AzTrials
AzTrials

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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

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
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
Are there results?
Not yet: the study is under way

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
Show all 11Show fewer
  • 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.

Pfizer CT.gov Call Center contact

1-800-718-1021

ClinicalTrials.gov_Inquiries@pfizer.com

372 sites in 17 countries

United States254 sites, 254 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

    Recruiting

  • Banner Gateway Medical Center

    Gilbert, Arizona, 85234

    Not yet recruiting

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234

    Not yet 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

    Recruiting

  • Comprehensive Cancer Centers Of Nevada

    Henderson, Nevada, 89052

    Not yet recruiting

  • Comprehensive Cancer Centers of Nevada

    Henderson, Nevada, 89074

    Not yet 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

    Recruiting

  • Kadlec Clinic Hematology and Oncology

    Kennewick, Washington, 99336

    Not yet recruiting

  • Tri-Cities Cancer Center

    Kennewick, Washington, 99336

    Not yet 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

    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

    Not yet 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

    Recruiting

  • Norton Cancer Institute, Downtown

    Louisville, Kentucky, 40202

    Not yet recruiting

  • Norton Hospital

    Louisville, Kentucky, 40202

    Not yet recruiting

  • UofL Health Brown Cancer Center

    Louisville, Kentucky, 40202

    Recruiting

  • Baptist Health Louisville

    Louisville, Kentucky, 40207

    Recruiting

  • Norton Audubon Hospital

    Louisville, Kentucky, 40217

    Not yet recruiting

  • Norton Cancer Institute, Audubon Hospital Campus

    Louisville, Kentucky, 40217

    Not yet recruiting

  • Baptist Health EastPoint

    Louisville, Kentucky, 40223

    Recruiting

  • Norton Brownsboro Hospital

    Louisville, Kentucky, 40241

    Not yet recruiting

  • Norton Cancer Institute Brownsboro Hospital Campus

    Louisville, Kentucky, 40241

    Not yet 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

    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

    Not yet 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

    Recruiting

  • Kadlec Outpatient Imaging Center

    Richland, Washington, 99352

    Not yet recruiting

  • Kadlec Regional Medical Center

    Richland, Washington, 99352

    Not yet 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

    Recruiting

  • Stamford Hospital

    Stamford, Connecticut, 06904

    Not yet recruiting

  • Texas Oncology - Gulf Coast

    Sugar Land, Texas, 77479

    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

    Not yet 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

    Recruiting

Other trials in United States

China24 sites, 24 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

    Recruiting

  • The First Affiliated hospital of Xiamen University

    Xiamen, Fujian, 361003

    Not yet recruiting

Other trials in China

Spain13 sites, 13 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

    Recruiting

Other trials in Spain

Japan11 sites, 11 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

    Recruiting

Other trials in Japan

Germany9 sites, 9 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

    Recruiting

Other trials in Germany

France8 sites, 8 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

    Recruiting

  • Institut Gustave Roussy

    Villejuif, Val-de-marne, 94800

    Not yet recruiting

Other trials in France

Brazil6 sites, 6 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

    Recruiting

Other trials in Brazil

Taiwan6 sites, 6 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

    Recruiting

Other trials in Taiwan

Argentina5 sites, 5 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

    Recruiting

Other trials in Argentina

Australia5 sites, 5 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

    Recruiting

Other trials in Australia

Israel5 sites, 5 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

    Recruiting

Other trials in Israel

Italy5 sites, 5 recruiting

  • Azienda Ospedaliera Universitaria Careggi

    Florence, 50134

    Not yet 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

    Recruiting

Other trials in Italy

Poland5 sites, 5 recruiting

  • Pratia Onkologia Katowice

    Katowice, Silesian Voivodeship, 40-519

    Recruiting

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    Koszalin, 75-581

    Recruiting

  • Pratia MCM Krakow

    Krakow, 30-727

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  • SP ZOZ Opolskie Centrum Onkologii im. prof. Tadeusza Koszarowskiego w Opolu

    Opole, 45-061

    Recruiting

  • Pratia Poznań

    Poznan, 60-192

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Other trials in Poland

Belgium4 sites, 4 recruiting

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    Charleroi, Hainaut, 6060

    Recruiting

  • AZ Sint-Lucas

    Ghent, 9000

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  • UZ Leuven

    Leuven, Vlaams Brabant, 3000

    Recruiting

  • AZ Delta vzw

    Roeselare, WEST Vlaanderen, 8800

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Other trials in Belgium

Canada4 sites, 4 recruiting

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2

    Recruiting

  • McGill University Health Centre

    Montreal, Quebec, H4A 3J1

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  • Sunnybrook Research Institute

    Toronto, Ontario, M4N 3M5

    Recruiting

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9

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Other trials in Canada

Denmark4 sites, 4 recruiting

  • Aalborg University Hospital

    Aalborg, 9000

    Recruiting

  • Rigshospitalet

    Copenhagen, 2100 KBH Ø

    Recruiting

  • Odense Universitetshospital

    Odense C, Region Syddanmark, 5000

    Recruiting

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    Vejle, Region Syddanmark, 7100

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Puerto Rico4 sites, 4 recruiting

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    Mayagüez, 00680

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    Rio Piedras, 00935

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    San Juan, 00907

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  • Pan American Center for Oncology Trials, LLC

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Other trials in Puerto Rico

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.
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 groups in NCT07222800
Study groupRoleWhat they receive
PF-08634404 + ChemotherapyExperimentalParticipants will receive PF-08634404 intravenously (IV) in combination with Chemotherapy.
Receives: Drug: PF-08634404; Drug: Chemotherapy
Bevacizumab + ChemotherapyActive comparatorParticipants 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.

  1. 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

  2. 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)

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. Number of Participants With Clinical Laboratory Abnormalities

    Measured: Through 90 days after the last study intervention; Approximately 4 years

  9. Pharmacokinetics (PK): Serum concentration of PF-08634404

    Measured: Approximately 21 months

  10. Immunogenicity: Incidence of positive Anti-Drug Antibody (ADA)

    To characterize the immunogenicity of PF-08634404

    Measured: Approximately 21 months

  11. 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

  12. 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

  13. 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

  14. 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.

  1. First posted30 Oct 2025
  2. Study start11 Dec 2025
  3. Primary completion23 Feb 2030 (estimated)
  4. Study completion17 Aug 2031 (estimated)

Resources

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)
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.

Questions about this trial

What is this clinical trial studying?

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.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 372 sites in United States, China, Spain, Japan, Germany and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Pfizer CT.gov Call Center (1-800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07222800.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.

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