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 completion of adjuvant treatment, or unresectable stage II soft tissue sarcoma or stage III-IV soft tissue sarcoma.

Trial Details

NCT ID
NCT05264974
Phase
PHASE1
Sponsor
University of Florida
Status
RECRUITING
Cancer Type
Melanoma
Interventions
  • Autologous total tumor mRNA loaded DOTAP liposome vaccine
Locations (sample)
  • Gainesville, Florida, United States|29.65163,-82.32483

Key Eligibility Criteria

  • Adults ≥ 18 years old
  • ECOG performance ≤ 2
  • Lab values within the specified ranges:
  • Hemoglobin ≥ 8G/DL

For full eligibility, visit ClinicalTrials.gov.

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