Phase Ib/II Trial of Pembrolizumab (MK-3475) in Combination Therapies
Research type
Research Study
Full title
Phase Ib/II Trial of Pembrolizumab (MK-3475) Combination Therapies in Metastatic Castration-Resistant Prostate Cancer (mCRPC) (KEYNOTE-365)
IRAS ID
213379
Contact name
Johann de Bono
Contact email
Sponsor organisation
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc
Eudract number
2016-002312-41
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 5 months, 31 days
Research summary
Prostate cancer represents the second most common cancer in men worldwide.
Prostate cancer found only in the prostate gland may be treated successfully with radiation therapy or surgery. 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 Ib/II trial is to examine the safety, tolerability, and efficacy of pembrolizumab in combination with different agents. Approximately 210 males older than 18 will be assigned to one of the three study groups based on prior treatment for mCRPC and other eligibility criteria. All patients will receive 200mg of pembrolizumab (MK-3475) intravenously every 3 weeks together with the study doctor’s choice of chemotherapy.
The study is funded by Merck Sharp & Dohme Limited and will take place at 2 study centre in the UK.
REC name
London - Chelsea Research Ethics Committee
REC reference
16/LO/1782
Date of REC Opinion
10 Nov 2016
REC opinion
Further Information Favourable Opinion