Clinical trial NCT02554812: A Study Of Avelumab In Combination With Other Cancer Immunotherapies In Advanced Malignancies (JAVELIN Medley)
Official title: A PHASE 1B/2 OPEN-LABEL STUDY TO EVALUATE SAFETY, CLINICAL ACTIVITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF AVELUMAB (MSB0010718C) IN COMBINATION WITH OTHER CANCER IMMUNOTHERAPIES IN PATIENTS WITH ADVANCED MALIGNANCIES
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Advanced Cancer
Keywords: anti PD-L1
anti 4-1BB
OX40 agonist
anti M-CSF
TLR9 agonist
Non-small cell lung cancer (NSCLC)
melanoma
squamous cell carcinoma of head and neck (SCCHN)
triple negative breast cancer (TNBC)
gastric cancer
Small cell lung cancer (SCLC)
bladder cancer
platinum resistant ovarian cancer
TGCT/PVNS
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2015-09-18
Enrollment: 409
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: This is a Phase 1b/2 dose-optimization study to evaluate safety, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of avelumab (MSB0010718C) in combination with other cancer immunotherapies in patients with locally advanced or metastatic solid tumors. The primary purpose is to assess the safety and early signs of efficacy of various avelumab combinations with other cancer immunotherapies, optimizing dosing regimens as appropriate, in a limited series of indications.

Detailed description: This is a Phase 1b/2, open-label, multi-center, multiple-dose, safety, clinical activity, PK, and PD study of avelumab in combination with other immune modulators in adult patients with locally advanced or metastatic solid tumors (eg, non-small cell lung cancer (NSCLC), melanoma, squamous cell carcinoma of the head and neck (SCCHN), triple-negative breast cancer (TNBC), gastric cancer, platinum resistant ovarian cancer, bladder cancer, small cell lung cancer (SCLC) and progressing tenosynovial giant cell tumor/pigmented villonodular synovitis (TGCT/PVNS) . In Phase 1b, this includes patients whose disease has progressed on standard of care therapy or for whom no standard therapy is available. In Phase 2, enrollment criteria regarding prior treatment(s) received varies by tumor type. Incorporation of the other immune modulators into this study is based on preclinical and clinical data supportive of single-agent tolerability and potential clinical benefit, as well as non-clinical data suggesting safety, tolerability and clinical benefit of the agent(s) in combination with avelumab. Combinations of avelumab plus other immune modulator(s) to be evaluated are as follows:

* Combination A: avelumab plus utomilumab (4-1BB agonist mAb)
* Combination B: avelumab plus PF-04518600 (OX40 agonist mAb)
* Combination C: avelumab plus PD 0360324 (M-CSF mAb)
* Combination D: avelumab plus utomilumab plus PF-04518600
* Combination F: avelumab plus CMP-001 (TLR9 agonist) and avelumab plus CMP-001 plus utomilumab and avelumab plus CMP-001 and PF-04518600 Each combination will be studied individually in 2 study parts: 1) a Phase 1b Lead-in part to evaluate safety, and determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) and RP2D (if applicable), of the combination, and 2) a Phase 2 part to evaluate efficacy and further evaluate safety of the selected dose from the Phase 1b portion in pre-specified patient populations.

