RecruitingMelanomaSoft Tissue Sarcoma

Novel RNA-lipid Particle (RNA-LP) Vaccine for Anti-PD-1 Antibody Therapy Sensitization

Eligible age

18–99 yrs

Accepts

All genders

Locations

1 state

Healthy volunteers

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About this study

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.

Sponsor: University of Florida

You may qualify if…

✓ Adults ≥ 18 years old
✓ ECOG performance ≤ 2
✓ Lab values within the specified ranges:
✓ Hemoglobin ≥ 8G/DL
✓ Platelets ≥ 100 thou/cumm
✓ Absolute Neutrophil Count (ANC) ≥ 1000 thou/cumm
✓ Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN)
✓ AST and ALT ≤ 2.5 x ULN; If confirmed liver metastases: AST and ALT ≤ 5 x ULN

You may not qualify if…

✕ Subjects that have an active second malignancy, however, previously treated early stage malignancies with no evidence of disease recurrence after 3 years of follow-up will be allowed
✕ Subjects with a history of immune-mediated treatment-related adverse reactions leading to discontinuation of prior aPD1 therapy or severe hypersensitivity reaction to any monoclonal antibody or any other baseline risk in the opinion of the investigator that precludes continued use of aPD1 therapy
✕ Patients with known active and symptomatic brain metastases or leptomeningeal metastases at time of inclusion. Patients with isolated brain lesions that have been treated with stereotactic radiosurgery or surgical resection as part of oligometastatic initial management prior to start of immunotherapy may be eligible as long as they have no new disease and are asymptomatic at time of inclusion.
✕ If patients develop new brain metastases during the time between tumor sampling and vaccine generation and administration, patients may remain on study as long as they can receive definitive stereotactic radiosurgery or surgery to brain metastases and be able to resume systemic therapy within 6 weeks of discovery of new brain metastases.
✕ Subjects who received an investigational drug in another clinical trial must wait 28 days or at least 5 half-lives of the study drug, whichever is shorter, prior to enrollment in this study
✕ Patients must not have required systemic corticosteroids (anything greater than 10mg of prednisone of equivalent, daily) or other immunosuppressive medications within 14 days of the start of trial treatment.
✕ Subjects with known active infection or immunosuppressive disease within seven days prior to tissue collection for vaccine creation or within seven days prior to vaccine administration (subjects on prophylactic agents are acceptable)
✕ Subjects with any known life-threatening illness, medical condition, or organ system dysfunction (aside from their cancer), which in the investigator's opinion, could compromise subject safety

Where it's recruiting

Florida

Gainesville

Source: ClinicalTrials.gov · NCT05264974 · last updated 2026-08-10