Phase II Trial of MK-3475 in Subjects with mCRPC
Research type
Research Study
Full title
Phase II Trial of Pembrolizumab (MK-3475) in Subjects with Metastatic Castration-Resistant Prostate Cancer (mCRPC) Previously Treated with Chemotherapy
IRAS ID
205702
Contact name
Johann De Bono
Contact email
Sponsor organisation
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eudract number
2015-003644-40
Duration of Study in the UK
3 years, 6 months, days
Research summary
Summary of Research
Prostate cancer is the second most common cancer in men worldwide. Over 1 million cases occur each year, with over 30,000 expected deaths.
Men who are initially diagnosed with prostate cancer found only in the prostate gland may be treated with radiation or surgery, while men who develop metastatic (spreading) prostate cancer, are usually treated with androgen deprivation therapy (ADT). Once the ADT no longer works in treating the cancer, it is known as (metastatic) castrate-resistant prostate cancer (mCRPC).
A number of important therapies been developed to treat mCRPC, including medicines such as docetaxel, carbazitaxel and mitoxantrone. Also, some therapies more targeted to the prostate gland have been examined in clinical trials. However, carbazitaxel has shown to be a toxic therapy, and men with mCRPC after docetaxel treatment are encouraged to participate in clinical trials.
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.
This Phase II nonrandomized, multinational, open-label trial (called KEYNOTE-199) of pembrolizumab will study the possible activity of pembrolizumab as single therapy in male subjects at least 18 years old with mCRPC, who have previously received docetaxel-based chemotherapy. Approximately 250 subjects will enter this clinical trial, which will last 36 months from the time the subject first signs the consent form. Subjects will receive 200mg of pembrolizumab (MK3475) intravenously every 3 weeks (Q3W).
The study is sponsored by MERCK Sharp & Dohme Limited and will take place at 4 sites in UK.
Summary of Results
Please refer to the results posted: https://clinicaltrials.gov/ct2/show/results/NCT02787005?term=NCT02787005&draw=2&rank=1
REC name
London - Surrey Borders Research Ethics Committee
REC reference
16/LO/1034
Date of REC Opinion
5 Jul 2016
REC opinion
Further Information Favourable Opinion