A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Metastatic Colorectal Cancer
NCT ID: NCT07222800
Last Updated: 2026-01-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
800 participants
INTERVENTIONAL
2025-12-11
2031-08-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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PF-08634404 + Chemotherapy
Participants will receive PF-08634404 intravenously (IV) in combination with Chemotherapy.
PF-08634404
Solution for infusion
Chemotherapy
Injection for intravenous use
Bevacizumab + Chemotherapy
Participants will receive bevacizumab IV in combination with Chemotherapy.
Bevacizumab
Injection for intravenous use
Chemotherapy
Injection for intravenous use
Interventions
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PF-08634404
Solution for infusion
Bevacizumab
Injection for intravenous use
Chemotherapy
Injection for intravenous use
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Mid Florida Hematology and Oncology Center
Orange City, Florida, United States
Cancer Care Centers of Brevard, Inc.
Palm Bay, Florida, United States
Illinois Cancer Care
Canton, Illinois, United States
Hope and Healing Cancer Services
Hinsdale, Illinois, United States
Hematology Oncology Associates of Rockland
Nyack, New York, United States
Oncology Associates of Oregon, P.C.
Albany, Oregon, United States
Texas Oncology - West Texas
Odessa, Texas, United States
Texas Oncology - Northeast Texas
Tyler, Texas, United States
Icon Cancer Centre Wesley
Auchenflower, , Australia
Icon Cancer Centre Hobart
Hobart, , Australia
Kyushu University Hospital
Fukuoka, , Japan
Saitama Medical University International Medical Center
Hidaka, , Japan
National Hospital Organization Osaka Medical Center
Osaka, , Japan
Saitama Prefectural Cancer Center
Saitama, , Japan
The Cancer Institute Hospital of JFCR
Tokyo, , Japan
Pan American Center for Oncology Trials, LLC
Rio Piedras, , Puerto Rico
Countries
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Central Contacts
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2025-523521-18-00
Identifier Type: CTIS
Identifier Source: secondary_id
Symbiotic-GI-03
Identifier Type: OTHER
Identifier Source: secondary_id
C6461003
Identifier Type: -
Identifier Source: org_study_id
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