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
Conditions
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
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