CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 35 enrolled / 35 target
Drug / intervention
Nivolumabdrug
Likely dose
240 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03557359
NCT03557359Phase 2CompletedUpdate Overdue (0.4/mo)Completion was 45mo ago
CompareCT.gov

A Phase II, Open Label, Single Arm Study of Nivolumab for Recurrent or Progressive IDH Mutant Gliomas With Prior Exposure to Alkylating Agents

Fabio Iwamoto, MD·interventional·Posted Jun 15, 2018·Updated Jun 10, 2026

In Brief

A Phase 2 clinical trial evaluating Nivolumab for Gliomas. Completed, enrolled 35 participants across 4 sites.

Signals

Enrollment appears stalled

Detailed Summary

The objective of this study is to determine response rates (partial and complete responses) to nivolumab of recurrent or progressive IDH mutant (grades 2, 3 or 4) gliomas with prior exposure to alkylating agents.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGliomas
CountriesUnited States
CollaboratorsBristol-Myers Squibb

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedJun 15, 2018
Enrollment StartJun 12, 2018
Primary CompletionSep 20, 2022
Study CompletionFeb 11, 2025
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 8.0 years ago

Arms & Interventions

Nivolumabexperimental

Nivolumab 240 mg will be given every 2 weeks for 8 cycles. Beginning with Cycle 9, nivolumab 480 mg will be given every 4 weeks for a total therapy duration of 2 years, or until progressive disease, unacceptable toxicity, or withdrawal of consent. Nivolumab will be administered as a 30-minute infusion. A finite treatment duration with immune therapies in this participant population remains an area of ongoing research; therefore the treatment duration chosen was 2 years.

Drug: Nivolumab

Interventions

Nivolumabdrug

Nivolumab (Opdivo®) is a human monoclonal antibody (HuMAb; immunoglobulin G4 (IgG4)- S228P) that targets the PD-1 cluster of differentiation 279 (CD279) cell surface membrane receptor.