Phase 3 Study of Pembrolizumab plus Enzalutamide in mCRPC
Research type
Research Study
Full title
A Phase 3, Randomized, Double-blind Trial of Pembrolizumab (MK-3475) Plus Enzalutamide Versus Placebo Plus Enzalutamide in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (KEYNOTE-641)
IRAS ID
261202
Contact name
Johann de Bono
Contact email
Sponsor organisation
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eudract number
2018-004117-40
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 8 months, 0 days
Research summary
Prostate cancer is the second most common cancer diagnosed in men worldwide, with an estimated annual incidence of over 1 million and an expected 300,000 plus deaths annually.
Men who are diagnosed with metastatic (spreading) prostate cancer, are treated first with therapy known as androgen deprivation therapy (ADT). This often controls the cancer for years but it invariably progresses. . Once ADT no longer works, the cancer is known as Metastatic Castration-Resistant Prostate Cancer (mCRPC).Endocrine (hormone) therapies that target the cancer, abiraterone and enzalutamide, and the medicines called taxanes, docetaxel and cabazitaxel, are approved to treat mCRPC. However cabazitaxel which is recommended after docetaxel, can have serious side effects and sometimes can lead to death. Thus, an unmet need remains after treatment with targeted endocrine therapy and docetaxel.
Programmed cell death 1 (PD1) is a protein present on the surface of immune (attacking) cells which fight cancer. When immune cells come upon 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 become exhausted or 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.
The Purpose of this Phase 3 Study is to test the safety and effectiveness of Pembrolizumab with Enzalutamide compared with Enzalutamide and placebo. The study will last approximately 4 and half years and will recruit 1200 participants, aged at least 18 years with mCRPC.
Participants will be assigned randomly in 1:1 ratio to one of the 2 treatment arms.
The Study is funded by Merck Sharp & Dohme Limited and will take place at 10 study centres in the UK.REC name
London - Chelsea Research Ethics Committee
REC reference
19/LO/1057
Date of REC Opinion
28 Aug 2019
REC opinion
Further Information Favourable Opinion