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

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Trial Identification

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

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

Study ID: NCT05217446

Study Description

Brief 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.

Detailed Description:

Eligibility

Minimum Age: 16 Years

Eligible Ages: CHILD, ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Mayo Clinic Building - Phoenix, Phoenix, Arizona, United States

Mayo Clinic Hospital, Phoenix, Arizona, United States

Mayo Clinic, Scottsdale, Arizona, United States

Keck Hospital of USC, Los Angeles, California, United States

Keck School of Medicine of USC, Los Angeles, California, United States

LAC USC Medical Center, Los Angeles, California, United States

USC Norris Comprehensive Cancer Center, Los Angeles, California, United States

USC/Norris Comprehensive Cancer Center / Investigational Drug Services, Los Angeles, California, United States

USC/Norris Comprehensive Cancer Center, Los Angeles, California, United States

Keck Hospital of USC Pasadena, Pasadena, California, United States

Mount Sinai Cancer Center, Miami Beach, Florida, United States

University of Miami Hospital and Clinics, Sylvester Cancer Center, Miami, Florida, United States

University of Miami Hospital and Clinics, Sylvester Cancer Center, Plantation, Florida, United States

UChicago Medicine - River East, Chicago, Illinois, United States

University of Chicago Medical Center, Chicago, Illinois, United States

UChicago Medicine at Ingalls - Flossmoor, Flossmoor, Illinois, United States

UChicago Medicine Ingalls Memorial, Harvey, Illinois, United States

University of Chicago Comprehensive Cancer Center at Silver Cross Hospital, New Lenox, Illinois, United States

The University of Chicago Medicine Center of Advanced Care Orland Park, Orland Park, Illinois, United States

UChicago Medicine at Ingalls - Tinley Park, Tinley Park, Illinois, United States

Mayo Clinic Cancer Center Outpatient Pharmacy, Rochester, Minnesota, United States

Mayo Clinic, Rochester, Minnesota, United States

Columbia University Medical Center, New York, New York, United States

The West Clinic, PLLC dba West Cancer Center, Germantown, Tennessee, United States

MD Anderson Cancer Center, Houston, Texas, United States

Chris O'Brien Lifehouse, Camperdown, New South Wales, Australia

GenesisCare North Shore, St Leonards, New South Wales, Australia

Gallipoli Medical Research Foundation, Brisbane, Queensland, Australia

Greenslopes Private Hospital, Greenslopes, Queensland, Australia

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

UZ Gent, Gent, Oost-vlaanderen, Belgium

UZ Leuven, Leuven, Vlaams-brabant, Belgium

ZNA Middelheim, Antwerpen, , Belgium

William Osler Health System, Brampton, Ontario, Canada

The Ottawa Hospital - General Campus, Ottawa, Ontario, Canada

Sunnybrook Health Sciences - Odette Cancer Centre, Toronto, Ontario, Canada

CIUSSS de l'Est-de-l'Île-de-Montréal, Montreal, Quebec, Canada

Saskatoon Cancer Center, Saskatoon, Saskatchewan, Canada

Fakultni nemocnice Hradec Kralove, Hradec Kralove, Hradec Králové, Czechia

Fakultni nemocnice Olomouc, Olomouc, Olomoucký KRAJ, Czechia

Fakultni Thomayerova nemocnice, Prague, Praha 4, Czechia

Fakultni nemocnice Bulovka, Prague, Praha 8, Czechia

Rigshospitalet, Copenhagen, Hovedstaden, Denmark

Herlev and Gentofte Hospital, Copenhagen, Hovedstaden, Denmark

Aalborg Universitetshospital, Syd, Aalborg, Nordjylland, Denmark

Vejle Sygehus, Vejle, Syddanmark, Denmark

Hôpital Européen Georges Pompidou, Paris Cedex 15, Paris, France

CHU Estaing, Clermont Ferrand, , France

Centre Hospitalier Universitaire Estaing, Clermont-Ferrand, , France

Institut Regional du Cancer de Montpellier - ICM Val d'Aurelle, Montpellier Cedex 5, , France

