Pattern of Use and Safety/Effectiveness of Nivolumab in Routine Oncology Practice
- Conditions
- MelanomaLung Cancer
- Registration Number
- NCT02847728
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1189
- Age ≥18
- Histologically or cytologically confirmed diagnosis of melanoma (including uveal melanoma) or lung cancer
- Treatment with commercial nivolumab for the first time, alone or in combination with ipilimumab, for the approved indications of nivolumab within 14 days before informed consent for this study OR in the case where treatment has not yet been initiated, documentation that the treatment strategy is determined before an informed consent to study participation, and treatment is initiated within 28 days after informed consent
- Prior participation in a clinical trial within the past 4 weeks
- Previously treated with anti-PD-1, anti-PD-L1, or anti-PD-L2 antibodies
- Previously treated with anti-CTLA-4 for lung cancer
- Current or pending participation in a clinical trial
- Current or pending systemic treatment for cancer other than melanoma and lung cancer
- Inability to comply with the study protocol
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence rate of and severity of immune-related hepatitis - Lung Cancer up to nine years Incidence rate of and severity of immune-related endocrinopathies - Melanoma 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 pneumonitis - 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 nephritis/renal dysfunction - 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 immune-related nephritis/renal dysfunction - 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 immune-related colitis - Lung Cancer 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 severe infusion reactions- Melanoma 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 immune-related rash (including toxic epidermal necrolysis), - Lung Cancer up to nine years
- Secondary Outcome Measures
Name Time Method Adverse Events Up to nine years Other nivolumab treatment-related AEs
Outcomes of Immune-related AEs: Up to nine years Management of Immune-related AEs: Up to nine years Overall Survival: Up to nine years 1-, 2-, 3-, 4-, and 5-year overall and median survival
Nivolumab treatment pattern Up to nine years
Trial Locations
- Locations (94)
Local Institution - 1901
🇺🇸Park Ridge, Illinois, United States
Local Institution - 1906
🇺🇸Tupelo, Mississippi, United States
Local Institution - 1430
🇩🇪Greifswald, Mecklenburg-Vorpommern, Germany
Local Institution - 1915
🇺🇸El Paso, Texas, United States
Local Institution - 1303
🇫🇷Toulouse, France
Local Institution - 1427
🇩🇪Berlin, Germany
Local Institution - 1419
🇩🇪Cologne, Germany
Local Institution - 1428
🇩🇪Giessen, Germany
Local Institution - 1422
🇩🇪Hamburg, Germany
Local Institution - 1424
🇩🇪Hamburg, Germany
Local Institution - 1405
🇩🇪Minden, Germany
Local Institution - 1402
🇩🇪Regensburg, Germany
Local Institution - 1421
🇩🇪Rostock, Germany
Local Institution - 1415
🇩🇪Rostock, Germany
Local Institution - 1412
🇩🇪Ulm, Germany
Local Institution - 2106
🇭🇺Farkasgyepu, Hungary
Local Institution - 1506
🇮🇹Lecce, Italy
Local Institution - 1503
🇮🇹Napoli, Italy
Local Institution - 2203
🇵🇱Olsztyn, Poland
Local Institution - 1801
🇬🇧Bristol, United Kingdom
Local Institution - 1410
🇩🇪Luebeck, Schleswig-Holstein, Germany
Local Institution - 1103
🇦🇹Innsbruck, Austria
Local Institution - 1102
🇦🇹Klagenfurt Am Woerthersee, Austria
Local Institution - 1702
🇨🇭Locarno, Switzerland
Local Institution - 1803
