MK-4280A Versus Standard of Care in Previously Treated Metastatic PD-L1 positive CRC
Research type
Research Study
Full title
A Phase 3 study of MK-4280A (coformulated favezelimab [MK-4280] plus pembrolizumab [MK-3475]) Versus Standard of Care in Previously Treated Metastatic PD-L1 positive Colorectal Cancer
IRAS ID
1003973
Contact name
David Fogelman
Contact email
Sponsor organisation
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eudract number
2021-001309-60
Clinicaltrials.gov Identifier
Research summary
In the US, colorectal cancer (CRC) is the third most common diagnosed cancer and the third leading cause of cancer death. It is estimated that 149,500 adults will be diagnosed with CRC in 2021 in the US, with 52,980 deaths expected. The 5-year survival rate is 65% for all stages of CRC, but just 14% for patients with metastatic disease. Approximately 4.5% of people will be diagnosed with colon and rectum cancer at some point during their lifetime.
This is a Phase 3, randomised, active-controlled, parallel-group, multi-site, open-label, safety and efficacy study of MK-4280A vs standard treatment in participants with a specific type of colorectal cancer that has spread to other parts of the study and who have previously received anti-cancer treatment.
MK-4280A is a mixture of 2 drugs: MK-4280 (favezelimab) and MK-3475 (pembrolizumab). MK-4280 is an experimental drug. MK-3475 has been approved by certain health authorities for treating various cancers and works by helping the immune system to fight cancer.
Approximately 432 participants will take part in this trial from approximately 21 countries and will be randomised in a 1:1 to enter either Group A or Group B:
Group A: 216 participants to receive MK-4280A administered every 3 weeks intravenously, for up to approximately 2 years (35 doses).
Group B: 216 participants to receive standard treatment (regorafenib, taken every 4 weeks orally or TAS-102, a combination of trifluridine and tipiracil hydrochloride, taken every 4 weeks twice daily).
The time each participant spends on the trial will depend on their treatment group and response to treatment.
This study is sponsored by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. (“MSD”), of Kenilworth, New Jersey, USA.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
21/NW/0221
Date of REC Opinion
21 Sep 2021
REC opinion
Further Information Favourable Opinion