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NCT01176461 · ClinicalTrials.gov registry record · Phase 1
Multiple Class I Peptides & Montanide ISA 51 VG w Escalating Doses of Anti-PD-1 ab BMS936558
A Phase 1 study of Melanoma (Skin), sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 127
- Enrollment target
- 1
- Study location
NCT01176461: Completed Phase 1 study of Melanoma (Skin), sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT01176461 is a Phase 1 study of Melanoma (Skin) that has completed, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 127 participants, roughly in line with the 133-participant average among 30 other Melanoma (Skin) trials with a reported enrollment target. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01176461, a Phase 1 study of Melanoma (Skin), has completed, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 127 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a pilot phase 1, open-label, single center, multi-dose, dose-escalation study of BMS-936558 in combination with or without a peptide vaccine. The purpose of this study is to test the side effects of an investigational vaccine with an immune booster. Investigators also wish to find out its effects on the patient's immune system and whether it will shrink their melanoma.
Primary Outcome
The primary analysis is the BORR as determined using irRC. The BORR will be summarized using descriptive statistics.
Conditions Studied
Interventions
- DRUG Montanide ISA 51 VG
- BIOLOGICAL gp100:209-217(210M)
- BIOLOGICAL MART-1
- BIOLOGICAL NY-ESO-1
- BIOLOGICAL gp100:280-288(288V)
Study Locations (1)
Florida
- H. Lee Moffitt Cancer Center and Research Institute - Tampa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 127 participants |
| Start Date | 2010-08-04 |
| Est. Completion | 2016-12-12 |
| Phase | Phase 1 |
What the finished NCT01176461 record still lists
NCT01176461 is an interventional study that assigns participants to a tested intervention. The registered 127 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30 other Melanoma (Skin) trials with a reported enrollment target.
The record links to 1 condition, with Melanoma (Skin) appearing as the primary indexed condition, and to 5 interventions - of which Montanide ISA 51 VG is the first listed.
NCT01176461 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT01176461 about?
NCT01176461 is a clinical study titled "Multiple Class I Peptides & Montanide ISA 51 VG w Escalating Doses of Anti-PD-1 ab BMS936558". This is a pilot phase 1, open-label, single center, multi-dose, dose-escalation study of BMS-936558 in combination with or without a peptide vaccine. The purpose of this study is to test the side effects of an investigational vaccine with an immune booster. Investigators also wish to find out its e...
What is the current status of trial NCT01176461?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 127 participants. The study started on 2010-08-04. Estimated completion is 2016-12-12.
What conditions does trial NCT01176461 study?
This clinical trial studies the following conditions: Melanoma (Skin).
What interventions are being tested in trial NCT01176461?
The interventions under investigation include: Montanide ISA 51 VG (DRUG), gp100:209-217(210M) (BIOLOGICAL), MART-1 (BIOLOGICAL), NY-ESO-1 (BIOLOGICAL), gp100:280-288(288V) (BIOLOGICAL).
Who is sponsoring clinical trial NCT01176461?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01176461 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01176461's enrollment target sits among peer trials
127 8th of 30 higher than 23 of 30 other Melanoma (Skin) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Melanoma (Skin) 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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