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 |
Soggetti con adenocarcinoma resecato o carcinoma a cellule squamose dell¿esofago o carcinoma della giunzione gastroesofagea |
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E.1.1.1 | Medical condition in easily understood language |
Subjects with Resected Esophageal, or Gastroesophageal Junction Cancer |
Soggetti con carcinoma resecato a dell¿esofago o della giunzione gastroesofagea |
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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 | 21.0 |
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 | 21.0 |
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 | 20.0 |
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.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
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) |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
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) |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.0 |
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.1.3 | 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. |
Lo scopo di questo studio ¿ determinare se Nivolumab migliorer¿ la sopravvivenza complessiva (overall survival, OS), la sopravvivenza libera da malattia (disease-free survival, DFS) o entrambe rispetto a placebo in soggetti con carcinoma resecato dell¿esofago o della giunzione gastroesofagea |
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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 |
Valutare i tassi di sopravvivenza di nivolumab a 1, 2 e 3 anni rispetto a placebo in soggetti con carcinoma resecato a dell¿esofago o della giunzione gastroesofagea |
|
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 |
- soggetti con diagnosi iniziale di carcinoma dell’esofago o della giunzione gastroesofagea allo Stadio II/III - soggetti che abbiano completato la chemioradioterapia pre-operatoria seguita da intervento chirurgico - soggetti con diagnosi di malattia patologica residua dopo essere stati resi chirurgicamente liberi da malattia con margini negativi in seguito a resezione completa
|
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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 |
- Soggetti con diagnosi di carcinoma dell’esofago cervicale - Soggetti con diagnosi di malattia resecabile allo Stadio IV - Soggetti che non ricevono Chemioradioterapia concomitante prima dell’intervento chirurgico
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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 |
La sopravvivenza complessiva (overall survival, OS) e la sopravvivenza libera da malattia (disease-free survival, DFS) sono obiettivi co-primari. - sopravvivenza libera da malattia di Nivolumab adiuvante in soggetti con carcinoma resecato dell’esofago o della giunzione gastroesofagea che hanno ricevuto chemioradioterapia seguita da intervento chirurgico - sopravvivenza complessiva di Nivolumab adiuvante in soggetti con carcinoma resecato dell’esofago o della giunzione gastroesofagea che hanno ricevuto chemioradioterapia seguita da intervento chirurgico |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
DFS: Approximately 36 months after the first subject is randomized - OS: Approximately 49 months after the first subject is randomized |
Sopravvivenza libera da malattia: circa 36 mesi dopo la randomizzazione del primo paziente Sopravvivenza complessiva: circa 49 mesi dopo la randomizzazione del primo paziente |
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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. |
Il tasso di sopravvivenza complessiva a 1, 2 e 3 anni ¿ definito come la probabilit¿ che un soggetto sia vivo a 1, 2 e 3 anni rispettivamente, a seguito della randomizzazione |
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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 |
tasso di sopravvivenza a 1, 2 e 3 anni
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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 |
Valutazione sui Biomarcatori, sulle cellule mononucleate del sangue periferico (PBMC), valutazioni sugli esiti della ricerca, valutazioni sull¿Immunogenicit¿ |
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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 | 5 |
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 | Information not present in EudraCT |
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 |
China |
Hong Kong |
Israel |
Mexico |
Peru |
Russian Federation |
Serbia |
Singapore |
Somalia |
Turkey |
United States |
Belgium |
Denmark |
France |
Germany |
Hungary |
Ireland |
Italy |
Netherlands |
Poland |
Romania |
Spain |
Switzerland |
United Kingdom |
Czechia |
Argentina |
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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. |
Lo studio terminer¿ quando si verificher¿ l¿ultimo evento per l¿analisi finale sulla sopravvivenza complessiva |
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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 | 8 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 8 |
E.8.9.2 | In all countries concerned by the trial months | 3 |
E.8.9.2 | In all countries concerned by the trial days | 0 |