Eligibility criteria: Inclusion Criteria:

* Histological or cytological diagnosis of advanced/metastatic solid tumor. Measurable disease by RECIST 1.1 with at least 1 measurable lesion that has not been previously irradiated. Availability of tumor specimen taken within 1 year prior to study entry, with no intervening systemic anti-cancer therapy. No prior PD-1/PDL-1 therapy allowed. Combination A: Phase 1b, patients with NSCLC that have progressed on standard therapy or for which no standard therapy is available, and Phase 2, patients with NSCLC, melanoma, SCCHN, TNBC in any line of therapy, SCLC, 1st line NSCLC. 1st line NSCLC must demonstrate to express PD-L1. Activating EGFR mutation, ALK, ROS1 translocation/rearrangements are not permitted. Combination B: Phase 1b, patients with advanced solid tumors (NSCLC, SCCHN, melanoma) that have progressed on standard therapy or for which no standard therapy is available, and Phase 2, patients with NSCLC, melanoma, or SCCHN. Up to 2 lines of prior therapy in advanced/metastatic disease setting allowed. Activating EGFR mutation, ALK, ROS1 translocation/rearrangements are not permitted. Combination C: Ovarian cancer, SCCHN, NSCLC, gastric cancer, platinum resistant ovarian cancer. Up to 2 lines of prior therapy in advanced/metastatic disease setting allowed. TGCT/PVNS that is either inoperable or requires extensive resection. Prior treatment with agents targeting CSF-1/CSF-1R not allowed. NSCLC activating EGFR mutation, ALK, ROS1 translocation/rearrangements are not permitted. Combination D: NSCLC, melanoma, SCCHN, bladder cancer. NSCLC activating EGFR mutation, ALK, ROS1 translocation/rearrangements are not permitted. Up to 2 lines of prior therapy in advanced/metastatic disease setting allowed. Combination F: Recurrent or metastatic SCCHN. One to three prior lines of systemic therapy for advanced stage or metastatic disease. Patients must have received anti PD-1/PD-L1 containing therapy (requires at least two doses of PD-1/PD-L1 agent).Disease progression no earlier than 6 weeks from initiation of the latest anticancer therapy. Evidence of radiologic progression is required. • Patient must be a candidate for intralesional administration with at least one tumor lesion which can be injected safely.
* ECOG performance status 0 or 1
* Estimated life expectancy of at least 3 months
* Adequate bone marrow, renal, and liver function
* Resolved acute effects of prior therapy
* Negative serum pregnancy test at screening
* Male and female patients able to have children must agree to use at least 1 highly effective method of contraception throughout the study and for at least 90 days after last dose
* Signed and dated informed consent

Exclusion Criteria:

* Monoclonal antibody based anti-cancer therapy within 28 days prior to study entry or small-molecule based anti-cancer therapy (targeted therapy or chemotherapy) within 14 days prior to study entry. Combination F:PD-1/PD-L1 agent within 14 days prior study entry.
* Current or prior use of immunosuppressive medication within 7 days prior to study entry
* Active autoimmune disease requiring systemic steroids or immunosuppressive agents within 7 days prior to study entry
* Known prior or suspected hypersensitivity to investigational products
* Major surgery within 4 weeks or radiation therapy within 14 days prior to study entry
* Patients with known symptomatic brain metastases requiring steroids
* Previous high-dose chemotherapy requiring stem cell rescue
* Prior allogeneic stem cell transplant or organ graft
* Any of the following within 6 months prior to study entry: myocardial infarction, uncontrolled angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, or transient ischemic attack
* Symptomatic pulmonary embolism within 6 months prior to study entry
* Known HIV or AIDS-related illness
* Active infection requiring systemic therapy
* Positive HBV or HCV test indicating acute or chronic infection
* Administration of a live vaccine within 4 weeks prior to study entry
* Diagnosis of other malignancy within 5 years, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the breast or cervix, or low-grade (Gleason ≤6) prostate cancer
* Participation in other studies involving investigational drug(s) within 4 weeks prior to study entry and/or during study participation
* Persisting toxicity related to prior therapy \>Grade 1
* Other severe acute or chronic medical condition
* Combo C :Existing periorbital edema.
