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

Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
Study ID
NCT04267146
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • High Grade Glioma

Eligibility Criteria

Sex
ALL
Age
3 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — DRUG
    Solution for intravenous injection 10 mg/ml. Initial dose : 3 mg/kg Nivolumab will be given at 3 mg/kg/injection every two weeks from the first day of radiotherapy to the last day of chemotherapy. One de-escalation dose : 1 mg/kg
  • Temozolomide — DRUG
    Capsules: 5, 20, 100, 140, 180 and 250 mg orally. Temozolomide will be given at 75mg/m2/day from the day of start of radiotherapy to the last day of radiotherapy, then, after one month rest at 200mg/m2/day for five consecutive days for 12 cycles (28 days cycle).
  • Radiotherapy — RADIATION
    Total dose of 54 Gray(Gy) units delivered in 30 daily fractions of 1.8 Gy over 6 weeks during the chemoradiation period.

Study Details

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.

Key Dates

Start date
Jul 15, 2019
Status verified
Nov 2024
Primary completion
Nov 26, 2024
Completion
Nov 26, 2024

Study Design

Enrollment
41 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: newly diagnosed high-grade glioma
    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.

Primary Outcome Measure

Event Free Survival [ Time Frame: The clinical activity of the combined treatment will be evaluated by the 1-year event free survival (EFS) ]

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