NCT03740165

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)

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) (KEYLYNK-001 / ENGOT-ov43 / GOG-3036)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,367 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Following a lead-in period during which all participants receive a single 3-week cycle of carboplatin/paclitaxel\*, participants will be randomly assigned in to one of three treatment arms, and will receive carboplatin/paclitaxel\* for 5 cycles plus: * Pembrolizumab + Olaparib * Pembrolizumab + Placebo for Olaparib * Placebo for Pembrolizumab + Placebo for Olaparib * At Investigator's discretion and prior to participant randomization, one of the following carboplatin/paclitaxel regimens is to be selected: 1. up to 5 cycles of carboplatin Area Under the Curve (AUC)5 or AUC6 AND paclitaxel 175 mg/m\^2 on Day 1 of each 3-week cycle 2. up to 5 cycles of carboplatin AUC5 or AUC6 on Day 1 of each 3-week cycle AND paclitaxel 80 mg/m\^2 on Days 1, 8 and 15 of each 3-week cycle; or 3. up to 5 cycles of carboplatin AUC2 or AUC2.7 AND paclitaxel 60 mg/m\^2 on Days 1, 8 and 15 of each 3-week cycle. Docetaxel may be considered for participants who experience either a severe hypersensitivity reaction to paclitaxel or an AE requiring discontinuation of paclitaxel only after consultation with the Sponsor. The recommended dose as determined by the Scottish Gynaecological Cancer Trials Group is Docetaxel 75 mg/m\^2 Q3W plus carboplatin AUC 5 Q3W.

Conditions

• Ovarian Cancer
• Fallopian Tube Cancer
• Peritoneal Neoplasms

Interventions

Type	Name	Description
BIOLOGICAL	Pembrolizumab	IV infusion
DRUG	Placebo for pembrolizumab	IV infusion
DRUG	Carboplatin	IV infusion
DRUG	Paclitaxel	IV infusion
DRUG	Olaparib	Oral tablet
DRUG	Placebo for olaparib	Oral tablet
BIOLOGICAL	Bevacizumab	IV infusion
DRUG	Docetaxel	IV infusion

Timeline

• Start date: 2018-12-18
• Primary completion: 2024-08-26
• Completion: 2026-05-29
• First posted: 2018-11-14
• Last updated: 2025-10-22
• Results posted: 2025-09-12

Locations

227 sites across 22 countries: United States, Australia, Belgium, Brazil, Canada, Chile, Colombia, Czechia, France, Germany, Hungary, Israel, Italy, Japan, Poland, Russia, South Africa, South Korea, Spain, Taiwan, Turkey (Türkiye), Ukraine

Regulatory

• FDA-regulated drug study