Clinical trial NCT02847728: Pattern of Use and Safety/Effectiveness of Nivolumab in Routine Oncology Practice
Official title: Pattern of Use and Safety/Effectiveness of Nivolumab in Routine Oncology Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Melanoma
Lung Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2016-07-28
Enrollment: 1189
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence rate of and severity of immune-related pneumonitis - Melanoma
timeFrame: up to nine years
measure: Incidence rate of and severity of immune-related colitis- Melanoma
timeFrame: up to nine years
measure: Incidence rate of and severity of immune-related hepatitis - Melanoma
timeFrame: up to nine years
measure: Incidence rate of and severity of immune-related nephritis/renal dysfunction - Melanoma
timeFrame: up to nine years
measure: Incidence rate of and severity of immune-related endocrinopathies - Melanoma
timeFrame: up to nine years
measure: Incidence rate of and severity of immune-related rash (including toxic epidermal necrolysis) - Melanoma
timeFrame: up to nine years
measure: Incidence rate of and severity of other immune-related adverse events (eg, uveitis, pancreatitis, demyelination, Guillain-Barre Syndrome, myasthenic syndrome, and encephalitis) - Melanoma
timeFrame: up to nine years
measure: Incidence rate of and severity of severe infusion reactions- Melanoma
timeFrame: up to nine years
measure: Incidence rate of and severity of immune-related pneumonitis - Lung Cancer
timeFrame: up to nine years
measure: Incidence rate of and severity of immune-related colitis - Lung Cancer
timeFrame: up to nine years
measure: Incidence rate of and severity of immune-related hepatitis - Lung Cancer
timeFrame: up to nine years
measure: Incidence rate of and severity of immune-related nephritis/renal dysfunction - Lung Cancer
timeFrame: up to nine years
measure: Incidence rate of and severity of immune-related endocrinopathies - Lung Cancer
timeFrame: up to nine years
measure: Incidence rate of and severity of other immune related adverse events (eg, uveitis, pancreatitis, demyelination, Guillain-Barre Syndrome, myasthenic syndrome, and encephalitis) - Lung Cancer
timeFrame: up to nine years
measure: Incidence rate of and severity of severe infusion reactions - Lung Cancer
timeFrame: up to nine years
measure: Incidence rate of and severity of immune-related rash (including toxic epidermal necrolysis), - Lung Cancer
timeFrame: up to nine years
Secondary outcomes:
measure: Adverse Events
timeFrame: Up to nine years
measure: Management of Immune-related AEs:
timeFrame: Up to nine years
measure: Outcomes of Immune-related AEs:
timeFrame: Up to nine years
measure: Overall Survival:
timeFrame: Up to nine years
measure: Nivolumab treatment pattern
timeFrame: Up to nine years
Other outcomes:
Locations:
city: Palm Springs
country: United States
facility: Local Institution - 1909
state: California
city: Jacksonville
country: United States
facility: Local Institution - 1912
state: Florida
city: Lake City
country: United States
facility: Local Institution - 1907
state: Florida
city: Park Ridge
country: United States
facility: Local Institution - 1901
state: Illinois
city: Alexandria
country: United States
facility: Local Institution - 1910
state: Louisiana
city: Tupelo
country: United States
facility: Local Institution - 1906
state: Mississippi
city: Kansas City
country: United States
facility: Local Institution - 1908
state: Missouri
city: Morristown
country: United States
facility: Local Institution - 1911
state: New Jersey
city: Bethlehem
country: United States
facility: Local Institution - 1902
state: Pennsylvania
city: Hilton Head Island
country: United States
facility: Local Institution - 1913
state: South Carolina
city: El Paso
country: United States
facility: Local Institution - 1915
state: Texas
city: Fort Sam Houston
country: United States
facility: Local Institution - 1905
state: Texas
city: Lismore
country: Australia
facility: Local Institution - 1001
state: New South Wales
city: Wagga Wagga
country: Australia
facility: Local Institution - 1002
state: New South Wales
city: Franskton
country: Australia
facility: Local Institution - 1006
state: Victoria
city: Wodonga
country: Australia
facility: Local Institution - 1003
state: Victoria
city: Subiaco
country: Australia
facility: Local Institution - 1005
state: Western Australia
city: Innsbruck
country: Austria
facility: Local Institution - 1103
city: Klagenfurt Am Woerthersee
country: Austria
facility: Local Institution - 1102
city: Krems an der Donau
country: Austria
facility: Local Institution - 1101
city: Brasschaat
country: Belgium
facility: Local Institution - 1202
state: Antwerpen
city: Kortrijk
country: Belgium
facility: Local Institution - 1203
city: Namur
country: Belgium
facility: Local Institution - 1201
city: Olomouc
country: Czechia
facility: Local Institution - 2002
city: Lyon
country: France
