Clinical Trial - NCT03486873

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)

Recruiting

Sponsor: Merck Sharp & Dohme Corp.

Collaborators:

Information provided by (Responsible party): Sponsor

ClinicalTrials.gov Identifier: NCT03486873

Protocol Info

Short Description: Phase III Extension Trial of Pembrolizumab in Advanced Tumors
Long Description: 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.
MGH Status: Open
Sponsor: Merck
Disease Program: Melanoma

Next Steps


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Purpose

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.
Condition Title Intervention Phase
Solid Tumors Pembrolizumab Standard of Care (SOC) Phase 3
Study Type Interventional
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

Primary Outcome Measures

Overall Survival (OS) [Time Frame: Up to approximately 10 years] [Designated as safety issue: ]


Secondary Outcome Measures

Duration of Response (DOR) Per Evaluation Criteria Used in the Parent Study [Time Frame: Up to approximately 10 years] [Designated as safety issue: ]

Duration of Complete Response (DOCR) Per Evaluation Criteria Used in the Parent Study [Time Frame: Up to approximately 10 years] [Designated as safety issue: ]

Number of Participants Who Experience Serious Adverse Events (SAEs) [Time Frame: Up to approximately 42 months (Up to 90 days after last dose of study treatment)] [Designated as safety issue: ]

Number of Participants Who Experience Adverse Events of Special Interest (AEOSI) [Time Frame: Up to approximately 40 months (Up to 30 days after last dose of study treatment)] [Designated as safety issue: ]

Number of Participants Who Experience Events of Clinical Interest (ECI) [Time Frame: Up to approximately 40 months (Up to 30 days after last dose of study treatment)] [Designated as safety issue: ]

Estimated Enrollment: 2300
Study Start Date: August 2018
Estimated Study Completion Date: May 2028
Estimated Primary Completion Date: May 2028
Arms Assigned Interventions

Experimental:Pembrolizumab 200 mg

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.
Drug:Pembrolizumab
200 or 400 mg IV infusion

Experimental:Pembrolizumab 400 mg

Participants receive pembrolizumab 400 mg via intravenous (IV) infusion on Day 1 of each 6-week cycle for up to 17 administrations or more for First Course participants and up to 8 administrations for Second Course participants.

Experimental:Pembrolizumab 200 mg + 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.
Drug:Standard of Care (SOC)
IV infusion or oral tablets

Experimental:Pembrolizumab 400 mg + SOC (Per Parent Study)

Participants receive pembrolizumab 400 mg via IV infusion on Day 1 of each 6-week cycle PLUS SOC treatment (or per parent study if there is no SOC) for up to 17 administrations or more for First Course participants and up to 8 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.

Active Comparator:SOC (Per Parent Study)

Participants receive the dose matched non-pembrolizumab SOC treatment (e.g. chemotherapy) they were receiving as per parent study protocol.

Eligibility

Ages Eligible for Study: N/A-N/A

Genders Eligible for Study: All

Accepts Healthly Volunteers: No

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.

Additional eligibility criteria for participants who enter Second Course Phase once they are enrolled on MK-3475-587:

  • Has not received any anticancer systemic treatment since the last dose of pembrolizumab or a pembrolizumab-based combination in First Course Phase
  • Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Demonstrates adequate organ function
  • Have resolution of any toxic effect(s) of First Course Phase trial treatment with pembrolizumab or a pembrolizumab-based combination to Grade 1 or less (except alopecia) before trial treatment in Second Course Phase is started. If participant received major surgery or radiation therapy of >30 Gray (Gy), they must have recovered from the toxicity and/or complications of the intervention.
  • Male participant must agree to use contraception during the Second Course Phase study treatment period and for =120 days, corresponding to time needed to eliminate any study combination treatment(s), plus 75 days (a spermatogenesis cycle) for study treatments with evidence of genotoxicity at any dose after the last dose of study treatment and refrain from donating sperm during this period.
  • A female participant is eligible to enroll if she is not pregnant, not breastfeeding, and =1 of the following conditions applies: A woman of childbearing potential (WOCBP) who agrees to use contraception during the study treatment period and for =120 days (corresponding to time needed to eliminate any study combination treatment(s) plus 30 days (a menstruation cycle) for study treatments with risk of genotoxicity.

Exclusion Criteria:

  • There are no exclusion criteria to participate in MK-3475-587.

Participants are excluded from entering Second Course trial treatment once they are enrolled on MK-3475-587 if any of the following criteria applies:

  • Has severe hypersensitivity (= Grade 3) to pembrolizumab and/or any of its excipients
  • Has received a live vaccine within 30 days prior to the first dose of Second Course Phase trial treatment
  • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the Cycle 1 Day 1 of Second Course Phase
  • Has a known additional malignancy that is progressing or requires active treatment. Exceptions include early stage cancers (carcinoma in situ or Stage 1) treated with curative intent, melanoma (non-ulcerated, thin primary), basal cell carcinoma of the skin, squamous cell carcinoma of the skin, in situ cervical cancer, or in situ breast cancer that has undergone potentially curative therapy.
  • Has known active central nervous system metastases and/or carcinomatous meningitis
  • Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
  • Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis. Note: Participants that experienced pneumonitis during First Course that did not meet the criteria for permanent discontinuation are eligible.
  • Non-small cell lung cancer (NSCLC) participants only: Has interstitial lung disease
  • Has an active infection requiring systemic therapy
  • Has a known history of human immunodeficiency virus (HIV) infection.
  • Has a known history of or is positive for hepatitis B or hepatitis C
  • Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the Second Course Phase eligibility Visit through 120 days after the last dose of study treatment.
  • Has severe cardiovascular disease, i.e., arrhythmias, requiring chronic treatment, congestive heart failure (New York Heart Association Class III or IV) or symptomatic ischemic heart disease.
  • Has hepatic decompensation (Child-Pugh score >6 [class B and C])
  • Has uncontrolled thyroid dysfunction
  • Has uncontrolled diabetes mellitus
  • Has had an allogeneic tissue/solid organ transplant
  • Has a known history of active tuberculosis (TB; Bacillus tuberculosis)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT03486873

