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NCT05217446 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Metastatic Colorectal Cancer, sponsored by Pfizer.

Active
Registry status
Phase 2
Development phase
107
Enrollment target
20
Study locations

NCT05217446 is a Phase 2 study of Metastatic Colorectal Cancer that is active but no longer recruiting, run by Pfizer. The registered enrollment target is 107 participants, below the 184-participant average among 45 other Metastatic Colorectal Cancer trials with a reported enrollment target (42% lower). The trial reports 20 study locations across 13 states.

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The verdict

NCT05217446, a Phase 2 study of Metastatic Colorectal Cancer, is active but no longer recruiting, sponsored by Pfizer.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
107 participants
Enrollment target
20
Study locations

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.

Conditions Studied

Metastatic Colorectal Cancer

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

1,845 total trials

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What the Registry Record Tells You About NCT05217446

The ClinicalTrials.gov registry entry for NCT05217446 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 107 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 184-participant average among 45 other Metastatic Colorectal Cancer trials with a reported enrollment target (42% lower). The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.

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.

NCT05217446 reports 20 study locations spanning 13 distinct geographic areas - top geographies include Arizona, Victoria, Bruxelles-capitale, Région de.

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.

What interventions are being tested in trial NCT05217446?

The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Cetuximab (BIOLOGICAL), Encorafenib (DRUG).

Who is sponsoring clinical trial NCT05217446?

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

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.

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

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.