Recruiting

Phase 3

PF-08634404 & ChemotherapySymbiotic-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

Code:

NCT07222800

Conditions

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Neoplasms by Site

Digestive System Diseases

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

PF-08634404

Bevacizumab

Chemotherapy

Study Details

Brief 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.

Conditions

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Neoplasms by Site

Digestive System Diseases

Study ID

NCT07222800

Start date

Dec 11, 2025

Status verified date

Aug, 2026

Completion date

Aug 1, 2031

Anticipated

Primary completion date

Mar 29, 2030

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

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
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

Study Design

Enrollment

800 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

PF-08634404

Solution for infusion

Bevacizumab

Injection for intravenous use

Chemotherapy

Injection for intravenous use

Primary outcome measure

Progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR) [ Time Frame: Approximately 4 years ]
Overall survival (OS) [ Time Frame: Approximately 4 years ]

Central Contacts and Locations

Central contacts

Pfizer CT.gov Call Center

1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations

Ironwood Cancer & Research Centers

Recruiting

Chandler, Arizona, United States, 85224

Ironwood Cancer & Research Centers

Recruiting

Gilbert, Arizona, United States, 85297

Ironwood Cancer & Research Centers

Recruiting

Glendale, Arizona, United States, 85306

Ironwood Cancer & Research Centers

Recruiting

Goodyear, Arizona, United States, 85395

Ironwood Cancer & Research Centers

Recruiting

Mesa, Arizona, United States, 85202

Ironwood Cancer & Research Centers

Recruiting

Mesa, Arizona, United States, 85206

Ironwood Cancer & Research Centers

Recruiting

Phoenix, Arizona, United States, 85028

Ironwood Cancer & Research Centers

Recruiting

Scottsdale, Arizona, United States, 85260

Highlands Oncology Group

Recruiting

Fayetteville, Arkansas, United States, 72703

Highlands Oncology Group

Recruiting

Rogers, Arkansas, United States, 72758

Highlands Oncology Group

Recruiting

Springdale, Arkansas, United States, 72762

UCSF at Berkeley Outpatient Center

Recruiting

Berkeley, California, United States, 94702

Alta Bates Summit Medical Center-Herrick Campus Comprehensive Cancer Center

Recruiting

Berkeley, California, United States, 94704

Palo Alto Medical Foundation - Fremont Center

Recruiting

Fremont, California, United States, 94538

Palo Alto Medical Foundation - Palo Alto Center

Recruiting

Palo Alto, California, United States, 94301

Roseville Medical Plaza Care Center

Recruiting

Roseville, California, United States, 95661

Sutter Medical Center, Sacramento Infusion Center at Roseville

Recruiting

Roseville, California, United States, 95661

UCSF at China Basin

Recruiting

San Francisco, California, United States, 94107

UCSF at Mount Zion

Recruiting

San Francisco, California, United States, 94115

UCSF at Parnassus

Recruiting

San Francisco, California, United States, 94143

UCSF Medical Center

Recruiting

San Francisco, California, United States, 94158

Dorothy Schneider Cancer Center

Recruiting

San Mateo, California, United States, 94401

Palo Alto Medical Foundation - San Mateo Care Center

Recruiting

San Mateo, California, United States, 94401

Airway Drive Care Center

Recruiting

Santa Rosa, California, United States, 95403

Palo Alto Medical Foundation - Sunnyvale Center

Recruiting

Sunnyvale, California, United States, 94086

Rocky Mountain Cancer Centers, LLP

Recruiting

Aurora, Colorado, United States, 80012

Rocky Mountain Cancer Centers - Boulder

Recruiting

Boulder, Colorado, United States, 80303

Rocky Mountain Cancer Centers, LLP

Recruiting

Centennial, Colorado, United States, 80112

Rocky Mountain Cancer Centers, LLP

Recruiting

Colorado Springs, Colorado, United States, 80907

Rocky Mountain Cancer Centers, LLP

Recruiting

Colorado Springs, Colorado, United States, 80923

Intermountain Health Cancer Center Saint Joseph

Recruiting

Denver, Colorado, United States, 80218

Intermountain Health Saint Joseph Hospital - Research Office

Recruiting

Denver, Colorado, United States, 80218

Intermountain Health Saint Joseph Hospital

Recruiting

Denver, Colorado, United States, 80218

Rocky Mountain Cancer Centers, LLP

Recruiting

Denver, Colorado, United States, 80218

Rocky Mountain Cancer Centers, LLP

Recruiting

Denver, Colorado, United States, 80220

Rocky Mountain Cancer Centers, LLP

Recruiting

Englewood, Colorado, United States, 80113

Rocky Mountain Cancer Centers, LLP

Recruiting

Lakewood, Colorado, United States, 80228

Rocky Mountain Cancer Centers, LLP

Recruiting

Littleton, Colorado, United States, 80120

Rocky Mountain Cancer Centers, LLP

Recruiting

Lone Tree, Colorado, United States, 80124

Rocky Mountain Cancer Centers, LLP

Recruiting

Longmont, Colorado, United States, 80504

Rocky Mountain Cancer Centers, LLP

Recruiting

Pueblo, Colorado, United States, 81003

Rocky Mountain Cancer Centers, LLP

Recruiting

Thornton, Colorado, United States, 80260

Florida Cancer Specialists

Recruiting

Bonita Springs, Florida, United States, 34135

Florida Cancer Specialists

Recruiting

Bradenton, Florida, United States, 34211

Comprehensive Hematology Oncology

Recruiting

Brandon, Florida, United States, 33511

Florida Cancer Specialists

Recruiting

Cape Coral, Florida, United States, 33909

BRCR Global - Coral Springs

Recruiting

Coral Springs, Florida, United States, 33065

Florida Cancer Specialists

Recruiting

Fort Myers, Florida, United States, 33905

Florida Cancer Specialists

Recruiting

Fort Myers, Florida, United States, 33908

Comprehensive Hematology Oncology

Recruiting

Largo, Florida, United States, 33770

Cancer Care Centers of Brevard, Inc.

Recruiting

Melbourne, Florida, United States, 32935

Florida Cancer Specialists

Recruiting

N. Venice, Florida, United States, 34275

Florida Cancer Specialists

Recruiting

Naples, Florida, United States, 34102

Mid Florida Hematology and Oncology Center

Recruiting

Orange City, Florida, United States, 32763

Cancer Care Centers of Brevard, Inc.

Recruiting

Palm Bay, Florida, United States, 32909

Comprehensive Hematology Oncology

Recruiting

Palm Harbor, Florida, United States, 34683

Florida Cancer Specialists

Recruiting

Port Charlotte, Florida, United States, 33980

Cancer Care Centers of Brevard, Inc.

