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Report for Clinical Trial NCT03475004

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Phase II Study of Pembrolizumab in Combination With Binimetinib and Bevacizumab in Patients With Refractory Colorectal Cancer

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.

NCT03475004 Colorectal Cancer Metastatic Cancer
MeSH:Colorectal Neoplasms
HPO:Neoplasm of the large intestine

1 Interventions

Name: Pembrolizumab, Bevacizumab, and Binimetinib

Description: Cohort A: binimetinib 45mg, orally, twice a day, for 7 days. This will be followed by bevacizumab 7.5mg/kg on day 1 every 21 days and pembrolizumab 200mg on day 1 every 21 days. Binimetinib, 45mg, PO BID, should be taken on a continuous dosing schedule. Cohort B: bevacizumab 7.5mg/kg on day 1 every 21 days and pembrolizumab 200mg on day 1 every 21 days. Binimetinib, 45mg, PO BID, should be taken on a continuous dosing schedule.
Type: Drug
Group Labels: 1

Combination Therapy


Primary Outcomes

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 months

Secondary Outcomes

Description: 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 weeks

Description: 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 weeks

Description: 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 months

Purpose: Treatment

Allocation: Randomized

Single Group Assignment


There is one SNP

SNPs


1 V600E

- Patients with BRAF V600E mutations are not elgible for the study. --- V600E ---



HPO Nodes


HPO: