Intestinal NeoplasmsPhase 3NCT07222800
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
A Phase 3 study testing PF-08634404, Bevacizumab and Chemotherapy in people with Intestinal Neoplasms and Gastrointestinal Neoplasms, run by Pfizer at 372 sites in 17 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intestinal Neoplasms, Gastrointestinal Neoplasms, Digestive System Neoplasms
- What is being tested?
- PF-08634404, Bevacizumab and Chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 372 sitesin 17 countries
- Study dates
- 11 Dec 2025to 17 Aug 2031
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Participants are excluded from the study if any of the following criteria apply:
- Locally confirmed BRAF V600E mutation
- Locally confirmed microsatellite instability (MSI)-high or DNA mismatch repair deficiency (dMMR) colorectal cancer
- Participants with known active symptomatic CNS lesions, including leptomeningeal metastasis, brainstem, meningeal, or spinal cord metastases or compression
- Clinically significant risk of hemorrhage or fistula
- Major surgery or severe trauma within 4 weeks prior to the first dose, or planned major surgery during the study
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- History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation
- Any Grade ≥3 bleeding/hemorrhage events within 28 days of Cycle 1 Day 1, or prior history of clinically significant bleeding events
- Clinically significant cardiovascular disease, or other comorbidities, within 6 months prior to first dose
- Participants with active autoimmune diseases requiring systemic treatment within the past 2 years
- Evidence of non-infectious or drug-induced interstitial lung disease (ILD) pneumonitis
Trial locations and contacts
372 sites in 17 countries. Contact the study team or a site near you to ask about taking part.
372 sites in 17 countries
United States254 sites, 254 recruiting
- Recruiting
Avera Cancer Institute- Aberdeen
Aberdeen, South Dakota, 57401
- Recruiting
Texas Oncology - West Texas
Abilene, Texas, 79606
- Recruiting
NYOH Albany Cancer Center
Albany, New York, 12206
- Recruiting
Oncology Associates of Oregon, P.C.
Albany, Oregon, 97321
- Recruiting
University of New Mexico Comprehensive Cancer Center
Albuquerque, New Mexico, 87131
- Recruiting
Texas Oncology - West Texas
Amarillo, Texas, 79124
- Recruiting
Virginia Cancer Specialists, PC
Arlington, Virginia, 22201
- Recruiting
Illinois Cancer Specialists
Arlington Heights, Illinois, 60005
- Recruiting
University Cancer & Blood Center, LLC
Athens, Georgia, 30607
- Recruiting
Hematology-Oncology Associates of Central New York, PC
Auburn, New York, 13021
- Recruiting
Rocky Mountain Cancer Centers, LLP
Aurora, Colorado, 80012
- Recruiting
North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists
Babylon, New York, 11702
- Recruiting
Greater Baltimore Medical Center
Baltimore, Maryland, 21204
- Recruiting
Texas Oncology - Gulf Coast
Beaumont, Texas, 77702
- Recruiting
UCSF at Berkeley Outpatient Center
Berkeley, California, 94702
- Recruiting
Alta Bates Summit Medical Center-Herrick Campus Comprehensive Cancer Center
Berkeley, California, 94704
- Recruiting
The Cancer & Hematology Centers
Big Rapids, Michigan, 49307
- Recruiting
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
Blacksburg, Virginia, 24060
- Recruiting
Illinois CancerCare - Bloomington
Bloomington, Illinois, 61704
- Recruiting
Saint Alphonsus Regional Medical Center
Boise, Idaho, 83706
- Recruiting
Florida Cancer Specialists
Bonita Springs, Florida, 34135
- Recruiting
Northwest Medical Specialties, PLLC
Bonney Lake, Washington, 98391
- Recruiting
Brigham and Women's Hospital (BWH)
Boston, Massachusetts, 02115
- Recruiting
Dana-Farber Cancer Institute (DFCI)
Boston, Massachusetts, 02215
- Recruiting
Rocky Mountain Cancer Centers - Boulder
Boulder, Colorado, 80303
- Recruiting
Florida Cancer Specialists
Bradenton, Florida, 34211
- Recruiting
Comprehensive Hematology Oncology
Brandon, Florida, 33511
- Recruiting
North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists
Brooklyn, New York, 11210
- Recruiting
Hematology-Oncology Associates of Central New York, PC
Camillus, New York, 13031
- Recruiting
Florida Cancer Specialists
Cape Coral, Florida, 33909
- Recruiting
Duke Cancer Center Cary
Cary, North Carolina, 27518
- Recruiting
Rocky Mountain Cancer Centers, LLP
Centennial, Colorado, 80112
- Recruiting
Ironwood Cancer & Research Centers
Chandler, Arizona, 85224
- Recruiting
Illinois Cancer Specialists
Chicago, Illinois, 60631
- Recruiting
Oncology Hematology Care - Eastgate
Cincinnati, Ohio, 45245
- Recruiting
Kaiser Permanente Sunnyside Medical Center
Clackamas, Oregon, 97015
- Recruiting
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
- Recruiting
New York Oncology Hematology - Clifton Park Cancer Center
Clifton Park, New York, 12065
- Recruiting
Rocky Mountain Cancer Centers, LLP
Colorado Springs, Colorado, 80907
- Recruiting
Rocky Mountain Cancer Centers, LLP
Colorado Springs, Colorado, 80923
- Recruiting
BRCR Global - Coral Springs
Coral Springs, Florida, 33065
- Recruiting
Oncology Associates of Oregon, P.C.
