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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

Status: Recruiting
Location: See all (228) locations...
Intervention Type: Drug, Biological
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Histological or cytological confirmed colorectal adenocarcinoma.

• Evidence of Stage IV metastatic disease.

• No prior systemic therapy for metastatic disease.

• Eastern Cooperative Oncology Group performance status (ECOG) 0-1

• At least one measurable lesion according to RECIST 1.1 per Investigator assessment.

• Adequate hepatic, liver, and renal function

Locations
United States
Arkansas
Highlands Oncology Group
RECRUITING
Fayetteville
Highlands Oncology Group
RECRUITING
Rogers
Highlands Oncology Group
RECRUITING
Springdale
Arizona
Ironwood Cancer & Research Centers
RECRUITING
Chandler
Ironwood Cancer & Research Centers
RECRUITING
Gilbert
Ironwood Cancer & Research Centers
RECRUITING
Glendale
Ironwood Cancer & Research Centers
RECRUITING
Goodyear
Ironwood Cancer & Research Centers
RECRUITING
Mesa
Ironwood Cancer & Research Centers
RECRUITING
Mesa
Ironwood Cancer & Research Centers
RECRUITING
Phoenix
Ironwood Cancer & Research Centers
RECRUITING
Scottsdale
California
UCSF at Berkeley Outpatient Center
RECRUITING
Berkeley
UCSF at China Basin
RECRUITING
San Francisco
UCSF at Mount Zion
RECRUITING
San Francisco
UCSF at Parnassus
RECRUITING
San Francisco
UCSF Medical Center
RECRUITING
San Francisco
Colorado
Rocky Mountain Cancer Centers, LLP
RECRUITING
Aurora
Rocky Mountain Cancer Centers - Boulder
RECRUITING
Boulder
Rocky Mountain Cancer Centers, LLP
RECRUITING
Centennial
Rocky Mountain Cancer Centers, LLP
RECRUITING
Colorado Springs
Rocky Mountain Cancer Centers, LLP
RECRUITING
Colorado Springs
Intermountain Health Cancer Center Saint Joseph
RECRUITING
Denver
Intermountain Health Saint Joseph Hospital
RECRUITING
Denver
Intermountain Health Saint Joseph Hospital - Research Office
RECRUITING
Denver
Rocky Mountain Cancer Centers, LLP
RECRUITING
Denver
Rocky Mountain Cancer Centers, LLP
RECRUITING
Denver
Rocky Mountain Cancer Centers, LLP
RECRUITING
Englewood
Rocky Mountain Cancer Centers, LLP
RECRUITING
Lakewood
Rocky Mountain Cancer Centers, LLP
RECRUITING
Littleton
Rocky Mountain Cancer Centers, LLP
RECRUITING
Lone Tree
Rocky Mountain Cancer Centers, LLP
RECRUITING
Longmont
Rocky Mountain Cancer Centers, LLP
RECRUITING
Pueblo
Rocky Mountain Cancer Centers, LLP
RECRUITING
Thornton
Florida
Florida Cancer Specialists
RECRUITING
Bonita Springs
Florida Cancer Specialists
RECRUITING
Bradenton
Comprehensive Hematology Oncology
RECRUITING
Brandon
Florida Cancer Specialists
RECRUITING
Cape Coral
BRCR Global - Coral Springs
RECRUITING
Coral Springs
Florida Cancer Specialists
RECRUITING
Fort Myers
Florida Cancer Specialists
RECRUITING
Fort Myers
Comprehensive Hematology Oncology
RECRUITING
Largo
Cancer Care Centers of Brevard, Inc.
RECRUITING
Melbourne
Florida Cancer Specialists
RECRUITING
N. Venice
Florida Cancer Specialists
RECRUITING
Naples
Mid Florida Hematology and Oncology Center
RECRUITING
Orange City
Cancer Care Centers of Brevard, Inc.
RECRUITING
Palm Bay
Comprehensive Hematology Oncology
RECRUITING
Palm Harbor
Florida Cancer Specialists
RECRUITING
Port Charlotte
Cancer Care Centers of Brevard, Inc.
RECRUITING
Rockledge
Florida Cancer Specialists
RECRUITING
Sarasota
Comprehensive Hematology Oncology
RECRUITING
St. Petersburg
Comprehensive Hematology Oncology
RECRUITING
St. Petersburg
Comprehensive Hematology Oncology
RECRUITING
Trinity
Georgia
University Cancer & Blood Center, LLC
RECRUITING
Athens
Illinois
Illinois Cancer Specialists
RECRUITING
Arlington Heights
Illinois CancerCare - Bloomington
