NCT04465643

Neoadjuvant Nivolumab Plus Ipilimumab for Newly Diagnosed Malignant Peripheral Nerve Sheath Tumor

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
• Sex: All
• Age: 12 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to evaluate safety and feasibility of neoadjuvant nivolumab plus ipilimumab prior to standard therapy (surgery, chemotherapy or radiation therapy) in patients with Neurofibromatosis Type 1 (NF1) and newly diagnosed pre-malignant and malignant peripheral nerve sheath tumors (MPNST) for whom surgery for resection of tumor is indicated.

Conditions

• Nerve Sheath Tumors

Interventions

Type	Name	Description
DRUG	Nivolumab	Nivolumab 4.5 mg/kg Q3W x 2
DRUG	Ipilimumab	Ipilimumab 1 mg/kg Q3W x 2

Timeline

• Start date: 2021-06-08
• Primary completion: 2025-07-30
• Completion: 2025-07-30
• First posted: 2020-07-10
• Last updated: 2025-10-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study