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 | 10053571 |
E.1.2 | Term | Melanoma |
E.1.2 | System Organ Class | 100000004864 |
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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 compare the clinical benefit, as measured by duration of overall survival, of BMS-936558 vs. Dacarbazine in subjects with previously untreated, unresectable or metastatic melanoma |
Objetivo principal es comparar el beneficio clínico, medido por la duración de la SG, aportado por BMS-936558 frente a dacarbacina en sujetos con melanoma irresecable o metastásico, no tratado previamente. |
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E.2.2 | Secondary objectives of the trial |
- Investigator-assessed progression-free survival - Investigator-assessed objective response rate - Overall survival based on PD-L1 expression levels - Changes from baseline in the EORTC QLQ-C30 global health status/QoL composite scale. |
Comparar la duración de la supervivencia libre de progresión (SLP) Comparar la tasa de respuestas objetivas (TRO) Evaluar si la expresión de PD-L1 es un biomarcador predictivo de la SG Evaluar la calidad de vida relacionada con la salud (CdVRS) evaluada mediante el QLQ-C30 de la Organización Europea para la Investigación y el Tratamiento del Cáncer (EORTC). |
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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 |
Pharmacogenetics Blood Sample Amendment Number 01 - Site Specific, dated 20-Sep-2012.
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, CA209066 to study the association between genetic variation and drug response. |
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, CA209066, para estudiar la asociación entre la variación genética y la respuesta a los medicamentos |
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E.3 | Principal inclusion criteria |
Key Inclusion Criteria: - Men and women > or = 18 years of age. - Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. - Untreated, histologically confirmed unresectable Stage III or Stage IV melanoma, as per AJCC staging system. - Measurable disease as per RECIST 1.1. - Recently acquired (within 90 days prior to randomization) tumor tissue from an unresectable or metastatic site of disease must be provided for biomarker analyses. - Known BRAF wild-type as per regionally acceptable V600 mutational status testing. BRAF mutant subjects and those with indeterminate or unknown BRAF status are not permitted to enroll. |
-Varones y mujeres ?=18 años. -Estado funcional del Eastern Cooperative Oncology Group (ECOG) de 0 ó 1. -Melanoma en estadio III o IV según el sistema de estadificación del AJCC, confirmado histológicamente, irresecable, no tratado. -Enfermedad medible según los RECIST 1.1. -Debe proporcionarse tejido tumoral adquirido recientemente (dentro de los 90 días anteriores a la aleatorización) de una localización de enfermedad irresecable o metastásica para los análisis de biomarcadores. Para ser aleatorizado, un sujeto debe ser clasificado como PD-L1 positivo, PD-L1 negativo o PD-L1 indeterminado. -BRAF natural conocido según pruebas de estado de mutación de V600 aceptables regionalmente. No se permite la inclusión de sujetos con mutación de BRAF ni de aquellos con estado de BRAF indeterminado o desconocido. |
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E.4 | Principal exclusion criteria |
Key Exclusion Criteria: - Active brain metastases or leptomeningeal metastases. - Ocular melanoma. - Any active, known or suspected autoimmune disease. |
Criterios de exclusión fundamentales: ? Metástasis cerebrales activas o metástasis leptomeníngeas. ? Melanoma ocular. ? Sujetos con enfermedad autoinmunitaria activa, conocida o de sospecha. |
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E.5 End points |
E.5.1 | Primary end point(s) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
From the beginning of randomization period up to date of event (expected to be no more than 5 years) |
Desde el comienzo de la randomización hasta la fecha del evento (se espera que no más de 5 años) |
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E.5.2 | Secondary end point(s) |
- Investigator-assessed progression-free survival - Investigator-assessed objective response rate - Overall survival based on PD-L1 expression levels - Changes from baseline in the EORTC QLQ-C30 global health status/QoL composite scale. |
Comparar la duración de la supervivencia libre de progresión (SLP) Comparar la tasa de respuestas objetivas (TRO) Evaluar si la expresión de PD-L1 es un biomarcador predictivo de la SG Evaluar la calidad de vida relacionada con la salud (CdVRS) evaluada mediante el QLQ-C30 de la Organización Europea para la Investigación y el Tratamiento del Cáncer (EORTC). |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Baseline, Week 9, every 6 weeks thereafter for the first 12 months, and then every 12 weeks until disease progression is documented (expected to be no more than 5 years)
Baseline, Week 9, every 6 weeks thereafter for the first 12 months, and then every 12 weeks until disease progression is documented (expected to be no more than 5 years)
From the beginning of randomization period up to date of event (expected to be no more than 5 years)
Baseline, every 6 weeks, and during follow-up (30 days after last dose, 100-114 days after last dose, and then every 3 months) (expected to be no more than 5 years) |
Visita Basal :semana 9, cada 6 semanas, durante los primeros 12 meses y luego cada 12 semanas hasta la progresión o la suspensión del tratamiento, lo que ocurra más tarde. Desde el comienzo de la randomización hasta la fecha del evento (se espera que no más de 5 años) Visita Basal :cada 6 semanas y durante la fase de seguimiento (30 dias despues de la ultima dosis y despues cada 3 meses ) (no mas de 5 años) |
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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 | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Yes |
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 |
Biomarker Assessments, Outcomes Research Assessments, Immunogenicity Assessments |
Evaluaciones de biomarcadores, evaluaciones de los resultados de investigación,Las evaluaciones de inmunogenicidad |
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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) | Yes |
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
| 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 | 45 |
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 |
Canada |
Chile |
Denmark |
Finland |
France |
Germany |
Israel |
Italy |
Mexico |
New Zealand |
Norway |
Poland |
Spain |
Sweden |
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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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LVLS |
ultima visita del ultimo paciente |
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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 | 7 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 7 |
E.8.9.2 | In all countries concerned by the trial months | 6 |