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

  • STATUS
    Recruiting
  • End date
    Feb 3, 2024
  • participants needed
    620
  • sponsor
    Pfizer
Updated on 22 November 2020
Investigator
Pfizer CT.gov Call Center
Primary Contact
Macquarie University Hospital Pharmacy (1.3 mi away) Contact
+113 other location
measurable disease
metastasis
gastric cancer
cancer treatment
solid tumor
metastatic solid tumor
solid neoplasm
squamous cell carcinoma of head and neck
bladder cancer

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.

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.

Details
Treatment Avelumab, Utomilumab, PF-04518600, PD 0360324, CMP-001
Clinical Study IdentifierNCT02554812
SponsorPfizer
Last Modified on22 November 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Advanced Cancer?
Do you have any of these conditions: cancer advanced or Advanced Cancer?
Do you have any of these conditions: Advanced Cancer or cancer advanced?
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)
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