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MelanomaNCT02847728

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

An observational study of Melanoma and Lung Cancer, run by Bristol-Myers Squibb at 94 sites in 14 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Melanoma, Lung Cancer
How many people
1,189 participants
Where
94 sitesin 14 countries
Study dates
28 Jul 2016to 31 Mar 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

94 sites in 14 countries.

94 sites in 14 countries

Germany36 sites

  • Local Institution - 1403

    Augsburg, 86156

  • Local Institution - 1423

    Ballenstedt, 06493

  • Local Institution - 1427

    Berlin, 10117

  • Local Institution - 1411

    Bochum, 44791

  • Local Institution - 1436

    Bonn, 53115

  • Local Institution - 1413

    Bremerhaven, 27574

  • Local Institution - 1407

    Buxtehude, 21614

  • Local Institution - 1419

    Cologne, 51109

  • Local Institution - 1417

    Erfurt, 99089

  • Local Institution - 1416

    Gera, 07548

  • Local Institution - 1428

    Giessen, 35385

  • Local Institution - 1430

    Greifswald, Mecklenburg-Vorpommern, 17475

  • Local Institution - 1422

    Hamburg, 20246

  • Local Institution - 1424

    Hamburg, 22081

  • Local Institution - 1429

    Heidelberg, Baden-Wurttemberg, 69120

  • Local Institution - 1408

    Jena, 07743

  • Local Institution - 1406

    Kassel, 34125

  • Local Institution - 1434

    Koblenz, Rheinland Pfa, 56068

  • Local Institution - 1425

    Leipzig, 04103

  • Local Institution - 1410

    Lübeck, Schleswig-Holstein, 23538

  • Local Institution - 1432

    Ludwigshafen, 67063

  • Local Institution - 1433

    Mainz, 55101

  • Local Institution - 1426

    Mainz, 55131

  • Local Institution - 1405

    Minden, 32429

  • Local Institution - 1431

    München, 80335

  • Local Institution - 1409

    München, 80336

  • Local Institution - 1420

    Münster, 48157

  • Local Institution - 1401

    Quedlinburg, Saxony-Anhalt, 06484

  • Local Institution - 1418

    Recklinghausen, 45657

  • Local Institution - 1402

    Regensburg, 93042

  • Local Institution - 1415

    Rostock, 18107

  • Local Institution - 1421

    Rostock, 18107

  • Local Institution - 1435

    Saarbrücken, 66113

  • Local Institution - 1414

    Schwerin, 19049

  • Local Institution - 1404

    Traunstein, 83278

  • Local Institution - 1412

    Ulm, 89081

Other trials in Germany

United States12 sites

  • Local Institution - 1910

    Alexandria, Louisiana, 71301

  • Local Institution - 1902

    Bethlehem, Pennsylvania, 18015

  • Local Institution - 1915

    El Paso, Texas, 79920

  • Local Institution - 1905

    Fort Sam Houston, Texas, 78234-6200

  • Local Institution - 1913

    Hilton Head Island, South Carolina, 29926

  • Local Institution - 1912

    Jacksonville, Florida, 32204

  • Local Institution - 1908

    Kansas City, Missouri, 64108

  • Local Institution - 1907

    Lake City, Florida, 32024

  • Local Institution - 1911

    Morristown, New Jersey, 07962

  • Local Institution - 1909

    Palm Springs, California, 92262

  • Local Institution - 1901

    Park Ridge, Illinois, 60068

  • Local Institution - 1906

    Tupelo, Mississippi, 38801

Other trials in United States

Spain7 sites

  • Local Institution - 1606

    Ávila, 05004

  • Local Institution - 1605

    Cáceres, 10003

  • Local Institution - 1602

    Jaén, 23007

  • Local Institution - 1601

    Madrid, 28033

  • Local Institution - 1604

    Salamanca, 37007

  • Local Institution - 1607

    Santander, 39008

  • Local Institution - 1603

    Toledo, 45004

Other trials in Spain

France6 sites

  • Local Institution - 1307

    Lyon, 69229

  • Local Institution - 1301

    Metz-Tessy, 74374

  • Local Institution - 1305

    Nancy, 54100

  • Local Institution - 1304

    Saint Jean Priest En Jarez, 42277

  • Local Institution - 1303

    Toulouse, 31059

  • Local Institution - 1302

    Vandœuvre-lès-Nancy, 54519

Other trials in France

Italy6 sites

  • Local Institution - 1501

    Bari, 70124

  • Local Institution - 1506

    Lecce, 73100

  • Local Institution - 1505

    Lucca, 5510

  • Local Institution - 1503

    Naples, 80131

  • Local Institution - 1502

    Ravenna, 48121

  • Local Institution - 1504

    Udine, 33100

Other trials in Italy

Australia5 sites

  • Local Institution - 1006

    Franskton, Victoria, 3199

  • Local Institution - 1001

    Lismore, New South Wales, 2480

  • Local Institution - 1005

    Subiaco, Western Australia, 6008

  • Local Institution - 1002

    Wagga Wagga, New South Wales, 2650

  • Local Institution - 1003

    Wodonga, Victoria, 3690

Other trials in Australia

Hungary5 sites

  • Local Institution - 2107

    Budapest, 1121

  • Local Institution - 2102

    Debrecen, 4032

  • Local Institution - 2106

    Farkasgyepű, 8582

  • Local Institution - 2101

    Gyöngyössolymos, Heves County, 3233

  • Local Institution - 2103

    Törökbálint, 2045

