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NCT01176474 · ClinicalTrials.gov registry record · Phase 1
Vaccine Combining Multiple Class I Peptides and Montanide ISA 51VG With Escalating Doses of Anti-PD-1 Antibody Nivolumab or Ipilimumab With Nivolumab For Patients With Resected Stages IIIC/ IV Melanoma
A Phase 1 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 73
- Enrollment target
NCT01176474: Completed Phase 1 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT01176474 is a Phase 1 study that has completed, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 73 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (22% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01176474, a Phase 1 study, has completed, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 73 participants
- Enrollment target
Study Summary
The purpose of this study is to test the side effects of an investigational vaccine with an immune booster, or 2 different boosters together. Investigators also want to find out its effects on the immune system and whether it will decrease the chance that melanoma will return.
Primary Outcome
Scanning and exams to detect recurrence will take place periodically during treatment and follow-up until relapse is confirmed.
Interventions
- DRUG Nivolumab
- DRUG Ipilimumab
- BIOLOGICAL NY-ESO-1 157-165 (165V)
- BIOLOGICAL gp100:280-288 (288V)
- DRUG Montanide ISA 51 vegetable grade (VG)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 73 participants |
| Start Date | 2010-08-13 |
| Est. Completion | 2023-01-06 |
| Phase | Phase 1 |
What the finished NCT01176474 record still lists
NCT01176474 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 73 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (22% higher).
The record links to 0 conditions, and to 5 interventions - of which Nivolumab is the first listed.
NCT01176474 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01176474 about?
NCT01176474 is a clinical study titled "Vaccine Combining Multiple Class I Peptides and Montanide ISA 51VG With Escalating Doses of Anti-PD-1 Antibody Nivolumab or Ipilimumab With Nivolumab For Patients With Resected Stages IIIC/ IV Melanoma". The purpose of this study is to test the side effects of an investigational vaccine with an immune booster, or 2 different boosters together. Investigators also want to find out its effects on the immune system and whether it will decrease the chance that melanoma will return.
What is the current status of trial NCT01176474?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 73 participants. The study started on 2010-08-13. Estimated completion is 2023-01-06.
What interventions are being tested in trial NCT01176474?
The interventions under investigation include: Nivolumab (DRUG), Ipilimumab (DRUG), NY-ESO-1 157-165 (165V) (BIOLOGICAL), gp100:280-288 (288V) (BIOLOGICAL), Montanide ISA 51 vegetable grade (VG) (DRUG).
Who is sponsoring clinical trial NCT01176474?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01176474's enrollment target sits among peer trials
73 732nd of 2000 higher than 1,265 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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