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NCT01425749 · ClinicalTrials.gov registry record · Early Phase 1
Study to Assess Safety and Immune Response of Stage IIB-IV Resected Melanoma After Treatment With MAGE-A3 ASCI
A Early Phase 1 study, sponsored by Craig L Slingluff, Jr.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 25
- Enrollment target
NCT01425749: Completed Early Phase 1 study, sponsored by Craig L Slingluff, Jr.
NCT01425749 is a Early Phase 1 study that has completed, run by Craig L Slingluff, Jr. The registered enrollment target is 25 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01425749, a Early Phase 1 study, has completed, sponsored by Craig L Slingluff, Jr.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 25 participants
- Enrollment target
Study Summary
The goals of this study are to 1) assess the safety of recombinant MAGE-A3 protein combined with AS15 Immunological Adjuvant System (recMAGE-A3 + AS15) as an Antigen-Specific Cancer Immunotherapeutic (MAGE-A3 ASCI) when administered in two different administration sites, intramuscular (IM) or intradermal/subcutaneous (ID/SC), and 2) to provide preliminary data on the immunological response to ASCI in the injection site microenvironment, in the node draining the vaccine site (sentinel immunized node) and in the blood and whether there are large differences in the magnitude, persistence, or type of immune response induced as a function of the ASCI injection. Evaluation of immune responses to the ASCI will include, amonth others antiMAGE-A3 antibody responses and CD4+ and CD8+ T cell responses.
Primary Outcome
grade 2 treatment-related adverse events graded by CTCAE v4
Interventions
- BIOLOGICAL recMAGE-A3 + AS15 ASCI
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2011-06 |
| Est. Completion | 2015-10 |
| Phase | Early Phase 1 |
What the finished NCT01425749 record still lists
NCT01425749 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 1 intervention - of which recMAGE-A3 + AS15 ASCI is the first listed.
NCT01425749 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01425749 about?
NCT01425749 is a clinical study titled "Study to Assess Safety and Immune Response of Stage IIB-IV Resected Melanoma After Treatment With MAGE-A3 ASCI". The goals of this study are to 1) assess the safety of recombinant MAGE-A3 protein combined with AS15 Immunological Adjuvant System (recMAGE-A3 + AS15) as an Antigen-Specific Cancer Immunotherapeutic (MAGE-A3 ASCI) when administered in two different administration sites, intramuscular (IM) or intrad...
What is the current status of trial NCT01425749?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 25 participants. The study started on 2011-06. Estimated completion is 2015-10.
What interventions are being tested in trial NCT01425749?
The interventions under investigation include: recMAGE-A3 + AS15 ASCI (BIOLOGICAL).
Who is sponsoring clinical trial NCT01425749?
This trial is sponsored by Craig L Slingluff, Jr, which has 23 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01425749's enrollment target sits among peer trials
25 1000th of 2000 higher than 964 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early 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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