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NCT04465643 · ClinicalTrials.gov registry record · Phase 1
Neoadjuvant Nivolumab Plus Ipilimumab for Newly Diagnosed Malignant Peripheral Nerve Sheath Tumor
A Phase 1 study of Nerve Sheath Tumors, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- Completed
- Registry status
- Phase 1
- Development phase
- 13
- Enrollment target
- 1
- Study location
NCT04465643: Completed Phase 1 study of Nerve Sheath Tumors, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
NCT04465643 is a Phase 1 study of Nerve Sheath Tumors that has completed, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 13 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04465643, a Phase 1 study of Nerve Sheath Tumors, has completed, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 13 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
Number of participants who experience grade 1 or higher adverse events, as defined by Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0).
Conditions Studied
Interventions
- DRUG Nivolumab
- DRUG Ipilimumab
Study Locations (1)
Maryland
- Johns Hopkins Medical Institution - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2021-06-08 |
| Est. Completion | 2025-07-30 |
| Phase | Phase 1 |
What the finished NCT04465643 record still lists
NCT04465643 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower).
The record links to 1 condition, with Nerve Sheath Tumors appearing as the primary indexed condition, and to 2 interventions - of which Nivolumab is the first listed.
NCT04465643 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT04465643 about?
NCT04465643 is a clinical study titled "Neoadjuvant Nivolumab Plus Ipilimumab for Newly Diagnosed Malignant Peripheral Nerve Sheath Tumor". 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 tumor...
What is the current status of trial NCT04465643?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2021-06-08. Estimated completion is 2025-07-30.
What conditions does trial NCT04465643 study?
This clinical trial studies the following conditions: Nerve Sheath Tumors.
What interventions are being tested in trial NCT04465643?
The interventions under investigation include: Nivolumab (DRUG), Ipilimumab (DRUG).
Who is sponsoring clinical trial NCT04465643?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04465643 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04465643's enrollment target sits among peer trials
13 1847th of 2000 higher than 149 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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