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This study examines Encorafenib plus Cetuximab, with or without chemotherapy, in previously untreated patients with metastatic colorectal cancer whose tumors carry a BRAF V600E mutation. It enrolled patients aged 16 and older with Stage IV colorectal cancer. The study is in Phase 3; it is not currently recruiting but is ongoing (active, not recruiting).
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
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Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: * Safety Lead-In = Male/female ≥ 18 years old * Phase 3 and Cohort 3: Male/female ≥ 16 years old (where permitted locally) * Histologically or cytologically confirmed Stage IV CRC that contains BRAF V600E mutation * Prior systemic treatment in metastatic setting: 0-1 regimens for Safety Lead In; none for Phase 3 and Cohort 3. (Note: Prior adjuvant or neoadjuvant therapy considered metastatic treatment if relapse/metastasis \< 6 month from end of adj/neoadjuvant treatment ) * Measurable disease (Phase 3 and Cohort 3)/ Measurable or evaluable disease (Safety Lead-in) * ECOG PS 0-1 * Adequate organ function Exclusion Criteria: * Tumors that are locally confirmed or unknown MSI-H or dMMR unless participant is ineligible to receive immune checkpoint inhibitors due to a pre-existing medical condition * Active bacterial or viral infections in 2 weeks prior to starting dosing * Symptomatic brain metastases