Mustafa Khasraw to Lead U.S. Arm of International Glioblastoma Trial

Mustafa Khasraw, MD, deputy director of the Duke Cancer Institute Center for Cancer Immunotherapy, is at the forefront of a promising clinical trial aimed at improving outcomes for patients with glioblastoma.Glioblastoma is a highly aggressive form of brain cancer known for its poor prognosis, with most patients surviving only 12 to 18 months after diagnosis. Approximately 75 percent of patients die within a year, and more than 95 percent die within three years. Traditional treatments have had limited success, necessitating innovative approaches to extend survival and improve quality of life.Based on existing research, a novel immunotherapy regimen combining nivolumab and relatlimab – previously used to treat melanoma – has been identified as a potential neoadjuvant treatment for glioblastoma. The Glioblastoma Immunotherapy Advancement with Nivolumab and Relatlimab Trial (GIANT) will be conducted at Duke in the United States and at the Peter MacCallum Cancer Center in Melbourne, Australia.Khasraw is the study chair and principal investigator for the U.S. portion of the GIANT trial, with Jim Whittle BSc., MBBS (Hons), FRACP, as the Australian co-principal investigator."Research from our group and others has shown that immunotherapy given before the surgical removal of cancer can reprogram the immune response, even in recurrent gliomas,” Khasraw said. “With this trial, we are moving that approach earlier, into newly diagnosed disease, to test whether this combination of immune checkpoint blockades can drive stronger and more lasting improvements in patient outcomes."The GIANT trial will start enrollment this summer, beginning with a small cohort of six to 12 patients with newly diagnosed isocitrate dehydrogenase (IDH) wild-type glioblastoma or those who have not received prior radiation or chemotherapy. These patients will receive the neoadjuvant immunotherapy regimen. If deemed safe, the trial will expand to include up to 80 participants, who will be randomly assigned to receive one of two treatment protocols.Khasraw's team at Duke will lead the analysis of tumor samples before and after treatment using advanced spatial technologies. A research consortium across the U.S. – including Duke, University of California Los Angeles, University of California San Francisco, Memorial Sloan Kettering Cancer Center, and MD Anderson Cancer Center – and Australian academic institutions led by the Peter McCallum Cancer Center has built a network for comprehensive biomarker and correlative science analysis, which will provide useful biological insights into the treatment's impact.“This trial will be significant in helping us better understand cancer biology,” Khasraw said. “We stand to gain valuable insights from this research that could help shape future research and therapies for glioblastoma.”

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