This phase 1/2 trial is examining the best dose and side effects of a combined treatment with encorafenib (Braftovi), cetuximab (Erbitux) and nivolumab (Opdivo). The main outcome to be measured will be the tumor response to the treatment. This trial is being conducted in Texas, US.
Colorectal cancer is one of the leading causes of death worldwide. Some patients present a mutation (permanent change) in the BRAF gene. This mutation increases the ability of the tumor to grow and spread.
The standard treatment for this disease used to be chemotherapy. However, this treatment was only of limited effectiveness. More recently, other agents begin to be added to the treatment of these patients. Encorafenib and cetuximab may stop the tumor growth by blocking some of the enzymes needed for cell growth. Nivolumab activates the immune system to kill tumor cells. Prior studies showed the positive effects of these agents alone. However, the effectiveness of encorafenib, cetuximab, and nivolumab (ECN) combined is not well known.
This trial is examining the best dose and side effects of a combined treatment with ECN. The main outcome to be measured will be the tumor response to the treatment.
Who are they looking for?
This trial is recruiting 38 participants with BRAF positive advanced colorectal cancer. Patients must have adequate bone marrow, liver, and kidney function. Participants must not have had prior treatment with more than two drugs within 6 months of this trial. Female patients must agree to use effective birth control.
Participants must not have received treatment with immunosuppressants, BRAF inhibitors, anti-EGFR or anti-PD1 therapy. Patients must not have received a transplant or live vaccine within 30 days prior to this trial. Must not have any active infection, or severe disease such as brain, heart, lung, bowel or mental disease. Participants should not have had a major surgery in the past 6 weeks or be pregnant or breastfeeding.
How will it work
All participants will receive encorafenib on days 1 to 28, cetuximab over 1h on days 1 and 15, and nivolumab over 30 minutes on day 1. Cycles repeat every 28 days until disease progression or toxicity.
After the treatment patients will be followed at 30 and 100 days, at 3 months and every 3 months after that. The main outcome will be measured by tumor size (through X-ray). Participants will be followed up for up to 5 years.