There is no limit to the number of prior lines of treatment a patient has received
There is no limit to the number of prior lines of treatment a patient has received
H&N, NETs, biliary tract, CUP: one or two prior chemotherapy-containing lines
Diagnosis of platinum resistant or refractory OVCA having received  or fewer prior lines, or recurrent advanced NSCLC having received  or fewer prior lines
For Arm B: must have received at least  but not more than  prior lines of therapy.
CRC - No more than four different prior lines of systemic therapy for advanced disease
Cohort : Are BRCA negative and have received  or more prior lines of therapy.
Cohort : Are BRCA negative and have received less than  prior lines of therapy.
Have received no more than  prior lines of therapy (maintenance therapy given in the metastatic setting will not be considered a separate regimen). Generally, treatments that are separated by an event of progression are considered different regimens.
Has previously received at least  lines of myeloma therapy.
Must have had at least two () prior lines of systemic therapy for liposarcoma (not to exceed  prior lines)
There is no limitation on the number of prior lines of systemic therapy
More than  lines of previous cytotoxic therapies. For patients of CTCL who failed romidepsin, more than  lines of previous therapies
No more than  prior lines of treatment for cGVHD.
The patient has received  to  prior lines of therapy; by definition, a single line of therapy may consist of  or more agents, and may include induction, hematopoietic stem cell transplantation, and maintenance therapy; radiotherapy, bisphosphonate, or a single short course of steroids (i.e., less than or equal to the equivalent of dexamethasone  mg/day for  days) would not be considered prior lines of therapy
 to  prior lines of therapy
No more than two prior lines of cytotoxic-containing chemotherapy regimens for advanced disease. There is no limit for prior targeted therapy, hormonal therapy and immunotherapy (such as nivolumab).
PHASE IB: =<  lines of prior systemic therapy for patients with progressive locally-advanced disease
Patients may have had no more than  prior lines of systemic therapy; prior therapy with a MET inhibitor is allowed as long as the patient has not had progressive disease while receiving the agent
Phase II: histologically confirmed colorectal adenocarcinoma post at least two lines of therapy, NSCLC post at least two lines of therapy, or granulosa cell ovarian cancer post at least one line of therapy; patients must have measurable disease
Has received four or more systemic anticancer regimens for mCRPC. Treatment with docetaxel or abiraterone for non-castrate metastatic disease is permissible and does not count towards the lines of therapy for mCRPC. A line is a regimen. Combinations of hormones and other types of therapies count as single lines
One to four prior lines of therapy
Greater than  lines of prior systemic therapy for CRPC
ARM I INCLUSION CRITERIA: There are no restrictions on the number of prior lines of treatment for systemic disease
Patients must have had at least  prior lines of therapy
More than  lines of prior systemic therapy in the preceding three years
Patients must have had at least two, but not more than four prior lines of therapy for their disease, with lines of therapy being separated by the presence of documented disease progression; using this definition, treatment with induction therapy, followed by high dose chemotherapy and autologous stem cell transplantation, and finally by maintenance therapy, would constitute one line, provided that multiple myeloma did not meet criteria for progression at any time during this period
Prior treatment with more than  lines of therapy (combination treatments are considered  line of therapy)
Patients with R/R PTCL who have received at least one and no more than three previous lines of therapy are eligible to be enrolled in this study
At least one and up to two previous lines of systemic cytotoxic therapy for advanced NSCLC, of which one must have been a platinum-based doublet therapy. Up to four total previous lines of systemic therapy (including immunotherapy and molecularly targeted therapy)
Relapsed disease after at least  lines of therapy
Receipt of >/= but not more than  prior lines of therapy (Cohorts A, B, C, D, E)
Receipt of >/= lines of prior therapy and are refractory to the last line of treatment (Cohort F)
Previously untreated or treated subjects with no limit on prior lines of systemic therapies are allowed
Patients with steroid refractory cGVHD typically have received salvage with multiple lines of therapy; hence in this trial there will be no restriction in terms of prior lines of therapy received; prior ECP exposure is allowed, however prior IL- use is excluded
Received less than  lines of anti-myeloma therapy
All lines of prior therapy accepted; subjects with prior hepatic or extra-hepatic resections of metastatic disease will be included
Patients can have any lines (including zero) of prior therapy to sign consent prior to tissue harvest; vaccination will not take place until at least one line of standard chemotherapy is given
Patients who have received up to two previous lines of systemic chemotherapy are eligible for this trial
Subjects must have had at least three lines of therapy for their disease, including a proteasome inhibitor and immunomodulatory drug (e.g., lenalidomide), with lines of therapy being separated by the presence of documented disease progression; using this definition, treatment with induction therapy, followed by high dose chemotherapy and autologous stem cell transplantation, and finally by maintenance therapy, would constitute one line, provided that multiple myeloma did not meet criteria for progression at any time during this period
Must have undergone prior treatment with ? treatment lines of anti-myeloma therapy and failed last line of treatment (disease progression ? days of completion of last therapy)
At least one but no more than three prior lines of therapy in the advanced stage are allowed. One prior line of therapy must be platinum doublet chemotherapy.
