PF-08634404 plus chemotherapy for adults with metastatic colorectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Ironwood Cancer & Research Centers
  Chandler, Arizona, United States Recruiting
• Ironwood Cancer & Research Centers
  Gilbert, Arizona, United States Recruiting
• Ironwood Cancer & Research Centers
  Glendale, Arizona, United States Recruiting
• Ironwood Cancer & Research Centers
  Goodyear, Arizona, United States Recruiting
• Ironwood Cancer & Research Centers
  Mesa, Arizona, United States Recruiting
• Ironwood Cancer & Research Centers
  Mesa, Arizona, United States Recruiting

+322 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Pfizer CT.gov Call Center
• Email: ClinicalTrials.gov_Inquiries@pfizer.com
• Phone: 1-800-718-1021

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.