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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
2031-08-01
Last Updated
2026-07-06
Healthy Volunteers
No
Conditions
Interventions
PF-08634404
Solution for infusion
Bevacizumab
Injection for intravenous use
Chemotherapy
Injection for intravenous use
Locations (259)
Ironwood Cancer & Research Centers
Chandler, 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
Ironwood Cancer & Research Centers
Phoenix, Arizona, United States
Ironwood Cancer & Research Centers
Scottsdale, 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
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
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
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
Rocky Mountain Cancer Centers, LLP
Pueblo, Colorado, United States
Rocky Mountain Cancer Centers, LLP
Thornton, Colorado, 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
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 Cancer Services
Hinsdale, Illinois, United States
Hope and Healing Cancer Services
New Lenox, Illinois, United States
Illinois Cancer Specialists
Niles, Illinois, United States
Illinois CancerCare-Ottawa-Fox River Cancer Center
Ottawa, Illinois, United States
Illinois CancerCare-Pekin
Pekin, Illinois, United States
Illinois Cancer Care
Peoria, Illinois, United States
Illinois CancerCare-Peru - Valley Regional Cancer Center
Peru, Illinois, United States
Illinois CancerCare-Washington
Washington, Illinois, United States
Franciscan Health
Indianapolis, Indiana, United States
Franciscan Health Mooresville
Mooresville, Indiana, United States
New England Cancer Specialists
Topsham, Maine, United States
New England Cancer Specialists
Westbrook, Maine, United States
Greater Baltimore Medical Center
Baltimore, Maryland, United States
Brigham and Women's Hospital (BWH)
Boston, Massachusetts, United States
Dana-Farber Cancer Institute (DFCI)
Boston, Massachusetts, United States
Dana-Farber Brigham Cancer Center - Foxborough
Foxborough, Massachusetts, United States
Dana-Farber Cancer Institute -Chestnut Hill
Newton, Massachusetts, United States
The Cancer & Hematology Centers
Big Rapids, Michigan, United States
The Cancer & Hematology Centers
Grand Rapids, Michigan, United States
The Cancer & Hematology Centers
Grand Rapids, Michigan, United States
The Cancer & Hematology Centers
Holland, Michigan, United States
The Cancer & Hematology Centers
Norton Shores, Michigan, United States
Avera Cancer Institute- Marshall
Marshall, Minnesota, United States
Cancer Partners of Nebraska
Lincoln, Nebraska, United States
Renown Health Medical Oncology
Reno, Nevada, United States
Renown Regional Medical Center
Reno, Nevada, United States
NYOH Albany Cancer Center
Albany, New York, United States
Hematology-Oncology Associates of Central New York, PC
Auburn, New York, United States
North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists
Babylon, New York, United States
North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists
Brooklyn, New York, United States
Hematology-Oncology Associates of Central New York, PC
Camillus, New York, United States
New York Oncology Hematology - Clifton Park Cancer Center
Clifton Park, New York, United States
Hematology-Oncology Associates of Central New York, PC
East Syracuse, New York, United States
North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists
New Hyde Park, New York, United States
North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists
New York, New York, United States
Hematology Oncology Associates of Rockland
Nyack, New York, United States
North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists
Patchogue, New York, United States
North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists
Port Jefferson Station, New York, United States
North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists
Riverhead, New York, United States
North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists
Shirley, New York, United States
North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists
The Bronx, New York, United States
Oncology Hematology Care - Eastgate
Cincinnati, Ohio, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Oncology Hematology Care Clinical Trials, LLC
Fairfield, Ohio, United States
Oncology Associates of Oregon, P.C.
Albany, Oregon, United States
Kaiser Permanente Sunnyside Medical Center
Clackamas, Oregon, United States
Oncology Associates of Oregon, P.C.
Corvallis, Oregon, United States
Oncology Associates of Oregon, P.C.
Eugene, Oregon, United States
Kaiser Permanente Westside Medical Center
Hillsboro, Oregon, United States
Kaiser Permanente Interstate Medical Office Central
Portland, Oregon, United States
Oncology Associates of Oregon, P.C.
Springfield, Oregon, United States
Avera Cancer Institute- Aberdeen
Aberdeen, South Dakota, United States
Avera Cancer Institute- Mitchell
Mitchell, South Dakota, United States
Avera Cancer Institute- Pierre
Pierre, South Dakota, United States
Avera Cancer Institute
Sioux Falls, South Dakota, United States
AMG Oncology & Hematology -Yankton
Yankton, South Dakota, United States
Henry-Joyce Cancer Clinic
Nashville, Tennessee, United States
Texas Oncology - West Texas
Abilene, Texas, United States
Texas Oncology - West Texas
Amarillo, Texas, United States
Texas Oncology - Gulf Coast
Beaumont, Texas, United States
Texas Oncology - Northeast Texas
Denison, Texas, United States
Texas Oncology - Northeast Texas
Denton, Texas, United States
Texas Oncology - West Texas
El Paso, Texas, United States
Texas Oncology - West Texas
El Paso, Texas, United States
Texas Oncology - West Texas
El Paso, Texas, United States
Texas Oncology - Northeast Texas
Flower Mound, Texas, United States
Oncology Consultants P.A.