More than three lines of prior therapy.
More than  lines of therapy beyond corticosteroids with or without calcineurin inhibitors or sirolimus
There will be no limits to prior lines of treatment
Prior systemic therapy: (a) Phase b: Any number of lines of prior therapy; (b) Phase : Progressed after  or  lines of prior chemotherapy
Received no more than  prior lines of systemic therapy for metastatic disease.
Patients must have received at least  prior lines of therapy (Note: Induction therapy and stem cell transplant  maintenance will be considered as one line).
Criteria  Received at least  but not more than  prior lines of therapy for multiple myeloma (induction therapy followed by stem cell transplant and consolidation/maintenance therapy will be considered as  line of therapy, see Appendix E for guidance)
No more than  prior lines of anti leukemia therapy (not including ibrutinib)
No more than  prior lines of anti leukemia therapy (not including ibrutinib)
Refractory to and disease progression within  months from the last dose of at least  lines of prior therapy
Has received at least  prior lines of therapy as described in the protocol.
For Part , prior treatment with less than  prior lines of chemotherapy
No limits to the prior lines of treatment
Progression on at least two prior lines of therapy for unresectable metastatic colorectal adenocarcinoma\r\n* Administration of bevacizumab previously does not impact study inclusion
RENAL COHORT: Any number of prior treatment lines is allowed on study
Patients can have any lines (including zero) of prior therapy to sign consent prior to tissue harvest
Any number of prior lines of therapy
Subjects with one to three lines of therapy for their disease with lines of therapy being separated by the presence of documented disease progression; using this definition, treatment with induction therapy, followed by high dose chemotherapy and autologous stem cell transplantation, and finally by maintenance therapy, would constitute one line, provided that multiple myeloma did not meet criteria for progression at any time during this period
Patient must have received  or more prior lines of systemic therapy for myeloma; patients must be off last treatment for at least  weeks (wks) by the beginning of treatment on this protocol
Subjects may have received no more than  lines of prior therapy for advanced disease.
Subjects may have received no more than  lines of prior therapy for advanced disease.
Subjects may have received no more than  lines of prior therapy for the advanced disease
previously received at least  but no more than  lines of therapy, one therapy must have included a VEGF TKI
previously received at least  but no more than  lines of therapy, one therapy must have included a fluoropyrimidine based regimen
Histologically confirmed metastatic soft tissue sarcoma (i.e., non-GIST, non-adipocytic) that has progressed by RECIST following treatment with anthracycline chemotherapy. Patients may have received up to four lines of systemic therapy for metastatic disease and no more than two lines of combination treatment ( Phase  only)
Received prior treatment with at least , but no more than , prior lines of therapy for MM.
Three or more prior lines of systemic therapy for GBM.
There is no limitation in the number of prior lines of therapy
Had more than  prior lines of systemic therapy. Maintenance therapies and hormonal therapies are not considered additional lines of therapy
Must have undergone prior treatment with ? treatment lines of anti-myeloma therapy
Has histopathologically confirmed nonsquamous or squamous NSCLC with documented disease progression after - prior lines of systemic therapy
Has histologically confirmed biliary tract adenocarcinoma with documented progression after - prior lines of systemic therapy
Has received ? lines of prior systemic therapy for gastric or GEJ adenocarcinoma and BTC or ? lines for NSCLC or urothelial cancer.
Patient has had at least  or more prior lines of therapy including lenalidomide and bortezomib and has demonstrated disease progression on or within  days of completion of the last therapy
Participant must have received prior treatment with at least one, but no more than three, prior lines of therapy for multiple myeloma. A line of therapy consists of greater than or equal to  complete cycle of a single agent, a regimen consisting of combination of several drugs, or a planned sequential therapy of various regimens.
must have received at least  but no greater than  prior lines of therapy (note: induction and stem cell transplants with or without maintenance therapy is considered  line of therapy)
MEL subjects may be treatment nave or may have received prior lines of therapy for metastatic disease (Parts A and B)
The patient must have received no more than  prior lines of therapy for metastatic disease.
The patient must have received no more than  prior lines of therapy for metastatic disease.
