Hepatocellular CarcinomaPhase 1NCT06218511
A Phase I Trial of IMA970A Plus Montanide in Combination With Durvalumab (Anti-PD-L1)
A Phase 1 study testing Peptide-based hepatocellular carcinoma vaccine IMA970A, Durvalumab and Montanide (Adjuvant) in people with Hepatocellular Carcinoma, run by National Cancer Institute, Naples at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Peptide-based hepatocellular carcinoma vaccine IMA970A, Durvalumab and Montanide (Adjuvant)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteItaly
- Study dates
- 22 Nov 2022to Nov 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Written informed consent and any locally required authorization (e.g., Health Insurance Portability and Accountability Act in the US, European Union [EU] Data Privacy Directive in the EU) obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations.
- Age > 18 years at time of study entry.
- HLA type: HLA-A*02 and/or HLA-A*24 positive.
- Very early, early and intermediate stage (Barcelona Clinic Liver Cancer (BCLC) stage 0, A, B disease) hepatocellular carcinoma (HCC) diagnosed by biopsy or resected tissue (patho-histological diagnosis) or imaging findings (non-invasive criteria) following any standard treatment (e.g. hepatic resection, Radiofrequency Ablation / Percutaneous Ethanol injection (RFA/PEI), Transarterial chemoembolization (TACE) and SIRT) and without any evidence of active disease that warrant further treatment.
- Minimum life expectancy of 1 year.
- Patho-histological diagnosis of HCC based on biopsy is required for all nodules occurring in non-cirrhotic livers, and for those cases with inconclusive or atypical imaging appearance in cirrhotic livers.
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- Non-invasive criteria can only be applied to cirrhotic patients and need to be based on imaging techniques obtained by 4-phase multidetector CT scan or dynamic contrast enhanced MRI and on the identification of the typical hallmark of HCC (hypervascular in the arterial phase with washout in the portal venous or delayed phase). One imaging technique is sufficient for nodules beyond 1 cm (> 1 cm) in diameter.
- Patients for whom no standard anti-tumour therapy is indicated for the next 3 months thereafter any standard anti-tumour therapies applied for the treatment of BCLC stage 0, A and B HCC (e.g. RFA/PEI, TACE, and SIRT) are allowed to be applied in combination with the study treatment. Patients for whom treatment for advanced disease (e.g.
- sorafenib) is indicated will be withdrawn from study treatment.
- Eastern Cooperative Oncology Group (ECOG) performance status 0/1 with the specific characteristics indicated in the exclusion criteria.
- Child-Pugh A5-6 and B7 disease or no liver function impairment.
- Body weight >30 kg.
- Adequate normal organ and marrow function as defined below:
- Haemoglobin ≥9.0 g/dL
- Absolute neutrophil count (ANC) ≥1.0 × 109 /L
- Platelet count ≥75 × 109
- /L
- Serum bilirubin ≤1.5 x institutional upper limit of normal (ULN). This will not apply to patients with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of haemolysis or hepatic pathology), who will be allowed only in consultation with their physician.
- AST (SGOT)/ALT (SGPT) ≤5 x institutional upper limit of normal
- Measured creatinine clearance (CL) >40 mL/min or Calculated creatinine CL>40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance:
- Males:
- Creatinine CL (mL/min)
- = Weight (kg) x (140 - Age) 72 x serum creatinine (mg/dL)
- Females:
- Creatinine CL (mL/min)
- = Weight (kg) x (140 - Age) x 0.85 72 x serum creatinine (mg/dL)
- Willingness and ability to comply with the study protocol for the duration of the study.