Locations

  • United States, Arizona
    • University of Arizona Cancer Center ( Site 0018) Tucson, Arizona, United States, 85724
  • United States, California
    • Comprehensive Blood & Cancer Center [Bakersfield, CA] ( Site 0054) Bakersfield, California, United States, 93309
    • California Cancer Associates for Research & Excellence ( Site 0016) Fresno, California, United States, 93720
    • The Angeles Clinic and Research Institute ( Site 0005) Los Angeles, California, United States, 90025
    • UCLA Medical Center Hematology Oncology ( Site 0009) Los Angeles, California, United States, 90095
    • UCSF Helen Diller Family Comprehensive Cancer Center ( Site 0004) San Francisco, California, United States, 94158
    • Providence Saint John's Health Center ( Site 0059) Santa Monica, California, United States, 90404
  • United States, Colorado
    • University of Colorado Cancer Center ( Site 0021) Aurora, Colorado, United States, 80045
  • United States, Connecticut
    • Yale Cancer Center ( Site 0014) New Haven, Connecticut, United States, 06511
  • United States, District of Columbia
    • Georgetown University Medical Center ( Site 0023) Washington, District of Columbia, United States, 20007
  • United States, Florida
    • Holy Cross Hospital, Michael & Dianne Bienes Comp Cancer Ctr ( Site 0022) Fort Lauderdale, Florida, United States, 33308
    • Mount Sinai Medical Center Comprehensive Cancer Center ( Site 0031) Miami Beach, Florida, United States, 33140
    • Moffitt Cancer Center ( Site 0011) Tampa, Florida, United States, 33612
  • United States, Georgia
    • Emory School of Medicine ( Site 0013) Atlanta, Georgia, United States, 30322
    • Northwest Georgia Oncology Centers PC ( Site 0061) Marietta, Georgia, United States, 30060
  • United States, Illinois
    • The University of Chicago ( Site 0020) Chicago, Illinois, United States, 60637
  • United States, Iowa
    • University of Iowa Hospital and Clinics ( Site 0026) Iowa City, Iowa, United States, 52242
  • United States, Kentucky
    • James Graham Brown Cancer Center ( Site 0058) Louisville, Kentucky, United States, 40202
  • United States, Maryland
    • MedStar Franklin Square Medical Center ( Site 0046) Baltimore, Maryland, United States, 21237
    • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Site 0056) Baltimore, Maryland, United States, 21287
  • United States, Massachusetts
    • Massachusetts General Hospital ( Site 0041) Boston, Massachusetts, United States, 02114
    • Dana-Farber Cancer Institute ( Site 0006) Boston, Massachusetts, United States, 02215
  • United States, Michigan
    • Karmanos Cancer Institute ( Site 0047) Detroit, Michigan, United States, 48201
  • United States, Minnesota
    • Mayo Clinic in Rochester, Minnesota-Medical Oncology ( Site 0002) Rochester, Minnesota, United States, 55905
  • United States, Nevada
    • Comprehensive Cancer Centers of Nevada ( Site 0043) Las Vegas, Nevada, United States, 89169
  • United States, New Jersey
    • John Theurer Cancer Center at Hackensack University Medical Center ( Site 0038) Hackensack, New Jersey, United States, 07601
    • Cancer Institute of New Jersey ( Site 0025) New Brunswick, New Jersey, United States, 08901
  • United States, New York
    • Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0032) New York, New York, United States, 10016
    • Memorial Sloan Kettering Cancer Center ( Site 0012) New York, New York, United States, 10065
  • United States, North Carolina
    • University of North Carolina at Chapel Hill ( Site 0040) Chapel Hill, North Carolina, United States, 27599
    • Levine Cancer Institute ( Site 0034) Charlotte, North Carolina, United States, 28204
    • Duke Cancer Center ( Site 0028) Durham, North Carolina, United States, 27710
  • United States, Ohio
    • University Hospitals ( Site 0044) Cleveland, Ohio, United States, 44106
  • United States, Oregon
    • Providence Portland Medical Center ( Site 0051) Portland, Oregon, United States, 97225
  • United States, Pennsylvania
    • St. Luke's University Health Network ( Site 0017) Easton, Pennsylvania, United States, 18045
    • University of Pennsylvania ( Site 0010) Philadelphia, Pennsylvania, United States, 19104
    • Fox Chase Cancer Center ( Site 0042) Philadelphia, Pennsylvania, United States, 19111
    • UPMC Hillman Cancer Center ( Site 0008) Pittsburgh, Pennsylvania, United States, 15232
  • United States, Tennessee
    • West Cancer Center and Research Institute ( Site 0055) Germantown, Tennessee, United States, 38138
    • Vanderbilt Health One Hundred Oaks Diagnostic ( Site 0060) Nashville, Tennessee, United States, 37204
    • Vanderbilt Ingram Cancer Center ( Site 0015) Nashville, Tennessee, United States, 37232
