Patients with Stage III/IV Malignant Melanoma
Conditions
Interventions
Product Name: CYT004-MelQbG10
Product Code: CYT004-MelQbG10
Pharmaceutical Form: Solution for injection
Current Sponsor code: CYT004-MelQbG10
Concentration unit: µg microgram(s)
Concentration type: eq
Sponsors
Cytos Biotechnology AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Able to provide written informed consent - Able to complete all protocol requirements - Age: 18 years and older - Histologically confirmed stage III or IV melanoma (per American Joint Committee on - HLA-A*0201 haplotype (serological and genomic typing) - Expected survival of at least 6 months - ECOG performance status of 0 or 1 - At least one and no more than two previous systemic therapies for metastatic melanoma. - Adequate organ and bone marrow functions - All AEs from prior anticancer therapy have resolved to >= Grade 1 -Sexually active males should use adequate contraception throughout the study and 3 months therafter - Females of child bearing potential should use adequate contraception that can be oral contraception or a double-barrier local contraception (intra-uterine device plus condom or spermicidal gel plus condom) and have a negative serum pregnancy test within 4 weeks prior to the first dose of the vaccine 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Pregnant or nursing - Use of an investigational drug within 30 days before enrolment - Known or suspected brain metastases - Current use of an immunosuppressive drug or any concomitant medication that could potentially interfere with the study drug - Presence of significant cardiovascular, renal, pulmonary, endocrine, infectious, or neurological disorders - Serum tests positive for HIV, HBV, HCV - Active autoimmune diseases or severe allergies - Current diagnosis or history of relevant and severe psychiatric disorder - Blood donation or loss of >400mL within 8 weeks prior to inclusion - Abuse of alcohol or other recreational drugs.- Smokers consuming >20 cigarettes per day - Previous participation in a clinical trial with a Qb based vaccine (DerQb, NicQb, TNFQb, AngQb, GhrQb, QbG10, AllQbG10)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To Evaluate safety, tolerability, and immunogenicity of 2 vaccination regimens of CYT004-MelQbG10 in patients with malignant melanoma. ;Secondary Objective: To assess T cell functionality and to monitor disease progression of CYT004-MelQbG10 vaccinated patients with malignant melanoma.;Primary end point(s): Safety and tolerability - Adverse events - Physical examination - ECG recordings - Vital signs (blood pressure, heart rate, body temperature) - Routine hematology and blood chemistry analyses - Urinalyses (Stix: Density, pH, Leukocytes, Nitrite, Protein, Glucose, Keton, Urobilinogen, Bilirubin, Erythrocytes) - Autoantibodies - Injection site inspection Immunogenicity - T cell stimulation will be assessed by delayed-type hypersensitivity reactions (DTH) - T-cell frequency; relevant T cells by RT-PCR/PCR. - T-cell functionality - Melan-A specific antibodies (IgG) - Tumor-antigen expression Clinical efficacy - The status of the disease will be monitored by CT and/or US examinations | — |
Countries
Germany
Outcome results
None listed