facility: Local Institution - 1307
city: Metz-Tessy
country: France
facility: Local Institution - 1301
city: Nancy
country: France
facility: Local Institution - 1305
city: Saint Jean Priest En Jarez
country: France
facility: Local Institution - 1304
city: Toulouse
country: France
facility: Local Institution - 1303
city: Vandoeuvre-les-Nancy
country: France
facility: Local Institution - 1302
city: Heidelberg
country: Germany
facility: Local Institution - 1429
state: Baden-Württemberg
city: Greifswald
country: Germany
facility: Local Institution - 1430
state: Mecklenburg-Vorpommern
city: Koblenz
country: Germany
facility: Local Institution - 1434
state: Rheinland Pfa
city: Quedlinburg
country: Germany
facility: Local Institution - 1401
state: Sachsen-Anhalt
city: Luebeck
country: Germany
facility: Local Institution - 1410
state: Schleswig-Holstein
city: Augsburg
country: Germany
facility: Local Institution - 1403
city: Ballenstedt
country: Germany
facility: Local Institution - 1423
city: Berlin
country: Germany
facility: Local Institution - 1427
city: Bochum
country: Germany
facility: Local Institution - 1411
city: Bonn
country: Germany
facility: Local Institution - 1436
city: Bremerhaven
country: Germany
facility: Local Institution - 1413
city: Buxtehude
country: Germany
facility: Local Institution - 1407
city: Cologne
country: Germany
facility: Local Institution - 1419
city: Erfurt
country: Germany
facility: Local Institution - 1417
city: Gera
country: Germany
facility: Local Institution - 1416
city: Giessen
country: Germany
facility: Local Institution - 1428
city: Hamburg
country: Germany
facility: Local Institution - 1422
city: Hamburg
country: Germany
facility: Local Institution - 1424
city: Jena
country: Germany
facility: Local Institution - 1408
city: Kassel
country: Germany
facility: Local Institution - 1406
city: Leipzig
country: Germany
facility: Local Institution - 1425
city: Ludwigshafen
country: Germany
facility: Local Institution - 1432
city: Mainz
country: Germany
facility: Local Institution - 1433
city: Mainz
country: Germany
facility: Local Institution - 1426
city: Minden
country: Germany
facility: Local Institution - 1405
city: Muenchen
country: Germany
facility: Local Institution - 1431
city: München
country: Germany
facility: Local Institution - 1409
city: Münster
country: Germany
facility: Local Institution - 1420
city: Recklinghausen
country: Germany
facility: Local Institution - 1418
city: Regensburg
country: Germany
facility: Local Institution - 1402
city: Rostock
country: Germany
facility: Local Institution - 1415
city: Rostock
country: Germany
facility: Local Institution - 1421
city: Saarbrucken
country: Germany
facility: Local Institution - 1435
city: Schwerin
country: Germany
facility: Local Institution - 1414
city: Traunstein
country: Germany
facility: Local Institution - 1404
city: Ulm
country: Germany
facility: Local Institution - 1412
city: Gyongyossolymos
country: Hungary
facility: Local Institution - 2101
state: Heves
city: Budapest
country: Hungary
facility: Local Institution - 2107
city: Debrecen
country: Hungary
facility: Local Institution - 2102
city: Farkasgyepu
country: Hungary
facility: Local Institution - 2106
city: Torokbalint
country: Hungary
facility: Local Institution - 2103
city: Bari
country: Italy
facility: Local Institution - 1501
city: Lecce
country: Italy
facility: Local Institution - 1506
city: Lucca
country: Italy
facility: Local Institution - 1505
city: Napoli
country: Italy
facility: Local Institution - 1503
city: Ravenna
country: Italy
facility: Local Institution - 1502
city: Udine
country: Italy
facility: Local Institution - 1504
city: Opole
country: Poland
facility: Local Institution - 2201
state: Opolskie
city: Gdansk
country: Poland
facility: Local Institution - 2202
city: Olsztyn
country: Poland
facility: Local Institution - 2203
city: Bayamon
country: Puerto Rico
facility: Local Institution - 1904
city: Avila
country: Spain
facility: Local Institution - 1606
city: Caceres
country: Spain
facility: Local Institution - 1605
city: Jaen
country: Spain
facility: Local Institution - 1602
city: Madrid
country: Spain
facility: Local Institution - 1601
city: Salamanca
country: Spain
facility: Local Institution - 1604
city: Santander
country: Spain
facility: Local Institution - 1607
city: Toledo
country: Spain
facility: Local Institution - 1603
city: Baden
country: Switzerland
facility: Local Institution - 1703
state: Aargau
city: Locarno
country: Switzerland
facility: Local Institution - 1702
city: Aberdeen
country: United Kingdom
facility: Local Institution - 1803
state: Aberdeenshire
city: Truro
country: United Kingdom
facility: Local Institution - 1802
state: Cornwall
city: Glasgow
country: United Kingdom
facility: Local Institution - 1804
state: Strathclyde
city: Bristol
country: United Kingdom
facility: Local Institution - 1801
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: