This is an open-label, single-center, single-arm phase II clinical trial evaluating the combination of pembrolizumab, binimetinib, and bevacizumab in patients with metastatic colorectal adenocarcinoma who have not responded to prior therapy.
Name: Pembrolizumab, Bevacizumab, and Binimetinib
Description: Overall Response Rate based on CT imaging and how it compares to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
Measure: Determine the effectiveness pembrolizumab, binimetinib, and bevacizumab on the response rate of colorectal cancer Time: Study beginning to study end; 12 monthsDescription: Kaplan-Meier product-limit method will be used to summarize the time to event results
Measure: Determine the effectiveness of pembrolizumab, binimetinib, and bevacizumab on progression free survival of colorectal cancer Time: Study start date to first sign of disease progression or death, whichever comes first, assessed up to 100 weeksDescription: Kaplan-Meier product-limit method will be used to summarize the time to event results
Measure: Determine the effectiveness of pembrolizumab, binimetinib, and bevacizumab on overall survival of colorectal cancer Time: Study start to first sign of disease progression or death. whichever comes first, assessed up to 100 weeksDescription: Grade 1, 2, 3, or 4 toxicities as defined by CTCAE v4 will be evaluated
Measure: Evaluation of the safety and tolerability of pembrolizumab, binimetinib, and bevacizumab when given together Time: Study beginning to study end, 12 monthsAllocation: Randomized
Single Group Assignment
There is one SNP
- Patients with BRAF V600E mutations are not elgible for the study. --- V600E ---