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

NCT02554812 | Terminated Phase 1 Results

• 3 other identifiers: B99910042015-002552-27JAVELIN MEDLEY
• Study Type: interventional
• Target: 409
• Locations: 8 countries
• Sites: 88

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.

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

Outcome Measures

Primary Outcomes (7)

• Phase 1b Lead-in: Number of Participants With First 2 Cycles Dose Limiting Toxicity (DLT) for Combination A

  Severity of AEs graded as per CTCAE v4.03. Phase 1b lead-in, AEs occurring during DLT observation period, that attributable to one or more study drug in combination was classified as DLT: Hematologic: Grade (G)4 neutropenia lasting \>7 day; Febrile neutropenia; Neutropenic infection; G \>=3 thrombocytopenia with bleeding; G4 thrombocytopenia; G4 anemia. Non-Hematologic (Non-Laboratory): Any G3 toxicity, except following: Transient (24 H) G3 fatigue, local reaction, or headache that resolved to G1; G3-4 nausea/vomiting controlled by medical therapy within 72H; G3 hypertension controlled by medical therapy; G3 diarrhea improved to G \<=2 within 72H after medical therapy; G3 skin toxicity resolved to G \<=1 in \<7 days after medical management; G \>=3 amylase or lipase abnormality not associated with pancreatitis;G3 endocrinopathies controlled with medical therapy; Tumor flare phenomenon.G4 or G3 CRS lasting \>24 H despite treatment.

  Baseline up to Cycle 2 (up to 8 weeks)

• Phase 1b Lead-in: Number of Participants With First 2 Cycles DLT for Combination B

  Severity of AEs graded as per CTCAE v4.03. Phase 1b lead-in, AEs occurring during DLT observation period, that attributable to one or more study drug in combination was classified as DLT: Hematologic: Grade (G)4 neutropenia lasting \>7 day; Febrile neutropenia; Neutropenic infection; G \>=3 thrombocytopenia with bleeding; G4 thrombocytopenia; G4 anemia. Non-Hematologic (Non-Laboratory): Any G3 toxicity, except following: Transient (24 H) G3 fatigue, local reaction, or headache that resolved to G1; G3-4 nausea/vomiting controlled by medical therapy within 72H; G3 hypertension controlled by medical therapy; G3 diarrhea improved to G \<=2 within 72H after medical therapy; G3 skin toxicity resolved to G \<=1 in \<7 days after medical management; G \>=3 amylase or lipase abnormality not associated with pancreatitis;G3 endocrinopathies controlled with medical therapy; Tumor flare phenomenon.G4 or G3 CRS lasting \>24 H despite treatment.

  Baseline up to Cycle 2 (up to 8 weeks)

• Phase 1b Lead-in: Number of Participants With First 2 Cycles DLT for Combination C

  Severity of AEs graded as per CTCAE v4.03. Phase 1b lead-in, AEs occurring during DLT observation period, that attributable to one or more study drug in combination was classified as DLT: Hematologic: Grade (G)4 neutropenia lasting \>7 day; Febrile neutropenia; Neutropenic infection; G \>=3 thrombocytopenia with bleeding; G4 thrombocytopenia; G4 anemia. Non-Hematologic (Non-Laboratory): Any G3 toxicity, except following: Transient (24 H) G3 fatigue, local reaction, or headache that resolved to G1; G3-4 nausea/vomiting controlled by medical therapy within 72H; G3 hypertension controlled by medical therapy; G3 diarrhea improved to G \<=2 within 72H after medical therapy; G3 skin toxicity resolved to G \<=1 in \<7 days after medical management; G \>=3 amylase or lipase abnormality not associated with pancreatitis;G3 endocrinopathies controlled with medical therapy; Tumor flare phenomenon.G4 or G3 CRS lasting \>24 H despite treatment.

