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NCT07222800 · ClinicalTrials.gov registry record · Phase 3

A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Metastatic Colorectal Cancer

A Phase 3 study of Colorectal Neoplasms and Gastrointestinal Diseases, sponsored by Pfizer.

Recruiting
Registry status
Phase 3
Development phase
800
Enrollment target
16
Study locations

NCT07222800 is a Phase 3 study of Colorectal Neoplasms and Gastrointestinal Diseases that is actively recruiting participants, run by Pfizer. The registered enrollment target is 800 participants, above the 562-participant average among 54 other Colorectal Neoplasms trials with a reported enrollment target (42% higher). The trial reports 16 study locations across 6 states.

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The verdict

NCT07222800, a Phase 3 study of Colorectal Neoplasms and Gastrointestinal Diseases, is actively recruiting participants, sponsored by Pfizer.

RECRUITING
Registry status
Phase 3
Development phase
800 participants
Enrollment target
16
Study locations

Study 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 a

Conditions Studied

Colorectal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms by Site Colonic Diseases Digestive System Diseases Intestinal Diseases Digestive System Neoplasms Rectal Diseases Intestinal Neoplasms

Interventions

  • DRUG Chemotherapy
  • BIOLOGICAL Bevacizumab
  • DRUG PF-08634404

Study Locations (16)

Other

  • Icon Cancer Centre Wesley - Auchenflower
  • Icon Cancer Centre Hobart - Hobart
  • Kyushu University Hospital - Fukuoka
  • Saitama Medical University International Medical Center - Hidaka
  • National Hospital Organization Osaka Medical Center - Osaka
  • Saitama Prefectural Cancer Center - Saitama
  • The Cancer Institute Hospital of JFCR - Tokyo
  • Pan American Center for Oncology Trials, LLC - Rio Piedras

Florida

  • Mid Florida Hematology and Oncology Center - Orange City
  • Cancer Care Centers of Brevard, Inc. - Palm Bay

Illinois

  • Illinois Cancer Care - Canton
  • Hope and Healing Cancer Services - Hinsdale

Texas

  • Texas Oncology - West Texas - Odessa
  • Texas Oncology - Northeast Texas - Tyler

New York

  • Hematology Oncology Associates of Rockland - Nyack

Oregon

  • Oncology Associates of Oregon, P.C. - Albany

Trial Details

FieldValue
Enrollment Target 800 participants
Start Date 2025-12-11
Est. Completion 2031-08-01
Phase Phase 3

Sponsor

Pfizer

1,845 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT07222800

The ClinicalTrials.gov registry entry for NCT07222800 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 800 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 562-participant average among 54 other Colorectal Neoplasms trials with a reported enrollment target (42% higher). The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.

The record links to 10 conditions, with Colorectal Neoplasms appearing as the primary indexed condition, and to 3 interventions - of which Chemotherapy is the first listed.

NCT07222800 reports 16 study locations spanning 6 distinct geographic areas - top geographies include Other, Florida, Illinois.

Frequently Asked Questions

What is clinical trial NCT07222800 about?

NCT07222800 is a clinical study titled "A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Metastatic Colorectal Cancer". 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...

What is the current status of trial NCT07222800?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 800 participants. The study started on 2025-12-11. Estimated completion is 2031-08-01.

What conditions does trial NCT07222800 study?

This clinical trial studies the following conditions: Colorectal Neoplasms, Gastrointestinal Diseases, Gastrointestinal Neoplasms, Neoplasms by Site, Colonic Diseases.

What interventions are being tested in trial NCT07222800?

The interventions under investigation include: Chemotherapy (DRUG), Bevacizumab (BIOLOGICAL), PF-08634404 (DRUG).

Who is sponsoring clinical trial NCT07222800?

This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07222800 being conducted?

This trial has 16 study locations across Florida, Illinois, New York, Oregon, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.