[c09aa8]: / clusters / 9knumclustersv2 / clust_383.txt

Download this file

77 lines (76 with data), 28.6 kB

 1
 2
 3
 4
 5
 6
 7
 8
 9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
46
47
48
49
50
51
52
53
54
55
56
57
58
59
60
61
62
63
64
65
66
67
68
69
70
71
72
73
74
75
76
Patients should be excluded if they have had prior treatment with an anti-programmed cell death protein (PD-), anti-programmed cell death ligand (PD-L), anti-PD-L, anti-cytotoxic T-lymphocyte-associated protein (CTLA-) antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways
Participants should be excluded if they have had prior treatment with an anti-PD-, anti-programmed cell death ligand (PD-L), anti-programmed cell death ligand (PD-L), anti-CTLA- antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways; prior immune modulating therapy including vaccines may be eligible; prior immune events must be evaluated and the risk for new events which may represent continued sub clinical disease or a new process at previously damaged site or immune potentiation (e.g. ipilimumab followed by IL causing bowel perforation, ipilimumab followed by indoleamine ,-dioxygenase [IDO] inhibitor resulting in clinical hypophysitis); please keep in mind that inflammatory events may occur weeks to months following the last dose of ipilimumab and possibly nivolumab; assessment of potential effects of prior therapy should include:\r\n* Immune status\r\n* Organ damage\r\n* Risk of autoimmunity\r\n* Immunopotentiation
Prior treatment with cluster of differentiation (CD) agonists, anti-cytotoxic T-lymphocyte-associated protein- (anti-CTLA-), anti-programmed death- (anti-PD?), or anti-programmed death-ligand (anti-PD-L) therapeutic antibody or pathway-targeting agents
No prior treatment with an immune checkpoint inhibitor (anti-programmed cell death [PD]-, anti-PD-L, anti-cytotoxic T-lymphocyte-associated protein [CTLA] monoclonal antibody)
No prior therapy with ipilimumab or nivolumab, or any agent targeting programmed cell death (PD-), PD-L or cytotoxic T-lymphocyte-associated protein (CTLA-)
Patients with prior treatment with anti-programmed cell death (PD)-, anti- programmed cell death ligand (PD-L) or anti-cytotoxic T-lymphocyte-associated protein (CTLA)- therapeutic antibody or other similar agents
No concurrent or prior systemic or local anti-cancer therapy for RCC is permitted; examples of these prohibited therapies include:\r\n* Radical or partial nephrectomy for prior RCC\r\n* Metastectomy for RCC\r\n* Radiation therapy to the renal bed or any distant metastatic sites\r\n* Antineoplastic systemic therapies for RCC: i.e., chemotherapy, hormonal therapy, immunotherapy, or standard or investigational agents for treatment of RCC\r\n* Prior treatment with an anti-programmed cell death (PD-), anti-programmed cell death-ligand (PD-L), anti-PD-L, anti-cluster of differentiation (CD), or anti-cytotoxic T-lymphocyte protein (CTLA-) antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
Has received prior therapy with an anti-programmed death (anti-PD-), anti-programmed death ligand (anti-PD-L), anti-programmed death ligand (anti-PD-L), anti-cluster of differentiation (anti-CD), or anti-cytotoxic T-lymphocyte-associated antigen- (CTLA-) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)
Have received any previous systemic therapy (including investigational agents) targeting PD-/programmed cell death ligand (PDL-) or PD-/PDL- signaling pathways (including previous participation in Merck MK- trials). Prior treatment with olaratumab is allowed. Prior therapy with other immune checkpoint inhibitors, including but not limited to, anti-CD antibody or anti-cytotoxic T-lymphocyte-associated antigen- (CTLA-) antibody, is not permitted.
SAFETY RUN-IN: Prior therapy with an anti-programmed cell death (PD-), anti-programmed cell death ligand (PDL-), anti-PD-L, anti-cluster of differentiation (CD) antibody, or anti-cytotoxic T-lymphocyte associated antigen- (CTLA-) antibody
RANDOMIZED PHASE II CLINICAL TRIAL: Prior therapy with an anti-programmed cell death (PD-), anti-programmed cell death ligand (PDL-), anti-PD-L, anti-CD antibody, or anti-cytotoxic T-lymphocyte associated antigen- (CTLA-) antibody
Has received previous treatment with an immunomodulatory therapy (e.g. anti-programmed cell death-/anti-programmed cell death-ligand [anti-PD-/anti-PD-L] or cytotoxic T-lymphocyte-associated protein [CTLA ] agent) and was discontinued from that therapy due to a Grade or higher irAE.
