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Brief Title: Phase Ib/II Study of Carboplatin + M6620 + Avelumab in PARPi-resistant Ovarian Cancer
Official Title: 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
Study ID: NCT03704467
Brief Summary: The study was to evaluate the efficacy and safety of avelumab in combination with M6620 + carboplatin in participants with PARPi-resistant, recurrent, platinum sensitive ovarian, primary peritoneal, or fallopian tube cancer.
Detailed Description: The study was intended to be a phase Ib/II trial, but after completing Phase 1b and confirming the safe combination dose, the sponsor decided not to conduct Phase II.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Marin Cancer Care, Inc., Greenbrae, California, United States
The Stamford Hospital, Stamford, Connecticut, United States
Covenant Health Care, Saginaw, Michigan, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Mount Sinai - PRIME, New York, New York, United States
Peggy & Charles Stephenson Oklahoma Cancer Ctr, Oklahoma City, Oklahoma, United States
Mary Crowley Cancer Research Centers, Dallas, Texas, United States
UZ Leuven, Leuven, , Belgium
CHU Sart Tilman, Liège, , Belgium
GZA Ziekenhuizen - Campus Sint-Augustinus, Wilrijk, , Belgium
Royal Cornwall Hospital, Truro, Cornwall, United Kingdom
Royal Marsden Hospital, Sutton, Surrey, United Kingdom
Royal Marsden Hospital, London, , United Kingdom
Name: Medical Responsible
Affiliation: Merck KGaA, Darmstadt, Germany
Role: STUDY_DIRECTOR