* Combo C : Hypocalcemia, clinically significant bone disease or recent bone fracture (within 12 weeks prior study entry)

Primary outcomes:
measure: Phase 1b Lead-in: Number of Participants With First 2 Cycles Dose Limiting Toxicity (DLT) for Combination A
timeFrame: Baseline up to Cycle 2 (up to 8 weeks)
measure: Phase 1b Lead-in: Number of Participants With First 2 Cycles DLT for Combination B
timeFrame: Baseline up to Cycle 2 (up to 8 weeks)
measure: Phase 1b Lead-in: Number of Participants With First 2 Cycles DLT for Combination C
timeFrame: Baseline up to Cycle 2 (up to 8 weeks)
measure: Phase 1b Lead-in: Number of Participants With First 2 Cycles DLT for Combination D
timeFrame: Baseline up to Cycle 2 (up to 8 weeks)
measure: Phase 1b Lead-in: Number of Participants With First Cycle DLT for Combination F
timeFrame: Baseline up to first Cycle (up to 4 weeks)
measure: Phase 2: Percentage of Participants With Confirmed Objective Response (OR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 by Investigator Assessment for Combination A
timeFrame: From start of the treatment until disease progression or death due to any cause, whichever occurred first (maximum up to 53 months approximately)
measure: Phase 2: Percentage of Participants With Confirmed OR as Per RECIST v 1.1 by Investigator Assessment for Combination B
timeFrame: From start of the treatment until disease progression or death due to any cause, whichever occurred first (approximately 26 months)
Secondary outcomes:
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Grade >= 3 TEAEs, Serious TEAEs and Treatment Related TEAEs: Combination A
timeFrame: Baseline up to 30 days after last dose of study treatment or the day before start day of new anti-cancer therapy (maximum of 6.5 years)
measure: Number of Participants With TEAEs, Grade >= 3 TEAEs, Serious TEAEs and Treatment Related TEAEs: Combination B
timeFrame: Baseline up to 30 days after last dose of study treatment or the day before start day of new anti-cancer therapy (maximum of 3.5 years)
measure: Number of Participants With TEAEs, Grade >= 3 TEAEs, Serious TEAEs and Treatment Related TEAEs: Combination C
timeFrame: Baseline up to 30 days after last dose of study treatment or the day before start day of new anti-cancer therapy (maximum of 1.8 years)
measure: Number of Participants With TEAEs, Grade >= 3 TEAEs, Serious TEAEs and Treatment Related TEAEs: Combination D
timeFrame: Baseline up to 30 days after last dose of study treatment or the day before start day of new anti-cancer therapy (maximum of 4.3 years)
measure: Number of Participants With TEAEs, Grade >= 3 TEAEs, Serious TEAEs and Treatment Related TEAEs: Combination F
timeFrame: Baseline up to 30 days after last dose of study treatment or the day before start day of new anti-cancer therapy (maximum of 3 years)
measure: Number of Participants With New Abnormal or Worsening Hematology Laboratory Test by Maximum Common Terminology Criteria for Adverse Events (CTCAE) Grade >=3: Combination A
timeFrame: Baseline up to end of treatment/withdrawal (maximum of 6.5 years)
measure: Number of Participants With New Abnormal or Worsening Hematology Laboratory Test by Maximum CTCAE Grade >=3: Combination B
timeFrame: Baseline up to end of treatment/withdrawal (maximum of 3.5 years)
measure: Number of Participants With New Abnormal or Worsening Hematology Laboratory Test by Maximum CTCAE Grade >=3: Combination C
timeFrame: Baseline up to end of treatment/withdrawal (maximum of 1.8 years)
measure: Number of Participants With New Abnormal or Worsening Hematology Laboratory Test by Maximum CTCAE Grade >=3: Combination D
timeFrame: Baseline up to end of treatment/withdrawal (maximum of 4.3 years)
measure: Number of Participants With New Abnormal or Worsening Hematology Laboratory Test by Maximum CTCAE Grade >=3: Combination F
timeFrame: Baseline up to end of treatment/withdrawal (maximum of 3 years)
measure: Number of Participants With New Abnormal or Worsening Chemistry Laboratory Test Results During the On-Treatment Period by Maximum CTCAE Grade >=3: Combination A
