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Pilot Study of Nivolumab in Pediatric Patients With Hypermutant Cancers

NCT02992964 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2024-04-02

No results posted yet for this study

Summary

This is an open-label, single arm, multi-center, pilot study of Nivolumab in pediatric patients with recurrent or refractory hypermutant malignancies aged 12 months to 18 years of age. This study is to assess clinical and radiological benefits of treatment with Nivolumab in children with hypermutated cancers, including those with bMMRD syndrome. It is our expectation that patients with bMMRD syndrome will account for the majority of patients enrolled on this study.

Conditions

  • Refractory or Recurrent Hypermutated Malignancies
  • Biallelic Mismatch Repair Deficiency (bMMRD) Positive Patients

Interventions

DRUG

Nivolumab

Nivolumab (also referred to as BMS-936558 or MDX1106) is a human monoclonal antibody (HuMAb; immunoglobulin G4 \[IgG4\]-S228P) that targets the programmed death-1 (PD-1) cluster of differentiation 279 (CD279) cell surface membrane receptor.

Sponsors & Collaborators

Principal Investigators

  • Daniel A Morgenstern, MB BChir PhD · The Hospital for Sick Children

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Months
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-15
Primary Completion
2023-11-20
Completion
2023-11-20
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • France
  • Israel

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 NCT02992964 on ClinicalTrials.gov