Symbiotic-GI-03: A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Metastatic Colorectal Cancer (NCT07222800)
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
🩺 Plain-English Summary (8th-Grade Level)
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 can join: Review the eligibility criteria below.
Location: Ironwood Cancer & Research Centers — Chandler, Arizona
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (308 Sites)
Showing the first 25 of 308 sites.
- Ironwood Cancer & Research Centers — Chandler, Arizona
- Ironwood Cancer & Research Centers — Gilbert, Arizona
- Ironwood Cancer & Research Centers — Glendale, Arizona
- Ironwood Cancer & Research Centers — Goodyear, Arizona
- Ironwood Cancer & Research Centers — Mesa, Arizona
- Ironwood Cancer & Research Centers — Mesa, Arizona
- Ironwood Cancer & Research Centers — Phoenix, Arizona
- Mayo Clinic Building- Phoenix — Phoenix, Arizona
- Mayo Clinic Hospital — Phoenix, Arizona
- Mayo Clinic — Scottsdale, Arizona
- Ironwood Cancer & Research Centers — Scottsdale, Arizona
- Highlands Oncology Group — Fayetteville, Arkansas
- Highlands Oncology Group — Rogers, Arkansas
- Highlands Oncology Group — Springdale, Arkansas
- UCSF at Berkeley Outpatient Center — Berkeley, California
- Alta Bates Summit Medical Center-Herrick Campus Comprehensive Cancer Center — Berkeley, California
- Palo Alto Medical Foundation - Fremont Center — Fremont, California
- Palo Alto Medical Foundation - Palo Alto Center — Palo Alto, California
- Roseville Medical Plaza Care Center — Roseville, California
- Sutter Medical Center, Sacramento Infusion Center at Roseville — Roseville, California
- UCSF at China Basin — San Francisco, California
- UCSF at Mount Zion — San Francisco, California
- UCSF at Parnassus — San Francisco, California
- UCSF Medical Center — San Francisco, California
- Dorothy Schneider Cancer Center — San Mateo, California
📞 Contact the Study Coordinator
Phone: (800) 718-1021
Email: ClinicalTrials.gov_Inquiries@pfizer.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
Explore by condition: All Intestinal Neoplasms clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.