Overview

Nivolumab in Combination With Temozolomide and Radiotherapy in Children and Adolescents With Newly Diagnosed High-grade Glioma

Status:
Recruiting

Trial end date:
2024-01-01

Target enrollment:

Participant gender:

Summary

Multicenter, open label, prospective study including successively a phase I trial and then a phase II trial Phase I : Open label, non-randomized, safety run study in nine patients. In case of safety issue a -1 dose level will be tested. Phase II : Open label, non randomized, efficacy study of nivolumab in addition to radiotherapy and temozolomide. This phase will start when the RP2D has been defined after the last patients evaluable for DLT achieved the first 6 weeks of treatment (the radio-chemotherapy period) with a DLT rate below 30% during the the phase I study.

Phase:

Phase 1/Phase 2

Details

Lead Sponsor:

Gustave Roussy, Cancer Campus, Grand Paris

Treatments:

Nivolumab
Temozolomide