[c09aa8]: / clusters / 9knumclustersv2 / clust_596.txt

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Prior exposure to immune-mediated therapy, including durvalumab and tremelimumab, except for anti-PD- or anti-PD-L therapy (including durvalumab) in NSCLC patients; this includes anti-CTLA- agents (prior treatment with these agents is NOT allowed in either cohort) and, excludes therapeutic anticancer vaccines, excluding therapeutic anticancer vaccines; exposure to other investigational agents may be permitted after discussion with the study principal investigator (PI)
Patients may have received prior anti-CTLA or other anti-PD-/anti-PD-L therapy, not both, provided that it is completed >= weeks prior to registration
Patients must not have achieved a confirmed partial or complete response to the anti-PD- or anti-PD-L agents prior to progression
Patients must not have had:\r\n* Prior treatment with ipilimumab or other CTLA- antagonists\r\n* Systemic therapy between progression on the anti-PD- or anti-PD-L agents and registration\r\n* Note: Systemic therapy (including BRAF-targeting agents) prior to anti-PD- or anti-PD-L therapy is allowed
Patients must not have had prior immunotherapy with anti-PD-L, anti-PD-, anti-CTLA or similar drugs; patients must not be planning to receive any of the prohibited therapies during the screening or treatment phases of the study
Prior treatment with any PARP inhibitor or any anti-PD-/anti-PD-L antibody
Prior IL- treatment or cytotoxic therapy, immunotherapy, radiotherapy, major surgery, antitumor vaccines or monoclonal antibodies in the weeks prior or for checkpoint inhibitors such as anti-CTLA- or anti PD/PD-L or nitrosoureas or mitomycin C for weeks prior to CD.
. Part A: Prior exposure to immunotherapy such as but not limited to other anti-CTLA-, anti-PD-, or anti-PD-L antibodies excluding vaccines. Part B: Exclusion of prior immunotherapy exposure will be limited to anti-PD-, anti-PD-L, or anti-PD-L;
Received any systemic therapy for cancer treatment including immunotherapeutic agents such as anti-PD or anti-PD-L antibody therapy.
Has received pembrolizumab, or prior therapy with an anti-PD-, anti-PD-L, anti-PD-L, or anti-Cytotoxic T-lymphocyte-associated antigen- (CTLA-) antibody as part of any previous therapy, including trials
Subjects previously treated with T cell immune-modulating antibodies, including anti-CTLA-, anti-PD- and/or anti-PD-L agents
Patient with melanoma, ovarian cancer, renal cell carcinoma, colorectal cancer, and other solid tumors who have received prior therapy with an anti-PD-, anti-PD-L, or anti-PDL antibody; melanoma patients who received anti-PD- antibodies in the adjuvant setting are allowed to participate as long as their last anti-PD- antibody was given at least months prior to their planned start of study therapy
Patients should be excluded if they have had prior systemic treatment with an anti-CTLA antibody and anti-PD/PDL antibody; prior treatment with single agent anti-CTLA, anti-PD or anti-PDL antibody is allowed
Prior treatment with an anti-PD-, anti-PD-L, anti-PD-L oranti-CTLA- antibody
Subject on prior chemotherapeutic, immunomodulator (such as anti-CTLA-, anti-PD- or anti-PD-L inhibitor), investigational, or other therapies for the treatment of cancer must wait at least days after the last dose of these therapies before administration of the first dose of the IMP.
Prior anti-PD- or anti-PD-L therapy may not be administered after ACT and before study atezolizumab (MPDLA) administration
Prior treatment with PV- or any anti-PD- antibody
Subjects previously treated with any anti-PD-L antibody are eligible for study participation).
Prior therapy with any anti-PD-, anti-PD-L, L, anti--BB (CD), or anti-CTLA therapy.
Subjects who have received prior anti-PD- or anti-PD-L antibody, or an IDO inhibitor; subjects who have received experimental vaccines or other immune therapies should be discussed with the principal investigator to confirm eligibility
Prior anti-cancer treatments such as chemotherapy, radiotherapy, hormonal, or immunotherapy (including anti-PD-/PD-L) are permitted
Received prior therapy with an anti-PD-, anti-PD-L, or anti-CTLA- antibody
For Cohort Expansion, patients who have previously received an immune checkpoint inhibitor (e.g., anti-PD-L, anti-PD-, anti-CTLA-) are not eligible for this study.