At least three prior lines of therapy for advanced ovarian cancer as defined in the protocol
Treatment naive patients in first-line or pre-treated patients with no more than  lines of prior therapy
Patients in Phase  expansion cohort B will have experienced disease progression with  or  prior lines of therapy, including up to  prior line of liver-directed therapy
Received  or  prior lines of therapy.
More than three prior lines of cytotoxic therapy.
Has histopathologically confirmed nonsquamous or squamous NSCLC with documented disease progression after - prior lines of systemic therapy
No more than two prior lines of chemotherapy for metastatic sarcoma are allowed; neoadjuvant/adjuvant chemotherapy with definitive therapy (radiation, surgery or radiation and surgery) will not be counted as one of these prior lines of therapy; non-cytotoxic therapies will not be counted as one of these prior lines of therapy
Pancreatic neuroendocrine patients must have had progression after prior therapy; patients with other foregut neuroendocrine tumors must have had progressive disease over the last  months, irrespective of prior therapy; patients with both functional (who may continue somatostatin analogues as required for control of related symptoms) and non-functional tumors are eligible; in patients who have previously received therapy, the number of prior lines of therapy should not be more than  lines of systemic therapy not including somatostatin analogues
Subject that have received more than  prior lines of chemotherapy must not have liver metastases
Patients must have received two or more prior lines of treatment. A previous regimen is defined as one of the following: at least two months of single-agent therapy, at least two consecutive cycles of polychemotherapy, autologous transplant, radioimmunotherapy.
Patients must have previously treated relapsed and/or refractory MCL with at least  prior lines of therapy (prior carfilzomib, ibrutinib, bortezomib, anthracycline, rituximab or stem cell transplant are acceptable); there is no upper limit for prior lines of therapy
Patients must have received at least two prior lines of therapy and also must be refractory to lenalidomide (defined as progression while on active therapy or within  days of discontinuation); one prior line of therapy may consist of all predetermined components of induction followed by autologous stem cell transplantation and maintenance
Patients may have received unlimited lines of prior therapy
At least  and no more than  prior lines of therapy for incurable or metastatic NSCLC
Received more than  lines of prior conventional therapy for advanced disease
No more than  prior lines of systemic anti-cancer therapy.
Male and female, ages  and above, with relapsed or refractory FL lymphoma after > or = prior treatment lines; each of the  prior treatment lines must include at least CD antibody and/or an alkylating agent
Symptomatic myeloma that has progressed/relapsed after  to  prior lines of therapy
One or more prior lines of cytotoxic treatment for advanced disease (prior hormonal therapy is not considered to count as prior lines of therapy)
The patient has received =<  lines of prior therapy
PART B: Patients must have received prior platinum-based chemotherapy but may have received any number of other lines of prior therapy
More than  prior lines of chemotherapy for recurrent cancer.
Secretory MM for which the patient previously received - prior lines of therapy (Phase ).
- prior lines of therapy
May have received up to two prior lines of chemotherapy for advanced disease
More than  prior lines of CLL therapy.
All patients may have received up to two prior lines of chemotherapy for recurrent/advanced disease
Patients must have received at least one but no more than  prior lines of systemic therapy
For participation in the Phase I portion, patients must have completed either one or two lines of prior therapy
No more than  prior lines of systemic anti-cancer therapy.
Subjects who progressed after receiving at least , but no more than , prior SoC treatment lines
For Phase b of the study: Participants who have experienced failure of multiple lines of prior chemotherapy are eligible.
Eligible subjects are required to have > or = to  line of multi-agent chemotherapy either neoadjuvantly or adjuvantly. Subjects may have had - lines of therapy for metastatic disease.
Previously received at least , but no more than , lines of therapy including at least  course of platinum-based therapy
More than three prior lines of chemotherapy
Must have received  or  prior lines of conventional molecularly targeted therapy
Received at least  prior lines of therapy (induction therapy and stem cell transplant  maintenance are to be considered a single line of therapy).
No more than  prior lines of therapy
Patients must have received >=  previous lines of therapy that must have included bortezomib and Revlimid; patients must have received , but no more than  prior treatment regimens or lines of therapy for multiple myeloma; (induction therapy followed by stem cell transplant and consolidation/maintenance therapy will be considered as one line of therapy)
For Part , subject has received  or more prior lines of cytotoxic chemotherapy for systemic disease.
Received , but no more than  prior treatment regimens or lines of therapy for multiple myeloma. (Induction therapy followed by stem cell transplant and consolidation/maintenance therapy will be considered as one line of therapy).
Subjects must have undergone prior treatment with ?  treatment lines of anti-myeloma therapy