Phase 2/3 Olaparib+Pembrolizumab vs Chemo+ Pembrolizumab in TNBC
Research type
Research Study
Full title
An Open-label, Randomized, Phase 2/3 Study of Olaparib Plus Pembrolizumab Versus Chemotherapy Plus Pembrolizumab After Induction of Clinical Benefit With First-line Chemotherapy Plus Pembrolizumab in Participants With Locally Recurrent Inoperable or Metastatic Triple Negative Breast Cancer (TNBC) (KEYLYNK-009)
IRAS ID
271118
Contact name
Peter Schmid
Contact email
Sponsor organisation
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co.,Inc
Eudract number
2019-001892-35
Duration of Study in the UK
4 years, 11 months, 3 days
Research summary
Triple Negative Breast Cancer (TNBC) represents 15 – 20% of all Breast cancers worldwide. Treatment of TNBC is challenging and represents an area of unmet medical need, as these tumours lack therapeutic targets, and become rapidly resistant to chemotherapy upon local recurrence and/or metastasis (even though they are often sensitive to chemotherapy at initial use). In a frequently referenced study, the median Overall Survival (OS) of all participants with mTNBC was 13.3 months.
Olaparib (MK-7339) is a type of targeted therapy called a PARP- inhibitor. PARP is an enzyme (protein) that helps damaged cells, including cancer cells, to repair themselves. Olaparib stops the PARP enzyme from repairing damage in cancer cells and thus the cancer cells die. Programmed cell death 1 (PD1) is a protein present on the surface of immune (attacking) cells which fight cancer. When immune cells meet cancer cells, PD1 becomes activated by programmed cell death ligands 1 and 2 (PDL1 and PDL2) which are proteins on the surface of cancer cells. The activated immune cells die thus stopping them from attacking the cancer. The study drug pembrolizumab has been developed to block PD1/PDL1 interaction, thereby increasing the immune attack on cancers.
This phase 2/3 study will recruit approximately 317 male and female (18+) participants in the phase 2 portion, and approximately 615 in the phase 3 portion, lasting for approximately 5 years. The purpose of this study is to assess the effectiveness and safety of Olaparib and pembrolizumab, versus pembrolizumab and Gemcitabine/Carboplatin in the treatment TNBC patients. Participants will be assigned randomly in 1:1 ratio to one of the two treatment arms.
The study is funded by Merck Sharp & Dohme Limited and will take place at 7 study centres in the UK.
REC name
London - Hampstead Research Ethics Committee
REC reference
19/LO/1462
Date of REC Opinion
29 Oct 2019
REC opinion
Further Information Favourable Opinion