INCLUSION CRITERIA - For Parts -:\n\n - Willing and able to provide written informed consent\n\n - Histologically confirmed diagnosis of a locally advanced (not amenable to curative\n therapy such as surgical resection) or metastatic melanoma, RCC, NSCLC, urothelial\n carcinoma, or TNBC\n\n - Male or female patients, age years or older at the time of signing the informed\n consent form (ICF)\n\n - Life expectancy > weeks\n\n - Patients must not have received prior interleukin- (IL-) therapy\n\n - Eastern Cooperative Oncology Group (ECOG) performance status or \n\n - Measurable disease per RECIST .\n\n - Demonstrated adequate organ function within days of treatment initiation\n\n - Oxygen saturation ? % on room air.\n\n - Subjects must be recovered from the effects of any prior chemotherapy, immunotherapy,\n other prior system anticancer therapy, radiotherapy, or surgery. Clinically\n significant toxic effect(s) of the most recent prior chemotherapy must be resolved to\n Grade or less (except alopecia and sensory neuropathy).\n\n - Women of childbearing potential must agree to use highly effective methods of birth\n control. All participants must agree to use double barrier contraception during study\n participation for at least months after the last dose of study drugs.\n\n - Patients with stable brain metastases may be enrolled if certain criteria are met.\n\n - Fresh and archival tumor tissue available\n\n - Additional criteria may apply.\n\n INCLUSION CRITERIA - For Part :\n\n - MELANOMA:\n\n - Histologically confirmed stage III (unresectable) or stage IV melanoma, as per\n American Joint Committee on Cancer (AJCC) staging system\n\n - Ocular melanoma will be excluded\n\n - Melanoma Subpopulation A st-line (L):\n\n - Have not received prior anti-cancer therapy for advanced or metastatic melanoma\n\n - Known BRAF status, or consent to testing, as per regionally acceptable V\n mutational status testing\n\n - Melanoma Subpopulation B (nd- and rd-line (-L), anti-PD- or anti-PD-L therapy\n relapsed/refractory):\n\n - -L, patients must have confirmed radiographic disease progression no earlier\n than weeks after initial disease progression but within months from last dose\n of anti-PD- or anti PD-L containing regimen. Patients must consent to providing\n pre-study scans (if available) to confirm radiographic progression.\n\n - Patients may have received no more than prior anti-angiogenic therapy or\n cytotoxic chemotherapy regimen.\n\n - RENAL CELL CARCINOMA (RCC):\n\n - Advanced (not amenable to curative surgery or radiation therapy) or metastatic\n (AJCC stage IV) RCC\n\n - Histologically confirmed RCC with a clear-cell component.\n\n - RCC Subpopulation A (L):\n\n - L, patients may have not received prior anti-cancer therapy for advanced or\n metastatic RCC.\n\n - RCC Subpopulation B (-L, anti-PD- or anti-PD-L relapsed/refractory):\n\n - -L, patients must have confirmed radiographic disease progression no earlier\n than weeks after initial disease progression but within months from last dose\n of anti-PD- or anti-PD-L containing regimen. Patients must consent to providing\n pre-study scans (if available) to confirm radiographic.\n\n - Patients may have received no more than prior anti-angiogenic therapy or\n cytotoxic chemotherapy regimen.\n\n - NON-SMALL CELL LUNG CANCER (NSCLC):\n\n - Histologically confirmed or cytologically confirmed diagnosis of stage IV NSCLC\n\n - Patients with nonsquamous NSCLC must lack epidermal growth factor receptor\n (EGFR)-sensitizing mutation and/or anaplastic lymphoma kinase (ALK)\n translocation\n\n - NSCLC Subpopulation A (L):\n\n - L, patients must not have received prior anti-cancer therapy for advanced or\n metastatic NSCLC. Patients must have known PD-L status as per validated\n immunohistochemistry testing. Up to patients will be enrolled in each\n subgroup:\n\n - PD-L negative (PD-L < %),\n\n - PD-L positive (PD-L ? %),\n\n - PD-L low/intermediate (PD-L ? % - < %).\n\n - For patients who do not have known PD-L status, testing must be done using an\n FDA-approved PD-L test.\n\n - NSCLC Subpopulation B (L, I-O therapy nave):\n\n - L, patients must have experienced disease recurrence or progression during or\n after one prior platinum doublet-based chemotherapy regimen for advanced or\n metastatic disease. Patients who received platinum-containing adjuvant,\n neoadjuvant, or definitive chemoradiation therapy given for locally advanced\n disease and developed recurrent (local or metastatic) disease within months of\n completing therapy are eligible. Patients must not have received any prior\n immune-oncology regimens, including but not limited to checkpoint inhibitors such\n as anti-PD-, anti-PD-L, anti-PD-L, anti-CD, or anti-CTLA- antibody, or any\n other antibody or drug specifically targeting T cell co-stimulation or checkpoint\n pathways, indoleamine , dioxygenase pathway inhibitors, cancer vaccines,\n adoptive cell therapies, or other cytokine therapies.\n\n - NSCLC Subpopulation C (-L, anti-PD- or anti-PD-L relapsed/refactory):\n\n - -L, patients must have confirmed radiographic disease progression no earlier\n than weeks after initial disease progression but within months from last dose\n of anti-PD- or anti-PD-L containing regimen. Patients must consent to providing\n pre-study scans (if available) to confirm radiographic.\n\n - UROTHELIAL CARCINOMA (UC)\n\n - Histologically or cytologically documented locally advanced or transitional cell\n carcinoma of the urothelium including renal pelvis, ureters, urinary bladder, or\n urethra. Patients with mixed histologies are required to have a dominant\n transitional cell pattern.