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.
Name: Binimetinib
Name: Encorafenib
Name: Nivolumab
Name: Questionnaire Administration
Description: Will be measured according to immune-related Response Evaluation Criteria in Solid Tumors (irRECIST). The point estimate of the objective response rate (ORR) and its 95% confidence interval will be obtained.
Measure: Radiographic Response Time: Up to 3 yearsDescription: Will be assessed in the following order of importance: complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), and not evaluable. The point estimate of the ORR and its 95% confidence interval will be obtained
Measure: Best investigator-assessed response Time: Up to 3 yearsDescription: Will be graded according to the Common Terminology Criteria for Adverse Events version 5.0. Safety data will be tabulated.
Measure: Incidence of treatment-related grade 3 or higher adverse events (AEs) Time: 100 days after last doseDescription: Will be defined by irRECIST criteria for the evaluable population. Will be estimated by Kaplan-Meier method and summarized with Kaplan-Meier curves and log rank test from start of treatment until death or PD
Measure: Progression-free survival Time: Up to 3 yearsDescription: Will be estimated by Kaplan-Meier method and summarized with Kaplan-Meier curves and log rank test from start of treatment until death occurs
Measure: Overall survival Time: Up to 3 yearsDescription: Will be defined by irRECIST criteria. Will be estimated by Kaplan-Meier method and summarized with Kaplan-Meier curves and log rank test from start of treatment until time of response.
Measure: Time (in days) to response criteria Time: Up to 3 yearsDescription: Will be estimated by Kaplan-Meier method and summarized with Kaplan-Meier curves and log rank test from first partial or CR to time of PD or death for subjects with a response
Measure: Duration of response Time: Up to 3 yearsDescription: The proportion of patients with CR, PR, or SD defined by irRECIST criteria in the evaluable population. The point estimate of DCR and its 95% confidence interval will be obtained.
Measure: Disease control rate (DCR) Time: Up to 3 yearsAllocation: N/A
Single Group Assignment
There is one SNP
Phase I/II Trial of Encorafenib, Binimetinib, and Nivolumab in Microsatellite Stable BRAF V600E Metastatic Colorectal Cancer. --- V600E ---
Encorafenib, Binimetinib, and Nivolumab in Treating Patients With 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). --- V600E ---