Date: 2016-04-29
Type of information: Initiation of the trial
phase: 1
Announcement: initiation of the trial
Company: SELLAS Life Sciences (Switzerland)
Product: galinpepimut-S (human Wilms tumor protein 1 peptides - WT1 vaccine) and nivolumab (Opdivo®)
Action
mechanism: peptide/vaccine/monoclonal antibody. This vaccine is comprised of four modified peptide chains that induce a strong adaptive T-cell immune response (CD4+/CD8+ T-cells) against the WT1 antigen. The WT1 vaccine is administered in combination with an adjuvant and an immune modulator to improve the immune response to the target. Based on its mechanism and the accumulating evidence of activity in mid-stage trials, the WT1 vaccine may have the potential to complement currently available therapies by destroying residual tumor cells of cancers in remission and providing ongoing immune surveillance for recurrent tumors. The WT1 vaccine has been originally developed by Memorial Sloan Kettering Cancer Center and licensed to Sellas. Opdivo® (nivolumab) is a human PD-1 immune checkpoint inhibitor that binds to the checkpoint receptor PD-1 (programmed death-1) expressed on activated T-cells.
Disease: ovarian cancer
Therapeutic area: Cancer - Oncology
Country:
Trial details:
Latest
news: * On April 29, 2016, SELLAS Life Sciences Group announced the initiation of a Phase 1 clinical trial to evaluate the safety and efficacy of galinpepimut-S in combination with nivolumab (Opdivo®), BMS’ PD-1 immune checkpoint inhibitor. The Phase 1 study is expected to enroll at least ten patients with recurrent ovarian cancer who are in second or greater clinical remission at Memorial Sloan Kettering Cancer Center. Ovarian cancer is one of the most common gynecologic malignancies and the fifth most frequent cause of cancer death in women in the United States. Over 22,000 cases are diagnosed annually, and there are an estimated 15,500 deaths per year. Patients enrolled in the Phase 1 study will receive the combination therapy during the trial’s 14-week treatment period. Individuals who have not progressed by the end of this period will also receive a maintenance course of the WT1 vaccine. Pending the successful progress of the trial a larger, follow-on, randomized study may be planned.
