Summary: The phase 2B SURVIVE trial evaluating SurVaxM, an investigational cancer vaccine for glioblastoma, will proceed as planned after an interim analysis showed the study meets predefined criteria to continue. SurVaxM is being tested alongside standard treatments—surgery, radiation, and chemotherapy—with the aim of extending survival and improving quality of life for people diagnosed with this aggressive brain tumor.
SurVaxM is designed to target survivin, a protein that helps tumor cells avoid programmed cell death. Earlier clinical work demonstrated a favorable safety profile and encouraging survival signals. Although the trial is ongoing and specific randomized data cannot be released under regulatory rules, the decision to continue the study signals sustained promise in advancing therapies for glioblastoma.
Key facts
- Trial continues: An interim futility analysis and ongoing safety oversight determined the SURVIVE trial has met the benchmarks required to move forward without modification.
- Targeted vaccine: SurVaxM targets survivin, a protein that helps malignant cells resist cell death.
- Earlier results: In a prior single-arm phase 2A study, 93.7% of patients were alive one year after diagnosis, compared with an expected ~65% based on historical controls.
Source: Roswell Park Comprehensive Cancer Center
Roswell Park Comprehensive Cancer Center today confirmed the ongoing phase 2B SURVIVE clinical trial of SurVaxM in glioblastoma will continue following an interim analysis of the study data.
The SURVIVE trial (NCT05163080) is evaluating safety, tolerability, and potential survival benefit when SurVaxM is added to the current standard of care for newly diagnosed glioblastoma: surgical resection followed by chemoradiation and adjuvant temozolomide. The trial is fully accrued at 11 U.S. sites and is no longer open for recruitment.
Following a scheduled interim futility review and continuous oversight by the study’s Independent Data Safety Monitoring Board, investigators concluded the trial should continue as designed. Regulatory and trial rules prevent publication of detailed randomized outcomes while the study is in progress, but the interim findings satisfied prespecified criteria for continuation.
“SurVaxM continues to show promise as a treatment option for patients with glioblastoma when paired with standard-of-care chemotherapy and radiation,” said Ajay Abad, MD, a medical oncologist and brain tumor specialist leading the study at Roswell Park. “The vaccine’s favorable safety profile and tolerability support efforts to preserve patient quality of life while exploring new ways to improve outcomes in this challenging disease.”
Michael Ciesielski, PhD, Assistant Professor of Neurosurgery at Roswell Park and CEO of MimiVax Inc., the sponsor of the SURVIVE trial, added that the team remains committed to advancing innovative therapeutic approaches that could provide meaningful clinical benefit for patients with glioblastoma and other cancers.
Multiple studies incorporating SurVaxM are ongoing or planned, including:
- NCT05163080 — Phase 2B SURVIVE trial in adults with newly diagnosed glioblastoma at 11 U.S. sites (fully accrued).
- NCT04978727 (NCI PBTC-060) — A pediatric pilot trial studying select medulloblastomas, high-grade gliomas, ependymomas, and newly diagnosed diffuse intrinsic pontine glioma (DIPG); currently recruiting at Roswell Park as part of a multi-center Pediatric Brain Tumor Consortium effort.
- NCT02334865 — Phase 1 study in adults with multiple myeloma combining SurVaxM with lenalidomide maintenance therapy; fully accrued at Roswell Park with results anticipated for publication.
- NCT03879694 — Phase 1 study in adults with neuroendocrine tumors; underway at Roswell Park and recruiting patients.
SurVaxM was developed at Roswell Park by Robert Fenstermaker, MD, Chair of Neurosurgery, and Michael Ciesielski, PhD. The vaccine aims to stimulate the immune system to recognize and attack tumor cells that express survivin, a protein widely observed in many cancers and associated with resistance to cell death.
The earlier single-arm phase 2A study in 63 patients with newly diagnosed glioblastoma reported a notably higher proportion of patients alive at one year than historical expectations. These results, together with the vaccine’s safety observations, provided the rationale for the larger randomized phase 2B SURVIVE trial now underway.
The research team acknowledges the vital role of philanthropic support in advancing this program, including donations to Roswell Park and community fundraising events such as the Ride for Roswell, which have supported the work through multiple phases of development.
For information about these studies or other clinical trials at Roswell Park, call 1-800-ROSWELL (1-800-767-9355) or email [email protected].
About this brain cancer vaccine research news
Author: Michael Ciesielski
Source: Roswell Park Comprehensive Cancer Center
Contact: Michael Ciesielski – Roswell Park Comprehensive Cancer Center
Image credit: Neuroscience News