Study to Evaluate the Safety and Efficacy of Two Different Dosing Schedules of Pembrolizumab (MK-3475) Compared to Ipilimumab in Participants With Advanced Melanoma (MK-3475-006/KEYNOTE-006)

This is a three-arm study to evaluate the safety and efficacy of two dosing schedules of pembrolizumab (MK-3475) compared to ipilimumab for the treatment of ipilimumab-naïve participants with unresectable or metastatic melanoma.


Study Type: Interventional
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Controlled, Three-Arm, Phase III Study to Evaluate the Safety and Efficacy of Two Dosing Schedules of MK-3475 Compared to Ipilimumab in Patients With Advanced Melanoma
Estimated Enrollment: 645
Study Start Date: August 2013
Estimated Study Completion Date: March 2016
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)

Arms:
- Experimental: Pembrolizumab Every 2 Weeks
- Experimental: Pembrolizumab Every 3 Weeks
- Active Comparator: Ipilimumab


Related journal: Pembrolizumab versus Ipilimumab in Advanced Melanoma.