Pembrolizumab (MK3457) in high risk NMIBC patients unresponsive to BCG
Research type
Research Study
Full title
A Phase II Clinical Trial to Study the Efficacy and Safety of Pembrolizumab (MK-3475) in Subjects with High Risk Non-muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Bacillus Calmette-Guerin (BCG) Therapy
IRAS ID
200373
Contact name
Andrew Protheroe
Contact email
Sponsor organisation
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc
Eudract number
2014-004026-17
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
This is a single arm, multi-site, open-label trial of pembrolizumab (MK-3475) in subjects with high risk non-muscle-invasive bladder cancer (NMIBC) unresponsive to Bacillus Calmette Guerin (BCG), who are considered ineligible for removal for the bladder or have elected not to undergo the procedure, to be conducted in conformance with Good Clinical Practices
Pembrolizumab (MK-3475) (previously known as SCH 9000475) is a potent and highly selective humanized monoclonal antibody (mAb) designed to block the interaction between Programmed cell death protein (PD-1) and its ligands, Programmed Cell Death 1 and 2 (PD-L1 and PD- L2).
PD1 is a protein present on the surface of immune cells which fight cancer. When immune cells encounter cancer cells, PD1 becomes activated by 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.
Approximately 260 male/female subjects older than 18 with high risk NMIBC (Non muscle invasive bladder cancer may be enrolled into the two
cohorts of this study with 130 subjects in each cohort.Cohort A will enroll participants with carcinoma in situ (CIS-where the tumour is still confined to the site from which it started) at baseline (CIS only or Ta+CIS, T1+CIS);
Cohort B will enroll participants without CIS at baseline (High Grade Ta or Any Grade T1).Participants will receive 200mg pembrolizumab on Day 1 of each 3-week dosing cycle.Each participant will receive the study medication Pembrolizumab for approximately 2 years.
The purpose of this study is to evaluate the anti tumor activity of Pembrolizumab as determined by cystoscopy, cytology, biopsy (if applicable) and radiologic imaging by central pathology and radiology review.
The study is funded by Merck Sharp & Dohme Limited and will take place at two study centres in the UK.
REC name
South Central - Oxford C Research Ethics Committee
REC reference
16/SC/0143
Date of REC Opinion
19 Apr 2016
REC opinion
Further Information Favourable Opinion