Date: 2016-12-29
Type of information: Initiation of the trial
phase: 1-2
Announcement: initiation of the trial
Company: Bavarian Nordic (Denmark)
Product: CV301 in combination with Opdivo® (nivolumab)
Action
mechanism: immunotherapy product/monoclonal antibody/immune checkpoint inhibitor. Opdivo® (nivolumab) is an investigational human PD-1 immune checkpoint inhibitor that binds to the checkpoint receptor PD-1 (programmed death-1) expressed on activated T-cells. CV301 is an immunotherapy product candidate for the treatment of multiple cancers. It originates from the same poxvirus technology platform as Prostvac®. Both products are prime-boost vaccines sequentially combining two different poxviruses (vaccinia and fowlpox). While Prostvac® incorporates a single antigen over-expressed in prostate cancer (PSA), CV-301 incorporates two antigens (CEA and MUC-1) that are over-expressed in other major cancers, including breast, colon, bladder and other cancers, which makes CV-301 potentially applicable in various cancers. CV301 incorporates a modified version of vaccinia (MVA-BN, a proprietary technology of Bavarian Nordic) as a priming dose, followed by multiple fowlpox boosts, and encodes the TRICOM costimulatory molecules.
Disease: non-small cell lung cancer (NSCLC)
Therapeutic area: Cancer - Oncology
Country:
Trial
details: The objective of the proposed clinical study is to investigate the safety and tolerability of CV301 in combination with Opdivo® (nivolumab), an anti PD1- inhibitor, compared to nivolumab alone in subjects with previously treated non-small cell lung cancer (NSCLC). The clinical study is designed to evaluate the possible enhanced antitumor activity of CV301 with nivolumab compared to nivolumab alone in a setting in which nivolumab is the standard-of-care, second-line therapy, for metastatic NSCLC. The rationale for combining CV301 with nivolumab is based on the hypothesis that CV301 can induce specific immune response in the tumor, and that in combination, nivolumab may augment the T cell-mediated immune response generated by CV301 by blocking the inhibitory signal of the PD-1. The study will include a Phase 1 dose escalation part to assess the safety and tolerability of CV301 alone, prior to moving into the combination with nivolumab (the Phase 1b component). The Phase 1 part of the trial will be followed by a Phase 1b component to test in a single arm lead-in stage the safety and tolerability of the combination treatment, i.e. CV301 plus nivolumab, before expanding the number of patients to be treated in the randomized Phase 2 part of the trial. The objective of the Phase 2 is to assess the safety and preliminary efficacy of CV301 in combination with nivolumab compared to nivolumab alone in subjects with previously treated NSCLC. (NCT02840994)
Latest
news: * On December 29, 2016, Bavarian Nordic announced the initiation of a clinical trial combining its proprietary cancer immunotherapy candidate, CV301, with the anti-PD-1 drug, Opdivo® (nivolumab) from BMS. 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.
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.
"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," said Paul Chaplin, President & CEO of Bavarian Nordic.
