OncoMatch/Clinical Trials/NCT05264974
Novel RNA-lipid Particle (RNA-LP) Vaccine for Anti-PD-1 Antibody Therapy Sensitization
Is NCT05264974 recruiting? Yes, currently enrolling (Sep 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
Treatments studied
Other
Cancer type
Melanoma
Sarcoma
Disease stage
Required: Stage II, III, IV, RESECTED STAGE IV
Patients with stage II, stage III, or resected stage IV melanoma... Patients with unresectable or widespread metastatic (stage IV) melanoma... Evidence of unresectable stage II disease; stage III or stage IV disease [sarcoma]
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Prior therapy
Must have received: anti-PD-1 therapy — adjuvant or neoadjuvant (melanoma, stage II/III/resected IV)
Patients with stage II, stage III, or resected stage IV melanoma who received anti-PD-1-based therapy in the adjuvant or neoadjuvant setting (either monotherapy or combination therapy) and experienced progressive disease (PD) per RECIST 1.1 during treatment or within 6 months of completing the planned course of therapy.
Must have received: anti-PD-1 therapy — unresectable or metastatic melanoma (any line)
Patients with unresectable or widespread metastatic (stage IV) melanoma who experienced PD per treating physician while receiving anti-PD-1-based therapy (either monotherapy or combination therapy) in any line of treatment.
Must have received: anti-PD-1 therapy — unresectable or metastatic melanoma (any line)
Patients with unresectable or widespread metastatic (stage IV) melanoma who: Completed a planned course of anti-PD-1-based therapy (monotherapy or combination), including planned treatment durations of approximately 1 year or 2 years, and experienced PD within 6 months of completion; or Were planned to receive anti-PD-1-based therapy (for either 1 year or 2 years) but discontinued early due to toxicity and experienced PD within 6 months of discontinuation.
Lab requirements
Blood counts
Hemoglobin ≥ 8G/DL; Platelets ≥ 100 thou/cumm; Absolute Neutrophil Count (ANC) ≥ 1000 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 ≥ 100 thou/cumm; ANC ≥ 1000 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
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Florida · Gainesville, Florida
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05264974 currently recruiting?
Yes, this trial is currently recruiting patients.
Is prior treatment required for enrollment?
Yes. Patients must have previously received anti-PD-1 therapy and anti-PD-1 therapy.
What disease stage is eligible?
Stage II or III or IV or RESECTED STAGE IV is required.
Is there an age limit?
Yes. Patients must be 99 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages