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Clinical Trial Summary

This Phase II research project will test the efficacy, safety, and tolerability of an experimental drug combination: either nivolumab and BBI608 or nivolumab and BNC105 in patients with metastatic colorectal cancer who have previously failed standard of care treatment.


Clinical Trial Description

This is an open-label, multicentre, parallel phase II study designed to assess the efficacy of the combination of nivolumab and BNC105 and the combination of nivolumab and BBI-608. Patients with microsatellite stable adenocarcinoma of colorectal origin that is not resectable are eligible and will be randomised in the ratio of 1:1 using permuted block randomisation with stratification by screening ECOG performance status (0 or 1) to receive either nivolumab and BNC105 or nivolumab and BBI-608. The expected sample size is 90 patients over a 24 month recruitment period. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03647839
Study type Interventional
Source Australasian Gastro-Intestinal Trials Group
Contact
Status Completed
Phase Phase 2
Start date September 6, 2018
Completion date April 9, 2021

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