Triple therapy shows promise for Hard-to-Treat colorectal cancer
NCT ID NCT05217446
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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ASST Grande Ospedale Metropolitano Niguarda
Milan, Milano, 20162, Italy
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Aalborg Universitetshospital, Syd
Aalborg, North Denmark, 9000, Denmark
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Aberdeen Royal Infirmary
Aberdeen, Aberdeen CITY, AB25 2ZN, United Kingdom
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Arcispedale Santa Maria Nuova
Reggio Emilia, 42123, Italy
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Austin Health
Heidelberg, Victoria, 3084, Australia
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Azienda Ospedaliera Universitaria dell'Università "Luigi Vanvitelli" Piazza Luigi Miraglia, 2 Napoli
Naples, Campania, 80131, Italy
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Azienda Ospedaliero Universitaria Pisana
Pisa, Tuscany, 56126, Italy
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Azienda USL Toscana Nord Ovest_Ospedale Civile di Livorno
Livorno, Tuscany, 57124, Italy
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CHU Estaing
Clermont-Ferrand, 63100, France
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CHUS - Hospital Clinico Universitario
Santiago de Compostela, A Coruña [LA Coruña], 15706, Spain
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Centre Hospitalier Universitaire Estaing
Clermont-Ferrand, 63100, France
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Cliniques universitaires Saint-Luc
Brussels, Bruxelles-capitale, Région de, 1200, Belgium
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Facharztzentrum Eppendorf
Hamburg, 20249, Germany
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Fakultni Thomayerova nemocnice
Prague, Praha 4, 14059, Czechia
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Fakultni nemocnice Bulovka
Prague, Praha 8, 180 81, Czechia
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Fakultni nemocnice Hradec Kralove
Hradec Králové, Hradec Králové, 500 05, Czechia
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Fondazione Poliambulanza Istituto Ospedaliero
Brescia, 25124, Italy
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Heartlands Hospital
Birmingham, B9 5SS, United Kingdom
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Herlev and Gentofte Hospital
Copenhagen, Capital Region, 2730, Denmark
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Hospital Clínic de Barcelona
Barcelona, Catalunya [cataluña], 08036, Spain
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Hospital General Universitario Gregorio Marañon
Madrid, 28007, Spain
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Hospital General Universitario de Valencia
Valencia, 46014, Spain
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Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [barcelona], 08035, Spain
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Hospital Universitario Miguel Servet
Zaragoza, 50009, Spain
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Hospital Universitario Ramón y Cajal
Madrid, Madrid, Comunidad de, 28034, Spain
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Hospital Universitario Virgen Del Rocio
Seville, 41013, Spain
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Hôpital Européen Georges Pompidou
Paris, Paris, 75015, France
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Hôpital Saint Antoine
Paris, 75571, France
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IRCCS Casa Sollievo della Sofferenza
San Giovanni Rotondo, Foggia, 71013, Italy
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Imelda General Hospital
Bonheiden, Antwerpen, 2820, Belgium
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Institut Català d'Oncologia - L'Hospitalet
L'Hospitalet de Llobregat, Catalunya [cataluña], 08908, Spain
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Institut Jules Bordet
Anderlecht, Bruxelles-capitale, Région de, 1070, Belgium
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Institut Regional du Cancer de Montpellier - ICM Val d'Aurelle
Montpellier, 34298, France
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Istituto Europeo di Oncologia IRCCS
Milan, 20141, Italy
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Istituto Oncologico Veneto IRCCS
Padova, Veneto, 35128, Italy
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Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia
Candiolo, Torino, 10060, Italy
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MD Anderson Cancer Center
Houston, Texas, 77030, United States
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Maastricht UMC+
Maastricht, Limburg, 6229 HX, Netherlands
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Mayo Clinic
Scottsdale, Arizona, 85259, United States
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Mayo Clinic Building - Phoenix
Phoenix, Arizona, 85054, United States
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Mayo Clinic Hospital
Phoenix, Arizona, 85054, United States
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Mount Sinai Cancer Center
Miami Beach, Florida, 33140, United States
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Muenchen Klinik Neuperlach, Klinik fuer Haematologie und Onkologie
Munich, Bavaria, 81737, Germany
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Narodny onkologicky ustav
Bratislava, 833 10, Slovakia
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Oslo Universitetssykehus Ullevål
Oslo, 0450, Norway
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Ospedale di Guastalla
Guastalla, Emilia-Romagna, 42016, Italy
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Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000, Australia
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Policlinico Universitario Monserrato
Monserrato, Cagliari, 09042, Italy
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Przychodnia Lekarska KOMED
Konin, Greater Poland Voivodeship, 62-500, Poland
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Rigshospitalet
Copenhagen, Capital, 2100, Denmark
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Royal Melbourne Hospital
Parkville, Victoria, 3000, Australia
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Saskatchewan Health Authority
Saskatoon, Saskatchewan, S7K 0M7, Canada
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Saskatoon Cancer Center
Saskatoon, Saskatchewan, S7N4H4, Canada
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Sunnybrook Health Sciences - Odette Cancer Centre
Toronto, Ontario, M4N 3M5, Canada
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Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im. Ks. B. Markiewicza
Brzozów, 36-200, Poland
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The Ottawa Hospital - General Campus
Ottawa, Ontario, K1H 8L6, Canada
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The West Clinic, PLLC dba West Cancer Center
Germantown, Tennessee, 38138, United States
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Vejle Hospital, Department of Oncology
Vejle, Region Syddanmark, 7100, Denmark
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Vejle Sygehus
Vejle, Region Syddanmark, 7100, Denmark
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can delivering cancer drug directly to the liver shrink tumors?
- Blood biomarkers could replace invasive biopsies for colorectal cancer monitoring
- One dose may not fit all: blood tests could tailor cancer drug dosing
- Can a Two-Drug combo outsmart resistant colorectal cancer?
- Can a pill boost the immune system to fight Hard-to-Treat cancers?
- Can a Triple-Drug rechallenge tame colorectal cancer?