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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

Status
Active
Cancer Type
Breast Cancer
Lung Cancer
Melanoma
Ovarian Cancer
Skin Cancer (Non-Melanoma)
Stomach/ Gastric Cancer
Unknown Primary
Trial Phase
Phase II
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCD ID
NCT02554812
Protocol IDs
B9991004 (primary)
NCI-2015-02263
2015-002552-27
JAVELIN MEDLEY
s16-02110
Study Sponsor
Pfizer

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.

Objectives

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), colorectal cancer (CRC), gastric cancer, ovarian cancer, bladder cancer, or small cell lung cancer (SCLC)). 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.
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