timeFrame: Baseline up to end of treatment/withdrawal (maximum of 6.5 years)
measure: Number of Participants With New Abnormal or Worsening Chemistry Laboratory Test Results During the On-Treatment Period by Maximum CTCAE Grade >=3: Combination B
timeFrame: Baseline up to end of treatment/withdrawal (maximum of 3.5 years)
measure: Number of Participants With New Abnormal or Worsening Chemistry Laboratory Test Results During the On-Treatment Period by Maximum CTCAE Grade >=3: Combination C
timeFrame: Baseline up to end of treatment/withdrawal (maximum of 1.8 years)
measure: Number of Participants With New Abnormal or Worsening Chemistry Laboratory Test Results During the On-Treatment Period by Maximum CTCAE Grade >=3: Combination D
timeFrame: Baseline up to end of treatment/withdrawal (maximum of 4.3 years)
measure: Number of Participants With New Abnormal or Worsening Chemistry Laboratory Test Results During the On-Treatment Period by Maximum CTCAE Grade >=3: Combination F
timeFrame: Baseline up to end of treatment/withdrawal (maximum of 3 years)
measure: Maximum Observed Plasma Concentration (Cmax) of Avelumab in Combination A
timeFrame: 1-hour post-dose (at end of infusion) on Day 1,15 of Cycle 1; Day 8 of Cycle 1 (non-dosing); Day 1 of Cycle 2, 4, 6, 10. For ''Phase 2 1L NSCLC: Utomilumab then Utomilumab + Avelumab'' reporting group: Day 1 of Cycle 2, 4, 6, 10
measure: Maximum Observed Plasma Concentration (Cmax) of Utomilumab in Combination A
timeFrame: 1-hour post-infusion (at end of infusion) on Day 1 of Cycle 1,3,5,8,12; Day 8 of Cycle 1 (non-dosing). For ''Phase 2 1L NSCLC: Avelumab then Utomilumab + Avelumab'' reporting group: Day 1 of Cycle 3,5,8,12
measure: Maximum Observed Plasma Concentration (Cmax) of Avelumab and PF-04518600 in Combination B
timeFrame: 1-hour post-dose on Day 1,15 of Cycle 1; Day 8 of Cycle 1 (non-dosing); Day 1 of Cycle 2, 4, 6 and Cycle 10
measure: Maximum Observed Plasma Concentration (Cmax) of Avelumab and PD 0360324 in Combination C
timeFrame: 1 hour (i.e. at the end of infusion) post-dose on Day 1,15 of Cycle 1; Day 8 of Cycle 1 (non-dosing); Day 1 of Cycle 2, 4, 6 and Cycle 10
measure: Maximum Observed Plasma Concentration (Cmax) of Avelumab in Combination D
timeFrame: 1 hour post-dose (at end of infusion) on Days 1 and 15 of Cycle 1; Day 8 of Cycle 1 (non-dosing); Pre-dose and 1 hour post-dose on Day 1 of Cycle 2, 4, 6, 10
measure: Maximum Observed Plasma Concentration (Cmax) of Utomilumab in Combination D
timeFrame: 1 hour (at end of infusion) post-dose on Day 1 of Cycles 1, 3, 5, 8 and Cycle 12; Days 8 of Cycle 1 (non-dosing)
measure: Maximum Observed Plasma Concentration (Cmax) of PF-04518600 in Combination D
timeFrame: 1 hour post-infusion (at end of infusion) on Day 1 and 15 of Cycle 1; Day 8 of Cycle 1 (non-dosing); Day 1 of Cycle 2, 4, 6 and Cycle 10
measure: Maximum Observed Plasma Concentration (Cmax) of Avelumab in Combination F
timeFrame: 1-hour post-infusion (i.e. at the end of infusion) on Days 1 and 15 of Cycle 1 (non-dosing); Day 1 of Cycles 2, 4, 6 and Cycle 10
measure: Pre-Dose Observed Plasma Concentration (Ctrough) of Avelumab in Combination A
timeFrame: Pre-dose on Days 1 and 15 of Cycle 1, Day 8 of Cycle 1 (non-dosing) and then Day 1 of Cycles 2,4,6 and Cycle 10. For ''Phase 2 1L NSCLC: Utomilumab then Utomilumab + Avelumab'' reporting group: Day 1 of Cycles 2,4,6,10
measure: Pre-Dose Observed Plasma Concentration (Ctrough) of Utomilumab in Combination A
timeFrame: Pre-dose on Day 1 of Cycles 1,3,5,8, and Cycle 12; Day 15 of Cycle 1 (non-dosing). For ''Phase 2 1L NSCLC: Avelumab then Utomilumab + Avelumab'' reporting group: Day 1 of Cycles 3,5,8 and 12
measure: Pre-Dose Observed Plasma Concentration (Ctrough) of Avelumab and PF-04518600 in Combination B
timeFrame: Pre-dose on Days 1 and 15 of Cycle 1 (non-dosing); Day 1 of Cycles 2, 4, 6 and Cycle 10
measure: Pre-Dose Observed Plasma Concentration (Ctrough) of Avelumab and PD 0360324 in Combination C
