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.

Conditions

• Ovarian Cancer
• Fallopian Tube Cancer
• Peritoneal Neoplasms

Interventions

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

Sponsors & Collaborators

• European Network of Gynaecological Oncological Trial Groups (ENGOT)

  collaborator OTHER

• Gynecologic Oncology Group

  collaborator NETWORK

• Merck Sharp & Dohme LLC

  lead INDUSTRY

Principal Investigators

• Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-12-18

Primary Completion

2024-08-26

Completion

2026-04-15

FDA Drug

Yes

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

Study Locations