Recruiting

PF-08634404 with Chemotherapy for Metastatic Colorectal Cancer

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What is being tested

PF-08634404

+ Chemotherapy

+ Bevacizumab

DrugBiological
Who is being recruted

Colonic Diseases+13

+ Colonic Neoplasms

+ Digestive System Diseases

Over 18 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: December 2025
See protocol details

Summary

Principal SponsorPfizer
Study ContactPfizer CT.gov Call Center
Last updated: January 31, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: December 11, 2025

Actual date on which the first participant was enrolled.

This study aims to evaluate a new medication called PF-08634404 in people with advanced colorectal cancer, which is cancer of the colon or rectum that has spread to other parts of the body. The study will compare the effectiveness and safety of PF-08634404 combined with standard chemotherapy against another treatment option, Bevacizumab combined with chemotherapy. The participants will be individuals who are at least 18 years old, have metastatic colorectal cancer, and are healthy enough to undergo the treatment. This research is important as it seeks to find a potentially more effective treatment option for patients whose cancer has progressed despite previous treatments. Participants will be randomly assigned to receive either PF-08634404 with chemotherapy or Bevacizumab with chemotherapy. Neither the participants nor the doctors will know which treatment is being administered to maintain objectivity. All medications will be given through IV infusions at a clinical site, where medical staff will carefully monitor participants. Treatments will be given in cycles, and participants will continue as long as they benefit and tolerate the treatment well. The study will last up to 33 months per participant, with regular health checks and tests at the study site. After the treatment ends, there will be a follow-up visit 30 to 37 days later, and ongoing follow-ups every 12 weeks to monitor health and any new treatments.

Official TitleAN 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
NCT07222800
Principal SponsorPfizer
Study ContactPfizer CT.gov Call Center
Last updated: January 31, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

800 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Colonic DiseasesColonic NeoplasmsDigestive System DiseasesDigestive System NeoplasmsGastrointestinal DiseasesGastrointestinal NeoplasmsIntestinal DiseasesIntestinal NeoplasmsNeoplasm MetastasisNeoplasmsNeoplasms by SiteNeoplastic ProcessesPathologic ProcessesRectal DiseasesPathological Conditions, Signs and SymptomsColorectal Neoplasms

Criteria

2 inclusion criteria required to participate
No prior systemic therapy for metastatic disease

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

5 exclusion criteria prevent from participating
Any Grade ≥3 bleeding/hemorrhage events within 28 days of Cycle 1 Day 1, or prior history of clinically significant bleeding events

Locally confirmed microsatellite instability (MSI)-high or DNA mismatch repair deficiency (dMMR) colorectal cancer

Known active symptomatic CNS lesions, including leptomeningeal metastasis, brainstem, meningeal, or spinal cord metastases or compression

History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Participants will receive PF-08634404 intravenously (IV) in combination with Chemotherapy.

Group II

Active Comparator
Participants will receive bevacizumab IV in combination with Chemotherapy.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 16 locations

Recruiting

Mid Florida Hematology and Oncology Center

Orange City, United StatesOpen Mid Florida Hematology and Oncology Center in Google Maps
Recruiting

Cancer Care Centers of Brevard, Inc.

Palm Bay, United States
Recruiting

Illinois Cancer Care

Canton, United States
Recruiting

Hope and Healing Cancer Services

Hinsdale, United States
Recruiting
16 Study Centers