E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10027481 |
E.1.2 | Term | Metastatic melanoma |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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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 purpose of this study is to determine whether giving ipilimumab at a dose of 10 mg/kg will extend the lives of subjects with unresectable or metastatic melanoma more than giving ipilimumab at a dose of 3 mg/kg |
Lo scopo dello studio e' determinare se la somministrazione di ipilimumab alla dose di 10 mg/kg prolunga la vita dei soggetti con melanona non resecabile o metastatico maggiormente rispetto a ipilimumab somministrato al dosaggio di 3 mg/kg. |
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E.2.2 | Secondary objectives of the trial |
Efficacy: To compare progression-free survival between doses of 3 mg/kg and 10 mg/kg by mWHO criteria; To compare best overall response rate between doses of 3 mg/kg and 10 mg/kg by mWHO criteria; To compare disease control rate between doses of 3 mg/kg and 10 mg/kg by mWHO criteria; To evaluate duration of response and stable disease for the of 3 mg/kg and 10 mg/kg dose groups by mWHO criteria; To evaluate the OS in each of the two dosing groups in the subset of subjects with brain metastases. |
Efficacia: Paragonare la sopravvivenza libera da progressione tra i dosaggi 3 mg/Kg e 10 mg/Kg tramite i criteri mWHO; Paragonare la velocità di risposta migliore complessiva tra i dosaggi 3 mg/Kg e 10 mg/Kg tramite i criteri mWHO; Paragonare la velocità di controllo della malattia tra i dosaggi 3 mg/Kg e 10 mg/Kg tramite i criteri mWHO; Valutare la durata della risposta e della stabilità di malattia per i gruppi con dosaggio di 3 mg/Kg e 10 mg/Kg tramite i criteri mWHO; Valutare la sopravvivenza complessiva (OS) in ciascuno dei due gruppi di dosaggio nel sottoinsieme dei soggetti con metastasi cerebrali. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Unresectable Stage III or Stage IV melanoma; ECOG PS 0 or 1. |
Melanoma non resecabile di Stadio III o melanoma di Stadio IV; ECOG PS 0 o 1. |
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E.4 | Principal exclusion criteria |
Brain metastases with symptoms or requiring treatment; History of automimmune disease. |
Metastasi Cerebrali con sintomi o che richiedono un trattamento; Storia di malattia autoimmune. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Overall Survival will be assessed. |
Sarà valutata la Sopravvivenza Complessiva. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Dopo che si sono verificati 540 eventi di decesso (analisi ad interim dopo che si sono verificati 360 eventi di decesso). |
Dopo che si sono verificati 540 eventi di decesso (analisi ad interim dopo che si sono verificati 360 eventi di decesso). |
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E.5.2 | Secondary end point(s) |
Progression Free Survival; Best Overall Response Rate; Disease Control Rate; Duration of Response; Duration of Stable Disease. |
Malattia libera da progressione; Velocità di risposta migliore complessiva; Velocità di controllo della malattia; Durata della risposta; Durata della stabilità di malattia. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
After 540 deaths have occurred (at the same time as the primary analysis). |
Dopo che si sono verificati 540 eventi di decesso (nello stesso momento dell’analisi primaria). |
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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 | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
HRQoL questionnaires, Biomarker Measures (ALC, CRP, ...) |
Questionari Qualità di vita legata alla salute,MisureBiomarcatori(Conta assol. Linfoc.,Prot.C reat.) |
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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) | 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 | 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 | Yes |
E.8.2.3.1 | Comparator description |
confronto tra due dosi di ipilimumab(3 e 10 mg/Kg) |
comparison of two doses of ipilimumab(3and10mg/Kg) |
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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
| No |
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 | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 58 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Argentina |
Australia |
Brazil |
Canada |
Chile |
Colombia |
Israel |
Mexico |
Russian Federation |
South Africa |
Switzerland |
Turkey |
United States |
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E.8.7 | Trial has a data monitoring committee | Yes |
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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The study will conclude when survival data on the last subject has been obtained or the study is otherwise terminated by the Sponsor. The last visit is defined as the last follow-up visit. |
Lo studio si concluderà quando si ottengono i dati di sopravvivenza dell'ultimo soggetto o fino a che lo studio viene dichiarato concluso dallo sponsor. L'ultima visita è definita come l'ultima visita di Follow-up. |
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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 | 0 |
E.8.9.1 | In the Member State concerned months | 66 |
E.8.9.1 | In the Member State concerned days | 15 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 66 |
E.8.9.2 | In all countries concerned by the trial days | 15 |