E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
MELANOMA UVEAL METASTASICO |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 13 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10025650 |
E.1.2 | Term | Melanoma maligno |
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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 |
Determinar la eficacia de ipilimumab en monoterapia en el tratamiento de pacientes con melanoma uve |
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E.2.2 | Secondary objectives of the trial |
Evaluar la supervivencia libre de progresión, seguridad, efecto sobre el recuento total de linfocitos y sobre los autoanticuerpos |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Pacientes con confirmación histológica de melanoma uveal metastásico. 2. Enfermedad en progresión definida como aparición de nuevas lesiones o incremento del tamaño de las existentes. 3. No tratamiento previo para melanoma uveal metastásico. 4. Edad superior o igual a 18 años. 5. ECOG 0 1. 6. Enfermedad medible definida por criterios mWHO. 7. Capacidad para firmar consentimiento informado. 8. Adecuada función organos vitales definidos por neutrófilos >1.5 x 109/L; plaquetas >100 x 109/L; Hb >9 g/dL; creatinina <1.5 x limite mayor de referencia del laboratorio; AST y ALT <2.5 x limite mayor de referencia del laboratorio o <5 si las alteraciones hepáticas son debidas a afectación metastásica hepática; bilirrubina <2.0 x limite mayor de referencia del laboratorio. |
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E.4 | Principal exclusion criteria |
1. Tratamiento previo con agonistas de CD137, inhibidores de CTLA-4 o quimioterapia previa para el tratamiento de melanoma uveal metastásico. 2. Presencia de metástasis cerebrales o leptomeníngeas a menos que se hayan tratado previamente, sean asintomáticas y no hayan requerido tratamiento esteroideo durante las últimas 4 semanas. 3. Mujeres embarazadas o en periodo de lactancia. 4. Enfermedades autoinmunes previas que no sea vitíligo o hipotiroidismo controlado con tratamiento. 5. Enfermedad inflamatoria intestinal u otra afectación crónica intestinal que curse con diarrea. 6. Neuropatía motora considerada de origen autoinmune (p.e. Guillain-Barre). 7. Infección activa. 8. Problemas generales, medicos o psicologicos que impidan dar su consentimiento informado o cumplir con el protocolo. 9. Tratamiento con otras drogas experimentales en las ultimas 4 semanas previas a la inclusión en el estudio. 10. Antecedentes de otras enfermedades neoplásicas en los últimos 5 años con excepción de tumores cutaneos no melanoma, carcinoma superficial de vejiga, carcinoma in situ de cervix o carcinoma de prostata incidental. 11. Uso crónico de inmunosupresores y/o corticoides sistémicos. 12. Uso de vacunas no-oncológicas para prevención de enfermedades infecciosas en las últimas 4 semanas previas a la inclusión en el estudio. |
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E.5 End points |
E.5.1 | Primary end point(s) |
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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 | No |
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 |
RECUENTO LINFOCITOS-EFECTO ANTITUMORAL |
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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 | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
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 | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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 | 3 |
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 | 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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será 18 meses tras la primera visita del último paciente o 6 meses tras la última visita del último paciente (lo que ocurra primero). |
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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 | 3 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |