OncoMatch/Clinical Trials/NCT05465954
Efineptakin Alfa and Pembrolizumab for the Treatment of Recurrent Glioblastoma
Is NCT05465954 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Efineptakin alfa and Pembrolizumab for high grade astrocytic tumor.
Treatment: Efineptakin alfa · Pembrolizumab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Glioblastoma
Biomarker criteria
Required: IDH1 wild-type
Disease stage
Required: Stage IV (WHO)
Grade: IV (WHO)
World Health Organization (WHO) Grade IV IDH wildtype glioblastoma (including molecular glioblastoma and gliosarcoma)
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: surgery or biopsy
Previously treated with maximum feasible resection or biopsy
Must have received: radiation therapy
Previously treated with...radiation
Must have received: temozolomide (temozolomide)
Previously treated with...temozolomide
Cannot have received: bevacizumab (bevacizumab)
Exception: allowed for symptom control during the adjuvant phase of the study
Received bevacizumab (AVASTIN) ≤ 4 months prior to registration
Cannot have received: live vaccine
Received a live vaccine ≤ 30 days prior to registration
Cannot have received: anti-PD-1 therapy
Exception: if such therapy was given ≥ 12 months prior to registration, patient is eligible
Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent within < 12 months prior to registration
Lab requirements
Blood counts
Hemoglobin ≥ 9.0 g/dL (without transfusion or erythropoietin dependency ≤ 7 days prior to assessment); ANC ≥ 1500/mm^3; Platelet count ≥ 100,000/mm^3
Kidney function
Creatinine ≤ 1.5 x ULN OR measured or calculated creatinine clearance ≥ 45 ml/min
Liver function
Total bilirubin ≤1.5 x ULN OR direct bilirubin ≤ ULN for patients with total bilirubin levels >1.5 x ULN; AST AND ALT ≤ 2.5 x ULN
Hemoglobin ≥ 9.0 g/dL (obtained ≤ 15 days prior to registration) (without transfusion or erythropoietin [EPO] dependency ≤ 7 days prior to assessment); Absolute neutrophil count (ANC) ≥ 1500/mm^3 (obtained ≤ 15 days prior to registration); Platelet count ≥ 100,000/mm^3 (obtained ≤ 15 days prior to registration); Creatinine ≤ 1.5 x upper limits of normal (ULN) OR measured or calculated creatinine clearance (per institutional standard) must be ≥ 45 ml/min (obtained ≤ 15 days prior to registration); Total bilirubin ≤1.5 x ULN OR direct bilirubin ≤ ULN for patients with total bilirubin levels >1.5 x ULN (obtained ≤ 15 days prior to registration); Aspartate transaminase (AST) AND alanine transaminase (ALT) ≤ 2.5 x ULN (obtained ≤ 15 days prior to registration); Prothrombin time (PT)/international normalized ratio (INR)/activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN OR if patient is receiving anticoagulant therapy then INR or aPTT is within target range of therapy (obtained ≤ 15 days prior to registration)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Mayo Clinic · Rochester, Minnesota
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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