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This is an observational, multicenter study in participants treated with nivolumab for the approved indications of melanoma and Lung cancer in Australia, the EU, Switzerland, the United Kingdom (UK), and the United States (US). The targeted countries in the EU for study participation include Austria, Belgium, Czech Republic, France, Germany, Hungary, Italy, Poland, and Spain. Study objectives are to assess the safety experience, survival, adverse event management, and outcomes of adverse events associated with nivolumab in routine oncology care facilities.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm Design | The study encompasses a single arm design with 417 adults treated with nivolumab for histologically or cytologically confirmed melanoma and 772 adults treated with nivolumab for histologically or cytologically confirmed lung cancer. |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence rate of and severity of immune-related pneumonitis - Melanoma | up to nine years | |
| Incidence rate of and severity of immune-related colitis- Melanoma | up to nine years | |
| Incidence rate of and severity of immune-related hepatitis - Melanoma | up to nine years | |
| Incidence rate of and severity of immune-related nephritis/renal dysfunction - Melanoma | up to nine years | |
| Incidence rate of and severity of immune-related endocrinopathies - Melanoma | up to nine years | |
| Incidence rate of and severity of immune-related rash (including toxic epidermal necrolysis) - Melanoma | up to nine years | |
| Incidence rate of and severity of other immune-related adverse events (eg, uveitis, pancreatitis, demyelination, Guillain-Barre Syndrome, myasthenic syndrome, and encephalitis) - Melanoma | up to nine years | |
| Incidence rate of and severity of severe infusion reactions- Melanoma | up to nine years | |
| Incidence rate of and severity of immune-related pneumonitis - Lung Cancer | up to nine years | |
| Incidence rate of and severity of immune-related colitis - Lung Cancer |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Other nivolumab treatment-related AEs | Up to nine years |
| Management of Immune-related AEs: | Up to nine years | |
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Inclusion Criteria:
Exclusion Criteria:
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The study population consists of 417 adults treated with nivolumab for histologically or cytologically confirmed melanoma and 772 adults treated with nivolumab for histologically or cytologically confirmed lung cancer in accordance with the approved indications in Australia, the EU, Switzerland, the UK, and the US. The targeted countries in the EU for participant enrollment include Austria, Belgium, Czech Republic, France, Germany, Hungary, Italy, Poland, and Spain. Participants who begin treatment with nivolumab for the first time will be enrolled in accordance with the approved indications and whose treatment strategy was determined independently from consideration of study participation. Treatment will be determined at the treating physician's discretion and with the participant's consent.
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 1909 | Palm Springs | California | 92262 | United States | ||
| Local Institution - 1912 |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| FDA Safety Alerts and Recalls | View source |
| BMS Clinical Trial Patient Recruiting |
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| up to nine years |
| Incidence rate of and severity of immune-related hepatitis - Lung Cancer | up to nine years |
| Incidence rate of and severity of immune-related nephritis/renal dysfunction - Lung Cancer | up to nine years |
| Incidence rate of and severity of immune-related endocrinopathies - Lung Cancer | up to nine years |
| Incidence rate of and severity of other immune related adverse events (eg, uveitis, pancreatitis, demyelination, Guillain-Barre Syndrome, myasthenic syndrome, and encephalitis) - Lung Cancer | up to nine years |
| Incidence rate of and severity of severe infusion reactions - Lung Cancer | up to nine years |
| Incidence rate of and severity of immune-related rash (including toxic epidermal necrolysis), - Lung Cancer | up to nine years |
| Outcomes of Immune-related AEs: |
| Up to nine years |
| Overall Survival: | 1-, 2-, 3-, 4-, and 5-year overall and median survival | Up to nine years |
| Nivolumab treatment pattern | Up to nine years |
| Jacksonville |
| Florida |
| 32204 |
| United States |
| Local Institution - 1907 | Lake City | Florida | 32024 | United States |
| Local Institution - 1901 | Park Ridge | Illinois | 60068 | United States |
| Local Institution - 1910 | Alexandria | Louisiana | 71301 | United States |
| Local Institution - 1906 | Tupelo | Mississippi | 38801 | United States |
| Local Institution - 1908 | Kansas City | Missouri | 64108 | United States |
| Local Institution - 1911 | Morristown | New Jersey | 07962 | United States |
| Local Institution - 1902 | Bethlehem | Pennsylvania | 18015 | United States |
| Local Institution - 1913 | Hilton Head Island | South Carolina | 29926 | United States |
| Local Institution - 1915 | El Paso | Texas | 79920 | United States |