\n\n - For patients who received prior adjuvant/neoadjuvant chemotherapy or\n chemo-radiation for urothelial carcinoma, a treatment-free interval of more than\n months between the last treatment administration and the date of recurrence is\n required to be considered treatment naive in the metastatic setting.\n\n - UC Subpopulation A (L)\n\n - Enrollment of urothelial carcinoma L patients will target accrual of up to \n patients who are cis-ineligible and up to patients, who after consultation\n with the Investigator, choose to forego front-line chemotherapy\n\n - Treatment naive and cisplatin-eligible patients who refuse standard of care.\n\n - UC Subpopulation B (L) cisplatin-ineligible\n\n - Treatment naive and cisplatin-ineligible patients who meet at least one of the\n following criteria:\n\n - Creatinine clearance (calculated or measured) < mL/min\n\n - Common Terminology Criteria for Adverse Events (CTCAE) v. Grade ? \n audiometric hearing loss\n\n - CTCAE v. Grade ? peripheral neuropathy\n\n - New York Heart Association (NYHA) Class III heart failure\n\n - No prior chemotherapy for inoperable locally advanced or metastatic urothelial\n carcinoma. Prior local intravesical chemotherapy is allowed if completed at least\n weeks prior to the initiation of study treatment.\n\n - Patients must not have received any prior immune-oncology regimens, including but\n not limited to checkpoint inhibitors such as anti-PD-, anti-PD-L, anti-PD-L,\n anti-CD, or anti-CTLA- antibody, or any other antibody or drug specifically\n targeting T cell co-stimulation or checkpoint pathways, indoleamine\n ,-dioxygenase pathway inhibitors, cancer vaccines, adoptive cell therapies, or\n other cytokine therapies.\n\n - UC Subpopulation C (L, anti-PD- or anti-PD-L relapse/refractory)\n\n - Patients must have progressed on only one prior line of therapy that contains\n platinum-based chemotherapy in the metastatic setting or post platinum-based\n chemotherapy in an adjuvant setting with progression < months.\n\n - Patients must have received only one prior line of therapy with an anti-PD- or\n anti-PD-L containing regimen, which must be their most recent anti-cancer\n treatment.\n\n - Patients must have confirmed radiographic disease progression no earlier than \n weeks after initial disease progression but within months from last dose of\n anti-PD- or anti-PD-L containing regimen. Patients must consent to providing\n pre-study scans (if available) to confirm radiographic.\n\n - TRIPLE-NEGATIVE BREAST CANCER (-L, I-O therapy nave)\n\n - Less than % of tumor cell nuclei test positive for estrogen and progesterone\n receptors determined by using standard immunohistochemistry (IHC)\n\n - Human epidermal growth factor (HER) negative as determined by local\n pathologist, using IHC or in situ hybridization\n\n - Patients may have received only prior line of therapy with chemotherapy,\n adjuvant setting excluded, or patient refuses standard of care.\n\n - Must not have received any prior immune-oncology regimens, including but not\n limited to checkpoint inhibitors such as anti-PD-, anti-PD-L, anti-PD-L,\n anti-CD, or anti-CTLA- antibody, or any other antibody or drug specifically\n targeting T cell co-stimulation or checkpoint pathways, indoleamine ,\n -dioxygenase pathway inhibitors, cancer vaccines, adoptive cell therapies, or\n other cytokine therapies.\n\n INCLUSION CRITERIA - For Parts and :\n\n - RENAL CELL CARCINOMA (L):\n\n - Advanced (not amenable to curative surgery or radiation therapy) or metastatic\n (AJCC stage IV) RCC.\n\n - Histologically confirmed RCC with a clear-cell component.\n\n - Patients must not have received prior anti-cancer therapy for advanced or\n metastatic RCC\n\n - NON-SMALL CELL LUNG CANCER (L):\n\n - Histologically confirmed or cytologically confirmed diagnosis of stage IV NSCLC\n\n - Patients with nonsquamous NSCLC must lack epidermal growth factor receptor\n (EGFR)-sensitizing mutation and/or anaplastic lymphoma kinase (ALK)\n translocation.\n\n - Patients must not have received prior anti-cancer therapy for advanced or\n metastatic NSCLC.\n\n EXCLUSION CRITERIA - For Parts -:\n\n - Use of an investigational agent or an investigational device within days before\n administration of first dose of NKTR--\n\n - Females who are pregnant or breastfeeding\n\n - Participants who have an active autoimmune disease requiring systemic treatment within\n the past months or have a documented history of clinically severe autoimmune disease\n that requires systemic steroids or immunosuppressive agents\n\n - History of organ transplant that requires use of immune suppressive agents\n\n - History of allergy or hypersensitivity to study drug components\n\n - Active malignancy not related to the current diagnosed malignancy\n\n - Evidence of clinically significant interstitial lung disease or active, noninfectious\n pneumonitis\n\n - Prior surgery or radiotherapy within days of therapy\n\n - Participants who have had < days since the last chemotherapy, biological therapy,\n or < days from approved tyrosine kinase inhibitor (TKI) therapy (sunitinib,\n sorafenib, vemurafenib, dabrafenib, cobimetinib, erlotinib, gefitinib, afatinib,\n osimertinib), or systemic or inhaled steroid therapy at doses greater than mg of\n prednisone or equivalent before administration of the first dose of study medication\n\n - Participant's inability to adhere to or tolerate protocol or study procedures\n\n - Additional criteria may apply.
