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NCT05264974 · ClinicalTrials.gov registry record · Phase 1
Novel RNA-lipid Particle (RNA-LP) Vaccine for Anti-PD-1 Antibody Therapy Sensitization
A Phase 1 study of Melanoma and Soft Tissue Sarcoma, sponsored by University of Florida.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
- 1
- Study location
NCT05264974: Recruiting Phase 1 study of Melanoma and Soft Tissue Sarcoma, sponsored by University of Florida.
NCT05264974 is a Phase 1 study of Melanoma and Soft Tissue Sarcoma that is actively recruiting participants, run by University of Florida. The registered enrollment target is 18 participants, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05264974, a Phase 1 study of Melanoma and Soft Tissue Sarcoma, is actively recruiting participants, sponsored by University of Florida.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this phase I trial is to evaluate the toxicity and feasibility of a tumor-specific RNA-NP vaccine in patients with stage IIB-IV melanoma who have evidence of progressive disease by RECIST 1.1 criteria while receiving adjuvant aPD1 therapy, or those who progress within 6 months of completion of adjuvant treatment, or unresectable stage II soft tissue sarcoma or stage III-IV soft tissue sarcoma.
Primary Outcome
Determine the maximum tolerated dose of RNA-NP vaccine
Conditions Studied
Interventions
- BIOLOGICAL Autologous total tumor mRNA loaded DOTAP liposome vaccine
Study Locations (1)
Florida
- University of Florida - Gainesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2026-02 |
| Est. Completion | 2026-09 |
| Phase | Phase 1 |
What NCT05264974 shows while recruiting
NCT05264974 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (97% lower).
The record links to 2 conditions, with Melanoma appearing as the primary indexed condition, and to 1 intervention - of which Autologous total tumor mRNA loaded DOTAP liposome vaccine is the first listed.
NCT05264974 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT05264974 about?
NCT05264974 is a clinical study titled "Novel RNA-lipid Particle (RNA-LP) Vaccine for Anti-PD-1 Antibody Therapy Sensitization". The goal of this phase I trial is to evaluate the toxicity and feasibility of a tumor-specific RNA-NP vaccine in patients with stage IIB-IV melanoma who have evidence of progressive disease by RECIST 1.1 criteria while receiving adjuvant aPD1 therapy, or those who progress within 6 months of complet...
What is the current status of trial NCT05264974?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2026-02. Estimated completion is 2026-09.
What conditions does trial NCT05264974 study?
This clinical trial studies the following conditions: Melanoma, Soft Tissue Sarcoma.
What interventions are being tested in trial NCT05264974?
The interventions under investigation include: Autologous total tumor mRNA loaded DOTAP liposome vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT05264974?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05264974 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
Similar trials for Melanoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05264974's enrollment target sits among peer trials
18 232nd of 266 higher than 32 of 266 other Melanoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Melanoma 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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