Prior treatment with a drug of the focal adhesion kinase (FAK) inhibitor class or with an anti-programmed cell death (PD), anti-programmed cell death ligand (PDL), anti- programmed cell death ligand (PDL), anti-cluster of differentiation (CD), or anti-cytotoxic T-lymphocyte associated antigen (CTLA-) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)
Prior VEGF targeted therapies for renal cell carcinoma (RCC) including adjuvant or neoadjuvant treatments; in phase only, one prior therapy with high dose IL- or anti-programmed cell death (PD)- compound alone or in combination with cytotoxic T-lymphocyte-associated protein (CTLA-) targeting drug is allowed on the trial
Prior exposure to immune-mediated therapy, including but not limited to, other anti-cytotoxic T-lymphocyte-associated protein (CTLA ), anti-PD, anti PD-L, or anti-programmed death ligand (PD-L) antibodies, including therapeutic anticancer vaccines is NOT permitted
Prior therapy with an anti-programmed cell death (PD-), anti-programmed cell death ligand (PDL-), anti-PD-L, anti-CD antibody, or anti-cytotoxic T-lymphocyte-associated antigen- (CTLA-) antibody
Has received prior therapy with an anti-programmed cell death protein (PD-), anti-PD-L, anti-programmed cell death ligand (PD-L), anti-cluster of differentiation (CD), or anti-cytotoxic t-lymphocyte-associated antigen- (CTLA-) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways); has participated in another MK- clinical trial
Patients must have no prior exposure to immune-mediated therapy, including anti- cytotoxic T-lymphocyte protein (CTLA-), anti-programmed cell death (PD-), antiprogrammed cell death ligand (PD-L), or antiprogrammed cell death ligand antibodies, excluding therapeutic anticancer vaccines
Received prior therapy with an anti-programmed cell death (PD-), anti-PD-L, anti-programmed cell death ligand (PD-L), anti-CD, or anti-cytotoxic T-lymphocyte-associated antigen- (CTLA-) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)
Has experienced grade - intracranial toxicity (hypophysitis or CNS toxicity) with either prior intracranial radiation, anti programmed cell death- (PD-), or cytotoxic t-lymphocyte-associated protein (CTLA-) inhibitor therapy
Patients with a history of prior treatment with immunotherapy agents (including, but not limited to: interleukin [IL]-, interferon, anti-PD-, anti-PD-L, anti-programmed cell death ligand [PD-L], anti-cluster of differentiation [CD], anti-tumor necrosis factor receptor superfamily member [OX-], anti-CD, or anti-cytotoxic t-lymphocyte-associated protein [CTLA-] antibodies)
Prior treatment with anti-cytotoxic T-lymphocyte antigen (CTLA), anti-programmed cell death protein (PD-), or anti-programmed death ligand (PD-L) (approved or investigational agent)
Patients should be excluded if they have had prior systemic treatment with an anti?programmed cell death protein (PD?), anti?PD?L, anti?programmed cell death ligand (PD?L), anti?cytotoxic T-lymphocyte-associated protein (CTLA?) antibody, or any other antibody or drug specifically targeting T?cell costimulation or immune checkpoint pathways
Patients who have had prior treatment with an anti-programmed cell death protein (PD-), anti-programmed death-ligand (PD-L), anti-programmed death-ligand (PD-L), anti-cytotoxic t-lymphocyte-associated protein (CTLA-) antibody, or any other antibody or drug specifically targeting T-cell costimulation or immune checkpoint pathways
Has received prior therapy with an anti-PD-, anti-programmed cell death ligand (PD-L), anti-programmed cell death ligand (PD-L), anti-tumor necrosis factor receptor superfamily, member (CD), or anti-cytotoxic T-lymphocyte-associated antigen- (CTLA-) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)
Has received prior therapy with an anti-programmed cell death (PD-), anti-programmed cell death ligand (PD-L), anti-programmed cell death ligand (PD-L), anti-cluster of differentiation (CD), or anti-cytotoxic T-lymphocyte-associated antigen- (CTLA-) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)
Prior immunotherapy with programmed cell death (PD) inhibitor (i), programmed cell death ligand (PDL)i, anti-cytotoxic T-lymphocyte-associated protein (CTLA) or vaccines is allowed
