High Grade Glioma Clinical Trial
Official title:
Phase I-II Study of Nivolumab in Combination With Temozolomide and Radiotherapy in Children and Adolescents With Newly Diagnosed High-grade Glioma
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.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
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