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.

View Eligibility Criteria

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).

Study is for people with:

Colon Cancer

Phase:

Phase 2

Estimated Enrollment:

104

Study ID:

NCT05217446

Recruitment Status:

Recruiting

Sponsor:

Pfizer

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There are 45 Locations for this study

See Locations Near You

Mount Sinai Cancer Center
Miami Beach Florida, 33140, United States
Columbia University Medical Center
New York New York, 10032, United States
GenesisCare North Shore
St Leonards New South Wales, 2065, Australia
Gallipoli Medical Research Foundation
Brisbane Queensland, 4120, Australia
Greenslopes Private Hospital
Greenslopes Queensland, 4120, Australia
Peter MacCallum Cancer Centre
Melbourne Victoria, 3000, Australia
Royal Melbourne Hospital
Parkville Victoria, 3052, Australia
Imelda General Hospital
Bonheiden Antwerpen, 2820, Belgium
Institut Jules Bordet
Anderlecht Bruxelles-capitale, Région DE, 1070, Belgium
ZNA Middelheim
Antwerpen , 2020, Belgium
Fakultni nemocnice Hradec Kralove
Hradec Kralove Hradec Králové, 500 0, Czechia
Fakultni Thomayerova nemocnice
Prague Praha 4, 14059, Czechia
Fakultni nemocnice Bulovka
Prague Praha 8, 180 8, Czechia
Hôpital Européen Georges Pompidou
Paris Cedex 15 Paris, 75015, France
Hôpital Saint Antoine
Paris , 75571, France
Klinikum Oldenburg
Oldenburg Niedersachsen, 26133, Germany
Onkologische Schwerpunktpraxis Kurfuerstendamm
Berlin , 10707, Germany
Facharztzentrum Eppendorf
Hamburg , 20249, Germany
Policlinico Universitario Monserrato
Monserrato Cagliari, 09042, Italy
IRCCS Casa Sollievo della Sofferenza
San Giovanni Rotondo Foggia, 71013, Italy
Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia
Candiolo Torino, 10060, Italy
Azienda USL Toscana Nord Ovest_Ospedale Civile di Livorno
Livorno Toscana, 57124, Italy
Azienda Ospedaliera Universitaria Pisana
Pisa Toscana, 56126, Italy
Fondazione Poliambulanza Istituto Ospedaliero
Brescia , 25124, Italy
Maastricht UMC+
Maastricht Limburg, 6229 , Netherlands
Przychodnia Lekarska KOMED
Konin Wielkopolskie, 62-50, Poland
Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im. Ks. B. Markiewicza
Brzozow , 36-20, Poland
SPZOZ Wojewodzki Szpital Specjalistyczny nr 4 w Bytomiu
Bytom , 41-90, Poland
Copernicus Podmiot Leczniczy Sp. z o.o. Wojewodzkie Centrum Onkologii
Gdansk , 80-21, Poland
Radomskie Centrum Onkologii im. Bohaterow Radomskiego Czerwca 76
Radom , 26-60, Poland
Fakultna nemocnica s poliklinikou F. D. Roosevelta Banska Bystrica
Banska Bystrica , 975 1, Slovakia
Narodny onkologicky ustav
Bratislava , 833 1, Slovakia
Vychodoslovensky onkologicky ustav, a.s.
Kosice , 04191, Slovakia
CHUS - Hospital Clinico Universitario
Santiago de Compostela A Coruña [LA Coruña], 15706, Spain
Hospital General Universitario de Elche
Elche Alicante, 03202, Spain
Hospital Universitari Vall d'Hebron
Barcelona Barcelona [barcelona], 08035, Spain
Hospital Clínic de Barcelona
Barcelona Catalunya [cataluña], 08036, Spain
Hospital Universitario Ramón y Cajal
Madrid Madrid, Comunidad DE, 28034, Spain
Hospital Universitario 12 de Octubre
Madrid Madrid, Comunidad DE, 28041, Spain
Hospital General Universitario Gregorio Marañon
Madrid , 28007, Spain
Hospital Universitario 12 de Octubre
Madrid , 28041, Spain
Hospital Universitario Virgen Del Rocio
Sevilla , 41013, Spain
Hospital General Universitario de Valencia
Valencia , 46014, Spain
Hospital Universitario Miguel Servet
Zaragoza , 50009, Spain
Södersjukhuset
Stockholm Stockholms LÄN [se-01], 11883, Sweden
Skaraborgs Sjukhus Skövde
Skövde , 541 8, Sweden
Aberdeen Royal Infirmary
Aberdeen Aberdeen CITY, AB25 , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Colon Cancer

Phase:

Phase 2

Estimated Enrollment:

104

Study ID:

NCT05217446

Recruitment Status:

Recruiting

Sponsor:


Pfizer

How clear is this clinincal trial information?

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