Pilot Study of Nivolumab in Pediatric Patients With Hypermutant Cancers

Conditions

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

Eligibility Criteria

Sex

ALL

Age

12 Months - 18 Years

Healthy Volunteers

Not accepted

Interventions

• Nivolumab — DRUG
  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.

Study Details

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.

Key Dates

Start date

May 15, 2017

Status verified

Apr 2024

Primary completion

Nov 20, 2023

Completion

Nov 20, 2023

Study Design

Enrollment

11 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Nivolumab
  Regimen: Nivolumab will be administered every 14 days until disease progression or treatment discontinuation due to unacceptable toxicities. Treatment may extend up to 2 years in patients who show clinical and radiological benefit. Dose: 3 mg/kg intravenously as a continuous infusion over 60 min (+/-10 min window)

Primary Outcome Measure

To evaluate the objective response rate to Nivolumab in bMMRD positive pediatric patients with refractory hypermutated malignancies [ Time Frame: 5 years (60 months) from date of enrollment ]

Locations (2)

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