A Phase I/II clinical study of IMA970A plus CV8102 and Cyclophosphamide for patients with liver cancer

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 22

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 Patients for whom treatment for advanced disease (e.g. sorafenib) is indicated will be withdrawn from study treatment.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 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

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
12. History of other malignancies within the last 3 years except for adequately treated cervical carcinoma in situ, basal cell carcinoma and, superficial bladder tumors [Ta, Tis & T1] or any cancer curatively treated > 3 years prior to signing of IC 2 by the patient

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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