A Study to Evaluate the Safety and Efficacy of Nivolumab Monotherapy and Nivolumab in Combination With Ipilimumab in Pediatric Participants With High Grade Primary Central Nervous System (CNS) Malignancies

Phase 2 Completed 166 enrolled Bristol-Myers Squibb

Non-randomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to determine the safety and effectiveness of nivolumab alone and in combination with ipilimumab in pediatric patients with high grade primary central nervous system (CNS) malignancies.

Timeline

Start: 2017-06-12
Primary completion: 2020-03-10
Completion: 2022-01-17

Publications

Dunkel IJ, Doz F, Foreman NK, Hargrave D, Lassaletta A, Andre N, Hansford JR, Hassall T, Eyrich M, Gururangan S, Bartels U, Gajjar A, Howell L, Warad D, Pacius M, Tam R, Wang Y, Zhu L, Cohen K. Nivolumab with or without ipilimumab in pediatric patients with high-grade CNS malignancies: Safety, efficacy, biomarker, and pharmacokinetics-CheckMate 908. Neuro Oncol. 2023 Aug 3;25(8):1530-1545. doi: 10.1093/neuonc/noad031.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ipilimumab	Monoclonal antibody	1 mg/kg	—
Subject	Nivolumab	Monoclonal antibody	3 mg/kg	—

A Study to Evaluate the Safety and Efficacy of Nivolumab Monotherapy and Nivolumab in Combination With Ipilimumab in Pediatric Participants With High Grade Primary Central Nervous System (CNS) Malignancies

Summary

Timeline

Publications

Drugs

Indications