Corvallis, Oregon, 97330
- Recruiting
Texas Oncology - Northeast Texas
Denison, Texas, 75020
- Recruiting
Texas Oncology - Northeast Texas
Denton, Texas, 76201
- Recruiting
Intermountain Health Cancer Center Saint Joseph
Denver, Colorado, 80218
- Recruiting
Intermountain Health Saint Joseph Hospital - Research Office
Denver, Colorado, 80218
- Recruiting
Intermountain Health Saint Joseph Hospital
Denver, Colorado, 80218
- Recruiting
Rocky Mountain Cancer Centers, LLP
Denver, Colorado, 80218
- Recruiting
Rocky Mountain Cancer Centers, LLP
Denver, Colorado, 80220
- Recruiting
Duke Cancer Center - Investigational Chemotherapy Service
Durham, North Carolina, 27710
- Recruiting
Duke Cancer Center
Durham, North Carolina, 27710
- Recruiting
Duke University Hospital - Vascular Interventional Radiology
Durham, North Carolina, 27710
- Recruiting
Hematology-Oncology Associates of Central New York, PC
East Syracuse, New York, 13057
- Recruiting
Swedish Cancer Institute - Edmonds Campus
Edmonds, Washington, 98026
- Recruiting
Swedish Medical Center - Edmonds
Edmonds, Washington, 98026
- Recruiting
Texas Oncology - West Texas
El Paso, Texas, 79902
- Recruiting
Texas Oncology - West Texas
El Paso, Texas, 79915
- Recruiting
Texas Oncology - West Texas
El Paso, Texas, 79938
- Recruiting
Baptist Health Hardin
Elizabethtown, Kentucky, 42701
- Recruiting
UCSD Medical Center - Encinitas
Encinitas, California, 92024
- Recruiting
Rocky Mountain Cancer Centers, LLP
Englewood, Colorado, 80113
- Recruiting
Oncology Associates of Oregon, P.C.
Eugene, Oregon, 97401
- Recruiting
Virginia Cancer Specialists, PC
Fairfax, Virginia, 22031
- Recruiting
Oncology Hematology Care Clinical Trials, LLC
Fairfield, Ohio, 45014
- Recruiting
Highlands Oncology Group
Fayetteville, Arkansas, 72703
- Recruiting
Northwest Medical Specialties, PLLC
Federal Way, Washington, 98003
- Recruiting
Texas Oncology - Northeast Texas
Flower Mound, Texas, 75028
- Recruiting
Florida Cancer Specialists
Fort Myers, Florida, 33905
- Recruiting
Florida Cancer Specialists
Fort Myers, Florida, 33908
- Recruiting
Dana-Farber Brigham Cancer Center - Foxborough
Foxborough, Massachusetts, 02035
- Recruiting
Frankfort BHMG Medical Oncology Office
Frankfort, Kentucky, 40601
- Recruiting
Palo Alto Medical Foundation - Fremont Center
Fremont, California, 94538
- Recruiting
Illinois CancerCare - Galesburg
Galesburg, Illinois, 61401
- Recruiting
Northwest Medical Specialties, PLLC
Gig Harbor, Washington, 98332
- Not yet recruiting
Banner Gateway Medical Center
Gilbert, Arizona, 85234
- Not yet recruiting
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234
- Recruiting
Ironwood Cancer & Research Centers
Gilbert, Arizona, 85297
- Recruiting
Ironwood Cancer & Research Centers
Glendale, Arizona, 85306
- Recruiting
Ironwood Cancer & Research Centers
Goodyear, Arizona, 85395
- Recruiting
The Cancer & Hematology Centers
Grand Rapids, Michigan, 49503
- Recruiting
The Cancer & Hematology Centers
Grand Rapids, Michigan, 49546
- Recruiting
Banner MD Anderson Cancer Center at North Colorado Medical Center
Greeley, Colorado, 80631
- Recruiting
Banner North Colorado Medical Center - Hospital
Greeley, Colorado, 80631
- Not yet recruiting
Comprehensive Cancer Centers Of Nevada
Henderson, Nevada, 89052
- Not yet recruiting
Comprehensive Cancer Centers of Nevada
Henderson, Nevada, 89074
- Recruiting
Kaiser Permanente Westside Medical Center
Hillsboro, Oregon, 97124
- Recruiting
Hope and Healing Clinical Research LLC
Hinsdale, Illinois, 60521
- Recruiting
The Cancer & Hematology Centers
Holland, Michigan, 49424
- Recruiting
Oncology Consultants P.A.
