Date: 2016-10-10
Type of information: Initiation of the trial
phase: 2
Announcement: initiation of the trial
Company: Bavarian Nordic (Denmark) University of California, San Francisco (UCSF) (USA - CA)
Product: Prostvac® (rilimogene) and ipilimumab (Yervoy®)
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.
Disease: prostate cancer
Therapeutic area: Cancer - Oncology
Country: USA
Trial
details: This is a multicentered, open label, randomized phase II trial of Prostvac® or ipilimumab or the combination of Prostvac® and ipilimumab as neoadjuvant therapy in patients with localized PC. Eligible patients will be randomized to Prostvac® monotherapy (Arm A), ipilimumab monotherapy (Arm B), or combination therapy with both Prostvac® and ipilimumab (Arm C), prior to RP. In arms A and C, Prostvac®-V will be administered subcutaneously as the primary vaccine on Day 1, which will be followed 2 weeks later with a series of 2 Prostvac®-F subcutaneous administrations, given 3 weeks apart. In arms B and C, ipilimumab will be administered twice, at a dose of 3mg/kg, 3 weeks apart. In the combination arm, ipilimumab administration will coincide with the Prostvac®-F administration. In arm B, ipilimumab will begin on Day 1. In all three arms, RP will occur 21 days, or three weeks, following final treatment administration of Prostvac® or ipilimumab. No further therapy will be administered on study following RP. (NCT02506114)
Latest
news: * On October 10, 2016, Bavarian Nordic announced the initiation of a Phase 2 clinical trial of its prostate cancer immunotherapy candidate, Prostvac® (rilimogene), in combination treatment with ipilimumab (Yervoy®), an immune checkpoint inhibitor from BMS, as neoadjuvant therapy in 75 patients with localized prostate cancer. Patients will be randomized into three cohorts of 25 each to receive either Prostvac® or ipilimumab or a combination of both. The primary endpoint of the study is to evaluate CD3+ T cell immune responses and secondary measures include immunologic infiltration, circulating effector T cells and regulatory T cells. The principal investigator of the study is Lawrence Fong, MD, Professor, Department of Medicine (Hematology/Oncology), University of California, San Francisco (UCSF) and UCSF is also sponsor of the study. This is the first trial conducted under the clinical collaboration with BMS which was entered in 2015 upon signing of an option and license agreement for Prostvac®. A second trial is planned in order to investigate the combination treatment of Prostvac®, ipilimumab and nivolumab (Opdivo®), the latter also a checkpoint inhibitor product from BMS' immuno-oncology portfolio.