- Female patient of child-bearing potential:
- Female patients of childbearing potential who are not totally sexually abstinent (i.e., refraining from heterosexual intercourse during the entire period of risk associated with study interventions) and intend to be sexually active with a non sterilised male partner must use at least 1 highly effective method of contraception (Appendix 4). They should have been stable on their chosen method of birth control for a minimum of 3 months before entering the study and continue to use it throughout the total duration of the drug treatment and the drug washout period (90 days after the last dose of study treatment). Non sterilised male partners of a female patient of childbearing potential must use male condom plus spermicide throughout this period. Cessation of birth control after this point should be discussed with a responsible physician. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Female patients should also refrain from breastfeeding throughout this period.
- Male patients with a female partner of childbearing potential:
- Non-sterilised male patients who are not abstinent and intend to be sexually active with a female partner of childbearing potential must use a male condom plus spermicide from the time of screening throughout the total duration of the drug treatment and the drug washout period (90 days after the last dose of study treatment). Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception. Male patients should refrain from sperm donation throughout this period. Vasectomised males are considered fertile and should still use a male condom plus spermicide as indicated above during the clinical study.
- Even if the female partner is pregnant, male participants should still use a condom plus spermicide (where approved), as indicated above during the clinical study, if there is a concern about damaging the developing foetus from drug in ejaculate.
- Female partners (of childbearing potential) of male patients must also use a highly effective method of contraception throughout this period (Appendix 4).
Who cannot join
- Patients should not enter the study if any of the following exclusion criteria are fulfilled:
- Any prior systemic anti-tumour treatment (including drug or treatment regimen, approved or experimental) within 2 weeks before study treatment administration.
- Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP. Note: Local surgery of isolated lesions for palliative intent is acceptable
- Liver transplanted patients; patients who are on the liver transplantation waiting list are not allowed to be enrolled.
- Concurrent enrolment in another clinical study, unless it is an observational (non interventional) clinical study or during the follow-up period of an interventional study.
- Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria
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- Patients with Grade ≥2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Physician.
- Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included only after consultation with the Study Physician.
- History of allogenic organ transplantation.
- History or evidence of systemic autoimmune disease, e.g. rheumatoid arthritis, multiple sclerosis, systemic lupus erythematosus (SLE), scleroderma, Sjögren's syndrome, Wegener's granulomatosis, Guillain-Barre syndrome.
- Need for concomitant treatment with immunosuppressive drugs or other immune modifying drugs. The use of inhaled and nasally applied steroids, as well as topical steroids outside the vaccination area are permitted.
- Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhoea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent.
- History of other malignancies within the last 3 years except for adequately treated except cervical carcinoma in situ, basal cell carcinoma and superficial bladder tumours [Ta, Tis \& T1] or any cancer curatively treated > 3 years prior to signing of informed consent by the patient.
- History of leptomeningeal carcinomatosis.
- Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥470 ms calculated from 3 ECGs (within 15 minutes at 5 minutes apart). Regardless of whether this criterion stays or not, all patients should have a baseline ECG.
- Any medically diagnosed or suspected condition of immunodeficiency or medical history thereof
- Known to have tested positive for human immunodeficiency virus (HIV) (positive HIV 1/2 antibodies) or active tuberculosis infection (clinical evaluation that may include clinical history, physical examination and radiographic findings, or tuberculosis testing in line with local practice).
- Any other known infection with a biological agent that can cause a severe disease and poses a severe danger to lab personnel working on patients' blood or tissue.
- Examples are: rabies, Mycobacterium leprae, Plasmodium falciparum, Coccidioides immitis.
- Acute and active infections requiring oral or intravenous antibiotics, antiviral or antifungal therapy within 30 days prior to enrolment (exception: Hepatitis B Virus (HBV) and/or Hepatitis C Virus (HCV) infections; direct-acting antivirals may be applied as medically indicated).
- Receipt of live attenuated vaccine within 30 days prior to the first dose of IP. Note:
- Patients, if enrolled, should not receive live vaccine whilst receiving IP and up to 30 days after the last dose of IP.
- Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 6 months after receiving the last dose of treatment combination or 3 months after receiving the last dose of durvalumab monotherapy.
- Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
- Prior randomisation or treatment in a previous durvalumab clinical study regardless of treatment arm assignment.
