Trials / Terminated
TerminatedNCT02992964
Pilot Study of Nivolumab in Pediatric Patients With Hypermutant Cancers
- Status
- Terminated
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 11 (actual)
- Sponsor
- The Hospital for Sick Children · Academic / Other
- Sex
- All
- Age
- 12 Months – 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2017-05-15
- Primary completion
- 2023-11-20
- Completion
- 2023-11-20
- First posted
- 2016-12-14
- Last updated
- 2024-04-02
Locations
10 sites across 5 countries: United States, Australia, Canada, France, Israel
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02992964. Inclusion in this directory is not an endorsement.