  Baseline up to Cycle 2 (up to 8 weeks)

• Phase 1b Lead-in: Number of Participants With First 2 Cycles DLT for Combination D

  Severity of AEs graded as per CTCAE v4.03. Phase 1b lead-in, AEs occurring during DLT observation period, that attributable to one or more study drug in combination was classified as DLT: Hematologic: Grade (G)4 neutropenia lasting \>7 day; Febrile neutropenia; Neutropenic infection; G \>=3 thrombocytopenia with bleeding; G4 thrombocytopenia; G4 anemia. Non-Hematologic (Non-Laboratory): Any G3 toxicity, except following: Transient (24 H) G3 fatigue, local reaction, or headache that resolved to G1; G3-4 nausea/vomiting controlled by medical therapy within 72H; G3 hypertension controlled by medical therapy; G3 diarrhea improved to G \<=2 within 72H after medical therapy; G3 skin toxicity resolved to G \<=1 in \<7 days after medical management; G \>=3 amylase or lipase abnormality not associated with pancreatitis;G3 endocrinopathies controlled with medical therapy; Tumor flare phenomenon.G4 or G3 CRS lasting \>24 H despite treatment.

  Baseline up to Cycle 2 (up to 8 weeks)

• Phase 1b Lead-in: Number of Participants With First Cycle DLT for Combination F

  Severity of AEs graded as per CTCAE v4.03. Phase 1b lead-in, AEs occurring during DLT observation period, that attributable to one or more study drug in combination was classified as DLT: Hematologic: Grade (G)4 neutropenia lasting \>7 day; Febrile neutropenia; Neutropenic infection; G \>=3 thrombocytopenia with bleeding; G4 thrombocytopenia; G4 anemia. Non-Hematologic (Non-Laboratory): Any G3 toxicity, except following: Transient (24 H) G3 fatigue, local reaction, or headache that resolved to G1; G3-4 nausea/vomiting controlled by medical therapy within 72H; G3 hypertension controlled by medical therapy; G3 diarrhea improved to G \<=2 within 72H after medical therapy; G3 skin toxicity resolved to G \<=1 in \<7 days after medical management; G \>=3 amylase or lipase abnormality not associated with pancreatitis;G3 endocrinopathies controlled with medical therapy; Tumor flare phenomenon.G4 or G3 CRS lasting \>24 H despite treatment.

  Baseline up to first Cycle (up to 4 weeks)

• 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

  OR: complete response(CR) or partial response(PR)determined by investigator according to RECIST v1.1 from date of first dose of study treatment until date of first documentation of progressive disease(PD),confirmed by repeat assessments performed no less than 4 weeks after first response. CR: disappearance of target and non-target lesions, with exception of nodal disease and normalization of tumor markers. All nodes, target and non-target must have short axis measures less than (\<)10 millimeter(mm). PR: \>=30% decrease in sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of target lesions, taking as reference baseline sum of diameters. Non-target lesions must be non-PD. PD: \>=20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to relative increase of 20%, sum must also demonstrate an absolute increase of at least 5mm, appearance of one or more new lesions was considered PD.

  From start of the treatment until disease progression or death due to any cause, whichever occurred first (maximum up to 53 months approximately)

• Phase 2: Percentage of Participants With Confirmed OR as Per RECIST v 1.1 by Investigator Assessment for Combination B

  OR: CR or PR determined by investigator according to RECIST v1.1 from date of first dose of study treatment until date of first documentation of PD, confirmed by repeat assessments performed no less than 4 weeks after first response. CR: disappearance of target and non-target lesions, with exception of nodal disease and normalization of tumor markers. All nodes, target and non-target must have short axis measures \<10 mm. PR: \>=30% decrease in sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of target lesions, taking as reference baseline sum of diameters. Non-target lesions must be non-PD. PD: \>=20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to relative increase of 20%, sum must also demonstrate an absolute increase of at least 5 mm, appearance of one or more new lesions was considered PD.

  From start of the treatment until disease progression or death due to any cause, whichever occurred first (approximately 26 months)

Secondary Outcomes (71)

• Number of Participants With Treatment Emergent Adverse Events (TEAEs), Grade >= 3 TEAEs, Serious TEAEs and Treatment Related TEAEs: Combination A

  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)

• Number of Participants With TEAEs, Grade >= 3 TEAEs, Serious TEAEs and Treatment Related TEAEs: Combination B

  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)

• Number of Participants With TEAEs, Grade >= 3 TEAEs, Serious TEAEs and Treatment Related TEAEs: Combination C

  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)

• Number of Participants With TEAEs, Grade >= 3 TEAEs, Serious TEAEs and Treatment Related TEAEs: Combination D

  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)

• Number of Participants With TEAEs, Grade >= 3 TEAEs, Serious TEAEs and Treatment Related TEAEs: Combination F

  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)

Study Arms (19)

Cohort A1

EXPERIMENTAL

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

Drug: Avelumab; Drug: Utomilumab

Cohort A2

EXPERIMENTAL

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

Drug: Avelumab; Drug: Utomilumab

Cohort A3

EXPERIMENTAL

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

Drug: Avelumab; Drug: Utomilumab

Cohort A4

EXPERIMENTAL

Melanoma patients treated with avelumab +utomilumab

Drug: Avelumab; Drug: Utomilumab

Cohort A5

EXPERIMENTAL

SCCHN patients treated with avelumab + utomilumab

Drug: Avelumab; Drug: Utomilumab

Cohort A6

EXPERIMENTAL

TNBC patients treated with avelumab + utomilumab

Drug: Avelumab; Drug: Utomilumab

Cohort A7

EXPERIMENTAL

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

Drug: Avelumab; Drug: Utomilumab

Cohort A8

EXPERIMENTAL

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

Drug: Avelumab; Drug: Utomilumab

Combination B Dose Escalation

EXPERIMENTAL

PF-04518600 + avelumab in selected tumor types

Drug: Avelumab; Drug: PF-04518600

Combination B Expansion Cohorts

EXPERIMENTAL

PF-04518600 + avelumab in selected tumor types

Drug: Avelumab; Drug: PF-04518600

Combination C Dose escalation cohorts

EXPERIMENTAL

PD 0360324 + avelumab in selected tumor types

Drug: Avelumab; Drug: PD 0360324

Combination C Dose expansion cohorts

EXPERIMENTAL

PD 0360324 + aveluamb in selected tumor types

Drug: Avelumab; Drug: PD 0360324

Combination D Dose escalation cohorts

EXPERIMENTAL

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

Drug: Avelumab; Drug: Utomilumab; Drug: PF-04518600

Combination D Dose expansion cohorts

EXPERIMENTAL

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

Drug: Avelumab; Drug: Utomilumab; Drug: PF-04518600

Cohort A9

EXPERIMENTAL

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

Drug: Avelumab; Drug: Utomilumab

Cohort A10

EXPERIMENTAL

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

Drug: Avelumab; Drug: Utomilumab

Cohort F1

EXPERIMENTAL

CMP-001 +avelumab in SCCHN

Drug: Avelumab; Drug: CMP-001

Cohort F2

EXPERIMENTAL

CMP-001+avelumab+utomilumab in SCCHN

Drug: Avelumab; Drug: Utomilumab; Drug: CMP-001

Cohort F3

EXPERIMENTAL

CMP-001 +avelumab+PF-04518600 in SCCHN

Drug: Avelumab; Drug: PF-04518600; Drug: CMP-001

Interventions

Avelumab DRUG

Anti-PD-L1 antibody

Also known as: MSB0010718C

Cohort A1; Cohort A10; Cohort A2; Cohort A3; Cohort A4; Cohort A5; Cohort A6; Cohort A7; Cohort A8; Cohort A9; Cohort F1; Cohort F2; Cohort F3; Combination B Dose Escalation; Combination B Expansion Cohorts; Combination C Dose escalation cohorts; Combination C Dose expansion cohorts; Combination D Dose escalation cohorts; Combination D Dose expansion cohorts

Utomilumab DRUG

Anti-4-1BB antibody

Also known as: PF-05082566

Cohort A1; Cohort A10; Cohort A2; Cohort A3; Cohort A4; Cohort A5; Cohort A6; Cohort A7; Cohort A8; Cohort A9; Cohort F2; Combination D Dose escalation cohorts; Combination D Dose expansion cohorts

