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)

Official Title

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)

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 Tumours Version 1.1 (RECIST 1.1) and/or Overall Survival (OS), 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 and/or OS.

Trial Description

Primary Outcome:

• Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1) as Assessed by the Investigator
• Overall Survival (OS)

Secondary Outcome:

• PFS Per RECIST 1.1 As Assessed by Blinded Independent Central Review
• PFS After Next-line Treatment (PFS2) Following Discontinuation of Study Treatment As Assessed by the Investigator
• Number of Participants Who Experience an Adverse Event (AE)
• Number of Participants Who Discontinue Study Treatment Due to an AE
• Change from Baseline in Global Health Status/Quality of Life (GHS/QoL) Score Using Questions from the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30)
• Change from Baseline in Abdominal and Gastrointestinal (Abdominal/GI) Symptoms Score Using the EORTC Quality of Life Questionnaire-Ovarian Cancer (QLQ-OV28) Abdominal/GI Symptom Scale
• Time to First Subsequent Anti-cancer Treatment (TFST)
• Time to Second Subsequent Anti-cancer Treatment (TSST)
• Time to Discontinuation of Study Treatment or Death (TDT)
• Pathological Complete Response (pCR) Rate
• Time Without Symptom of Disease Progression or Toxicity of Treatment (TWiST)

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:

• Pembrolizumab+Olaparib,
• Pembrolizumab+Placebo for Olaparib, or
• 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.

View this trial on ClinicalTrials.gov