Detail

Study ID: GOG 3036 Merck MK7339-001

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)

Description:
(Short Title) First-line Chemotherapy plus Pembrolizumab and Olaparib for BRCA Non-Mutated Advance EOC (MK7339-001/ENGOT-ov43/GOG-3036) or (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 Advance Epithelial Ovarian Cancer (EOC) (MK7339-001/ENGOT-ov43/GOG-3036) Pembrolizumab (MK-3475), also called KEYTRUDA® has been approved for use in certain types of cancers; however, not in ovarian cancer, and Olaparib (Lynparza®) has been approved for ovarian cancer but is not yet approved for maintenance treatment after first line treatment in non-mutated BRCA ovarian cancer, so the purpose of this study is to test the safety of the study drug, pembrolizumab (MK-3475) with chemotherapy followed by olaparib OR pembrolizumab with chemotherapy compared to chemotherapy alone to see how well the drug works and to see how your body handles the drugs. This study will also test if adding pembrolizumab (MK-3475) to standard chemotherapy or pembrolizumab to standard chemotherapy followed by olaparib improves survival compared to chemotherapy alone in women with non-mutated BRCA advanced epithelial ovarian cancer (EOC).
Location:
Sioux Falls Region
Principal Investigator:
Maria Bell, MD
Disease:
Ovary/Fallopian Tube/Primary Peritoneal
Stage:
Phase III
Status:
Active - Open to Accrual