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

Official Title

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 antitumour activity of avelumab (MSB0010718C) in combination with other cancer immunotherapies in patients with locally advanced or metastatic solid tumours. 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.

Trial Description

Primary Outcome:

  • Number of participants with Dose-Limiting Toxicities (DLT)
  • Objective Response - Number of Participants With Objective Response
Secondary Outcome:
  • Cmax of avelumab (MSB0010718C)
  • Cmax of PF-05082566
  • Ctrough of avelumab (MSB0010718C)
  • Ctrough of PF-05082566
  • Anti-Drug Antibody (ADA) levels of avelumab (MSB0010718C)
  • Anti-Drug Antibody (ADA) levels of PF-05082566
  • Time to Tumour Response (TTR)
  • Duration of Response (DR)
  • Progression-Free Survival (PFS)
  • Overall Survival (OS)
  • Tumour tissue biomarkers
  • Cmax of PF-04518600
  • Anti-Drug Antibody (ADA) levels of PF-04518600
  • Ctrough of PF-04518600

View this trial on ClinicalTrials.gov

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Canadian Cancer Society

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