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A Study of Encorafenib Plus Cetuximab Taken Together With Pembrolizumab Compared to Pembrolizumab Alone in People With Previously Untreated Metastatic Colorectal Cancer
Sponsor: Pfizer
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.
Official title: A PHASE 2, RANDOMIZED, OPEN-LABEL STUDY OF ENCORAFENIB AND CETUXIMAB PLUS PEMBROLIZUMAB VERSUS PEMBROLIZUMAB ALONE IN PARTICIPANTS WITH PREVIOUSLY UNTREATED BRAF V600E-MUTANT, MSI H/DMMR METASTATIC COLORECTAL CANCER
Key Details
Gender
All
Age Range
16 Years - Any
Study Type
INTERVENTIONAL
Enrollment
107
Start Date
2022-07-11
Completion Date
2027-01-26
Last Updated
2026-04-07
Healthy Volunteers
No
Conditions
Interventions
Encorafenib
capsule
Cetuximab
IV
Pembrolizumab
IV
Locations (59)
Mayo Clinic Building - Phoenix
Phoenix, Arizona, United States
Mayo Clinic Hospital
Phoenix, Arizona, United States
Mayo Clinic
Scottsdale, Arizona, United States
Mount Sinai Cancer Center
Miami Beach, Florida, United States
The West Clinic, PLLC dba West Cancer Center
Germantown, Tennessee, United States
MD Anderson Cancer Center
Houston, Texas, United States
Austin Health
Heidelberg, Victoria, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Royal Melbourne Hospital
Parkville, Victoria, Australia
Imelda General Hospital
Bonheiden, Antwerpen, Belgium
Institut Jules Bordet
Anderlecht, Bruxelles-capitale, Région de, Belgium
Cliniques universitaires Saint-Luc
Brussels, Bruxelles-capitale, Région de, Belgium
The Ottawa Hospital - General Campus
Ottawa, Ontario, Canada
Sunnybrook Health Sciences - Odette Cancer Centre
Toronto, Ontario, Canada
Saskatchewan Health Authority
Saskatoon, Saskatchewan, Canada
Saskatoon Cancer Center
Saskatoon, Saskatchewan, Canada
Fakultni nemocnice Hradec Kralove
Hradec Králové, Hradec Králové, Czechia
Fakultni Thomayerova nemocnice
Prague, Praha 4, Czechia
Fakultni nemocnice Bulovka
Prague, Praha 8, Czechia
Rigshospitalet
Copenhagen, Capital Region, Denmark
Herlev and Gentofte Hospital
Copenhagen, Capital Region, Denmark
Aalborg Universitetshospital, Syd
Aalborg, North Denmark, Denmark
Vejle Hospital, Department of Oncology
Vejle, Region Syddanmark, Denmark
Vejle Sygehus
Vejle, Region Syddanmark, Denmark
Hôpital Européen Georges Pompidou
Paris, Paris, France
Centre Hospitalier Universitaire Estaing
Clermont-Ferrand, France
CHU Estaing
Clermont-Ferrand, France
Institut Regional du Cancer de Montpellier - ICM Val d'Aurelle
Montpellier, France
Hôpital Saint Antoine
Paris, France
Muenchen Klinik Neuperlach, Klinik fuer Haematologie und Onkologie
Munich, Bavaria, Germany
Facharztzentrum Eppendorf
Hamburg, Germany
Policlinico Universitario Monserrato
Monserrato, Cagliari, Italy
Azienda Ospedaliera Universitaria dell'Università "Luigi Vanvitelli" Piazza Luigi Miraglia, 2 Napoli
Naples, Campania, Italy
Ospedale di Guastalla
Guastalla, Emilia-Romagna, Italy
IRCCS Casa Sollievo della Sofferenza
San Giovanni Rotondo, Foggia, Italy
ASST Grande Ospedale Metropolitano Niguarda
Milan, Milano, Italy
Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia
Candiolo, Torino, Italy
Azienda USL Toscana Nord Ovest_Ospedale Civile di Livorno
Livorno, Tuscany, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, Tuscany, Italy
Istituto Oncologico Veneto IRCCS
Padova, Veneto, Italy
Fondazione Poliambulanza Istituto Ospedaliero
Brescia, Italy
Istituto Europeo di Oncologia IRCCS
Milan, Italy
Arcispedale Santa Maria Nuova
Reggio Emilia, Italy
Maastricht UMC+
Maastricht, Limburg, Netherlands
Oslo Universitetssykehus Ullevål
Oslo, Norway
Przychodnia Lekarska KOMED
Konin, Greater Poland Voivodeship, Poland
Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im. Ks. B. Markiewicza
Brzozów, Poland
Narodny onkologicky ustav
Bratislava, Slovakia
CHUS - Hospital Clinico Universitario
Santiago de Compostela, A Coruña [LA Coruña], Spain
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [barcelona], Spain
Hospital Clínic de Barcelona
Barcelona, Catalunya [cataluña], Spain
Institut Català d'Oncologia - L'Hospitalet
L'Hospitalet de Llobregat, Catalunya [cataluña], Spain
Hospital Universitario Ramón y Cajal
Madrid, Madrid, Comunidad de, Spain
Hospital General Universitario Gregorio Marañon
Madrid, Spain
Hospital Universitario Virgen Del Rocio
Seville, Spain
Hospital General Universitario de Valencia
Valencia, Spain
Hospital Universitario Miguel Servet
Zaragoza, Spain
Aberdeen Royal Infirmary
Aberdeen, Aberdeen CITY, United Kingdom
Heartlands Hospital
Birmingham, United Kingdom