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A Study Of Avelumab In Combination With Other Cancer Immunotherapies In Advanced Malignancies (JAVELIN Medley)

Sponsor
Pfizer (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT02554812
Collaborator
(none)
398
Enrollment
87
Locations
19
Arms
87.7
Anticipated Duration (Months)
4.6
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
398 participants
Allocation:
Randomized
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A PHASE 1B/2 OPEN-LABEL STUDY TO EVALUATE SAFETY, CLINICALACTIVITY, PHARMACOKINETICS AND PHARMACODYNAMICS OFAVELUMAB (MSB0010718C) IN COMBINATION WITH OTHER CANCERIMMUNOTHERAPIES IN PATIENTS WITH ADVANCED MALIGNANCIES
Actual Study Start Date :
Nov 9, 2015
Anticipated Primary Completion Date :
Feb 28, 2023
Anticipated Study Completion Date :
Feb 28, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cohort A1

NSCLC patients treated with avelumab + utomilumab (Dose level 1)

Drug: Avelumab
Anti-PD-L1 antibody
Other Names:
  • MSB0010718C

    • Drug: Utomilumab
    Anti-4-1BB antibody
    Other Names:
  • PF-05082566

    		•
    Experimental: Cohort A2

    NSCLC patients treated with avelumab + utomilumab (Dose level 2)

    Drug: Avelumab
    Anti-PD-L1 antibody
    Other Names:
  • MSB0010718C

    • Drug: Utomilumab
    Anti-4-1BB antibody
    Other Names:
  • PF-05082566

    		•
    Experimental: Cohort A3

    NSCLC patients treated with avelumab + utomilumab (Dose level 3)

    Drug: Avelumab
    Anti-PD-L1 antibody
    Other Names:
  • MSB0010718C

    • Drug: Utomilumab
    Anti-4-1BB antibody
    Other Names:
  • PF-05082566

    		•
    Experimental: Cohort A4

    Melanoma patients treated with avelumab +utomilumab

    Drug: Avelumab
    Anti-PD-L1 antibody
    Other Names:
  • MSB0010718C

    • Drug: Utomilumab
    Anti-4-1BB antibody
    Other Names:
  • PF-05082566

    		•
    Experimental: Cohort A5

    SCCHN patients treated with avelumab + utomilumab

    Drug: Avelumab
    Anti-PD-L1 antibody
    Other Names:
  • MSB0010718C

    • Drug: Utomilumab
    Anti-4-1BB antibody
    Other Names:
  • PF-05082566

    		•
    Experimental: Cohort A6

    TNBC patients treated with avelumab + utomilumab

    Drug: Avelumab
    Anti-PD-L1 antibody
    Other Names:
  • MSB0010718C

    • Drug: Utomilumab
    Anti-4-1BB antibody
    Other Names:
  • PF-05082566

    		•
    Experimental: Cohort A7

    SCLC that has progressed after at least 1 line of platinum-containing therapy treated with avelumab +utomilumab

    Drug: Avelumab
    Anti-PD-L1 antibody
    Other Names:
  • MSB0010718C

    • Drug: Utomilumab
    Anti-4-1BB antibody
    Other Names:
  • PF-05082566

    		•
    Experimental: Cohort A8

    NSCLC first-line Stage IV treated with avelumab +PF-05082566

    Drug: Avelumab
    Anti-PD-L1 antibody
    Other Names:
  • MSB0010718C

    • Drug: Utomilumab
    Anti-4-1BB antibody
    Other Names:
  • PF-05082566

    		•
    Experimental: Combination B Dose Escalation

    PF-04518600 + avelumab in selected tumor types

    Drug: Avelumab
    Anti-PD-L1 antibody
    Other Names:
  • MSB0010718C

    • Drug: PF-04518600
    OX40 Agonist
    Experimental: Combination B Expansion Cohorts