Prior treatment with anti?PD-, or anti?PD-L therapeutic antibody or pathway-targeting agents
Previous therapy with histone deacetylase (HDAC) inhibitor and/or anti PD , anti PD L, or anti CTLA immunotherapy.
Last dose of prior immunotherapies including but not limited to: interferon alpha, interferon-beta, interleukin (IL)-, conjugated IL-, cergutuzumab amunaleukin (CEA-ILv) , cytokines, anti-cytotoxic T lymphocyte antigen-, anti-PD-L, or anti-PD- < days prior to first cergutuzumab amunaleukin infusion
Prior therapy with anti-PD-L and anti-PD antibodies, MEK inhibitors or MDM antagonists.
Patients must not have had prior immunotherapy with anti-PD-L, anti-PD-, anti-CTLA or similar drugs.
Prior immunotherapy including but not limited to anti-CTLA, including tremelimumab anti-PD-, and anti-PD-L, including durvalumab.
Previous systemic exposure to anti-CTLA- antibody or anti-PD antibody
Prior therapy with any antibody / drug targeting T cell coregulatory proteins (immune checkpoints) such as anti-PD-, anti-PD-L, or anti-CTLA- antibody
Participants may have had prior immuno-oncology (IO) therapy (including but not limited to anti-CTLA and anti-PD/L) excluding prior CSFR directed agents for the study arm containing cabiralizumab
Has received prior therapy with an anti-CTLA-, anti-PD-, anti-PD-L, or anti-PDL agent
Immune-checkpoint inhibitors (e.g., anti-PD-, anti-PD-L, or anti-CTLA-), monoclonal antibodies, antibody-drug conjugates, radioimmunoconjugates, or T-cell or other cell-based therapies: weeks ( weeks with documented disease progression).
ARM I INCLUSION CRITERIA: Subjects are currently on checkpoint inhibitor (anti-PD-, anti-PD-L, anti-PD-L, anti-CD, or anti-cytotoxic T-lymphocyte-associated antigen- (CTLA-) antibody, or antibodies to tumor necrosis factor family including OX) or tumor vaccine for systemic disease who develop new brain metastases, must have documented stable systemic disease within days of signing consent
ARM I INCLUSION CRITERIA: Subjects who have completed prior checkpoint inhibitor (anti-PD-, anti-PD-L, anti-PD-L, anti-CD, or anti-cytotoxic T-lymphocyte-associated antigen- (CTLA-) antibody, or antibodies to tumor necrosis factor family including OX) or tumor vaccine for systemic disease but are now off therapy with documented stable systemic disease within days of signing consent may be enrolled after discussion with the Merck & Co clinical team
Prior therapy with an anti-PD-, anti PD-L, anti-PD-L, anti-CD antibody, or anti-cytotoxic T-lymphocyte-associated antigen- (CTLA-) agents
Prior or concurrent immunotherapy, including treatment with an anti-PD-, anti-PD-L, anti-PD-L, or anti-CTLA- antibody; tumor vaccines; interferon, or interleukins.
Prior treatment with anti-PD-, CTLA-, or anti-PD-L therapeutic antibody or pathway-targeting agents
No prior treatment with cancer immunotherapy including, but not limited to, other anti-CTLA-, anti-PD-, anti-PD-L, and anti-programmed cell death ligand anti- (PD-L) antibodies, excluding therapeutic anticancer vaccines
Patients can be either naive for any previous systemic treatment or have had any number of prior systemic therapies. However, patients must not have received prior anticancer therapy with anti-PD, anti-PD-L, or anti-CTLA- immune checkpoint inhibitors.
Patients must not have received prior anticancer therapy with anti-PD, anti-PD-L, or anti- CTLA- immune checkpoint inhibitors.