  • United States, Texas
    • Texas Oncology-Baylor Sammons Cancer Center ( Site 0062) Dallas, Texas, United States, 75246
    • University of Texas MD Anderson Cancer Center ( Site 0007) Houston, Texas, United States, 77030
    • South Texas Accelerated Research Therapeutics, LLC (START) ( Site 0001) San Antonio, Texas, United States, 78229
  • United States, Virginia
    • University of Virginia Health System ( Site 0035) Charlottesville, Virginia, United States, 22903
  • United States, Washington
    • Seattle Cancer Care Alliance ( Site 0024) Seattle, Washington, United States, 98109
  • Argentina, Santa Fe
    • Instituto de Oncologia de Rosario ( Site 1350) Rosario, Santa Fe, Argentina, S2000KZE
  • Australia, New South Wales
    • Chris OBrien Lifehouse ( Site 3003) Camperdown, New South Wales, Australia, 2050
    • Macquarie University ( Site 3010) Macquarie University, New South Wales, Australia, 2109
    • Mater Hospital Sydney ( Site 3007) North Sydney, New South Wales, Australia, 2060
    • Melanoma Institute Australia ( Site 3001) North Sydney, New South Wales, Australia, 2060
    • Calvary Mater Newcastle ( Site 3005) Waratah, New South Wales, Australia, 2298
    • Westmead Hospital ( Site 3000) Westmead, New South Wales, Australia, 2145
  • Australia, Queensland
    • Gallipoli Medical Research Foundation ( Site 3011) Brisbane, Queensland, Australia, 4120
    • Royal Brisbane and Women s Hospital ( Site 3009) Herston, Queensland, Australia, 4029
    • Tasman Oncology Research Pty Ltd ( Site 3012) Southport, Queensland, Australia, 4215
    • Princess Alexandra Hospital ( Site 3002) Woolloongabba, Queensland, Australia, 4102
  • Australia, South Australia
    • Royal Adelaide Hospital ( Site 3014) Adelaide, South Australia, Australia, 5000
  • Australia, Victoria
    • Austin Health-Austin Hospital ( Site 3004) Heidelberg, Victoria, Australia, 3084
    • Peter MacCallum Cancer Centre ( Site 3008) Melbourne, Victoria, Australia, 3000
  • Australia, Western Australia
    • Sir Charles Gairdner Hospital ( Site 3006) Nedlands, Western Australia, Australia, 6009
    • St John of God Subiaco Hospital ( Site 3013) Subiaco, Western Australia, Australia, 6008
  • Austria, Steiermark
    • Medical University of Graz ( Site 2952) Graz, Steiermark, Austria, 8036
  • Austria, Tirol
    • Medizinische Universitaet Innsbruck ( Site 2951) Innsbruck, Tirol, Austria, 6020
  • Austria,
    • Medizinische Universitaet Wien, Universitaetsklinik fuer Dermatologie ( Site 2953) Wien, , Austria, 1090
  • Belgium, Antwerpen
    • AZ Sint-Maarten ( Site 2904) Mechelen, Antwerpen, Belgium, 2800
  • Belgium, Bruxelles-Capitale, Region De
    • Institut Jules Bordet ( Site 2903) Brussels, Bruxelles-Capitale, Region De, Belgium, 1000
    • UZ Brussel ( Site 2900) Brussels, Bruxelles-Capitale, Region De, Belgium, 1090
    • Cliniques Universitaires de Bruxelles - CUB - Hopital Erasme ( Site 2905) Bruxelles, Bruxelles-Capitale, Region De, Belgium, 1070
  • Belgium, Vlaams-Brabant
    • UZ Leuven ( Site 2901) Leuven, Vlaams-Brabant, Belgium, 3000
    • UZ Leuven - Campus Gasthuisberg ( Site 2906) Leuven, Vlaams-Brabant, Belgium, 3000
    • UZ Leuven Gasthuisberg, Gynaecologie-Verloskunde ( Site 2907) Leuven, Vlaams-Brabant, Belgium, 3000
  • Brazil, Rio Grande Do Sul
    • Hospital de Clinicas de Porto Alegre ( Site 1000) Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
  • Brazil,
    • Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 1001) Sao Paulo, , Brazil, 01246-000
  • Canada, Alberta
    • Cross Cancer Institute ( Site 2804) Edmonton, Alberta, Canada, T6G 1Z2
  • Canada, Ontario
    • Hamilton Health Sciences-Juravinski Cancer Centre ( Site 2801) Hamilton, Ontario, Canada, L8V5C2
    • Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 2808) Kingston, Ontario, Canada, K7L 2V7
    • London Regional Cancer Program - LHSC ( Site 2806) London, Ontario, Canada, N6A 4L6
    • Sunnybrook Research Institute ( Site 2802) Toronto, Ontario, Canada, M4N 3M5
    • Princess Margaret Cancer Centre ( Site 2803) Toronto, Ontario, Canada, M5G 2M9
  • Canada, Quebec
    • Centre Hospitalier de l Universite de Montreal - CHUM ( Site 2807) Montreal, Quebec, Canada, H2X 3E4
    • Jewish General Hospital ( Site 2800) Montreal, Quebec, Canada, H3T 1E2
  • Canada,
    • CHUQ-Univ Laval-Hotel Dieu de Quebec ( Site 2805) Quebec, , Canada, G1R 2J6
  • Chile, Region M. De Santiago
    • Fundacion Arturo Lopez Perez FALP ( Site 2750) Santiago, Region M. De Santiago, Chile, 7500921
  • China, Beijing
    • Beijing Cancer Hospital ( Site 3451) Beijing, Beijing, China, 100035
  • Colombia, Distrito Capital De Bogota
