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



Status:Recruiting
Conditions:Lung Cancer, Skin Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:11/3/2018
Start Date:July 31, 2016
End Date:December 31, 2024
Contact:Recruiting sites have contact information. Please contact sites directly. If there in no contact information,
Email:clinical.trials@bms.com
Phone:Please email:

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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, 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.

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, 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.

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

Other protocol defined inclusion and exclusion criteria could apply
We found this trial at
16
sites
Alexandria, Louisiana 71301
Principal Investigator: Steven Saccaro, MD
Phone: 318-466-6026
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from
Alexandria, LA
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Columbia, Missouri 65203
Principal Investigator: Daniel Kingsley
Phone: 573-884-4979
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mi
from
Columbia, MO
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Easton, Pennsylvania 18045
Principal Investigator: Sanjiv Agarwala
Phone: 484-503-4500
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mi
from
Easton, PA
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El Paso, Texas 79920
Phone: 915-742-3432
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mi
from
El Paso, TX
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Germantown, Tennessee 38138
Phone: 901-685-5969
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mi
from
Germantown, TN
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Hilton Head Island, South Carolina 29926
Principal Investigator: Gary Thomas
Phone: 843-689-2895
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mi
from
Hilton Head Island, SC
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Houston, Texas 77030
Phone: 210-916-3332
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from
Houston, TX
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Jacksonville, Florida 32256
Principal Investigator: Troy H. Guthrie
Phone: 904-427-1217
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mi
from
Jacksonville, FL
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2508 Hamilton Road
LaGrange, Georgia 30240
Phone: 706-812-2437
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mi
from
LaGrange, GA
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289 Southwest Stonegate Terrace
Lake City, Florida 32024
Principal Investigator: Waseemullah Khan
Phone: 386-755-2330
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from
Lake City, FL
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58 Ballina Road
Lismore, New South Wales 2480
Phone: +612 6629 4559
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from
Lismore,
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Niles, Illinois 60714
Principal Investigator: Sigrun Hallmeyer
Phone: 847-268-8200
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from
Niles, IL
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555 East Tachevah Drive
Palm Springs, California 92262
Phone: 760-416-4736
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mi
from
Palm Springs, CA
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Park Ridge, Illinois 60068
Principal Investigator: Sigrun Hallmeyer
Phone: 847-268-8200
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mi
from
Park Ridge, IL
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Summit, New Jersey 07901
Principal Investigator: Dennis Lowenthal, MD
Phone: 973-971-6298
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mi
from
Summit, NJ
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961 South Gloster Street
Tupelo, Mississippi 38801
Principal Investigator: Jiahuai Tan
Phone: 662-377-4550
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from
Tupelo, MS
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