A Study of Encorafenib Plus Cetuximab Taken Together With Pembrolizumab Compared to Pembrolizumab Alone in People With Previously Untreated Metastatic Colorectal Cancer
NCT ID: NCT05217446
Last Updated: 2026-02-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
107 participants
INTERVENTIONAL
2022-07-11
2027-01-26
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A: encorafenib, cetuximab and pembrolizumab
Participants receive encorafenib orally + cetuximab IV + pembrolizumab IV.
Encorafenib
capsule
Cetuximab
IV
Pembrolizumab
IV
Arm B: pembrolizumab
Participants receive pembrolizumab IV.
Pembrolizumab
IV
Interventions
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Encorafenib
capsule
Cetuximab
IV
Pembrolizumab
IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
16 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Merck KGaA, Darmstadt, Germany
INDUSTRY
Eli Lilly and Company
INDUSTRY
Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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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
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 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
Napoli, 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
Padua, 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
Countries
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References
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Elez E, Kopetz S, Tabernero J, Bekaii-Saab T, Taieb J, Yoshino T, Manji G, Fernandez K, Abbattista A, Zhang X, Morris VK. SEAMARK: phase II study of first-line encorafenib and cetuximab plus pembrolizumab for MSI-H/dMMR BRAFV600E-mutant mCRC. Future Oncol. 2024 Apr;20(11):653-663. doi: 10.2217/fon-2022-1249. Epub 2023 Oct 10.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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SEAMARK
Identifier Type: OTHER
Identifier Source: secondary_id
2024-512119-34-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
KEYNOTE-D31
Identifier Type: OTHER
Identifier Source: secondary_id
MK-3475-D31
Identifier Type: OTHER
Identifier Source: secondary_id
C4221022
Identifier Type: -
Identifier Source: org_study_id
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