RECRUITING
Bloomington
Illinois Cancer Specialists
RECRUITING
Chicago
Illinois CancerCare - Galesburg
RECRUITING
Galesburg
Hope and Healing Cancer Services
RECRUITING
Hinsdale
Hope and Healing Cancer Services
RECRUITING
New Lenox
Illinois Cancer Specialists
RECRUITING
Niles
Illinois CancerCare-Ottawa-Fox River Cancer Center
RECRUITING
Ottawa
Illinois CancerCare-Pekin
RECRUITING
Pekin
Illinois Cancer Care
RECRUITING
Peoria
Illinois CancerCare-Peru - Valley Regional Cancer Center
RECRUITING
Peru
Illinois CancerCare-Washington
RECRUITING
Washington
Indiana
Franciscan Health
RECRUITING
Indianapolis
Franciscan Health Mooresville
RECRUITING
Mooresville
Michigan
The Cancer & Hematology Centers
RECRUITING
Big Rapids
The Cancer & Hematology Centers
RECRUITING
Grand Rapids
The Cancer & Hematology Centers
RECRUITING
Grand Rapids
The Cancer & Hematology Centers
RECRUITING
Holland
The Cancer & Hematology Centers
RECRUITING
Norton Shores
Minnesota
Avera Cancer Institute- Marshall
RECRUITING
Marshall
Nebraska
Cancer Partners of Nebraska
RECRUITING
Lincoln
Nevada
Renown Health Medical Oncology
RECRUITING
Reno
Renown Regional Medical Center
RECRUITING
Reno
New York
NYOH Albany Cancer Center
RECRUITING
Albany
Hematology-Oncology Associates of Central New York, PC
RECRUITING
Auburn
North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists
RECRUITING
Babylon
North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists
RECRUITING
Brooklyn
Hematology-Oncology Associates of Central New York, PC
RECRUITING
Camillus
New York Oncology Hematology - Clifton Park Cancer Center
RECRUITING
Clifton Park
Hematology-Oncology Associates of Central New York, PC
RECRUITING
East Syracuse
North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists
RECRUITING
New Hyde Park
North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists
RECRUITING
New York
Hematology Oncology Associates of Rockland
RECRUITING
Nyack
North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists
RECRUITING
Patchogue
North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists
RECRUITING
Port Jefferson Station
North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists
RECRUITING
Riverhead
North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists
RECRUITING
Shirley
North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists
RECRUITING
The Bronx
Ohio
Oncology Hematology Care - Eastgate
RECRUITING
Cincinnati
University Hospitals Cleveland Medical Center
NOT_YET_RECRUITING
Cleveland
Oncology Hematology Care Clinical Trials, LLC
RECRUITING
Fairfield
Oregon
Oncology Associates of Oregon, P.C.
RECRUITING
Albany
Kaiser Permanente Sunnyside Medical Center
RECRUITING
Clackamas
Oncology Associates of Oregon, P.C.
RECRUITING
Corvallis
Oncology Associates of Oregon, P.C.
RECRUITING
Eugene
Kaiser Permanente Westside Medical Center
RECRUITING
Hillsboro
Kaiser Permanente Interstate Medical Office Central
RECRUITING
Portland
Oncology Associates of Oregon, P.C.
RECRUITING
Springfield
South Dakota
Avera Cancer Institute- Aberdeen
RECRUITING
Aberdeen
Avera Cancer Institute- Mitchell
RECRUITING
Mitchell
Avera Cancer Institute- Pierre
RECRUITING
Pierre
Avera Cancer Institute
RECRUITING
Sioux Falls
AMG Oncology & Hematology -Yankton
RECRUITING
Yankton
Tennessee
Henry-Joyce Cancer Clinic
RECRUITING
Nashville
Texas
Texas Oncology - West Texas
RECRUITING
Abilene
Texas Oncology - West Texas
RECRUITING
Amarillo
Texas Oncology - Gulf Coast
RECRUITING
Beaumont
Texas Oncology - Northeast Texas
RECRUITING
Denison
Texas Oncology - Northeast Texas
RECRUITING
Denton
Texas Oncology - West Texas
RECRUITING
El Paso
Texas Oncology - West Texas
RECRUITING
El Paso
Texas Oncology - West Texas