Recruiting

Rockledge, Florida, United States, 32955

Florida Cancer Specialists

Recruiting

Sarasota, Florida, United States, 34236

Comprehensive Hematology Oncology

Recruiting

St. Petersburg, Florida, United States, 33701

Comprehensive Hematology Oncology

Recruiting

St. Petersburg, Florida, United States, 33709

Comprehensive Hematology Oncology

Recruiting

Trinity, Florida, United States, 34655

University Cancer & Blood Center, LLC

Recruiting

Athens, Georgia, United States, 30607

Saint Alphonsus Regional Medical Center

Recruiting

Boise, Idaho, United States, 83706

Saint Alphonsus Nampa Cancer Care Center

Recruiting

Nampa, Idaho, United States, 83687

Illinois Cancer Specialists

Recruiting

Arlington Heights, Illinois, United States, 60005

Illinois CancerCare - Bloomington

Recruiting

Bloomington, Illinois, United States, 61704

Illinois Cancer Specialists

Recruiting

Chicago, Illinois, United States, 60631

Illinois CancerCare - Galesburg

Recruiting

Galesburg, Illinois, United States, 61401

Hope and Healing Cancer Services

Recruiting

Hinsdale, Illinois, United States, 60521

Hope and Healing Cancer Services

Recruiting

New Lenox, Illinois, United States, 60451

Illinois Cancer Specialists

Recruiting

Niles, Illinois, United States, 60714

Illinois CancerCare-Ottawa-Fox River Cancer Center

Recruiting

Ottawa, Illinois, United States, 61350

Illinois CancerCare-Pekin

Recruiting

Pekin, Illinois, United States, 61554

Illinois Cancer Care

Recruiting

Peoria, Illinois, United States, 61615

Illinois CancerCare-Peru - Valley Regional Cancer Center

Recruiting

Peru, Illinois, United States, 61354

Illinois CancerCare-Washington

Recruiting

Washington, Illinois, United States, 61571

Franciscan Health

Recruiting

Indianapolis, Indiana, United States, 46237

Franciscan Health Mooresville

Recruiting

Mooresville, Indiana, United States, 46158

University Medical Center, Inc. ; DBA UofL Health - UofL Hospital/Brown Cancer Center

Recruiting

Louisville, Kentucky, United States, 40202

UofL Health Medical Center Northeast

Recruiting

Louisville, Kentucky, United States, 40245

New England Cancer Specialists

Recruiting

Topsham, Maine, United States, 04086

New England Cancer Specialists

Recruiting

Westbrook, Maine, United States, 04092

Greater Baltimore Medical Center

Recruiting

Baltimore, Maryland, United States, 21204

Brigham and Women's Hospital (BWH)

Recruiting

Boston, Massachusetts, United States, 02115

Dana-Farber Cancer Institute (DFCI)

Recruiting

Boston, Massachusetts, United States, 02215

Dana-Farber Brigham Cancer Center - Foxborough

Recruiting

Foxborough, Massachusetts, United States, 02035

Dana-Farber Brigham Cancer Center at Milford Regional Medical Center

Recruiting

Milford, Massachusetts, United States, 01757

Dana-Farber Cancer Institute -Chestnut Hill

Recruiting

Newton, Massachusetts, United States, 02467

The Cancer & Hematology Centers

Recruiting

Big Rapids, Michigan, United States, 49307

The Cancer & Hematology Centers

Recruiting

Grand Rapids, Michigan, United States, 49503

The Cancer & Hematology Centers

Recruiting

Grand Rapids, Michigan, United States, 49546

The Cancer & Hematology Centers

Recruiting

Holland, Michigan, United States, 49424

The Cancer & Hematology Centers

Recruiting

Norton Shores, Michigan, United States, 49444

Avera Cancer Institute- Marshall

Recruiting

Marshall, Minnesota, United States, 56258

Mayo Clinic Hospital, Methodist Campus, Research Pharmacy

Recruiting

Rochester, Minnesota, United States, 55902

Mayo Clinic Pharmacy

Recruiting

Rochester, Minnesota, United States, 55902

Mayo Clinic Cancer Center Outpatient Pharmacy

Recruiting

Rochester, Minnesota, United States, 55905

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Rochester Methodist Clinical Research Unit