Has received prior therapy with an anti-PD-, anti-programmed cell death ligand (PD-L), anti- programmed cell death ligand (PD-L), anti-cluster of differentiation (CD), anti-tumor necrosis factor receptor superfamily member (OX-), anti-CD, or anti-cytotoxic T-lymphocyte-associated antigen- (CTLA-) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways); prior therapies with other immunomodulatory agents must be reviewed by the principal investigator (PI) and may be cause for ineligibility
Has received prior therapy with an anti-programmed cell death- (PD-), anti-programmed cell death ligand (PD-L) , anti-PD-L, anti-CD, or anti-cytotoxic T-lymphocyte-associated antigen- (CTLA-) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways) or chimeric antigen receptor (CAR)-T cell therapy or with an agent directed to another stimulatory or co-inhibitory T-cell receptor
No anti-cancer therapy (chemotherapy, biologic therapy, or immunotherapy) in the weeks prior to the T cell infusion (and all hematologic effects have resolved); no prior immunotherapy with checkpoint blockade (i.e. anti-programmed cell death [PD] inhibitor, programmed cell death ligand [PDL] inhibitor or cytotoxic T-lymphocyte-associated protein [CTL] -antagonist or similar agent) in the months prior to the T cell infusion (and all clinically significant related side-effects related must be resolved)
Prior immune checkpoint targeting drugs (e.g., anti-programmed cell death [PD], and programmed cell death ligand [PDL], anti-killer cell immunoglobulin-like receptors [kir], anti-cluster of differentiation [CD] ...etc)
Has received prior therapy with an anti-programmed cell death (PD-), anti-PD-L, anti-programmed cell death ligand (PD-L), anti-cluster of differentiation (CD), or anti-cytotoxic T-lymphocyte-associated antigen- (CTLA-) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)
Patients receiving anti programmed cell death protein (PD-) immunotherapy such as pembrolizumab or nivolumab, or human cytotoxic T-lymphocyte antigen blocking antibody such as ipilimumab should wait weeks before Melphalan/HDS treatment.
Has received prior therapy with an anti-programmed cell death protein (PD-), anti-programmed cell death ligand (PD-L), anti-programmed cell death ligand (PD-L), anti-cluster of differentiation (CD), or anti-cytotoxic T-lymphocyte-associated antigen- (CTLA-) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)
Has received prior therapy with an anti-programmed cell death- (PD-), anti-programmed death-ligand (PD-L), anti-programmed cell death ligand (PD-L), anti-cluster of differentiation (CD), ziv-aflibercept or anti-cytotoxic T-lymphocyte-associated protein (CTLA-) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)(prior treatment with bevacizumab is not an exclusion criteria)
Prior therapy with anti-cytotoxic T-lymphocyte-associated protein (CTLA-) antibody, anti programmed cell death (PD-), or an experimental immune system-targeted therapy
Subjects may have received any number of the following therapies: cytokine therapy (e.g. high dose interleukin-) or checkpoint inhibitor therapy (e.g. anti-programmed cell death [PD]/programmed cell death ligand [PDL], anti-cytotoxic T-lymphocyte-associated protein [CTLA]) or mechanistic target of rapamycin (mTOR) inhibitor therapy (e.g. everolimus, temsirolimus)
Prior therapy with an anti-programmed cell death (PD)-, anti-PD-ligand (L), anti-PDL-, or anti-cytotoxic T-lymphocyte-associated protein (CTLA)- antibody (or any other antibody targeting T-cell co-stimulation pathways)
Prior treatment with cluster of differentiation (CD) agonist, anti-programmed death (PD) , or anti-programmed death ligand (PD-L) therapeutic antibody or pathway-targeting agents
Has received prior therapy with an anti-programmed cell death receptor (anti-PD-), anti-programmed death-ligand (anti-PD-L), anti-PD-L, anti-CD, or anti-cytotoxic T-lymphocyte-associated antigen- (CTLA-) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).
Has received prior therapy with an anti-programmed cell death (anti-PD-), anti-programmed cell death ligand (anti-PD-L), anti-PD-L, anti-CD, or anti-cytotoxic T-lymphocyte-associated antigen- (CTLA-) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).
