Study of Chemotherapy With Pembrolizumab (MK-3475) Followed by Maintenance With Olaparib (MK-7339) for the First-Line Treatment of Women With BRCA Non-mutated Advanced Epithelial Ovarian Cancer (EOC) (MK-7339-001/KEYLYNK-001/ENGOT-ov43/GOG-3036)
Summary
The purpose of this study is to assess the efficacy and safety of treatment with carboplatin/paclitaxel\* PLUS pembrolizumab (MK-3475) and maintenance olaparib (MK-7339) in women with epithelial ovarian cancer (EOC), fallopian tube cancer, or primary peritoneal cancer. The primary study hypotheses are that the combination of pembrolizumab plus carboplatin/paclitaxel\* followed by continued pembrolizumab and maintenance olaparib is superior to carboplatin/paclitaxel alone with respect to Progression Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in participants with programmed death-ligand 1 (PD-L1) positive tumors (Combined Positive Score \[CPS\]≥10) and in all participants, and that the combination of pembrolizumab plus carboplatin/paclitaxel followed by continued pembrolizumab is superior to carboplatin/paclitaxel alone with respect to PFS per RECIST 1.1 in participants with PD-L1 positive tumors (CPS≥10) and in all participants.
Timeline
- Start
- 2018-12-18
- Primary completion
- 2024-08-26
- Completion
- 2026-04-15
Outcome
Sources disagree · no verdict is set; each source's reading is shown below
registry Carboplatin + Paclitaxel + Pembrolizumab + Olaparib vs Carboplatin + Paclitaxel; p <0.0001; Hazard Ratio (HR) 0.71 (95% CI 0.61 to 0.84) reads as mixed primary results NCT03740165 ↗
registry Carboplatin + Paclitaxel + Pembrolizumab vs Carboplatin + Paclitaxel; p = 0.5527; Hazard Ratio (HR) 1.01 (95% CI 0.87 to 1.18) reads as mixed primary results NCT03740165 ↗
release “第3相KEYLYNK−001試験において、主要評価項目である無増悪生存期間（PFS）の改善を達成したことを発表しました。” reads as met primary endpoint msd.co.jp ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Olaparib | Small molecule | 300 mg | Oral |
| Subject | Pembrolizumab | Monoclonal antibody | 200 mg | Intravenous |
| Background | Bevacizumab | Monoclonal antibody | — | Intravenous |
| Background | Carboplatin | Small molecule | — | Intravenous |
| Background | Docetaxel | Small molecule | 75 mg/m2 | Intravenous |
| Background | Paclitaxel | Small molecule | 60 mg/m2 | Intravenous |
| Background | Paclitaxel | Small molecule | 80 mg/m2 | Intravenous |
| Background | Paclitaxel | Small molecule | 175 mg/m2 | Intravenous |