OncoMatch/Clinical Trials/NCT05264974
Novel RNA-lipid Particle (RNA-LP) Vaccine for Anti-PD-1 Antibody Therapy Sensitization
Is NCT05264974 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies Autologous total tumor mRNA loaded DOTAP liposome vaccine for melanoma.
Treatment: Autologous total tumor mRNA loaded DOTAP liposome vaccine — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Melanoma
Sarcoma
Biomarker criteria
Required: BRAF wild-type
Disease stage
Required: Stage IIB, III, IV, II
progression (progressive disease, or PD) by RECIST 1.1 criteria while receiving adjuvant aPD1 therapy, or progression within 6 months after completing adjuvant treatment for stage IIB-IV melanoma; Evidence of unresectable stage II disease; stage III or stage IV disease
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: immune checkpoint inhibitor (anti-PD-1 therapy, combination anti-PD-1/CTLA-4 inhibition, PD-1/LAG-3 inhibitor) — adjuvant or definitive metastatic treatment for stage IIB-IV melanoma following surgical resection
Must have received either aPD1, combination aPD1/CTLA-4 inhibition, or PD1/LAG-3 inhibitor as adjuvant or definitive metastatic treatment for stage IIB-IV melanoma following surgical resection
Cannot have received: dual checkpoint inhibition
Subjects with sarcoma who have received dual checkpoint inhibition are not eligible
Lab requirements
Blood counts
Hemoglobin ≥ 8G/DL; Platelets ≥ 150 thou/cumm; Absolute Neutrophil Count (ANC) ≥ 1500 thou/cumm
Kidney function
Creatinine clearance (CrCl) ≥ 15 ml/min (based on modified Cockcroft and Gault formula)
Liver function
Serum total bilirubin ≤ 1.5 x ULN; AST and ALT ≤ 2.5 x ULN; If confirmed liver metastases: AST and ALT ≤ 5 x ULN
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 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)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Florida · Gainesville, Florida
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