anti-CTLA-4 therapeutic antibodies
+Patients currently receiving anticancer therapies or who have received anticancer therapies within 4 weeks of the start of everolimus (including chemotherapy, radiation therapy, antibody based therapy, etc)
+Previous standard of care anti-tumor treatment including surgery and/or biopsy and chemoradiation. The washout periods from prior therapies are intended as follows:
+Prior experimental (non-Food and Drug Administration [FDA] approved) therapies and immunotherapies are allowed; patients must not have received these therapies for 3 weeks prior to the initiation of study treatment and must have full recovery from any acute effects of these therapies
+GVHD therapies within 4 weeks of leukapheresis and JCAR017 administration.
+Prior exposure to daratumumab or prior exposure to other anti-Cluster of Differentiation 38 (anti-CD38) therapies
+Patients currently receiving anticancer therapies (except biphosphonate, denosumab);
+No limit to prior therapies with last anti-cancer treatment >= 2 weeks from initiation of WBRT; please note: there is no washout period required for trastuzumab, pertuzumab for patients who have developed new parenchymal brain metastases while on these agents
+Prohibited treatments and/or therapies:\r\n* Prior history of breast cancer surgery and/or radiotherapy
+Planned procedures or therapies in between SOC scans and study scan on s-DCT, e.g., biopsy or excision of lung lesion
+Prior therapies including involved field radiation therapy
+Patients can have had any number of prior therapies, including but not limited to molecularly targeted therapies and anti-angiogenic therapies, however they must have had prior chemotherapy with either temozolomide or lomustine
+Patients must not have received any study therapies prior to registration
+Subjects may not be receiving any experimental therapies
+Patients on any experimental anti-EGFR targeted therapies
+Has undergone ? 2 prior standard therapies
+There is no limit to the number of prior therapies
+Experienced PD on >2 endocrine therapies for metastatic breast cancer or for locoregional recurrence that was not amenable to resection or radiation therapy with curative intent.