Houston, Texas, United States
Oncology Consultants P.A.
Houston, Texas, United States
Texas Oncology - Gulf Coast
Houston, Texas, United States
Oncology Consultants P.A.
Houston, Texas, United States
Texas Oncology - Gulf Coast
Houston, Texas, United States
Texas Oncology - Gulf Coast
Houston, Texas, United States
Radnet/Houston Medical Imaging
Houston, Texas, United States
Texas Oncology - Gulf Coast
Humble, Texas, United States
US Oncology Investigational Products Center (IPC)
Irving, Texas, United States
US Oncology Investigational Products Center
Irving, Texas, United States
Texas Oncology - Northeast Texas
Longview, Texas, United States
Texas Oncology - West Texas
Midland, Texas, United States
Texas Oncology - West Texas
Odessa, Texas, United States
Texas Oncology - Gulf Coast
Pearland, Texas, United States
Texas Oncology - Gulf Coast
Sugar Land, Texas, United States
Texas Oncology - Gulf Coast
The Woodlands, Texas, United States
Texas Oncology - Northeast Texas
Tyler, Texas, United States
Texas Oncology - West Texas
Wichita Falls, Texas, United States
Virginia Cancer Specialists, PC
Arlington, Virginia, United States
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
Blacksburg, Virginia, United States
Virginia Cancer Specialists, PC
Fairfax, Virginia, United States
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
Low Moor, Virginia, United States
Virginia Cancer Specialists, PC
Manassas, Virginia, United States
Virginia Cancer Institute
Mechanicsville, Virginia, United States
Virginia Cancer Institute
Midlothian, Virginia, United States
Virginia Cancer Institute
Petersburg, Virginia, United States
Virginia Cancer Specialists, PC
Reston, Virginia, United States
Virginia Cancer Institute
Richmond, Virginia, United States
Virginia Cancer Institute
Richmond, Virginia, United States
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
Roanoke, Virginia, United States
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
Salem, Virginia, United States
Virginia Cancer Specialists, PC
Woodbridge, Virginia, United States
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
Wytheville, Virginia, United States
Northwest Medical Specialties, PLLC
Bonney Lake, Washington, United States
Northwest Medical Specialties, PLLC
Federal Way, Washington, United States
Northwest Medical Specialties, PLLC
Gig Harbor, Washington, United States
Northwest Medical Specialties, PLLC
Puyallup, Washington, United States
Fred Hutchinson Cancer Center
Seattle, Washington, United States
University of Washington Medical Center
Seattle, Washington, United States
Northwest Medical Specialties, PLLC
Tacoma, Washington, United States
Hospital Universitario Austral
Pilar, Buenos Aires, Argentina
Centro Para la Atención Integral del Paciente Oncologico (CAIPO)
San Miguel de Tucumán, Tucumán Province, Argentina
Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.L
San Miguel de Tucumán, Tucumán Province, Argentina
Instituto de Investigaciones Clínicas Córdoba S.A.
Córdoba, Argentina
Fundación CORI para la Investigación y Prevención del Cáncer
La Rioja, Argentina
Icon Cancer Centre Wesley
Auchenflower, Queensland, Australia
Icon Cancer Centre Hobart
Hobart, Tasmania, Australia
Monash Health
Clayton, Victoria, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Grand Hôpital de Charleroi
Charleroi, Hainaut, Belgium
UZ Leuven
Leuven, Vlaams Brabant, Belgium
AZ Delta vzw
Roeselare, WEST Vlaanderen, Belgium
AZ Sint-Lucas
Ghent, Belgium
Hospital de Câncer de Recife
Recife, Pernambuco, Brazil
Centro de Oncologia - CEON+ - Unidade São Caetano do Sul
São Caetano do Sul, São Paulo, Brazil
Instituto do Cancer Doutor Arnaldo Vieira de Carvalho
São Paulo, Brazil
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
São Paulo, Brazil
Sunnybrook Research Institute
Toronto, Ontario, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Jewish General Hospital
Montreal, Quebec, Canada
McGill University Health Centre
Montreal, Quebec, Canada
Peking University First Hospital
Beijing, Beijing Municipality, China
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, China
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
Mianyang Central Hospital
Mianyang, Sichuan, China
Odense Universitetshospital
Odense C, Region Syddanmark, Denmark
Vejle Sygehus
Vejle, Region Syddanmark, Denmark
Aalborg University Hospital
Aalborg, Denmark
Institut Gustave Roussy
Villejuif, Val-de-marne, France
CHU Brest, Hopital La Cavale Blanche
Brest, France
Centre Georges-François Leclerc health establishment, centre or care home
Dijon, France
CHU de Lille, Hopital Claude Huriez
Lille, France
Hôpital Saint-Louis
Paris, France
Hôpital Européen Georges Pompidou
Paris, France
Centre Hospitalier Universitaire de Poitiers
Poitiers, France
Henri Mondor Hospital
Créteil, Île-de-France Region, France
Universitäres Krebszentrum Leipzig (UCCL), UKL AöR
Leipzig, Saxony, Germany
DRK Kliniken Berlin - Köpenick
Berlin, Germany
Charité Universitaetsmedizin Berlin - Campus Mitte
Berlin, Germany
Gemeinschaftspraxis Hämatologie - Onkologie Freiberg-Richter, Jacobasch, Illmer, Wolf
Dresden, Germany
TU Dresden Medizinische Fakultät Carl Gustav Carus
Dresden, Germany
Krankenhaus Nordwest GmbH
Frankfurt, Germany
Asklepios Altona
Hamburg, Germany
Rabin Medical Center
Petah Tikva, HA Merkaz, Israel
Sheba Medical Center
Ramat Gan, HA Merkaz, Israel
Rambam Health Care Campus
Haifa, HA Tsafon, Israel
Hadassah Medical Center
Jerusalem, Jerusalem, Israel
Sourasky Medical Center
Tel Aviv, TELL ABĪB, Israel
Pia Fondazione Di Culto E Di Religione Card. G. Panico
Tricase, Lecce, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore
Roma, ROME, Italy
Istituto Europeo di Oncologia IRCCS
Milan, Italy
Aichi Cancer Center Hospital
Nagoya, Aichi-ken, Japan
Chiba cancer center
Chiba, Chiba, Japan
Kanagawa cancer center
Yokohama, Kanagawa, Japan
Saitama Medical University International Medical Center
Hidaka, Saitama, Japan
Saitama Prefectural Cancer Center
Kitaadachi-gun, Saitama, Japan
Shizuoka Cancer Center
Nagaizumi-cho, Shizuoka, Japan
The Cancer Institute Hospital of JFCR
Koto-ku, Tokyo, Japan
Kyushu University Hospital
Fukuoka, Japan
National Hospital Organization Osaka Medical Center
Osaka, Japan
Osaka Prefectural Hospital Organization Osaka International Cancer Institute
Osaka, Japan
Pratia Onkologia Katowice
Katowice, Silesian Voivodeship, Poland
Szpital Wojewódzki im. Mikołaja Kopernika w Koszalinie
Koszalin, Poland
Pratia MCM Krakow
Krakow, Poland
SP ZOZ Opolskie Centrum Onkologii im. prof. Tadeusza Koszarowskiego w Opolu
Opole, Poland
Pratia Poznań
Poznan, Poland
Pan American Center for Oncology Trials - Mayaguez
Mayagüez, Puerto Rico
Pan American Center for Oncology Trials, LLC
Rio Piedras, Puerto Rico
Pan American Center for Oncology Trials, LLC - Centro Europa Office
San Juan, Puerto Rico
Pan American Center for Oncology Trials, LLC
San Juan, Puerto Rico
CHUS - Hospital Clinico Universitario
Santiago de Compostela, A Coruña [LA Coruña], Spain
Clínica Radiológica HLA Mario Gallegos
Málaga, Andalusia, Spain
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [barcelona], Spain
Hospital Jerez de la Frontera
Jerez de la Frontera, Cádiz, Spain
Hospital Universitario Ramón y Cajal
Madrid, Madrid, Comunidad de, Spain
CETIR
Barcelona, Spain
Hospital Clinic de Barcelona
Barcelona, Spain
Hospital Universitario Reina Sofia
Córdoba, Spain
Hospital Regional Universitario de Malaga (Hospital Civil)
Málaga, Spain
Instituto Valenciano de Oncología (IVO)
Valencia, Spain
Zentro Diagnostico Avanzado
Zaragoza, Spain
Hospital Universitario Miguel Servet
Zaragoza, Spain
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan
Chang Gung Memorial Hospital at Kaohsiung
Kaohsiung City, Taiwan
National Cheng Kung University Hospital
Tainan, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
Chang Gung Medical Foundation-Linkou Branch
Taoyuan, Taiwan