NCT05465954 Efineptakin Alfa and Pembrolizumab for the Treatment of Recurrent Glioblastoma

Trial Parameters

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Brief Summary

This phase II trial tests the safety and side effects of efineptakin alfa and pembrolizumab in treating patients with glioblastoma that has come back (recurrent). Efineptakin alfa is an immunotherapy drug that works by helping the immune system fight tumor cells. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving efineptakin alfa and pembrolizumab may kill more tumor cells in patients with recurrent glioblastoma.

Eligibility Criteria

Inclusion Criteria: * Age \>= 18 years * Disease characteristics: * Tissue-confirmed progressive or recurrent World Health Organization (WHO) Grade IV IDH wildtype glioblastoma (including molecular glioblastoma and gliosarcoma) * Previously treated with maximum feasible resection or biopsy, radiation, and temozolomide * Have an enhancing mass on magnetic resonance imaging (MRI) amenable to resection or biopsy of the tumor (as determined by the neurosurgeon pre-operatively) and histological diagnosis of glioblastoma from a prior biopsy or surgery * Willing to undergo clinically indicated biopsy and/or resection of their glioblastoma at Mayo Clinic in Rochester, Minnesota (MN). * Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1 and Karnofsky Performance Scale (KPS) \>= 70 NOTE: PS must be assessed (again) within 7 days prior to first dose of study drug * Hemoglobin \>= 9.0 g/dL (obtained =\< 15 days prior to registration) (without transfusion or erythropoietin

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