Modulation Of The Tumour Microenvironment Using Either Vascular Disrupting Agents or STAT3 Inhibition in Order to Synergise With PD1 Inhibition in Microsatellite Stable, Refractory Colorectal Cancer — MODULATE  

Colorectal Cancer Metastatic Clinical Trial

Official title: Modulation Of The Tumour Microenvironment Using Either Vascular Disrupting Agents or STAT3 Inhibition in Order to Synergise With PD1 Inhibition in Microsatellite Stable, Refractory Colorectal Cancer

Status Completed

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. ;

Related Conditions & MeSH terms

• Colorectal Cancer Metastatic
• Colorectal Neoplasms

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