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

Overview

Información sobre este estudio

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.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

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).

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 5/2/23. Questions regarding updates should be directed to the study team contact.

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Rochester, Minn.

Investigador principal de Mayo Clinic

Zhaohui Jin, M.D.

Cerrado para la inscripción

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Scottsdale/Phoenix, Ariz.

Investigador principal de Mayo Clinic

Christina Wu, M.B., B.Ch., M.D.

Abierto para la inscripción

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publicaciones

Publications are currently not available

Otros temas en investigación

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CLS-20536359

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