Colon Cancer Clinical Trial
A Study of Encorafenib Plus Cetuximab Taken Together With Pembrolizumab Compared to Pembrolizumab Alone in People With Previously Untreated Metastatic Colorectal Cancer
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.
Eligibility 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:
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).
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There are 87 Locations for this study
Phoenix Arizona, 85054, United States
Phoenix Arizona, 85054, United States
Scottsdale Arizona, 85259, United States
Los Angeles California, 90033, United States
Los Angeles California, 90033, United States
Los Angeles California, 90033, United States
Los Angeles California, 90033, United States
Los Angeles California, 90033, United States
Los Angeles California, 90033, United States
Pasadena California, 91105, United States
Miami Beach Florida, 33140, United States
Miami Florida, 33136, United States
Plantation Florida, 33324, United States
Rochester Minnesota, 55905, United States
Rochester Minnesota, 55905, United States
New York New York, 10032, United States
Germantown Tennessee, 38138, United States
Houston Texas, 77030, United States
Camperdown New South Wales, 2050, Australia
St Leonards New South Wales, 2065, Australia
Brisbane Queensland, 4120, Australia
Greenslopes Queensland, 4120, Australia
Heidelberg Victoria, 3084, Australia
Melbourne Victoria, 3000, Australia
Parkville Victoria, 3052, Australia
Bonheiden Antwerpen, 2820, Belgium
Anderlecht Bruxelles-capitale, Région DE, 1070, Belgium
Brussels Bruxelles-capitale, Région DE, 1200, Belgium
Gent Oost-vlaanderen, 9000, Belgium
Leuven Vlaams-brabant, 3000, Belgium
Antwerpen , 2020, Belgium
Brampton Ontario, L6R 3, Canada
Ottawa Ontario, K1H 8, Canada
Toronto Ontario, M4N 3, Canada
Montreal Quebec, h1t2m, Canada
Saskatoon Saskatchewan, S7N4H, Canada
Hradec Kralove Hradec Králové, 500 0, Czechia
Olomouc Olomoucký KRAJ, 779 0, Czechia
Prague Praha 4, 14059, Czechia
Prague Praha 8, 180 8, Czechia
Copenhagen Hovedstaden, 2100, Denmark
Copenhagen Hovedstaden, 2730, Denmark
Aalborg Nordjylland, 9000, Denmark
Vejle Syddanmark, 7100, Denmark
Paris Cedex 15 Paris, 75015, France
Clermont Ferrand , 63100, France
Clermont-Ferrand , 63100, France
Montpellier Cedex 5 , 34298, France
Montpellier , 34298, France
Paris , 75571, France
Muenchen Bayern, 81737, Germany
Frankfurt Hessen, 60488, Germany
Oldenburg Niedersachsen, 26133, Germany
Halle (Saale) Sachsen-anhalt, 06108, Germany
Leipzig Sachsen, 04103, Germany
Berlin , 10707, Germany
Halle /Saale , 06108, Germany
Hamburg , 20249, Germany
Monserrato Cagliari, 09042, Italy
Napoli Campania, 80131, Italy
Guastalla Emilia-romagna, 42016, Italy
San Giovanni Rotondo Foggia, 71013, Italy
Milan Milano, 20162, Italy
Candiolo Torino, 10060, Italy
Livorno Toscana, 57124, Italy
Pisa Toscana, 56126, Italy
Padova Veneto, 35128, Italy
Brescia , 25124, Italy
Milano , 20141, Italy
Reggio Emilia , 42123, Italy
Maastricht Limburg, 6229 , Netherlands
Leidschendam Zuid-holland, 2262 , Netherlands
Trondheim Sør-trøndelag, 7030, Norway
Oslo , 0450, Norway
Konin Wielkopolskie, 62-50, Poland
Brzozow , 36-20, Poland
Bytom , 41-90, Poland
Gdansk , 80-21, Poland
Radom , 26-60, Poland
Banska Bystrica , 975 1, Slovakia
Bratislava , 812 5, Slovakia
Bratislava , 833 1, Slovakia
Kosice , 04191, Slovakia
Santiago de Compostela A Coruña [LA Coruña], 15706, Spain
Elche Alicante, 03202, Spain
Barcelona Barcelona [barcelona], 08035, Spain
Barcelona Catalunya [cataluña], 08036, Spain
L'Hospitalet de Llobregat Catalunya [cataluña], 08908, Spain
Madrid Madrid, Comunidad DE, 28034, Spain
Madrid Madrid, Comunidad DE, 28041, Spain
Madrid , 28007, Spain
Madrid , 28041, Spain
Sevilla , 41013, Spain
Valencia , 46014, Spain
Zaragoza , 50009, Spain
Solna Stockholms LÄN [se-01], 171 6, Sweden
Stockholm Stockholms LÄN [se-01], 11883, Sweden
Skövde , 541 8, Sweden
Aberdeen Aberdeen CITY, AB25 , United Kingdom
London England, SE1 9, United Kingdom
London London, CITY OF, SE1 9, United Kingdom
Birmingham , B9 5S, United Kingdom
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