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

May 31, 2024 updated by: Bristol-Myers Squibb
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

1189

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Lismore, New South Wales, Australia, 2480
        • Local Institution - 1001
      • Wagga Wagga, New South Wales, Australia, 2650
        • Local Institution - 1002
    • Victoria
      • Franskton, Victoria, Australia, 3199
        • Local Institution - 1006
      • Wodonga, Victoria, Australia, 3690
        • Local Institution - 1003
    • Western Australia
      • Subiaco, Western Australia, Australia, 6008
        • Local Institution - 1005
  • Austria
      • Innsbruck, Austria, 6020
        • Local Institution - 1103
      • Klagenfurt Am Woerthersee, Austria, 9020
        • Local Institution - 1102
      • Krems an der Donau, Austria, 3500
        • Local Institution - 1101
  • Belgium
      • Kortrijk, Belgium, 8500
        • Local Institution - 1203
      • Namur, Belgium, 5000
        • Local Institution - 1201
    • Antwerpen
      • Brasschaat, Antwerpen, Belgium, 2930
        • Local Institution - 1202
  • Czechia
      • Olomouc, Czechia, 779 00
        • Local Institution - 2002
  • France
      • Lyon, France, 69229
        • Local Institution - 1307
      • Metz-Tessy, France, 74374
        • Local Institution - 1301
      • Nancy, France, 54100
        • Local Institution - 1305
      • Saint Jean Priest En Jarez, France, 42277
        • Local Institution - 1304
      • Toulouse, France, 31059
        • Local Institution - 1303
      • Vandoeuvre-les-Nancy, France, 54519
        • Local Institution - 1302
  • Germany
      • Augsburg, Germany, 86156
        • Local Institution - 1403
      • Ballenstedt, Germany, 06493
        • Local Institution - 1423
      • Berlin, Germany, 10117
        • Local Institution - 1427
      • Bochum, Germany, 44791
        • Local Institution - 1411
      • Bonn, Germany, 53115
        • Local Institution - 1436
      • Bremerhaven, Germany, 27574
        • Local Institution - 1413
      • Buxtehude, Germany, 21614
        • Local Institution - 1407
      • Cologne, Germany, 51109
        • Local Institution - 1419
      • Erfurt, Germany, 99089
        • Local Institution - 1417
      • Gera, Germany, 07548
        • Local Institution - 1416
      • Giessen, Germany, 35385
        • Local Institution - 1428
      • Hamburg, Germany, 20246
        • Local Institution - 1422
      • Hamburg, Germany, 22081
        • Local Institution - 1424
      • Jena, Germany, 07743
        • Local Institution - 1408
      • Kassel, Germany, 34125
        • Local Institution - 1406
      • Leipzig, Germany, 04103
        • Local Institution - 1425
      • Ludwigshafen, Germany, 67063
        • Local Institution - 1432
      • Mainz, Germany, 55101
        • Local Institution - 1433
      • Mainz, Germany, 55131
        • Local Institution - 1426
      • Minden, Germany, 32429
        • Local Institution - 1405
      • Muenchen, Germany, 80335
        • Local Institution - 1431
      • München, Germany, 80336
        • Local Institution - 1409
      • Münster, Germany, 48157
        • Local Institution - 1420
      • Recklinghausen, Germany, 45657
        • Local Institution - 1418
      • Regensburg, Germany, 93042
        • Local Institution - 1402
      • Rostock, Germany, 18107
        • Local Institution - 1415
      • Rostock, Germany, 18107
        • Local Institution - 1421
      • Saarbrucken, Germany, 66113
        • Local Institution - 1435
      • Schwerin, Germany, 19049
        • Local Institution - 1414
      • Traunstein, Germany, 83278
        • Local Institution - 1404
      • Ulm, Germany, 89081
        • Local Institution - 1412
    • Baden-Württemberg
      • Heidelberg, Baden-Württemberg, Germany, 69120
        • Local Institution - 1429
    • Mecklenburg-Vorpommern
      • Greifswald, Mecklenburg-Vorpommern, Germany, 17475
        • Local Institution - 1430
    • Rheinland Pfa
      • Koblenz, Rheinland Pfa, Germany, 56068
        • Local Institution - 1434
    • Sachsen-Anhalt
      • Quedlinburg, Sachsen-Anhalt, Germany, 06484
        • Local Institution - 1401
    • Schleswig-Holstein
      • Luebeck, Schleswig-Holstein, Germany, 23538
        • Local Institution - 1410
  • Hungary
      • Budapest, Hungary, 1121
        • Local Institution - 2107
      • Debrecen, Hungary, 4032
        • Local Institution - 2102
      • Farkasgyepu, Hungary, 8582
        • Local Institution - 2106
      • Torokbalint, Hungary, 2045
        • Local Institution - 2103
    • Heves
      • Gyongyossolymos, Heves, Hungary, 3233
        • Local Institution - 2101
  • Italy
      • Bari, Italy, 70124
        • Local Institution - 1501
      • Lecce, Italy, 73100
        • Local Institution - 1506
      • Lucca, Italy, 5510
        • Local Institution - 1505
      • Napoli, Italy, 80131
        • Local Institution - 1503
      • Ravenna, Italy, 48121
        • Local Institution - 1502
      • Udine, Italy, 33100
        • Local Institution - 1504
  • Poland
      • Gdansk, Poland, 80-219
        • Local Institution - 2202
      • Olsztyn, Poland, 10-357
        • Local Institution - 2203
    • Opolskie
      • Opole, Opolskie, Poland, 45-061
        • Local Institution - 2201
  • Puerto Rico
      • Bayamon, Puerto Rico, 00961
        • Local Institution - 1904
  • Spain
      • Avila, Spain, 05004
        • Local Institution - 1606
      • Caceres, Spain, 10003
        • Local Institution - 1605
      • Jaen, Spain, 23007
        • Local Institution - 1602
      • Madrid, Spain, 28033
        • Local Institution - 1601
      • Salamanca, Spain, 37007
        • Local Institution - 1604
      • Santander, Spain, 39008
        • Local Institution - 1607
      • Toledo, Spain, 45004
        • Local Institution - 1603
  • Switzerland
      • Locarno, Switzerland, 6600
        • Local Institution - 1702
    • Aargau
      • Baden, Aargau, Switzerland, 5404
        • Local Institution - 1703
  • United Kingdom
      • Bristol, United Kingdom, BS2 8ED
        • Local Institution - 1801
    • Aberdeenshire
      • Aberdeen, Aberdeenshire, United Kingdom, AB25 2ZN
        • Local Institution - 1803
    • Cornwall
      • Truro, Cornwall, United Kingdom, TR1 3LJ
        • Local Institution - 1802
    • Strathclyde
      • Glasgow, Strathclyde, United Kingdom, G12 0YN
        • Local Institution - 1804
  • United States
    • California
      • Palm Springs, California, United States, 92262
        • Local Institution - 1909
    • Florida
      • Jacksonville, Florida, United States, 32204
        • Local Institution - 1912
      • Lake City, Florida, United States, 32024
        • Local Institution - 1907
    • Illinois
      • Park Ridge, Illinois, United States, 60068
        • Local Institution - 1901
    • Louisiana
      • Alexandria, Louisiana, United States, 71301
        • Local Institution - 1910
    • Mississippi
      • Tupelo, Mississippi, United States, 38801
        • Local Institution - 1906
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Local Institution - 1908
    • New Jersey
      • Morristown, New Jersey, United States, 07962
        • Local Institution - 1911
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18015
        • Local Institution - 1902
    • South Carolina
      • Hilton Head Island, South Carolina, United States, 29926
        • Local Institution - 1913
    • Texas
      • El Paso, Texas, United States, 79920
        • Local Institution - 1915
      • Fort Sam Houston, Texas, United States, 78234-6200
        • Local Institution - 1905

