Roswell Park Announces Positive Progress in Clinical Trial of Novel Immunotherapy SurVaxM

Roswell Park Comprehensive Cancer Center announced that the ongoing phase 2B SURVIVE clinical trial of SurVaxM in glioblastoma will continue following an interim analysis of trial data. The clinical trial is designed to evaluate the safety, efficacy and overall survival benefit of SurVaxM in patients with newly diagnosed glioblastoma who receive standard-of-care treatment (resection, chemoradiation and adjuvant temozolomide) combined with SurVaxM.

Based on the results of a recently completed interim futility analysis, and ongoing review by the study’s Independent Data Safety Monitoring Board, the SURVIVE trial (NCT05163080) will continue as planned without modification. While regulatory requirements bar disclosure of detailed data findings from randomized, controlled studies still in progress, the findings of the interim analysis met prespecified standards for the research to continue.

“SurVaxM continues to show promise as a treatment option for patients with glioblastoma when paired with standard-of-care chemotherapy and radiation,” says Ajay Abad, MD, a medical oncologist and brain cancer expert leading the study at Roswell Park — one of 11 U.S. SURVIVE trial. “SurVaxM’s excellent safety profile and tolerability to date also help optimize quality of life for patients with this highly aggressive cancer, where additional treatment options are direly needed.”

“We are encouraged by the progress of our clinical trial and remain focused on our goal to develop innovative therapies that can drive meaningful improvements for patients with glioblastoma and other cancers. We are excited about the continued advancement of this important program,” says Michael Ciesielski, PhD, Assistant Professor of Neurosurgery at Roswell Park and CEO of MimiVax Inc., which is sponsoring the SURVIVE trial.

Four studies that incorporate SurVaxM are currently underway:

• NCT05163080, the phase 2B SURVIVE trial in adults with newly diagnosed glioblastoma at 11 U.S. sites — fully accrued; no longer open for recruitment
• NCT04978727 (NCI PBTC-060), a pilot study in children with some forms of medulloblastoma, high-grade glioma, ependymoma and newly diagnosed diffuse intrinsic pontine glioma (DIPG) — underway and open for recruitment at Roswell Park under the direction of Clare Twist, MD. PBTC-60 is supported by the National Cancer Institute (NCI), part of the National Institutes of Health, and conducted by the NCI-funded Pediatric Brain Tumor Consortium with participation from Roswell Park and 13 other North American centers.
• NCT02334865, a phase 1 study in adults with multiple myeloma, in combination with lenalidomide maintenance therapy — fully accrued at Roswell Park under the direction of Jens Hillengass, MD; publication of results anticipated in 2025
• NCT03879694, a phase 1 study in adults with neuroendocrine tumors — underway at Roswell Park under the direction of Renuka Iyer, MD, and open for recruitment

Developed at Roswell Park by Robert Fenstermaker, MD, Chair of Neurosurgery, and Dr. Ciesielski, SurVaxM is a treatment vaccine targeting survivin, a protein that helps glioblastoma cancer cells stay alive. The earlier single-arm phase 2A study in 63 patients with newly diagnosed glioblastoma demonstrated significantly longer survival time for patients treated with SurVaxM; 93.7% of patients were alive a year after diagnosis, compared to expected 65% survival based on historical studies.

The research team gratefully acknowledges support from donations to Roswell Park, including funds raised through events like the Ride for Roswell, as critical for their work through all phases of research. For information about these studies or other clinical trials at Roswell Park, call 1-800-ROSWELL (1-800-767-9355) or email ASKRoswell@RoswellPark.org.