timeFrame: Pre-dose on Days 1 and 15 of Cycle 1 (non-dosing); Day 1 of Cycles 2, 4, 6 and Cycle 10
measure: Pre-Dose Observed Plasma Concentration (Ctrough) of Avelumab in Combination D
timeFrame: Pre-dose on Day 1 of Cycle 1, 2, 4, 6 and Cycle 10; Day 15 of Cycle 1 (non-dosing)
measure: Pre-Dose Observed Plasma Concentration (Ctrough) of Utomilumab in Combination D
timeFrame: Pre-dose on Day 1 of Cycle 1, 3, 5, 8 and Cycle 12; Day 15 of Cycle 1 (non-dosing)
measure: Pre-Dose Observed Plasma Concentration (Ctrough) of PF-04518600 in Combination D
timeFrame: Pre-dose on Day 1 and 15 of Cycle 1 (non-dosing); Pre-dose on Day 1 of Cycle 2, 4, 6 and Cycle 10
measure: Pre-Dose Observed Plasma Concentration (Ctrough) of Avelumab in Combination F
timeFrame: Pre-dose on Day 1 and 15 of Cycle 1 (non-dosing); Pre-dose on Day 1 of Cycle 2, 4, 6 and Cycle 10
measure: Pre-Dose Observed Plasma Concentration (Ctrough) of Utomilumab in Combination F
timeFrame: Pre-dose on Day 1 of Cycle 1 (non-dosing); Pre-dose on Day 1 of Cycle 2 and 4
measure: Pre-Dose Observed Plasma Concentration (Ctrough) of PF-04518600 in Combination F
timeFrame: Pre-dose on Day 1 of Cycle 1 (non-dosing); Pre-dose on Day 1 of Cycles 2 and 4
measure: Number of Participants With Positive Anti-Drug Antibody (ADA) Against Avelumab For Combination A
timeFrame: Pre-dose on Day 1 of Cycle 1, 2, 4, 6, 10. For ''Phase 2 1L NSCLC: Utomilumab then Utomilumab + Avelumab'' reporting group: Day 1 of Cycle 2, 4, 6, 10
measure: Number of Participants With Positive ADA Levels Against Utomilumab For Combination A
timeFrame: Pre-dose on Day 1 of Cycle 1, 3, 5, 8, 12. For ''Phase 2 1L NSCLC: Avelumab then Utomilumab + Avelumab'' reporting group: Day 1 of Cycle 3, 5, 8, 12
measure: Number of Participants With Positive ADA Levels For Combination B
timeFrame: Pre-dose on Day 1 of Cycle 1, 2, 4, 6, and 10
measure: Number of Participants With Positive ADA Levels For Combination C
timeFrame: Pre-dose on Day 1 of Cycle 1, 2, 4, 6, and 10
measure: Number of Participants With Positive ADA Levels Against Avelumab and PF-04518600 For Combination D
timeFrame: Pre-dose on Day 1 of Cycle 1, 2, 4, 6, and 10
measure: Number of Participants With Positive ADA Levels Against Utomilumab For Combination D
timeFrame: Pre-dose on Day 1 of Cycle 1, 3, 5, 8, 12
measure: Number of Participants With Positive ADA Levels Against Avelumab and PF-04518600 For Combination F
timeFrame: Pre-dose on Day 1 of Cycle 1, 2, 4, 6, and 10
measure: Number of Participants With Positive ADA Levels Against Utomilumab For Combination F
timeFrame: Pre-dose on Day 1 of Cycle 1, 2, 4, 6, and 10
measure: Time to Tumor Response (TTR) for Combination A
timeFrame: From first dose of study drug until first documentation of CR or PR (maximum up to 7.3 years)
measure: TTR for Combination B
timeFrame: From first dose of study drug until first documentation of CR or PR (maximum up to 7.3 years)
measure: TTR for Combination C
timeFrame: From first dose of study drug until first documentation of CR or PR (maximum up to 7.3 years)
measure: TTR for Combination D
timeFrame: From first dose of study drug until first documentation of CR or PR (maximum up to 7.3 years)
measure: TTR for Combination F
timeFrame: From first dose of study drug until first documentation of CR or PR (maximum up to 7.3 years)
measure: Duration of Response (DR) for Combination A
timeFrame: From first documentation of CR or PR until first documentation of tumor progression or death due to any cause or data censoring date, whichever occurred first (maximum up to 7.3 years)
measure: DR for Combination B
timeFrame: From first documentation of CR or PR until first documentation of tumor progression or death due to any cause or data censoring date, whichever occurred first (maximum up to 7.3 years)
measure: DR for Combination C
timeFrame: From first documentation of CR or PR until first documentation of tumor progression or death due to any cause or data censoring date, whichever occurred first (maximum up to 7.3 years)
