Ph3 perioperative pembrolizumab/placebo+neoadjuvant chemotherapy, MIBC
Research type
Research Study
Full title
A Phase 3, Randomized Double Blind Study to Evaluate Peri-operative Pembrolizumab (MK-3475) + Neoadjuvant Chemotherapy versus Perioperative Placebo + Neoadjuvant Chemotherapy in Cisplatin-Eligible Participants with Muscle-invasive Bladder Cancer (KEYNOTE-866)
IRAS ID
264067
Contact name
Vincent Khoo
Contact email
Sponsor organisation
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eudract number
2018-003808-39
Duration of Study in the UK
5 years, 2 months, 7 days
Research summary
Muscle-invasive Bladder Cancer (MIBC) accounts for approximately 30% of all bladder cancers. It is an aggressive cancer where cancer cells have spread beyond the inner lining of the bladder and into the muscle layer. Cystectomy (surgery to remove all or part of the bladder) is currently the gold standard of treatment. Given poor outcomes in this population, neoadjuvant (before the main treatment) chemotherapy (NAC) has emerged as the preferred modality of delivering systemic therapy to non-metastatic MIBC patients planning to undergo surgery. This poor utilisation of NAC and lack of data on the benefit of alternative regimens underscores the need for improved therapies in this population/setting.
This study is designed to assess the anti-tumour efficacy and safety of pembrolizumab in combination with chemotherapy and surgery versus placebo (a look-alike product with no active ingredients) with chemotherapy and surgery.
Pembrolizumab is a type of immunotherapy that stimulates the body's immune system to fight cancer cells. Pembrolizumab targets and blocks a protein called PD-1 on the surface of certain immune cells called T-cells. Blocking PD-1 triggers the T-cells to find and kill cancer cells. Pembrolizumab has been approved for certain types of bladder cancer, but not for non-metastatic MIBC.
The chemotherapies being used in this study (Gemcitabine and Cisplatin) are approved for patients with MIBC, however combination of pembrolizumab and chemotherapy is considered experimental.
Approximately 790 participants will be randomised in a 1:1 ratio to receive either Arm A (pembrolizumab + chemotherapy before surgery + pembrolizumab only after surgery) or Arm B (placebo + chemotherapy before surgery + placebo only after surgery). Each participant will be in the study for approximately 5 years including 1 year of treatment and 4 years of follow-up.
The study is funded by Merck Sharp and Dohme Limited and will take place at 9 study centres in UK.
REC name
London - Chelsea Research Ethics Committee
REC reference
19/LO/0943
Date of REC Opinion
14 Aug 2019
REC opinion
Further Information Favourable Opinion