A phase 2b clinical trial evaluating the efficacy and safety of an immunotherapy drug for patients with brain cancer has opened at Roswell Park Comprehensive Cancer Center in Buffalo, New York, with additional plans to be carried out at more than a dozen sites.
A clinical trial to analyze an immunotherapy treatment option for adult patients with newly diagnosed glioblastoma, an aggressive and fast-moving brain tumor, is open for patient recruitment and is expected to be carried out at 15 sites across the United States and China.
The portion of the phase 2B trial — called SURVIVE — at Roswell Park Comprehensive Cancer Center is to be led by neurologic oncologist and faculty member Dr. Ajay Abad. The aim of the trial is to examine whether SurVaxM, an immunotherapy brain cancer vaccine, improves clinical outcomes when added to the standard-of-care chemotherapy Temodar (temozolomide). Researchers expect to enroll 265 patients who will be randomized in the trial.
“For years, we’ve struggled to move the needle as far as good treatment options for glioblastoma. Our hope is that SurVaxM will offer patients both longer survival and better quality of life,” Abad said in a press release. “To hopefully be on the precipice of meaningful progress against glioblastoma and to be able to possibly see my patients outside of the hospital — years after their diagnosis — would be incredible.”
The patients in the trial group receiving SurVaxM should also receive montanide, which is an oil-based substance that helps the patient’s immune system to recognize the drug. Additionally, the researchers intend to give them a second injection of Leukine (sargramostim), a bone marrow stimulant to boost the patient’s immune system at the first injection site.
The primary goal of the study is to compare the effects of SurVaxM on overall survival. Secondary goals are to track the number of grade 3 and 4 (severe and life-threatening) side effects, progression-free survival (PFS; time until disease progresses), as well as overall survival and PFS rates at specified time points.
SurVaxM was initially developed at Roswell Park by Dr. Robert Fenstermaker, chair of the Department of Neurosurgery and Michael Ciesielski, assistant professor of Oncology. It is now being developed by MimiVax, a Buffalo, New York-based pharmaceutical company. The vaccine functions by targeting survivin, which is a protein that helps cancer cells persist.
“Glioblastoma is a notoriously aggressive and hard-to-treat cancer. We are encouraged by the results from our earlier studies and excited to bring this treatment option to more brain cancer patients at more centers,” Fenstermaker said.
The treatment previously demonstrated positive results in a phase 2 study of 63 patients, who had a 93.7% survival rate one year after diagnosis — compared with a 65% survival rate in historical studies.
The trial is expected to be completed by April 2024. Recruitment is currently open at Dana-Farber Cancer Institute in Boston and Roswell Park Comprehensive Cancer Center in Buffalo, New York.
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