Pembrolizumab+Olaparib vs Abiraterone Acetate or Enzalutamide in mCRPC
Research type
Research Study
Full title
A Phase 3, Randomized Open-label Study of Pembrolizumab (MK-3475) Plus Olaparib Versus Abiraterone Acetate or Enzalutamide in Participants with Metastatic Castrationresistant Prostate Cancer (mCRPC) Who are Unselected for Homologous Recombination Repair Defects and Have Failed Prior Treatment with One Next generation Hormonal Agent (NHA) and Chemotherapy (KEYLYNK-010)
IRAS ID
262406
Contact name
Johann de Bono
Contact email
Sponsor organisation
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co.,Inc
Eudract number
2018-004118-16
Duration of Study in the UK
2 years, 3 months, 14 days
Research summary
Prostate cancer represents the second most common cancer diagnosed in men worldwide with an incidence of over 1,000,000 cases and >300,000 deaths annually. While the currently available therapies are initially effective, patients with metastatic prostate cancer develop a lethal disease stage known as metastatic castration-resistant prostate cancer (mCRPC) and no curative
therapy is currently available therefore a high unmet medical need for an effective well-tolerated therapy remains.
This clinical trial will study the combination of study drugs olaparib and pembrolizumab in the treatment of participants with mCRPC who did not respond to treatment with either abiraterone acetate or enzalutamide (but not both) and to chemotherapy. Olaparib is a type of targeted therapy called a PARP inhibitor. PARP is protein that helps damaged cells to repair themselves. Olaparib stops PARP working. Some cancer cells rely on PARP to keep their DNA healthy. This includes cancer cells with a change in the BRCA gene. So, when olaparib stops PARP from repairing DNA damage, the cancer cells die. This type of drug is called a cancer growth blocker. Pembrolizumab is a type of immunotherapy that stimulates the body's immune system to fight cancer cells. Pembrolizumab targets and blocks a protein called PD-1 on the surface of certain immune cells called T-cells.Blocking PD-1 triggers the T-cells to find and kill cancer cells.
The study is designed to assess the overall survival and progression free survival (determined by imaging) of patients between the experimental treatments and standard of care treatment. Approximately 780 participants will be randomly assigned in 2:1 ratio to treatment (for approximately 2 years) with either pembrolizumab and olaparib or standard of care treatments abiraterone acetate or enzalutamide.The study is funded by Merck Sharp and Dohme Limited and will take place at 8 study centres in UK.
REC name
London - Chelsea Research Ethics Committee
REC reference
19/LO/0928
Date of REC Opinion
8 Aug 2019
REC opinion
Further Information Favourable Opinion