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NCT00142454 · ClinicalTrials.gov registry record · Phase 1
NY-ESO-1 Protein Vaccine With Imiquimod in Melanoma (Adjuvant Setting)
A Phase 1 study, sponsored by Ludwig Institute for Cancer Research.
- Completed
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
NCT00142454: Completed Phase 1 study, sponsored by Ludwig Institute for Cancer Research.
NCT00142454 is a Phase 1 study that has completed, run by Ludwig Institute for Cancer Research. The registered enrollment target is 9 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00142454, a Phase 1 study, has completed, sponsored by Ludwig Institute for Cancer Research.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
Study Summary
This was a Phase 1, single-arm, open-label, pilot study of NY-ESO-1 protein vaccination with imiquimod as an adjuvant in patients with resected Stage IIB, IIC, and III malignant melanoma. The primary study objective was to determine the safety of NY-ESO-1 protein/imiquimod treatment, and the secondary objective was to evaluate the immunogenicity of treatment.
Primary Outcome
Toxicity was graded in accordance with the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0, as follows: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (life-threatening), and Grade 5 (fatal). Adverse events (AEs) were reported based on clinical laboratory tests, vital sign and weight measurements, physical examinations, performance status evaluations, and any other medically indicated assessments, including patient interviews, fr
Interventions
- DRUG Imiquimod
- BIOLOGICAL NY-ESO-1 protein
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2005-08-24 |
| Est. Completion | 2006-04-25 |
| Phase | Phase 1 |
What the finished NCT00142454 record still lists
NCT00142454 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 2 interventions - of which Imiquimod is the first listed.
NCT00142454 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00142454 about?
NCT00142454 is a clinical study titled "NY-ESO-1 Protein Vaccine With Imiquimod in Melanoma (Adjuvant Setting)". This was a Phase 1, single-arm, open-label, pilot study of NY-ESO-1 protein vaccination with imiquimod as an adjuvant in patients with resected Stage IIB, IIC, and III malignant melanoma. The primary study objective was to determine the safety of NY-ESO-1 protein/imiquimod treatment, and the seconda...
What is the current status of trial NCT00142454?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2005-08-24. Estimated completion is 2006-04-25.
What interventions are being tested in trial NCT00142454?
The interventions under investigation include: Imiquimod (DRUG), NY-ESO-1 protein (BIOLOGICAL).
Who is sponsoring clinical trial NCT00142454?
This trial is sponsored by Ludwig Institute for Cancer Research, which has 30 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00142454's enrollment target sits among peer trials
9 1955th of 2000 higher than 42 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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