The first patient has been dosed in a Phase 2 study evaluating the combination therapy of its cancer vaccine, CV301, and Bristol Myers Squibb’s checkpoint inhibitor, nivolumab (OPDIVO), for the treatment of patients with resectable hepatic-limited metastatic colorectal cancer (mCRC).
Bavarian Nordic’s CV301 is designed to create a T-cell response against the tumor antigens CEA and MUC1, which are overexpressed on multiple solid tumors, including colorectal cancers. Preclinical data supports the premise that CV301 is highly synergistic with checkpoint inhibitors and holds the potential to broaden their efficacy in cancers where monotherapy has been ineffective.
A multiple site study
The randomized, multiple-site, Phase 2 trial is being led by Darren Carpizo, M.D., Ph.D., the Director of the Liver Cancer and Bile Duct Cancer Program at Rutgers Cancer Institute, with material support from Bavarian Nordic and Bristol Myers Squibb. The study is expected to enroll 78 patients. Prior to surgical removal of their tumors, patients will be randomized to receive four cycles of either chemotherapy plus nivolumab or a combination of chemotherapy, nivolumab, and CV301. After resection, patients will continue receiving respective treatments in each study arm. Overall survival (OS) and several secondary measures will be evaluated in each arm.
“We are thrilled to see the first dose administered in this trial to evaluate the combination therapy of CV301 and nivolumab in patients with resectable, oligometastatic, microsatellite stable colorectal cancer (MSS),” said Paul Chaplin, President and CEO of Bavarian Nordic. “While checkpoint inhibitors have been impressive in some tumors, there are hundreds of thousands of cancer patients in dire need of new treatments, particularly in MSS. We are eager to explore how CV301 enhances the overall survival and lowers the risk of reoccurrence in these patients.”