Other trials in Hungary

United Kingdom4 sites

  • Local Institution - 1803

    Aberdeen, Aberdeenshire, AB25 2ZN

  • Local Institution - 1801

    Bristol, BS2 8ED

  • Local Institution - 1804

    Glasgow, Strathclyde, G12 0YN

  • Local Institution - 1802

    Truro, Cornwall, TR1 3LJ

Other trials in United Kingdom

Austria3 sites

  • Local Institution - 1103

    Innsbruck, 6020

  • Local Institution - 1102

    Klagenfurt, 9020

  • Local Institution - 1101

    Krems, 3500

Other trials in Austria

Belgium3 sites

  • Local Institution - 1202

    Brasschaat, Antwerpen, 2930

  • Local Institution - 1203

    Kortrijk, 8500

  • Local Institution - 1201

    Namur, 5000

Other trials in Belgium

Poland3 sites

  • Local Institution - 2202

    Gdansk, 80-219

  • Local Institution - 2203

    Olsztyn, 10-357

  • Local Institution - 2201

    Opole, Opole Voivodeship, 45-061

Other trials in Poland

Switzerland2 sites

  • Local Institution - 1703

    Baden, Canton of Aargau, 5404

  • Local Institution - 1702

    Locarno, 6600

Other trials in Switzerland

Czechia1 site

  • Local Institution - 2002

    Olomouc, 779 00

Other trials in Czechia

Puerto Rico1 site

  • Local Institution - 1904

    Bayamón, 00961

Other trials in Puerto Rico

About this study

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.

Medical subject headings
Melanoma, Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02847728
Study groupRoleWhat they receive
Single Arm DesignThe 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence rate of and severity of immune-related pneumonitis - Melanoma

    Measured: up to nine years

  2. Incidence rate of and severity of immune-related colitis- Melanoma

    Measured: up to nine years

  3. Incidence rate of and severity of immune-related hepatitis - Melanoma

    Measured: up to nine years

  4. Incidence rate of and severity of immune-related nephritis/renal dysfunction - Melanoma

    Measured: up to nine years

  5. Incidence rate of and severity of immune-related endocrinopathies - Melanoma

    Measured: up to nine years

  6. Incidence rate of and severity of immune-related rash (including toxic epidermal necrolysis) - Melanoma

    Measured: up to nine years

  7. Incidence rate of and severity of other immune-related adverse events (eg, uveitis, pancreatitis, demyelination, Guillain-Barre Syndrome, myasthenic syndrome, and encephalitis) - Melanoma

    Measured: up to nine years

  8. Incidence rate of and severity of severe infusion reactions- Melanoma

    Measured: up to nine years

  9. Incidence rate of and severity of immune-related pneumonitis - Lung Cancer

    Measured: up to nine years

  10. Incidence rate of and severity of immune-related colitis - Lung Cancer

    Measured: up to nine years

  11. Incidence rate of and severity of immune-related hepatitis - Lung Cancer

    Measured: up to nine years

  12. Incidence rate of and severity of immune-related nephritis/renal dysfunction - Lung Cancer

    Measured: up to nine years

  13. Incidence rate of and severity of immune-related endocrinopathies - Lung Cancer

    Measured: up to nine years

  14. Incidence rate of and severity of other immune related adverse events (eg, uveitis, pancreatitis, demyelination, Guillain-Barre Syndrome, myasthenic syndrome, and encephalitis) - Lung Cancer

    Measured: up to nine years

  15. Incidence rate of and severity of severe infusion reactions - Lung Cancer

    Measured: up to nine years

  16. Incidence rate of and severity of immune-related rash (including toxic epidermal necrolysis), - Lung Cancer

    Measured: up to nine years

Secondary outcomes (5)

  1. Adverse Events

    Other nivolumab treatment-related AEs

    Measured: Up to nine years

  2. Management of Immune-related AEs:

    Measured: Up to nine years

  3. Outcomes of Immune-related AEs:

    Measured: Up to nine years

  4. Overall Survival:

    1-, 2-, 3-, 4-, and 5-year overall and median survival

    Measured: Up to nine years

  5. Nivolumab treatment pattern

    Measured: Up to nine years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jul 2016 (estimated)
  2. Study start28 Jul 2016
  3. Primary completion31 Mar 2024
  4. Study completion31 Mar 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
1,189 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02847728
Sponsor's protocol ID
CA209-234
Status last verified
May 2024
First submitted
28 Jun 2016
Last updated
3 Jun 2024
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Melanoma and Lung Cancer, run by Bristol-Myers Squibb at 94 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 94 sites in Germany, United States, Spain, France, Italy and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence rate of and severity of immune-related pneumonitis - Melanoma (time frame: up to nine years). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02847728.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2024.

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