Houston, Texas, 77008
- Recruiting
Oncology Consultants P.A.
Houston, Texas, 77024
- Recruiting
Texas Oncology - Gulf Coast
Houston, Texas, 77024
- Recruiting
Memorial Hermann Hospital-TMC (IP Storage)
Houston, Texas, 77030
- Recruiting
Oncology Consultants P.A.
Houston, Texas, 77030
- Recruiting
UTHealth/Memorial Hermann Cancer Center - Texas Medical Center
Houston, Texas, 77030
- Recruiting
Texas Oncology - Gulf Coast
Houston, Texas, 77054
- Recruiting
Texas Oncology - Gulf Coast
Houston, Texas, 77070
- Recruiting
Radnet/Houston Medical Imaging
Houston, Texas, 77098
- Recruiting
Texas Oncology - Gulf Coast
Humble, Texas, 77338
- Recruiting
Franciscan Health
Indianapolis, Indiana, 46237
- Recruiting
US Oncology Investigational Products Center (IPC)
Irving, Texas, 75063
- Recruiting
US Oncology Investigational Products Center
Irving, Texas, 75063
- Recruiting
Swedish Cancer Institute - Issaquah Campus
Issaquah, Washington, 98029
- Recruiting
Mayo Clinic Pharmacy
Jacksonville, Florida, 32224
- Recruiting
Mayo Clinic
Jacksonville, Florida, 32224
- Not yet recruiting
Kadlec Clinic Hematology and Oncology
Kennewick, Washington, 99336
- Not yet recruiting
Tri-Cities Cancer Center
Kennewick, Washington, 99336
- Recruiting
UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion)
La Jolla, California, 92037
- Recruiting
UC San Diego Moores Cancer Center
La Jolla, California, 92037
- Recruiting
UCSD Koman Family Outpatient Pavilion
La Jolla, California, 92037
- Recruiting
Rocky Mountain Cancer Centers, LLP
Lakewood, Colorado, 80228
- Recruiting
Comprehensive Hematology Oncology
Largo, Florida, 33770
- Not yet recruiting
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89106
- Not yet recruiting
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89128
- Not yet recruiting
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89144
- Not yet recruiting
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89148
- Not yet recruiting
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89169
- Recruiting
Baptist Health Lexington
Lexington, Kentucky, 40503
- Recruiting
Baptist Health Richmond
Lexington, Kentucky, 40503
- Recruiting
Baptist Health Hamburg
Lexington, Kentucky, 40509
- Recruiting
University of Kentucky Medical Center
Lexington, Kentucky, 40536
- Recruiting
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, 40536
- Recruiting
Cancer Partners of Nebraska
Lincoln, Nebraska, 68516
- Recruiting
Rocky Mountain Cancer Centers, LLP
Littleton, Colorado, 80120
- Recruiting
Rocky Mountain Cancer Centers, LLP
Lone Tree, Colorado, 80124
- Recruiting
Rocky Mountain Cancer Centers, LLP
Longmont, Colorado, 80504
- Recruiting
Texas Oncology - Northeast Texas
Longview, Texas, 75601
- Not yet recruiting
Norton Cancer Institute, Downtown
Louisville, Kentucky, 40202
- Not yet recruiting
Norton Hospital
Louisville, Kentucky, 40202
- Recruiting
UofL Health Brown Cancer Center
Louisville, Kentucky, 40202
- Recruiting
Baptist Health Louisville
Louisville, Kentucky, 40207
- Not yet recruiting
Norton Audubon Hospital
Louisville, Kentucky, 40217
- Not yet recruiting
Norton Cancer Institute, Audubon Hospital Campus
Louisville, Kentucky, 40217
- Recruiting
Baptist Health EastPoint
Louisville, Kentucky, 40223
- Not yet recruiting
Norton Brownsboro Hospital
Louisville, Kentucky, 40241
- Not yet recruiting
Norton Cancer Institute Brownsboro Hospital Campus
Louisville, Kentucky, 40241
- Recruiting
UofL Health Medical Center Northeast
Louisville, Kentucky, 40245
- Recruiting
Banner MD Anderson Cancer Center at North Colorado Medical Center - Loveland Campus
Loveland, Colorado, 80538
- Recruiting
Banner North Colorado Medical Center - Loveland Campus (Hospital)
Loveland, Colorado, 80538
- Recruiting
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
Low Moor, Virginia, 24457
- Recruiting
Virginia Cancer Specialists, PC
Manassas, Virginia, 20110
- Recruiting
Avera Cancer Institute- Marshall
Marshall, Minnesota, 56258
- Recruiting
Virginia Cancer Institute
Mechanicsville, Virginia, 23116
- Recruiting
Cancer Care Centers of Brevard, Inc.
