This study will generate safety data on Nivolumab given by itself in treatment of advanced Renal Cell Carcinoma (RCC). The primary objective of this study is to assess immune related side effects, also known as immune-mediated adverse events (IMAEs), in patients treated with Nivolumab.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
197
Percentage of Participants Who Experienced High-Grade (Grade 3-4 and Grade 5) Immune Mediated Adverse Events (IMAEs)
IMAEs were tabulated using worst grade per Common Terminology Criteria for Adverse Events, National Cancer Institute (NCI CTCAE) Version 4.0 criteria by system organ class and MedDRA version 20.1 preferred term.
Time frame: Up to 100 days of the last dose of study drug (Approximately 2 years)
Median Time to Onset of High Grade (Grade 3-5) Immune Mediated Adverse Events
Time to onset was calculated from first dosing date to the event onset date. If a participant never experienced the given AE, the participant will be censored at the last contact date.
Time frame: Up to 100 days of the last dose of study drug (Approximately 10 months up to 26 months)
Median Time to Resolution of High Grade (Grade 3-5) Immune Mediated Adverse Events
Time-to resolution of grade 3-5 AE was defined as the longest time from onset to complete resolution or improvement to the grade at baseline among all clustered select AEs in the category experienced by the participant. Events which worsened into grade 5 events (death) or have a resolution date equal to the date of death are considered unresolved. If a clustered AE is considered as unresolved, the resolution date will be censored to the last known date alive.
Time frame: From onset of grade 3-5 IMAEs to resolution of IMAEs (Approximately 4 years and 7 months)
Percentage of Participants Who Receive Immune Modulating Medication for the Immune-Mediated Event (Any Grade)
Immune modulating medication includes corticosteroids, infliximab, cyclophosphamide, Intravenous immunoglobulin (IVIG), and mycophenolate mofetil
Time frame: Up to 100 days of the last dose of study drug (Approximately 3 years and 2 months)
Percentage of Participants Who Receive More Than Equal to (>=) 40 mg Prednisone Equivalents for the Immune-Mediated Event
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Local Institution - 0030
Phoenix, Arizona, United States
Comprehensive Blood And Cancer Center
Bakersfield, California, United States
St. Jude Hospital Yorba Linda
Fullerton, California, United States
Cancer Care Associates Medical Group, Inc.
Redondo Beach, California, United States
Sansum Santa Barbara Medical Foundation Clinic
Santa Barbara, California, United States
University Of Colorado
Aurora, Colorado, United States
Local Institution - 0028
Grand Junction, Colorado, United States
Local Institution - 0018
Lakewood, Colorado, United States
Local Institution - 0008
Fort Myers, Florida, United States
Baptist Health Medical Group Oncology
Miami, Florida, United States
...and 29 more locations
Immune modulating medication includes corticosteroids, infliximab, cyclophosphamide, Intravenous immunoglobulin (IVIG), and mycophenolate mofetil
Time frame: Up to 100 days of the last dose of study drug (Approximately 3 years and 2 months)
Total Duration of All Immune Modulating Medications Given for the Immune-Mediated Event
Immune modulating medication includes corticosteroids, infliximab, cyclophosphamide, Intravenous immunoglobulin (IVIG), and mycophenolate mofetil.
Time frame: From the initiation of Immune modulating medication to discontinuation (approximately 4 years and 9 months).)
Percentage of Participants With a Resolution of IMAEs After Initiating Immune Modulating Medication
Percentage of participants with a resolution of IMAEs after initiating immune modulating medication.
Time frame: Up to 100 days of the last dose of study drug (Approximately 2 years)