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)
Kaiser Permanente Oncology Clinical Trial - Walnut Creek ( Site 0080)(2.8 mi away)Contact
+248 other location
ovarian epithelial cancer
cancer antigen 125
primary peritoneal carcinoma
ovarian epithelial carcinoma
cancer of the ovary
fallopian tube cancer
epithelial ovarian cancer
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
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) 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.
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+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:
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
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
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.
Placebo for Pembrolizumab,
Placebo for olaparib
Clinical Study Identifier
Merck Sharp & Dohme Corp.
Last Modified on
9 January 2021
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