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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02847728




Registration number
NCT02847728
Ethics application status
Date submitted
28/06/2016
Date registered
28/07/2016
Date last updated
23/02/2021

Titles & IDs
Public title
Pattern of Use and Safety/Effectiveness of Nivolumab in Routine Oncology Practice
Scientific title
Pattern of Use and Safety/Effectiveness of Nivolumab in Routine Oncology Practice
Secondary ID [1] 0 0
CA209-234
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Melanoma 0 0
Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Single Arm Design - The study encompasses a single arm design with 400 adults treated with nivolumab for histologically or cytologically confirmed melanoma and 800 adults treated with nivolumab for histologically or cytologically confirmed lung cancer.

Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence rate of and severity of immune-related pneumonitis - Melanoma
Timepoint [1] 0 0
up to nine years
Primary outcome [2] 0 0
Incidence rate of and severity of immune-related colitis- Melanoma
Timepoint [2] 0 0
up to nine years
Primary outcome [3] 0 0
Incidence rate of and severity of immune-related hepatitis - Melanoma
Timepoint [3] 0 0
up to nine years
Primary outcome [4] 0 0
Incidence rate of and severity of immune-related nephritis/renal dysfunction - Melanoma
Timepoint [4] 0 0
up to nine years
Primary outcome [5] 0 0
Incidence rate of and severity of immune-related endocrinopathies - Melanoma
Timepoint [5] 0 0
up to nine years
Primary outcome [6] 0 0
Incidence rate of and severity of immune-related rash (including toxic epidermal necrolysis) - Melanoma
Timepoint [6] 0 0
up to nine years
Primary outcome [7] 0 0
Incidence rate of and severity of other immune-related adverse events (eg, uveitis, pancreatitis, demyelination, Guillain-Barre Syndrome, myasthenic syndrome, and encephalitis) - Melanoma
Timepoint [7] 0 0
up to nine years
Primary outcome [8] 0 0
Incidence rate of and severity of severe infusion reactions- Melanoma
Timepoint [8] 0 0
up to nine years
Primary outcome [9] 0 0
Incidence rate of and severity of immune-related pneumonitis - Lung Cancer
Timepoint [9] 0 0
up to nine years
Primary outcome [10] 0 0
Incidence rate of and severity of immune-related colitis - Lung Cancer
Timepoint [10] 0 0
up to nine years
Primary outcome [11] 0 0
Incidence rate of and severity of immune-related hepatitis - Lung Cancer
Timepoint [11] 0 0
up to nine years
Primary outcome [12] 0 0
Incidence rate of and severity of immune-related nephritis/renal dysfunction - Lung Cancer
Timepoint [12] 0 0
up to nine years
Primary outcome [13] 0 0
Incidence rate of and severity of immune-related endocrinopathies - Lung Cancer
Timepoint [13] 0 0
up to nine years
Primary outcome [14] 0 0
Incidence rate of and severity of other immune related adverse events (eg, uveitis, pancreatitis, demyelination, Guillain-Barre Syndrome, myasthenic syndrome, and encephalitis) - Lung Cancer
Timepoint [14] 0 0
up to nine years
Primary outcome [15] 0 0
Incidence rate of and severity of severe infusion reactions - Lung Cancer
Timepoint [15] 0 0
up to nine years
Primary outcome [16] 0 0
Incidence rate of and severity of immune-related rash (including toxic epidermal necrolysis), - Lung Cancer
Timepoint [16] 0 0
up to nine years
Secondary outcome [1] 0 0
Adverse Events - Other nivolumab treatment-related AEs
Timepoint [1] 0 0
Up to nine years
Secondary outcome [2] 0 0
Management of Immune-related AEs:
Timepoint [2] 0 0
Up to nine years
Secondary outcome [3] 0 0
Outcomes of Immune-related AEs:
Timepoint [3] 0 0
Up to nine years
Secondary outcome [4] 0 0
Overall Survival: - 1-, 2-, 3-, 4-, and 5-year overall and median survival
Timepoint [4] 0 0
Up to nine years
Secondary outcome [5] 0 0
Nivolumab treatment pattern
Timepoint [5] 0 0
Up to nine years

