MS201943-0029:A Phase Ib Safety Run-in and Randomized Phase II, Open-label Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of M6620 in Combination with Avelumab and Carboplatin in Comparison to Standard of Care Therapy in Participants with PARPi-resistant Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube Cancer (EMD Serono MS201943-0029)

Study Details

This Phase Ib / II study is an open-label, randomized, controlled study consisting of 2 parts. Part A is a safety run-in dose de-escalation to identify a safe dose of carboplatin + M6620 in combination with avelumab for Part B. In Part B, participants will be randomly assigned to receive open-label treatment with either the triplet combination (carboplatin + M6620 + avelumab) or Standard of Care (platinum-based doublet therapy with optional bevacizumab). Participants will be randomized (stratified by BRCA [breast cancer gene] status) to one of the treatment arms.

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ClinicalTrials.gov NCT number
NCT03704467

Principal Investigators

  • Salvatore Del Prete, MD
Sponsor(s)
EMD Serono
Contact
Maureen Magnani, BSN, RN at 203-358-8879
or officeofresearch@stamhealth.org

Location

  • Bennett Cancer Center
    One Hospital Plaza
    Stamford, CT 06902
    Main: 203-276-2695