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
    • 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
  • 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, 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 University ( Site 0013) Atlanta, Georgia, United States, 30322
  • 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, Maryland
    • MedStar Franklin Square Medical Center ( Site 0046) Baltimore, Maryland, United States, 21237
  • 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, Minnesota
    • Mayo Clinic Rochester - St. Mary's Hospital ( 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 Med Ctr ( Site 0038) Hackensack, New Jersey, United States, 07601
    • Cancer Institute of New Jersey ( Site 0025) New Brunswick, New Jersey, United States, 08903
  • 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, 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
    • 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
    • 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, 22908
  • 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
    • Mater Hospital Sydney ( Site 3007) North Sydney, New South Wales, Australia, 2060
    • Melanoma Institute Australia ( Site 3001) North Sydney, New South Wales, Australia, 2065
    • Calvary Mater Newcastle ( Site 3005) Waratah, New South Wales, Australia, 2298
    • Westmead Hospital ( Site 3000) Westmead, New South Wales, Australia, 2145
  • Australia, Queensland
    • Royal Brisbane and Women s Hospital ( Site 3009) Herston, Queensland, Australia, 4029
    • Princess Alexandra Hospital ( Site 3002) Woolloongabba, Queensland, Australia, 4102
  • 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
  • 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 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
    • Juravinski Cancer Centre ( Site 2801) Hamilton, Ontario, Canada, L8V 1C3
    • Sunnybrook Research Institute ( Site 2802) Toronto, Ontario, Canada, M4N 3M5
    • Princess Margaret Cancer Centre ( Site 2803) Toronto, Ontario, Canada, M5G 2M9
  • Canada, Quebec
    • Jewish General Hospital ( Site 2800) Montreal, Quebec, Canada, H3T 1E2
  • Canada,
    • CHU de Quebec-Universite 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
  • 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
  • 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, 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
  • France, Indre-et-Loire
    • Hopital Trousseau ( Site 2512) Chambray-Les-Tours, Indre-et-Loire, France, 37170
    • C.H.U. de Tours - Hopital Bretonneau ( Site 2515) Tours, Indre-et-Loire, France, 37044
  • France, Nord
    • CHRU Lille Hospital Claude Huriez ( Site 2506) Lille, Nord, France, 59037
  • 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, Sachsen
    • Universitatsklinikum Carl Gustav Carus ( Site 2407) Dresden, Sachsen, Germany, 01307
  • Germany, Thuringen
    • SRH Wald-Klinikum Gera GmbH ( Site 2403) Gera, Thuringen, Germany, 07548
  • Guatemala,
    • Oncomedica ( Site 3401) Guatemala, , Guatemala, 01010
  • Hungary, Jasz-Nagykun-Szolnok
    • Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 1401) Szolnok, Jasz-Nagykun-Szolnok, Hungary, 5000
  • Hungary,
    • Somogy Megyei Kaposi Mor Oktato Korhaz ( Site 1402) Kaposvar, , Hungary, 7400
    • Zala Megyei Szent Rafael Korhaz ( Site 1400) Zalaegerszeg, , Hungary, 8900
  • Israel, Tel Aviv
    • Chaim Sheba Medical Center ( Site 2055) Ramat Gan, Tel Aviv, Israel, 5266202
  • Israel, Tell Abib
    • Sourasky Medical Center ( Site 2054) Tel Aviv, Tell Abib, Israel, 6423906
  • Israel, Yerushalayim
    • Hadassah Ein Kerem Medical Center ( Site 2051) Jerusalem, Yerushalayim, Israel, 9112001
  • Israel,
    • Rambam Medical Center ( Site 2053) Afula, , Israel, 1834111
    • Chaim Sheba Medical Center. ( Site 2052) Ramat gan, , Israel, 5265601
    • Shamir Medical Center-Assaf Harofeh ( Site 2058) Zerifin, , Israel, 70300
  • Italy, Piemonte
    • Ospedale San Luigi Gonzaga ( Site 1956) Orbassano, Piemonte, Italy, 10043
  • Italy,
    • Humanitas Gavazzeni ( Site 1954) Bergamo, , Italy, 24125
    • Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 1955) Napoli, , Italy, 80131
    • IRCCS CRO Aviano, Hematology/Oncology ( Site 1957) Pordenone, , Italy, 33170
    • Azienda Ospedaliera San Camillo Forlanini ( Site 1958) Roma, , Italy, 00152
    • 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, 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
    • 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
    • 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
    • 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, Tokyo
    • Kyorin University Hospital ( Site 3103) Mitaka, Tokyo, Japan, 181-8611
  • Japan, Yamaguchi
    • Yamaguchi University Hospital ( Site 3114) Ube, Yamaguchi, Japan, 755-8505
  • Japan,
    • Chiba Cancer Center ( Site 3117) Chiba, , Japan, 260-8717
    • Okayama University Hospital ( Site 3107) Okayama, , Japan, 700-8558
    • The Cancer Institute Hospital of JFCR ( Site 3108) Tokyo, , Japan, 135-8550
    • Teikyo University Hospital ( Site 3104) Tokyo, , Japan, 173-8606
  • 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,
    • 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
    • Asan Medical Center ( Site 0952) Seoul, , Korea, Republic of, 05505
    • Samsung Medical Center ( Site 0950) Seoul, , Korea, Republic of, 06351
  • 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,
    • 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
  • Philippines, National Capital Region
    • St. Luke s Medical Center ( Site 1700) Quezon City, National Capital Region, Philippines, 1102
  • Poland, Wielkopolskie
    • SKPP UM im. Karola Marcinkowkiego w Poznaniu ( Site 1601) Poznan, Wielkopolskie, Poland, 60-569
  • 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, 430032
  • 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
  • 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, Madrid
    • Hospital Universitario Puerta de Hierro-Majadahonda ( Site 0861) Majadahonda, Madrid, Spain, 28222
  • 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
  • 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
    • 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, Zurich
    • Universitaetsspital Zuerich ( Site 0750) Zuerich, Zurich, Switzerland, 8091
  • Taiwan,
    • Kaohsiung Chang Gung Memorial Hospital ( Site 3203) Kaohsiung, , Taiwan, 83301
    • China Medical University Hospital ( Site 3204) Taichung, , Taiwan, 404
    • 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
  • 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
    • 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,
    • Mid Essex Hospitals Service Trust. Broomfield Hospital ( Site 0503) Broomfield, , United Kingdom, CM1 7ET

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 November 12, 2020