Institut Régional du Cancer Montpellier, Montpellier, , France

Hôpital Saint Antoine, Paris, , France

Muenchen Klinik Neuperlach, Klinik fuer Haematologie und Onkologie, Muenchen, Bayern, Germany

Institut für Klinisch Onkologische Forschung, Frankfurt, Hessen, Germany

Klinikum Oldenburg, Oldenburg, Niedersachsen, Germany

Studiengesellschaft BSF Unternehmergesellschaft, Halle (Saale), Sachsen-anhalt, Germany

Universitätsklinikum Leipzig, Leipzig, Sachsen, Germany

Onkologische Schwerpunktpraxis Kurfuerstendamm, Berlin, , Germany

Studiengesellschaft BSF UG, Halle /Saale, , 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, Toscana, Italy

Azienda Ospedaliero Universitaria Pisana, Pisa, Toscana, Italy

Istituto Oncologico Veneto IRCCS, Padova, Veneto, Italy

Fondazione Poliambulanza Istituto Ospedaliero, Brescia, , Italy

Istituto Europeo di Oncologia IRCCS, Milano, , Italy

Arcispedale Santa Maria Nuova, Reggio Emilia, , Italy

Maastricht UMC+, Maastricht, Limburg, Netherlands

Haaglanden MC - locatie Antoniushove, Leidschendam, Zuid-holland, Netherlands

St. Olavs Hospital, Trondheim, Sør-trøndelag, Norway

Oslo Universitetssykehus Ullevål, Oslo, , Norway

Przychodnia Lekarska KOMED, Konin, Wielkopolskie, Poland

Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im. Ks. B. Markiewicza, Brzozow, , Poland

SPZOZ Wojewodzki Szpital Specjalistyczny nr 4 w Bytomiu, Bytom, , Poland

Copernicus Podmiot Leczniczy Sp. z o.o. Wojewodzkie Centrum Onkologii, Gdansk, , Poland

Radomskie Centrum Onkologii im. Bohaterow Radomskiego Czerwca 76, Radom, , Poland

Fakultna nemocnica s poliklinikou F. D. Roosevelta Banska Bystrica, Banska Bystrica, , Slovakia

Onkologicky ustav sv. Alzbety, s.r.o., Bratislava, , Slovakia

Narodny onkologicky ustav, Bratislava, , Slovakia

Vychodoslovensky onkologicky ustav, a.s., Kosice, , Slovakia

CHUS - Hospital Clinico Universitario, Santiago de Compostela, A Coruña [LA Coruña], Spain

Hospital General Universitario de Elche, Elche, Alicante, 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 Universitario 12 de Octubre, Madrid, Madrid, Comunidad DE, Spain

Hospital General Universitario Gregorio Marañon, Madrid, , Spain

Hospital Universitario 12 de Octubre, Madrid, , Spain

Hospital Universitario Virgen Del Rocio, Sevilla, , Spain

Hospital General Universitario de Valencia, Valencia, , Spain

Hospital Universitario Miguel Servet, Zaragoza, , Spain

Karolinska Universitetssjukhuset Solna, Solna, Stockholms LÄN [se-01], Sweden

Södersjukhuset, Stockholm, Stockholms LÄN [se-01], Sweden

Skaraborgs Sjukhus Skövde, Skövde, , Sweden

Aberdeen Royal Infirmary, Aberdeen, Aberdeen CITY, United Kingdom

Guy's & St Thomas's NHS Foundation Trust, London, England, United Kingdom

Guy's & St Thomas' NHS Foundation Trust, London, London, CITY OF, United Kingdom

Heartlands Hospital, Birmingham, , United Kingdom

Contact Details

Name: Pfizer CT.gov Call Center

Affiliation: Pfizer

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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