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)



Status:Recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/27/2019
Start Date:August 21, 2018
End Date:May 10, 2028
Contact:Toll Free Number
Email:Trialsites@merck.com
Phone:1-888-577-8839

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A Multicenter, Open Label, Phase III Extension Trial to Study the Long-term Safety and Efficacy in Participants With Advanced Tumors Who Are Currently on Treatment or in Follow-up in a Pembrolizumab Trial

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 rollover
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 cycles of
study treatment with pembrolizumab or a pembrolizumab-based combination. 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 cycles of study treatment with pembrolizumab or a pembrolizumab-based combination.


Inclusion Criteria:

- Advanced unresectable or metastatic tumor(s)

- Currently enrolled in a Merck-sponsored pembrolizumab study and is receiving study
treatment or in a Follow-up Phase at the time MK-3475-587 is open. The parent studies
must have completed all regulatory requirements and submissions, if any, or have fully
addressed their primary endpoint(s) before all their participants roll over into this
MK-3475-587 extension study.

Exclusion Criteria:

-There are no exclusion criteria to participate in MK-3475-587.
We found this trial at
20
sites
92 2nd St
Hackensack, New Jersey 07601
(201) 996-5900
Phone: 551-996-5900
John Theurer Cancer Center at the Hackensack University Medical Center The mission of the John...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Phone: 617-632-5990
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Boston, MA
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1600 Divisadero Street
San Francisco, California 94115
888.689.8273
Phone: 415-514-6382
UCSF Helen Diller Family Comprehensive Cancer Center UCSF’s long tradition of excellence in cancer research...
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San Francisco, CA
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Aurora, Colorado 80045
Phone: 720-848-7135
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Phone: 617-582-7227
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, MA
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1215 Lee St
Charlottesville, Virginia 22903
(434) 924-0211
Phone: 434-297-7784
University of Virginia Health System UVA Health System includes a 604-bed hospital, level I trauma...
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Easton, Pennsylvania 18045
Phone: 484-503-4153
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Fort Lauderdale, Florida 33308
Phone: 954-776-3036
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Fresno, California 93720
Phone: 559-326-1222
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Iowa City, Iowa 52242
Phone: 319-356-1228
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Iowa City, IA
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Los Angeles, California 90095
Phone: 310-794-6913
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Los Angeles, California 90025
Phone: 310-231-2181
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Miami Beach, Florida 33140
Phone: 305-674-2625
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New Brunswick, New Jersey 08901
Phone: 917-991-4174
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333 Cedar Street
New Haven, Connecticut 06520
(203) 785-4095
Phone: 203-584-0406
Yale Cancer Center Yale Cancer Center combines a tradition of innovative cancer treatment and quality...
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Phone: 215-662-7908
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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Pittsburgh, Pennsylvania 15232
Phone: 412-623-3272
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San Antonio, Texas 78229
Phone: 210-593-5250
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Tampa, Florida 33612
Phone: 801-581-4477
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Waratah, New South Wales 2298
Phone: +61240143288
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