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

Sponsor
Australasian Gastro-Intestinal Trials Group
Study ID
NCT03647839
Phase
PHASE2
Status
Completed

Conditions

  • Colorectal Cancer Metastatic

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab 10 MG/ML — DRUG
    Nivolumab will be supplied free of charge by Bristol-Myers Squibb (BMS) as sterile liquid in 10mL glass vials.
  • BNC 105 — DRUG
    BNC105 will be provided free of charge by Bionomics, as a sterile solution of BNC105P. BNC105P is a clear, colorless to yellow liquid presented in a clear glass vial and is intended to be diluted with commercially available sterile 0.9% saline prior to IV administration.
  • BBI608 — DRUG
    BBI-608 will be supplied free of charge by Boston Biomedical as capsules.

Study Details

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.

Key Dates

Start date
Sep 6, 2018
Status verified
Aug 2021
Primary completion
Jan 29, 2021
Completion
Apr 9, 2021

Study Design

Enrollment
90 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1
    Nivolumab and BNC105
  • Experimental: Arm 2
    Nivolumab and BBI-608

Primary Outcome Measure

Objective response per iRECIST [ Time Frame: From start of treatment up to the date when the last patient has their 6 months follow-up assessment ]

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