    • Administradora Country S.A. ( Site 2701) Bogota, Distrito Capital De Bogota, Colombia, 110221
  • Colombia, Valle Del Cauca
    • Fundacion Valle del Lili ( Site 2700) Cali, Valle Del Cauca, Colombia, 760032
  • Czechia,
    • Fakultni nemocnice Olomouc ( Site 0701) Olomouc, , Czechia, 775 20
    • Fakultni nemocnice v Motole ( Site 0700) Praha 5, , Czechia, 150 06
  • Denmark, Syddanmark
    • Odense Universitetshospital ( Site 0650) Odense, Syddanmark, Denmark, 5000
  • Finland, Pirkanmaa
    • Tampere University Hospital [Tampere Finland] ( Site 0600) Tampere, Pirkanmaa, Finland, 33520
  • Finland, Varsinais-Suomi
    • Turku University Hospital ( Site 0601) Turku, Varsinais-Suomi, Finland, 20521
  • France, Bouches-du-Rhone
    • Hopital Nord ( Site 2516) Marseille, Bouches-du-Rhone, France, 13015
    • CHU La Timone ( Site 2508) Marseille, Bouches-du-Rhone, France, 13385
  • France, Bretagne
    • Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer ( Site 2525) Rennes, Bretagne, France, 35042
  • France, Centre
    • C.H.U. de Tours - Hopital Bretonneau ( Site 2515) Tours, Centre, France, 37044
  • France, Doubs
    • CHU Jean Minjoz ( Site 2520) Besancon, Doubs, France, 25030
  • France, Finistere
    • CHU de Brest -Site Hopital Morvan ( Site 2504) Brest, Finistere, France, 29200
  • France, Gironde
    • Institut Bergonie ( Site 2502) Bordeaux, Gironde, France, 33076
  • France, Haute-Garonne
    • CHU Toulouse - Hopital Rangueil ( Site 2518) Toulouse, Haute-Garonne, France, 31059
  • France, Hauts-de-Seine
    • Ambroise Pare Hopital ( Site 2503) Boulogne, Hauts-de-Seine, France, 92100
    • Hôpital Beaujon ( Site 2524) Clichy, Hauts-de-Seine, France, 92110
  • France, Indre-et-Loire
    • Hopital Trousseau ( Site 2512) Chambray-Les-Tours, Indre-et-Loire, France, 37170
  • France, Loire-Atlantique
    • Institut de Cancérologie de l'Ouest-Oncologie Médicale ( Site 2522) Saint Herblain, Loire-Atlantique, France, 44805
  • France, Nord
    • CHRU Lille Hospital Claude Huriez ( Site 2506) Lille, Nord, France, 59037
  • France, Rhone-Alpes
    • CH Lyon Sud Hospices Civils de Lyon ( Site 2521) Pierre Benite, Rhone-Alpes, France, 69495
  • France, Rhone
    • C.H.U. Pontchaillou ( Site 2511) Pierre Benite, Rhone, France, 35033
  • France, Val-de-Marne
    • Centre Hopitalier Intercommunal Creteil ( Site 2514) Creteil, Val-de-Marne, France, 94010
    • Institut Gustave Roussy ( Site 2513) Villejuif, Val-de-Marne, France, 94800
  • France,
    • Hopital Cochin ( Site 2509) Paris, , France, 75006
    • Hopital Saint Louis ( Site 2510) Paris, , France, 75010
    • CHU Hopital Saint Antoine ( Site 2517) Paris, , France, 75012
  • Germany, Baden-Wurttemberg
    • Universitaetsklinikum Tuebingen ( Site 2405) Tuebingen, Baden-Wurttemberg, Germany, 72076
  • Germany, Bayern
    • Universitätsklinikum Erlangen ( Site 2408) Erlangen, Bayern, Germany, 91054
    • Universitaetsklinik Muenchen ( Site 2406) Muenchen, Bayern, Germany, 80337
  • Germany, Hessen
    • Krankenhaus Nordwest ( Site 2409) Frankfurt, Hessen, Germany, 60488
  • Germany, Niedersachsen
    • Elbe Klinikum Buxtehude ( Site 2400) Buxtehude, Niedersachsen, Germany, 21614
    • Medizinische Hochschule Hannover ( Site 2402) Hannover, Niedersachsen, Germany, 30625
  • Germany, Nordrhein-Westfalen
    • Universitaetsklinikum Essen ( Site 2404) Essen, Nordrhein-Westfalen, Germany, 45147
  • Germany, Saarland
    • Universitaetsklinikum des Saarlandes ( Site 2411) Homburg, Saarland, Germany, 66421
  • Germany, Sachsen
    • Universitatsklinikum Carl Gustav Carus ( Site 2407) Dresden, Sachsen, Germany, 01307
  • Germany, Schleswig-Holstein
    • LungenClinic Grosshansdorf GmbH ( Site 2412) Grosshansdorf, Schleswig-Holstein, Germany, 22927
  • Germany, Thuringen
    • SRH Wald-Klinikum Gera GmbH ( Site 2403) Gera, Thuringen, Germany, 07548
  • Germany,
    • Facharztzentrum Eppendorf ( Site 2415) Hamburg, , Germany, 20249
  • Greece, Attiki
    • Sotiria Regional Chest Diseases Hospital of Athens ( Site 1850) Athens, Attiki, Greece, 115 27
  • Guatemala,
    • Oncomedica ( Site 3401) Guatemala, , Guatemala, 01010
  • Hong Kong,
    • Queen Mary Hospital-Department of Medicine (Respiratory) ( Site 1900) Hksar, , Hong Kong,
  • Hungary, Jasz-Nagykun-Szolnok
    • Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 1401) Szolnok, Jasz-Nagykun-Szolnok, Hungary, 5004
  • Hungary,
    • Orszagos Koranyi Pulmonologiai Intezet ( Site 1403) Budapest, , Hungary, 1121
    • Somogy Megyei Kaposi Mor Oktato Korhaz ( Site 1402) Kaposvar, , Hungary, 7400
    • Zala Megyei Szent Rafael Korhaz ( Site 1400) Zalaegerszeg, , Hungary, 8900
  • Ireland, Leinster
    • Mater Misercordiae University Hospital ( Site 1800) Dublin, Leinster, Ireland, DO7R2DWY