PF-04518600 DRUG

OX40 Agonist

Cohort F3; Combination B Dose Escalation; Combination B Expansion Cohorts; Combination D Dose escalation cohorts; Combination D Dose expansion cohorts

PD 0360324 DRUG

Anti-M-CSF

Combination C Dose escalation cohorts; Combination C Dose expansion cohorts

CMP-001 DRUG

TLR9 agonist

Cohort F1; Cohort F2; Cohort F3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (88)

UCSD Medical Center - Encinitas

Encinitas, California, 92024, United States

Location

Koman Family Outpatient Pavilion

La Jolla, California, 92037, United States

Location

UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion)

La Jolla, California, 92037, United States

Location

UC San Diego Perlman Medical Offices

La Jolla, California, 92037, United States

Location

UC San Diego Moores Cancer Center

La Jolla, California, 92093, United States

Location

UCLA Clinical Research Unit (Adminstration Office)

Los Angeles, California, 90024, United States

Location

Ronald Reagan UCLA Medical Center

Los Angeles, California, 90095, United States

Location

UCLA Hematology-Oncology Clinic

Los Angeles, California, 90095, United States

Location

UCLA Hematology-Oncology Infusion Center

Los Angeles, California, 90095, United States

Location

UC San Diego Medical Center - Hillcrest

San Diego, California, 92103, United States

Location

UCSD Medical Center - Vista

Vista, California, 92081, United States

Location

Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States

Location

Mount Sinai Comprehensive Cancer Center - Aventura

Aventura, Florida, 33180, United States

Location

Mount Sinai Comprehensive Cancer Center

Miami Beach, Florida, 33140, United States

Location

Florida Cancer Specialists

Sarasota, Florida, 34232, United States

Location

H Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

University of Michigan Hospitals

Ann Arbor, Michigan, 48109-5008, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Investigational Pharmacy, Karmanos Cancer Center

Detroit, Michigan, 48201, United States

Location

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Karmanos Cancer Institute Weisberg Cancer Treatment Center

Farmington Hills, Michigan, 48334, United States

Location

VA NY Harbor Healthcare System

New York, New York, 10010, United States

Location

NYU Investigational Pharmacy

New York, New York, 10016, United States

Location

NYU Langone Medical Center

New York, New York, 10016, United States

Location

NYU Laura and Isaac Perlmutter Cancer Center

New York, New York, 10016, United States

Location

Weill Cornell Medical College

New York, New York, 10021, United States

Location

Research Pharmacy #PH#

New York, New York, 10065, United States

Location

Weill Cornell Medical College/New York Presbyterian Hospital

New York, New York, 10065, United States

Location

Sampson Regional Medical Center

Clinton, North Carolina, 28328, United States

Location

Southeastern Medical Oncology Center

Clinton, North Carolina, 28328, United States

Location

Southeastern Medical Oncology Center

Goldsboro, North Carolina, 27534, United States

Location

Wayne Memorial Hospital

Goldsboro, North Carolina, 27534, United States

Location

Onslow Memorial Hospital

Jacksonville, North Carolina, 28546, United States

Location

Southeastern Medical Oncology Center

Jacksonville, North Carolina, 28546, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

University of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, 15232, United States

Location

UPCI Investigational Drug Service

Pittsburgh, Pennsylvania, 15232, United States

Location

UPMC Shadyside Hospital

Pittsburgh, Pennsylvania, 15232, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Miriam Hospital

Providence, Rhode Island, 02906, United States

Location

Sanford Cancer Center Oncology Clinic & Pharmacy

Sioux Falls, South Dakota, 57104, United States

Location

Sanford Gynecologic Oncology Clinic

Sioux Falls, South Dakota, 57104, United States

Location

Sanford Interventional Radiology

Sioux Falls, South Dakota, 57104, United States

Location

Sanford ENT Clinic

Sioux Falls, South Dakota, 57105, United States

Location

Sanford Research

Sioux Falls, South Dakota, 57105, United States

Location

Sanford USD Medical Center

Sioux Falls, South Dakota, 57105, United States

Location

Tennessee Oncology, PLLC

Nashville, Tennessee, 37203, United States

Location

The Sarah Cannon Research Institute / Tennessee Oncology, PLLC

Nashville, Tennessee, 37203, United States

Location

Henry-Joyce Cancer Clinic

Nashville, Tennessee, 37232, United States

Location

Vanderbilt University Oncology Pharmacy

Nashville, Tennessee, 37232, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75235, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

