Program Status
Active, not recruitingPhase
Phase 2Prior Immunotherapy Allowed
NoCRC-directed Trial
YesDrugs
encorafenib, Braftovi, Erbitux, KeytrudaTags
MSI-H/ MMRdComments
Trial only for patients with metastatic MSI-H/MMRd colorectal cancer AND a BRAF mutation who have not started treatment yet. Some patients will receive the standard of care anti PD-1 pembrolizumab, while others will receive the combination of pembrolizumab (Keytruda, immunotherapy), cetuximab (Erbitux) and encorafenib (Braftovi, BRAF-inhbitor, oral).
No prior checkpoint inhibitor allowed, no prior BRAF inhibitor allowed.
Location | Location Status |
---|---|
United States | |
Mayo Clinic Building - Phoenix Phoenix, Arizona 85054 |
Active, not recruiting |
Mayo Clinic Hospital Phoenix, Arizona 85054 |
Active, not recruiting |
Mayo Clinic Scottsdale, Arizona 85259 |
Active, not recruiting |
Keck Hospital of USC Los Angeles, California 90033 |
Active, not recruiting |
Keck School of Medicine of USC Los Angeles, California 90033 |
Active, not recruiting |
LAC USC Medical Center Los Angeles, California 90033 |
Active, not recruiting |
USC Norris Comprehensive Cancer Center Los Angeles, California 90033 |
Active, not recruiting |
USC/Norris Comprehensive Cancer Center / Investigational Drug Services Los Angeles, California 90033 |
Active, not recruiting |
USC/Norris Comprehensive Cancer Center Los Angeles, California 90033 |
Active, not recruiting |
Keck Hospital of USC Pasadena Pasadena, California 91105 |
Active, not recruiting |
Mount Sinai Cancer Center Miami Beach, Florida 33140 |
Active, not recruiting |
University of Miami Hospital and Clinics, Sylvester Cancer Center Miami, Florida 33136 |
Active, not recruiting |
University of Miami Hospital and Clinics, Sylvester Cancer Center Plantation, Florida 33324 |
Active, not recruiting |
UChicago Medicine - River East Chicago, Illinois 60611 |
Active, not recruiting |
University of Chicago Medical Center Chicago, Illinois 60637 |
Active, not recruiting |
UChicago Medicine at Ingalls - Flossmoor Flossmoor, Illinois 60422 |
Active, not recruiting |
UChicago Medicine Ingalls Memorial Harvey, Illinois 60426 |
Active, not recruiting |
University of Chicago Comprehensive Cancer Center at Silver Cross Hospital New Lenox, Illinois 60451 |
Active, not recruiting |
The University of Chicago Medicine Center of Advanced Care Orland Park Orland Park, Illinois 60462 |
Active, not recruiting |
UChicago Medicine at Ingalls - Tinley Park Tinley Park, Illinois 60477 |
Active, not recruiting |
Mayo Clinic Cancer Center Outpatient Pharmacy Rochester, Minnesota 55905 |
Active, not recruiting |
Mayo Clinic Rochester, Minnesota 55905 |
Active, not recruiting |
Columbia University Medical Center New York, New York 10032 |
Active, not recruiting |
The West Clinic, PLLC dba West Cancer Center Germantown, Tennessee 38138 |
Active, not recruiting |
MD Anderson Cancer Center Houston, Texas 77030 |
Active, not recruiting |
Australia | |
Chris O'Brien Lifehouse Camperdown, New South Wales 2050 |
Active, not recruiting |
GenesisCare North Shore St Leonards, New South Wales 2065 |
Active, not recruiting |
Gallipoli Medical Research Foundation Brisbane, Queensland 4120 |
Active, not recruiting |
Greenslopes Private Hospital Greenslopes, Queensland 4120 |
Active, not recruiting |
Austin Health Heidelberg, Victoria 3084 |
Active, not recruiting |
Peter MacCallum Cancer Centre Melbourne, Victoria 3000 |
Active, not recruiting |
Royal Melbourne Hospital Parkville, Victoria 3052 |
Active, not recruiting |
Belgium | |
Imelda General Hospital Bonheiden, Antwerpen 2820 |
Active, not recruiting |
Institut Jules Bordet Anderlecht, Bruxelles-capitale, Région DE 1070 |
Active, not recruiting |
