Bavarian Nordic has revealed a new Phase II trial that will explore a combination of its cancer vaccine, CV301, and Bristol-Myers Squibb’s nivolumab (OPDIVO) for treating patients with metastatic colorectal cancer (mCRC).
Led by Rutgers Cancer Institute in New Jersey, US, Liver Cancer and Bile Duct Cancer Programme director Dr Darren Carpizo, the trial will enrol up to 74 patients with oligometastatic, microsatellite stable mCRC eligible for complete resection.
As part of the trial patients will be randomised to receive four cycles of either chemotherapy plus nivolumab or a combination of chemotherapy, nivolumab, and CV301, before the surgical removal of their tumours.
Following resection, patients will continue to receive respective treatments in each study group.
The trial aims to begin enrolment soon.
Dr Carpizo said: “In about 80% of colorectal cancer patients whose disease has spread to the liver, the cancer returns after complete resection.
“By exploring unique combinations of vaccine therapy and checkpoint inhibition along with standard of care, we believe it is possible to improve overall survival and risk of recurrence in this patient population.”
Bavarian Nordic president and CEO Paul Chaplin noted that so far no checkpoint inhibitors have been approved for the treatment of microsatellite stable colorectal cancer.
Chaplin said: “We believe that CV301, with its ability to elicit T-cells against specific tumour antigens, has the potential to address cancers in which monotherapy checkpoint inhibition may not be possible, and we are happy to further explore how we can best serve patients in need of new therapies.”
CV301 is Bavarian’s immunotherapy candidate, which is being developed under a cooperative research and development agreement (CRADA) with the US National Cancer Institute (NCI).