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)

  • End date
    May 30, 2025
  • participants needed
  • sponsor
    Merck Sharp & Dohme Corp.
Updated on 4 July 2021
tumor markers
solid tumors
cancer chemotherapy
solid tumour
ovarian cancer
fallopian tube
ovarian epithelial cancer
cancer antigen 125
excisional biopsy
peritoneal cancer
primary peritoneal carcinoma
tumor debulking
ovarian epithelial carcinoma
cancer of the ovary
fallopian tube cancer
epithelial ovarian cancer
debulking surgery
primary debulking surgery
interval debulking surgery


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 (CPS10) and in all participants.


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

  • 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.

Condition Ovarian disorder, Peritoneal Neoplasm, Abdominal Neoplasm, Fallopian Tube Cancer, Ovarian Cancer, Neoplasm of unspecified nature of digestive system, Ovarian Function, Recurrent Ovarian Cancer, Abdominal Cancer, Digestive System Neoplasms, ovarian carcinomas, cancer, ovarian, cancer ovarian, cancer of the ovary, fallopian tube cancers, ovarian tumors
Treatment docetaxel, carboplatin, Paclitaxel, bevacizumab, Pembrolizumab, olaparib, Placebo for Pembrolizumab, Placebo for olaparib
Clinical Study IdentifierNCT03740165
SponsorMerck Sharp & Dohme Corp.
Last Modified on4 July 2021

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