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

NCT ID: NCT02847728

Last Updated: 2024-06-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1189 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-07-28
• Study Completion Date: 2024-03-31

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.

Conditions

Melanoma; Lung Cancer

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

Local Institution - 1909

Palm Springs, California, United States

Local Institution - 1912

Jacksonville, Florida, United States

Local Institution - 1907

Lake City, Florida, United States

Local Institution - 1901

Park Ridge, Illinois, United States

Local Institution - 1910

Alexandria, Louisiana, United States

Local Institution - 1906

Tupelo, Mississippi, United States

Local Institution - 1908

Kansas City, Missouri, United States

Local Institution - 1911

Morristown, New Jersey, United States

Local Institution - 1902

Bethlehem, Pennsylvania, United States

Local Institution - 1913

Hilton Head Island, South Carolina, United States

Local Institution - 1915

El Paso, Texas, United States

Local Institution - 1905

Fort Sam Houston, Texas, United States

Local Institution - 1001

Lismore, New South Wales, Australia

Local Institution - 1002

Wagga Wagga, New South Wales, Australia

Local Institution - 1006

Franskton, Victoria, Australia

Local Institution - 1003

Wodonga, Victoria, Australia

Local Institution - 1005

Subiaco, Western Australia, Australia

Local Institution - 1103

Innsbruck, , Austria

Local Institution - 1102

Klagenfurt, , Austria

Local Institution - 1101

Krems, , Austria

Local Institution - 1202

Brasschaat, Antwerpen, Belgium

Local Institution - 1203

Kortrijk, , Belgium

Local Institution - 1201

Namur, , Belgium

Local Institution - 2002

Olomouc, , Czechia

Local Institution - 1307

Lyon, , France

Local Institution - 1301

Metz-Tessy, , France

Local Institution - 1305

Nancy, , France

Local Institution - 1304

Saint Jean Priest En Jarez, , France

Local Institution - 1303

Toulouse, , France

Local Institution - 1302

Vandœuvre-lès-Nancy, , France

Local Institution - 1429

Heidelberg, Baden-Wurttemberg, Germany

Local Institution - 1430

Greifswald, Mecklenburg-Vorpommern, Germany

Local Institution - 1434

Koblenz, Rheinland Pfa, Germany

Local Institution - 1401

Quedlinburg, Saxony-Anhalt, Germany

Local Institution - 1410

Lübeck, Schleswig-Holstein, Germany

Local Institution - 1403

Augsburg, , Germany

Local Institution - 1423

Ballenstedt, , Germany

Local Institution - 1427

Berlin, , Germany

Local Institution - 1411

Bochum, , Germany

Local Institution - 1436

Bonn, , Germany

Local Institution - 1413

Bremerhaven, , Germany

Local Institution - 1407

Buxtehude, , Germany

Local Institution - 1419

Cologne, , Germany

Local Institution - 1417

Erfurt, , Germany

Local Institution - 1416

Gera, , Germany

Local Institution - 1428

Giessen, , Germany

Local Institution - 1422

Hamburg, , Germany

Local Institution - 1424

Hamburg, , Germany

Local Institution - 1408

Jena, , Germany

Local Institution - 1406

Kassel, , Germany

Local Institution - 1425

Leipzig, , Germany

Local Institution - 1432

Ludwigshafen, , Germany

Local Institution - 1433

Mainz, , Germany

Local Institution - 1426

Mainz, , Germany

Local Institution - 1405

Minden, , Germany

Local Institution - 1431

München, , Germany

Local Institution - 1409

München, , Germany

Local Institution - 1420

Münster, , Germany

Local Institution - 1418

Recklinghausen, , Germany

Local Institution - 1402

Regensburg, , Germany

Local Institution - 1415

Rostock, , Germany

Local Institution - 1421

Rostock, , Germany

Local Institution - 1435

Saarbrücken, , Germany

Local Institution - 1414

Schwerin, , Germany

Local Institution - 1404

Traunstein, , Germany

Local Institution - 1412

Ulm, , Germany

Local Institution - 2101

Gyöngyössolymos, Heves County, Hungary

Local Institution - 2107

Budapest, , Hungary

Local Institution - 2102

Debrecen, , Hungary

Local Institution - 2106

Farkasgyepű, , Hungary

Local Institution - 2103

Törökbálint, , Hungary

Local Institution - 1501

Bari, , Italy

Local Institution - 1506

Lecce, , Italy

Local Institution - 1505

Lucca, , Italy

Local Institution - 1503

Napoli, , Italy

Local Institution - 1502

Ravenna, , Italy

Local Institution - 1504

Udine, , Italy

Local Institution - 2201

Opole, Opole Voivodeship, Poland

Local Institution - 2202

Gdansk, , Poland

Local Institution - 2203

Olsztyn, , Poland

Local Institution - 1904

Bayamón, , Puerto Rico

Local Institution - 1606

Ávila, , Spain

Local Institution - 1605

Cáceres, , Spain

Local Institution - 1602

Jaén, , Spain

Local Institution - 1601

Madrid, , Spain

Local Institution - 1604

Salamanca, , Spain

Local Institution - 1607

Santander, , Spain

Local Institution - 1603

Toledo, , Spain

Local Institution - 1703

Baden, Canton of Aargau, Switzerland

Local Institution - 1702

Locarno, , Switzerland

Local Institution - 1803

Aberdeen, Aberdeenshire, United Kingdom

Local Institution - 1802

Truro, Cornwall, United Kingdom

Local Institution - 1804

Glasgow, Strathclyde, United Kingdom

Local Institution - 1801

Bristol, , United Kingdom

Countries

United States; Australia; Austria; Belgium; Czechia; France; Germany; Hungary; Italy; Poland; Puerto Rico; Spain; Switzerland; United Kingdom

Related Links

https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

BMS Clinical Trial Information

https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm

FDA Safety Alerts and Recalls

https://www.bmsstudyconnect.com/s/US/English/USenHome

BMS Clinical Trial Patient Recruiting

Other Identifiers

CA209-234

Identifier Type: -

Identifier Source: org_study_id