Prior therapy with an anti-PD-, anti-PD-L, anti-PD-L, anti-CD or anti CTLA- antibody
Current or prior anti-cancer treatment prior to the first dose of pembrolizumab as defined below:\r\n* Chemotherapy, targeted small molecule therapy, or other anti-cancer treatment not otherwise specified below within weeks\r\n* Radiation therapy within weeks\r\n* Anti-cancer monoclonal antibody (mAb) treatment within weeks\r\n* Use of an investigational agent (e.g., biologic, drug, or other) within weeks\r\n* Allogeneic stem cell transplant within days\r\n* Prior therapy with an anti-PD-, anti-PD-L, or anti-PD-L agent at any time
Has prior exposure to anti-PD/PD-L or anti-CTLA therapy
Prior treatment with anti-PD-/PD-L, and anti-CTLA- is NOT allowed; prior intravesical Bacillus CalmetteGurin (BCG) therapy is allowed
No prior exposure to immune-mediated therapy including, but not limited to, other anti CTLA-, anti-PD-, anti-PD-L, and anti-programmed cell death ligand (anti-PD-L) antibodies, including therapeutic anticancer vaccines; the exception to this is those whose tumors are microsatellite instable-high (MSI-hi) and are refractory to anti-PD monotherapy
Prior checkpoint inhibitor therapy including anti-PD, anti-PD-L, anti-CTLA, anti- CD, or anti-PD-L therapy
Prior treatment with an anti-PD-, anti-PD-L or anti-CTLA- antibody
Patients with prior therapy with antibodies that modulate T-cell function (e.g., anti-PD-, anti-PD-L)
Any previous treatment with an anti-PD-, anti-PD-L or anti-CTLA- therapy, including durvalumab and tremelimumab
Exclusion criteria related to study medication (any cancer immunotherapy including CD agonists, anti-PD-, anti-PD-L, or anti-CTLA or any MEK or ERK inhibitor)
Patients may not have had prior therapy with a checkpoint inhibitor (e.g. anti-CTLA-, anti-PD- or anti-PD-L therapy)
Patients should be excluded if they have had prior treatment with anti-CTLA- antibody or any other antibody or drug specifically targeting T-cell co-stimulation; previous treatment with anti-PD-, anti-PD-L or anti-PD-L is allowed and patients will be enrolled in the exploratory cohort (arm C) at the time of progression from last line of treatment (treatment with immune check point inhibitor does not have to necessary be the last line of treatment)
Prior history of receiving immune modulators including, but not limited to, anti-CTLA, anti-PD, anti-PD-L
Patients must not have received prior anticancer therapy with any immune checkpoint inhibitors such as anti-CLTA-, anti-PD, or anti-PD-L
Prior therapy with an anti-PD-, anti-PD-L, or anti-PDL- antibody
Prior therapy with an anti-PD-/PD-L antibody or a TRAIL-DR antibody
patients who have received all therapy known to confer clinical benefit (including anti-PD- or anti-PDL therapies, if relevant), or for whom no therapy of proven efficacy exists, or who are not amenable to standard therapies. Patients with anti- PD- or anti-PDL experience must have a minimum of days between the last dose of the previous anti PD-/PD-L and Cycle Day of BI treatment.
patients who are anti-PD- and anti-PDL-nave but have failed conventional treatment (excluding anti-PD- treatment), or for whom no therapy of proven efficacy exists, or who are not amenable to standard therapies.
No prior immune checkpoint inhibitors (e.g., anti-CTLA, anti-PD- or anti-PDL are allowed
Patients with ongoing toxicities related to prior therapies targeting T cell coregulatory proteins (immune checkpoints) such as anti-PD-, anti-PD-L, or anti-CTLA- antibody are excluded
Patients must have no more than one prior systemic therapeutic regimen. This includes chemotherapy, biologic therapy, biochemotherapy, or investigational treatment. This does not include any therapies given in the adjuvant setting. No prior anti-CTLA therapy. Prior anti PD- or anti-PDL- antibody therapy is acceptable.
Prior exposure to any anti-PD- or anti-PD-L antibody, or any anti-cytotoxic T-lymphocyte-associated protein (CTLA) antibodies
Patients who have received prior therapy with immune checkpoint inhibitors (e.g. anti-PD-, anti-PD-L, anti-LAG, anti-CTLA-) or immune costimulatory molecules (e.g. anti-CD, anti-OX, anti-GITR) directed agents
Prior therapy with anti-PD, anti-PD-L or anti-cytotoxic T-lymphocyte protein (CTLA)- antibody
Subjects must have no prior exposure to immunotherapy, such as, but not limited to other anti-CTLA-, anti-PD-, or anti-PD-L antibodies excluding vaccines
Prior therapy with anti-PD antibody
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-PD-L antibodies, including therapeutic anticancer vaccines. Prior local intervesical chemotherapy or immunotherapy is allowed if completed at least days prior to the initiation of study treatment.
For Dose escalation: subjects with cervical, ovarian, bladder and colorectal cancer (CRC), head and neck, gastric and hepatocellular cancer naive to immuno-oncology agents; st line melanoma and st line/nd line NSCLC; Renal Cell Carcinoma naive to IO; NSCLC progressing while on or after therapy with anti-PD/anti-PDL- and melanoma subjects progressed while-on or after treatment with anti-PD or anti-PDL with or without anti-CTLA-.
Patients who have had prior therapy (BRAF inhibitors, ipilimumab, anti PD- antibody or anti PD-L antibody) or treatment naive patients are eligible as long as toxicity from therapy is grade =< or at baseline
Prior immunotherapy is allowed (previous immune checkpoint inhibitors; anti-CTLA-, anti-PD-, anti-PD-L and/or combinations), except for the patients enrolled to the immunotherapy nave group of the phase IB dose expansion.
Patients with a history of prior treatment with anti-CTLA-, anti-PD antibody, or anti-PDL antibody
Prior exposure to immune-mediated therapy, including anti-PD-, anti-PD-L (including durvalumab) or anti-CTLA- directed therapy (including tremelimumab); therapeutic anticancer vaccines are not included in this category; exposure to other investigational agents may be permitted after discussion with the study principal investigator (PI)
Prior exposure to anti-PD-, anti-PD-L, CCR/, or anti-CTLA antibodies
Patients who have had prior exposure to immune-mediated therapy defined as prior exposure to T-cell and natural killer cell directed therapy (e.g. anti-PD-, anti-PD-L, anti-CD, and anti-CTLA, etc).