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Other protocol defined inclusion and exclusion criteria could apply

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - Lismore
Recruitment hospital [2] 0 0
Local Institution - Wagga Wagga
Recruitment hospital [3] 0 0
Local Institution - Frankston
Recruitment hospital [4] 0 0
Local Institution - Wodonga
Recruitment hospital [5] 0 0
Local Institution - Subiaco
Recruitment postcode(s) [1] 0 0
2480 - Lismore
Recruitment postcode(s) [2] 0 0
2650 - Wagga Wagga
Recruitment postcode(s) [3] 0 0
3199 - Frankston
Recruitment postcode(s) [4] 0 0
3690 - Wodonga
Recruitment postcode(s) [5] 0 0
6008 - Subiaco
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Louisiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Mississippi
Country [7] 0 0
United States of America
State/province [7] 0 0
Missouri
Country [8] 0 0
United States of America
State/province [8] 0 0
New Jersey
Country [9] 0 0
United States of America
State/province [9] 0 0
Pennsylvania
Country [10] 0 0
United States of America
State/province [10] 0 0
South Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
Texas
Country [12] 0 0
Austria
State/province [12] 0 0
Donau
Country [13] 0 0
Austria
State/province [13] 0 0
InnsBruck
Country [14] 0 0
Austria
State/province [14] 0 0
Klagenfurt
Country [15] 0 0
Belgium
State/province [15] 0 0
Brasschaat
Country [16] 0 0
Belgium
State/province [16] 0 0
Kortrijk
Country [17] 0 0
Belgium
State/province [17] 0 0
Namur
Country [18] 0 0
Czechia
State/province [18] 0 0
Olomouc
Country [19] 0 0
Czechia
State/province [19] 0 0
Prague
Country [20] 0 0
France
State/province [20] 0 0
Lyon
Country [21] 0 0
France
State/province [21] 0 0
Nancy
Country [22] 0 0
France
State/province [22] 0 0
Pringy
Country [23] 0 0
France
State/province [23] 0 0
Saint-Priest en Jarez
Country [24] 0 0
France
State/province [24] 0 0
Toulouse
Country [25] 0 0
France
State/province [25] 0 0
Vandoeuvre-les-Nancy Cedex
Country [26] 0 0
Germany
State/province [26] 0 0
Baden-Württemberg
Country [27] 0 0
Germany
State/province [27] 0 0
Bavaria
Country [28] 0 0
Germany
State/province [28] 0 0
Hamburg
Country [29] 0 0
Germany
State/province [29] 0 0
Hesse
Country [30] 0 0
Germany
State/province [30] 0 0
Mecklenburg-Western Pomerania
Country [31] 0 0
Germany
State/province [31] 0 0
Rhineland-Palatinate
Country [32] 0 0
Germany
State/province [32] 0 0
Augsburg
Country [33] 0 0
Germany
State/province [33] 0 0
Ballenstedt
Country [34] 0 0
Germany
State/province [34] 0 0
Berlin
Country [35] 0 0
Germany
State/province [35] 0 0
Bochum
Country [36] 0 0
Germany
State/province [36] 0 0
Bonn
Country [37] 0 0
Germany
State/province [37] 0 0
Bremerhaven
Country [38] 0 0
Germany
State/province [38] 0 0
Buxtehude
Country [39] 0 0
Germany
State/province [39] 0 0
Erfurt
Country [40] 0 0
Germany
State/province [40] 0 0
Gera
Country [41] 0 0
Germany
State/province [41] 0 0
Jena
Country [42] 0 0
Germany
State/province [42] 0 0
Kassel
Country [43] 0 0
Germany
State/province [43] 0 0
Koblenz
Country [44] 0 0
Germany
State/province [44] 0 0
Krefeld
Country [45] 0 0
Germany
State/province [45] 0 0
Köln
Country [46] 0 0
Germany
State/province [46] 0 0
Leipzig
Country [47] 0 0
Germany
State/province [47] 0 0
Lübeck
Country [48] 0 0
Germany
State/province [48] 0 0
Mainz
Country [49] 0 0
Germany
State/province [49] 0 0
Minden
Country [50] 0 0
Germany
State/province [50] 0 0
Muenster
Country [51] 0 0
Germany
State/province [51] 0 0
Munchen
Country [52] 0 0
Germany
State/province [52] 0 0
Quedlinburg
Country [53] 0 0
Germany
State/province [53] 0 0
Recklinghausen
Country [54] 0 0
Germany
State/province [54] 0 0
Regensburg
Country [55] 0 0
Germany
State/province [55] 0 0
Rostock
Country [56] 0 0
Germany
State/province [56] 0 0
Saarbruecken
Country [57] 0 0
Germany
State/province [57] 0 0
Schwerin
Country [58] 0 0
Germany
State/province [58] 0 0
Traunstein
Country [59] 0 0
Germany
State/province [59] 0 0
Ulm
Country [60] 0 0
Hungary
State/province [60] 0 0
Budapest
Country [61] 0 0
Hungary
State/province [61] 0 0
Debrecen
Country [62] 0 0
Hungary
State/province [62] 0 0
Deszk
Country [63] 0 0
Hungary
State/province [63] 0 0
Farkasgyepu
Country [64] 0 0
Hungary
State/province [64] 0 0
Miskolc
Country [65] 0 0
Hungary
State/province [65] 0 0
Mátraháza
Country [66] 0 0
Hungary
State/province [66] 0 0
Törökbálint
Country [67] 0 0
Italy
State/province [67] 0 0
Perugia
Country [68] 0 0
Italy
State/province [68] 0 0
Tuscany
Country [69] 0 0
Italy
State/province [69] 0 0
Bari
Country [70] 0 0
Italy
State/province [70] 0 0
Lecce
Country [71] 0 0
Italy
State/province [71] 0 0
Napoli
Country [72] 0 0
Italy
State/province [72] 0 0
Ravenna
Country [73] 0 0
Poland
State/province [73] 0 0
Gdansk
Country [74] 0 0
Poland
State/province [74] 0 0
Olsztyn
Country [75] 0 0
Poland
State/province [75] 0 0
Opole
Country [76] 0 0
Puerto Rico
State/province [76] 0 0
Bayamon
Country [77] 0 0
Spain
State/province [77] 0 0
Cáceres
Country [78] 0 0
Spain
State/province [78] 0 0
Jaen
Country [79] 0 0
Spain
State/province [79] 0 0
Madrid
Country [80] 0 0
Spain
State/province [80] 0 0
Salamanca
Country [81] 0 0
Spain
State/province [81] 0 0
Santander
Country [82] 0 0
Spain
State/province [82] 0 0
Toledo
Country [83] 0 0
Spain
State/province [83] 0 0
Ávila
Country [84] 0 0
Switzerland
State/province [84] 0 0
Aarau
Country [85] 0 0
Switzerland
State/province [85] 0 0
Baden
Country [86] 0 0
Switzerland
State/province [86] 0 0
Chur
Country [87] 0 0
Switzerland
State/province [87] 0 0
Locarno
Country [88] 0 0
United Kingdom
State/province [88] 0 0
Aberdeen
Country [89] 0 0
United Kingdom
State/province [89] 0 0
Bristol
Country [90] 0 0
United Kingdom
State/province [90] 0 0
Cornwall
Country [91] 0 0
United Kingdom
State/province [91] 0 0
Glasgow

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is an observational, multicenter study in patients treated with nivolumab for the
approved indications of melanoma and lung cancer in Australia, the EU, Switzerland, and the
United States (US). Targeted countries in the EU for study participation include Austria,
Belgium, France, Germany, Italy, Spain, Czech Republic, Hungary, Poland and the United
Kingdom (UK). 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.
Trial website
https://clinicaltrials.gov/show/NCT02847728
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Recruiting sites have contact information. Please contact sites directly. If there is no contact information,
Address 0 0
Country 0 0
Phone 0 0
Please email:
Fax 0 0
Email 0 0
clinical.trials@bms.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02847728