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)

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT01866319
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pembrolizumab — BIOLOGICAL
    10 mg/kg IV, administered Q2W or Q3W based upon randomization.
  • Ipilimumab — BIOLOGICAL
    3 mg/kg IV Q3W.

Study Details

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).

Key Dates

Start date
Aug 28, 2013
Status verified
May 2020
Primary completion
Mar 3, 2015
Completion
Jun 3, 2019

Study Design

Enrollment
834 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ipilimumab
    Participants receive ipilimumab, 3 mg/kg intravenously (IV), once every 3 weeks (Q3W) for a total of 4 doses (up to approximately 3 months).
  • Experimental: Pembrolizumab Q2W
    Participants receive pembrolizumab, 10 mg/kg IV, once every 2 weeks (Q2W) for up to approximately 24 months.
  • Active Comparator: Pembrolizumab Q3W
    Participants receive pembrolizumab, 10 mg/kg IV, Q3W for up to approximately 24 months.

Primary Outcome Measure

Progression-free Survival (PFS) According to Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Independent Radiology Plus Oncology Review (IRO) [ Time Frame: Up to approximately 12 months (through first pre-specified statistical analysis cut-off date of 03-Sep-2014) ]

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