MK-3475-905
Research type
Research Study
Full title
A Randomized Phase 3 Study Evaluating Cystectomy with Perioperative Pembrolizumab and Cystectomy with Perioperative Enfortumab Vedotin and Pembrolizumab versus Cystectomy Alone in Cisplatin-Ineligible Participants with Muscle-Invasive Bladder Cancer (KEYNOTE-905/EV-303)
IRAS ID
264047
Contact name
Mohammed Naveed Sarwar
Contact email
Sponsor organisation
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eudract number
2018-003809-26
Duration of Study in the UK
7 years, 10 months, days
Research summary
Bladder cancer is one of the most common types of cancer worldwide, with 25% of new cases being muscle-invasive bladder cancers (MIBC). The standard of care for these patients is cisplatin-based chemotherapy followed by surgery to remove the bladder and pelvic lymph nodes. The five-year survival rates for patients who receive chemotherapy before surgery are 5-10% better than those who receive surgery alone. However, approximately 40% of patients are cisplatin-ineligible, and the standard of care for these patients is surgery alone. Therefore, there is an unmet need for new therapies for MIBC patients that can be used in combination with surgery.
Programmed cell death 1 (PD1) is a protein present on the surface of immune (attacking) cells which fight cancer. When immune cells meet 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 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. Pembrolizumab is approved for several other types of cancer and has shown promising results in other studies of advanced bladder cancer. Therefore, it is thought that treatment with pembrolizumab will also work for MIBC as therapy before and after surgery.
This phase 3 study will last approximately 82 months and will recruit approximately 610 cisplatin-ineligible participants, aged at least 18 years, with MIBC. The purpose of the study is to assess the effectiveness and safety of pembrolizumab plus surgery versus surgery alone. Participants will be assigned randomly in 1:1 ratio to one of the two treatment arms.
The study is funded by Merck Sharp & Dohme Limited and will take place at eleven study centres in the UK.
REC name
London - City & East Research Ethics Committee
REC reference
19/LO/0879
Date of REC Opinion
26 Jul 2019
REC opinion
Further Information Favourable Opinion