  • Ireland,
    • St. James s Hospital ( Site 1801) Dublin, , Ireland, D08 K0Y5
  • Israel,
    • Rambam Medical Center ( Site 2053) Haifa, , Israel, 3109601
    • Hadassah Ein Kerem Medical Center ( Site 2051) Jerusalem, , Israel, 9112001
    • Rabin Medical Center ( Site 2059) Petah-Tikva, , Israel, 49100
    • Chaim Sheba Medical Center ( Site 2055) Ramat Gan, , Israel, 5262000
    • Chaim Sheba Medical Center. ( Site 2052) Ramat gan, , Israel, 5265601
    • Sourasky Medical Center ( Site 2054) Tel Aviv, , Israel, 6423906
    • Shamir Medical Center-Assaf Harofeh ( Site 2058) Zerifin, , Israel, 70300
  • Italy, Milano
    • Humanitas-U.O di Oncologia medica ed Ematologia ( Site 1968) Rozzano, Milano, Italy, 20089
  • Italy, Piemonte
    • Ospedale San Luigi Gonzaga ( Site 1956) Orbassano, Piemonte, Italy, 10043
  • Italy, Torino
    • Istituto di Candiolo - IRCCS ( Site 1960) Candiolo, Torino, Italy, 10060
  • Italy,
    • Humanitas Gavazzeni ( Site 1954) Bergamo, , Italy, 24125
    • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII-UOC Oncologia ( Site 1967) Bergamo, , Italy, 24127
    • IRCCS A.O.U. San Martino - IST ( Site 1961) Genova, , Italy, 16132
    • Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 1955) Napoli, , Italy, 80131
    • Azienda Ospedaliero Universitaria di Parma-UO Oncologia Medica ( Site 1964) Parma, , Italy, 43126
    • IRCCS CRO Aviano, Hematology/Oncology ( Site 1957) Pordenone, , Italy, 33170
    • Azienda Ospedaliera San Camillo Forlanini ( Site 1958) Roma, , Italy, 00152
    • Policlinico Universitario Agostino Gemelli ( Site 1965) Roma, , Italy, 00168
    • Azienda Ospedaliera Santa Maria ( Site 1962) Terni, , Italy, 05100
  • Japan, Aichi
    • National Hospital Organization Nagoya Medical Center ( Site 3109) Nagoya, Aichi, Japan, 460-0001
    • Aichi Cancer Center Hospital ( Site 3101) Nagoya, Aichi, Japan, 464-8681
  • Japan, Chiba
    • National Cancer Center Hospital East ( Site 3121) Kashiwa, Chiba, Japan, 277-8577
  • Japan, Ehime
    • National Hospital Organization Shikoku Cancer Center ( Site 3116) Matsuyama, Ehime, Japan, 791-0280
  • Japan, Fukuoka
    • Kurume University Hospital ( Site 3105) Kurume, Fukuoka, Japan, 830-0011
  • Japan, Hokkaido
    • Sapporo Medical University Hospital ( Site 3113) Sapporo, Hokkaido, Japan, 060-8543
  • Japan, Hyogo
    • Hyogo Cancer Center ( Site 3131) Akashi, Hyogo, Japan, 673-8558
    • National Hospital Organization Himeji Medical Center ( Site 3111) Himeji, Hyogo, Japan, 670-8520
    • Hyogo College of Medicine Hospital ( Site 3100) Nishinomiya, Hyogo, Japan, 663-8501
  • Japan, Miyagi
    • Miyagi Cancer Center ( Site 3122) Natori, Miyagi, Japan, 981-1293
    • Sendai Kousei Hospital ( Site 3115) Sendai, Miyagi, Japan, 980-0873
  • Japan, Nara
    • Nara Medical University Hospital ( Site 3110) Kashihara, Nara, Japan, 634-8522
  • Japan, Osaka
    • Kansai Medical University Hospital ( Site 3126) Hirakata, Osaka, Japan, 573-1191
    • Kindai University Hospital ( Site 3102) Osakasayama, Osaka, Japan, 589-8511
  • Japan, Saitama
    • Saitama Medical University International Medical Center ( Site 3118) Hidaka, Saitama, Japan, 350-1298
    • Saitama Cancer Center ( Site 3112) Kitaadachi-gun, Saitama, Japan, 362-0806
  • Japan, Shizuoka
    • Shizuoka Cancer Center ( Site 3128) Nagaizumi, Shizuoka, Japan, 411-8777
  • Japan, Tokyo
    • Kyorin University Hospital ( Site 3103) Mitaka, Tokyo, Japan, 181-8611
  • Japan, Yamaguchi
    • National Hospital Organization Yamaguchi Ube Medical Center ( Site 3123) Ube, Yamaguchi, Japan, 755-0241
    • Yamaguchi University Hospital ( Site 3114) Ube, Yamaguchi, Japan, 755-8505
  • Japan,
    • Chiba Cancer Center ( Site 3117) Chiba, , Japan, 260-8717
    • Hiroshima City Hiroshima Citizens Hospital ( Site 3119) Hiroshima, , Japan, 730-8518
    • Okayama University Hospital ( Site 3107) Okayama, , Japan, 700-8558
    • Osaka City General Hospital ( Site 3125) Osaka, , Japan, 534-0021
    • Osaka International Cancer Institute-Gynecologic Oncology ( Site 3129) Osaka, , Japan,
    • St.Luke's International Hospital ( Site 3120) Tokyo, , Japan, 104-8560
    • The Cancer Institute Hospital of JFCR ( Site 3108) Tokyo, , Japan, 135-8550
    • Keio University Hospital ( Site 3127) Tokyo, , Japan, 160-8582
    • Teikyo University Hospital ( Site 3104) Tokyo, , Japan, 173-8606
    • Wakayama Medical University Hospital ( Site 3124) Wakayama, , Japan, 641-8510
  • Korea, Republic of, Kyonggi-do
    • National Cancer Center ( Site 0955) Goyang-si, Kyonggi-do, Korea, Republic of, 10408
    • CHA Bundang Medical Center CHA University ( Site 0957) Seongnam si, Kyonggi-do, Korea, Republic of, 13496
