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NCT02847728 Clinical Trial

Pattern of Use and Safety/Effectiveness of Nivolumab in Routine Oncology Practice

Lung Cancer Clinical Trial

Official title:
Pattern of Use and Safety/Effectiveness of Nivolumab in Routine Oncology Practice

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02847728
Other study ID # CA209-234
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 28, 2016
Est. completion date March 31, 2024

Study information
Verified date May 2024
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 1189
Est. completion date March 31, 2024
Est. primary completion date March 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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

Related Conditions & MeSH terms

Locations
Country Name City State
Australia Local Institution - 1006 Franskton Victoria
Australia Local Institution - 1001 Lismore New South Wales
Australia Local Institution - 1005 Subiaco Western Australia
Australia Local Institution - 1002 Wagga Wagga New South Wales
Australia Local Institution - 1003 Wodonga Victoria
Austria Local Institution - 1103 Innsbruck
Austria Local Institution - 1102 Klagenfurt Am Woerthersee
Austria Local Institution - 1101 Krems an der Donau
Belgium Local Institution - 1202 Brasschaat Antwerpen
Belgium Local Institution - 1203 Kortrijk
Belgium Local Institution - 1201 Namur
Czechia Local Institution - 2002 Olomouc
France Local Institution - 1307 Lyon
France Local Institution - 1301 Metz-Tessy
France Local Institution - 1305 Nancy
France Local Institution - 1304 Saint Jean Priest En Jarez
France Local Institution - 1303 Toulouse
France Local Institution - 1302 Vandoeuvre-les-Nancy
Germany Local Institution - 1403 Augsburg
Germany Local Institution - 1423 Ballenstedt
Germany Local Institution - 1427 Berlin
Germany Local Institution - 1411 Bochum
Germany Local Institution - 1436 Bonn
Germany Local Institution - 1413 Bremerhaven
Germany Local Institution - 1407 Buxtehude
Germany Local Institution - 1419 Cologne
Germany Local Institution - 1417 Erfurt
Germany Local Institution - 1416 Gera
Germany Local Institution - 1428 Giessen
Germany Local Institution - 1430 Greifswald Mecklenburg-Vorpommern
Germany Local Institution - 1422 Hamburg
Germany Local Institution - 1424 Hamburg
Germany Local Institution - 1429 Heidelberg Baden-Württemberg
Germany Local Institution - 1408 Jena
Germany Local Institution - 1406 Kassel
Germany Local Institution - 1434 Koblenz Rheinland Pfa
Germany Local Institution - 1425 Leipzig
Germany Local Institution - 1432 Ludwigshafen
Germany Local Institution - 1410 Luebeck Schleswig-Holstein
Germany Local Institution - 1426 Mainz
Germany Local Institution - 1433 Mainz
Germany Local Institution - 1405 Minden
Germany Local Institution - 1431 Muenchen
Germany Local Institution - 1409 München
Germany Local Institution - 1420 Münster
Germany Local Institution - 1401 Quedlinburg Sachsen-Anhalt
Germany Local Institution - 1418 Recklinghausen
Germany Local Institution - 1402 Regensburg
Germany Local Institution - 1415 Rostock
Germany Local Institution - 1421 Rostock
Germany Local Institution - 1435 Saarbrucken
Germany Local Institution - 1414 Schwerin
Germany Local Institution - 1404 Traunstein
Germany Local Institution - 1412 Ulm
Hungary Local Institution - 2107 Budapest
Hungary Local Institution - 2102 Debrecen
Hungary Local Institution - 2106 Farkasgyepu
Hungary Local Institution - 2101 Gyongyossolymos Heves
Hungary Local Institution - 2103 Torokbalint
Italy Local Institution - 1501 Bari
Italy Local Institution - 1506 Lecce
Italy Local Institution - 1505 Lucca
Italy Local Institution - 1503 Napoli
Italy Local Institution - 1502 Ravenna
Italy Local Institution - 1504 Udine
Poland Local Institution - 2202 Gdansk
Poland Local Institution - 2203 Olsztyn
Poland Local Institution - 2201 Opole Opolskie
Puerto Rico Local Institution - 1904 Bayamon
Spain Local Institution - 1606 Avila
Spain Local Institution - 1605 Caceres
Spain Local Institution - 1602 Jaen
Spain Local Institution - 1601 Madrid
Spain Local Institution - 1604 Salamanca
Spain Local Institution - 1607 Santander
Spain Local Institution - 1603 Toledo
Switzerland Local Institution - 1703 Baden Aargau
Switzerland Local Institution - 1702 Locarno
United Kingdom Local Institution - 1803 Aberdeen Aberdeenshire
United Kingdom Local Institution - 1801 Bristol
United Kingdom Local Institution - 1804 Glasgow Strathclyde
United Kingdom Local Institution - 1802 Truro Cornwall
United States Local Institution - 1910 Alexandria Louisiana
United States Local Institution - 1902 Bethlehem Pennsylvania
United States Local Institution - 1915 El Paso Texas
United States Local Institution - 1905 Fort Sam Houston Texas
United States Local Institution - 1913 Hilton Head Island South Carolina
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 - 1911 Morristown New Jersey
United States Local Institution - 1909 Palm Springs California
United States Local Institution - 1901 Park Ridge Illinois
United States Local Institution - 1906 Tupelo Mississippi

Sponsors (1)
Lead Sponsor Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Czechia,  France,  Germany,  Hungary,  Italy,  Poland,  Puerto Rico,  Spain,  Switzerland,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence rate of and severity of immune-related pneumonitis - Melanoma up to nine years
Primary Incidence rate of and severity of immune-related colitis- Melanoma up to nine years
Primary Incidence rate of and severity of immune-related hepatitis - Melanoma up to nine years
Primary Incidence rate of and severity of immune-related nephritis/renal dysfunction - Melanoma up to nine years
Primary Incidence rate of and severity of immune-related endocrinopathies - Melanoma up to nine years
Primary Incidence rate of and severity of immune-related rash (including toxic epidermal necrolysis) - Melanoma up to nine years
Primary 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
Primary Incidence rate of and severity of severe infusion reactions- Melanoma up to nine years
Primary Incidence rate of and severity of immune-related pneumonitis - Lung Cancer up to nine years
Primary Incidence rate of and severity of immune-related colitis - Lung Cancer up to nine years
Primary Incidence rate of and severity of immune-related hepatitis - Lung Cancer up to nine years
Primary Incidence rate of and severity of immune-related nephritis/renal dysfunction - Lung Cancer up to nine years
Primary Incidence rate of and severity of immune-related endocrinopathies - Lung Cancer up to nine years
Primary 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
Primary Incidence rate of and severity of severe infusion reactions - Lung Cancer up to nine years
Primary Incidence rate of and severity of immune-related rash (including toxic epidermal necrolysis), - Lung Cancer up to nine years
Secondary Adverse Events Other nivolumab treatment-related AEs Up to nine years
Secondary Management of Immune-related AEs: Up to nine years
Secondary Outcomes of Immune-related AEs: Up to nine years
Secondary Overall Survival: 1-, 2-, 3-, 4-, and 5-year overall and median survival Up to nine years
Secondary Nivolumab treatment pattern Up to nine years
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