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This randomized trial evaluated neoadjuvant immune checkpoint blockade in 63 patients with surgically resectable recurrent glioblastoma; 58 received study treatment. Patients received nivolumab + ipilimumab, nivolumab alone, or placebo before surgery. The primary endpoint was met: dual checkpoint blockade significantly increased tumor-infiltrating lymphocyte (TIL) density versus untreated control. Median overall survival was 402 days (95% CI, 265–571) among patients assigned to dual ICB versus 273 days (95% CI, 166–506) with nivolumab alone. Dual ICB also produced robust intratumoral and systemic immune activation, including increased interferon-related gene expression in blood. Higher TIL density and early systemic interferon-signature induction were associated with improved survival, whereas tumor mutational burden was not. No unanticipated toxicities were observed.
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This randomized trial evaluated neoadjuvant immune checkpoint blockade in 63 patients with surgically resectable recurrent glioblastoma; 58 received study treatment. Patients received nivolumab + ipilimumab, nivolumab alone, or placebo before surgery. The primary endpoint was met: dual checkpoint blockade significantly increased tumor-infiltrating lymphocyte (TIL) density versus untreated control. Median overall survival was 402 days (95% CI, 265–571) among patients assigned to dual ICB versus 273 days (95% CI, 166–506) with nivolumab alone. Dual ICB also produced robust intratumoral and systemic immune activation, including increased interferon-related gene expression in blood. Higher TIL density and early systemic interferon-signature induction were associated with improved survival, whereas tumor mutational burden was not. No unanticipated toxicities were observed.
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