A Phase 2 trial testing Immunovaccine‘s combination of DPX-Survivac with chemotherapy and an immune checkpoint inhibitor in diffuse large B-cell lymphoma (DLBCL) has dosed its first participant.
The trial is supported by Merck Canada and Immunovaccine, and is being led by Neil Berinstein, MD, an affiliate scientist at Sunnybrook Research Institute and professor of medicine and immunology at the University of Toronto.
“We designed DPX-Survivac in large part to boost the rates of other novel immuno-modulating agents, and continue to see clinical data that support this goal in other cancer types,” Frederic Ors, CEO of Immunovaccine, said in a press release. “We look forward to working with our partners at Sunnybrook Research Institute and Merck Canada to further this endeavor.”
DPX-Survivac is a cancer vaccine that helps the immune system attack cells producing the survivin protein, an important mediator of tumor progression and treatment resistance that is present in 60 percent of DLBCL cases.
The new trial called SPiReL (NCT03349450), was designed to test a combination of the vaccine with low-dose cyclophosphamide and Keytruda (pembrolizumab) in patients with DLBCL who failed to respond or progress after prior lines of therapy and whose tumors are positive for survivin. Participants will be included from four clinical sites in Canada.
The vaccine will be given in two shoots, three weeks apart, but patients may receive six additional booster vaccinations during the course of the study. Also, patients will receive twice-daily cyclophosphamide and Keytruda every three weeks for up to one year.
Treatment-related toxicities and response to treatment, with measurements of tumor regression and duration of response, will be assessed every two months. Investigators will also assess potential biomarkers of immune and clinical response.
“Working with Immunovaccine’s candidate DPX-Survivac gives us the opportunity to assess whether these patients may experience enhanced anti-cancer activity with novel combination treatments,” Berinstein said. “Despite recent breakthroughs, this is an unmet medical need and this approach may have relevance to many other cancers.”
The triple combination is also being evaluated as a treatment for patients with advanced ovarian cancer in a second Phase 2 trial (NCT03029403).
