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

NCT04465643 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2025-10-08

No results posted yet for this study

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

DRUG

Nivolumab

Nivolumab 4.5 mg/kg Q3W x 2

DRUG

Ipilimumab

Ipilimumab 1 mg/kg Q3W x 2

Sponsors & Collaborators

  • Bristol-Myers Squibb

    collaborator INDUSTRY

  • Congressionally Directed Medical Research Programs

    collaborator FED

  • Cancer Research and Biostatistics Clinical Trials Consortium

    collaborator NETWORK

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    lead OTHER

Principal Investigators

  • Jaishri Blakeley, MD · Johns Hopkins University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-08
Primary Completion
2025-07-30
Completion
2025-07-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04465643 on ClinicalTrials.gov