Neoadjuvant Dual Checkpoint Inhibition and Cryoablation in Relapsed/Refractory Pediatric Solid Tumors

Hepatocellular Carcinoma Clinical Trial

Official title: Phase II Study Investigating the Efficacy of Neoadjuvant Dual Checkpoint Inhibition and Cryoablation Therapy in Children, Adolescents, and Young Adults With Relapsed/Refractory Solid Tumors

Status Active, not recruiting

Clinical Trial Summary

The is a phase II, single arm, open-label, multi-site trial studying the combination of cryoablation therapy and dual checkpoint inhibition with nivolumab (anti-PD-1) and ipilimumab (anti-CTLA-4) given at the recommended phase 2 dose (RP2D) in pediatric and young adult patients with relapsed or refractory solid tumors.

Clinical Trial Description

Patients less than 40 years old with relapsed/refractory solid tumors and at least two sites of measurable disease will receive the current pediatric RP2D of nivolumab and ipilimumab for one cycle and undergo cryoablation therapy of one tumor site. Patients will continue to receive cycles of checkpoint inhibition as long as there is no disease progression of unacceptable toxicity (maximum of 13 cycles [12 months]). ;

Related Conditions & MeSH terms

• Ewing Sarcoma
• Hepatoblastoma
• Hepatocellular Carcinoma
• Melanoma
• Neoplasms
• Neuroblastoma
• Osteosarcoma
• Refractory Pediatric Solid Tumor
• Relapsed Pediatric Solid Tumor
• Rhabdomyosarcoma
• Sarcoma, Ewing
• Wilms Tumor

• NCT number: NCT05302921
• Study type: Interventional
• Source: Children's National Research Institute
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: February 18, 2022
• Completion date: July 1, 2025