Novel RNA-lipid Particle (RNA-LP) Vaccine for Anti-PD-1 Antibody Therapy Sensitization
Trial Parameters
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Adults ≥ 18 years old * ECOG performance ≤ 2 * Lab values within the specified ranges: * Hemoglobin ≥ 8G/DL * Platelets ≥ 150 thou/cumm * Absolute Neutrophil Count (ANC) ≥ 1500 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 * Creatinine clearance (CrCl) ≥ 15 ml/min (based on modified Cockcroft and Gault formula) * Must have disease that is amenable to surgical sampling for RNA extraction, amplification, and loading of lipid particles * Subjects must not have more than one active malignancy at the time of enrollment (subjects with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen \[as determined by the treating physician and approved by the PI\] may be included) * Written informed consent obtained from the subject. * Female subjects of c