PF-08634404 + Chemotherapy for Colorectal Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
The purpose of this study is to learn more about a new medicine called PF-08634404, and how well it works in people with cancer of the colon or rectum (CRC)). The goal is to understand if the new study medicine, combined with chemotherapy that is approved for colorectal cancer, can help people whose cancer has spread or returned after treatments taken before.
To join the study, participants must meet the following conditions:
* Be 18 years or older.
* Have colorectal cancer that has spread to other parts of your body.
* Be in good enough health to receive study treatment.
* Should not be pregnant before starting treatment.
Participants will be randomized (like flipping a coin) to one of 2 different treatment arms. The first arm (Arm A) will include the new medicine PF-08634404 in combination with chemotherapy that is approved for colorectal cancer, and the second arm (Arm B) will include an approved medicine for colorectal cancer, called Bevacizumab, in combination with chemotherapy that is approved for this type of cancer. Participants and their doctors will not know which arm they are being assigned to. Participants will receive all the study medications through intravenous (IV) infusions, which means the medicine is given directly into a vein. The treatment will be given in cycles, and participants may continue receiving it if it is helping and they are not experiencing serious side effects.
The medicine will be given at a clinical site, where trained medical staff will check participants during and after each treatment.
* The study is expected to last approximately 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 to37 days later to check their health and review any side effects.
* Follow-up will continue every 12 weeks by phone or in person or by reviewing health records to check on health status and any new treatments.
Who Is on the Research Team?
Pfizer CT.gov Call Center
Principal Investigator
Pfizer
Are You a Good Fit for This Trial?
Adults with colorectal cancer that has spread, who are in good health overall and have at least one measurable tumor. They must not be pregnant and should have normal liver and kidney function. The trial is not suitable for those outside these criteria.Inclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- PF-08634404
Trial Overview
The study compares a new drug, PF-08634404 combined with standard chemotherapy, against the approved drug Bevacizumab with chemotherapy in metastatic colorectal cancer patients. Treatments are assigned randomly and administered intravenously in cycles.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants will receive PF-08634404 intravenously (IV) in combination with Chemotherapy.
Participants will receive bevacizumab IV in combination with Chemotherapy.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Pfizer
Lead Sponsor
Albert Bourla
Pfizer
Chief Executive Officer since 2019
PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki
Patrizia Cavazzoni
Pfizer
Chief Medical Officer
MD from McGill University
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