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.
Status | Active |
---|---|
Effective start/end date | 2/27/20 → 8/24/25 |
Funding
- Gynecological Oncology Group Foundation Incorporated: $118,586.00
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