A Randomized Phase 3, Double-Blind Study of Chemotherapy With or Without Pembrolizumab Followed by Maintenance With Olaparib or Placebo for the First-Line Treatment of BRCA Non-Mutated Advanced Epithelial Ovarian Cancer (EOC)

Grants and Contracts Details

Description

A Randomized Phase 3, Double-Blind Study of Chemotherapy With or Without Pembrolizumab Followed by Maintenance With Olaparib or Placebo for the First-Line Treatment of BRCA non-mutated Advanced Epithelial Ovarian Cancer (EOC) In participants with previously untreated BRCA1/2 non-mutated advanced EOC treated with pembrolizumab plus carboplatin/paclitaxel followed by continued pembrolizumab treatment plus olaparib maintenance (Arm 1) or pembrolizumab plus carboplatin/paclitaxel followed by continued pembrolizumab treatment (Arm 2) versus carboplatin/paclitaxel alone (Arm 3): Objective: To compare the progressionfree survival (PFS) as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) Hypothesis (H1): The combination of pembrolizumab plus carboplatin/paclitaxel followed by continued pembrolizumab treatment and olaparib maintenance (Arm 1) is superior to carboplatin/paclitaxel alone (Arm 3) with respect to PFS per RECIST 1.1. Hypothesis (H2): The combination of pembrolizumab plus carboplatin/paclitaxel followed by continued pembrolizumab treatment (Arm 2) is superior to carboplatin/paclitaxel alone (Arm 3) with respect to PFS per RECIST 1.1.
StatusActive
Effective start/end date2/27/2010/20/22

Funding

  • Gynecological Oncology Group Foundation Incorporated: $113,497.00

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