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NCT03958383 · ClinicalTrials.gov registry record · Phase 1
IT-hu14.18-IL2 With Radiation, Nivolumab and Ipilimumab for Melanoma
A Phase 1 study of Melanoma, sponsored by University of Wisconsin, Madison.
- Active
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
- 1
- Study location
NCT03958383 is a Phase 1 study of Melanoma that is active but no longer recruiting, run by University of Wisconsin, Madison. The registered enrollment target is 8 participants, below the 707-participant average among 266 other Melanoma trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03958383, a Phase 1 study of Melanoma, is active but no longer recruiting, sponsored by University of Wisconsin, Madison.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I/II trial is designed to determine the maximum tolerated dose or the maximum administered dose of intratumoral administration of hu14.18-IL2 and to evaluate side effects of intratumoral hu14.18-IL2 when given alone, after radiation therapy, after radiation therapy and in combination with nivolumab, and after radiation therapy and in combination with nivolumab and ipilimumab in patients with melanoma that is advanced (stage IV) or with melanoma that cannot be removed by surgery and is considered surgically incurable. Hu14.18-IL2 is a molecule called a fusion protein that can bind to some tumor cells and cause immune cells to become activated to kill tumor cells. Radiation therapy is a type of cancer treatment that uses beams of high energy x-rays to kill tumor cells and shrink tumors. Immunotherapy with immune checkpoint inhibitors, such as nivolumab and ipilimumab, can help the body's immune system attack cancer by releasing the "brakes" on the immune system to allow cancer fighting immune cells to remain activated. This study will evaluate whether giving intratumoral hu14.18-IL2 with radiation therapy, nivolumab and ipilimumab has antitumor activity for participants with advanced melanoma. After completion of study treatment, participants are followed up at 30 days, every 12 weeks for up to 2 years, and then every 6 months thereafter.
Conditions Studied
Interventions
- RADIATION Radiation Therapy
- BIOLOGICAL Nivolumab
- BIOLOGICAL Ipilimumab
- BIOLOGICAL hu14.18-IL2
Study Locations (1)
Wisconsin
- University of Wisconsin Carbone Cancer Center - Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2020-01-30 |
| Est. Completion | 2026-08-15 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03958383
The ClinicalTrials.gov registry entry for NCT03958383 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 707-participant average among 266 other Melanoma trials with a reported enrollment target (99% lower). The listed sponsor is University of Wisconsin, Madison, which has 1,039 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Melanoma appearing as the primary indexed condition, and to 4 interventions - of which Radiation Therapy is the first listed.
NCT03958383 reports 1 study location spanning 1 distinct geographic area - top geographies include Wisconsin.
Frequently Asked Questions
What is clinical trial NCT03958383 about?
NCT03958383 is a clinical study titled "IT-hu14.18-IL2 With Radiation, Nivolumab and Ipilimumab for Melanoma". This phase I/II trial is designed to determine the maximum tolerated dose or the maximum administered dose of intratumoral administration of hu14.18-IL2 and to evaluate side effects of intratumoral hu14.18-IL2 when given alone, after radiation therapy, after radiation therapy and in combination with...
What is the current status of trial NCT03958383?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2020-01-30. Estimated completion is 2026-08-15.
What conditions does trial NCT03958383 study?
This clinical trial studies the following conditions: Melanoma.
What interventions are being tested in trial NCT03958383?
The interventions under investigation include: Radiation Therapy (RADIATION), Nivolumab (BIOLOGICAL), Ipilimumab (BIOLOGICAL), hu14.18-IL2 (BIOLOGICAL).
Who is sponsoring clinical trial NCT03958383?
This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03958383 being conducted?
This trial has 1 study location across Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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