NCT02793466

Durvalumab in Pediatric and Adolescent Patients

A Phase I, Open-Label, Single Institution Study to Assess the Safety, Tolerability, and Pharmacokinetics of Durvalumab in Pediatric Patients With Relapsed or Refractory Solid Tumors, Lymphoma, and Central Nervous System Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Leo Mascarenhas · Academic / Other
• Sex: All
• Age: 1 Year – 17 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial is the first clinical trial to study Durvalumab, a checkpoint inhibitor which stimulates the patient's own immune system to act against cancer cells in children and adolescents. This trial will assess the safety and tolerability of Durvalumab in children and adolescents and also study how Durvalumab is processed in their bodies.

Detailed description

This trial will assess the safety and tolerability of Durvalumab in children and adolescents and also study how Durvalumab is processed in their bodies.

Conditions

• Solid Tumor
• Lymphoma
• Central Nervous System Tumors

Interventions

Type	Name	Description
DRUG	Durvalumab; MEDI4736	IV Infusion every 2 weeks for a maximum of 26

Timeline

• Start date: 2016-07-01
• Primary completion: 2022-11-30
• Completion: 2023-04-30
• First posted: 2016-06-08
• Last updated: 2023-09-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study