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Long-term Safety and Efficacy Extension Study for Participants With Advanced Tumors Who Are Currently on Treatment or in Follow-up in a Pembrolizumab (MK-3475) Study (MK-3475-587/KEYNOTE-587)


Active: Yes
Cancer Type: Unknown Primary NCT ID: NCT03486873
Trial Phases: Phase III Protocol IDs: 3475-587 (primary)
2017-004417-42
NCI-2018-01717
MK-3475-587
Eligibility: 18 Years and older, Male and Female Study Type: Treatment
Study Sponsor: Merck Sharp & Dohme LLC
NCI Full Details: http://clinicaltrials.gov/show/NCT03486873

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
roll-over 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 roll-over 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 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 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 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 - Austell
1700 Hospital South Drive
Suite 300
Austell, GA 30106
770-281-5131
www.ngoc.com



Northwest Georgia Oncology Centers - Bremen
200 Allen Memorial Drive
Suite 302-B
Bremen, GA 30110
770-281-5131
www.ngoc.com



Northwest Georgia Oncology Centers - Carrollton
157 Clinic Avenue
Suite 101
Carrollton, GA 30117
770-281-5131
www.ngoc.com



Northwest Georgia Oncology Centers - Cartersville
100 Market Place Boulevard
Suite 200
Cartersville, GA 30121
770-281-5131
www.ngoc.com



Northwest Georgia Oncology Centers - Douglasville
6002 Professional Parkway
Suite 220
Douglasville, GA 30134
770-281-5131
www.ngoc.com



Northwest Georgia Oncology Centers - Jasper
1020 J.L. White Drive
Suite 160
Jasper, GA 30143
770-281-5131
www.ngoc.com



Northwest Georgia Oncology Centers - Marietta
340 Kennestone Hospital Boulevard
Suite 200
Marietta, GA 30060
770-281-5131
www.ngoc.com



Northwest Georgia Oncology Centers - Paulding
144 Bill Carruth Parkway
Suite 3100
Hiram, GA 30141
770-281-5131
www.ngoc.com



Northwest Georgia Oncology Centers - Villa Rica
705 Dallas Highway
Suite 204
Villa Rica, GA 30180
770-281-5131
www.ngoc.com

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.