E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Subjects with resected adenocarcinoma or squamous cell carcinoma esophageal or gastroesophageal junction cancer |
Sujetos con adenocarcinoma resecado o carcinoma escamoso de esófago o cáncer de la unión gastroesofágica. |
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E.1.1.1 | Medical condition in easily understood language |
Subjects with Resected Esophageal, or Gastroesophageal Junction Cancer |
Sujetos con cáncer de esófago resecado, o cáncer de la unión gastroesofágica. |
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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 | 19.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10015362 |
E.1.2 | Term | Esophageal cancer |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10062878 |
E.1.2 | Term | Gastrooesophageal cancer |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10030191 |
E.1.2 | Term | Oesophageal squamous cell carcinoma stage III |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10030190 |
E.1.2 | Term | Oesophageal squamous cell carcinoma stage II |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10030143 |
E.1.2 | Term | Oesophageal adenocarcinoma stage II |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10030144 |
E.1.2 | Term | Oesophageal adenocarcinoma stage III |
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 | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The purpose of this study is to determine whether nivolumab will improve overall survival, disease-free survival, or both compared with placebo in subjects with resected Esophageal or Gastroesophageal Junction Cancer. |
El objetivo de este estudio es determinar si nivolumab mejorará la supervivencia global, la supervivencia libre de progresión o ambas comparado con placebo en sujetos con cáncer de esófago resecado, o cáncer de la unión gastroesofágica. |
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E.2.2 | Secondary objectives of the trial |
To evaluate 1, 2, and 3 year survival rates of nivolumab versus placebo in subjects with resected Esophageal or Gastroesophageal Junction Cancer |
Evaluar las tasas de supervivencia a 1, 2 y 3 años de nivolumab frente a placebo en sujetos con cáncer de esófago resecado o cáncer de la unión gastroesofágica. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- subjects diagnosed with Stage II/III carcinoma of the esophagus or gastroesophageal junction - subjects completed pre-operative chemoradiotherapy followed by surgery - subjects diagnosed with residual pathologic disease after being surgically rendered free of disease with negative margins following complete resection |
- Sujetos con carcinoma de esófago o de la unión gastroesofágica diagnosticado estadio II o III. - Sujetos deben completar un tratamiento con quimioradioterapia preoperatoria seguida de cirugía antes de la aleatorización. - Sujetos diagnosticados con enfermedad patológica desigual después de quedado quirúrgicamente libres de enfermedad con márgenes negativos en las muestras resecadas. La resección completa debe realizarse en un margen de 4-12 semanas antes de la aleatorización. |
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E.4 | Principal exclusion criteria |
-subjects diagnosed with cervical esophageal carcinoma -subjects diagnosed with Stage IV resectable disease -subjects who did not receive concurrent chemoradiotherapy prior to surgery |
- Sujetos con carcinoma del esófago cervical diagnosticado - Sujetos diagnosticados con enfermedad resecable estadio III ó IV - Sujetos que no recibieron quimioradioterapia concurrente antes de la cirugía. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Overall survival and Disease-Free Survival are co-primary endpoints. - Disease-Free Survival of adjuvant nivolumab in subjects with resected esophageal cancer or gastroesophageal junction cancer who have received chemoradiotherapy followed by surgery - Overall Survival of adjuvant nivolumab in subjects with resected esophageal cancer or gastroesophageal junction cancer who have received chemoradiotherapy followed by surgery |
Este ensayo tiene dos objetivos coprincipales: SG y SLP - SLP de nivolumab en adyuvancia en sujetos con cáncer de esófago resecado o cáncer de la unión gastroesofágica que habían recibido quimioradioterapia después de la cirugía. - SG de nivolumab en adyuvancia en sujetos con cáncer de esófago resecado o cáncer de la unión gastroesofágica que habían recibido quimioradioterapia después de la cirugía. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
- DFS: Approximately 29 months after the first subject is randomized - OS: Approximately 42 months after the first subject is randomized |
PFS: aproximadamente 29 meses después de que el primer paciente sea aleatorizado. OS: aproximadamente 42 meses después de que el primer paciente se aleatorizado. |
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E.5.2 | Secondary end point(s) |
Overall survival rate at 1, 2, and 3 years is defined as the probability that a subject is alive at 1, 2, and 3 years, respectively, following randomization. |
TRG a 1, 2 y 3 años definida como la probabilidad de que un paciente esté vivo a 1, 2 y 3 años respectivamente, después de la aleatorización. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Overall survival rate at 1, 2, and 3 years |
Tasa de SG a 1, 2 y 3 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 | Yes |
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 | 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 |
Biomarker Assessments, Peripheral Blood Mononuclear Cells, Outcomes Research Assessments, Immunogenicity Assessments |
Evaluaciones de biomarcadores, células mononucleares en sangre periférica, evaluaciones de resultados en salud y 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) | 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 | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 53 |
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 |
Belgium |
Brazil |
Canada |
Czech Republic |
Denmark |
France |
Germany |
Hungary |
Ireland |
Israel |
Italy |
Mexico |
Netherlands |
New Zealand |
Peru |
Poland |
Romania |
Russian Federation |
Spain |
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
|
The study will end once the last event occurs for the final analysis of overall survival. |
Este ensayo terminará una vez que ocurra el último evento para el análisis final de la SG. |
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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 | 9 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 10 |