    PF-04518600 + avelumab in selected tumor types

    Drug: Avelumab
    Anti-PD-L1 antibody
    Other Names:
  • MSB0010718C

    • Drug: PF-04518600
    OX40 Agonist
    Experimental: Combination C Dose escalation cohorts

    PD 0360324 + avelumab in selected tumor types

    Drug: Avelumab
    Anti-PD-L1 antibody
    Other Names:
  • MSB0010718C

    • Drug: PD 0360324
    Anti-M-CSF
    Experimental: Combination C Dose expansion cohorts

    PD 0360324 + aveluamb in selected tumor types

    Drug: Avelumab
    Anti-PD-L1 antibody
    Other Names:
  • MSB0010718C

    • Drug: PD 0360324
    Anti-M-CSF
    Experimental: Combination D Dose escalation cohorts

    PF-05082566 + PF-04518600 + avelumab in selected tumor types

    Drug: Avelumab
    Anti-PD-L1 antibody
    Other Names:
  • MSB0010718C

    • Drug: Utomilumab
    Anti-4-1BB antibody
    Other Names:
  • PF-05082566

    • Drug: PF-04518600
    OX40 Agonist
    Experimental: Combination D Dose expansion cohorts

    PF-05082566 + PF-04518600 + avelumab in selected tumor types

    Drug: Avelumab
    Anti-PD-L1 antibody
    Other Names:
  • MSB0010718C

    • Drug: Utomilumab
    Anti-4-1BB antibody
    Other Names:
  • PF-05082566

    • Drug: PF-04518600
    OX40 Agonist
    Experimental: Cohort A9

    NSCLC first-line Stage IV treated with avelumab +utomilumab (sequential starting with utomilumab monotherapy followed by combination)

    Drug: Avelumab
    Anti-PD-L1 antibody
    Other Names:
  • MSB0010718C

    • Drug: Utomilumab
    Anti-4-1BB antibody
    Other Names:
  • PF-05082566

    		•
    Experimental: Cohort A10

    NSCLC first-line Stage IV treated with avelumab + utomilumab (sequential starting with avelumab monotherapy followed by combination)

    Drug: Avelumab
    Anti-PD-L1 antibody
    Other Names:
  • MSB0010718C

    • Drug: Utomilumab
    Anti-4-1BB antibody
    Other Names:
  • PF-05082566

    		•
    Experimental: Cohort F1

    CMP-001 +avelumab in SCCHN

    Drug: Avelumab
    Anti-PD-L1 antibody
    Other Names:
  • MSB0010718C

    • Drug: CMP-001
    TLR9 agonist
    Experimental: Cohort F2

    CMP-001+avelumab+utomilumab in SCCHN

    Drug: Avelumab
    Anti-PD-L1 antibody
    Other Names:
  • MSB0010718C

    • Drug: Utomilumab
    Anti-4-1BB antibody
    Other Names:
  • PF-05082566

    • Drug: CMP-001
    TLR9 agonist
    Experimental: Cohort F3

    CMP-001 +avelumab+PF-04518600 in SCCHN

    Drug: Avelumab
    Anti-PD-L1 antibody
    Other Names:
  • MSB0010718C

    • Drug: PF-04518600
    OX40 Agonist

    Drug: CMP-001
    TLR9 agonist

    Outcome Measures

    Primary Outcome Measures

    1. Number of participants with Dose-Limiting Toxicities (DLT) [First 8 weeks of treatment (Combination A-D) First 4 weeks of treatment (CombinationF)]

      For Phase 1b: DLTs for Combination A (avelumab and PF-05082566) or Combination B (avelumab and PF-04518600) or Combination C (avelumab and PD 0360324) or Combination D (Avelumab and utomilumab and PF-04518600)occurring during the first 8 weeks of treatment (first 2 cycles). For Phase 1b: DLT for Combination F (avelumab plus CMP-001 and utomilumab or PF-04518600) occurring during the first 4 weeks of treatment (first cycle).

