Clinical Trial

A Phase I Trial of IMA970A Plus Montanide in Combination With Durvalumab (Anti-PD-L1)

Active, Not Recruiting Phase 1
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Summary
The trial is designed as a single-arm, open-label, phase I study investigating an off-the-shelf, multi-peptide-base HCC vaccine plus Montanide, combined with Durvalumab in patients with very early, early and intermediate stage of HCC. The investigational agents will be applied without concomitant anti-tumour therapy with the intention to reduce risk of recurrence/progression in patients who have received all indicated standard treatments.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2024-01-18; most recent amendment 2025-12-16.
Status change: Recruiting → Active, Not Recruiting 2025-12-16
Trial Details
NCT Number NCT06218511
Lead Sponsor National Cancer Institute, Naples
Conditions Hepatocellular Carcinoma
Enrollment 10 participants
Start Date 2022-11-22
Primary Completion 2025-08-28 (estimated)
Study Completion 2026-11 (estimated)
Updated on ClinicalTrials.gov 2025-12-22