UT Southwestern Simmons Comprehensive Cancer Center

Dallas, Texas, 75390, United States

Location

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Seattle Cancer Care Alliance

Seattle, Washington, 98109, United States

Location

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

Chris O'Brien Lifehouse

Camperdown, New South Wales, 2050, Australia

Location

Macquarie University

Macquarie University, New South Wales, 2109, Australia

Location

Melanoma Institute Australia

North Sydney, New South Wales, 2060, Australia

Location

The Mater Hospital

North Sydney, New South Wales, 2060, Australia

Location

Baxter Healthcare

Old Toongabie, New South Wales, 2146, Australia

Location

Brighton Medical Imaging

Brighton, Victoria, 3186, Australia

Location

Cabrini Hospital Brighton

Brighton, Victoria, 3186, Australia

Location

Austin Health

Heidelberg, Victoria, 3084, Australia

Location

Cabrini Hospital Malvern

Malvern, Victoria, 3144, Australia

Location

Cabrini Hospital

Malvern, Victoria, 3144, Australia

Location

Malvern Medical Imaging

Malvern, Victoria, 3144, Australia

Location

Macquarie Heart

New South Wales, 2109, Australia

Location

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

British Columbia Cancer Agency - Vancouver Centre

Vancouver, British Columbia, V5Z 4E6, Canada

Location

The Ottawa Hospital Cancer Centre

Ottawa, Ontario, K1H 8L6, Canada

Location

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

PH 145294, Centre Hospitalier de l'Universite de Montreal (CHUM), Oncology Research Pharmacy

Montreal, Quebec, H2X 0C2, Canada

Location

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, H2X 3E4, Canada

Location

Institut Gustave Roussy

Villejuif, Cedex, 94805, France

Location

Institut Gustave Roussy

Villejuif, 94805, France

Location

National Cancer Center Hospital East

Kashiwa, Chiba, 277-8577, Japan

Location

National Cancer Center Hospital

Chuo-ku, Tokyo, 104-0045, Japan

Location

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy

Warsaw, Masovian Voivodeship, 02-781, Poland

Location

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy

Warsaw, 02-781, Poland

Location

Investigational Drug Services, National Taiwan University Hospital

Taipei, 100, Taiwan

Location

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

The Royal Marsden Hospital

London, SW3 6JJ, United Kingdom

Location

The Royal Marsden NHS Foundation Trust

London, SW3 6JJ, United Kingdom

Location

Sarah Cannon Research Institute UK

London, W1G 6AD, United Kingdom

Location

The Harley Street Clinic

London, W1G 7LJ, United Kingdom

Location

The Harley Street Clinic

London, W1G 8PP, United Kingdom

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Melanoma; Squamous Cell Carcinoma of Head and Neck; Triple Negative Breast Neoplasms; Stomach Neoplasms; Small Cell Lung Carcinoma; Urinary Bladder Neoplasms

Interventions

avelumab; utomilumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Head and Neck Neoplasms; Breast Neoplasms; Breast Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Limitations and Caveats

For combination C and D the level of clinical activity observed in Cohorts C11 to C13 and D11 to D32 did not support development beyond Phase 1b. For combination F, the level of clinical activity did not warrant further enrolment. Therefore, Phase 2 was not planned.

Results Point of Contact

• Title: Pfizer Inc.
• Organization: Pfizer ClinicalTrials.gov Call Center

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2015
• First Posted: September 18, 2015
• Study Start: November 9, 2015
• Primary Completion: March 23, 2023
• Study Completion: March 23, 2023
• Last Updated: July 30, 2024
• Results First Posted: July 30, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share

Locations

CA (6); US (57); TW (2); AU (12); JP (2); FR (2); GB (5); PL (2)