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
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E.1.1.1 | Medical condition in easily understood language |
Subjects with Resected Esophageal, or Gastroesophageal Junction Cancer |
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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 | 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) |
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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 | 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 | 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 | 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 | 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.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
-To compare disease-free survival (DFS) of nivolumab versus placebo in subjects with resected esophageal cancer (EC), or gastro-esophageal junction (GEJ) cancer
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E.2.2 | Secondary objectives of the trial |
- To compare overall survival (OS) of nivolumab versus placebo in subjects with resected EC or GEJ cancer.
- T o evaluate 1, 2, and 3 year survival rates of nivolumab versus placebo in subjects with resected EC or GEJ cancer.
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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 |
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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 |
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E.5 End points |
E.5.1 | Primary end point(s) |
Disease-free survival is the primary endpoint of this study. Disease-free survival is the time between randomization date and first date of recurrence or death, whichever occurs first. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Subjects will be evaluated for disease recurrence every 12 weeks from the date of first treatment for the first 2 years, and then every 6-12 months between years 3-5. |
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E.5.2 | Secondary end point(s) |
Overall survival and overall survival rates are secondary endpoints.
- Overall Survival is time between the date of randomization and the date of death. For subjects without documentation of death, OS will be censored on the last date the subject was known to be alive.
-The 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.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
up to 5 years from the last patient last treatment |
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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 |
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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 | 3 |
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 |
China |
Czech Republic |
Denmark |
France |
Germany |
Hong Kong |
Hungary |
Ireland |
Israel |
Italy |
Mexico |
Netherlands |
New Zealand |
Peru |
Poland |
Romania |
Russian Federation |
Singapore |
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
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The study will end once the last event occurs for the final analysis of overall survival. |
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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 | 9 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 9 |
E.8.9.2 | In all countries concerned by the trial months | 3 |