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)

  • STATUS
    Recruiting
  • End date
    May 30, 2025
  • participants needed
    1284
  • sponsor
    Merck Sharp & Dohme Corp.
Updated on 4 July 2021
paclitaxel
cancer
tumor markers
carboplatin
pembrolizumab
bevacizumab
docetaxel
solid tumors
cancer chemotherapy
solid tumour
olaparib
ovarian cancer
BRCA1/2
BRCA1
fallopian tube
mk-3475
ovarian epithelial cancer
cancer antigen 125
excisional biopsy
carcinosarcoma
carboplatin/paclitaxel
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

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 (CPS10) and in all participants.

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
  • 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.

Details
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

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note