OncoMatch/Clinical Trials/NCT06097975
A Clinical Trial on Combined (Neo-)Adjuvant Intravenous Plus Intracranial Administration of Ipilimumab and Nivolumab in Recurrent Glioblastoma
Is NCT06097975 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Neo-adjuvant nivolumab and ipililumab IV + adjuvant nivolumab and ipililumab IV and Adjuvant nivolumab IV + nivolumab and ipililumab intracavitary for recurrent glioblastoma.
Treatment: Neo-adjuvant nivolumab and ipililumab IV + adjuvant nivolumab and ipililumab IV · Adjuvant nivolumab IV + nivolumab and ipililumab intracavitary — The goal of this phase I interventional study is to determine the safety and feasibility of the proposed investigational (neo-)adjuvant treatment regimen in patients with resectable reccurent glioblastoma. Participants will: * receive neo-adjuvant administration of intravenous immunotherapy * followed by a maximal safe neurosurgical resection * afterwards, immunotherapy will be injected into the brain tissue * followed by insertion of an Ommaya reservoir * postoperatively, administration of immunotherapy will be continued
Check if I qualifyExtracted eligibility criteria
Cancer type
Glioblastoma
Biomarker criteria
Required: IDH1 wild-type
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: surgery — for resectable lesions
prior standard of care treatment (surgery for resectable lesions, radiation therapy and temozolomide chemotherapy)
Must have received: radiation therapy
prior standard of care treatment (surgery for resectable lesions, radiation therapy and temozolomide chemotherapy)
Must have received: cytotoxic chemotherapy (temozolomide)
prior standard of care treatment (surgery for resectable lesions, radiation therapy and temozolomide chemotherapy)
Cannot have received: anti-CTLA-4 therapy (ipilimumab)
No prior treatment on a nivolumab and/or ipilimumab trial; No prior treatment with an anti-CTLA-4 or anti-PD-1/-L1 targeted therapy
Cannot have received: anti-PD-1 therapy (nivolumab)
No prior treatment on a nivolumab and/or ipilimumab trial; No prior treatment with an anti-CTLA-4 or anti-PD-1/-L1 targeted therapy
Cannot have received: anti-PD-L1 therapy
No prior treatment with an anti-CTLA-4 or anti-PD-1/-L1 targeted therapy
Lab requirements
Blood counts
ANC > 1500/mm³ without growth factor support; Platelets > 75,000 cells/mm³; Hemoglobin ≥9 g/dL (may be obtained by transfusion or growth factor support)
Kidney function
Serum creatinine ≤1.5 x ULN or calculated creatinine clearance ≥60 mL/min
Liver function
Total serum bilirubin < 1.5 x ULN (patients with Gilbert's disease exempt who should have bilirubin < 2x ULN); AST and ALT < 2.5 x ULN
Adequate organ function as defined by the following criteria: Total serum bilirubin < 1.5 x ULN (patients with Gilbert's disease exempt who should have bilirubin < 2x ULN); AST and ALT < 2.5 x ULN; Serum creatinine ≤1.5 x ULN or calculated creatinine clearance ≥60 mL/min; ANC > 1500/mm³ without growth factor support; Platelets > 75,000 cells/mm³; Hemoglobin ≥9 g/dL (which may be obtained by transfusion or growth factor support); FT4 hormone levels within normal range
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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