OncoMatch/Clinical Trials/NCT04323046
Immunotherapy Before and After Surgery for Treatment of Recurrent or Progressive High Grade Glioma in Children and Young Adults
Is NCT04323046 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies Nivolumab for glioblastoma.
Treatment: Nivolumab — This phase I trial studies the side effects of nivolumab before and after surgery in treating children and young adults with high grade glioma that has come back (recurrent) or is increasing in scope or severity (progressive). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
Check if I qualifyExtracted eligibility criteria
Cancer type
Glioblastoma
Disease stage
Required: Stage PROGRESSIVE (WHO)
Grade: IIIIV (WHO)
recurrent or progressive high-grade gliomas (HGG) (World Health Organization (WHO) grade III or grade IV)
Prior therapy
Must have received: radiation therapy — first line
Previous first line therapy with radiation and/or chemotherapy
Must have received: cytotoxic chemotherapy — first line
Previous first line therapy with radiation and/or chemotherapy
Cannot have received: allogenic hematopoietic stem cell transplant
Participants who have had prior allogenic hematopoietic stem cell transplant (HSCT).
Lab requirements
Blood counts
Peripheral absolute neutrophil count (ANC) >= 1000/mm^3; Platelet count >= 100,000/mm^3
Kidney function
Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 OR a serum creatinine based on age/gender
Liver function
Bilirubin (sum of conjugated and unconjugated) <= 1.5 x upper limit of normal (ULN) for age (except participants with Gilbert syndrome who must have a total bilirubin level of < 3.0); Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) <= 3.0 x ULN; Serum albumin >= 2
Organ Function Requirements: Peripheral absolute neutrophil count (ANC) >= 1000/mm^3; Platelet count >= 100,000/mm^3; Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 OR a serum creatinine based on age/gender as follows... Bilirubin (sum of conjugated and unconjugated) <= 1.5 x upper limit of normal (ULN) for age (except participants with Gilbert syndrome who must have a total bilirubin level of < 3.0); Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) <= 3.0 x ULN; Serum albumin >= 2
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Alabama at Birmingham, Children's of Alabama · Birmingham, Alabama
- Children's Hospital of Los Angeles · Los Angeles, California
- Rady Children's Hospital · San Diego, California
- University of California, San Francisco · San Francisco, California
- Children's National Hospital · Washington D.C., District of Columbia
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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