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

Conditions

• Nerve Sheath Tumors

Eligibility Criteria

Sex

ALL

Age

12 Years - 100 Years

Healthy Volunteers

Not accepted

Interventions

• Nivolumab — DRUG
  Nivolumab 4.5 mg/kg Q3W x 2
• Ipilimumab — DRUG
  Ipilimumab 1 mg/kg Q3W x 2

Study Details

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.

Key Dates

Start date

Jun 8, 2021

Status verified

May 2026

Primary completion

Jul 30, 2025

Completion

Jul 30, 2025

Study Design

Enrollment

13 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Other: Immunotherapy with Nivolumab and Ipilimumab
  Nivolumab 4.5 mg/kg every 3 weeks (Q3W) x 2 Ipilimumab 1 mg/kg Q3W x 2 Nivolumab monotherapy 4.5mg/kg Q3W concurrent with standard therapy Nivolumab monotherapy should be held for at least 2 weeks before and 2 weeks after surgery

Primary Outcome Measure

Safety of combination nivolumab and ipilimumab as assessed by number of participants who experience adverse events [ Time Frame: Up to 2 years ]

Locations (1)

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