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Triple therapy shows promise for Hard-to-Treat colorectal cancer

NCT ID NCT05217446

Disease control Sponsor: Pfizer Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 31, 2026 · Updated 1 time

Summary

This study tests whether adding two targeted drugs (encorafenib and cetuximab) to standard immunotherapy (pembrolizumab) works better than immunotherapy alone for people with a specific genetic type of advanced colorectal cancer. About 107 participants with untreated, metastatic BRAF V600E-mutant, MSI-H/dMMR colorectal cancer will be randomly assigned to receive either the triple combination or pembrolizumab alone. The main goal is to see if the combination delays cancer growth or improves survival.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

108 people

The number who actually took part.

Started

Jul 2022

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

16 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Locally confirmed microsatellite instability-high/ deficient mismatch repair (MSI-H/dMMR) stage IV colorectal carcinoma * Locally confirmed BRAF V600E mutation in tumor tissue or blood * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Have not received prior systemic regimens for metastatic disease. * Measurable disease per RECIST 1.1 * Adequate organ function Exclusion Criteria: * Colorectal adenocarcinoma that is RAS mutant or for which RAS mutation status is unknown * Known active central nervous system metastases and/or carcinomatous meningitis; leptomeningeal disease * Immunodeficiency or active autoimmune disease requiring systemic treatment in the past 2 years * Presence of acute or chronic pancreatitis * Clinically significant cardiovascular diseases (eg, thromboembolic or cerebrovascular accident events ≤ 12 wks prior) * Received a live or live-attenuated vaccine within 30 days of planned start of study medication * Previous treatment with any selective BRAF inhibitor (eg, encorafenib, dabrafenib, vemurafenib, XL281/BMS-908662) or any epidermal growth factor receptor (EGFR) inhibitor (eg, cetuximab, panitumumab). * Previous treatment with an immune checkpoint inhibitor (eg, anti-programmed cell death \[PD-1\], anti-PD-L1 or anti-PD-L2 agent); or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).

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Conditions

The condition(s) this trial relates to.

colonic neoplasm colorectal cancer colorectal neoplasm rectal neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Metastatic colorectal cancer

Contacts and locations

Locations

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, Milano, 20162, Italy

  • Aalborg Universitetshospital, Syd

    Aalborg, North Denmark, 9000, Denmark

  • Aberdeen Royal Infirmary

    Aberdeen, Aberdeen CITY, AB25 2ZN, United Kingdom

  • Arcispedale Santa Maria Nuova

    Reggio Emilia, 42123, Italy

  • Austin Health

    Heidelberg, Victoria, 3084, Australia

  • Azienda Ospedaliera Universitaria dell'Università "Luigi Vanvitelli" Piazza Luigi Miraglia, 2 Napoli

    Naples, Campania, 80131, Italy

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, Tuscany, 56126, Italy

  • Azienda USL Toscana Nord Ovest_Ospedale Civile di Livorno

    Livorno, Tuscany, 57124, Italy

  • CHU Estaing

    Clermont-Ferrand, 63100, France

  • CHUS - Hospital Clinico Universitario

    Santiago de Compostela, A Coruña [LA Coruña], 15706, Spain

  • Centre Hospitalier Universitaire Estaing

    Clermont-Ferrand, 63100, France

  • Cliniques universitaires Saint-Luc

    Brussels, Bruxelles-capitale, Région de, 1200, Belgium

  • Facharztzentrum Eppendorf

    Hamburg, 20249, Germany

  • Fakultni Thomayerova nemocnice

    Prague, Praha 4, 14059, Czechia

  • Fakultni nemocnice Bulovka

    Prague, Praha 8, 180 81, Czechia

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové, Hradec Králové, 500 05, Czechia

  • Fondazione Poliambulanza Istituto Ospedaliero

    Brescia, 25124, Italy

  • Heartlands Hospital

    Birmingham, B9 5SS, United Kingdom

  • Herlev and Gentofte Hospital

    Copenhagen, Capital Region, 2730, Denmark

  • Hospital Clínic de Barcelona

    Barcelona, Catalunya [cataluña], 08036, Spain

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007, Spain

  • Hospital General Universitario de Valencia

    Valencia, 46014, Spain

  • Hospital Universitari Vall d'Hebron

    Barcelona, Barcelona [barcelona], 08035, Spain

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009, Spain

  • Hospital Universitario Ramón y Cajal

    Madrid, Madrid, Comunidad de, 28034, Spain

  • Hospital Universitario Virgen Del Rocio

    Seville, 41013, Spain

  • Hôpital Européen Georges Pompidou

    Paris, Paris, 75015, France

  • Hôpital Saint Antoine

    Paris, 75571, France

  • IRCCS Casa Sollievo della Sofferenza

    San Giovanni Rotondo, Foggia, 71013, Italy

  • Imelda General Hospital

    Bonheiden, Antwerpen, 2820, Belgium

  • Institut Català d'Oncologia - L'Hospitalet

    L'Hospitalet de Llobregat, Catalunya [cataluña], 08908, Spain

  • Institut Jules Bordet

    Anderlecht, Bruxelles-capitale, Région de, 1070, Belgium

  • Institut Regional du Cancer de Montpellier - ICM Val d'Aurelle

    Montpellier, 34298, France

  • Istituto Europeo di Oncologia IRCCS

    Milan, 20141, Italy

  • Istituto Oncologico Veneto IRCCS

    Padova, Veneto, 35128, Italy

  • Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia

    Candiolo, Torino, 10060, Italy

  • MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Maastricht UMC+

    Maastricht, Limburg, 6229 HX, Netherlands

  • Mayo Clinic

    Scottsdale, Arizona, 85259, United States

  • Mayo Clinic Building - Phoenix

    Phoenix, Arizona, 85054, United States

  • Mayo Clinic Hospital

    Phoenix, Arizona, 85054, United States

  • Mount Sinai Cancer Center

    Miami Beach, Florida, 33140, United States

  • Muenchen Klinik Neuperlach, Klinik fuer Haematologie und Onkologie

    Munich, Bavaria, 81737, Germany

  • Narodny onkologicky ustav

    Bratislava, 833 10, Slovakia

  • Oslo Universitetssykehus Ullevål

    Oslo, 0450, Norway

  • Ospedale di Guastalla

    Guastalla, Emilia-Romagna, 42016, Italy

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3000, Australia

  • Policlinico Universitario Monserrato

    Monserrato, Cagliari, 09042, Italy

  • Przychodnia Lekarska KOMED

    Konin, Greater Poland Voivodeship, 62-500, Poland

  • Rigshospitalet

    Copenhagen, Capital, 2100, Denmark

  • Royal Melbourne Hospital

    Parkville, Victoria, 3000, Australia

  • Saskatchewan Health Authority

    Saskatoon, Saskatchewan, S7K 0M7, Canada

  • Saskatoon Cancer Center

    Saskatoon, Saskatchewan, S7N4H4, Canada

  • Sunnybrook Health Sciences - Odette Cancer Centre

    Toronto, Ontario, M4N 3M5, Canada

  • Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im. Ks. B. Markiewicza

    Brzozów, 36-200, Poland

  • The Ottawa Hospital - General Campus

    Ottawa, Ontario, K1H 8L6, Canada

  • The West Clinic, PLLC dba West Cancer Center

    Germantown, Tennessee, 38138, United States

  • Vejle Hospital, Department of Oncology

    Vejle, Region Syddanmark, 7100, Denmark

  • Vejle Sygehus

    Vejle, Region Syddanmark, 7100, Denmark

More trials for these conditions

Other studies related to the condition(s) this trial covers.