C6461003 A Study to Learn about PF-08634404 in Combination with Chemotherapy in mCRC
Research type
Research Study
Full title
AN INTERVENTIONAL, PHASE 3, DOUBLE-BLIND, RANDOMIZED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY VERSUS BEVACIZUMAB IN COMBINATION WITH CHEMOTHERAPY IN TREATMENT-NAÏVE PARTICIPANTS WITH METASTATIC COLORECTAL CANCER
IRAS ID
1013113
Contact name
Svitlana Tonkovyd
Contact email
Sponsor organisation
Pfizer Inc.
Clinicaltrials.gov Identifier
Research summary
This study is being done to learn more about a new medicine called PF-08634404, and how well it works in people with colorectal cancer (CRC). The goal is to understand if PF-08634404, when combined with chemotherapy that is approved for CRC, can help people whose cancer has spread or returned after previous treatments.
Participants must meet the following conditions to take part:
• Be 18 years or older.
• Have CRC that has spread to other areas.
• Be in good enough health to receive study treatment.
• Have a negative pregnancy test (if applicable) before starting treatment.
Participants will be randomized (like flipping a coin) to one of 2 different treatment arms. The first arm will include PF-08634404 in combination with chemotherapy approved for CRC. The second arm will include an approved drug for CRC, called Bevacizumab, in combination with chemotherapy that is approved for CRC. Participants and their doctors will not know which arm they are assigned too. Participants will receive all study medications through intravenous infusions, which means the medicine is given directly into a vein. The treatment will be given in cycles, and participants may continue treatment as long as it is helping and they are not experiencing serious side effects. The medicine will be given at a clinical trial site, where trained medical staff will monitor participants during and after each treatment.
• The study is expected to last up to 33 months for each participant.
• Participants will have regular visits to the study site for treatment, health checks, and tests.
• After stopping treatment, participants will return for a final visit about 30–37 days later to check their health and review any side effects.
• Follow-up will continue every 12 weeks by phone, in person or by reviewing health records to check on health status and any new treatments.REC name
London - Chelsea Research Ethics Committee
REC reference
25/LO/0793
Date of REC Opinion
9 Feb 2026
REC opinion
Further Information Unfavourable Opinion