The purpose of this study is to determine the rate and frequency of high-grade (CTCAE v4.0 Grade 3 or higher), treatment-related, select adverse events in subjects with histologically confirmed stage III (unresectable) or stage IV melanoma and progression post prior treatment containing an anti-Cytotoxic T Lymphocyte Antigen (CTLA-4) monoclonal antibody, treated with Nivolumab (BMS-936558) at a dose of 3 mg/kg every two weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1,009
Local Institution
Graz, Austria
Local Institution
Innsbruck, Austria
Local Institution
Salzburg, Austria
Local Institution
Sankt Pölten, Austria
Local Institution
Vienna, Austria
Local Institution
Wein, Austria
the Incidence of Highgrade (CTCAE v4.0 Grade 3 or Higher), Treatment Related,Select Adverse Events.
The number of participants who reported high-grade (CTCAE v4.0 Grade 3 or higher), treatment-related, select AEs (pulmonary,gastrointestinal, skin, renal, hepatic, endocrine) were summarized using the all treated analysis set by system organ class and Medical Dictionary for Regulatory (MedDRA) preferred term.
Time frame: Up to 2 years
The Incidence of All High-grade (Grades 3 and Higher), Select Adverse Events
The number of Participants who reported high-grade (CTCAE v4.0 Grade 3 or higher), select AEs were summarized using the all treated analysis set by system organ class and MedDRA preferred term.
Time frame: Up to 2 years
Median Time to Onset (Grades 3-4) of Select Adverse Events
Select AEs were summarized according to their incidence as well as their time to onset.
Time frame: Up to 2 years.
Median Time to Resolution (Grades 3-4) of Select Adverse Events
Select AEs were summarized according to their incidence as well as their time to resolution
Time frame: Up to 2 years
Overall Survival
The time from first dosing date to the date of death.
Time frame: Up to 4 years
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Institut Jules Bordet
Brussels, Belgium
Universitair Ziekenhuis Brussel
Brussels, Belgium
Cliniques Universitaires Saint-Luc
Brussels, Belgium
Local Institution
Edegem, Belgium
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