Very early, early and intermediate stage hepatocellular carcinoma MedDRA version: 20.0 Level: LLT Classification code 10049010 Term: Carcinoma hepatocellular System Organ Class: 100000004864
Conditions
Interventions
Product Name: IMA970A
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Not known yet
Current Sponsor code: IMA970
Other descriptive name: IMA970
Concentration unit: mg milli
Sponsors
Istituto Nazionale Tumori G. "Pascale"
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged at least 18 years 2. HLA type: HLA-A*02 and/or HLA-A*24 positive (Screening 1) 3. 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 (pathohistological diagnosis), or imaging findings (non-invasive criteria) following any standard treatment (e.g. hepatic resection, RFA/PEI, TACE, and SIRT) and without any evidence of active disease that warrant further treatment 4. Patients for whom no standard anti-tumor therapy is indicated for the next 3 months (until after visit 7); thereafter any standard anti-tumor 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 Patients for whom treatment for advanced disease (e.g. sorafenib) is indicated will be withdrawn from study treatment. 5. Eastern Cooperative Oncology Group (ECOG) performance status 0 6. Child-Pugh A5-6 and B7 disease or no liver function impairment Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 28 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 12
Exclusion criteria
Exclusion criteria: 1. Any prior systemic anti-tumor treatment (including drug or treatment regimen, approved or experimental) within 2 weeks before CY application 2. Liver transplanted patients; patients who are on the liver transplantation waiting list are allowed to be enrolled 3. Patients with a history or evidence of systemic autoimmune disease, e.g. rheumatoid arthritis, multiple sclerosis, systemic lupus erythematodes (SLE), scleroderma, Sjögren's syndrome, Wegener's granulomatosis, Guillain-Barre syndrome 4. 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 5. Any medically diagnosed or suspected condition of immunodeficiency or medical history thereof 6. Known HIV infection 7. Acute and active infections requiring oral or intravenous antibiotics, antiviral or antifungal therapy within 30 days prior to signing of the IC 2 by the patient (exception: HBV and / or HCV infections; direct-acting antivirals may be applied as medically indicated) 8. Patients undergoing renal dialysis or with relevant chronic renal failure 9. Abnormal laboratory values as specified 10. 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). 11. Evidence of current alcohol or drug abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the present phase I/II study is to investigate whether treatment with IMA970A plus CV8102 following a single pre-vaccination infusion of cyclophosphamide (CY) is safe and tolerable, and able to induce a T-cell response in very early, early and intermediate stage hepatocellular carcinoma (HCC) patients after any standard treatment and without any evidence of active disease that warrant further treatment.;Secondary Objective: Secondary/exploratory objectives are the investigation of additional immunological parameters, infiltrating T-lymphocytes, immune cells and potential other (bio)markers in tumor tissue, influence of standard therapy on natural immune response to IMA970A, time to progression and overall survival.;Primary end point(s): The primary endpoints of the study are safety and tolerability, and immunogenicity (T-cell response in peripheral blood).;Timepoint(s) of evaluation of this end point: Safety and Tolerability: continuous full safety surveillance between S2 and EOV visit. Limited safety surveillance between S1 and S2 and during the non-interventional follow-up starting after EOV Visit. Immunogenicity: PBMCs for immunogenicity assessment will be drawn at visits S1, S2, C, 4, 5, 6, 7, 9, EOV. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Additional immunological parameters in blood (e.g. regulatory T-cells, myeloid-derived suppressor cells) • Infiltrating T-lymphocytes, immune cells and potential other (bio)markers in tumor tissue (depending on availability of tissue) • Assessment of the potential impact of the standard therapy on the natural immune response to peptides contained in IMA970A • Time to progression (TTP) • Overall survival (OS);Timepoint(s) of evaluation of this end point: Additional immunological parameters in blood: PBMCs for immunogenicity assessment will be drawn at visits S1, S2, C, 4, 5, 6, 7, 9, EOV. Infiltrating T-lymphocytes: depending on availability of tumor tissue Assessment of potential impact of standard therapy: S1 and S2 TTP: S1, S2, V7, EOV visit OS: continues capture until end-of-trial. | — |
Countries
Belgium, Germany, Italy, Spain
Contacts
Public ContactClinical Trial Information
HepaVac Consortium @ Istituto Nazionale Tumori G. "Pascale"
Outcome results
None listed