Breast Cancer Clinical Trial

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

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.

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Full 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.

View Eligibility Criteria

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)

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

398

Study ID:

NCT02554812

Recruitment Status:

Active, not recruiting

Sponsor:

Pfizer

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There are 58 Locations for this study

See Locations Near You

UCSD Medical Center - Encinitas
Encinitas California, 92024, United States
Koman Family Outpatient Pavilion
La Jolla California, 92037, United States
UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion)
La Jolla California, 92037, United States
UC San Diego Perlman Medical Offices
La Jolla California, 92037, United States
UC San Diego Moores Cancer Center
La Jolla California, 92093, United States
UCLA Clinical Research Unit (Adminstration Office)
Los Angeles California, 90024, United States
Ronald Reagan UCLA Medical Center
Los Angeles California, 90095, United States
UCLA Hematology-Oncology Clinic
Los Angeles California, 90095, United States
UCLA Hematology-Oncology Infusion Center
Los Angeles California, 90095, United States
UC San Diego Medical Center - Hillcrest
San Diego California, 92103, United States
UCSD Medical Center - Vista
Vista California, 92081, United States
Georgetown University Medical Center
Washington District of Columbia, 20007, United States
Mount Sinai Comprehensive Cancer Center - Aventura
Aventura Florida, 33180, United States
Mount Sinai Comprehensive Cancer Center
Miami Beach Florida, 33140, United States
Florida Cancer Specialists
Sarasota Florida, 34232, United States
H Lee Moffitt Cancer Center and Research Institute
Tampa Florida, 33612, United States
University of Iowa Hospitals and Clinics
Iowa City Iowa, 52242, United States
University of Michigan Hospitals
Ann Arbor Michigan, 48109, United States
University of Michigan
Ann Arbor Michigan, 48109, United States
Investigational Pharmacy, Karmanos Cancer Center
Detroit Michigan, 48201, United States
Karmanos Cancer Institute
Detroit Michigan, 48201, United States
Karmanos Cancer Institute Weisberg Cancer Treatment Center
Farmington Hills Michigan, 48334, United States
VA NY Harbor Healthcare System
New York New York, 10010, United States
NYU Investigational Pharmacy
New York New York, 10016, United States
NYU Langone Medical Center
New York New York, 10016, United States
NYU Laura and Isaac Perlmutter Cancer Center
New York New York, 10016, United States
Weill Cornell Medical College
New York New York, 10021, United States
Research Pharmacy #PH#
New York New York, 10065, United States
Weill Cornell Medical College/New York Presbyterian Hospital
New York New York, 10065, United States
Sampson Regional Medical Center
Clinton North Carolina, 28328, United States
Southeastern Medical Oncology Center
Clinton North Carolina, 28328, United States
Southeastern Medical Oncology Center
Goldsboro North Carolina, 27534, United States
Wayne Memorial Hospital
Goldsboro North Carolina, 27534, United States
Onslow Memorial Hospital
Jacksonville North Carolina, 28546, United States
Southeastern Medical Oncology Center
Jacksonville North Carolina, 28546, United States
Fox Chase Cancer Center
Philadelphia Pennsylvania, 19111, United States
University of Pittsburgh Cancer Institute
Pittsburgh Pennsylvania, 15232, United States
UPCI Investigational Drug Service
Pittsburgh Pennsylvania, 15232, United States
UPMC Shadyside Hospital
Pittsburgh Pennsylvania, 15232, United States
Rhode Island Hospital
Providence Rhode Island, 02903, United States
Miriam Hospital
Providence Rhode Island, 02906, United States
Sanford Cancer Center Oncology Clinic & Pharmacy
Sioux Falls South Dakota, 57104, United States
Sanford Gynecologic Oncology Clinic
Sioux Falls South Dakota, 57104, United States
Sanford Interventional Radiology
Sioux Falls South Dakota, 57104, United States
Sanford ENT Clinic
Sioux Falls South Dakota, 57105, United States
Sanford Research
Sioux Falls South Dakota, 57105, United States
Sanford USD Medical Center
Sioux Falls South Dakota, 57105, United States
Tennessee Oncology, PLLC
Nashville Tennessee, 37203, United States
The Sarah Cannon Research Institute / Tennessee Oncology, PLLC
Nashville Tennessee, 37203, United States
Henry-Joyce Cancer Clinic
Nashville Tennessee, 37232, United States
Vanderbilt University Oncology Pharmacy
Nashville Tennessee, 37232, United States
UT Southwestern Medical Center
Dallas Texas, 75235, United States
University of Texas Southwestern Medical Center
Dallas Texas, 75390, United States
UT Southwestern Simmons Comprehensive Cancer Center
Dallas Texas, 75390, United States
The University of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States
Seattle Cancer Care Alliance
Seattle Washington, 98109, United States
University of Washington Medical Center
Seattle Washington, 98195, United States
Chris O'Brien Lifehouse
Camperdown New South Wales, 2050, Australia
Macquarie University
Macquarie University New South Wales, 2109, Australia
Melanoma Institute Australia
North Sydney New South Wales, 2060, Australia
The Mater Hospital
North Sydney New South Wales, 2060, Australia
Baxter Healthcare
Old Toongabie New South Wales, 2146, Australia
Brighton Medical Imaging
Brighton Victoria, 3186, Australia
Cabrini Hospital Brighton
Brighton Victoria, 3186, Australia
Austin Health
Heidelberg Victoria, 3084, Australia
Cabrini Hospital Malvern
Malvern Victoria, 3144, Australia
Cabrini Hospital
Malvern Victoria, 3144, Australia
Malvern Medical Imaging
Malvern Victoria, 3144, Australia
Macquarie Heart
New South Wales , 2109, Australia
Cross Cancer Institute
Edmonton Alberta, T6G 1, Canada
British Columbia Cancer Agency - Vancouver Centre
Vancouver British Columbia, V5Z 4, Canada
The Ottawa Hospital Cancer Centre
Ottawa Ontario, K1H 8, Canada
Princess Margaret Cancer Centre
Toronto Ontario, M5G 2, Canada
PH 145294, Centre Hospitalier de l'Universite de Montreal (CHUM), Oncology Research Pharmacy
Montreal Quebec, H2X 0, Canada
Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal Quebec, H2X 3, Canada
Institut Gustave Roussy
Villejuif Cedex, 94805, France
Institut Gustave Roussy
Villejuif , 94805, France
National Cancer Center Hospital East
Kashiwa Chiba, 277-8, Japan
National Cancer Center Hospital
Chuo-ku Tokyo, 104-0, Japan
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy
Warszawa Mazowieckie, 02-78, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy
Warszawa , 02-78, Poland
Investigational Drug Services, National Taiwan University Hospital
Taipei , 100, Taiwan
National Taiwan University Hospital
Taipei , 100, Taiwan
The Royal Marsden Hospital
London , SW3 6, United Kingdom
The Royal Marsden NHS Foundation Trust
London , SW3 6, United Kingdom
Sarah Cannon Research Institute UK
London , W1G 6, United Kingdom
The Harley Street Clinic
London , W1G 7, United Kingdom
The Harley Street Clinic
London , W1G 8, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

398

Study ID:

NCT02554812

Recruitment Status:

Active, not recruiting

Sponsor:


Pfizer

How clear is this clinincal trial information?

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