- Patients who have received prior anti-PD-1, anti PD-L1 or anti CTLA-4:
- Must not have experienced a toxicity that led to permanent discontinuation of prior immunotherapy.
- All AEs while receiving prior immunotherapy must have completely resolved or resolved to baseline prior to screening for this study.
- Must not have experienced a ≥Grade 3 immune related AE or an immune related neurologic or ocular AE of any grade while receiving prior immunotherapy. NOTE: Patients with endocrine AE of ≤Grade 2 are permitted to be enrolled if they are stably maintained on appropriate replacement therapy and are asymptomatic.
- Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab. The following are exceptions to this criterion:
- Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection
- Systemic corticosteroids at physiologic doses not to exceed <<10 mg/day>> of prednisone or its equivalent
- Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)
- Patients undergoing renal dialysis or with relevant chronic renal failure.
- Abnormal laboratory values as specified below:
- Haematology: Haemoglobin (< 8.5 g/dL), platelets (< 75,000/μL), leukocytes (< 2,500/μL), neutrophils (< 1,000/μL), lymphocytes (< 500/μL)
- Liver function: serum bilirubin (≥ 3 x ULN), Alanine aminotransferase (ALAT) or Aspartate aminotransferase (ASAT) (≥ 5 x ULN)
- Renal function: serum creatinine (≥ 1.5 x ULN)
- Patients with seizure disorder requiring medication (such as steroids or anti epileptics drugs).
- Encephalopathy.
- Clinically relevant ascites with the only exception of patients that remain free from symptomatic ascites under low-dose diuretics (Spironolactone >100 mg daily and Furosemide >40 mg daily).
- Hypersensitivity to the study drugs (IMA970A, Montanide or Durvalumab) including excipients and to CT/MRI contrast agent.
- Evidence of current alcohol or drug abuse.
- Serious intercurrent illness, which according to the investigator, poses an undue risk to the patient when participating in the trial, including, but not limited to, any of the following:
- Clinically significant cardiovascular disease (e.g., uncontrolled hypertension; clinically significant cardiac arrhythmia, clinically significant QT-prolongation)
- New York Heart Association class III-IV congestive heart failure
- Symptomatic peripheral vascular disease
- Severe pulmonary dysfunction
- Psychiatric illness or known social situation that would preclude study compliance
- Systemic inflammatory condition
- Less than 6 months since any of the following:
- Myocardial infarction
- Severe or unstable angina pectoris
- Coronary or peripheral artery bypass graft
- Cerebrovascular event incl. transient ischemic attack
- Pulmonary embolism / deep vein thrombosis (DVT)
- Any condition which in the judgment of the investigator would place the patient at undue risk or interfere with the results of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the 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
- Being tested
- Peptide-based hepatocellular carcinoma vaccine IMA970A, Durvalumab, Montanide (Adjuvant)
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peptide-based hepatocellular carcinoma vaccine IMA970ABiological
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.
DurvalumabCombination 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 group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | single-arm open-label Receives: Biological: Peptide-based hepatocellular carcinoma vaccine IMA970A; Combination Product: Durvalumab; Other: Montanide (Adjuvant) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
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.
Measured: 55 months (approximately 4.5 years)
Secondary outcomes (5)
Additional immunological parameters in blood (e.g. regulatory T-cells, myeloid derived suppressor cells)
The number of events and the frequency of several MDSC and Treg populations will be presented.
Measured: 55 months (approximately 4.5 years)
Infiltrating T-lymphocytes, immune cells and potential other (bio)markers in tumour tissue (depending on availability of tissue)
The number of events and the frequency of infiltrating T-lymphocytes (TILs), other immune cells and potential other (bio)markers will be presented.