measure: DR for Combination D
timeFrame: From first documentation of CR or PR until first documentation of tumor progression or death due to any cause or data censoring date, whichever occurred first (maximum up to 7.3 years)
measure: DR for Combination F
timeFrame: From first documentation of CR or PR until first documentation of tumor progression or death due to any cause or data censoring date, whichever occurred first (maximum up to 7.3 years)
measure: Progression-free Survival (PFS) for Combination A
timeFrame: From first dose of study drug until first documentation of PD or death due to any cause or data censoring date, whichever occurred first (maximum up to 7.3 years)
measure: PFS for Combination B
timeFrame: From first dose of study drug until first documentation of PD or death due to any cause or data censoring date, whichever occurred first (maximum up to 7.3 years)
measure: PFS for Combination C
timeFrame: From first dose of study drug until first documentation of PD or death due to any cause or data censoring date, whichever occurred first (maximum up to 7.3 years)
measure: PFS for Combination D
timeFrame: From first dose of study drug until first documentation of PD or death due to any cause or data censoring date, whichever occurred first (maximum up to 7.3 years)
measure: PFS for Combination F
timeFrame: From first dose of study drug until first documentation of PD or death due to any cause or data censoring date, whichever occurred first (maximum up to 7.3 years)
measure: Overall Survival (OS) for Combination A
timeFrame: From first dose of study drug to date of death from any cause or data censoring date, whichever occurred first (maximum up to 7.3 years)
measure: OS for Combination B
timeFrame: From first dose of study drug to date of death from any cause or data censoring date, whichever occurred first (maximum up to 7.3 years)
measure: OS for Combination C
timeFrame: From first dose of study drug to date of death from any cause or data censoring date, whichever occurred first (maximum up to 7.3 years)
measure: OS for Combination D
timeFrame: From first dose of study drug to date of death from any cause or data censoring date, whichever occurred first (maximum up to 7.3 years)
measure: OS for Combination F
timeFrame: From first dose of study drug to date of death from any cause or data censoring date, whichever occurred first (maximum up to 7.3 years)
measure: Phase 1b: Percentage of Participants With Objective Response (OR) for Combination A
timeFrame: From first dose of study drug until disease progression or death due to any cause (maximum up to 7.3 years)
measure: Phase 1b: Percentage of Participants With Objective Response (OR) for Combination B
timeFrame: From first dose of study drug until disease progression or death due to any cause (maximum up to 7.3 years)
measure: Phase 1b: Percentage of Participants With Objective Response (OR) for Combination C
timeFrame: From first dose of study drug until disease progression or death due to any cause (maximum up to 7.3 years)
measure: Phase 1b: Percentage of Participants With Objective Response (OR) for Combination D
timeFrame: From first dose of study drug until disease progression or death due to any cause (maximum up to 7.3 years)
measure: Phase 1b: Percentage of Participants With Objective Response (OR) for Combination F
timeFrame: From first dose of study drug until disease progression or death due to any cause (maximum up to 7.3 years)
measure: Number of Participants With Positive Programmed Death Ligand-1 (PD-L1) Biomarker Expression and Tumor Infiltrating Cluster of Differentiation 8 (CD8+) Lymphocytes at Baseline for Combination A
timeFrame: Baseline (Day 1)
measure: Number of Participants With Positive Programmed Death Ligand-1 (PD-L1) Biomarker Expression and Tumor Infiltrating CD8+ Lymphocytes at Baseline for Combination B
timeFrame: Baseline (Day 1)
measure: Number of Participants With Positive Programmed Death Ligand-1 (PD-L1) Biomarker Expression and Tumor Infiltrating CD8+ Lymphocytes at Baseline for Combination C
