This trial is examining the effectiveness and safety of treatment with nivolumab (Opdivo) and relatlimab in patients with advanced colorectal cancer. The main outcome to be measured will be tumor response to the treatment. This trial is being conducted in Maryland, US.
The details
Colorectal cancer is the third most common cancer in the US. The standard treatment is surgery and chemotherapy. However, chemotherapy in metastatic (spread to other parts of the body) disease has only a limited effect. The addition of targeted therapy such as nivolumab or relatlimab to the treatment might improve the cancer outcomes. These agents activate the immune system to attack and kill cancer cells.
This trial is evaluating the safety and effectiveness of nivolumab and relatlimab in patients with advanced colorectal cancer. The main outcome will be measured by the number of participants with tumor response (tumor shrinkage).
Who are they looking for?
This study will be recruiting 64 participants with advanced colorectal cancer with a life expectancy of more than 3 months. Patients must have good organ function and must accept using birth control and give biopsies.
Patients must not have brain metastasis, history of prior treatment with anti-PD1 agents (targeted therapy), had chemotherapy, radiation or steroids within 14 days prior to the study. Patients must not have an allergy to the drugs used in the study and must not have any severe medical illness. Patients should also not have an immune disease, HIV or hepatitis B or C, prior transplant, must not require oxygen, must not have an active infection or an abnormal heart rhythm, and must not be pregnant or breastfeeding.
How will it work
All participants will receive treatment every 28 days for up to 2 years. Nivolumab (480 mg) and relatlimab (160 mg) will be given by injection on day 1.
The outcomes will be measured by the number of participants with tumor response and treatment toxicity. Patients will be followed up for up to 4 years.
