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 2 or fewer prior lines, or recurrent advanced NSCLC having received 3 or fewer prior lines
Patients with gastric cancer must have received, or been intolerant to, a fluoropyrimidine-platinum combination as part of their prior therapy for advanced/metastatic disease; Subjects in Part B must not have had more than 3 prior lines of cytotoxic chemotherapy;
For Arm B: must have received at least 2 but not more than 4 prior lines of therapy.
Failure or intolerance to at least two prior lines of standard chemotherapies with each containing one or more of the following agents:
CRC - No more than four different prior lines of systemic therapy for advanced disease
Patients must have failed at least 2 lines of stand therapy as outlined for the specific diseases
Cohort 1: Are BRCA negative and have received 3 or more prior lines of therapy.
Cohort 2: Are BRCA negative and have received less than 3 prior lines of therapy.
Has previously received at least 3 lines of myeloma therapy.
Must have had at least two (2) prior lines of systemic therapy for liposarcoma (not to exceed 5 prior lines)
There is no limitation on the number of prior lines of systemic therapy
INCLUSION CRITERIA FOR REGISTRATION (HER2 MUTATION IDENTIFIED BY WASH U GPS LABORATORY): There is no limitation on the number of prior lines of systemic therapy
INCLUSION CRITERIA FOR REGISTRATION (HER2 MUTATION IDENTIFIED AT AN OUTSIDE CLIA CERTIFIED LOCATION): There is no limitation on the number of prior lines of systemic therapy
More than 5 lines of previous cytotoxic therapies. For patients of CTCL who failed romidepsin, more than 4 lines of previous therapies
No more than 3 prior lines of treatment for cGVHD.
The patient has received 1 to 3 prior lines of therapy; by definition, a single line of therapy may consist of 1 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 40 mg/day for 4 days) would not be considered prior lines of therapy
1 to 4 prior lines of therapy
Patients may have received any number of lines of prior systemic therapy for locally advanced/metastatic disease
PHASE IB: =< 2 lines of prior systemic therapy for patients with progressive locally-advanced disease
Patients may have had no more than 3 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 no more than 5 previous lines of chemotherapy and has received at least two lines of chemotherapy in the metastatic setting.
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
Have received any number lines of prior systemic therapy (including systemic therapy in the curative intent setting, and including a platinum containing regimen)
One to four prior lines of therapy
Greater than 2 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 4 prior lines of therapy
Subjects must have received at least one line of systemic therapy in the advanced/metastatic setting. Subjects with diseases without known effective options are also eligible. a) Subjects with relapsed and/or refractory lymphoma must have had at least 2 prior lines of systemic therapy and are not candidates for high dose therapy/autologous stem cell transplant.
Have received no prior lines of systemic therapy and are suitable to receive doxorubicin, ifosfamide and mesna. All previous anticancer treatments must have completed ?3 weeks (21 days) prior to the first dose of study treatment.
