A Randomized Phase II Trial of Triplet Therapy (a PD-L1 Inhibitor Durvalumab (MEDI4736) in Combination with Olapaprib and Cediranib) Compared to Olaparib and Cediranib or Durvalumab (MEDI4736) and Cediranib or Standard of Care Chemotherapy in Women with Platinum-Resistant Recurrent Epithelial Ovarian Cancer, Primary Peritoneal or Fallopian Tube Cancer who Have Received Prior Becizumab
Categories (click each to see list of all clinical trials associated with that category): Gyn/Onc (OB/GYNONC)
Current Status: Open
Phase: II
Principal Investigator: Rodabaugh, Kerry
Contact Information:
Pamela Nielsen
pnielsen@nebraskamed.com
Eligibility: https://clinicaltrials.gov/ct2/show/NCT04739800?term=NCT04739800&draw=2&rank=1#eligibility
Summary
Primary Objective
To assess the efficacy of the combinations durvalumab (MEDI4736) plus olaparib and
cediranib, durvalumab (MEDI4736) plus cediranib, or olaparib and cediranib, as
measured by progression-free survival (PFS), as compared to physician's choice standard
of care chemotherapy, in patients with recurrent platinum-resistant ovarian, primary
peritoneal or fallopian tube cancer who had prior bevacizumab.
Secondary Objectives
To assess the efficacy of the combinations durvalumab (MEDI4736)) plus olaparib and
cediranib, durvalumab (MEDI4736) plus cediranib, or olaparib and cediranib, as
measured by overall response rate (ORR) by RECIST version 1.1 criteria, as compared to
physician's choice standard of care chemotherapy, in patients with recurrent platinum resistant ovarian, primary peritoneal or fallopian tube cancer who had prior bevacizumab.
To assess the efficacy of the combinations durvalumab (MEDI4736) plus olaparib and
cediranib, durvalumab (MEDI4736) plus cediranib, or olaparib and cediranib, as
measured by overall survival (OS), as compared to physician's choice standard of care
chemotherapy, in patients with recurrent platinum-resistant ovarian, primary peritoneal or
fallopian tube cancer who had prior bevacizumab