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NCT02009397 · ClinicalTrials.gov registry record · Phase 1
A Phase I/II Open-Label Study of Ipilimumab and GM-CSF Administered to Unresectable Stage IIIC and Stage IV Melanoma Patients
A Phase 1 study, sponsored by University of Louisville.
- Completed
- Registry status
- Phase 1
- Development phase
- 27
- Enrollment target
NCT02009397: Completed Phase 1 study, sponsored by University of Louisville.
NCT02009397 is a Phase 1 study that has completed, run by University of Louisville. The registered enrollment target is 27 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02009397, a Phase 1 study, has completed, sponsored by University of Louisville.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 27 participants
- Enrollment target
Study Summary
The purpose of this study is to test the combination of Ipilimumab and GM-CSF. Both ipilimumab and GM-CSF are intended to work with the body's own immune system to attack melanoma cells in the body. This study will also demostrate how safe the combined drugs are when used to treat patients with Stage 3 or Stage 4 melanoma (metastatic melanoma), which cannot be removed by surgery.
Interventions
- DRUG Ipilimumab
- DRUG GM-CSF
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2012-02 |
| Est. Completion | 2016-11 |
| Phase | Phase 1 |
What the finished NCT02009397 record still lists
NCT02009397 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 2 interventions - of which Ipilimumab is the first listed.
NCT02009397 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02009397 about?
NCT02009397 is a clinical study titled "A Phase I/II Open-Label Study of Ipilimumab and GM-CSF Administered to Unresectable Stage IIIC and Stage IV Melanoma Patients". The purpose of this study is to test the combination of Ipilimumab and GM-CSF. Both ipilimumab and GM-CSF are intended to work with the body's own immune system to attack melanoma cells in the body. This study will also demostrate how safe the combined drugs are when used to treat patients with Stag...
What is the current status of trial NCT02009397?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2012-02. Estimated completion is 2016-11.
What interventions are being tested in trial NCT02009397?
The interventions under investigation include: Ipilimumab (DRUG), GM-CSF (DRUG).
Who is sponsoring clinical trial NCT02009397?
This trial is sponsored by University of Louisville, which has 217 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02009397's enrollment target sits among peer trials
27 1463rd of 2000 higher than 519 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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