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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
Sponsor: Pfizer
Summary
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.
Official 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
800
Start Date
2025-12-11
Completion Date
2031-08-17
Last Updated
2026-10-08
Healthy Volunteers
No
Conditions
Interventions
PF-08634404
Solution for infusion
Bevacizumab
Injection for intravenous use
Chemotherapy
Injection for intravenous use
Locations (372)
Ironwood Cancer & Research Centers
Chandler, Arizona, United States
Banner Gateway Medical Center
Gilbert, Arizona, United States
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
Ironwood Cancer & Research Centers
Gilbert, Arizona, United States
Ironwood Cancer & Research Centers
Glendale, Arizona, United States
Ironwood Cancer & Research Centers
Goodyear, Arizona, United States
Ironwood Cancer & Research Centers
Mesa, Arizona, United States
Ironwood Cancer & Research Centers
Mesa, Arizona, United States
Banner MD Anderson Cancer Center at Banner University Medical Center- Phoenix
Phoenix, Arizona, United States
Banner MD Anderson Cancer Center
Phoenix, Arizona, United States
Banner University Medical Center Phoenix
Phoenix, Arizona, United States
Ironwood Cancer & Research Centers
Phoenix, Arizona, United States
Mayo Clinic Building- Phoenix
Phoenix, Arizona, United States
Mayo Clinic Hospital
Phoenix, Arizona, United States
Mayo Clinic
Scottsdale, Arizona, United States
Ironwood Cancer & Research Centers
Scottsdale, Arizona, United States
Banner Boswell Medical Center
Sun City, Arizona, United States
Banner MD Anderson Cancer Center
Sun City, Arizona, United States
BMDACC Boswell
Sun City, Arizona, United States
Highlands Oncology Group
Fayetteville, Arkansas, United States
Highlands Oncology Group
Rogers, Arkansas, United States
Highlands Oncology Group
Springdale, Arkansas, United States
UCSF at Berkeley Outpatient Center
Berkeley, California, United States
Alta Bates Summit Medical Center-Herrick Campus Comprehensive Cancer Center
Berkeley, California, United States
UCSD Medical Center - Encinitas
Encinitas, California, United States
Palo Alto Medical Foundation - Fremont Center
Fremont, California, United States
UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion)
La Jolla, California, United States
UC San Diego Moores Cancer Center
La Jolla, California, United States
UCSD Koman Family Outpatient Pavilion
La Jolla, California, United States
Palo Alto Medical Foundation - Palo Alto Center
Palo Alto, California, United States
Roseville Medical Plaza Care Center
Roseville, California, United States
Sutter Medical Center, Sacramento Infusion Center at Roseville
Roseville, California, United States
University of California, Davis Comprehensive Cancer Center
Sacramento, California, United States
University of California, Davis Medical Center
Sacramento, California, United States
UC San Diego McGrath Outpatient Pavilion - Hillcrest
San Diego, California, United States
UC San Diego Medical Center - Hillcrest
San Diego, California, United States
UC San Diego Medical Center - Rancho Bernardo
San Diego, California, United States
UCSF at China Basin
San Francisco, California, United States
UCSF at Mount Zion
San Francisco, California, United States
UCSF at Parnassus
San Francisco, California, United States
UCSF Medical Center
San Francisco, California, United States
Dorothy Schneider Cancer Center
San Mateo, California, United States
Palo Alto Medical Foundation - San Mateo Care Center
San Mateo, California, United States
Airway Drive Care Center
Santa Rosa, California, United States
Palo Alto Medical Foundation - Sunnyvale Center
Sunnyvale, California, United States
UCSD Medical Center - Vista
Vista, California, United States
Rocky Mountain Cancer Centers, LLP
Aurora, Colorado, United States
Rocky Mountain Cancer Centers - Boulder
Boulder, Colorado, United States
Rocky Mountain Cancer Centers, LLP
Centennial, Colorado, United States
Rocky Mountain Cancer Centers, LLP
Colorado Springs, Colorado, United States
Rocky Mountain Cancer Centers, LLP
Colorado Springs, Colorado, United States
Intermountain Health Cancer Center Saint Joseph
Denver, Colorado, United States
Intermountain Health Saint Joseph Hospital - Research Office
Denver, Colorado, United States
Intermountain Health Saint Joseph Hospital
Denver, Colorado, United States
Rocky Mountain Cancer Centers, LLP
Denver, Colorado, United States
Rocky Mountain Cancer Centers, LLP
Denver, Colorado, United States
Rocky Mountain Cancer Centers, LLP
Englewood, Colorado, United States
Banner MD Anderson Cancer Center at North Colorado Medical Center
Greeley, Colorado, United States
Banner North Colorado Medical Center - Hospital
Greeley, Colorado, United States
Rocky Mountain Cancer Centers, LLP
Lakewood, Colorado, United States
Rocky Mountain Cancer Centers, LLP
Littleton, Colorado, United States
Rocky Mountain Cancer Centers, LLP
Lone Tree, Colorado, United States
Rocky Mountain Cancer Centers, LLP
Longmont, Colorado, United States
Banner MD Anderson Cancer Center at North Colorado Medical Center - Loveland Campus
Loveland, Colorado, United States
Banner North Colorado Medical Center - Loveland Campus (Hospital)
Loveland, Colorado, United States
Rocky Mountain Cancer Centers, LLP
Pueblo, Colorado, United States
Rocky Mountain Cancer Centers, LLP
Thornton, Colorado, United States
Stamford Hospital
Stamford, Connecticut, United States
Florida Cancer Specialists
Bonita Springs, Florida, United States
Florida Cancer Specialists
Bradenton, Florida, United States
Comprehensive Hematology Oncology
Brandon, Florida, United States
Florida Cancer Specialists
Cape Coral, Florida, United States
BRCR Global - Coral Springs
Coral Springs, Florida, United States
Florida Cancer Specialists
Fort Myers, Florida, United States
Florida Cancer Specialists
Fort Myers, Florida, United States
Mayo Clinic Pharmacy
Jacksonville, Florida, United States
Mayo Clinic
Jacksonville, Florida, United States
Comprehensive Hematology Oncology
Largo, Florida, United States
Cancer Care Centers of Brevard, Inc.
Melbourne, Florida, United States
Florida Cancer Specialists
N. Venice, Florida, United States
Florida Cancer Specialists
Naples, Florida, United States
Mid Florida Hematology and Oncology Center
Orange City, Florida, United States
Cancer Care Centers of Brevard, Inc.
Palm Bay, Florida, United States
Comprehensive Hematology Oncology
Palm Harbor, Florida, United States
Florida Cancer Specialists
Port Charlotte, Florida, United States
Cancer Care Centers of Brevard, Inc.
Rockledge, Florida, United States
Florida Cancer Specialists
Sarasota, Florida, United States
Comprehensive Hematology Oncology
St. Petersburg, Florida, United States
Comprehensive Hematology Oncology
St. Petersburg, Florida, United States
Comprehensive Hematology Oncology
Trinity, Florida, United States
University Cancer & Blood Center, LLC
Athens, Georgia, United States
Saint Alphonsus Regional Medical Center
Boise, Idaho, United States
Saint Alphonsus Nampa Cancer Care Center
Nampa, Idaho, United States
Illinois Cancer Specialists
Arlington Heights, Illinois, United States
Illinois CancerCare - Bloomington
Bloomington, Illinois, United States
Illinois Cancer Specialists
Chicago, Illinois, United States
Illinois CancerCare - Galesburg
Galesburg, Illinois, United States
Hope and Healing Clinical Research LLC
Hinsdale, Illinois, United States
Hope and Healing Clinical Research LLC
Morris, Illinois, United States
Hope and Healing Clinical Research LLC
New Lenox, Illinois, United States