E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patient with a histologically confirmed stage IIc, IIIb or IIIc primary cutaneous melanoma or unknown primary (AJCC staging). |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the vaccine specific immune response in patients following treatment with IDD-3, with or without PegIFN-alfa 2b |
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E.2.2 | Secondary objectives of the trial |
To assess the safety of IDD-3 vaccination and to estimate the median disease free survival in patients following treatment with IDD-3, with or without PegIFN-alfa 2b. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
- Age >= 18 years old
- Patient with a histologically confirmed stage IIc, IIIb or IIIc primary cutaneous melanoma or unknown primary (AJCC staging). All patients must fulfill one of the criteria below: - Thick (>4.0mm), ulcerated melanoma (stage IIc) - Ulcerated primary melanoma with one or more involved lymph nodes (micro or macro) (T1-4b, N1a/b, N2a/b disease) - Non-ulcerated melanoma with one or more macro lymph node metastasis and/or matted nodes (T1-4a, N1b, N2b disease) - Any satellite/in-transit metastasis with or without lymph node involvement - Nodal recurrence after resection of regional primary melanoma - Nodal recurrence in the basin of a previously complete lymphadenectomy or satellite/in-transit recurrence after previous complete lymphadenectomy
- Patients are eligible for this trial either at initial presentation of their melanoma or at the time of the first clinically detected nodal or satellite/in-transit recurrence - Patients must have been surgically rendered free of disease with pathologically negative margins on resected specimens. - Patients must be randomized no longer than 56 days (8 weeks) after final surgical resection.
- Life expectancy >= 12 months - ECOG performance status 0-1 - Women of child bearing potential and fertile men are required to use effective contraception for the duration (negative bHCG for women of child-bearing age) |
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E.4 | Principal exclusion criteria |
- Prior therapy with IFN-a or Peg-interferon a - Prior vaccine therapy with one or more melanoma antigens or peptides (with the exception of the GM2 vaccine) - Positive serology (HIV 1 & 2, HTLV-I and II, hepatitis B, hepatitis C, syphilis) - Other significant medical or surgical condition (including history of severe pre existing cardiac disease, chronic renal failure or severe hepatic dysfunction), or any medication or treatment regimens, that would interfere with study participation - Contraindication to apheresis - Presence of another concurrent malignancy. Prior malignancy in the last 5 years except adequately treated basal or squamous cell skin cancer or carcinoma in situ of the cervix - Active bacterial, viral or fungal infection within 72 hours of study entry - History of autoimmune disease or immunodeficiency syndrome, except vitiligo - Immunosuppressive treatment within 4 weeks prior to study entry, or anticipated use of immunosuppressives. Inhaled steroid are permitted. - Use of another investigational product within 4 weeks prior to study entry - Pregnant women or nursing women - History of significant psychiatric problems - Epilepsy and/or compromised CNS function - Diabetes milletus or hyperglycemia not effectively treated by medication - Hypersensitivity to PEG-interferon a or any other component of product. - Known hypersensitivity to any of the components of the study drugs (e.g. DMSO) |
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E.5 End points |
E.5.1 | Primary end point(s) |
Immune response: The induction or increase of immune responses to lysate, as well as tumor associated antigens will be assessed. This includes T cell responses to lysate and tumor-associated antigen (TAA)-derived peptides |
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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 | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
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 | No |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
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 | 24 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 24 |