Has received prior therapy with an anti-programmed cell death receptor (anti-PD-), antiprogrammed death-ligand (anti-PD-L), anti-PD-L, anti-CD, or anti-cytotoxic T-lymphocyte-associated antigen- (CTLA-) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways).
Has received prior therapy with an anti-programmed cell death receptor (anti-PD-), antiprogrammed death-ligand (anti-PD-L), anti-PD-L, anti-CD, or anti-cytotoxic T-lymphocyte-associated antigen- (CTLA-) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways)
Has received prior therapy with an anti-programmed cell death (anti-PD-), anti-programmed cell death ligand (anti-PD-L), anti-PD-L, anti-CD, or anti-Cytotoxic T-lymphocyte-associated antigen- (CTLA-) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)
Has received prior therapy with an anti-programmed cell death receptor (anti-PD-), antiprogrammed death-ligand (anti-PD-L), antiprogrammed death-ligand (anti-PD-L), anti-CD, or anti-cytotoxic T-lymphocyte-associated antigen- (CTLA-) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways).
Inclusion Criteria:\n\n For inclusion in the study, patients should fulfill the following criteria:\n\n - Aged at least years\n\n - Documented evidence of Stage IV NSCLC\n\n - No sensitizing EGFR mutation or ALK rearrangement\n\n - No prior chemotherapy or any other systemic therapy for recurrent/metastatic NSCLC\n\n - World Health Organization (WHO) Performance Status of or \n\n Exclusion Criteria:\n\n Patients should not enter the study if any of the following exclusion criteria are\n fulfilled:\n\n . Mixed small-cell lung cancer and NSCLC histology, sarcomatoid variant\n\n . Brain metastases or spinal cord compression unless asymptomatic, treated and stable\n (not requiring steroids)\n\n . Prior exposure to Immunomodulatory therapy (IMT), including, but not limited to, other\n anti-cytotoxic T-lymphocyte-associated antigen (CTLA-), anti-programmed cell death\n (PD-), anti-programmed cell death ligand (PD-L), or anti PD-L antibodies,\n excluding therapeutic anticancer vaccines\n\n . Active or prior documented autoimmune or inflammatory disorders (including\n inflammatory bowel disease [eg, colitis or Crohn's disease]
have not received previous systemic therapy (including investigational agents) targeting programmed cell death protein (PD-)/ PD- ligand (PDL ) or PD-/PDL- signaling pathways. Prior therapy with other immune checkpoint inhibitors, including but not limited to, anti-CD antibody or anticytotoxic T-lymphocyte-associated antigen- antibody, is not permitted
Previous treatment with an anti-programmed cell death [PD] or programmed cell death ligand [PDL] inhibitor, including MEDI, or an anti-cytotoxic T-lymphocyte-associated protein (CTLA) inhibitory agent
Has received prior therapy with an anti-programmed cell death (PD-), PD-L, anti-programmed cell death ligand (PD-L), anti-cluster of differentiation (CD), or anti-cytotoxic T-lymphocyte-associated antigen- (CTLA-) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways); patients who have previously received MK- or participated in an MK- clinical trial will be ineligible
Has received prior therapy with an anti-programmed cell death (PD-), anti-programmed cell death-ligand (PD-L), anti-programmed cell death-ligand (PD-L), anti-cluster of differentiation (CD), or anti-cytotoxic T-lymphocyte-associated antigen- (CTLA-) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)
Has received prior therapy with an anti-programmed cell death (PD-), anti-programmed cell death ligand (PD-L), anti-programmed cell death ligand (PD-L), anti-cluster of differentiation (CD), or anti-cytotoxic T-lymphocyte-associated antigen- (CTLA-) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)
Received prior therapy with an anti-programmed cell death protein (anti-PD-), anti-PD-L, anti-programmed cell death-ligand (anti-PD-L), anti-CD (-BB ligand, a member of the Tumor Necrosis Factor Receptor [TNFR] family), or anti-Cytotoxic T-lymphocyte-associated antigen- (anti-CTLA-) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)
Patients must not have had any prior therapy with an anti-PD-, anti-programmed cell death ligand (PD-L), anti-programmed cell death ligand (PD-L), anti-cluster of differentiation (CD) or anti-cytotoxic t-lymphocyte-associated protein ligand (CTLA-) antibody (or any antibody or drug specifically targeting T-cell costimulation or checkpoint pathways; for questions or uncertainties, please contact the PI or quality assurance manager (QAM)
Prior anti-cancer therapy including: Fludarabine or alemtuzumab within months prior to DC; radioimmunoconjugate within weeks prior to DC; monoclonal antibody or antibody drug conjugate (ADC) within half-lives or weeks prior to DC ; radiotherapy, chemotherapy, hormonal therapy, or targeted small-molecule therapy within weeks prior to DC; anti-programmed death- (anti-PD-), anti-programmed death-ligand (anti-PD-L), anti-cytotoxic T-lymphocyte-associated protein (CTLA), anti-CD/-BB agonist, or anti-CD agonist antibodies
Prohibited prior treatments and/or therapies: a) prior therapy with an anti-killer cell immunoglobulin-like receptors (KIR), anti-programmed cell death (PD-), or anti-programmed cell death ligand (PD-L), antibody ; b) prior treatment regimens with any immune cell modulating antibody such as anti-cluster of differentiation (CD) and anti-OX; however, prior anti-cytotoxic T-lymphocyte-associated protein (CTLA) therapy is allowed if the last dose is days or more from the first dose of study drug; c) exposure to any other investigational drug within weeks prior to the first dose of study drug (within days for anti-CTLA therapy); d) any anti-cancer therapy (e.g., chemotherapy, biologics, vaccines, radiotherapy with curative intent, or hormonal treatment) within weeks prior to the first dose of study drug administration (within days for anti-CTLA therapy administration); e) use of non-oncology vaccines containing live virus for prevention of infectious diseases within weeks prior to study drug; the use of the inactivated seasonal influenza vaccine (Fluzone) is allowed; f) systemic corticosteroid at immunosuppressive doses (> mg/day of prednisone or equivalent), must be discontinued at least weeks prior to enrollment
Prior treatment with an anti-programmed cell death (PD)-, anti-PD-L or anti-cytotoxic T-lymphocyte-associated protein (CTLA-) antibody
Treatment with an EGFR-TKI within x half-life of study entry; any cytotoxic chemotherapy, investigational agents or other anticancer drugs within days of study entry; current treatment with potent inhibitors/inducers of cytochrome P A (CYPA); previous treatment with AZD (or other agents specifically targeted against EGFR TM mutation positive NSCLC); Prior neo-adjuvant or adjuvant chemotherapy treatment within months of starting st EGFR TKI treatment; prior exposure to immune-mediated therapy including, but not limited to, other anti cytotoxic T-lymphocyte-associated antigen (anti CTLA-), anti- programmed cell death (anti-PD-), anti- programmed cell death ligand (anti-PD-L), and anti-programmed cell death ligand (anti-PD-L) antibodies, excluding therapeutic anticancer vaccines; radiotherapy treatment to more than % of the bone marrow or with a wide field of radiation within weeks; major surgery within weeks;
Has received prior therapy with an anti-programmed cell death (PD-), anti-programmed cell death ligand (PD-L), anti-programmed cell death ligand (PD-L), anti- cluster of differentiation (CD), or anti-cytotoxic T-lymphocyte-associated antigen- (CTLA-) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways); Note: subjects that received prior therapy with pidilizumab are an exception to this criterion and may qualify for the study
Has received prior therapy with an anti- programmed cell death protein (PD-), anti- programmed cell death ligand (PD-L), anti-programmed cell death ligand (PD-L), anti-tumor necrosis factor receptor superfamily, member (CD), or anti-Cytotoxic T-lymphocyte-associated antigen- (CTLA-) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)
Has received prior therapy with an anti- programmed cell death (PD-), anti- programmed cell death ligand (PD-L), anti- programmed cell death ligand (PD-L), anti- cluster of differentiation (CD), or anti-cytotoxic T-lymphocyte-associated antigen- (CTLA-) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)
Prior therapy with anti-programmed cell death protein (PD-), anti-programmed cell death ligand (PD-L), anti-programmed cell death ligand (PD-L), anti-cluster of differentiation (CD), or anti-cytotoxic T-lymphocyte-associated protein (CTLA-) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)
Prior therapy with anti-programmed cell death protein (PD-), anti-PD-ligand (L), anti-PD-L, anti-cluster of differentiation (CD), anti-cytotoxic T-lymphocyte antigen (CTLA-) antibody therapies, any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways, deoxyribonucleic acid (DNA) methyltransferase therapy or histone deacetylase (HDAC) inhibitor therapy