Recruiting

Rochester, Minnesota, United States, 55905

St. Marys Campus

Recruiting

Rochester, Minnesota, United States, 55905

Cancer Partners of Nebraska

Recruiting

Lincoln, Nebraska, United States, 68516

Renown Health Medical Oncology

Recruiting

Reno, Nevada, United States, 89502

Renown Regional Medical Center

Recruiting

Reno, Nevada, United States, 89502

NYOH Albany Cancer Center

Recruiting

Albany, New York, United States, 12206

Hematology-Oncology Associates of Central New York, PC

Recruiting

Auburn, New York, United States, 13021

North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists

Recruiting

Babylon, New York, United States, 11702

North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists

Recruiting

Brooklyn, New York, United States, 11210

Hematology-Oncology Associates of Central New York, PC

Recruiting

Camillus, New York, United States, 13031

New York Oncology Hematology - Clifton Park Cancer Center

Recruiting

Clifton Park, New York, United States, 12065

Hematology-Oncology Associates of Central New York, PC

Recruiting

East Syracuse, New York, United States, 13057

North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists

Recruiting

New Hyde Park, New York, United States, 11042

North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists

Recruiting

New York, New York, United States, 10028

Hematology Oncology Associates of Rockland

Recruiting

Nyack, New York, United States, 10960

North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists

Recruiting

Patchogue, New York, United States, 11772

North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists

Recruiting

Port Jefferson Station, New York, United States, 11776

North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists

Recruiting

Riverhead, New York, United States, 11901

North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists

Recruiting

Shirley, New York, United States, 11967

North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists

Recruiting

The Bronx, New York, United States, 10469

Duke Cancer Center Cary

Recruiting

Cary, North Carolina, United States, 27518

Duke Cancer Center - Investigational Chemotherapy Service

Recruiting

Durham, North Carolina, United States, 27710

Duke Cancer Center

Recruiting

Durham, North Carolina, United States, 27710

Duke University Hospital - Vascular Interventional Radiology

Recruiting

Durham, North Carolina, United States, 27710

Duke Cancer Center Raleigh

Recruiting

Raleigh, North Carolina, United States, 27609

Oncology Hematology Care - Eastgate

Recruiting

Cincinnati, Ohio, United States, 45245

University Hospitals Cleveland Medical Center

Recruiting

Cleveland, Ohio, United States, 44106

Oncology Hematology Care Clinical Trials, LLC

Recruiting

Fairfield, Ohio, United States, 45014

Oncology Associates of Oregon, P.C.

Recruiting

Albany, Oregon, United States, 97321

Kaiser Permanente Sunnyside Medical Center

Recruiting

Clackamas, Oregon, United States, 97015

Oncology Associates of Oregon, P.C.

Recruiting

Corvallis, Oregon, United States, 97330

Oncology Associates of Oregon, P.C.

Recruiting

Eugene, Oregon, United States, 97401

Kaiser Permanente Westside Medical Center

Recruiting

Hillsboro, Oregon, United States, 97124

Kaiser Permanente Interstate Medical Office Central

Recruiting

Portland, Oregon, United States, 97227

Oncology Associates of Oregon, P.C.

Recruiting

Springfield, Oregon, United States, 97477

Avera Cancer Institute- Aberdeen

Recruiting

Aberdeen, South Dakota, United States, 57401

Avera Cancer Institute- Mitchell

Recruiting

Mitchell, South Dakota, United States, 57301

Avera Cancer Institute- Pierre

Recruiting

Pierre, South Dakota, United States, 57501

Avera Cancer Institute

Recruiting

Sioux Falls, South Dakota, United States, 57105

Avera Cancer Institute - Yankton

Recruiting

Yankton, South Dakota, United States, 57078

Henry-Joyce Cancer Clinic

Recruiting

Nashville, Tennessee, United States, 37232

Texas Oncology - West Texas

Recruiting

Abilene, Texas, United States, 79606

Texas Oncology - West Texas

Recruiting

Amarillo, Texas, United States, 79124

Texas Oncology - Gulf Coast

Recruiting

Beaumont, Texas, United States, 77702

Texas Oncology - Northeast Texas

Recruiting

Denison, Texas, United States, 75020

Texas Oncology - Northeast Texas

Recruiting

Denton, Texas, United States, 76201

Texas Oncology - West Texas

Recruiting

El Paso, Texas, United States, 79902

Texas Oncology - West Texas

Recruiting

El Paso, Texas, United States, 79915

Texas Oncology - West Texas

Recruiting

El Paso, Texas, United States, 79938

Texas Oncology - Northeast Texas

Recruiting

Flower Mound, Texas, United States, 75028

Oncology Consultants P.A.

Recruiting

Houston, Texas, United States, 77008

Oncology Consultants P.A.

