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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bristol-Myers Squibb

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 28, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 28, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2016

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 28, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 3, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 31, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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