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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.
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Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
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Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Observational |
| Eligible Ages | 18 Years and Over |
| Gender | All |
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Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT02847728 |
|
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
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Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Bristol-Myers Squibb |
|
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Bristol-Myers Squibb |
| Principal Investigator Affiliation | Bristol-Myers Squibb |
|
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
| Overall Status | Recruiting |
| Countries | Australia, Austria, Belgium, Czechia, France, Germany, Hungary, Italy, Poland, Puerto Rico, Spain, Switzerland, United Kingdom, United States |
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Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Melanoma, Lung Cancer |
| Study Website: | View Trial Website |
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. The study will be started in 2016, and data collection will be continued until March 2024.
: 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.
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Recruiting
Address
Local Institution
Palm Springs, California, 92262
Status
Recruiting
Address
21st Century Oncology
Jacksonville, Florida, 32204
Status
Recruiting
Address
Lake City Cancer Care, LLC
Lake City, Florida, 32024
Status
Terminated
Address
Local Institution
LaGrange, Georgia, 30240
Status
Recruiting
Address
Oncology Specialists
Park Ridge, Illinois, 60714
Status
Recruiting
Address
CHRISTUS Health St Frances Cabrini Hospital Cancer Center
Alexandria, Louisiana, 71303
Status
Recruiting
Address
NMMC-Hematology and Oncology Clinic
Tupelo, Mississippi, 38801
Status
Active, not recruiting
Address
Ellis Fischel Cancer Center
Columbia, Missouri, 65212
Status
Recruiting
Address
Atlantic Health System/Overlook Medical Center
Summit, New Jersey, 07901
Status
Active, not recruiting
Address
St. Luke's Cancer Center - Anderson
Easton, Pennsylvania, 18045
Status
Recruiting
Address
St. Joseph's/Candler SC Cancer Specialist
Hilton Head Island, South Carolina, 29926
Status
Recruiting
Address
William Beaumont Army Medical Canter
El Paso, Texas, 79920
Status
Recruiting
Address
Local Institution
Houston, Texas, 78234
Status
Recruiting
Address
Local Institution
Lismore, New South Wales, 2480
Status
Recruiting
Address
Local Institution
Wagga Wagga, New South Wales, 2650
Status
Withdrawn
Address
Local Institution
Frankston, Victoria, 3199
Status
Active, not recruiting
Address
Local Institution
Wodonga, Victoria, 3690
Status
Recruiting
Address
Local Institution
Subiaco, Western Australia, 6008
Status
Recruiting
Address
Local Institution
Donau, ,
Status
Recruiting
Address
Local Institution
InnsBruck, , 6020
Status
Recruiting
Address
Local Institution
Klagenfurt, , 9020
Status
Recruiting
Address
Local Institution
Brasschaat, ,
Status
Active, not recruiting
Address
Local Institution
Kortrijk, ,
Status
Recruiting
Address
Local Institution
Namur, ,
Status
Not yet recruiting
Address
Klinika plicnich nemoci Fakultni nemocnice Olomouc
Olomouc, ,
Status
Terminated
Address
Thomayer Hospital Dept. of Pneumology
Prague, ,
Status
Recruiting
Address
Hospices Civils de Lyon
Lyon, , 69002
Status
Recruiting
Address
Local Institution
Nancy, , 54000
Status
Recruiting
Address
Local Institution
Pringy, , 74374
Status
Recruiting
Address
Local Institution
Saint-Priest en Jarez, , 42271
Status
Recruiting
Address
Local Institution
Toulouse, , 31059
Status
Terminated
Address
Local Institution
Vandoeuvre-les-Nancy Cedex, , 54519
Status
Active, not recruiting
Address
Local Institution
Heidelberg, Baden-Württemberg, 69120
Status
Withdrawn
Address
Local Institution
München, Bavaria, 80335
Status
Recruiting
Address
Local Institution
Lerchenfeld, Hamburg, 22081
Status
Recruiting
Address
Local Institution
Giessen, Hesse, 35392
Status
Active, not recruiting
Address
Local Institution
Greifswald, Mecklenburg-Western Pomerania, 17475
Status
Active, not recruiting
Address
Local Institution
Ludwigshafen, Rhineland-Palatinate, 67063
Status
Active, not recruiting
Address
Local Institution
Augsburg, , DE-86179
Status
Withdrawn
Address
Local Institution
Ballenstedt, , 06493
Status
Active, not recruiting
