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

  • STATUS
    Recruiting
  • End date
    Aug 10, 2026
  • participants needed
    18
  • sponsor
    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Updated on 10 July 2022
Investigator
Stella Krawiec, M.A.
Primary Contact
Johns Hopkins Medical Institution (7.6 mi away) Contact

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.

Details
Condition Nerve Sheath Tumors
Treatment Ipilimumab, Nivolumab
Clinical Study IdentifierNCT04465643
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Last Modified on10 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Histologically confirmed diagnosis of atypical neurofibromatous neoplasms of uncertain biologic potential (ANNUBP), low grade malignant peripheral nerve sheath tumor (MPNST) or high grade MPNST in accordance with the Miettinen et al diagnostic criteria via biopsy
Plexiform neurofibroma or other tumors such as optic pathway glioma, other low-grade glioma or other neoplasm in addition to the ANNUBP, low grade MPNST or high grade MPNST that is stable (has not required treatment in the last 12 months and is not anticipated to need treatment in the next 12 months)
Measureable disease by RECIST criteria in at least one site
Karnofsky Performance Scale ≥ 60%
No contraindications for Nivolumab or Ipilimumab
Normal organ and marrow function on routine laboratory tests
Evidence of post-menopausal status or negative urinary/serum pregnancy test for female pre-menopausal subjects. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause
Ability to understand and willingness of sign consent form
Willingness to comply with the protocol for the duration of the study

Exclusion Criteria

Chemotherapy or other investigational agent for the current episode of newly diagnosed atypical neurofibroma or MPNST
Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PDL-2 antibody
Known allergy to compounds of similar chemical or biologic composition to Nivolumab or Ipilimumab
Pregnant or breastfeeding women
Known history of Human Immunodeficiency Virus
Active infection requiring therapy, including known positive tests for Hepatitis B surface antigen or Hepatitis C ribonucleic acid (RNA)
Active autoimmune disease, history of autoimmune disease or history of syndrome that required systemic steroids or immunosuppressive medications, e.g. organ, tissue, or allogenic hematopoietic stem cell transplant (HSCT) recipients. Exceptions include those with resolved childhood asthma/atopy. Subjects with asthma who require intermittent use of bronchodilators (such as albuterol) will not be excluded from this study. Subjects are also permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger
A condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease
Use of any vaccines against infectious diseases (e.g. varicella, influenza, etc.) up to 4 weeks (28 days) before receiving nivolumab and ipilimumab
Prisoners or subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g. infectious disease) illness
Prior radiation doses equivalent to, or greater than, 8000 centigray (cGy) to the target lesions at 200 cGy fractions at any time point
Any radiation to the the target lesions within 6 months of enrollment
Other concurrent severe and/or uncontrolled medical disease, which could compromise participation in the study (e.g. uncontrolled diabetes, uncontrolled hypertension, severe infection, severe malnutrition, chronic liver or renal disease, active upper GI tract ulceration, congestive heart failure, etc.)
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