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

Sponsor
National Cancer Institute, Naples
Study ID
NCT06218511
Phase
PHASE1
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Peptide-based hepatocellular carcinoma vaccine IMA970A — BIOLOGICAL
    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.
  • Durvalumab — COMBINATION_PRODUCT
    anti-PD-L1
  • Montanide (Adjuvant) — OTHER
    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 .

Study Details

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.

Key Dates

Start date
Nov 22, 2022
Status verified
Jul 2025
Primary completion
Aug 28, 2025
Completion
Nov 30, 2026

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Single arm
    single-arm open-label

Primary Outcome Measure

Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) [ Time Frame: 55 months (approximately 4.5 years) ]

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