RNA-Nanoparticle Vaccine for Melanoma Recurrence

Overseen by Bently Doonan, MD, MS

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: University of Florida

Stay on Your Current Meds

No Placebo Group

Trial Summary

What is the purpose of this trial?

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 progressed on anti-PD1 (a-PD1) adjuvant therapy.

Research Team

Bently Doonan, MD, MS

Principal Investigator

University of Florida

Eligibility Criteria

This trial is for adults over 18 with stage IIB-IV melanoma that worsened on anti-PD1 therapy. They must be in good physical condition, not have multiple cancers, and agree to use birth control. The disease must allow for vaccine creation from a surgical sample, and they can't have had certain treatments or conditions that would risk their safety.

Inclusion Criteria

I do not have more than one active cancer.

I am fully active and can carry on all my pre-disease activities without restriction.

I am a woman who can have children and have a negative pregnancy test.

Exclusion Criteria

I have unstable chest pain.

I am willing and able to use birth control during and for 4 months after the study.

I am currently pregnant or breastfeeding.

Treatment Details

Interventions

• Autologous total tumor mRNA loaded DOTAP liposome vaccine (Cancer Vaccine)

Trial Overview The study tests a new RNA-nanoparticle (RNA-NP) vaccine made from the patient's own tumor material against early melanoma recurrence after previous anti-PD-1 antibody treatment. It aims to see if this personalized vaccine is safe and feasible as a treatment option.

Participant Groups

Group I: mRNA-nanoparticle (mRNA-NP) vaccine Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

Dr. Stephen J. Motew

University of Florida

Chief Executive Officer since 2024

MD cum laude from the University of Illinois at Chicago School of Medicine, Master's in Healthcare Administration from the University of North Carolina at Chapel Hill

Dr. Timothy E. Morey

University of Florida

Chief Medical Officer since 2023

MD and Bachelor's from the University of Florida