CI

At a glance

ClinicalIndex Comparison Record
Phase 1Active· 9 enrolled / 9 target
Drug / intervention
Nivolumab +2 morebiological
Likely dose
Not stated in 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/NCT04323046
NCT04323046Phase 1ActiveOn Track (0.1/mo)

A Single Arm, Pilot of Neoadjuvant Checkpoint Inhibition Followed by Adjuvant Checkpoint Inhibition in Children and Young Adults With Recurrent or Progressive High Grade Glioma (HGG)

Sabine Mueller, MD, PhD·interventional·Posted Mar 26, 2020·Updated Jun 15, 2026

In Brief

A Phase 1 clinical trial evaluating Nivolumab, Quality-of-Life Assessment, and 1 other intervention for Glioblastoma and 5 related conditions. Active but no longer recruiting, targeting 9 participants across 20 sites in 2 countries.

Detailed Summary

This phase I trial studies the side effects of nivolumab before and after surgery in treating children and young adults with high grade glioma that has come back (recurrent) or is increasing in scope or severity (progressive). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, United States

Timeline

Phase 1Active
20212022202320242025202620272028
First PostedMar 26, 2020
Enrollment StartOct 2, 2020
Primary CompletionJun 30, 2028
TodayJul 2, 2026
Enrollment to primary: 7.7 yearsPosted 6.3 years agoPrimary completion in 2.0 years

Arms & Interventions

Neoadjuvant nivolumab and adjuvant nivolumabexperimental

NEOADJUVANT: Patients receive nivolumab IV over 30 minutes 14 days before undergoing standard of care surgical resection. ADJUVANT MAINTENANCE: After completion of neoadjuvant infusion, patients receive nivolumab IV over 30 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Biological: NivolumabOther: Quality-of-Life AssessmentOther: Questionnaire Administration

Interventions

Nivolumabbiological

Given IV

Quality-of-Life Assessmentother

Ancillary studies, given in person or online

Questionnaire Administrationother

Ancillary studies, given in person or online