Prior treatment with an anti-Programmed Death receptor- (PD-), anti-Programmed Death- ligand- (PD-L), anti-PD-L, or anti-cytotoxic T lymphocyte associated antigen- (anti-CTLA-) antibody
Prior therapy with anti-programmed death- (anti-PD-), anti-programmed cell death ligand (anti-PD-L), anti-programmed cell death ligand (anti-PD-L), anti-cluster of differentiation (anti-CD), or anti-Cytotoxic T lymphocyte-associated antigen (anti-CTLA-) antibody (including Ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)
Prior treatment with any therapy on the programmed cell death (PD-)/PD-L axis or anti-cytotoxic T-lymphocyte-associated protein (CTLA-) inhibitors unless enrolling the urothelial carcinoma with previous checkpoint inhibition therapy expansion cohort
Prior treatment with CD or OX agonists, anti?cytotoxic T-lymphocyte-associated protein (CTLA), anti?programmed death- (PD-), anti- programmed death-ligand (PD-L), anti-CD-, anti- glucocorticoid-induced tumor necrosis factor receptor (GITR) therapeutic antibody or pathway-targeting agents
Prior treatment with immune checkpoint blockade therapies, including anti-cytotoxic T-lymphocyte-associated protein (CTLA), anti-programmed cell death (PD-), and anti-programmed cell death ligand (PD-L) therapeutic antibodies
Prior immune checkpoint inhibition with anti-PD/programmed death-ligand (PD-L) or anti-cytotoxic T-lymphocyte-associated protein (CTLA) therapy or other specific T cell targeting agents
Prior therapy with any antibody/drug that targets the T cell coregulatory proteins, including but not limited to, anti-CD, Anti Cytotoxic T lymphocyte-associated antigen (anti-CTLA) or Anti-Glucocorticoid-induced tumor necrosis factor receptor (anti-GITR). However, Anti-Programmed Death- (anti-PD-), Anti-Programmed Death-Ligand (anti-PD-L) are permissible as prior therapy
Prior use of ipilimumab, other cytotoxic T-lymphocyte-associated protein (CTLA-) blocking therapies, anti-programmed cell death (PD ) antibody, cluster of differentiation (CD) agonist or other immune activating therapy such as anti-CD antibody within the last months of enrollment in the study; if any of these of these agents were used more than months earlier to enrollment in study, the patient should have recovered from all toxicity and at least months had passed since last use to allow for clearance and observation of any other side effects from the previous therapy
Subjects who received other anti Cytotoxic T-lymphocytic antigen (CTLA-) (non-ipilimumab) or other anti-Programmed death- (PD-) (non-nivolumab) treatment
Prior treatment with anti-cytotoxic T-lymphocyte-associated protein (anti-CTLA), anti-programmed death- (anti-PD-), or anti-programmed death ligand- (anti-PD-L) therapeutic antibody
Subjects who have received prior therapy with any T cell co-stimulation or checkpoint pathways such as anti-programmed cell death (PD-), anti-PD-L, anti-programmed cell death ligand (PD-L), anti-cytotoxic T-lymphocyte antigen (CTLA-), anti-cluster of differentiation (CD); or other medicines specifically targeting T cells are prohibited; prior therapy with Bacillus Calmette-Guerin (BCG) is permitted; prior interleukin (IL)- is permitted
Has received previous treatment with an immunomodulatory agent (e.g., anti-programmed cell death / anti-programmed cell death ligand or cytotoxic T-lymphocyte-associated protein ) and was discontinued from that treatment due to a Grade or higher immune-related adverse event
Prior therapy with experimental antitumor vaccines; any T-cell co-stimulation agents or inhibitors of checkpoint pathways, such as anti- programmed cell death protein (PD-), anti- programmed cell death ligand (PD-L), anti- programmed cell death ligand (PD-L), anti-CD, or anti-CTLA- antibody; or other agents specifically targeting T cells are prohibited. However, for dose escalation, prior treatment with the marketed inhibitors of the immune checkpoint pathway, such as nivolumab and pembrolizumab, is allowed. In addition, in each of the expansion cohorts, response-evaluable participants with prior exposure to anti-PD- or anti-PD-L agents will be allowed to enroll.
Have received prior treatment with an anti PD-, anti-programmed death ligand (PD-L), or anti cytotoxic T-lymphocyte-associated protein (CTLA-) agent.