Colorectal Cancer Clinical Trials

Find Colorectal Cancer Clinical Trials Near You

AN INTERVENTIONAL, PHASE 3, DOUBLE-BLIND, RANDOMIZED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY VERSUS BEVACIZUMAB IN COMBINATION WITH CHEMOTHERAPY IN TREATMENT-NAÏVE PARTICIPANTS WITH METASTATIC COLORECTAL CANCER

Status: Recruiting
Location: See all (115) locations...
Intervention Type: Drug, Biological
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The purpose of this study is to learn more about a new medicine called PF-08634404, and how well it works in people with cancer of the colon or rectum (CRC)). The goal is to understand if the new study medicine, combined with chemotherapy that is approved for colorectal cancer, can help people whose cancer has spread or returned after treatments taken before. To join the study, participants must meet the following conditions: * Be 18 years or older. * Have colorectal cancer that has spread to other parts of your body. * Be in good enough health to receive study treatment. * Should not be pregnant before starting treatment. Participants will be randomized (like flipping a coin) to one of 2 different treatment arms. The first arm (Arm A) will include the new medicine PF-08634404 in combination with chemotherapy that is approved for colorectal cancer, and the second arm (Arm B) will include an approved medicine for colorectal cancer, called Bevacizumab, in combination with chemotherapy that is approved for this type of cancer. Participants and their doctors will not know which arm they are being assigned to. Participants will receive all the study medications through intravenous (IV) infusions, which means the medicine is given directly into a vein. The treatment will be given in cycles, and participants may continue receiving it if it is helping and they are not experiencing serious side effects. The medicine will be given at a clinical site, where trained medical staff will check participants during and after each treatment. * The study is expected to last approximately 33 months for each participant. * Participants will have regular visits to the study site for treatment, health checks, and tests. * After stopping treatment, participants will return for a final visit about 30 to37 days later to check their health and review any side effects. * Follow-up will continue every 12 weeks by phone or in person or by reviewing health records to check on health status and any new treatments.

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

• Histological or cytological confirmed colorectal adenocarcinoma.

• Evidence of Stage IV metastatic disease.

• No prior systemic therapy for metastatic disease.

