E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Metastatic or Unresectable Melanoma that is Previously Untreated |
Melanoma irresecable o metastasico no tratado previamente |
|
E.1.1.1 | Medical condition in easily understood language |
Advanced Melanoma |
Melanoma avanzado |
|
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 | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10027481 |
E.1.2 | Term | Metastatic 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 |
To compare PFS of BMS-986205 combined with nivolumab to nivolumab monotherapy in participants with unresectable or metastatic melanoma that is previously untreated
To evaluate -DOR and TTR of BMS- 986205 combined with nivolumab vs nivolumab monotherapy in participants with unresectable or metastatic melanoma that is previously untreated -PFS of BMS-986205 combined with nivolumab vs nivolumab monotherapy in participants with unresectable or metastatic melanoma that is previously untreated in key subgroups of participants, defined by demographic and disease characteristics (including selected biomarkers such as PD-L1) -changes in quality of life in treatment groups as assessed by the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30
To assess the overall safety and tolerability of BMS-986205 in combination with nivolumab |
Comparar la SLP de BMS-986205 en combinación con nivolumab con la de nivolumab en monoterapia en participantes con melanoma irresecable o metastásico previamente no tratado Evaluar la DdR y el THR de BMS-986205 combinado con nivolumab frente a nivolumab en monoterapia en participantes con melanoma irresecable o metastásico que no han recibido tratamiento previo Evaluar la SLP de BMS-986205 en combinación con nivolumab frente a la de nivolumab en monoterapia en participantes con melanoma irresecable o metastásico que no ha sido tratado previamente en subgrupos clave de participantes, definidos por características demográficas y de la enfermedad (incluidos biomarcadores seleccionados como PD-L1) Evaluar los cambios en la calidad de vida en los brazos de tratamiento evaluados por el QLQ-C30 de la Organización Europea para la Investigación y el Tratamiento del Cáncer (EORTC) Evaluar la seguridad y la tolerabilidad globales de BMS-986205 en combinación con nivolumab |
|
E.2.2 | Secondary objectives of the trial |
To compare ORR of BMS-986205 combined with nivolumab to nivolumab monotherapy in participants with unresectable or metastatic melanoma that is previously untreated |
Comparar la TRO de BMS-986205 en combinación con nivolumab con la de nivolumab en monoterapia en participantes con melanoma irresecable o metastásico previamente no tratado |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 1 - Histologically confirmed Stage III (unresectable) or Stage IV melanoma, per the American Joint Committee on Cancer (AJCC) Staging Manual (8th edition) - Treatment-naïve participants (no prior systemic anticancer therapy for unresectable or metastatic melanoma) - Measurable disease |
• Al menos una lesión medible mediante tomografía computerizada (TC) o resonancia magnética (RM) según los Criterios de Evaluación de la Respuesta en Tumores Sólidos (RECIST) v1.1 • Melanoma confirmado histológicamente, en estadio III (irresecable) o en estadio IV, según el Manual de Estadificación del American Joint Committee on Cancer (AJCC) (8ª edición) • Participantes sin tratamiento previo (esto es, ningún tratamiento oncológico sistémico previo para melanoma irresecable o metastásico). • Enfermedad apreciable |
|
E.4 | Principal exclusion criteria |
- Active brain metastases or leptomeningeal metastases - Uveal or ocular melanoma - Participants with active, known, or suspected autoimmune disease - Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured |
Metástasis cerebrales activas o metástasis leptomeníngeas Melanoma de úvea u ocular Participantes con enfermedad autoinmune activa, conocida o sospechada Malignidad activa previa en los 3 años previos excepto por cánceres localmente curables que aparentemente se han curado |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Progression Free Survival (PFS) of BMS-986205 combined with nivolumab to nivolumab monotherapy |
SLP de BMS-986205 en combinación con nivolumab frente a la de nivolumab en monoterapia |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Up to 19 months |
hasta 19 meses |
|
E.5.2 | Secondary end point(s) |
1/ Overall Response Rate (ORR) of BMS-986205 combined with nivolumab to nivolumab monotherapy 2/ Overall Survival (OS) of BMS-986205 combined with nivolumab to nivolumab monotherapy 3/ Duration of response (DOR) of BMS-986205 combined with nivolumab vs nivolumab monotherapy 4/ Time to objective response (TTR) 5/ PFS in subgroups defined by demographic and disease characteristics 6/ Changes in Quality of Life 7/ Percentage of subjects with adverse events |
1 / Tasa de respuesta global (TRG) de BMS-986205 combinada con nivolumab a monoterapia con nivolumab 2 / Supervivencia global (SG) de BMS-986205 combinado con nivolumab a monoterapia con nivolumab 3 / Duración de la respuesta (DOR) de BMS-986205 combinada con nivolumab vs monoterapia con nivolumab 4 / Tiempo hasta la respuesta objetiva (TRO) 5 / SLP en subgrupos definidos por características demográficas y de enfermedad 6 / Cambios en la calidad de vida 7 / Porcentaje de sujetos con eventos adversos |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1/ Up to 19 months 2/ Up to three years 3/ Up to 19 months 4/ Up to 19 months 5/ Up to 19 months 6/ Up to 19 months 7/ Up to 19 months |
hasta 19 meses hasta 3 años hasta 19 meses hasta 19 meses hasta 19 meses hasta 19 meses hasta 19 meses |
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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 | No |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | No |
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 | 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 | 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 | 61 |
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 |
Australia |
Brazil |
Canada |
Chile |
Czech Republic |
France |
Germany |
Greece |
Ireland |
Israel |
Italy |
Mexico |
Netherlands |
New Zealand |
Poland |
Romania |
Russian Federation |
Spain |
Switzerland |
United Kingdom |
United States |
|
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
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | 20 |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 11 |
E.8.9.2 | In all countries concerned by the trial days | 27 |