At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 834 enrolled
Drug / intervention
Pembrolizumab +1 morebiological
Likely dose
Pembrolizumab 10 mg/kgfrom 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 Multicenter, Randomized, Controlled, Three-Arm, Phase III Study to Evaluate the Safety and Efficacy of Two Dosing Schedules of Pembrolizumab (MK-3475) Compared to Ipilimumab in Patients With Advanced Melanoma
In Brief
A Phase 3 clinical trial evaluating Pembrolizumab and Ipilimumab for Melanoma. Completed, enrolled 834 participants.
Detailed Summary
This study will evaluate the safety and efficacy of 2 different dosing schedules of pembrolizumab (MK-3475), every 2 weeks (Q2W) and every 3 weeks (Q3W), and compare the 2 schedules to treatment with ipilimumab in ipilimumab-naïve participants with unresectable or metastatic melanoma. The primary hypotheses are that pembrolizumab is superior to ipilimumab with respect to progression-free survival (PFS) and overall survival (OS).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMelanoma
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMay 2013
Enrollment StartAug 2013
Primary CompletionMar 2015
Study CompletionJun 2019
TodayJul 2026
First PostedMay 31, 2013
Enrollment StartAug 28, 2013
Primary CompletionMar 3, 2015
Study CompletionJun 3, 2019
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 13.1 years ago
Interventions
Pembrolizumabbiological
10 mg/kg IV, administered Q2W or Q3W based upon randomization.
Ipilimumabbiological
3 mg/kg IV Q3W.