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A study to estimate the overall survival in real-life conditions in France of adult participants treated with nivolumab in combination with chemotherapy as first-line treatment for gastric and gastroesophageal junction cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Participants with a diagnosis of gastric adenocarcinoma, gastro-esophageal junction adenocarcinoma or esophageal adenocarcinoma |
| |
| Cohort 2 | Participants with a diagnosis of untreated, unresectable, advanced, recurrent, or metastatic esophageal squamous cell carcinoma |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nivolumab + chemotherapy | Drug | As prescribed by the treating clinician, as per product label |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36 |
| Measure | Description | Time Frame |
|---|---|---|
| Cause of death (where available) | Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36 | |
| Disease progression | As assessed by the Site Investigator | Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36 |
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Inclusion Criteria:
Cohorts 1 & 2
Cohort 1 only • Diagnosis of untreated HER2 negative advanced or metastatic gastric adenocarcinoma, GEJ adenocarcinoma or EAC whose tumor express PD-L1 with a CPS ≥5
Cohort 2 only
• Diagnosis of untreated unresectable advanced, recurrent or metastatic ESCC with tumor cell PD-L1 expression (TPS) ≥1%
Exclusion Criteria:
Cohorts 1 & 2
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Adult participants in France diagnosed with Gastric Adenocarcinoma, Gastro-Esophageal Junction (GEJ) adenocarcinoma, Esophageal Adenocarcinoma (EAC) or Esophageal Squamous Cell Carcinoma (ESCC) and treated with nivolumab in combination with fluoropyrimidine- and platinum-based chemotherapy
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 0001 | Paris | 75002 | France | |||
| Kappa Santé |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| FDA Safety Alerts and Recalls | View source |
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| Progression-free survival (PFS) | Day 0 and months 2, 3, 4-6, 8-9, 12, 18, 24, 30 and 36 |
| Time to treatment discontinuation (TTD) | Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36 |
| Time to failure of strategy (TFS) | Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36 |
| Time to next Treatment (TTNT) | Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36 |
| Second progression-free survival (PFS2) | Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36 |
| Treatment Free Interval (TFI) | Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36 |
| Overall tumor response (ORR) | Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36 |
| Response rate | Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36 |
| Duration of response (DOR) | Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36 |
| Participant socio-demographics | Baseline |
| Participant clinical characteristics | Baseline |
| Participant treatment history | Baseline |
| Nivolumab treatment regime | Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36 |
| Chemotherapy treatment regime | Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36 |
| Reason for treatment discontinuation | Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36 |
| Subsequent non-systemic treatment received post first-line treatment | Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36 |
| Subsequent systemic treatment received post first-line treatment | Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36 |
| Subsequent systemic treatment effectiveness | Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36 |
| Participant adverse events (AEs) | Up to 3 years |
| Participant health related quality of life as assessed by 5-level EuroQoL-5 dimension version (EQ-5D-5L) | Day 0 and months 2-3, 4-6, 8-9, 12, 18, 24, 30 and 36 |
| Paris |
| France |
| ID | Term |
|---|---|
| C562730 | Adenocarcinoma Of Esophagus |
| D000077277 | Esophageal Squamous Cell Carcinoma |
| D000230 | Adenocarcinoma |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018307 | Neoplasms, Squamous Cell |
| D004938 | Esophageal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D013812 | Therapeutics |
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