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news.Bavarian Nordic has started a clinical trial combining its cancer immunotherapy candidate, CV301, with Bristol-Myers Squibb's anti-PD-1 drug, OPDIVO (nivolumab).
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The study is enrolling patients with non-small cell lung cancer (NSCLC) who have failed prior therapy.
The trial will begin with a Phase 1 safety component, enrolling up to 40 patients; the Phase 2 portion of the study will enroll 120 patients who will be randomized to receive either nivolumab (monotherapy) or a combination of CV301 and nivolumab.
The study will enroll patients from up to 20 clinical sites throughout the United States.
The rationale for this combination approach is for the vaccine to generate a tumor specific T cell response and allow the checkpoint inhibitor to maintain that immune effect by preventing the tumor from turning that response off.
While the primary endpoint of the study is overall survival, numerous secondary endpoints including response rate, progression free survival and duration of response will be evaluated and offer the potential for an early efficacy signal, prior to an overall survival endpoint.
Bavarian Nordic president & CEO Paul Chaplin said: “We are pleased to announce the initiation of this study, which marks the entry for Bavarian Nordic into lung cancer.
"While CV301 has shown the ability to generate immune responses to tumor-associated antigens in a variety of cancers, this study is the first seeking proof-of-concept for a promising combination approach and we look forward to the results as well as to advance CV301 as combination therapy in additional indications over the next years."