Have experienced disease progression during treatment with an anti-PD/L antibody as the treatment regimen immediately prior to accrual to this study or disease progression within months of adjuvant anti-PD antibody
Prior treatment with an investigational compound being tested in this study (e.g., poly ADP ribose polymerase [PARP] inhibitor, anti-PD-, anti-PD-L, or anti-PD-L)
Patients who have had prior treatment with anti-PD or anti-CTLA therapy
Prior treatment with anti?PD-, or anti?PD-L therapeutic antibody or pathway targeting agents
Patients who have had a grade one or grade two gastrointestinal adverse event during or after receiving anti-CTLA-, anti-PD or anti-PD, without a colonoscopy verifying complete resolution of the adverse event
Immune-checkpoint inhibitors (i.e., anti-PD-, anti-PD-L, or anti-CTLA-): weeks
Melanoma immune checkpoint-nave: Subjects must not have received immunotherapy with anti-PD-, anti-PD-L, or anti-CTLA- therapy. Exception: Prior anti?CTLA- in the adjuvant setting would be permitted.
Primary refractory melanoma: Subjects must have received prior treatment with anti-PD- or anti-PD-L therapy (alone or as part of a combination) in the advanced or metastatic setting and have progressive disease as their best response to treatment that is confirmed weeks later.
Subjects must not have received prior immunotherapy with anti-PD-, anti-PD-L, or anti-CTLA- therapy.
Subject has had prior therapy with T-cell immune modulating antibodies, including anti-CTLA-, anti-PD- or anti-PD-L.
Patients must not have any prior exposure to immunotherapy such as, but not limited to anti-programmed death (PD-) or anti-PD-L antibodies; prior exposure to the following is allowed: anti-cytotoxic T lymphocyte antigen (CTLA-) antibodies, live attenuated vaccines, anti-EGFR agents and sargramostim (GM-GSF)
Subject had prior exposure to immunotherapy, including, but not limited to, other anti- CTLA-,anti-PD-, anti-PD-L monoclonal antibody or inhibitor, cell-based therapies, or cancer vaccines
Prior therapy with an anti-PD-, anti-PD-L, anti-PD-L agent, or agents targeting other checkpoint pathways (e.g. CTLA-)
Prior exposure to tremelimumab or durvalumab or other anti-CTLA-, anti-PD-, anti-PD-L antibodies
No prior therapy with an anti-PD-, anti-PD-L, anti-PD-L, anti-CD, or anti-CTLA- antibody.
Prior treatment with anti-PD-, or anti-PD-L therapeutic antibody or pathway targeting agents
Prior treatment with anti-PD-, and CTLA-, or anti-PD-L therapeutic antibody or pathway-targeting agents
Received therapy with any immunotherapeutic agents including, but not limited to, any anti-PD or anti-PDL antibody therapy, with these exceptions: Melanoma patients having received and progressed on anti-CTLA (cyctotoxic T lymphocyte-associated antigen ) may participate in the trial; Bladder cancer patients having received intra-vesical BCG may participate in the trial.
Prior treatment with an anti PD-, anti PD-L, or anti CTLA- agent; participants who entered clinical remission with one of those agents and proceeded to ASCT without intervening relapse may be eligible after discussion with the study chair; note that for patients who enter remission with checkpoint blockade therapy, this will not count towards the lines of prior therapy
Prior immunotherapies including but not limited to CD, anti-PD-, anti-PD-L, and CTLA.
Prior treatment with anti-PD-, or anti-PD-L therapeutic antibody or pathway-targeting agents
Prior treatment with anti-PD-, PD-L, or CTLA, or ensartinib (X-).
Patients who have had prior exposure to checkpoint blockade therapy, such as anti-PD-/PD-L, anti-cytotoxic T-lymphocyte associated protein (CTLA), anti-CD, and anti-OX antibody therapy, are not eligible
Prior therapy with anti-PD-, anti-PDL, anti-PD-L, anti-CD, or anti-CTLA- antibody
Prior exposure to doxorubicin, PLD or any other anthracycline, motolimod and other TLR agonists, MEDI or checkpoint inhibitors, such as anti-CTLA and anti-PD/anti-PD-L antibodies.
For patients in the pazopanib hydrochloride (pazopanib) cohort, no prior systemic therapy for mRCC is allowed, with the exception of prior cytokine therapy (such as interleukin-, IFN-a), immunotherapy (such as anti-PD- or anti-PD-L), or supportive therapies (such as zoledronic acid, denosumab)
Received prior therapies: ibrutinib, or other BTK inhibitor and/or anti-PD, anti-PD-L, anti-PD-L, anti-CD, or CTLA- antibody
Has received prior therapy with an anti-PD-, anti-PD-L, anti-PD-L, or anti-cluster of differentiation (CD); patients who received anti-cytotoxic T-lymphocyte antigen (CTLA) (ipilimumab, tremelimumab) will NOT be excluded and are eligible for inclusion
Prior exposure to any anti-PD- or anti-PD-L antibody or anti CTLA
Prior BTK inhibitor or anti PD, anti PDL, anti PD-L and anti-CD, anti-cytotoxic T-lymphocyte associated antigen (CTLA-) antibody
Patients with a history of prior treatment with anti-PD-, anti-PD-ligand (L), anti-PD-L, anti-cytotoxic T-lymphocyte-associated protein (CTLA) antibodies, or who have received both GVAX or CRS- will be excluded
Prior exposure to any anti-PD- or anti-PD-L antibody.
