drugset / Trial / NCT04465643
Neoadjuvant Nivolumab Plus Ipilimumab for Newly Diagnosed Malignant Peripheral Nerve Sheath Tumor
Phase 1
Completed
13 enrolled
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Bristol-Myers Squibb · collabCancer Research and Biostatistics Clinical Trials Consortium · collabCongressionally Directed Medical Research Programs · collab
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2021-06-08
- Primary completion
- 2025-07-30
- Completion
- 2025-07-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ipilimumab | Monoclonal antibody | 1 mg/kg | — |
| Subject | Nivolumab | Monoclonal antibody | 4.5 mg/kg | — |