At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 170 enrolled
Drug / intervention
Nivolumab +1 morebiological
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.
An Exploratory Study of the Biologic Effects of Nivolumab and Ipilimumab Monotherapy and Nivolumab in Combination With Ipilimumab Treatment in Subjects With Advanced Melanoma (Unresectable or Metastatic)
In Brief
A Phase 1 clinical trial evaluating Nivolumab and Ipilimumab for Advanced Melanoma and Metastatic Melanoma. Completed, enrolled 170 participants across 14 sites in 3 countries.
Detailed Summary
The purpose of this study is to evaluate pharmacodynamic changes of Nivolumab and Nivolumab in combination with Ipilimumab treatment on the biomarkers measured in the peripheral blood and tumor tissues of subjects with advanced melanoma (unresectable or advanced)
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced Melanoma, Metastatic Melanoma
CountriesNetherlands, Spain, United States
Collaborators--
Timeline
Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJun 2012
Enrollment StartSep 2012
Primary CompletionSep 2017
Study CompletionOct 2018
TodayJul 2026
First PostedJun 18, 2012
Enrollment StartSep 27, 2012
Primary CompletionSep 12, 2017
Study CompletionOct 25, 2018
TodayJul 2, 2026
Enrollment to primary: 5.0 yearsPosted 14.0 years ago
Interventions
Nivolumabbiological
Ipilimumabdrug