A Phase 1 Study Assessing Nivolumab Plus Ipilimumab Immunotherapy for Newly Diagnosed Malignant and Pre-malignant Peripheral Nerve Sheath Tumors

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Full Title

Neoadjuvant Nivolumab Plus Ipilimumab for Newly Diagnosed Malignant Peripheral Nerve Sheath Tumor (JHU IRB)

Purpose

Researchers are assessing the combination of two immunotherapy drugs to treat peripheral nerve sheath tumors (PNST). The people in this study have cancerous or precancerous PNST, such as atypical neurofibroma or atypical neurofibromatous neoplasms of uncertain biologic potential (ANNUBP). They have not yet received treatment for their tumors.

If you join this study, you will get the drugs nivolumab and ipilimumab before surgery. Both of these drugs inhibit proteins that put the brakes on the immune response. By doing so, they boost the ability of the immune system to see and destroy cancer cells. Both medications are given intravenously (by vein).

Who Can Join

To join this study, there are a few conditions. You or your child must:

  • Have neurofibromatosis type 1 (NF1) and a cancerous or precancerous PNST.
  • Not have received prior treatment for the tumor.
  • Have a tumor that can be taken out with surgery.
  • Be able to walk and do routine activities for more than half the time you are awake.
  • Be age 12 or older.

Contact

For more information and to see if you can join this study, please call Dr. Ping Chi’s office at 646-888-4166.

Protocol

23-220

Phase

Phase I (phase 1)

Disease Status

Newly Diagnosed

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT04465643