    • Seoul National University Bundang Hospital ( Site 0951) Seongnam-si, Kyonggi-do, Korea, Republic of, 13620
  • Korea, Republic of, Seoul
    • Asan Medical Center ( Site 0952) Songpagu, Seoul, Korea, Republic of, 05505
  • Korea, Republic of,
    • Korea University Anam Hospital ( Site 0956) Seoul, , Korea, Republic of, 02841
    • Seoul National University Hospital ( Site 0953) Seoul, , Korea, Republic of, 03080
    • Severance Hospital ( Site 0954) Seoul, , Korea, Republic of, 03722
    • Samsung Medical Center ( Site 0950) Seoul, , Korea, Republic of, 06351
  • Lithuania,
    • Vilniaus Universiteto Ligonine Santaros Klinikos ( Site 3300) Vilnius, , Lithuania, 08460
  • Malaysia, Pulau Pinang
    • Gleneagles Penang ( Site 0625) Georgetown, Pulau Pinang, Malaysia, 10050
  • Malaysia,
    • University Malaya Medical Centre ( Site 0626) Kuala Lumpur, , Malaysia, 59100
  • Netherlands, Noord-Holland
    • Antoni van Leeuwenhoek Ziekenhuis ( Site 1551) Amsterdam, Noord-Holland, Netherlands, 1066 CX
  • Netherlands,
    • Universitair Medisch Centrum Groningen ( Site 1550) Groningen, , Netherlands, 9713 GZ
  • New Zealand, Canterbury
    • Canterbury Regional Cancer & Blood Service ( Site 1500) Christchurch, Canterbury, New Zealand, 8011
  • New Zealand, Waikato
    • Waikato Hospital ( Site 1502) Hamilton, Waikato, New Zealand, 3204
  • New Zealand,
    • Auckland City Hospital ( Site 1503) Auckland, , New Zealand, 1023
    • Capital & Coast District Health Board - Wellington Hospital ( Site 1501) Wellington, , New Zealand, 6021
  • Norway, Vestfold
    • Helse Bergen Haukeland universitetssykehus ( Site 1451) Bergen, Vestfold, Norway, 5021
  • Norway,
    • Oslo Universitetssykehus Radiumhospitalet ( Site 1450) Oslo, , Norway, 0379
    • Oslo Universitetssykehus Ullevål-Avdeling for kreftbehandling, Ullevål ( Site 1452) Oslo, , Norway, 0450
  • Philippines, National Capital Region
    • St. Luke s Medical Center ( Site 1700) Quezon City, National Capital Region, Philippines, 1102
  • Poland, Wielkopolskie
    • Szpital Kliniczny im. Przemienienia Panskiego Uniwersytetu Medycznego im. K. Marcinkowskiego w Pozna Poznan, Wielkopolskie, Poland, 61-848
  • Portugal,
    • Centro Hospitalar Lisboa Norte E.P.E. - Hospital Pulido Valente ( Site 1750) Lisboa, , Portugal, 1769-001
  • Puerto Rico,
    • UPR Comprehensive Cancer Center ( Site 1150) San Juan, , Puerto Rico, 00935
  • Russian Federation, Baskortostan, Respublika
    • Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 1204) Ufa, Baskortostan, Respublika, Russian Federation, 450054
  • Russian Federation, Mordoviya, Respublika
    • Mordovia Republican Oncological Dispensary ( Site 1206) Saransk, Mordoviya, Respublika, Russian Federation, 430005
  • Russian Federation, Moskva
    • N.N. Blokhin NMRCO ( Site 1209) Moscow, Moskva, Russian Federation, 115478
    • Russian Oncological Research Center n.a. N.N.Blokhin of MoH ( Site 1201) Moscow, Moskva, Russian Federation, 115478
    • FSAI Treatment and Rehabilitation Centre of the MoH and SD of RF ( Site 1208) Moscow, Moskva, Russian Federation, 125367
  • Russian Federation, Sankt-Peterburg
    • Clinical Research Center of specialized types medical care-Oncology ( Site 1205) Saint-Petersburg, Sankt-Peterburg, Russian Federation, 197758
  • Russian Federation, Tatarstan, Respublika
    • Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 1203) Kazan, Tatarstan, Respublika, Russian Federation, 420029
  • Singapore, Central Singapore
    • National Cancer Centre Singapore ( Site 2200) Singapore, Central Singapore, Singapore, 169610
  • South Africa, Kwazulu-Natal
    • The Oncology Centre ( Site 2000) Durban, Kwazulu-Natal, South Africa, 4001
  • Spain, Barcelona
    • Instituto Catalan de Oncologia ICO - Hospital Duran i Reynals ( Site 0860) Hospitalet de Llobregat, Barcelona, Spain, 08907
  • Spain, Cantabria
    • H. Marques de Valdecilla ( Site 0865) Santander, Cantabria, Spain, 39008
  • Spain, Las Palmas
    • Hospital Universitario Insular de Gran Canaria ( Site 0867) Las Palmas de Gran Canaria, Las Palmas, Spain, 35016
  • Spain, Madrid
    • Hospital Universitario Puerta de Hierro-Majadahonda ( Site 0861) Majadahonda, Madrid, Spain, 28222
    • Hospital Universitario Quiron Madrid ( Site 0868) Pozuelo de Alarcon, Madrid, Spain, 28223
  • Spain, Valenciana, Comunitat
    • Instituto Valenciano de Oncologia - IVO ( Site 0863) Valencia, Valenciana, Comunitat, Spain, 46009
    • Hospital Clinico de Valencia ( Site 0858) Valencia, Valenciana, Comunitat, Spain, 46010
    • Hospital General Universitario de Valencia ( Site 0854) Valencia, Valenciana, Comunitat, Spain, 46014
    • Hospital Arnau de Vilanova ( Site 0866) Valencia, Valenciana, Comunitat, Spain, 46015