Melbourne, Florida, 32935
- Recruiting
Ironwood Cancer & Research Centers
Mesa, Arizona, 85202
- Recruiting
Ironwood Cancer & Research Centers
Mesa, Arizona, 85206
- Recruiting
Texas Oncology - West Texas
Midland, Texas, 79701
- Recruiting
Virginia Cancer Institute
Midlothian, Virginia, 23112
- Recruiting
Dana-Farber Brigham Cancer Center at Milford Regional Medical Center
Milford, Massachusetts, 01757
- Recruiting
Avera Cancer Institute- Mitchell
Mitchell, South Dakota, 57301
- Recruiting
Franciscan Health Mooresville
Mooresville, Indiana, 46158
- Recruiting
Hope and Healing Clinical Research LLC
Morris, Illinois, 60450
- Recruiting
Florida Cancer Specialists
N. Venice, Florida, 34275
- Recruiting
Saint Alphonsus Nampa Cancer Care Center
Nampa, Idaho, 83687
- Recruiting
Florida Cancer Specialists
Naples, Florida, 34102
- Recruiting
Henry-Joyce Cancer Clinic
Nashville, Tennessee, 37232
- Recruiting
North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists
New Hyde Park, New York, 11042
- Recruiting
Hope and Healing Clinical Research LLC
New Lenox, Illinois, 60451
- Recruiting
North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists
New York, New York, 10028
- Recruiting
Dana-Farber Cancer Institute -Chestnut Hill
Newton, Massachusetts, 02467
- Recruiting
Illinois Cancer Specialists
Niles, Illinois, 60714
- Recruiting
The Cancer & Hematology Centers
Norton Shores, Michigan, 49444
- Recruiting
Hematology Oncology Associates of Rockland
Nyack, New York, 10960
- Recruiting
Texas Oncology - West Texas
Odessa, Texas, 79761
- Recruiting
Mid Florida Hematology and Oncology Center
Orange City, Florida, 32763
- Recruiting
Illinois CancerCare-Ottawa-Fox River Cancer Center
Ottawa, Illinois, 61350
- Recruiting
Cancer Care Centers of Brevard, Inc.
Palm Bay, Florida, 32909
- Recruiting
Comprehensive Hematology Oncology
Palm Harbor, Florida, 34683
- Recruiting
Palo Alto Medical Foundation - Palo Alto Center
Palo Alto, California, 94301
- Recruiting
North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists
Patchogue, New York, 11772
- Recruiting
Texas Oncology - Gulf Coast
Pearland, Texas, 77584
- Recruiting
Illinois CancerCare-Pekin
Pekin, Illinois, 61554
- Recruiting
Illinois Cancer Care
Peoria, Illinois, 61615
- Recruiting
Illinois CancerCare-Peru - Valley Regional Cancer Center
Peru, Illinois, 61354
- Recruiting
Virginia Cancer Institute
Petersburg, Virginia, 23805
- Not yet recruiting
Banner MD Anderson Cancer Center at Banner University Medical Center- Phoenix
Phoenix, Arizona, 85006
- Not yet recruiting
Banner MD Anderson Cancer Center
Phoenix, Arizona, 85006
- Not yet recruiting
Banner University Medical Center Phoenix
Phoenix, Arizona, 85006
- Recruiting
Ironwood Cancer & Research Centers
Phoenix, Arizona, 85028
- Recruiting
Mayo Clinic Building- Phoenix
Phoenix, Arizona, 85054
- Recruiting
Mayo Clinic Hospital
Phoenix, Arizona, 85054
- Recruiting
Avera Cancer Institute- Pierre
Pierre, South Dakota, 57501
- Recruiting
Florida Cancer Specialists
Port Charlotte, Florida, 33980
- Recruiting
North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists
Port Jefferson Station, New York, 11776
- Recruiting
Kaiser Permanente Interstate Medical Office Central
Portland, Oregon, 97227
- Recruiting
Rocky Mountain Cancer Centers, LLP
Pueblo, Colorado, 81003
- Recruiting
Northwest Medical Specialties, PLLC
Puyallup, Washington, 98373
- Recruiting
Duke Cancer Center Raleigh
Raleigh, North Carolina, 27609
- Recruiting
Renown Health Medical Oncology
Reno, Nevada, 89502
- Recruiting
Renown Regional Medical Center
Reno, Nevada, 89502
- Recruiting
Virginia Cancer Specialists, PC
Reston, Virginia, 20190
- Not yet recruiting
Kadlec Outpatient Imaging Center
Richland, Washington, 99352
- Not yet recruiting
Kadlec Regional Medical Center
Richland, Washington, 99352
- Recruiting
Richmond BHMG Medical Oncology Clinic
Richmond, Kentucky, 40475
- Recruiting
Virginia Cancer Institute
Richmond, Virginia, 23229
- Recruiting
Virginia Cancer Institute
Richmond, Virginia, 23235
- Recruiting
North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists
Riverhead, New York, 11901
- Recruiting
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
Roanoke, Virginia, 24014
- Recruiting
Mayo Clinic Hospital, Methodist Campus, Research Pharmacy
Rochester, Minnesota, 55902
- Recruiting
Mayo Clinic Pharmacy
Rochester, Minnesota, 55902
- Recruiting
Mayo Clinic Cancer Center Outpatient Pharmacy
Rochester, Minnesota, 55905
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
- Recruiting
Rochester Methodist Clinical Research Unit
Rochester, Minnesota, 55905
- Recruiting
St. Marys Campus
Rochester, Minnesota, 55905
- Recruiting
Cancer Care Centers of Brevard, Inc.