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

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

• Adequate hepatic, liver, and renal function

Locations
United States
Arkansas
Highlands Oncology Group
RECRUITING
Fayetteville
Highlands Oncology Group
RECRUITING
Rogers
Highlands Oncology Group
RECRUITING
Springdale
Arizona
Ironwood Cancer & Research Centers
RECRUITING
Chandler
Ironwood Cancer & Research Centers
RECRUITING
Gilbert
Ironwood Cancer & Research Centers
RECRUITING
Glendale
Ironwood Cancer & Research Centers
RECRUITING
Goodyear
Ironwood Cancer & Research Centers
RECRUITING
Mesa
Ironwood Cancer & Research Centers
RECRUITING
Mesa
Ironwood Cancer & Research Centers
RECRUITING
Phoenix
Ironwood Cancer & Research Centers
RECRUITING
Scottsdale
Colorado
Rocky Mountain Cancer Centers - Boulder
RECRUITING
Boulder
Intermountain Health Cancer Center Saint Joseph
NOT_YET_RECRUITING
Denver
Intermountain Health Saint Joseph Hospital
NOT_YET_RECRUITING
Denver
Intermountain Health Saint Joseph Hospital - Research Office
NOT_YET_RECRUITING
Denver
Florida
Florida Cancer Specialists
RECRUITING
Bonita Springs
Florida Cancer Specialists
RECRUITING
Bradenton
Florida Cancer Specialists
RECRUITING
Cape Coral
Florida Cancer Specialists
RECRUITING
Fort Myers
Florida Cancer Specialists
RECRUITING
Fort Myers
Cancer Care Centers of Brevard, Inc.
RECRUITING
Melbourne
Florida Cancer Specialists
RECRUITING
N. Venice
Florida Cancer Specialists
RECRUITING
Naples
Mid Florida Hematology and Oncology Center
RECRUITING
Orange City
Cancer Care Centers of Brevard, Inc.
RECRUITING
Palm Bay
Florida Cancer Specialists
RECRUITING
Port Charlotte
Cancer Care Centers of Brevard, Inc.
RECRUITING
Rockledge
Florida Cancer Specialists
RECRUITING
Sarasota
Illinois
Illinois Cancer Specialists
RECRUITING
Arlington Heights
Illinois CancerCare - Bloomington
RECRUITING
Bloomington
Illinois Cancer Specialists
RECRUITING
Chicago
Illinois CancerCare - Galesburg
RECRUITING
Galesburg
Hope and Healing Cancer Services
RECRUITING
Hinsdale
Hope and Healing Cancer Services
RECRUITING
New Lenox
Illinois Cancer Specialists
RECRUITING
Niles
Illinois CancerCare-Ottawa-Fox River Cancer Center
RECRUITING
Ottawa
Illinois CancerCare-Pekin
RECRUITING
Pekin
Illinois Cancer Care
RECRUITING
Peoria
Illinois CancerCare-Peru - Valley Regional Cancer Center
RECRUITING
Peru
Illinois CancerCare-Washington
RECRUITING
Washington
Michigan
The Cancer & Hematology Centers
RECRUITING
Big Rapids
The Cancer & Hematology Centers
RECRUITING
Grand Rapids
The Cancer & Hematology Centers
RECRUITING
Grand Rapids
The Cancer & Hematology Centers
RECRUITING
Holland
The Cancer & Hematology Centers
RECRUITING
Norton Shores
Nebraska
Cancer Partners of Nebraska
NOT_YET_RECRUITING
Lincoln
Nevada
Renown Regional Medical Center
RECRUITING
Reno
New York
Hematology-Oncology Associates of Central New York, PC
NOT_YET_RECRUITING
Camillus
Hematology-Oncology Associates of Central New York, PC
NOT_YET_RECRUITING
East Syracuse
Hematology Oncology Associates of Rockland
RECRUITING
Nyack
Ohio
Oncology Hematology Care - Eastgate
RECRUITING
Cincinnati
Oncology Hematology Care Clinical Trials, LLC
RECRUITING
Fairfield
Oregon
Oncology Associates of Oregon, P.C.
RECRUITING
Albany
Oncology Associates of Oregon, P.C.
RECRUITING
Corvallis
Oncology Associates of Oregon, P.C.
RECRUITING
Eugene
Oncology Associates of Oregon, P.C.
RECRUITING
Springfield
Texas
Texas Oncology - West Texas
RECRUITING
Abilene
Texas Oncology - West Texas
RECRUITING
Amarillo
Texas Oncology - Gulf Coast
RECRUITING
Beaumont
Texas Oncology - Northeast Texas
RECRUITING
Denison
Texas Oncology - Northeast Texas
RECRUITING
Denton
Texas Oncology - West Texas
RECRUITING
El Paso
Texas Oncology - West Texas
RECRUITING
El Paso
Texas Oncology - West Texas
RECRUITING
El Paso
Texas Oncology - Northeast Texas
RECRUITING
Flower Mound
Oncology Consultants P.A.
NOT_YET_RECRUITING
Houston
Oncology Consultants P.A.
NOT_YET_RECRUITING
Houston
Oncology Consultants P.A.
NOT_YET_RECRUITING
Houston
Radnet/Houston Medical Imaging
NOT_YET_RECRUITING
Houston
Texas Oncology - Gulf Coast
RECRUITING
Houston
Texas Oncology - Gulf Coast
RECRUITING
Houston
Texas Oncology - Gulf Coast
RECRUITING
Houston
Texas Oncology - Gulf Coast
RECRUITING
Humble
US Oncology Investigational Products Center
RECRUITING
Irving
US Oncology Investigational Products Center (IPC)
RECRUITING
Irving
Texas Oncology - Northeast Texas
RECRUITING
Longview
Texas Oncology - West Texas
RECRUITING
Midland
Texas Oncology - West Texas
RECRUITING
Odessa
Texas Oncology - Gulf Coast
RECRUITING
Pearland
Texas Oncology - Gulf Coast
RECRUITING
Sugar Land
Texas Oncology - Gulf Coast
RECRUITING
The Woodlands
Texas Oncology - Northeast Texas
RECRUITING
Tyler
Texas Oncology - West Texas
RECRUITING
Wichita Falls
Virginia
Virginia Cancer Specialists, PC
RECRUITING
Arlington
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
RECRUITING
Blacksburg
Virginia Cancer Specialists, PC
RECRUITING
Fairfax
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
RECRUITING
Low Moor
Virginia Cancer Specialists, PC
RECRUITING
Manassas
Virginia Cancer Specialists, PC
RECRUITING
Reston
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
RECRUITING
Roanoke
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
RECRUITING
Salem
Virginia Cancer Specialists, PC
RECRUITING
Woodbridge
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
RECRUITING
Wytheville
Other Locations
Australia
Icon Cancer Centre Wesley
RECRUITING
Auchenflower
Icon Cancer Centre Hobart
RECRUITING
Hobart
Peter MacCallum Cancer Centre
NOT_YET_RECRUITING
Melbourne
Canada
Princess Margaret Cancer Centre
RECRUITING
Toronto
Israel
Hadassah Medical Center
NOT_YET_RECRUITING
Jerusalem
Sourasky Medical Center
NOT_YET_RECRUITING
Tel Aviv
Japan
Chiba cancer center
RECRUITING
Chiba
Kyushu University Hospital
RECRUITING
Fukuoka
Saitama Medical University International Medical Center
RECRUITING
Hidaka
Saitama Prefectural Cancer Center
RECRUITING
Kitaadachi-gun
The Cancer Institute Hospital of JFCR
RECRUITING
Koto-ku
Shizuoka Cancer Center
RECRUITING
Nagaizumi-cho
Aichi Cancer Center Hospital
RECRUITING
Nagoya
National Hospital Organization Osaka Medical Center
RECRUITING
Osaka
Kanagawa cancer center
RECRUITING
Yokohama
Puerto Rico
Pan American Center for Oncology Trials - Mayaguez
RECRUITING
Mayagüez
Pan American Center for Oncology Trials, LLC
RECRUITING
Rio Piedras
Pan American Center for Oncology Trials, LLC
RECRUITING
San Juan
Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
RECRUITING
Kaohsiung City
National Cheng Kung University Hospital
NOT_YET_RECRUITING
Tainan
National Taiwan University Hospital
NOT_YET_RECRUITING
Taipei
Taipei Veterans General Hospital
NOT_YET_RECRUITING
Taipei
Contact Information
Primary
Pfizer CT.gov Call Center
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021
Time Frame
Start Date: 2025-12-11
Estimated Completion Date: 2031-08-01
Participants
Target number of participants: 800
Treatments
Experimental: PF-08634404 + Chemotherapy
Participants will receive PF-08634404 intravenously (IV) in combination with Chemotherapy.
Active_comparator: Bevacizumab + Chemotherapy
Participants will receive bevacizumab IV in combination with Chemotherapy.
Related Therapeutic Areas
Sponsors
Leads: Pfizer

This content was sourced from clinicaltrials.gov

Similar Clinical Trials