Prior exposure to any anti-PD- or anti-PD-L antibody
Prior exposure to tremelimumab or MEDI or other anti-CTLA-, anti-PD-, anti-PDL antibodies
Ocular melanoma; and have received no more than one line of systemic therapy for metastatic disease. Patients must not have received immune modifying agents (eg. anti PD-L, anti PD-, anti CTLA, TNF agonist, etc.) for metastatic disease, or
Cutaneous/acral melanoma; and have ) only previously received systemic therapy for advanced/metastatic disease with the following therapies: BRAF and MEK inhibitors, anti PD-L, anti PD-, or anti-CTLA and ) have received checkpoint inhibitor (anti PD-L, anti PD-, or anti-CTLA) based treatment as most recent line of therapy on which disease progressed, as long as progression did not occur in the first months of receiving checkpoint inhibitor treatment. Arm only:
Prior exposure to any anti-PD- or anti-PD-L antibody
Prior histone deacetylase (HDAC) inhibitor and/or anti-PD, anti-PDL, anti-PD-L, anti-CD or anti-cytotoxic T- lymphocyte associated antigen (CTLA-) antibody allowed as long patient received clinical benefit from it, best response was not progressive disease and it was not the most recent treatment
Expansion Cohort : Subjects with Stage IV non-squamous NSCLC who have radiographically progressed on or after treatment with one prior immune checkpoint inhibitor (anti-PD- or anti-PD-L) as the most recent therapy for metastatic disease.
Expansion Cohort : Subjects with Stage IV non-squamous NSCLC who have not received prior immune checkpoint inhibitor therapy (anti-PD- or anti-PD-L).
Prior treatment with cabozantinib or immune checkpoint inhibitors including anti-CTLA-, anti-PD-, anti-PD-L, or anti-PD-L therapy except in Expansion Cohorts and in which prior anti-PD- or anti-PD-L therapy is required for eligibility. Other restrictions regarding prior therapy may apply.
Prior therapy with any antibody/drug targeting T-cell co-regulatory proteins (immune checkpoints) such as anti-PD-, anti-PD-L, or anti-cytotoxic T-lymphocyte antigen (CTLA-) antibodies. For subjects with metastatic melanoma, prior treatment with CTLA--blocking antibody is permissible.
Tumor for which standard therapy, including approved anti-PD- or anti-PD-L therapy, when applicable, does not exist or is no longer effective.
Participants in the Monotherapy Expansion Cohort must have one of the following advanced or recurrent malignancies: cutaneous melanoma showing primary progression following treatment with an anti-programmed cell death (PD) or anti-PDL regimen; or anti-PD or anti-PD-L treatment-nave colorectal or gastric cancer, including gastroesophageal junction cancer of Siewert Type II and Type III.
Participants in the Combination Expansion Cohorts must have one of the following advanced or recurrent malignancies: non-small cell lung adenocarcinoma or cutaneous melanoma showing primary progression following treatment with an anti-PD or anti-PD-L regimen; or anti-PD or anti-PD-L treatment-nave colorectal or gastric cancer, including gastroesophageal junction cancer of Siewert Type II and Type III.
Must have received either nivolumab or pembrolizumab or a different IND-approved anti-PD or anti-PD-L therapy, unless medically contraindicated
Previous treatment with anti-CD antibody, ipilimumab or other anti-CTLA- targeted therapies. Previous therapy with other checkpoint blockers such as anti-PD- or anti-PD-L is acceptable, unless treatment was discontinued for intolerance.
Prior exposure to immunotherapy (either as a single agent or in combination) including but not limited to CD or OX agonists, anti-CTLA-, anti-PD-, or anti-PD-L, anti-PD-L antibody or pathway-targeting agents
Prior treatment with anti-PD-, anti-cytotoxic T-lymphocyte-associated protein (CTLA-), or anti-PD-L therapeutic antibody or pathway-targeting agents
Prior treatment with an anti-PD-, anti-PD-L, or anti-PD-L antibody; neuroblastoma (NB)-patients who have received prior anti-cytotoxic T-lymphocyte antigen (CTLA)- antibody therapy are eligible assuming such therapy was discontinued within days of enrollment
Has received prior therapy with an anti-PD-, anti-PD-L, anti-PD-L, anti-CD, or CTLA- antibody.
Subjects who are treatment-naive or pretreated (prior anti-PD- or anti-PD-L required) in the recurrent/metastatic setting.
Recipient of any blood product and immunotherapy (such as anti-PD, anti-PDL- and anti-CTLA) within months of enrollment;
Prior treatment with ibrutinib or other BTK inhibitor anti-CD or CTLA- antibody. The following are exceptions to this criterion: Subjects previously treated with an anti-PD, anti-PD-L, or anti-PD-L antibody.
Prior exposure to immunotherapy, such as, but not limited to, other anti-CTLA-, anti-PD-, or anti-PD-L antibodies, excluding therapeutic cancer vaccines
Patients who have received prior anti-CTLA or anti-PD therapy less than weeks prior to enrollment
NSCLC Cohorts (CIT-Nave): Participants with histologically confirmed incurable, advanced NSCLC not previously treated with anti-PD?L/PD- and/or with anti-CTLA? (investigational or approved), for whom a clinical trial of an investigational agent in combination with an anti-PD?L/PD- antibody is considered an acceptable treatment option (if CIT [including anti-PD?L/PD- agents] is approved as treatment for NSCLC by local regulatory authorities).
NSCLC Cohort (CIT-Treated): Participants with histologically confirmed incurable, advanced NSCLC previously treated with anti-PD-L/PD- with or without anti-CTLA- (investigational or approved)
Colorectal cancer (CRC) Cohort: Participants with histologically confirmed incurable, advanced adenocarcinoma of the colon or rectum not previously treated with anti-PD-L/PD- and/or anti-CTLA- (investigational or approved)
Urothelial carcinoma (UC) Cohort (CIT-Nave): Participants with histologically confirmed incurable, advanced transitional cell carcinoma of the urothelium including renal pelvis, ureters, urinary bladder, and urethra, not previously treated with anti-PD-L/PD- with or without anti-CTLA- (investigational or approved), for whom a clinical trial of an investigational agent in combination with an anti-PD?L antibody is considered an acceptable treatment option, if CIT (including anti-PD?L/PD- agents) is approved as treatment for UC by local regulatory authorities
Melanoma Cohort: Participants with histologically confirmed incurable, advanced melanoma not previously treated with anti-PD-L/PD- and/or anti-CTLA- (investigational or approved) in the metastatic setting Additional Inclusion Criteria for Participants in the Serial-Biopsy Expansion Cohort of Phase b:
In the NSCLC CIT-Treated exploration cohort in Phase b, the most recent systemic treatment should have been anti-PD?L/PD- and/or anti-CTLA- as monotherapy or in combination
In the NSCLC CIT-Nave expansion cohort in Phase b, prior treatment with anti-PD?L/PD- and/or anti-CTLA- (investigational or approved) is not allowed
No prior exposure to immune-mediated therapy defined as prior exposure to T-cell and natural killer cell directed therapy (e.g., anti-PD-, anti-PD-L, anti-CD, and anti-CTLA, etc).
Participants with a history of treatment with an anti-PD-, anti-PD-L, anti-CTLA- or other investigational agents that target immune checkpoint inhibitors
Chemotherapy, or immunotherapy or any other systemic anticancer therapy =< weeks prior to study drug administration date; patients receiving anti-PD- treatment, and continue to receiving this treatment in combination with selinexor (Arms L and M), can start receiving the selinexor and anti-PD- combination without washout of the prior anti-PD- antibody
Prior treatment with checkpoint inhibitors and other immunotherapy treatments, including anti-LAG-, anti-PD-, anti-PD-L or anti-CTLA- antibodies, if less than half lives before study drug administration
Prior therapy with anti-PD-, anti-PD-L, anti-PD-L, anti-CD, anti CTLA , or anti-CD antibody, or allogeneic stem cell transplantation
Prior systemic chemotherapy within weeks of planed anti-PD treatment.
Eligible for with plan to undergo neoadjuvant treatment with atezolizumab followed by surgery as part CC# , or planned to undergo treatment with anti-PD- or anti-PD-L per standard of care
History of prior treatment with immune checkpoint antibodies (e.g. anti-PD, anti-PDL, anti-CTLA antibody) or co-stimulatory agonist antibodies (e.g. anti-BB, anti-OX)\r\n* Prior intravesical treatment with Bacillus Calmette-Guerin (BCG) is allowed; however, the last dose must be at least weeks from time of enrollment and patients must have documented progressive disease at least weeks from completion of last BCG
Patients must not have had prior exposure to any immune checkpoint inhibitors including anti-PD-, anti-PD-L gents, anti-PD-L agents, or anti-CTLA- monoclonal antibodies
Patients who have previously received anti-PD or anti-PD-L therapy; patients who have previously received anti-CTLA- therapy (e.g. ipilimumab) are eligible for study
Prior therapy with any antibody/drug that targets the T cell coregulatory proteins, including but not limited to, anti-PD-, anti-PD-L, anti-PD-L, anti-CD, anti-OX-,and anti-CD antibodies. However, half the patients must have progressed on anti Cytotoxic T lymphocyte-associated antigen (anti-CTLA) monoclonal antibody therapy
Prior treatment with PD-L inhibitor, PD- inhibitor, anti-CTLA, anti-CD, anti-OX or other immune checkpoint blockade or activator therapy with the exception of subjects who received atezolizumab in this study and are eligible for re-treatment