Recruiting

Houston, Texas, United States, 77024

Texas Oncology - Gulf Coast

Recruiting

Houston, Texas, United States, 77024

Oncology Consultants P.A.

Recruiting

Houston, Texas, United States, 77030

Texas Oncology - Gulf Coast

Recruiting

Houston, Texas, United States, 77054

Texas Oncology - Gulf Coast

Recruiting

Houston, Texas, United States, 77070

Radnet/Houston Medical Imaging

Recruiting

Houston, Texas, United States, 77098

Texas Oncology - Gulf Coast

Recruiting

Humble, Texas, United States, 77338

US Oncology Investigational Products Center (IPC)

Recruiting

Irving, Texas, United States, 75063

US Oncology Investigational Products Center

Recruiting

Irving, Texas, United States, 75063

Texas Oncology - Northeast Texas

Recruiting

Longview, Texas, United States, 75601

Texas Oncology - West Texas

Recruiting

Midland, Texas, United States, 79701

Texas Oncology - West Texas

Recruiting

Odessa, Texas, United States, 79761

Texas Oncology - Gulf Coast

Recruiting

Pearland, Texas, United States, 77584

Texas Oncology - Gulf Coast

Recruiting

Sugar Land, Texas, United States, 77479

Texas Oncology - Gulf Coast

Recruiting

The Woodlands, Texas, United States, 77380

Texas Oncology - Northeast Texas

Recruiting

Tyler, Texas, United States, 75702

Texas Oncology - West Texas

Recruiting

Wichita Falls, Texas, United States, 76310

Virginia Cancer Specialists, PC

Recruiting

Arlington, Virginia, United States, 22201

Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care

Recruiting

Blacksburg, Virginia, United States, 24060

Virginia Cancer Specialists, PC

Recruiting

Fairfax, Virginia, United States, 22031

Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care

Recruiting

Low Moor, Virginia, United States, 24457

Virginia Cancer Specialists, PC

Recruiting

Manassas, Virginia, United States, 20110

Virginia Cancer Institute

Recruiting

Mechanicsville, Virginia, United States, 23116

Virginia Cancer Institute

Recruiting

Midlothian, Virginia, United States, 23112

Virginia Cancer Institute

Recruiting

Petersburg, Virginia, United States, 23805

Virginia Cancer Specialists, PC

Recruiting

Reston, Virginia, United States, 20190

Virginia Cancer Institute

Recruiting

Richmond, Virginia, United States, 23229

Virginia Cancer Institute

Recruiting

Richmond, Virginia, United States, 23235

Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care

Recruiting

Roanoke, Virginia, United States, 24014

Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care

Recruiting

Salem, Virginia, United States, 24153

Virginia Cancer Specialists, PC

Recruiting

Woodbridge, Virginia, United States, 22191

Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care

Recruiting

Wytheville, Virginia, United States, 24382

Northwest Medical Specialties, PLLC

Recruiting

Bonney Lake, Washington, United States, 98391

Northwest Medical Specialties, PLLC

Recruiting

Federal Way, Washington, United States, 98003

Northwest Medical Specialties, PLLC

Recruiting

Gig Harbor, Washington, United States, 98332

Northwest Medical Specialties, PLLC

Recruiting

Puyallup, Washington, United States, 98373

Fred Hutchinson Cancer Center

Recruiting

Seattle, Washington, United States, 98109

University of Washington Medical Center

Recruiting

Seattle, Washington, United States, 98195

Northwest Medical Specialties, PLLC

Recruiting

Tacoma, Washington, United States, 98405

Sunnybrook Research Institute

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Princess Margaret Cancer Centre

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Jewish General Hospital

Recruiting

Montreal, Quebec, Canada, H3T 1E2

McGill University Health Centre

Recruiting

Montreal, Quebec, Canada, H4A 3J1

More Information

Sponsor

Pfizer

Last update posted

Aug 17, 2026

Last verified

Aug, 2026

Keywords

mCRC
metastatic disease
first-line
metastatic colorectal cancer
colon cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Pfizer on 2026-08-17.