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 |
El propósito de este estudio es determinar si la supervivencia global de pacientes con melanoma irresecable o metastásico tratados con ipilimumab a dosis de 10 mg/kg será mayor que en pacientes que reciban ipilimumab a dosis de 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 |
Eficacia: -Comparar la supervivencia libre de progresión entre dosis de 3 mg/kg y 10 mg/kg mediante los criterios de la OMSm -Comparar la tasa de mejor respuesta global entre las dosis de 3 mg/kg y 10 mg/kg según los criterios de la OMSm - Comparar la tasa de control de la enfermedad entre las dosis de 3 mg/kg y 10 mg/kg según los criterios de la OMSm - Evaluar la duración de la respuesta y la enfermedad estable en los grupos de dosis de3 mg/kg y 10 mg/kg según los criterios de la OMSm - Evaluar la SG en cada uno de los dos grupos de dosis en el subgrupo de sujetos con metástasis cerebrales |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
(1) Pharmacogenetics Blood Sample Amendment Number 01 - Site Specific The objective of this Amendment is to permit the collection and storage of blood samples for use in future exploratory pharmacogenetic research. Bristol-Myers Squibb will use DNA obtained from the blood sample and health information collected from the main clinical trial, CA184169 to study the association between genetic variation and drug response. Bristol-Myers Squibb may also use the DNA to study the causes and further progression of melanoma and other oncologic diseases. Samples from this study may also be used in conjunction with pharmacogenetic research results from other clinical studies to accomplish this objective. |
(1)Enmienda sobre muestras de sangre para farmacogenética Número 01 - Específica de centro El objetivo de esta enmienda es permitir la recogida y la conservación de muestras de sangre para uso en estudios de investigación farmacogenética exploratorios futuros. Bristol-Myers Squibb usará el ADN obtenido de la muestra de sangre y la información de salud recogida del cuaderno de recogida de datos del ensayo clínico principal, CA184169, para estudiar la asociación entre la variación genética y la respuesta a los medicamentos. Bristol-Myers Squibb también puede usar el ADN para estudiar las causas y progresión adicional del melanoma y otras enfermedades oncológicas. Para conseguir este objetivo pueden usarse conjuntamente muestras de este y otros estudios de investigación farmacogenética |
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E.3 | Principal inclusion criteria |
? Unresectable Stage III or Stage IV melanoma ? ECOG PS 0 or 1 |
-Melanoma estadio III irresecable o estadio IV -Estado funcional del ECOG de 0 ó 1 |
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E.4 | Principal exclusion criteria |
? Brain metastases with symptoms or requiring treatment ? History of automimmune disease |
? Metástasis cerebrales activas con síntomas o que precisan tratamiento ?Antecedentes de enfermedades autoinmunitarias, |
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E.5 End points |
E.5.1 | Primary end point(s) |
Overall Survival will be assessed |
Evaluar la supervivencia global |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
After 540 deaths events have occurred (interim analysis after 360 deaths have occured) |
Después de 540 muertes (se hará un análisis preliminar cuando se hayan producido 360 muertes) |
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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 |
-Comparar la supervivencia libre de progresión -Comparar la tasa de mejor respuesta global -Comparar la tasa de control de la enfermedad -Duración de respuesta -Duración de enfermedad estable |
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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 ) |
Después de 540 muertes (se hará un análisis preliminar cuando se hayan producido 360 muertes) |
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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, ...) |
cuestionarios de calidad de vida (relacionados con la salud), medida de biomarcadores (recuento absoluto de linfocitos, proteína C reactiva, etc) |
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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 |
Comparacion entre dos dosis de ipilimumab (3 and 10 mg/kg) |
comparison of two doses of ipilimumab (3 and 10 mg/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 | 5 |
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 |
Austria |
Belgium |
Brazil |
Canada |
Chile |
Colombia |
Czech Republic |
Denmark |
France |
Germany |
Hungary |
Israel |
Italy |
Mexico |
Netherlands |
Norway |
Poland |
Russian Federation |
South Africa |
Spain |
Sweden |
Switzerland |
Turkey |
United Kingdom |
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. |
El estudio concluirá cuando se haya obtenido información de supervivencia del último paciente o finalizado por el Sponsor. La última visita se define como la última visita de seguimiento |
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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 | 5 |
E.8.9.1 | In the Member State concerned months | 5 |
E.8.9.1 | In the Member State concerned days | 21 |
E.8.9.2 | In all countries concerned by the trial years | 5 |
E.8.9.2 | In all countries concerned by the trial months | 5 |
E.8.9.2 | In all countries concerned by the trial days | 21 |