    2. Objective Response - Number of Participants With Objective Response [Baseline up to approximately 24 months]

      For Phase 2: Number of participants with objective response (ie, confirmed complete or partial response according to RECIST Version 1.1).

    Secondary Outcome Measures

    1. Cmax of avelumab (MSB0010718C) [Pre-dose and 1 hour post-dose on Days 1, 8, and 15 of Cycle 1, then on Day 1 of Cycles 2, 4, 6, and 10]

      Cmax defined as the maximum plasma concentration of avelumab (MSB0010718C)

    2. Cmax of PF-05082566 [Pre-dose and 1 hour post-dose on Days 1, 8, and 15 of Cycle 1, and then on Day 1 of Cycles 3, 5, 8, and 12]

      Cmax defined as the maximum plasma concentration of PF-05082566

    3. Ctrough of avelumab (MSB0010718C) [Pre-dose and 1 hour post-dose on Days 1, 8, and 15 of Cycle 1, then on Day 1 of Cycles 2, 4, 6, and 10]

      Ctrough is defined as the trough plasma concentration at the end of an avelumab dosage interval.

    4. Ctrough of PF-05082566 [Pre-dose and 1 hour post-dose on Days 1, 8, and 15 of Cycle 1, and then on Day 1 of Cycles 3, 5, 8, and 12]

      Ctrough is defined as the trough plasma concentration at the end of a PF-05082566 dosage interval.

    5. Anti-Drug Antibody (ADA) levels of avelumab (MSB0010718C) [Pre-dose on Day 1 of Cycles 1, 2, 4, 6, and 10]

      Immunogenicity assessment of avelumab (MSB0010718C).

    6. Anti-Drug Antibody (ADA) levels of PF-05082566 [Pre-dose on Day 1 of Cycles 1, 3, 5, 8, and 12]

      Immunogenicity assessment of PF-05082566.

    7. Time to Tumor Response (TTR) [Baseline up to approximately 24 months]

      Time to Tumor Response (TTR) is defined for patients with confirmed objective response (CR or PR) as the time from the date of randomization (NSCLC) or date of first dose of study treatment (melanoma and SCCHN) to the first documentation of objective tumor response.

    8. Duration of Response (DR) [Baseline up to approximately 24 months]

      Duration of Response (DR) is defined for patients with confirmed objective response (CR or PR) as the time from the first documentation of objective tumor response to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first.

    9. Progression-Free Survival (PFS) [Baseline up to approximately 24 months]

      Progression-Free Survival (PFS) is defined as the time from the date of randomization (NSCLC) or date of first dose of study treatment (melanoma and SCCHN) to the date of disease progression by RECIST v1.1 or death due to any cause, whichever occurs first.

    10. Overall Survival (OS) [Baseline up to approximately 24 months]

      Overall Survival (OS) is defined as the time from the date of randomization (NSCLC) or date of first dose of study treatment (melanoma and SCCHN) to the date of death.

    11. Tumor tissue biomarkers [Baseline]

      Tumor tissue biomarkers, including, but not limited to, PD-L1 expression and tumor infiltrating CD8+ T lymphocytes

    12. Cmax of PF-04518600 [Pre-dose and 1 hour post-dose on Days 1, 8, and 15 of Cycle 1, then on Day 1 of Cycles 2, 4, 6, and 10]

      Cmax defined as the maximum plasma concentration of PF-04518600

    13. Anti-Drug Antibody (ADA) levels of PF-04518600 [Pre-dose on Day 1 of Cycles 1, 2, 4, 6, and 10]

      Immunogenicity assessment of PF-04518600.

    14. Ctrough of PF-04518600 [Pre-dose and 1 hour post-dose on Days 1, 8, and 15 of Cycle 1, then on Day 1 of Cycles 2, 4, 6, and 10]

      Ctrough is defined as the trough plasma concentration at the end of a PF-04518600 dosage interval.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UCSD Medical Center - Encinitas Encinitas California United States 92024
    2 Koman Family Outpatient Pavilion La Jolla California United States 92037
    3 UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion) La Jolla California United States 92037
    4 UC San Diego Perlman Medical Offices La Jolla California United States 92037
    5 UC San Diego Moores Cancer Center La Jolla California United States 92093
    6 UCLA Clinical Research Unit (Adminstration Office) Los Angeles California United States 90024
    7 Ronald Reagan UCLA Medical Center Los Angeles California United States 90095
    8 UCLA Hematology-Oncology Clinic Los Angeles California United States 90095
    9 UCLA Hematology-Oncology Infusion Center Los Angeles California United States 90095
    10 UC San Diego Medical Center - Hillcrest San Diego California United States 92103
    11 UCSD Medical Center - Vista Vista California United States 92081
    12 Georgetown University Medical Center Washington District of Columbia United States 20007
    13 Mount Sinai Comprehensive Cancer Center - Aventura Aventura Florida United States 33180
    14 Mount Sinai Comprehensive Cancer Center Miami Beach Florida United States 33140
    15 Florida Cancer Specialists Sarasota Florida United States 34232
    16 H Lee Moffitt Cancer Center and Research Institute Tampa Florida United States 33612
    17 University of Iowa Hospitals and Clinics Iowa City Iowa United States 52242
    18 University of Michigan Hospitals Ann Arbor Michigan United States 48109-5008
    19 University of Michigan Ann Arbor Michigan United States 48109
    20 Investigational Pharmacy, Karmanos Cancer Center Detroit Michigan United States 48201
    21 Karmanos Cancer Institute Detroit Michigan United States 48201
    22 Karmanos Cancer Institute Weisberg Cancer Treatment Center Farmington Hills Michigan United States 48334
    23 VA NY Harbor Healthcare System New York New York United States 10010
    24 NYU Investigational Pharmacy New York New York United States 10016
    25 NYU Langone Medical Center New York New York United States 10016
    26 NYU Laura and Isaac Perlmutter Cancer Center New York New York United States 10016
    27 Weill Cornell Medical College New York New York United States 10021
    28 Research Pharmacy #PH# New York New York United States 10065
    29 Weill Cornell Medical College/New York Presbyterian Hospital New York New York United States 10065
    30 Sampson Regional Medical Center Clinton North Carolina United States 28328
    31 Southeastern Medical Oncology Center Clinton North Carolina United States 28328
    32 Southeastern Medical Oncology Center Goldsboro North Carolina United States 27534
    33 Wayne Memorial Hospital Goldsboro North Carolina United States 27534
    34 Onslow Memorial Hospital Jacksonville North Carolina United States 28546
    35 Southeastern Medical Oncology Center Jacksonville North Carolina United States 28546
    36 Fox Chase Cancer Center Philadelphia Pennsylvania United States 19111
    37 University of Pittsburgh Cancer Institute Pittsburgh Pennsylvania United States 15232
    38 UPCI Investigational Drug Service Pittsburgh Pennsylvania United States 15232
    39 UPMC Shadyside Hospital Pittsburgh Pennsylvania United States 15232
    40 Rhode Island Hospital Providence Rhode Island United States 02903
    41 Miriam Hospital Providence Rhode Island United States 02906
    42 Sanford Cancer Center Oncology Clinic & Pharmacy Sioux Falls South Dakota United States 57104
    43 Sanford Gynecologic Oncology Clinic Sioux Falls South Dakota United States 57104
