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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: Active Phase 1 study of Melanoma, sponsored by University of Wisconsin, Madison.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The number and severity of toxicity incidents per (Common Terminology Criteria for Adverse Events (CTCAE) v 5.0 will be summarized with frequency and proportion. The 95% confidence interval for the proportion of subjects with severe complications (grade 3 or higher toxicities) will be constructed.
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 |
What the registry record for NCT03958383 still lists
NCT03958383 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 707-participant average among 266 other Melanoma trials with a reported enrollment target (99% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03958383's enrollment target sits among peer trials
8 255th of 266 higher than 10 of 266 other Melanoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Melanoma 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.
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