Cliniques universitaires Saint-Luc Brussels, Bruxelles-capitale, Région DE 1200 |
Active, not recruiting |
UZ Gent Gent, Oost-vlaanderen 9000 |
Active, not recruiting |
UZ Leuven Leuven, Vlaams-brabant 3000 |
Active, not recruiting |
ZNA Middelheim Antwerpen 2020 |
Active, not recruiting |
Canada | |
William Osler Health System Brampton, Ontario L6R 3J7 |
Active, not recruiting |
The Ottawa Hospital - General Campus Ottawa, Ontario K1H 8L6 |
Active, not recruiting |
Sunnybrook Health Sciences - Odette Cancer Centre Toronto, Ontario M4N 3M5 |
Active, not recruiting |
CIUSSS de l'Est-de-l'Île-de-Montréal Montreal, Quebec h1t2m4 |
Active, not recruiting |
Saskatoon Cancer Center Saskatoon, Saskatchewan S7N4H4 |
Active, not recruiting |
Czechia | |
Fakultni nemocnice Hradec Kralove Hradec Kralove, Hradec Králové 500 05 |
Active, not recruiting |
Fakultni nemocnice Olomouc Olomouc, Olomoucký KRAJ 779 00 |
Active, not recruiting |
Fakultni Thomayerova nemocnice Prague, Praha 4 14059 |
Active, not recruiting |
Fakultni nemocnice Bulovka Prague, Praha 8 180 81 |
Active, not recruiting |
Denmark | |
Rigshospitalet Copenhagen, Hovedstaden 2100 |
Active, not recruiting |
Herlev and Gentofte Hospital Copenhagen, Hovedstaden 2730 |
Active, not recruiting |
Aalborg Universitetshospital, Syd Aalborg, Nordjylland 9000 |
Active, not recruiting |
Vejle Sygehus Vejle, Syddanmark 7100 |
Active, not recruiting |
France | |
Hôpital Européen Georges Pompidou Paris Cedex 15, Paris 75015 |
Active, not recruiting |
CHU Estaing Clermont Ferrand 63100 |
Active, not recruiting |
Centre Hospitalier Universitaire Estaing Clermont-Ferrand 63100 |
Active, not recruiting |
Institut Regional du Cancer de Montpellier - ICM Val d'Aurelle Montpellier Cedex 5 34298 |
Active, not recruiting |
Institut Régional du Cancer Montpellier Montpellier 34298 |
Active, not recruiting |
Hôpital Saint Antoine Paris 75571 |
Active, not recruiting |
Germany | |
Muenchen Klinik Neuperlach, Klinik fuer Haematologie und Onkologie Muenchen, Bayern 81737 |
Active, not recruiting |
Institut für Klinisch Onkologische Forschung Frankfurt, Hessen 60488 |
Active, not recruiting |
Klinikum Oldenburg Oldenburg, Niedersachsen 26133 |
Active, not recruiting |
Studiengesellschaft BSF Unternehmergesellschaft Halle (Saale), Sachsen-anhalt 06108 |
Active, not recruiting |
Universitätsklinikum Leipzig Leipzig, Sachsen 04103 |
Active, not recruiting |
Onkologische Schwerpunktpraxis Kurfuerstendamm Berlin 10707 |
Active, not recruiting |
Studiengesellschaft BSF UG Halle /Saale 06108 |
Active, not recruiting |
Facharztzentrum Eppendorf Hamburg 20249 |
Active, not recruiting |
Italy | |
Policlinico Universitario Monserrato Monserrato, Cagliari 09042 |
Active, not recruiting |
Azienda Ospedaliera Universitaria dell'Università "Luigi Vanvitelli" Piazza Luigi Miraglia, 2 Napoli Napoli, Campania 80131 |
Active, not recruiting |
Ospedale di Guastalla Guastalla, Emilia-romagna 42016 |
Active, not recruiting |
IRCCS Casa Sollievo della Sofferenza San Giovanni Rotondo, Foggia 71013 |
Active, not recruiting |
ASST Grande Ospedale Metropolitano Niguarda Milan, Milano 20162 |
Active, not recruiting |
Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia Candiolo, Torino 10060 |
Active, not recruiting |
Azienda USL Toscana Nord Ovest_Ospedale Civile di Livorno Livorno, Toscana 57124 |
Active, not recruiting |
Azienda Ospedaliero Universitaria Pisana Pisa, Toscana 56126 |
Active, not recruiting |
Istituto Oncologico Veneto IRCCS Padova, Veneto 35128 |
Active, not recruiting |
Fondazione Poliambulanza Istituto Ospedaliero Brescia 25124 |
Active, not recruiting |
Istituto Europeo di Oncologia IRCCS Milano 20141 |
Active, not recruiting |
