Actively Recruiting
Novel RNA-lipid Particle (RNA-LP) Vaccine for Anti-PD-1 Antibody Therapy Sensitization
Led by University of Florida · Updated on 2026-04-28
18
Participants Needed
1
Research Sites
24 weeks
Total Duration
On this page
Sponsors
U
University of Florida
Lead Sponsor
F
Florida Department of Health
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Novel RNA-lipid Particle (RNA-LP) Vaccine for Anti-PD-1 Antibody Therapy Sensitization
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years or older
- ECOG performance status of 2 or lower
- Laboratory values within specified ranges: Hemoglobin �3 8 G/DL, Platelets �3 150,000 /cumm, Absolute Neutrophil Count �3 1500 /cumm, Serum total bilirubin �4 1.5 times upper limit of normal, AST and ALT �4 2.5 times upper limit of normal (up to 5 times if liver metastases present), Creatinine clearance �3 15 ml/min
- Disease amenable to surgical sampling for RNA extraction and vaccine preparation
- Only one active malignancy at enrollment unless prior or concurrent malignancy does not interfere with study
- Written informed consent obtained
- Negative pregnancy test for females of childbearing potential at screening
- Use of adequate contraception during study and for four months after last dose for females of childbearing potential
- Males with partners of childbearing potential agree to use contraception and avoid sperm donation during and for four months after treatment
- For melanoma patients: measurable disease with progression by RECIST 1.1 during or within 6 months after adjuvant anti-PD1 therapy; or stage IV nonresectable rare melanoma subtypes after first-line immunotherapy failure
- For melanoma patients: prior immune checkpoint inhibition with primary or secondary resistance as defined
- For melanoma patients: prior treatment with anti-PD1, combination anti-PD1/CTLA-4, or PD1/LAG-3 inhibitors for stage IIB-IV melanoma
- For melanoma patients: BRAF wildtype or BRAF mutation with contraindication or progression on BRAF/MEK inhibitors or refusal of BRAF/MEK therapy
- For soft tissue sarcoma patients: measurable and biopsy-accessible tumor with specified sarcoma morphologies
- Soft tissue sarcoma patients with unresectable stage II, III, or IV disease
- Soft tissue sarcoma patients may have prior immune checkpoint inhibitor exposure, but it is not required
- Soft tissue sarcoma patients without available standard therapy may be eligible
You will not qualify if you...
- Active second malignancy, except early stage malignancies with no recurrence after 3 years
- History of immune-mediated adverse reactions causing discontinuation of prior anti-PD1 therapy or severe hypersensitivity to monoclonal antibodies
- Active symptomatic brain or leptomeningeal metastases, except treated isolated brain lesions without new disease
- Recent development of brain metastases requiring treatment and ability to resume systemic therapy within 6 weeks
- Receipt of investigational drug within 28 days or 5 half-lives before enrollment
- Use of corticosteroids over 10 mg prednisone equivalent or other immunosuppressants within 14 days of treatment
- Uncontrolled infections requiring intravenous antimicrobial therapy within 7 days before vaccine preparation or administration
- Life-threatening illness or organ dysfunction compromising safety
- Active hepatitis B or untreated hepatitis C infection
- Clinically relevant active autoimmune disease posing significant risk
- Symptomatic congestive heart failure NYHA class 3 or 4
- Unstable angina
- Post-splenectomy, asplenia, or moderate to severe splenomegaly
- History of anaphylaxis to prior vaccination
- Known hypersensitivity to vaccine components
- HIV with CD4+ count �350 cells/ul, detectable viral load, or recent AIDS-defining infection
- Unwillingness or inability to use contraception during and 4 months after study
- Pregnant or breastfeeding females
- Any disease or condition contraindicating protocol therapy or affecting study interpretation
- Receipt of live virus vaccine within 30 days prior to first dose
- Prisoners, involuntarily incarcerated, or compulsorily detained individuals
- Sarcoma originating from bone or cartilage
- Sarcomatous malignancies without metastatic potential
- Prior dual checkpoint inhibition for sarcoma patients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Florida
Gainesville, Florida, United States, 32608
Actively Recruiting
Research Team
K
Karine Charles
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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