| Local Institution - 1905 | Fort Sam Houston | Texas | 78234-6200 | United States |
| Local Institution - 1001 | Lismore | New South Wales | 2480 | Australia |
| Local Institution - 1002 | Wagga Wagga | New South Wales | 2650 | Australia |
| Local Institution - 1006 | Franskton | Victoria | 3199 | Australia |
| Local Institution - 1003 | Wodonga | Victoria | 3690 | Australia |
| Local Institution - 1005 | Subiaco | Western Australia | 6008 | Australia |
| Local Institution - 1103 | Innsbruck | 6020 | Austria |
| Local Institution - 1102 | Klagenfurt | 9020 | Austria |
| Local Institution - 1101 | Krems | 3500 | Austria |
| Local Institution - 1202 | Brasschaat | Antwerpen | 2930 | Belgium |
| Local Institution - 1203 | Kortrijk | 8500 | Belgium |
| Local Institution - 1201 | Namur | 5000 | Belgium |
| Local Institution - 2002 | Olomouc | 779 00 | Czechia |
| Local Institution - 1307 | Lyon | 69229 | France |
| Local Institution - 1301 | Metz-Tessy | 74374 | France |
| Local Institution - 1305 | Nancy | 54100 | France |
| Local Institution - 1304 | Saint Jean Priest En Jarez | 42277 | France |
| Local Institution - 1303 | Toulouse | 31059 | France |
| Local Institution - 1302 | Vandœuvre-lès-Nancy | 54519 | France |
| Local Institution - 1429 | Heidelberg | Baden-Wurttemberg | 69120 | Germany |
| Local Institution - 1430 | Greifswald | Mecklenburg-Vorpommern | 17475 | Germany |
| Local Institution - 1434 | Koblenz | Rheinland Pfa | 56068 | Germany |
| Local Institution - 1401 | Quedlinburg | Saxony-Anhalt | 06484 | Germany |
| Local Institution - 1410 | Lübeck | Schleswig-Holstein | 23538 | Germany |
| Local Institution - 1403 | Augsburg | 86156 | Germany |
| Local Institution - 1423 | Ballenstedt | 06493 | Germany |
| Local Institution - 1427 | Berlin | 10117 | Germany |
| Local Institution - 1411 | Bochum | 44791 | Germany |
| Local Institution - 1436 | Bonn | 53115 | Germany |
| Local Institution - 1413 | Bremerhaven | 27574 | Germany |
| Local Institution - 1407 | Buxtehude | 21614 | Germany |
| Local Institution - 1419 | Cologne | 51109 | Germany |
| Local Institution - 1417 | Erfurt | 99089 | Germany |
| Local Institution - 1416 | Gera | 07548 | Germany |
| Local Institution - 1428 | Giessen | 35385 | Germany |
| Local Institution - 1422 | Hamburg | 20246 | Germany |
| Local Institution - 1424 | Hamburg | 22081 | Germany |
| Local Institution - 1408 | Jena | 07743 | Germany |
| Local Institution - 1406 | Kassel | 34125 | Germany |
| Local Institution - 1425 | Leipzig | 04103 | Germany |
| Local Institution - 1432 | Ludwigshafen | 67063 | Germany |
| Local Institution - 1433 | Mainz | 55101 | Germany |
| Local Institution - 1426 | Mainz | 55131 | Germany |
| Local Institution - 1405 | Minden | 32429 | Germany |
| Local Institution - 1431 | München | 80335 | Germany |
| Local Institution - 1409 | München | 80336 | Germany |
| Local Institution - 1420 | Münster | 48157 | Germany |
| Local Institution - 1418 | Recklinghausen | 45657 | Germany |
| Local Institution - 1402 | Regensburg | 93042 | Germany |
| Local Institution - 1415 | Rostock | 18107 | Germany |
| Local Institution - 1421 | Rostock | 18107 | Germany |
| Local Institution - 1435 | Saarbrücken | 66113 | Germany |
| Local Institution - 1414 | Schwerin | 19049 | Germany |
| Local Institution - 1404 | Traunstein | 83278 | Germany |
| Local Institution - 1412 | Ulm | 89081 | Germany |
| Local Institution - 2101 | Gyöngyössolymos | Heves County | 3233 | Hungary |
| Local Institution - 2107 | Budapest | 1121 | Hungary |
| Local Institution - 2102 | Debrecen | 4032 | Hungary |
| Local Institution - 2106 | Farkasgyepű | 8582 | Hungary |
| Local Institution - 2103 | Törökbálint | 2045 | Hungary |
| Local Institution - 1501 | Bari | 70124 | Italy |
| Local Institution - 1506 | Lecce | 73100 | Italy |
| Local Institution - 1505 | Lucca | 5510 | Italy |
| Local Institution - 1503 | Naples | 80131 | Italy |
| Local Institution - 1502 | Ravenna | 48121 | Italy |
| Local Institution - 1504 | Udine | 33100 | Italy |
| Local Institution - 2201 | Opole | Opole Voivodeship | 45-061 | Poland |
| Local Institution - 2202 | Gdansk | 80-219 | Poland |
| Local Institution - 2203 | Olsztyn | 10-357 | Poland |
| Local Institution - 1904 | Bayamón | 00961 | Puerto Rico |
| Local Institution - 1606 | Ávila | 05004 | Spain |
| Local Institution - 1605 | Cáceres | 10003 | Spain |
| Local Institution - 1602 | Jaén | 23007 | Spain |
| Local Institution - 1601 | Madrid | 28033 | Spain |
| Local Institution - 1604 | Salamanca | 37007 | Spain |
| Local Institution - 1607 | Santander | 39008 | Spain |
| Local Institution - 1603 | Toledo | 45004 | Spain |
| Local Institution - 1703 | Baden | Canton of Aargau | 5404 | Switzerland |
| Local Institution - 1702 | Locarno | 6600 | Switzerland |
| Local Institution - 1803 | Aberdeen | Aberdeenshire | AB25 2ZN | United Kingdom |
| Local Institution - 1802 | Truro | Cornwall | TR1 3LJ | United Kingdom |
| Local Institution - 1804 | Glasgow | Strathclyde | G12 0YN | United Kingdom |
| Local Institution - 1801 | Bristol | BS2 8ED | United Kingdom |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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