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 |
|
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 | |
|
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 |
| Canada | |
|
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 |
|
Saskatoon Cancer Center Saskatoon, Saskatchewan S7N4H4 |
Active, not recruiting |
| Czechia | |
|
Fakultni nemocnice Hradec Kralove Hradec Kralove, Hradec Králové 500 05 |
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 |
|
Hôpital Saint Antoine Paris 75571 |
Active, not recruiting |
| Germany | |
|
Muenchen Klinik Neuperlach, Klinik fuer Haematologie und Onkologie Muenchen, Bayern 81737 |
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 |
| Norway | |
|
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 |
| Slovakia | |
|
Narodny onkologicky ustav Bratislava 833 10 |
Active, not recruiting |
| Spain | |
|
CHUS - Hospital Clinico Universitario Santiago de Compostela, A Coruña [LA Coruña] 15706 |
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 General Universitario Gregorio Marañon Madrid 28007 |
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 |
| United Kingdom | |
|
Aberdeen Royal Infirmary Aberdeen, Aberdeen CITY AB25 2ZN |
Active, not recruiting |
|
Heartlands Hospital Birmingham B9 5SS |
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).
