Pilot Study of Nivolumab in Pediatric Patients With Hypermutant Cancers

Official Title

Pilot Study of Nivolumab in Pediatric Patients With Hypermutant Cancers

Summary:

This is an open-label, single arm, multi-centre, 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.

Trial Description

Primary Outcome:

• To evaluate the objective response rate to Nivolumab in bMMRD positive pediatric patients with refractory hypermutated malignancies
• To evaluate the objective response rate to Nivolumab in bMMRD positive pediatric patients with recurrent hypermutated malignancies.
• Estimating the feasibility of using Nivolumab as a treatment in bMMRD positive, pediatric patients with refractory or recurrent hypermutated malignancies.

• The progression free survival (PFS) of pediatric patients with progressive or recurrent hypermutated malignancies including bMMRD patients treated with Nivolumab.
• Number of Participants with Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment

View this trial on ClinicalTrials.gov