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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 is a Phase 1 study that has completed, run by Ludwig Institute for Cancer Research. The registered enrollment target is 9 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00142454
The ClinicalTrials.gov registry entry for NCT00142454 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ludwig Institute for Cancer Research, which has 30 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Imiquimod is the first listed.
NCT00142454 reports 0 study locations.
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.
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