timeFrame: Baseline (Day 1)
measure: Number of Participants With Positive Programmed Death Ligand-1 (PD-L1) Biomarker Expression and Tumor Infiltrating CD8+ Lymphocytes at Baseline for Combination D
timeFrame: Baseline (Day 1)
measure: Number of Participants With Positive Programmed Death Ligand-1 (PD-L1) Biomarker Expression and Tumor Infiltrating CD8+ Lymphocytes at Baseline for Combination F
timeFrame: Baseline (Day 1)
Other outcomes:
Locations:
city: Encinitas
country: United States
facility: UCSD Medical Center - Encinitas
state: California
city: La Jolla
country: United States
facility: Koman Family Outpatient Pavilion
state: California
city: La Jolla
country: United States
facility: UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion)
state: California
city: La Jolla
country: United States
facility: UC San Diego Perlman Medical Offices
state: California
city: La Jolla
country: United States
facility: UC San Diego Moores Cancer Center
state: California
city: Los Angeles
country: United States
facility: UCLA Clinical Research Unit (Adminstration Office)
state: California
city: Los Angeles
country: United States
facility: Ronald Reagan UCLA Medical Center
state: California
city: Los Angeles
country: United States
facility: UCLA Hematology-Oncology Clinic
state: California
city: Los Angeles
country: United States
facility: UCLA Hematology-Oncology Infusion Center
state: California
city: San Diego
country: United States
facility: UC San Diego Medical Center - Hillcrest
state: California
city: Vista
country: United States
facility: UCSD Medical Center - Vista
state: California
city: Washington
country: United States
facility: Georgetown University Medical Center
state: District of Columbia
city: Aventura
country: United States
facility: Mount Sinai Comprehensive Cancer Center - Aventura
state: Florida
city: Miami Beach
country: United States
facility: Mount Sinai Comprehensive Cancer Center
state: Florida
city: Sarasota
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Tampa
country: United States
facility: H Lee Moffitt Cancer Center and Research Institute
state: Florida
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Ann Arbor
country: United States
facility: University of Michigan Hospitals
state: Michigan
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Detroit
country: United States
facility: Investigational Pharmacy, Karmanos Cancer Center
state: Michigan
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: Farmington Hills
country: United States
facility: Karmanos Cancer Institute Weisberg Cancer Treatment Center
state: Michigan
city: New York
country: United States
facility: VA NY Harbor Healthcare System
state: New York
city: New York
country: United States
facility: NYU Investigational Pharmacy
state: New York
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
city: New York
country: United States
facility: NYU Laura and Isaac Perlmutter Cancer Center
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: New York
country: United States
facility: Research Pharmacy #PH#
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College/New York Presbyterian Hospital
state: New York
city: Clinton
country: United States
facility: Sampson Regional Medical Center
state: North Carolina
city: Clinton
country: United States
facility: Southeastern Medical Oncology Center
state: North Carolina
city: Goldsboro
country: United States
facility: Southeastern Medical Oncology Center
state: North Carolina
city: Goldsboro
country: United States
facility: Wayne Memorial Hospital
state: North Carolina
city: Jacksonville
country: United States
facility: Onslow Memorial Hospital
state: North Carolina
city: Jacksonville
country: United States
facility: Southeastern Medical Oncology Center
state: North Carolina
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Cancer Institute
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPCI Investigational Drug Service
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Shadyside Hospital
