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ACTIVE NOT RECRUITING Phase 2

A Study of Encorafenib Plus Cetuximab Taken Together With Pembrolizumab Compared to Pembrolizumab Alone in People With Previously Untreated Metastatic Colorectal Cancer

NCT05217446 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of this study is to learn about the effects of three study medicines (encorafenib, cetuximab, and pembrolizumab) given together for the treatment of colorectal cancer that: * is metastatic (spread to other parts of the body); * has the condition of genetic hypermutability (tendency to mutation) or impaired DNA mismatch repair (MMR) * has a certain type of abnormal gene called "BRAF" and; * has not received prior treatment. All participants in this study will receive pembrolizumab at the study clinic as an intravenous (IV) infusion (given directly into a vein) at the study clinic. In addition, half of the participants will take encorafenib by mouth at home every day and cetuximab by IV infusion at the study clinic. The study team will monitor how each participant is doing with the study treatment during regular visits at the study clinic.

Interventions

  • BIOLOGICAL Pembrolizumab
  • BIOLOGICAL Cetuximab
  • DRUG Encorafenib

Study Locations (20)

Arizona

  • Mayo Clinic Building - Phoenix — Phoenix
  • Mayo Clinic Hospital — Phoenix
  • Mayo Clinic — Scottsdale

Victoria

  • Austin Health — Heidelberg
  • Peter MacCallum Cancer Centre — Melbourne
  • Royal Melbourne Hospital — Parkville

Bruxelles-capitale, Région de

  • Institut Jules Bordet — Anderlecht
  • Cliniques universitaires Saint-Luc — Brussels

Ontario

  • The Ottawa Hospital - General Campus — Ottawa
  • Sunnybrook Health Sciences - Odette Cancer Centre — Toronto

Saskatchewan

  • Saskatoon City Hospital — Saskatoon
  • Saskatoon Cancer Center — Saskatoon

Florida

  • Mount Sinai Cancer Center — Miami Beach

Tennessee

  • The West Clinic, PLLC dba West Cancer Center — Germantown

Texas

  • MD Anderson Cancer Center — Houston

Trial Details

FieldValue
Enrollment Target 107 participants
Start Date 2022-07-11
Est. Completion 2027-01-26
Phase Phase 2

Sponsor

Pfizer

769 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05217446

The ClinicalTrials.gov registry entry for NCT05217446 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 107 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 769 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Metastatic Colorectal Cancer appearing as the primary indexed condition, and to 3 interventions — of which Pembrolizumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05217446 reports 20 study locations spanning 13 distinct geographic areas — top geographies include Arizona, Victoria, Bruxelles-capitale, Région de. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05217446 about?

NCT05217446 is a clinical study titled "A Study of Encorafenib Plus Cetuximab Taken Together With Pembrolizumab Compared to Pembrolizumab Alone in People With Previously Untreated Metastatic Colorectal Cancer". The purpose of this study is to learn about the effects of three study medicines (encorafenib, cetuximab, and pembrolizumab) given together for the treatment of colorectal cancer that: * is metastatic (spread to other parts of the body); * has the condition of genetic hypermutability (tendency to m...

What is the current status of trial NCT05217446?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 107 participants. The study started on 2022-07-11. Estimated completion is 2027-01-26.

What conditions does trial NCT05217446 study?

This clinical trial studies the following conditions: Metastatic Colorectal Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05217446?

The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Cetuximab (BIOLOGICAL), Encorafenib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05217446?

This trial is sponsored by Pfizer, which has 769 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05217446 being conducted?

This trial has 20 study locations across Arizona, Florida, Tennessee, Texas, Victoria. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial