At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 1,009 enrolled
Drug / intervention
Nivolumab (BMS-936558)drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Single-Arm, Open-Label, Multicenter Clinical Trial With Nivolumab (BMS-936558) for Subjects With Histologically Confirmed Stage III (Unresectable) or Stage IV Melanoma Progressing Post Prior Treatment Containing an Anti-CTLA4 Monoclonal Antibody
In Brief
A Phase 2 clinical trial evaluating Nivolumab (BMS-936558) for Melanoma. Completed, enrolled 1,009 participants across 170 sites in 20 countries.
Detailed Summary
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 Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMelanoma
CountriesAustria, Belgium, Czechia, Finland, Germany, Greece, Hungary, Ireland, Italy, Luxembourg, Netherlands, Norway, Poland, Portugal, Romania, Russia, Spain, Sweden, Switzerland, United Kingdom
Collaborators--
Timeline
Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJun 2014
Enrollment StartOct 2014
Primary CompletionJan 2019
TodayJul 2026
First PostedJun 5, 2014
Enrollment StartOct 7, 2014
Primary CompletionJan 18, 2019
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 12.1 years ago
Interventions
Nivolumab (BMS-936558)drug