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

NCT06218511 Phase 1 ACTIVE_NOT_RECRUITING

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.

Details

Lead sponsor	National Cancer Institute, Naples
Phase	Phase 1
Status	ACTIVE_NOT_RECRUITING
Enrolment	10
Start date	2022-11-22
Completion	2026-11

Conditions

• Hepatocellular Carcinoma

Interventions

• Peptide-based hepatocellular carcinoma vaccine IMA970A
• Durvalumab
• Montanide (Adjuvant)

Primary outcomes

• Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) — 55 months (approximately 4.5 years)
  Safety assessments will consist of continuous monitoring and reporting of adverse events (AEs) including serious adverse events (SAEs), regular monitoring of vital signs, ECOG performance status and regular conduct of physical examinations and laboratory assessments (haematology, clinical \[bio\]chemistry including C reactive protein (CRP) and glomerular filtration rate (GFR), coagulation test, assessment of viral infection, thyroid function test (TFT), urinalysis), electrocardiogram (ECG) and pregnancy tests (if applicable). Possible cross-reactivity with live attenuated vaccination or flu vaccine will be assessed.

Countries

Italy