Summary
The purpose of this study is to evaluate the long-term safety and efficacy of
pembrolizumab (MK-3475) in participants from previous Merck pembrolizumab-based parent
studies who transition into this extension study.
This study will consist of three phases: 1) First Course Phase, 2) Survival Follow-up
Phase or 3) Second Course Phase. Each participant will transition to this extension study
in one of the following three phases, depending on the study phase they were in at the
completion of the parent study. Participants who were in the First Course Phase of study
treatment with pembrolizumab or lenvatinib in their parent study will enter the First
Course Phase of this study and complete up to 35 doses or more every 3 weeks (Q3W) or 17
doses or more every 6 weeks (Q6W) of study treatment with pembrolizumab or a
pembrolizumab-based combination or lenvatinib according to arm assignment. Participants
who were in the Follow-up Phase in the parent study (post-treatment or Survival Follow-up
Phase) will enter the Survival Follow-up Phase of this study. Participants who were in
the Second Course Phase in their parent study will enter Second Course Phase of this
study and complete up to 17 doses Q3W or 8 doses Q6W of study treatment with
pembrolizumab or a pembrolizumab-based combination according to arm assignment.
Any participant originating from a parent trial where crossover to pembrolizumab was
permitted upon disease progression may be eligible for 35 doses as Q3W or 17 doses Q6W of
pembrolizumab (approximately 2 years), if they progress while on the control arm and
pembrolizumab is approved for the indication in the country where the potential eligible
crossover participant is being evaluated.
Treatment Sites in Georgia
Emory University School of Medicine
1440 Clifton Road
Atlanta, GA 30322
Northwest Georgia Oncology Centers - Cobb Hospital (Hiram)144 Bill Carruth Parkway
Suite 3100
Hiram, GA 30141
770-281-5131
www.ngoc.com
Northwest Georgia Oncology Centers - Tanner Medical Center Villa Rica157 Clinic Avenue
Suite 101 and Suite 102
Carrollton, GA 30117
770-281-5101
www.ngoc.com