E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
melanoma patients with regional lymph node metastases (stage III) |
melanoom patiënten met regionale lymfeklier metastasen (stadium III) |
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E.1.1.1 | Medical condition in easily understood language |
regionally metastasised skin cancer |
regionaal gemetastaseerde huidkanker |
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E.1.1.2 | Therapeutic area | Diseases [C] - Skin and Connective Tissue Diseases [C17] |
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 |
The primary objective of this study is to determine whether adjuvant nDC vaccination improves 2-year RFS rate as compared to placebo in patients with completely resected stage IIIB or IIIC melanoma. Based on previous results on adjuvant DC vaccination in stage IIIB and IIIC melanoma patients, we expect that 70% of the DC vaccinated patients will remain recurrence free for 2 years. The anticipated 2-year RFS rate of the control arm is 50%. |
De primaire uitkomstmaat is het bepalen of adjuvante nDC toediening the 2-jaars recidiefvrije overleving verbetert ten opzichte van placebo in compleet gereseceerde stadium IIIB en IIIC melanoom patiënten. Op basis van onze eerdere onderzoeksresultaten verwachten we dat 70% van de patiënten in arm A (nDC toedieningen) recidiefvrij is na 2 jaar en 50% in arm B (placebo). |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives are to compare the median RFS, 2-year and median overall survival, adverse events profiles (safety), immunological responses, quality of life and health economic aspects of nDC vaccination versus placebo. |
De secundaire uitkomstmaten zijn totale overleving, de veiligheid, de immunologische responsen, de kwaliteit van leven en kosten van de zorg. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Histologically confirmed, completely resected stage III cutaneous melanoma, classified as stage IIIB or IIIC disease (AJCC 2009). - Radical lymph node dissection must be performed within 12 weeks prior to start of study. - Absence of distant metastases
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- Histologisch bewezen, volledig gereseceerd stadium IIIB of IIIC huid melanoom (AJCC 2009). - Lymfe klierdissectie verricht binnen 12 weken voor start van de studie - Afwezigheid van afstandsmetastasen.
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E.4 | Principal exclusion criteria |
- No concomitant use of immunosuppressive drugs orally or intravenously. Topical and intranasal steroids are permitted. - No uncontrolled infectious disease - No autoimmune disease. Patients with type 1 diabetes mellitus, hypothyroidism after autoimmune thyroiditis and skin disorders are not excluded.
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- Geen gebruik van immuunonderdrukkende intraveneuze of orale medicatie. Cutane en intranasale steroiden zijn toegestaan. - Geen ongecontroleerde infectieuze ziekten. - Geen autoimmuunziekten. Type 1 diabetes mellitus, hypothyreoidie ten gevolge van autoimuun thyreoiditis en huidafwijkingen zijn geen exclusie criteria. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary objective of this study is to determine whether adjuvant nDC vaccination improves 2-year RFS rate as compared to placebo in patients with completely resected stage IIIB or IIIC melanoma. Based on previous results on adjuvant DC vaccination in stage IIIB and IIIC melanoma patients, we expect that 70% of the DC vaccinated patients will remain recurrence free for 2 years. The anticipated 2-year RFS rate of the control arm is 50%. |
De primaire uitkomstmaat is het bepalen of adjuvante nDC toediening the 2-jaars recidiefvrije overleving verbetert ten opzichte van placebo in compleet gereseceerde stadium IIIB en IIIC melanoom patiënten. Op basis van onze eerdere onderzoeksresultaten verwachten we dat 70% van de patiënten in arm A (nDC toedieningen) recidiefvrij is na 2 jaar en 50% in arm B (placebo). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
The secondary objectives are to compare the median RFS, 2-year and median overall survival, adverse events profiles (safety), immunological responses, quality of life and health economic aspects of nDC vaccination versus placebo. |
De secundaire uitkomstmaten zijn totale overleving, de veiligheid, de immunologische responsen, de kwaliteit van leven en kosten van de zorg. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Safety: during the whole trial Quality of life + costs questionnaires: every 3-12 months Survival: during whole trial |
Veiligheid: gedurende de hele studie Kwaliteit van leven vragenlijsten en kosten: elke 3-12 maanden Overleving: gedurende de gehele studie |
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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 | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | Yes |
E.6.13 | Others | No |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
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 | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
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 | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
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 | No |
E.8.7 | Trial has a data monitoring committee | No |
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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LVLS |
Laatste visite van laatste patient |
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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 | 8 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |