NCT06218511

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

A Phase I Trial of IMA970A Plus Montanide in Combination With Durvalumab (Anti-PD-L1) in Patients With Very Early, Early and Intermediate Stage of Hepatocellular Carcinoma After Any Standard Treatments

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: National Cancer Institute, Naples · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The proposed phase I HepaVac-201 will investigate safety, tolerability and immunogenicity of the same investigational IMA-970A agent, formulated in Montanide combined with an anti-PD-L1 (i.e.Durvalumab). Compared to the previous HepaVac-101 clinical trial, two major differences are introduced. The adjuvant Montanide (oil and water mix) will replace the CV8102 (TLR agonist) which was used in the HepaVac-101 trial. The anti-PD-L1 Durvalumab is introduced in the protocol. Indeed, several reports have shown that, inhibitory receptors are induced after vaccination. Blocking these inhibitory pathways lead to amplification of the T cell-mediated immune response. In particular, IFNγ production by antitumour-specific T cells could also upregulate PD-L1 on tumour cells, as a resistance mechanism to adaptive immunity, thereby promoting PD-L1-PD-1 blockade after vaccination. Several early phases clinical trials have been performed to validate this hypothesis. The aim is to verify whether these two changes in the HepaVac-201 protocol will improve the immunogenicity of the vaccine keeping the same safety profile as in the HepaVac-101 protocol. The phase I clinical trial HepaVac-201 will be conducted at the Istituto Nazionale Tumori, IRCCS Fondazione G. Pascale, Naples, Italy. Dr. Luigi Buonaguro will be the coordinator of the trial. Dr. Francesco Izzo and Dr. Paolo A. Ascierto are the lead Investigators. 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 treatment.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
BIOLOGICAL	Peptide-based hepatocellular carcinoma vaccine IMA970A	IMA970A is a lyophilized multi-peptide vaccine consisting of 17 individual peptides (active pharmaceutical ingredients) and 2 excipients (Poloxamer 338 and Mannitol). All peptides have been chemically manufactured by well established solid phase peptide synthesis procedures. All peptides are composed of linear, unmodified L- amino acid chains with chain length in the range of 9 to 21 amino acids.
COMBINATION_PRODUCT	Durvalumab	anti-PD-L1
OTHER	Montanide (Adjuvant)	Montanide ISA™ 51 is a water-in-oil (W/O) emulsion composed of a mineral oil and a surfactant from the mannide monooleate family with immune stimulatory effect .

Timeline

• Start date: 2022-11-22
• Primary completion: 2025-08-28
• Completion: 2026-11-01
• First posted: 2024-01-23
• Last updated: 2025-12-22

Locations

1 site across 1 country: Italy