Yükleniyor... / Loading...
This study compares Pembrolizumab given together with Encorafenib plus Cetuximab against Pembrolizumab alone in people with previously untreated metastatic colorectal cancer. It enrolled patients whose tumors carry a BRAF V600E mutation and are MSI-H/dMMR and who had not received prior systemic therapy for metastatic disease. It is being conducted in Phase 2 and is active but not currently recruiting participants.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
+19
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
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).