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NCT02320305 · ClinicalTrials.gov registry record · Early Phase 1
MART-1 Antigen With or Without TLR4 Agonist GLA-SE in Treating Patients With Stage II-IV Melanoma That Has Been Removed by Surgery
A Early Phase 1 study, sponsored by Mayo Clinic.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 23
- Enrollment target
NCT02320305: Completed Early Phase 1 study, sponsored by Mayo Clinic.
NCT02320305 is a Early Phase 1 study that has completed, run by Mayo Clinic. The registered enrollment target is 23 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02320305, a Early Phase 1 study, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 23 participants
- Enrollment target
Study Summary
This randomized pilot clinical trial studies melanoma antigen recognized by T-cells 1 (MART-1) antigen with or without toll-like receptor 4 (TLR4) agonist glucopyranosyl lipid A-stable oil-in-water emulsion (GLA-SE) in treating patients with stage II-IV melanoma that has been removed by surgery. Vaccines made from MART-1a peptide or antigen may help the body build an effective immune response to kill tumor cells. Giving TLR4 agonist GLA-SE with MART-1 antigen may help increase the immune response to MART-1a antigen.
Primary Outcome
A patient is considered to have achieved an immune response if there is a 2-fold or more increase from pre-treatment levels in the absolute number of vaccine peptide-specific (MART-1a-specific) CTL as measured by tetramer staining, or if the frequency of MART-1a-specific CTL is initially undetectable (\< 0.05% of CD8 T cells) and becomes detectable during the vaccine treatment period. The proportion of successes will be estimated and the exact binomial 95% confidence intervals for the true immun
Interventions
- OTHER Laboratory Biomarker Analysis
- BIOLOGICAL MART-1 Antigen
- DRUG TLR4 Agonist GLA-SE
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2015-01-27 |
| Est. Completion | 2019-04-11 |
| Phase | Early Phase 1 |
What the finished NCT02320305 record still lists
NCT02320305 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (57% lower).
The record links to 0 conditions, and to 3 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT02320305 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02320305 about?
NCT02320305 is a clinical study titled "MART-1 Antigen With or Without TLR4 Agonist GLA-SE in Treating Patients With Stage II-IV Melanoma That Has Been Removed by Surgery". This randomized pilot clinical trial studies melanoma antigen recognized by T-cells 1 (MART-1) antigen with or without toll-like receptor 4 (TLR4) agonist glucopyranosyl lipid A-stable oil-in-water emulsion (GLA-SE) in treating patients with stage II-IV melanoma that has been removed by surgery. Vac...
What is the current status of trial NCT02320305?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 23 participants. The study started on 2015-01-27. Estimated completion is 2019-04-11.
What interventions are being tested in trial NCT02320305?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), MART-1 Antigen (BIOLOGICAL), TLR4 Agonist GLA-SE (DRUG).
Who is sponsoring clinical trial NCT02320305?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02320305's enrollment target sits among peer trials
23 1088th of 2000 higher than 898 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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