Arcispedale Santa Maria Nuova Reggio Emilia 42123 |
Active, not recruiting |
Netherlands | |
Maastricht UMC+ Maastricht, Limburg 6229 HX |
Active, not recruiting |
Haaglanden MC - locatie Antoniushove Leidschendam, Zuid-holland 2262 BA |
Active, not recruiting |
Norway | |
St. Olavs Hospital Trondheim, Sør-trøndelag 7030 |
Active, not recruiting |
Oslo Universitetssykehus Ullevål Oslo 0450 |
Active, not recruiting |
Poland | |
Przychodnia Lekarska KOMED Konin, Wielkopolskie 62-500 |
Active, not recruiting |
Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im. Ks. B. Markiewicza Brzozow 36-200 |
Active, not recruiting |
SPZOZ Wojewodzki Szpital Specjalistyczny nr 4 w Bytomiu Bytom 41-902 |
Active, not recruiting |
Copernicus Podmiot Leczniczy Sp. z o.o. Wojewodzkie Centrum Onkologii Gdansk 80-219 |
Active, not recruiting |
Radomskie Centrum Onkologii im. Bohaterow Radomskiego Czerwca 76 Radom 26-600 |
Active, not recruiting |
Slovakia | |
Fakultna nemocnica s poliklinikou F. D. Roosevelta Banska Bystrica Banska Bystrica 975 17 |
Active, not recruiting |
Onkologicky ustav sv. Alzbety, s.r.o. Bratislava 812 50 |
Active, not recruiting |
Narodny onkologicky ustav Bratislava 833 10 |
Active, not recruiting |
Vychodoslovensky onkologicky ustav, a.s. Kosice 04191 |
Active, not recruiting |
Spain | |
CHUS - Hospital Clinico Universitario Santiago de Compostela, A Coruña [LA Coruña] 15706 |
Active, not recruiting |
Hospital General Universitario de Elche Elche, Alicante 03202 |
Active, not recruiting |
Hospital Universitari Vall d'Hebron Barcelona, Barcelona [barcelona] 08035 |
Active, not recruiting |
Hospital Clínic de Barcelona Barcelona, Catalunya [cataluña] 08036 |
Active, not recruiting |
Institut Català d'Oncologia - L'Hospitalet L'Hospitalet de Llobregat, Catalunya [cataluña] 08908 |
Active, not recruiting |
Hospital Universitario Ramón y Cajal Madrid, Madrid, Comunidad DE 28034 |
Active, not recruiting |
Hospital Universitario 12 de Octubre Madrid, Madrid, Comunidad DE 28041 |
Active, not recruiting |
Hospital General Universitario Gregorio Marañon Madrid 28007 |
Active, not recruiting |
Hospital Universitario 12 de Octubre Madrid 28041 |
Active, not recruiting |
Hospital Universitario Virgen Del Rocio Sevilla 41013 |
Active, not recruiting |
Hospital General Universitario de Valencia Valencia 46014 |
Active, not recruiting |
Hospital Universitario Miguel Servet Zaragoza 50009 |
Active, not recruiting |
Sweden | |
Karolinska Universitetssjukhuset Solna Solna, Stockholms LÄN [se-01] 171 64 |
Active, not recruiting |
Södersjukhuset Stockholm, Stockholms LÄN [se-01] 11883 |
Active, not recruiting |
Skaraborgs Sjukhus Skövde Skövde 541 85 |
Active, not recruiting |
United Kingdom | |
Aberdeen Royal Infirmary Aberdeen, Aberdeen CITY AB25 2ZN |
Active, not recruiting |
Guy's & St Thomas's NHS Foundation Trust London, England SE1 9RT |
Active, not recruiting |
Royal Marsden Hospital (Chelsea) London, Kensington AND Chelsea SW3 6JJ |
Active, not recruiting |
Guy's & St Thomas' NHS Foundation Trust London, London, CITY OF SE1 9RT |
Active, not recruiting |
Royal Marsden Hospital (Sutton) London, Sutton, Surrey SM2 5PT |
Active, not recruiting |
Heartlands Hospital Birmingham B9 5SS |
Active, not recruiting |
The Royal Marsden NHS Foundation Trust London SW3 6JJ |
Active, not recruiting |
Inclusion Criteria
Inclusion Criteria:
* Locally confirmed microsatellite instability-high/ deficient mismatch repair (MSI-H/dMMR) stage IV colorectal carcinoma
* 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
Exclusion Criteria:
* Colorectal adenocarcinoma that is RAS mutant or for which RAS mutation status is unknown
* 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).