More than 2 lines of chemotherapy in the metastatic setting; no limit on endocrine therapy lines; prior exposure to CDK4/6 inhibitor acceptable
More than 5 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 2 lines of therapy (combination treatments are considered 1 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
Must be refractory or intolerant to standard lines of therapy
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 2 lines of therapy
Receipt of >/=1 but not more than 3 prior lines of therapy (Cohorts A, B, C, D1, E)
Receipt of >/=4 lines of prior therapy and are refractory to the last line of treatment (Cohort F)
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-2 use is excluded
Received less than 4 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
In the first 5 patients enrolled in treatment groups on part B of this study (receiving combination ipilimumab and nivolumab), patients may have had 1-0 prior lines of systemic therapy after being diagnosed with metastatic disease; this restriction will be lifted in all subsequent cohorts of patients treated on part B
Patients with solid tumors as described below:\r\n* Inoperable or metastatic (advanced) melanoma:\r\n** Has received, is intolerant, or refused a CTLA-4 inhibitor (ipilimumab) or a PD-1 inhibitor (nivolumab or pembrolizumab) as monotherapy and/or a combination of ipilimumab and nivolumab\r\n** Has received or is intolerant of a BRAF inhibitor or the combination of BRAF and MEK inhibitors for BRAFv600 mutant melanoma and a PD-1 inhibitor as monotherapy or in combination\r\n* Inoperable or metastatic (advanced) ovarian, primary peritoneal or fallopian tube carcinoma:\r\n** Has received platinum containing chemotherapy and has platinum refractory or resistant disease that has progressed on second line therapy\r\n** If platinum sensitive disease, should have received >= 2 lines of chemotherapy\r\n** May have received PARP inhibitors, bevacizumab or other targeted VEGF inhibitor therapy\r\n* Inoperable or metastatic (advanced) synovial sarcoma:\r\n** Should have received and progressed on >= two lines of systemic therapy\r\n* Subjects with other histologies:\r\n** Must have previously received two lines of systemic standard care (or effective salvage chemotherapy regimens) for metastatic disease, if known to be effective for that disease, and have been deemed either non-responders (progressive disease) or have recurred
Patients can have received up to 4 lines of systemic treatment; psoralen plus ultraviolet light therapy (PUVA) is not considered to be a systemic therapy
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
To be eligible for Cohorts 1-4, patients must have failed one or two prior lines of systemic therapy for advanced/metastatic disease
Must have undergone prior treatment with ?2 treatment lines of anti-myeloma therapy and failed last line of treatment (disease progression ?60 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 2 lines of therapy beyond corticosteroids with or without calcineurin inhibitors or sirolimus
Arms 2, 2E, 3, 3E: patients who previously received > 2 lines of systemic chemotherapy for advanced or metastatic disease
There will be no limits to prior lines of treatment
Prior systemic therapy: (a) Phase 1b: Any number of lines of prior therapy; (b) Phase 2: Progressed after 1 or 2 lines of prior chemotherapy
Received no more than 3 prior lines of systemic therapy for metastatic disease.
Patients must have received at least 3 prior lines of therapy (Note: Induction therapy and stem cell transplant ± maintenance will be considered as one line).
Criteria 4 Received at least 1 but not more than 3 prior lines of therapy for multiple myeloma (induction therapy followed by stem cell transplant and consolidation/maintenance therapy will be considered as 1 line of therapy, see Appendix E for guidance)
Refractory to and disease progression within 6 months from the last dose of at least 2 lines of prior therapy
Subjects who have received up to 3 lines of therapy for advanced disease, without prior exposure to taxane in the advanced stage setting
Has received at least 2 prior lines of therapy as described in the protocol.
For Part 1, prior treatment with less than 4 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
For the dose expansion cohort, participants must have histologically or cytologically confirmed diagnosis of either:\r\n* Ovarian, fallopian tube, or primary peritoneal cancer of high grade serous histology which has recurred despite standard therapy; up to 3 prior lines in the platinum resistant setting (i.e. up to 3 lines after patients have become platinum resistant); patients may have received unlimited lines while platinum sensitive\r\n* Triple-negative breast cancer (TNBC) which has recurred despite standard therapy; recurrent TNBC needs to have metastatic disease and patients with an in breast recurrence are not eligible; up to 4 prior lines in the recurrent setting for patients with triple-negative breast cancer are allowed
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 2 or more prior lines of systemic therapy for myeloma; patients must be off last treatment for at least 2 weeks (wks) by the beginning of treatment on this protocol
Subjects may have received no more than 2 lines of prior therapy for advanced disease.
Subjects may have received no more than 2 lines of prior therapy for advanced disease.
Subjects may have received no more than 2 lines of prior therapy for the advanced disease
previously received at least 1 but no more than 4 lines of therapy, one therapy must have included a VEGF TKI
previously received at least 1 but no more than 3 lines of therapy, one therapy must have included a fluoropyrimidine based regimen
Must have received at least two prior lines of systemic therapy, including at least one VEGFR-targeting TKI (e.g., sunitinib, sorafenib, pazopanib, cabozantinib)
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 2 only)
Received prior treatment with at least 1, but no more than 3, 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 2 prior lines of systemic therapy. Maintenance therapies and hormonal therapies are not considered additional lines of therapy
Must have undergone prior treatment with ?2 treatment lines of anti-myeloma therapy
Has histopathologically confirmed gastric or GEJ adenocarcinoma with documented disease progression after 0-2 prior lines of systemic therapy
Has histopathologically confirmed nonsquamous or squamous NSCLC with documented disease progression after 0-3 prior lines of systemic therapy
Has histologically confirmed biliary tract adenocarcinoma with documented progression after 1-2 prior lines of systemic therapy
Has received ?3 lines of prior systemic therapy for gastric or GEJ adenocarcinoma and BTC or ?4 lines for NSCLC or urothelial cancer.
Patient has had at least 2 or more prior lines of therapy including lenalidomide and bortezomib and has demonstrated disease progression on or within 60 days of completion of the last therapy
No more than 2 prior lines of anti-cancer therapy, one of which must have included pemetrexed and a platinum.
Have received any number lines of prior systemic therapy (including systemic therapy in the curative intent setting)
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
MEL subjects may be treatment naïve or may have received prior lines of therapy for metastatic disease (Parts 1A and 1B)
The patient must have received no more than 3 prior lines of therapy for metastatic disease.
The patient must have received no more than 2 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 2 lines of prior therapy
Patients in Phase 2 expansion cohort B will have experienced disease progression with 1 or 2 prior lines of therapy, including up to 1 prior line of liver-directed therapy
Received 1 or 2 prior lines of therapy.
More than three prior lines of cytotoxic therapy.
Has histopathologically confirmed gastric or GEJ adenocarcinoma with documented disease progression after 1-2 prior lines of systemic therapy
Has histopathologically confirmed nonsquamous or squamous NSCLC with documented disease progression after 1-3 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 12 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 2 lines of systemic therapy not including somatostatin analogues
No more than 2 prior lines of cytotoxic therapy, which should have included pemetrexed and a platinum
Subject that have received more than 2 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 2 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
No more than 2 prior lines of systemic chemotherapy for metastatic urothelial cancer
Patients may have received unlimited lines of prior therapy
At least 2 and no more than 3 prior lines of therapy for incurable or metastatic NSCLC
Received more than 3 lines of prior conventional therapy for advanced disease
Unlimited number of lines of endocrine therapy and up to two lines of cytotoxic chemotherapy in the metastatic setting (Phase Ib)
No more than 4 prior lines of systemic anti-cancer therapy.
Male and female, ages 18 and above, with relapsed or refractory FL lymphoma after > or =2 prior treatment lines; each of the 2 prior treatment lines must include at least CD20 antibody and/or an alkylating agent
Symptomatic myeloma that has progressed/relapsed after 1 to 3 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 =< 5 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 3 prior lines of chemotherapy for recurrent cancer.
Secretory MM for which the patient previously received 1-3 prior lines of therapy (Phase 2).
1-3 prior lines of therapy
May have received up to two prior lines of chemotherapy for advanced disease
Progression on or following, or intolerant of, at least two prior lines of standard systemic therapy for advanced or metastatic colorectal cancers.
More than 2 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 4 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 4 prior lines of systemic anti-cancer therapy.
Subjects who progressed after receiving at least 2, but no more than 3, prior SoC treatment lines
For Phase 1b of the study: Participants who have experienced failure of multiple lines of prior chemotherapy are eligible.
Must have received one or two prior lines of systemic chemotherapy for advanced or metastatic disease, one of which must be a platinum-doublet therapy.
Previously received at least 3, but no more than 6, lines of therapy including at least 1 course of platinum-based therapy
More than three prior lines of chemotherapy
Must have received 2 or 3 prior lines of conventional molecularly targeted therapy
Received at least 2 prior lines of therapy (induction therapy and stem cell transplant ± maintenance are to be considered a single line of therapy).
No more than 3 prior lines of therapy
Patients must have received >= 2 previous lines of therapy that must have included bortezomib and Revlimid; patients must have received 1, but no more than 4 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 3, subject has received 4 or more prior lines of cytotoxic chemotherapy for systemic disease.
Received 1, but no more than 3 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 ? 2 treatment lines of anti-myeloma therapy