RECRUITING
El Paso
Texas Oncology - Northeast Texas
RECRUITING
Flower Mound
Oncology Consultants P.A.
RECRUITING
Houston
Oncology Consultants P.A.
RECRUITING
Houston
Oncology Consultants P.A.
RECRUITING
Houston
Radnet/Houston Medical Imaging
RECRUITING
Houston
Texas Oncology - Gulf Coast
RECRUITING
Houston
Texas Oncology - Gulf Coast
RECRUITING
Houston
Texas Oncology - Gulf Coast
RECRUITING
Houston
Texas Oncology - Gulf Coast
RECRUITING
Humble
US Oncology Investigational Products Center
RECRUITING
Irving
US Oncology Investigational Products Center (IPC)
RECRUITING
Irving
Texas Oncology - Northeast Texas
RECRUITING
Longview
Texas Oncology - West Texas
RECRUITING
Midland
Texas Oncology - West Texas
RECRUITING
Odessa
Texas Oncology - Gulf Coast
RECRUITING
Pearland
Texas Oncology - Gulf Coast
RECRUITING
Sugar Land
Texas Oncology - Gulf Coast
RECRUITING
The Woodlands
Texas Oncology - Northeast Texas
RECRUITING
Tyler
Texas Oncology - West Texas
RECRUITING
Wichita Falls
Virginia
Virginia Cancer Specialists, PC
RECRUITING
Arlington
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
RECRUITING
Blacksburg
Virginia Cancer Specialists, PC
RECRUITING
Fairfax
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
RECRUITING
Low Moor
Virginia Cancer Specialists, PC
RECRUITING
Manassas
Virginia Cancer Institute
RECRUITING
Mechanicsville
Virginia Cancer Institute
RECRUITING
Midlothian
Virginia Cancer Institute
RECRUITING
Petersburg
Virginia Cancer Specialists, PC
RECRUITING
Reston
Virginia Cancer Institute
RECRUITING
Richmond
Virginia Cancer Institute
RECRUITING
Richmond
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
RECRUITING
Roanoke
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
RECRUITING
Salem
Virginia Cancer Specialists, PC
RECRUITING
Woodbridge
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
RECRUITING
Wytheville
Other Locations
Argentina
Instituto de Investigaciones Clínicas Córdoba S.A.
NOT_YET_RECRUITING
Córdoba
Fundación CORI para la Investigación y Prevención del Cáncer
RECRUITING
La Rioja
Hospital Universitario Austral
NOT_YET_RECRUITING
Pilar
Centro Para la Atención Integral del Paciente Oncologico (CAIPO)
RECRUITING
San Miguel De Tucumán
Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.L
RECRUITING
San Miguel De Tucumán
Australia
Icon Cancer Centre Wesley
RECRUITING
Auchenflower
Icon Cancer Centre Hobart
RECRUITING
Hobart
Peter MacCallum Cancer Centre
RECRUITING
Melbourne
Belgium
Grand Hôpital de Charleroi
NOT_YET_RECRUITING
Charleroi
AZ Sint-Lucas
NOT_YET_RECRUITING
Ghent
UZ Leuven
NOT_YET_RECRUITING
Leuven
AZ Delta vzw
NOT_YET_RECRUITING
Roeselare
Brazil
Hospital de Câncer de Recife
NOT_YET_RECRUITING
Recife
Centro de Oncologia - CEON+ - Unidade São Caetano do Sul
RECRUITING
São Caetano Do Sul
Canada
Jewish General Hospital
RECRUITING
Montreal
McGill University Health Centre
RECRUITING
Montreal
Princess Margaret Cancer Centre
RECRUITING
Toronto
Sunnybrook Research Institute
RECRUITING
Toronto
China
Peking University First Hospital
NOT_YET_RECRUITING
Beijing
Chongqing University Cancer Hospital
NOT_YET_RECRUITING
Chongqing
Sun Yat-sen University Cancer Center
RECRUITING
Guangzhou
Sun Yat-sen University Cancer Center
RECRUITING
Guangzhou
Guangxi Medical University Cancer Hospital
NOT_YET_RECRUITING
Nanning
Denmark
Vejle Sygehus
NOT_YET_RECRUITING
Vejle
France
CHU Brest, Hopital La Cavale Blanche
NOT_YET_RECRUITING
Brest
Henri Mondor Hospital
NOT_YET_RECRUITING
Créteil
Centre Georges-François Leclerc health establishment, centre or care home
NOT_YET_RECRUITING
Dijon
CHU de Lille, Hopital Claude Huriez
NOT_YET_RECRUITING
Lille
Hôpital Européen Georges Pompidou
NOT_YET_RECRUITING
Paris
Hôpital Saint-Louis
NOT_YET_RECRUITING
Paris
Centre Hospitalier Universitaire de Poitiers
NOT_YET_RECRUITING
Poitiers
Institut Gustave Roussy
NOT_YET_RECRUITING
Villejuif
Germany
DRK Kliniken Berlin - Köpenick
NOT_YET_RECRUITING
Berlin
Gemeinschaftspraxis Hämatologie - Onkologie Freiberg-Richter, Jacobasch, Illmer, Wolf
NOT_YET_RECRUITING
Dresden
Asklepios Altona
NOT_YET_RECRUITING
Hamburg
Universitäres Krebszentrum Leipzig (UCCL), UKL AöR
NOT_YET_RECRUITING
Leipzig
Israel
Rambam Health Care Campus
RECRUITING
Haifa
Hadassah Medical Center
RECRUITING
Jerusalem
Rabin Medical Center
RECRUITING
Petah Tikva
Sheba Medical Center
NOT_YET_RECRUITING
Ramat Gan
Sourasky Medical Center
NOT_YET_RECRUITING
Tel Aviv
Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore
NOT_YET_RECRUITING
Roma
Pia Fondazione Di Culto E Di Religione Card. G. Panico
NOT_YET_RECRUITING
Tricase
Japan
Chiba cancer center
RECRUITING
Chiba
Kyushu University Hospital
RECRUITING
Fukuoka
Saitama Medical University International Medical Center
RECRUITING
Hidaka
Saitama Prefectural Cancer Center
RECRUITING
Kitaadachi-gun
The Cancer Institute Hospital of JFCR
RECRUITING
Koto-ku
Shizuoka Cancer Center
RECRUITING
Nagaizumi-cho
Aichi Cancer Center Hospital
RECRUITING
Nagoya
National Hospital Organization Osaka Medical Center
RECRUITING
Osaka
Osaka Prefectural Hospital Organization Osaka International Cancer Institute
RECRUITING
Osaka
Kanagawa cancer center
RECRUITING
Yokohama
Poland
Pratia Onkologia Katowice
NOT_YET_RECRUITING
Katowice
Pratia MCM Krakow
NOT_YET_RECRUITING
Krakow
SP ZOZ Opolskie Centrum Onkologii im. prof. Tadeusza Koszarowskiego w Opolu
NOT_YET_RECRUITING
Opole
Pratia Poznań
RECRUITING
Poznan
Puerto Rico
Pan American Center for Oncology Trials - Mayaguez
RECRUITING
Mayagüez
Pan American Center for Oncology Trials, LLC
RECRUITING
Rio Piedras
Pan American Center for Oncology Trials, LLC
RECRUITING
San Juan
Pan American Center for Oncology Trials, LLC - Centro Europa Office
RECRUITING
San Juan
Spain
CETIR
NOT_YET_RECRUITING
Barcelona
Hospital Clinic de Barcelona
NOT_YET_RECRUITING
Barcelona
Hospital Universitari Vall d'Hebron
NOT_YET_RECRUITING
Barcelona
Hospital Universitario Reina Sofia
NOT_YET_RECRUITING
Córdoba
Hospital Jerez de la Frontera
NOT_YET_RECRUITING
Jerez De La Frontera
Hospital Universitario Ramón y Cajal
RECRUITING
Madrid
Clínica Radiológica HLA Mario Gallegos
NOT_YET_RECRUITING
Málaga
Hospital Regional Universitario de Malaga (Hospital Civil)
NOT_YET_RECRUITING
Málaga
Instituto Valenciano de Oncología (IVO)
NOT_YET_RECRUITING
Valencia
Hospital Universitario Miguel Servet
NOT_YET_RECRUITING
Zaragoza
Zentro Diagnostico Avanzado
NOT_YET_RECRUITING
Zaragoza
Taiwan
Chang Gung Memorial Hospital at Kaohsiung
RECRUITING
Kaohsiung City
Kaohsiung Medical University Chung-Ho Memorial Hospital
RECRUITING
Kaohsiung City
National Cheng Kung University Hospital
RECRUITING
Tainan
National Taiwan University Hospital
RECRUITING
Taipei
Taipei Veterans General Hospital
RECRUITING
Taipei
Chang Gung Medical Foundation-Linkou Branch
RECRUITING
Taoyuan
Contact Information
Primary
Pfizer CT.gov Call Center
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021
Time Frame
Start Date: 2025-12-11
Estimated Completion Date: 2031-08-01
Participants
Target number of participants: 800
Treatments
Experimental: PF-08634404 + Chemotherapy
Participants will receive PF-08634404 intravenously (IV) in combination with Chemotherapy.
Active_comparator: Bevacizumab + Chemotherapy
Participants will receive bevacizumab IV in combination with Chemotherapy.
Related Therapeutic Areas
Sponsors
Leads: Pfizer

This content was sourced from clinicaltrials.gov

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