🇬🇧Aberdeen, Aberdeenshire, United Kingdom
Local Institution - 1101
🇦🇹Krems an der Donau, Austria
Local Institution - 1429
🇩🇪Heidelberg, Baden-Württemberg, Germany
Local Institution - 1505
🇮🇹Lucca, Italy
Local Institution - 1504
🇮🇹Udine, Italy
Local Institution - 1909
🇺🇸Palm Springs, California, United States
Local Institution - 1912
🇺🇸Jacksonville, Florida, United States
Local Institution - 1908
🇺🇸Kansas City, Missouri, United States
Local Institution - 1907
🇺🇸Lake City, Florida, United States
Local Institution - 1001
🇦🇺Lismore, New South Wales, Australia
Local Institution - 1911
🇺🇸Morristown, New Jersey, United States
Local Institution - 1902
🇺🇸Bethlehem, Pennsylvania, United States
Local Institution - 1913
🇺🇸Hilton Head Island, South Carolina, United States
Local Institution - 1905
🇺🇸Fort Sam Houston, Texas, United States
Local Institution - 1005
🇦🇺Subiaco, Western Australia, Australia
Local Institution - 1002
🇦🇺Wagga Wagga, New South Wales, Australia
Local Institution - 1202
🇧🇪Brasschaat, Antwerpen, Belgium
Local Institution - 1006
🇦🇺Franskton, Victoria, Australia
Local Institution - 1201
🇧🇪Namur, Belgium
Local Institution - 1203
🇧🇪Kortrijk, Belgium
Local Institution - 1307
🇫🇷Lyon, France
Local Institution - 1301
🇫🇷Metz-Tessy, France
Local Institution - 2002
🇨🇿Olomouc, Czechia
Local Institution - 1304
🇫🇷Saint Jean Priest En Jarez, France
Local Institution - 1305
🇫🇷Nancy, France
Local Institution - 1434
🇩🇪Koblenz, Rheinland Pfa, Germany
Local Institution - 1302
🇫🇷Vandoeuvre-les-Nancy, France
Local Institution - 1403
🇩🇪Augsburg, Germany
Local Institution - 1401
🇩🇪Quedlinburg, Sachsen-Anhalt, Germany
Local Institution - 1436
🇩🇪Bonn, Germany
Local Institution - 1411
🇩🇪Bochum, Germany
Local Institution - 1423
🇩🇪Ballenstedt, Germany
Local Institution - 1417
🇩🇪Erfurt, Germany
Local Institution - 1407
🇩🇪Buxtehude, Germany
Local Institution - 1413
🇩🇪Bremerhaven, Germany
Local Institution - 1416
🇩🇪Gera, Germany
Local Institution - 1408
🇩🇪Jena, Germany
Local Institution - 1426
🇩🇪Mainz, Germany
Local Institution - 1418
🇩🇪Recklinghausen, Germany
Local Institution - 1420
🇩🇪Münster, Germany
Local Institution - 1406
🇩🇪Kassel, Germany
Local Institution - 1409
🇩🇪München, Germany
Local Institution - 1425
🇩🇪Leipzig, Germany
Local Institution - 1432
🇩🇪Ludwigshafen, Germany
Local Institution - 1433
🇩🇪Mainz, Germany
Local Institution - 1431
🇩🇪Muenchen, Germany
Local Institution - 1414
🇩🇪Schwerin, Germany
Local Institution - 1435
🇩🇪Saarbrucken, Germany
Local Institution - 1404
🇩🇪Traunstein, Germany
Local Institution - 2101
🇭🇺Gyongyossolymos, Heves, Hungary
Local Institution - 2102
🇭🇺Debrecen, Hungary
Local Institution - 2107
🇭🇺Budapest, Hungary
Local Institution - 2103
🇭🇺Torokbalint, Hungary
Local Institution - 1501
🇮🇹Bari, Italy
Local Institution - 2202
🇵🇱Gdansk, Poland
Local Institution - 2201
🇵🇱Opole, Opolskie, Poland
Local Institution - 1502
🇮🇹Ravenna, Italy
Local Institution - 1602
🇪🇸Jaen, Spain
Local Institution - 1904
🇵🇷Bayamon, Puerto Rico
Local Institution - 1601
🇪🇸Madrid, Spain
Local Institution - 1606
🇪🇸Avila, Spain
Local Institution - 1604
🇪🇸Salamanca, Spain
Local Institution - 1605
🇪🇸Caceres, Spain
Local Institution - 1603
🇪🇸Toledo, Spain
Local Institution - 1607
🇪🇸Santander, Spain
Local Institution - 1804
🇬🇧Glasgow, Strathclyde, United Kingdom
Local Institution - 1703
🇨🇭Baden, Aargau, Switzerland
Local Institution - 1802
🇬🇧Truro, Cornwall, United Kingdom
Local Institution - 1910
🇺🇸Alexandria, Louisiana, United States
Local Institution - 1003
🇦🇺Wodonga, Victoria, Australia