Rockledge, Florida, 32955
- Recruiting
Highlands Oncology Group
Rogers, Arkansas, 72758
- Recruiting
Roseville Medical Plaza Care Center
Roseville, California, 95661
- Recruiting
Sutter Medical Center, Sacramento Infusion Center at Roseville
Roseville, California, 95661
- Recruiting
University of California, Davis Comprehensive Cancer Center
Sacramento, California, 95817
- Recruiting
University of California, Davis Medical Center
Sacramento, California, 95817
- Recruiting
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
Salem, Virginia, 24153
- Recruiting
UC San Diego McGrath Outpatient Pavilion - Hillcrest
San Diego, California, 92103
- Recruiting
UC San Diego Medical Center - Hillcrest
San Diego, California, 92103
- Recruiting
UC San Diego Medical Center - Rancho Bernardo
San Diego, California, 92127
- Recruiting
UCSF at China Basin
San Francisco, California, 94107
- Recruiting
UCSF at Mount Zion
San Francisco, California, 94115
- Recruiting
UCSF at Parnassus
San Francisco, California, 94143
- Recruiting
UCSF Medical Center
San Francisco, California, 94158
- Recruiting
Dorothy Schneider Cancer Center
San Mateo, California, 94401
- Recruiting
Palo Alto Medical Foundation - San Mateo Care Center
San Mateo, California, 94401
- Recruiting
Airway Drive Care Center
Santa Rosa, California, 95403
- Recruiting
Florida Cancer Specialists
Sarasota, Florida, 34236
- Recruiting
Mayo Clinic
Scottsdale, Arizona, 85259
- Recruiting
Ironwood Cancer & Research Centers
Scottsdale, Arizona, 85260
- Recruiting
Swedish Cancer Institute
Seattle, Washington, 98104
- Recruiting
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
- Recruiting
Swedish Medical Center
Seattle, Washington, 98122
- Recruiting
University of Washington Medical Center
Seattle, Washington, 98195
- Recruiting
North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists
Shirley, New York, 11967
- Recruiting
Avera Cancer Institute
Sioux Falls, South Dakota, 57105
- Recruiting
Highlands Oncology Group
Springdale, Arkansas, 72762
- Recruiting
Oncology Associates of Oregon, P.C.
Springfield, Oregon, 97477
- Recruiting
Comprehensive Hematology Oncology
St. Petersburg, Florida, 33701
- Recruiting
Comprehensive Hematology Oncology
St. Petersburg, Florida, 33709
- Not yet recruiting
Stamford Hospital
Stamford, Connecticut, 06904
- Recruiting
Texas Oncology - Gulf Coast
Sugar Land, Texas, 77479
- Not yet recruiting
Banner Boswell Medical Center
Sun City, Arizona, 85351
- Not yet recruiting
Banner MD Anderson Cancer Center
Sun City, Arizona, 85351
- Not yet recruiting
BMDACC Boswell
Sun City, Arizona, 85351
- Recruiting
Palo Alto Medical Foundation - Sunnyvale Center
Sunnyvale, California, 94086
- Recruiting
Northwest Medical Specialties, PLLC
Tacoma, Washington, 98405
- Recruiting
Baylor Scott & White Medical Center-Temple
Temple, Texas, 76508
- Recruiting
North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists
The Bronx, New York, 10469
- Recruiting
Texas Oncology - Gulf Coast
The Woodlands, Texas, 77380
- Recruiting
Rocky Mountain Cancer Centers, LLP
Thornton, Colorado, 80260
- Recruiting
New England Cancer Specialists
Topsham, Maine, 04086
- Recruiting
Comprehensive Hematology Oncology
Trinity, Florida, 34655
- Recruiting
Texas Oncology - Northeast Texas
Tyler, Texas, 75702
- Recruiting
UCSD Medical Center - Vista
Vista, California, 92081
- Recruiting
Illinois CancerCare-Washington
Washington, Illinois, 61571
- Recruiting
New England Cancer Specialists
Westbrook, Maine, 04092
- Recruiting
Texas Oncology - West Texas
Wichita Falls, Texas, 76310
- Recruiting
Virginia Cancer Specialists, PC
Woodbridge, Virginia, 22191
- Recruiting
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
Wytheville, Virginia, 24382
- Recruiting
Avera Cancer Institute - Yankton
Yankton, South Dakota, 57078
China24 sites, 24 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 102627
- Recruiting
Hunan Cancer Hospital
Changsha, Hunan, 410013
- Recruiting
The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410013
- Recruiting
Sichuan Cancer hospital
Chengdu, Sichuan, 610213
- Recruiting
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, 400030
- Recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510555
- Recruiting
The Sixth Affiliated Hospital, Sun Yet-sen University
Guangzhou, Guangdong, 510655
- Recruiting
The second Affiliated Hospital of College of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310017
- Recruiting
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081
- Recruiting
Anhui Provincial Cancer Hospital
Hefei, Anhui, 230031
- Recruiting
Shandong Cancer Hospital
Jinan, Shandong, 250117
- Recruiting
Meizhou People's Hospital
Meizhou, Guangdong, 514031
- Recruiting
Mianyang Central Hospital
Mianyang, Sichuan, 621000
- Recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330200
- Recruiting
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210008
- Recruiting
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, 530200
- Recruiting
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266031
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 201315
- Recruiting
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, 430030
- Recruiting
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, 430048
- Not yet recruiting
The First Affiliated hospital of Xiamen University
Xiamen, Fujian, 361003
Spain13 sites, 13 recruiting
- Recruiting
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [barcelona], 08035
- Recruiting
CETIR
Barcelona, 08029
- Recruiting
Hospital Clinic de Barcelona
Barcelona, 08036
- Recruiting
Hospital Universitario Reina Sofia
Córdoba, 14004
- Recruiting
Hospital Jerez de la Frontera
Jerez de la Frontera, Cádiz, 11407
- Recruiting
Institut Català d'Oncologia - L'Hospitalet
L'Hospitalet de Llobregat, Barcelona, 08908
- Recruiting
Hospital Universitario Ramón y Cajal
Madrid, Madrid, Comunidad de, 28034
- Recruiting
Clínica Radiológica HLA Mario Gallegos
Málaga, Andalusia, 29016
- Recruiting
Hospital Regional Universitario de Malaga (Hospital Civil)
Málaga, 29011
- Recruiting
CHUS - Hospital Clinico Universitario
Santiago de Compostela, A Coruña [LA Coruña], 15706
- Recruiting
Instituto Valenciano de Oncología (IVO)
Valencia, 46009
- Recruiting
Zentro Diagnostico Avanzado
Zaragoza, 50006
- Recruiting
Hospital Universitario Miguel Servet
Zaragoza, 50009
Japan11 sites, 11 recruiting
- Recruiting
Chiba cancer center
Chiba, Chiba, 260-8717
- Recruiting
Kyushu University Hospital
Fukuoka, 812-8582
- Recruiting
Saitama Medical University International Medical Center
Hidaka, Saitama, 350-1298
- Recruiting
National Cancer Center Hospital East
Kashiwa, Chiba, 277-8577
- Recruiting
Saitama Prefectural Cancer Center
Kitaadachi-gun, Saitama, 362-0806
- Recruiting
The Cancer Institute Hospital of JFCR
Koto-ku, Tokyo, 135-8550
- Recruiting
Shizuoka Cancer Center
Nagaizumi-cho, Shizuoka, 411-8777
- Recruiting
Aichi Cancer Center Hospital
Nagoya, Aichi-ken, 464-8681
- Recruiting
National Hospital Organization Osaka Medical Center
Osaka, 540-0006
- Recruiting
Osaka Prefectural Hospital Organization Osaka International Cancer Institute
Osaka, 541-8567
- Recruiting
Kanagawa cancer center
Yokohama, Kanagawa, 241-8515
Germany9 sites, 9 recruiting
- Recruiting
DRK Kliniken Berlin - Köpenick
Berlin, 12559
- Recruiting
Charité Universitaetsmedizin Berlin - Campus Mitte
Berlin, 13353
- Recruiting
Gemeinschaftspraxis Hämatologie - Onkologie Freiberg-Richter, Jacobasch, Illmer, Wolf
Dresden, 01307
- Recruiting
Universitätsklinikum Carl Gustav Carus, Technischen Universitaet Dresden
Dresden, 01307
- Recruiting
Universitaetsklinikum Essen
Essen, North Rhine-Westphalia, 45147
- Recruiting
Krankenhaus Nordwest GmbH
Frankfurt am Main, Hesse, 60488
- Recruiting
Asklepios Altona
Hamburg, 22763
- Recruiting
Universitäres Krebszentrum Leipzig (UCCL), UKL AöR
Leipzig, Saxony, 04103
- Recruiting
Muenchen Klinik Neuperlach
München, 81737
France8 sites, 8 recruiting
- Recruiting
CHU Brest, Hopital La Cavale Blanche
Brest, 29200
- Recruiting
Henri Mondor Hospital
Créteil, Île-de-France Region, 94000
- Recruiting
Centre Georges-François Leclerc health establishment, centre or care home
Dijon, 21079 Cedex
- Recruiting
CHU de Lille, Hopital Claude Huriez
Lille, 59037
- Recruiting
Hôpital Saint-Louis
Paris, 75010
- Recruiting
Hôpital Européen Georges Pompidou
Paris, 75015
- Recruiting
Centre Hospitalier Universitaire de Poitiers
Poitiers, 86021
- Not yet recruiting
Institut Gustave Roussy
Villejuif, Val-de-marne, 94800
Brazil6 sites, 6 recruiting
- Recruiting
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903
- Recruiting
Hospital de Câncer de Recife
Recife, Pernambuco, 50040-000
- Recruiting
Instituto Nacional de Câncer - INCA
Rio de Janeiro, 20230-130
- Recruiting
Centro de Oncologia - CEON+ - Unidade São Caetano do Sul
São Caetano do Sul, São Paulo, 09541-270
- Recruiting
Instituto do Cancer Doutor Arnaldo Vieira de Carvalho
São Paulo, 01221-020
- Recruiting
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
São Paulo, 05652-900
Taiwan6 sites, 6 recruiting
- Recruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807
- Recruiting
Chang Gung Memorial Hospital at Kaohsiung
Kaohsiung City, 83301
- Recruiting
National Cheng Kung University Hospital
Tainan, 704
- Recruiting
National Taiwan University Hospital
Taipei, 10002
- Recruiting
Taipei Veterans General Hospital
Taipei, 11217
- Recruiting
Chang Gung Medical Foundation-Linkou Branch
Taoyuan, 333
Argentina5 sites, 5 recruiting
- Recruiting
Instituto de Investigaciones Clínicas Córdoba S.A.
