A Study of Encorafenib Plus Cetuximab Taken Together With Pembrolizumab Compared to Pembrolizumab Alone in People With Previously Untreated Metastatic Colorectal Cancer ( SEAMARK )

Program Status

Active, not recruiting

Phase

Phase 2

Prior Immunotherapy Allowed

No

CRC-directed Trial

Yes

Drugs

encorafenib, Braftovi, Erbitux, Keytruda

Tags

MSI-H/ MMRd

Comments

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).

NCT ID

NCT05217446

Date Trial Added

2022-02-01

Updated Date

2024-11-13