Address
Local Institution
Berlin, , 10117
Status
Terminated
Address
Local Institution
Bochum, , 5644791
Status
Recruiting
Address
Local Institution
Bonn, , 53115
Status
Withdrawn
Address
Local Institution
Bremerhaven, , 27574
Status
Active, not recruiting
Address
Local Institution
Buxtehude, , DE-21614
Status
Active, not recruiting
Address
Local Institution
Erfurt, , 99089
Status
Active, not recruiting
Address
Local Institution
Gera, , 07548
Status
Active, not recruiting
Address
Local Institution
Hamburg, , 20246
Status
Active, not recruiting
Address
Local Institution
Jena, , DE-07743
Status
Active, not recruiting
Address
Local Institution
Kassel, , DE-34125
Status
Recruiting
Address
Local Institution
Koblenz, , 56068
Status
Recruiting
Address
Local Institution
Krefeld, , 47805
Status
Recruiting
Address
Local Institution
Köln, , 51109
Status
Active, not recruiting
Address
Local Institution
Leipzig, , 04103
Status
Active, not recruiting
Address
Local Institution
Lübeck, , 23538
Status
Active, not recruiting
Address
Local Institution
Mainz, , 155131
Status
Active, not recruiting
Address
Local Institution
Mainz, , 55131
Status
Active, not recruiting
Address
Local Institution
Minden, , DE-32429
Status
Active, not recruiting
Address
Local Institution
Muenster, , 48157
Status
Recruiting
Address
Local Institution
Munchen, , DE-80336
Status
Active, not recruiting
Address
Local Institution
Quedlinburg, , DE-06484
Status
Active, not recruiting
Address
Local Institution
Recklinghausen, , 45659
Status
Active, not recruiting
Address
Local Institution
Regensburg, , DE93053
Status
Recruiting
Address
Local Institution
Rostock, , 18107
Status
Recruiting
Address
Local Institution
Saarbruecken, , 66113
Status
Active, not recruiting
Address
Local Institution
Schwerin, , 19049
Status
Active, not recruiting
Address
Local Institution
Traunstein, , 383278
Status
Recruiting
Address
Local Institution
Ulm, , 23 89081
Status
Not yet recruiting
Address
OKPI Orszagos Koranyi TBC es Pulmonologiai Intezet
Budapest, ,
Status
Not yet recruiting
Address
Orszagos Koranyi Pulm. Intezet
Budapest, ,
Status
Not yet recruiting
Address
University of Debrecen, Clinical Centre Departure of Pulmonology- Debreceni Egyetem Klinikai Központ Tüdőgyógyászati Klinika
Debrecen, ,
Status
Terminated
Address
Csongrad Megyei Mellkasi Betegsegek Szakkorhaza
Deszk, ,
Status
Active, not recruiting
Address
Veszprem Megyei Tudogyogyintezet Farkasgyepu
Farkasgyepű, ,
Status
Not yet recruiting
Address
Semmelweis Hospital and University Teaching Hospital Miskolc, Department of Pulmonology
Miskolc, ,
Status
Active, not recruiting
Address
Mátrai Gyógyintézet
Mátraháza, ,
Status
Not yet recruiting
Address
Pulmonology Hospital Torokbalint
Törökbálint, ,
Status
Recruiting
Address
Local Institution
Sant'Andrea Delle Fratte, Perugia, 06132
Status
Recruiting
Address
Local Institution
Lucca, Tuscany, 55100
Status
Active, not recruiting
Address
Local Institution
Bari, , 70124
Status
Recruiting
Address
A.O Vito Fazzi -Polo Oncologico
Lecce, , 73100
Status
Active, not recruiting
Address
Local Institution
Napoli, , 80131
Status
Recruiting
Address
Local Institution
Ravenna, , 48121
Status
Not yet recruiting
Address
Wojevodzkie Centrum Onkologii u Gdansk
Gdańsk, ,
Status
Not yet recruiting
Address
Samodzielny Publiczny Zespół Gruźlicy i Chorób Płuc, Oddzial Onkologii z Pododzialem Chemioterapii
Olsztyn, ,
Status
Not yet recruiting
Address
Opolskie Centrum Onkologii im. Prof. T. Koszarowskiego w Opolu, Oddział Onkologii Klinicznej z Odcinkiem Dziennym
Opole, ,
Status
Active, not recruiting
Address
Puerto Rico Hematology Oncology Group
Bayamon, , 00961
Status
Terminated
Address
Local Institution
Cáceres, , 10003
Status
Recruiting
Address
Local Institution
Jaen, , 23007
Status
Recruiting
Address
Local Institution
Madrid, , 28033
Status
Recruiting
Address
Local Institution
Salamanca, , 37007
Status
Active, not recruiting
Address
Local Institution
Santander, , 39008
Status
Recruiting
Address
Local Institution
Toledo, , 45004
Status
Recruiting
Address
Local Institution
Ávila, , 05004
Status
Terminated
Address
Local Institution
Aarau, , 5001
Status
Recruiting
Address
Local Institution
Baden, , 5404
Status
Terminated
Address
Local Institution
Chur, , CH-7000
Status
Recruiting
Address
Local Institution
Locarno, , 6600
Status
Recruiting
Address
Local Institution
Aberdeen, , AB252ZN
Status
Active, not recruiting
Address
Local Institution
Bristol, , BS2 8ED
Status
Active, not recruiting
Address
Local Institution
Cornwall, , TR1 3LJ
Status
Terminated
Address
Local Institution
Glasgow, , G12 0YN