Córdoba, X5000AAW
- Recruiting
Fundación CORI para la Investigación y Prevención del Cáncer
La Rioja, F5300COE
- Recruiting
Centro de Investigación Pergamino
Pergamino, Buenos Aires, B2700
- Recruiting
Hospital Universitario Austral
Pilar, Buenos Aires, 1629
- Recruiting
Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.L
San Miguel de Tucumán, Tucumán Province, 4000
Australia5 sites, 5 recruiting
- Recruiting
Sunshine Coast Haematology and Oncology Clinic
Buderim, Queensland, 4556
- Recruiting
Monash Health
Clayton, Victoria, 3168
- Recruiting
Icon Cancer Centre Hobart
Hobart, Tasmania, 7000
- Recruiting
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000
- Recruiting
The Queen Elizabeth Hospital
Woodville South, South Australia, 5011
Israel5 sites, 5 recruiting
- Recruiting
Rambam Health Care Campus
Haifa, HA Tsafon, 3109601
- Recruiting
Hadassah Medical Center
Jerusalem, Jerusalem, 9112001
- Recruiting
Rabin Medical Center
Petah Tikva, HA Merkaz, 4941492
- Recruiting
Sheba Medical Center
Ramat Gan, HA Merkaz, 5265601
- Recruiting
Sourasky Medical Center
Tel Aviv, TELL ABĪB, 6423906
Italy5 sites, 5 recruiting
- Not yet recruiting
Azienda Ospedaliera Universitaria Careggi
Florence, 50134
- Recruiting
Istituto Europeo di Oncologia IRCCS
Milan, 20141
- Recruiting
Istituto Oncologico Veneto IRCCS
Padova, Veneto, 35128
- Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore
Roma, ROME, 00168
- Recruiting
Pia Fondazione Di Culto E Di Religione Card. G. Panico
Tricase, Lecce, 73039
Poland5 sites, 5 recruiting
- Recruiting
Pratia Onkologia Katowice
Katowice, Silesian Voivodeship, 40-519
- Recruiting
Szpital Wojewódzki im. Mikołaja Kopernika w Koszalinie
Koszalin, 75-581
- Recruiting
Pratia MCM Krakow
Krakow, 30-727
- Recruiting
SP ZOZ Opolskie Centrum Onkologii im. prof. Tadeusza Koszarowskiego w Opolu
Opole, 45-061
- Recruiting
Pratia Poznań
Poznan, 60-192
Belgium4 sites, 4 recruiting
- Recruiting
Grand Hôpital de Charleroi
Charleroi, Hainaut, 6060
- Recruiting
AZ Sint-Lucas
Ghent, 9000
- Recruiting
UZ Leuven
Leuven, Vlaams Brabant, 3000
- Recruiting
AZ Delta vzw
Roeselare, WEST Vlaanderen, 8800
Canada4 sites, 4 recruiting
- Recruiting
Jewish General Hospital
Montreal, Quebec, H3T 1E2
- Recruiting
McGill University Health Centre
Montreal, Quebec, H4A 3J1
- Recruiting
Sunnybrook Research Institute
Toronto, Ontario, M4N 3M5
- Recruiting
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
Denmark4 sites, 4 recruiting
- Recruiting
Aalborg University Hospital
Aalborg, 9000
- Recruiting
Rigshospitalet
Copenhagen, 2100 KBH Ø
- Recruiting
Odense Universitetshospital
Odense C, Region Syddanmark, 5000
- Recruiting
Vejle Sygehus
Vejle, Region Syddanmark, 7100
Puerto Rico4 sites, 4 recruiting
- Recruiting
Pan American Center for Oncology Trials - Mayaguez
Mayagüez, 00680
- Recruiting
Pan American Center for Oncology Trials, LLC
Rio Piedras, 00935
- Recruiting
Pan American Center for Oncology Trials, LLC - Centro Europa Office
San Juan, 00907
- Recruiting
Pan American Center for Oncology Trials, LLC
San Juan, 00909
About this study
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
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:
Read more
- 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.