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Providence
country: United States
facility: Miriam Hospital
state: Rhode Island
city: Sioux Falls
country: United States
facility: Sanford Cancer Center Oncology Clinic & Pharmacy
state: South Dakota
city: Sioux Falls
country: United States
facility: Sanford Gynecologic Oncology Clinic
state: South Dakota
city: Sioux Falls
country: United States
facility: Sanford Interventional Radiology
state: South Dakota
city: Sioux Falls
country: United States
facility: Sanford ENT Clinic
state: South Dakota
city: Sioux Falls
country: United States
facility: Sanford Research
state: South Dakota
city: Sioux Falls
country: United States
facility: Sanford USD Medical Center
state: South Dakota
city: Nashville
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
city: Nashville
country: United States
facility: The Sarah Cannon Research Institute / Tennessee Oncology, PLLC
state: Tennessee
city: Nashville
country: United States
facility: Henry-Joyce Cancer Clinic
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Oncology Pharmacy
state: Tennessee
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Dallas
country: United States
facility: UT Southwestern Simmons Comprehensive Cancer Center
state: Texas
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance
state: Washington
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
city: Camperdown
country: Australia
facility: Chris O'Brien Lifehouse
state: New South Wales
city: Macquarie University
country: Australia
facility: Macquarie University
state: New South Wales
city: North Sydney
country: Australia
facility: Melanoma Institute Australia
state: New South Wales
city: North Sydney
country: Australia
facility: The Mater Hospital
state: New South Wales
city: Old Toongabie
country: Australia
facility: Baxter Healthcare
state: New South Wales
city: Brighton
country: Australia
facility: Brighton Medical Imaging
state: Victoria
city: Brighton
country: Australia
facility: Cabrini Hospital Brighton
state: Victoria
city: Heidelberg
country: Australia
facility: Austin Health
state: Victoria
city: Malvern
country: Australia
facility: Cabrini Hospital Malvern
state: Victoria
city: Malvern
country: Australia
facility: Cabrini Hospital
state: Victoria
city: Malvern
country: Australia
facility: Malvern Medical Imaging
state: Victoria
city: New South Wales
country: Australia
facility: Macquarie Heart
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Vancouver
country: Canada
facility: British Columbia Cancer Agency - Vancouver Centre
state: British Columbia
city: Ottawa
country: Canada
facility: The Ottawa Hospital Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
city: Montreal
country: Canada
facility: PH 145294, Centre Hospitalier de l'Universite de Montreal (CHUM), Oncology Research Pharmacy
state: Quebec
city: Montreal
country: Canada
facility: Centre Hospitalier de l'Université de Montréal (CHUM)
state: Quebec
city: Villejuif
country: France
facility: Institut Gustave Roussy
state: Cedex
city: Villejuif
country: France
facility: Institut Gustave Roussy
city: Kashiwa
country: Japan
facility: National Cancer Center Hospital East
state: Chiba
city: Chuo-ku
country: Japan
facility: National Cancer Center Hospital
state: Tokyo
city: Warszawa
country: Poland
facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy
state: Mazowieckie
city: Warszawa
country: Poland
facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy
city: Taipei
country: Taiwan
facility: Investigational Drug Services, National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: London
country: United Kingdom
facility: The Royal Marsden Hospital
city: London
country: United Kingdom
facility: The Royal Marsden NHS Foundation Trust
city: London
country: United Kingdom
facility: Sarah Cannon Research Institute UK
city: London
country: United Kingdom
facility: The Harley Street Clinic
city: London
country: United Kingdom
facility: The Harley Street Clinic
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: