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NCT01672450 · ClinicalTrials.gov registry record · Phase 1
A Study of Intratumoral Injection of Interleukin-2 and Ipilimumab in Patients With Unresectable Stages III-IV Melanoma
A Phase 1 study, sponsored by University of Utah.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT01672450: Completed Phase 1 study, sponsored by University of Utah.
NCT01672450 is a Phase 1 study that has completed, run by University of Utah. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01672450, a Phase 1 study, has completed, sponsored by University of Utah.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
This is a single center, open phase I dose escalation study. This study will assess the highest tolerable intratumoral dose of ipilimumab (Yervoy) in combination with IL-2 (Proleukin) in patients with unresectable stages III-IV melanoma with accessible cutaneous, subcutaneous, and/or nodal lesions. The objective is to primarily assess the safety of the drug combination, and to secondarily obtain preliminary data on the clinical efficacy of the combination.
Primary Outcome
To assess safety of interleukin-2 and Ipilimumab combination and to select the recommended dose regimen for future phase II studies
Interventions
- DRUG Intratumoral Ipilimumab and Interleukin-2
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2012-09 |
| Est. Completion | 2014-08 |
| Phase | Phase 1 |
What the finished NCT01672450 record still lists
NCT01672450 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 1 intervention - of which Intratumoral Ipilimumab and Interleukin-2 is the first listed.
NCT01672450 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01672450 about?
NCT01672450 is a clinical study titled "A Study of Intratumoral Injection of Interleukin-2 and Ipilimumab in Patients With Unresectable Stages III-IV Melanoma". This is a single center, open phase I dose escalation study. This study will assess the highest tolerable intratumoral dose of ipilimumab (Yervoy) in combination with IL-2 (Proleukin) in patients with unresectable stages III-IV melanoma with accessible cutaneous, subcutaneous, and/or nodal lesions. ...
What is the current status of trial NCT01672450?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2012-09. Estimated completion is 2014-08.
What interventions are being tested in trial NCT01672450?
The interventions under investigation include: Intratumoral Ipilimumab and Interleukin-2 (DRUG).
Who is sponsoring clinical trial NCT01672450?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01672450's enrollment target sits among peer trials
12 1852nd of 2000 higher than 90 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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