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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)

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ClinicalTrials.gov Identifier: NCT03486873
Recruitment Status : Recruiting
First Posted : April 3, 2018
Last Update Posted : October 18, 2018
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief 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 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.


Condition or disease Intervention/treatment Phase
Solid Tumors Biological: Pembrolizumab Drug: Standard of Care (SOC) Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2300 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : August 21, 2018
Estimated Primary Completion Date : May 10, 2028
Estimated Study Completion Date : May 10, 2028

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Pembrolizumab
Participants receive pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations or more for First Course participants and up to 17 administrations for Second Course participants.
Biological: Pembrolizumab
200 mg IV infusion
Other Name: MK-3475

Experimental: Pembrolizumab+SOC (Per Parent Study)
Participants receive pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle PLUS standard of care (SOC) treatment (or per parent study if there is no SOC) for up to 35 administrations or more for First Course participants and up to 17 administrations for Second Course participants. Participants receiving a pembrolizumab-based combination treatment will receive the dose regimen of the combination drug(s) which is recommended per SOC, or was used in the parent study protocol if there is no SOC recommendation.
Biological: Pembrolizumab
200 mg IV infusion
Other Name: MK-3475

Drug: Standard of Care (SOC)
IV infusion or oral tablets

Active Comparator: SOC (Per Parent Study)
Participants receive the same non-pembrolizumab SOC treatment (e.g. chemotherapy) they were receiving in the parent study for up to 35 administrations or more for First Course participants and up to 17 administrations for Second Course participants.
Drug: Standard of Care (SOC)
IV infusion or oral tablets




Primary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: Up to approximately 10 years ]
    OS is defined as the time from randomization or start of study treatment for non-randomized participants (on the parent study) to death due to any cause. Participants without documented death at the time of analysis will be censored at the date of the last follow-up.


Secondary Outcome Measures :
  1. Duration of Response (DOR) Per Evaluation Criteria Used in the Parent Study [ Time Frame: Up to approximately 10 years ]
    DOR is determined by disease assessment and is defined as the time from the earliest date of qualifying response on the parent study until earliest date of disease progression or death from any cause, whichever comes first based upon investigator assessment. The DOR will be presented.

  2. Duration of Complete Response (DOCR) Per Evaluation Criteria Used in the Parent Study [ Time Frame: Up to approximately 10 years ]
    DOCR is determined by disease assessment and is defined as the time from the date of complete response (CR) on the parent study until earliest date of disease progression or death from any cause, whichever comes first based upon investigator assessment. The DOCR will be presented.

  3. Serious Adverse Events (SAEs) [ Time Frame: Up to approximately 42 months (Up to 90 days after last dose of study treatment) ]
    A SAE is defined as any untoward medical occurrence that, at any dose: Results in death, Is life-threatening, Requires inpatient hospitalization or prolongation of existing hospitalization, Results in persistent or significant disability/incapacity or Is a congenital anomaly/birth defect. The number of participants who experience a SAE in this study will be presented.

  4. Adverse Events of Special Interest (AEOSI) [ Time Frame: Up to approximately 40 months (Up to 30 days after last dose of study treatment) ]
    AEOSI for this study include selected preferred terms from Medical Dictionary for Regulatory Activities (MedDRA) version 20.1 for the following higher-level terms: Pneumonitis, Colitis, Hepatitis, Nephritis, Adrenal Insufficiency, Hypophysitis, Hyperthyroidism, Hypothyroidism, Thyroiditis, Type 1 Diabetes Mellitus, Severe Skin Reactions Including Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN): or If grade 3 or higher, Uveitis, Pancreatitis, Myositis, Guillain-Barre Syndrome, Myocarditis, Encephalitis, Sarcoidosis, Infusion Reactions and Myasthenic Syndrome. The number of participants who experience an AEOSI in this study will be presented.

  5. Events of Clinical Interest (ECI) [ Time Frame: Up to approximately 40 months (Up to 30 days after last dose of study treatment) ]
    ECIs for this study include: 1) An overdose of Sponsor's product, that is not associated with clinical symptoms or abnormal laboratory results or 2) An elevated aspartate aminotransferase (AST) or alanine aminotransferase (ALT) lab value that is ≥3X the upper limit of normal (ULN) and an elevated total bilirubin lab value that is ≥2X ULN and, at the same time, an alkaline phosphatase lab value that is <2X ULN, as determined by way of protocol-specified laboratory testing or unscheduled laboratory testing. The number of participants who experience an ECI in this study will be presented.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03486873


Contacts
Contact: Toll Free Number 1-888-577-8839 Trialsites@merck.com

Locations
United States, California
California Cancer Associates for Research & Excellence ( Site 0016) Recruiting
Fresno, California, United States, 93720
Contact: Study Coordinator    559-326-1222      
United States, Connecticut
Yale Cancer Center ( Site 0014) Recruiting
New Haven, Connecticut, United States, 06511
Contact: Study Coordinator    203-584-0406      
United States, Florida
Holy Cross Hospital, Michael & Dianne Bienes Comp Cancer Ctr ( Site 0022) Recruiting
Fort Lauderdale, Florida, United States, 33308
Contact: Study Coordinator    954-776-3036      
United States, Pennsylvania
University of Pennsylvania ( Site 0010) Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Study Coordinator    215-662-7908      
United States, Texas
South Texas Accelerated Research Therapeutics, LLC (START) ( Site 0001) Recruiting
San Antonio, Texas, United States, 78229
Contact: Study Coordinator    210-593-5250      
Australia, New South Wales
Westmead Hospital ( Site 3000) Recruiting
Westmead, New South Wales, Australia, 2145
Contact: Study Coordinator    +61298459553      
France
Institut Bergonie ( Site 2502) Recruiting
Bordeaux, France, 33076
Contact: Study Coordinator    +33556333333      
CHU de Brest. Hopital Morvan ( Site 2504) Recruiting
Brest, France, 29200
Contact: Study Coordinator    +33298223578      
Institut Gustave Roussy ( Site 2513) Recruiting
Villejuif, France, 94805
Contact: Study Coordinator    +33142114210      
Germany
SRH Wald-Klinikum Gera GmbH ( Site 2403) Recruiting
Gera, Germany, 07548
Contact: Study Coordinator    +493658287758      
Israel
Rambam Medical Center ( Site 2053) Recruiting
Haifa, Israel, 3109601
Contact: Study Coordinator    +97247773811      
Hadassah Ein Kerem Medical Center ( Site 2051) Recruiting
Jerusalem, Israel, 9112001
Contact: Study Coordinator    +97226776781      
Italy
Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 1955) Recruiting
Napoli, Italy, 80131
Contact: Study Coordinator    +390815903236      
Korea, Republic of
Seoul National University Bundang Hospital ( Site 0951) Recruiting
Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
Contact: Study Coordinator    +82215883369      
Asan Medical Center ( Site 0952) Recruiting
Seoul, Korea, Republic of, 05505
Contact: Study Coordinator    +82216887575      
Samsung Medical Center ( Site 0950) Recruiting
Seoul, Korea, Republic of, 06351
Contact: Study Coordinator    +82215993114      
Norway
Helse Bergen Haukeland universitetssykehus ( Site 1451) Recruiting
Bergen, Norway, 5021
Contact: Study Coordinator    +4755974200      
Oslo Universitetssykehus Radiumhospitalet ( Site 1450) Recruiting
Oslo, Norway, 0379
Contact: Study Coordinator    +4722934809      
Spain
H.U. Vall de Hebron ( Site 0850) Recruiting
Barcelona, Spain, 08035
Contact: Study Coordinator    +34934894158      
Hospital Clinic de Barcelona ( Site 0852) Recruiting
Barcelona, Spain, 08036
Contact: Study Coordinator    +34932275402      
Hospital Germans Trias i Pujol ( Site 0851) Recruiting
Barcelona, Spain, 08916
Contact: Study Coordinator    +34934978925      
Switzerland
Universitaetsspital Zuerich ( Site 0750) Recruiting
Zuerich, Switzerland, 8091
Contact: Study Coordinator    +41442553847      
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT03486873     History of Changes
Other Study ID Numbers: 3475-587
MK-3475-587 ( Other Identifier: Merck Protocol Number )
2017-004417-42 ( EudraCT Number )
First Posted: April 3, 2018    Key Record Dates
Last Update Posted: October 18, 2018
Last Verified: October 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Merck Sharp & Dohme Corp.:
PD1
PD-1
PDL1
PD-L1

Additional relevant MeSH terms:
Pembrolizumab
Antineoplastic Agents