Phase 3 study of MK-3475 vs placebo for HCC after complete response
Research type
Research Study
Full title
A Phase 3 Double-blinded, Two-arm Study to Evaluate the Safety and Efficacy of Pembrolizumab (MK-3475) versus Placebo as Adjuvant Therapy in Participants with Hepatocellular Carcinoma and Complete Radiological Response after Surgical Resection or Local Ablation (KEYNOTE-937)
IRAS ID
262671
Contact name
Daniel Palmer
Contact email
Sponsor organisation
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eudract number
2018-004800-20
Duration of Study in the UK
10 years, 2 months, 14 days
Research summary
Hepatocellular carcinoma (HCC) (liver cancer) is one of the leading causes of cancer deaths worldwide. About 30% of HCC patients who have early stage disease may be able to be treated with curative options, which can either remove or destroy the tumour. These treatments have a 5-year survival rate of 40–80% depending on the type of treatment, however tumour recurrence is common for these patients at a rate of approximately 50% at 3 years. There is no standard of care adjuvant therapy (treatment after surgery) for HCC patients, therefore there is an unmet need to develop such therapy to prevent disease recurrence.
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 in the USA for the treatment of HCC for patients previously treated with a drug called Sorafenib. Therefore it is thought that treatment with pembrolizumab will also work for HCC as adjuvant therapy.
This phase 3 study will last approximately 10 years and will recruit approximately 950 participants, aged at least 18 years, with complete radiological response after HCC. The purpose of the study is to assess the effectiveness and safety of pembrolizumab versus placebo as adjuvant therapy. 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 nine study centres in the UK.
REC name
East of England - Cambridge South Research Ethics Committee
REC reference
19/EE/0152
Date of REC Opinion
2 Jul 2019
REC opinion
Further Information Favourable Opinion