Date: 2017-04-19
Type of
information: Initiation of the trial
phase: 2
Announcement: initiation of the trial
Company: Bavarian Nordic (Denmark) BMS (USA - NY)
Product: Prostvac® (rilimogene), in combination treatment with Yervoy® (ipilimumab) and/or Opdivo® (nivolumab)
Action
mechanism:
- immunotherapy product/gene therapy/monoclonal antibody/immune checkpoint inhibitor.
- Prostvac® is a PSA-targeted, ready-to-use active immunotherapy for the treatment of prostate cancer. Administered subcutaneously, it induces a specific, targeted immune response that attacks prostate cancer cells.
- Cytotoxic T-lymphocyte antigen-4 (CTLA-4) is a negative regulator of T-cell activation. Ipilimumab binds to CTLA-4 and blocks the interaction of CTLA-4 with its ligands, CD80/CD86. Blockade of CTLA-4 has been shown to augment T-cell activation and proliferation, including the activation and proliferation of tumor infiltrating T-effector cells. Inhibition of CTLA-4 signaling can also reduce T-regulatory cell function, which may contribute to a general increase in T-cell responsiveness, including the anti-tumor immune response.
- Opdivo® (nivolumab) is a fully-human PD-1 immune checkpoint inhibitor that binds to the checkpoint receptor PD-1 (programmed death-1) expressed on activated T-cells. PD-1, a receptor expressed on the surface of lymphocytes, plays a role in a regulatory pathway that suppresses activated lymphocytes in the body. Available evidence suggests that cancer cells exploit this pathway to escape from immune responses. Opdivo® is thought to provide benefit by blocking PD-1-mediated negative regulation of lymphocytes (i.e., the interaction of PD-1 with its ligands PD-L1 and PD-L2), thereby enhancing the ability of the immune system to recognize cancer cells as foreign and eliminate them.
Disease: localized prostate cancer
Therapeutic
area: Cancer - Oncology
Country: USA
Trial
details: The trial will evaluate the safety of the combination of all three drugs in 10 patients with castration-resistant prostate cancer, followed by enrollment of up to 55 patients with localized prostate cancer in three cohorts, who will receive Prostvac® (rilimogene) in combination with either ipilimumab or nivolumab, or a combination of all three drugs prior to undergoing radical prostatectomy. The primary endpoint of the study is to evaluate and compare changes in T cell infiltration in the tumor after neoadjuvant treatment across the three different cohorts. The principal investigator of the study is James L. Gulley, MD, Senior Investigator, Center for Cancer Research, part of the National Cancer Institute (NCI), and the sponsor of the study.(NCT02933255)
Latest
news:
- • On April 19, 2017, Bavarian Nordic announced the initiation of a Phase 2 clinical trial of its prostate cancer immunotherapy candidate, Prostvac® (rilimogene), in combination treatment with Yervoy® (ipilimumab) and/or Opdivo® (nivolumab), both of which are immune checkpoint inhibitors from BMS, as neoadjuvant therapy in patients with localized prostate cancer.
- This is the second trial conducted in collaboration with BMS. The first trial was initiated in October 2016, and is investigating the combination treatment of Prostvac® and ipilimumab at the University of California, San Francisco (UCSF), also in a neoadjuvant setting.
Is
general: Yes