Measured: 55 months (approximately 4.5 years)
DFS
Disease-free survival
Measured: 55 months (approximately 4.5 years)
PFS
progression-free survival
Measured: 55 months (approximately 4.5 years)
OS
Overall survival
Measured: Patients will be followed for overall survival every 2 months for up to 2 years after having completed the interventional part of the study at EOS.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2024
- Study start22 Nov 2022
- Primary completion28 Aug 2025
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open-label
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Naples
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paolo Antonio Ascierto, Principal investigator, IRCCS I.N.T. "G. Pascale"Francesco Izzo, Principal investigator, IRCCS I.N.T. "G. Pascale"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06218511
- Sponsor's protocol ID
- HEPAVAC 201
- Other IDs
- 46/22
- Status last verified
- Jul 2025
- First submitted
- 30 Oct 2023
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06218511
- Acronym / sponsor ID
- HEPAVAC 201
- Conditions
- Hepatocellular Carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- National Cancer Institute, NaplesUniversity, hospital or other
- Study start
- 22 Nov 2022 (actual)
- Primary completion
- 28 Aug 2025 (actual)
- Study completion
- Nov 2026 (estimated)
- First posted
- 23 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open-label
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Biological: Peptide-based hepatocellular carcinoma vaccine IMA970A, Combination Product: Durvalumab, Other: Montanide (Adjuvant)single-arm open-label |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (33 listed)
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Written informed consent and any locally required authorization (e.g., Health Insurance Portability and Accountability Act in the US, European Union [EU] Data Privacy Directive in the EU) obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations.
- Age > 18 years at time of study entry.
- HLA type: HLA-A*02 and/or HLA-A*24 positive.
- Very early, early and intermediate stage (Barcelona Clinic Liver Cancer (BCLC) stage 0, A, B disease) hepatocellular carcinoma (HCC) diagnosed by biopsy or resected tissue (patho-histological diagnosis) or imaging findings (non-invasive criteria) following any standard treatment (e.g. hepatic resection, Radiofrequency Ablation / Percutaneous Ethanol injection (RFA/PEI), Transarterial chemoembolization (TACE) and SIRT) and without any evidence of active disease that warrant further treatment.
- Minimum life expectancy of 1 year.
Key exclusion criteria (57 listed)
- Patients should not enter the study if any of the following exclusion criteria are fulfilled:
- Any prior systemic anti-tumour treatment (including drug or treatment regimen, approved or experimental) within 2 weeks before study treatment administration.
- Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP. Note: Local surgery of isolated lesions for palliative intent is acceptable
- Liver transplanted patients; patients who are on the liver transplantation waiting list are not allowed to be enrolled.
- Concurrent enrolment in another clinical study, unless it is an observational (non interventional) clinical study or during the follow-up period of an interventional study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peptide-based hepatocellular carcinoma vaccine IMA970AIMA970A 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. | Biological | Single arm |
| Durvalumabanti-PD-L1 | Combination product | Single arm |
| 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 . | Other | Single arm |
Primary outcome
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Time frame: 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.
5 secondary outcomes
Additional immunological parameters in blood (e.g. regulatory T-cells, myeloid derived suppressor cells)
Time frame: 55 months (approximately 4.5 years)
Infiltrating T-lymphocytes, immune cells and potential other (bio)markers in tumour tissue (depending on availability of tissue)
Time frame: 55 months (approximately 4.5 years)
DFS
Time frame: 55 months (approximately 4.5 years)
PFS
Time frame: 55 months (approximately 4.5 years)
OS
Time frame: Patients will be followed for overall survival every 2 months for up to 2 years after having completed the interventional part of the study at EOS.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paolo Antonio Ascierto principal investigator
IRCCS I.N.T. "G. Pascale"
Francesco Izzo principal investigator
IRCCS I.N.T. "G. Pascale"
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Peptide-based hepatocellular carcinoma vaccine IMA970A, Durvalumab and Montanide (Adjuvant) in people with Hepatocellular Carcinoma, run by National Cancer Institute, Naples at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 33 inclusion and 57 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) (time frame: 55 months (approximately 4.5 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.