drugset / Trial / NCT05457959

Peptide-Pulsed Dendritic Cell Vaccination in Combination With Nivolumab and Ipilimumab for the Treatment of Recurrent and/or Progressive Diffuse Hemispheric Glioma, H3 G34-mutant

NCT05457959

RandomizedSequentialSingle-blindTreatment

Summary

This phase I trial tests peptide-pulsed dendritic cell vaccination in combination with immunotherapy nivolumab and ipilimumab for the treatment diffuse hemispheric glioma with a H3 G34 mutation that has come back (recurrent) and/or is growing, spreading, or getting worse (progressive). Vaccines made from the patient's own white blood cells and peptide-pulsed dendritic cells may help the body build an effective immune response to kill tumor cells. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, also may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Together, the vaccine and immunotherapy drugs given before and after surgical resection (the removal of tumor cells through surgery) may improve stimulation of anti-tumor immunity to help fight the cancer.

Timeline

Start
2024-12-01
Primary completion
2029-12-01
Completion
2030-12-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Dendritic Cell Tumor Peptide Vaccine Vaccine Other
Subject Ipilimumab Monoclonal antibody Intravenous
Subject Nivolumab Monoclonal antibody Intravenous
Background Hiltonol Other / unclassified Intramuscular