    44 Sanford Interventional Radiology Sioux Falls South Dakota United States 57104
    45 Sanford ENT Clinic Sioux Falls South Dakota United States 57105
    46 Sanford Research Sioux Falls South Dakota United States 57105
    47 Sanford USD Medical Center Sioux Falls South Dakota United States 57105
    48 Tennessee Oncology, PLLC Nashville Tennessee United States 37203
    49 The Sarah Cannon Research Institute / Tennessee Oncology, PLLC Nashville Tennessee United States 37203
    50 Henry-Joyce Cancer Clinic Nashville Tennessee United States 37232
    51 Vanderbilt University Oncology Pharmacy Nashville Tennessee United States 37232
    52 University of Texas Southwestern Medical Center Dallas Texas United States 75390
    53 UT Southwestern Simmons Comprehensive Cancer Center Dallas Texas United States 75390
    54 The University of Texas MD Anderson Cancer Center Houston Texas United States 77030
    55 Seattle Cancer Care Alliance Seattle Washington United States 98109
    56 University of Washington Medical Center Seattle Washington United States 98195
    57 Chris O'Brien Lifehouse Camperdown New South Wales Australia 2050
    58 Macquarie University Macquarie University New South Wales Australia 2109
    59 Melanoma Institute Australia North Sydney New South Wales Australia 2060
    60 The Mater Hospital North Sydney New South Wales Australia 2060
    61 Baxter Healthcare Old Toongabie New South Wales Australia 2146
    62 Brighton Medical Imaging Brighton Victoria Australia 3186
    63 Cabrini Hospital Brighton Brighton Victoria Australia 3186
    64 Austin Health Heidelberg Victoria Australia 3084
    65 Cabrini Hospital Malvern Malvern Victoria Australia 3144
    66 Cabrini Hospital Malvern Victoria Australia 3144
    67 Malvern Medical Imaging Malvern Victoria Australia 3144
    68 Macquarie Heart New South Wales Australia 2109
    69 Cross Cancer Institute Edmonton Alberta Canada T6G 1Z2
    70 British Columbia Cancer Agency - Vancouver Centre Vancouver British Columbia Canada V5Z 4E6
    71 The Ottawa Hospital Cancer Centre Ottawa Ontario Canada K1H 8L6
    72 Princess Margaret Cancer Centre Toronto Ontario Canada M5G 2M9
    73 PH 145294, Centre Hospitalier de l'Universite de Montreal (CHUM), Oncology Research Pharmacy Montreal Quebec Canada H2X 0C2
    74 Centre Hospitalier de l'Université de Montréal (CHUM) Montreal Quebec Canada H2X 3E4
    75 Institut Gustave Roussy Villejuif Cedex France 94805
    76 Institut Gustave Roussy Villejuif France 94805
    77 National Cancer Center Hospital East Kashiwa Chiba Japan 277-8577
    78 National Cancer Center Hospital Chuo-ku Tokyo Japan 104-0045
    79 Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy Warszawa Mazowieckie Poland 02-781
    80 Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy Warszawa Poland 02-781
    81 Investigational Drug Services, National Taiwan University Hospital Taipei Taiwan 100
    82 National Taiwan University Hospital Taipei Taiwan 100
    83 The Royal Marsden Hospital London United Kingdom SW3 6JJ
    84 The Royal Marsden NHS Foundation Trust London United Kingdom SW3 6JJ
    85 Sarah Cannon Research Institute UK London United Kingdom W1G 6AD
    86 The Harley Street Clinic London United Kingdom W1G 7LJ
    87 The Harley Street Clinic London United Kingdom W1G 8PP

    Sponsors and Collaborators

    • Pfizer

    Investigators

    • Study Director: Pfizer CT.gov Call Center, Pfizer

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Pfizer
    ClinicalTrials.gov Identifier:
    NCT02554812
    Other Study ID Numbers:
    • B9991004
    • 2015-002552-27
    • JAVELIN MEDLEY
    First Posted:
    Sep 18, 2015
    Last Update Posted:
    Jul 26, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Keywords provided by Pfizer
    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
    Additional relevant MeSH terms:
    Neoplasms
    Avelumab

    Study Results

    No Results Posted as of Jul 26, 2022