- Conditions
- Intestinal Neoplasms, Gastrointestinal Neoplasms, Digestive System Neoplasms, Neoplasms by Site, Digestive System Diseases, Gastrointestinal Diseases
- Being tested
- PF-08634404, Bevacizumab, Chemotherapy
- Keywords
- mCRC, metastatic disease, first-line, metastatic colorectal cancer, colon cancer
- Medical subject headings
- Intestinal Neoplasms, Gastrointestinal Neoplasms, Digestive System Neoplasms, Neoplasms by Site, Digestive System Diseases, Gastrointestinal Diseases, Colonic Diseases, Intestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-08634404Drug
Solution for infusion
BevacizumabBiological
Also called Avastin
Injection for intravenous use
ChemotherapyDrug
Injection for intravenous use
| Study group | Role | What they receive |
|---|---|---|
| PF-08634404 + Chemotherapy | Experimental | Participants will receive PF-08634404 intravenously (IV) in combination with Chemotherapy. Receives: Drug: PF-08634404; Drug: Chemotherapy |
| Bevacizumab + Chemotherapy | Active comparator | Participants will receive bevacizumab IV in combination with Chemotherapy. Receives: Biological: Bevacizumab; Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR)
Progression-free survival is defined as the time from the date of randomization to the date of the first documentation of objective progressive disease (PD) assessed by BICR per RECIST 1.1, or death due to any cause, whichever occurs first.
Measured: Approximately 4 years
Overall survival (OS)
Overall survival defined as the time from the date of randomization to the date of death due to any cause.
Measured: Approximately 4 years
Secondary outcomes (14)
PFS per RECIST 1.1 by investigator assessment
Progression Free Survival (PFS) is defined as the time from the date of randomization to the date of the first documentation of objective PD assessed by investigator per RECIST 1.1, or death due to any cause, whichever occurs first.
Measured: Approximately 4 years
Objective Response Rate (ORR) by BICR
The proportion of participants who have a confirmed CR or PR, as best overall response assessed by BICR as per RECIST 1.1.
Measured: Approximately 4 years
Objective Response Rate (ORR) by investigator
The proportion of participants who have a confirmed CR or PR, as best overall response assessed by investigator as per RECIST 1.1.
Measured: Approximately 4 years
Duration of Response (DOR) by BICR
The time from the first documentation of objective response (CR or PR that is subsequently confirmed) to the date of the first documentation of PD as determined by BICR assessment per RECIST 1.1, or death due to any cause, whichever occurs first.
Measured: Approximately 4 years
DOR by investigator
The time from the first documentation of objective response (CR or PR that is subsequently confirmed) to the date of the first documentation of PD as determined by Investigator per RECIST 1.1, or death due to any cause, whichever occurs first.
Measured: Approximately 4 years
PFS2 (PFS after next-line therapy) by investigator
PFS2 is defined as the time from the date of randomization to the date of second objective disease progression or death due to any cause, whichever occurs first. Second objective disease progression is PD after the start of subsequent anticancer therapy (excluding curative surgery) as assessed by the investigator.
Measured: Approximately 4 years
Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: Through 90 days after the last study intervention; Approximately 4 years
Number of Participants With Clinical Laboratory Abnormalities
Measured: Through 90 days after the last study intervention; Approximately 4 years
Pharmacokinetics (PK): Serum concentration of PF-08634404
Measured: Approximately 21 months
Immunogenicity: Incidence of positive Anti-Drug Antibody (ADA)
To characterize the immunogenicity of PF-08634404
Measured: Approximately 21 months
Mean scores and Change from baseline in the global health status/quality of life (QoL) score on the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
The EORTC QLQ-C30 is a questionnaire for quantitative measure of health-related quality of life pertinent to participants with a broad range of cancers who are participating in international clinical trials.
Measured: Approximately 4 years
Mean score change from baseline in participant reported function and symptoms scales per EORTC QLQ-CR29
The EORTC QLQ-CR29 is a supplemental colorectal cancer-specific module with measures of symptoms associated with colorectal cancer.
Measured: Approximately 4 years
Time to definitive deterioration (TTdD) in the global health status/QoL score on the EORTC QLQ-C30
TTdD is defined as the time from date of randomization to first onset of Patient Reported Outcome (PRO) deterioration without subsequent recovery.
Measured: Approximately 4 years
Time to definitive deterioration (TTdD) in participant reported function and symptoms per EORTC QLQ-CR29
TTdD is defined as the time from date of randomization to first onset of Patient Reported Outcome (PRO) deterioration without subsequent recovery.
Measured: Approximately 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2025
- Study start11 Dec 2025
- Primary completion23 Feb 2030 (estimated)
- Study completion17 Aug 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intestinal NeoplasmsStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07222800
- Sponsor's protocol ID
- C6461003
- Other IDs
- 2025-523521-18-00, Symbiotic-GI-03, 2025
- Status last verified
- Oct 2026
- First submitted
- 28 Oct 2025
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.