This trial is examining the effectiveness of mFOLFOX6 (oxaliplatin, leucovorin, fluorouracil) and nivolumab (Opdivo) with and without a new cancer vaccine (CV301) for patients with colorectal cancer that has spread to the liver. The main outcome will be overall survival.
This trial is being conducted in California and New Jersey, US.
Colorectal cancer is one of the most common cancers in the US. Often patients present advanced disease at diagnostic. Metastatic disease is associated with poorer outcomes and chemotherapy has limited effectiveness in these cases. Therefore, other agents are often added to the treatment to improve effectiveness such as the vaccines MVA-BN-CV301 and FPV-CV301. A vaccine is a type of immunotherapy, that helps the immune system to find and kill cancer cells.
This trial is examining the effectiveness of CV301 vaccination (MVA-BN-CV301 and FPV-CV301) with mFOLFOX6 and nivolumab in patients with colorectal cancer spread to the liver. Overall survival will be evaluated.
Who are they looking for?
This trial is recruiting 78 participants with cancer that has spread to the liver. Patients must have an operable disease and adequate blood cell counts and liver and kidney function tests.
Patients must not have had prior treatment for advanced disease, must not have cancer mutations (a permanent change in the genes), must not be pregnant or breastfeeding and must not have any other metastasis. Patients must not have any active infections, HIV or hepatitis B and C, heart disease, immune disease or allergies to the therapies being used in this trial.
How will it work
There will be two groups in this trial. One group will be assigned to receive mFOLFOX6 and nivolumab every 2 weeks for 4 cycles. The other group will receive two doses of nivolumab and an initial dose of MVA-BN-CV301 each given 2 weeks apart. This will be followed by four doses of nivolumab plus the second vaccine dose FPV-CV301 given two weeks apart and mFOLFOX6 (every 2 weeks, for 4 cycles).
After treatment, all patients with operable disease will be given surgery. This will be followed by either 8 cycles of mFOLFOX6 plus nivolumab, followed by Nivolumab every 4 weeks until week 110 or 8 cycles of mFOLFOX6 plus nivolumab and FPV-CV301 (given on days 0 and 14 and then every 4 weeks). After day 98, FPV-CV301 will be given every 12 weeks until week 110.
Overall survival, recurrence-free survival (time from treatment to cancer coming back) and tumor response rate will be measured up to 3 years.