  • Spain,
    • H.U. Vall de Hebron ( Site 0850) Barcelona, , Spain, 08035
    • Hospital Clinic de Barcelona ( Site 0852) Barcelona, , Spain, 08036
    • Institut Catala d Oncologia Hospital Germans Trias i Pujol ( Site 0851) Barcelona, , Spain, 08916
    • Hospital Universitario Gregorio Maranon ( Site 0864) Madrid, , Spain, 28009
    • Clinica Universitaria de Navarra ( Site 0855) Madrid, , Spain, 28027
    • Hospital Clinico San Carlos ( Site 0857) Madrid, , Spain, 28040
    • Hospital General Universitario 12 de Octubre ( Site 0856) Madrid, , Spain, 28041
    • Hospital Universitario La Paz ( Site 0853) Madrid, , Spain, 28046
    • Centro Integral Oncologico Clara Campal-Hospital HM Universitario Sanchinarro-START Madrid, ( Site 0 Madrid, , Spain, 28050
    • Hospital Clinico Universitario Lozano Blesa ( Site 0859) Zaragoza, , Spain, 50009
  • Sweden, Stockholms Lan
    • Karolinska Universitetssjukhuset Solna ( Site 0802) Stockholm, Stockholms Lan, Sweden, 171 76
  • Sweden, Uppsala Lan
    • Blod och Tumorssjukdomar. Akademiska sjukhuset ( Site 0801) Uppsala, Uppsala Lan, Sweden, 751 85
  • Sweden, Vasterbottens Lan
    • Norrlands Universitetssjukhus ( Site 0800) Umea, Vasterbottens Lan, Sweden, 901 85
  • Switzerland, Aargau
    • University Hospital Basel ( Site 0752) Basel, Aargau, Switzerland, 4031
  • Switzerland, Zurich
    • Universitaetsspital Zuerich ( Site 0750) Zürich-Flughafen, Zurich, Switzerland, 8058
  • Taiwan,
    • Kaohsiung Chang Gung Memorial Hospital ( Site 3203) Kaohsiung, , Taiwan, 83301
    • China Medical University Hospital ( Site 3204) Taichung, , Taiwan, 40447
    • National Cheng Kung University Hospital ( Site 3201) Tainan, , Taiwan, 70457
    • National Taiwan University Hospital ( Site 3200) Taipei, , Taiwan, 10048
    • Taipei Veterans General Hospital ( Site 3202) Taipei, , Taiwan, 11217
  • Turkey,
    • Trakya Universitesi Tip Fakultesi ( Site 1301) Edirne, , Turkey, 22030
    • Bezmialem Vakf Üniversitesi-Oncology ( Site 1308) Istanbul, , Turkey, 34093
    • Istanbul Universitesi Cerrahpasa-Medical Oncology ( Site 1302) Istanbul, , Turkey, 34668
    • Ege Universitesi Tip Fakultesi Hastanesi ( Site 1300) Izmir, , Turkey, 35040
    • Inonu Universitesi ( Site 1309) Malatya, , Turkey, 44280
  • Ukraine, Kirovohradska Oblast
    • Private Enterprise Private Manufacturing Company Acinus-Medical and Diagnostic Centre ( Site 3656) Kropyvnytskyi, Kirovohradska Oblast, Ukraine, 25006
  • Ukraine, Kyivska Oblast
    • Municipal non-profit enterprise "Kyiv City Clinical Oncology Center" of executive body of Kyiv City Kyiv, Kyivska Oblast, Ukraine, 03115
  • Ukraine, Lvivska Oblast
    • Municipal institution of Lviv regional council Lviv Oncology-Chemotherapy ( Site 3653) Lviv, Lvivska Oblast, Ukraine, 79031
  • Ukraine, Zakarpatska Oblast
    • Transcarpathian Regional Clinical Oncology Center-Chemotherapy dept. ( Site 3652) Uzhhorod, Zakarpatska Oblast, Ukraine, 88000
  • United Kingdom, Edinburgh, City Of
    • Western General Hospital ( Site 0502) Edinburgh, Edinburgh, City Of, United Kingdom, EH4 2XU
  • United Kingdom, Glasgow City
    • The Beatson West of Scotland Cancer Centre ( Site 0506) Glasgow, Glasgow City, United Kingdom, G12 0YN
  • United Kingdom, London, City Of
    • Barts Health NHS Trust ( Site 0512) London, London, City Of, United Kingdom, EC1A 7BE
    • Royal Free Hospital ( Site 0507) London, London, City Of, United Kingdom, NW3 2QG
    • Royal Marsden Hospital ( Site 0505) London, London, City Of, United Kingdom, SW3 6JJ
    • Sarah Cannon Research UK ( Site 0504) London, London, City Of, United Kingdom, W1G 6AD
  • United Kingdom, Northern Ireland
    • Belfast City Hospital ( Site 0508) Belfast, Northern Ireland, United Kingdom, BT9 7AB
  • United Kingdom, Nottinghamshire
    • Nottingham University Hospitals NHS Trust ( Site 0510) Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
  • United Kingdom,
    • Mid Essex Hospitals Service Trust. Broomfield Hospital ( Site 0503) Broomfield, , United Kingdom, CM1 7ET
    • St James University Hospital ( Site 0509) Leeds, , United Kingdom, LS9 7TF
    • The Royal Marsden NHS Foundation Trust. ( Site 0513) Sutton, , United Kingdom, SM2 5PT

Sponsors and Collaborators

Merck Sharp & Dohme Corp.

More Information

No publications provided

Responsible Party: Sponsor
ClinicalTrials.gov Identifier: NCT03486873
Other Study ID Numbers: MK-3475-587
Study First Received:
Last Updated:
Health Authority:

Keywords provided by Merck Sharp & Dohme Corp.:

PD1

PD-1

PDL1

PD-L1

Additional relevant MeSH terms:

Pembrolizumab

Next Steps


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ClinicalTrials.gov processed this data on October 14, 2021