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



Status:Recruiting
Conditions:Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/15/2019
Start Date:November 9, 2015
End Date:December 7, 2020
Contact:Pfizer CT.gov Call Center
Email:ClinicalTrials.gov_Inquiries@pfizer.com
Phone:1-800-718-1021

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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

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.

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 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.

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.

- 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 2 highly effective
methods of contraception throughout the study and for at least 60 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.

- 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)
We found this trial at
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593 Eddy Street
Providence, Rhode Island 02903
401-444-4000
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825 Eastlake Ave E
Seattle, Washington 98109
(206) 288-7222
Seattle Cancer Care Alliance Seattle Cancer Care Alliance (SCCA) is a cancer treatment center that...
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12902 USF Magnolia Dr
Tampa, Florida 33612
(888) 663-3488
H. Lee Moffitt Cancer Center & Research Institute Moffitt Cancer Center in Tampa, Florida, has...
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Ann Arbor, Michigan 48106
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
University of Michigan The University of Michigan was founded in 1817 as one of the...
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Camperdown, New South Wales 2050
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Clinton, North Carolina 28328
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5323 Harry Hines Boulevard
Dallas, Texas 75390
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1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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Detroit, Michigan 48201
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Encinitas, California 92024
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Goldsboro, North Carolina 27534
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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200 Hawkins Dr,
Iowa City, Iowa 52242
866-452-8507
University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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Jacksonville, North Carolina 28546
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3855 Health Sciences Dr,
La Jolla, California 92093
(858) 822-6100
UC San Diego Moores Cancer Center Established in 1978, UC San Diego Moores Cancer Center...
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La Jolla, California 92037
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250 25th Ave N, Ste 100
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5150 Centre Ave
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164 Summit Ave
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San Diego, California 92103
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Sarasota, Florida 34232
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1959 NE Pacific St
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Sioux Falls, South Dakota 57104
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910 Sycamore Avenue
Vista, California 92081
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3800 Reservoir Rd NW
Washington, District of Columbia 20007
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Wilson, North Carolina 27893
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