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 16 June 2021
Investigator
Pfizer CT.gov Call Center
Primary Contact
Miriam Hospital (2.3 mi away) Contact
+123 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
Condition Advanced Cancer, cancer advanced
Treatment Avelumab, Utomilumab, PF-04518600, PD 0360324, CMP-001
Clinical Study IdentifierNCT02554812
SponsorPfizer
Last Modified on16 June 2021

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