E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with Stage III/IV Malignant Melanoma |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To Evaluate safety, tolerability, and immunogenicity of 2 vaccination regimens of CYT004-MelQbG10 in patients with malignant melanoma. |
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E.2.2 | Secondary objectives of the trial |
To assess T cell functionality and to monitor disease progression of CYT004-MelQbG10 vaccinated patients with malignant melanoma. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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
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E.4 | Principal 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)
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E.5 End points |
E.5.1 | 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
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Yes |
E.7.1.1 | First administration to humans | Yes |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |