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PF-08634404 plus chemotherapy for adults with metastatic colorectal cancer

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

Phase 3 Interventional Pfizer · NCT07222800

This trial will test whether adding a new drug called PF-08634404 to standard chemotherapy helps adults whose colorectal cancer has spread.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment800 (estimated)
Ages18 Years and up
SexAll
SponsorPfizer Industry-sponsored
Drugs / interventionsBevacizumab, chemotherapy
Locations156 sites (Chandler, Arizona and 155 other locations)
Trial IDNCT07222800 on ClinicalTrials.gov

What this trial studies

This randomized phase 3 trial enrolls adults with previously untreated metastatic colorectal adenocarcinoma and assigns them to receive either PF-08634404 plus standard chemotherapy or bevacizumab plus the same chemotherapy. Eligible participants must have measurable disease, ECOG performance status 0–1, and adequate organ function, while tumors with BRAF V600E mutation or MSI‑high/dMMR are excluded. The study will compare clinical outcomes such as tumor response and survival and will monitor safety and adverse events throughout treatment. The trial is being run at several Ironwood Cancer & Research Centers locations in Arizona.

Who should consider this trial

Good fit: Adults (≥18) with stage IV colorectal adenocarcinoma who have not received prior systemic therapy for metastatic disease, have at least one measurable lesion, ECOG 0–1, and adequate organ function are the intended participants.

Not a fit: Patients with MSI‑high/dMMR tumors, BRAF V600E mutations, active symptomatic central nervous system metastases, significant bleeding/fistula risk, recent major surgery, or prior allogeneic organ transplant are unlikely to qualify or benefit.

Why it matters

Potential benefit: If successful, adding PF-08634404 to chemotherapy could provide better tumor control or extend survival compared with current first‑line therapy.

How similar studies have performed: Combining targeted agents with chemotherapy, such as bevacizumab plus chemo, has an established benefit in metastatic colorectal cancer, while PF-08634404 is a novel agent now being tested in a phase 3 comparison.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Chandler, Arizona and 155 other locations

+106 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.