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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

NCT03130959 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 166

Last updated 2022-08-09

Study results available
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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.

Conditions

  • Various Advanced Cancer

Interventions

BIOLOGICAL

Nivolumab

Specified dose on specified days

BIOLOGICAL

Ipilimumab

Specified dose on specified days

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-12
Primary Completion
2020-03-10
Completion
2022-01-17
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Brazil
  • Canada
  • France
  • Germany
  • Hong Kong
  • Israel
  • Netherlands
  • Norway
  • Poland
  • Russia
  • Spain
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03130959 on ClinicalTrials.gov