Stage IV Colon Cancer Clinical Trial
Official title:
Phase I/II Trial of Encorafenib, Binimetinib, and Nivolumab in Microsatellite Stable BRAF V600E Metastatic Colorectal Cancer
This phase I/II trial studies the side effects and how well encorafenib, binimetinib, and nivolumab work in treating patients with microsatellite stable, BRAFV600E gene-mutated colorectal cancer that has spread to other places in the body (metastatic). Encorafenib and binimetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving encorafenib, binimetinib, and nivolumab may work better in treating patients with colorectal cancer compared to standard treatments.
This was intended to be a phase I/II study of Encorafenib, Binimetinib, and Nivolumab for treating participants with Microsatellite Stable BRAF V600E Metastatic Colorectal Cancer. The study was terminated before Phase II was initiated. The study did not open Phase II for enrollment. PRIMARY OBJECTIVES: I. To describe overall response rate (ORR) upon treatment with encorafenib, binimetinib, and nivolumab in patients with BRAFV600E, microsatellite stable (MSS) metastatic colorectal cancer (mCRC). II. To determine the safety and tolerability of nivolumab, encorafenib, and binimetinib in patients with BRAFV600E, MSS mCRC. SECONDARY OBJECTIVES: I. To estimate median progression-free survival (PFS) upon treatment with encorafenib, binimetinib, and nivolumab. II. To estimate median overall survival (OS) upon treatment with encorafenib, binimetinib, and nivolumab. III. To estimate median time to response (TTR) upon treatment with encorafenib, binimetinib, and nivolumab. IV. To estimate median duration of response (DoR) upon treatment with encorafenib, binimetinib, and nivolumab. V. To estimate disease control rate (DCR) upon treatment with encorafenib, binimetinib, and nivolumab. EXPLORATORY (CORRELATIVE) OBJECTIVES: I. To assess genomic and immune changes upon treatment with encorafenib, binimetinib, and nivolumab in tumor tissue, blood and stool. II. To correlate genomic and immune changes upon treatment with encorafenib, binimetinib, and nivolumab in tumor tissue, blood and stool with radiographic response. III. To evaluate contrast-enhanced computed tomography (CT) imaging for disease burden that is not measurable by immune-related Response Evaluation Criteria in Solid Tumors (irRECIST) and to correlate location and patterns of metastatic disease with clinical outcomes. OUTLINE: Participants in received encorafenib orally (PO) once daily (QD) on days 1-28, binimetinib PO twice daily (BID) on days 1-28, and nivolumab intravenously (IV) on day 1. Cycles repeat every 28 days for a maximum of 24 cycles of treatment. If disease progression or recurrence occurs, treatment may be resumed outside of the context of the clinical trial. After completion of study treatment, patients are followed up at 30 and 100 days, then every 3 months thereafter. Only participants in Phase 1 were enrolled. ;
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