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence rate of and severity of immune-related pneumonitis - Melanoma
Time Frame: up to nine years
up to nine years
Incidence rate of and severity of immune-related colitis- Melanoma
Time Frame: up to nine years
up to nine years
Incidence rate of and severity of immune-related hepatitis - Melanoma
Time Frame: up to nine years
up to nine years
Incidence rate of and severity of immune-related nephritis/renal dysfunction - Melanoma
Time Frame: up to nine years
up to nine years
Incidence rate of and severity of immune-related endocrinopathies - Melanoma
Time Frame: up to nine years
up to nine years
Incidence rate of and severity of immune-related rash (including toxic epidermal necrolysis) - Melanoma
Time Frame: up to nine years
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
Time Frame: up to nine years
up to nine years
Incidence rate of and severity of severe infusion reactions- Melanoma
Time Frame: up to nine years
up to nine years
Incidence rate of and severity of immune-related pneumonitis - Lung Cancer
Time Frame: up to nine years
up to nine years
Incidence rate of and severity of immune-related colitis - Lung Cancer
Time Frame: up to nine years
up to nine years
Incidence rate of and severity of immune-related hepatitis - Lung Cancer
Time Frame: up to nine years
up to nine years
Incidence rate of and severity of immune-related nephritis/renal dysfunction - Lung Cancer
Time Frame: up to nine years
up to nine years
Incidence rate of and severity of immune-related endocrinopathies - Lung Cancer
Time Frame: up to nine years
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
Time Frame: up to nine years
up to nine years
Incidence rate of and severity of severe infusion reactions - Lung Cancer
Time Frame: up to nine years
up to nine years
Incidence rate of and severity of immune-related rash (including toxic epidermal necrolysis), - Lung Cancer
Time Frame: up to nine years
up to nine years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: Up to nine years
Other nivolumab treatment-related AEs
Up to nine years
Management of Immune-related AEs:
Time Frame: Up to nine years
Up to nine years
Outcomes of Immune-related AEs:
Time Frame: Up to nine years
Up to nine years
Overall Survival:
Time Frame: Up to nine years
1-, 2-, 3-, 4-, and 5-year overall and median survival
Up to nine years
Nivolumab treatment pattern
Time Frame: Up to nine years
Up to nine years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 28, 2016

Primary Completion (Actual)

March 31, 2024

Study Completion (Actual)

March 31, 2024

Study Registration Dates

First Submitted

June 28, 2016

First Submitted That Met QC Criteria

July 25, 2016

First Posted (Estimated)

July 28, 2016

Study Record Updates

Last Update Posted (Actual)

June 3, 2024

Last Update Submitted That Met QC Criteria

May 31, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA209-234

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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