Safety and Efficacy of Pembrolizumab (MK-3475) Versus Placebo as Adjuvant Therapy in Participants With Hepatocellular Carcinoma (HCC) and Complete Radiological Response After Surgical Resection or Local Ablation (MK-3475-937 / KEYNOTE-937)

Sponsor
Merck Sharp & Dohme LLC (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03867084
Collaborator
(none)
950
249
2
73.1
3.8
0.1

Study Details

Study Description

Brief Summary

This study will evaluate the safety and efficacy of pembrolizumab (MK-3475) versus placebo as adjuvant therapy in participants with hepatocellular carcinoma (HCC) and complete radiological response after surgical resection or local ablation. The primary hypotheses of this study are that adjuvant pembrolizumab is superior to placebo with respect to: 1) recurrence-free survival (RFS) as assessed by blinded independent central review (BICR); and 2) overall survival (OS).

Condition or Disease Intervention/Treatment Phase
  • Biological: Pembrolizumab
  • Drug: Placebo
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
950 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Phase 3 Double-blinded, Two-arm Study to Evaluate the Safety and Efficacy of Pembrolizumab (MK-3475) Versus Placebo as Adjuvant Therapy in Participants With Hepatocellular Carcinoma and Complete Radiological Response After Surgical Resection or Local Ablation (KEYNOTE-937)
Actual Study Start Date :
May 28, 2019
Anticipated Primary Completion Date :
Jun 30, 2025
Anticipated Study Completion Date :
Jun 30, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Pembrolizumab

Participants receive intravenous (IV) pembrolizumab at 200 mg on Day 1 of each 21-day cycle for up to 17 cycles.

Biological: Pembrolizumab
IV infusion of Pembrolizumab 200 mg.
Other Names:
  • KEYTRUDA®
  • MK-3475
  • Placebo Comparator: Placebo

    Participants receive IV placebo on Day 1 of each 21-day cycle for up to 17 cycles.

    Drug: Placebo
    IV infusion of 0.9% normal saline.

    Outcome Measures

    Primary Outcome Measures

    1. Recurrence-Free Survival (RFS) [Up to ~4 years]

      RFS is defined as the time from randomization to first documentation of disease recurrence (local, regional, or distant) as assessed by BICR or by pathology consistent with HCC if required per the site's standard of care, or death due to any cause (both cancer and non-cancer causes of death), whichever occurs first.

    2. Overall Survival (OS) [Up to ~6 years]

      OS is defined as the time from randomization to death due to any cause.

    Secondary Outcome Measures

    1. Percentage of Participants who Experience an Adverse Event (AE) [Up to ~6 years]

      An AE is defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy can be determined.

    2. Percentage of Participants who Discontinue Study Treatment Due to an AE [Up to ~1 year]

      An AE is defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy can be determined.

    3. Change from Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Combined Global Health Status (GHS) / Quality of Life (QoL) Scale Score [Baseline and time of last patient reported outcome (PRO) assessment (up to ~7 years)]

      The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients, including a combined GHS/QoL (Items 29 and 30) scale. Per protocol, the change from baseline in the combined GHS/QoL score (range: 0-100) will be reported. Higher overall GHS/QoL scores indicate higher GHS/QoL.

    4. Change from Baseline in EORTC QLQ-Hepatocellular Carcinoma Module (EORTC QLQ-HCC18) Scale Score [Baseline and time of last PRO assessment (up to ~7 years)]

      The EORTC QLQ-HCC18 is an HCC-specific questionnaire, administered in addition to the EORTC QLQ-C30, with scores ranging from 0-100. Higher scores indicate more severe symptoms/problems. Change from baseline in the EORTC QLQ-HCC18 scale score will be reported.

    5. Change from Baseline in European Quality of Life (EuroQoL)-5 Dimensions, 5-level Questionnaire (EQ-5D-5L) Health Utility Score [Baseline and time of last PRO assessment (up to ~7 years)]

      The EQ-5D-5L measured health-related outcomes, assessing 5 health state dimensions (mobility, selfcare, usual activities, pain/discomfort, and anxiety/depression) on a 5-point scale from 1 (no problem) to 5 (extreme problems). The EQ-5D-5L also includes a graded (0 to 100) vertical visual analog scale on which the participant rates their general state of health.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Has a diagnosis of HCC by radiological criteria and/or pathological confirmation.

    • Has an eligibility scan (CT of the chest, triphasic CT scan or MRI of the abdomen, and CT or MRI of the pelvis) confirming complete radiological response ≥4 weeks after complete surgical resection or local ablation. Randomization needs to occur within 12 weeks of the date of surgical resection or local ablation.

    • Has no radiologic evidence of disease prior to enrollment.

    • Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days prior to Cycle 1, Day 1.

    • Has a Child-Pugh class A liver score (5 to 6 points) within 7 days prior to Cycle 1, Day 1.

    • Has alpha fetoprotein (AFP) concentration lower than 400 ng/mL within 28 days prior to Cycle 1, Day 1.

    • Has controlled hepatitis B (Hep B).

    • Has recovered adequately from toxicity and/or complications from the local intervention (surgical resection or local ablation) prior to starting study treatment.

    • If female, is not pregnant or breastfeeding, and at least one of the following conditions applies: 1) Is not a woman of childbearing potential (WOCBP); or 2) Is a WOCBP and using a contraceptive method that is highly effective or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (a WOCBP must have a negative pregnancy test within 72 hours before the first dose of study treatment).

    • If undergoing surgical resection, has submitted a tumor tissue sample during Screening.

    • Has adequate organ function.

    Exclusion Criteria:
    • Has a known additional malignancy that is progressing or has required active antineoplastic treatment (including hormonal) or surgery within the past 3 years.

    • Has had esophageal or gastric variceal bleeding within the last 6 months.

    • Has clinically apparent ascites on physical examination.

    • Has had clinically diagnosed hepatic encephalopathy in the last 6 months.

    • Has received local therapy to liver ablation other than with radiofrequency or microwave ablation.

    • Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.

    • Has an active infection requiring systemic therapy.

    • Has dual active Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV) infection at study entry.

    • Has a known history of human immunodeficiency virus (HIV) infection.

    • Has known active tuberculosis (TB; Bacillus tuberculosis).

    • Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137).

    • Has received prior systemic anti-cancer therapy for HCC including investigational agents.

    • Is receiving any of the following prohibited concomitant therapies:1) Antineoplastic systemic chemotherapy or biological therapy; 2) Immunotherapy not specified in this protocol; 3) Investigational agents other than pembrolizumab; 4) Radiation therapy; 5) Oncological surgical therapy; or systemic glucocorticoids for any purpose other than to modulate symptoms from an AE that is suspected to have an immunologic etiology.

    • Has received a live vaccine within 30 days prior to the first dose of study treatment.

    • Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to Cycle 1, Day 1.

    • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to Cycle 1, Day 1.

    • Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.

    • Has an active autoimmune disease that has required systemic treatment in past 2 years.

    • Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study.

    • Has had an allogenic tissue/solid organ transplant.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Banner MD Anderson Cancer Center ( Site 0026) Gilbert Arizona United States 85234
    2 The University of Arizona Cancer Center - North Campus ( Site 0039) Tucson Arizona United States 85719
    3 City of Hope Medical Center ( Site 0027) Duarte California United States 91010
    4 Smilow Cancer Hospital at Yale New Haven ( Site 0042) New Haven Connecticut United States 06510
    5 Regional Cancer Center ( Site 0054) Fort Myers Florida United States 33905
    6 Indiana University Simon Cancer Center ( Site 0075) Indianapolis Indiana United States 46202
    7 University of Iowa ( Site 0067) Iowa City Iowa United States 52242
    8 James Graham Brown Cancer Center ( Site 0088) Louisville Kentucky United States 40202
    9 University of Louisville ( Site 0059) Louisville Kentucky United States 40202
    10 University Medical Center New Orleans ( Site 0014) New Orleans Louisiana United States 70112
    11 Massachusetts General Hospital ( Site 0062) Boston Massachusetts United States 02114
    12 Boston Medical Center ( Site 0025) Boston Massachusetts United States 02118
    13 Beth Israel Deaconess Medical Ctr. ( Site 0033) Boston Massachusetts United States 02215
    14 University of Massachusetts Worcester ( Site 0017) Worcester Massachusetts United States 01655
    15 Henry Ford Hospital-GI/Hepatology Research ( Site 0047) Detroit Michigan United States 48202
    16 University of New Mexico ( Site 0041) Albuquerque New Mexico United States 87131
    17 North Shore-Long Island Jewish Health System ( Site 0068) Lake Success New York United States 11042
    18 Miami Valley Hospital South ( Site 0093) Centerville Ohio United States 45459
    19 University of Cincinnati Medical Center ( Site 0084) Cincinnati Ohio United States 45219
    20 ProMedica Flower Hospital ( Site 0090) Sylvania Ohio United States 43560
    21 Stephenson Cancer Center ( Site 0045) Oklahoma City Oklahoma United States 73104
    22 Vanderbilt Ingram Cancer Center ( Site 0006) Nashville Tennessee United States 37232
    23 Baylor Scott & White Medical Center - Temple ( Site 0089) Temple Texas United States 76508
    24 Virginia Mason Medical Center ( Site 0028) Seattle Washington United States 98101
    25 Hospital Universitario Austral ( Site 0795) Pilar Buenos Aires Argentina B1629AHJ
    26 Fundación favaloro para la Docencia e Investigación Médica ( Site 0808) Buenos Aires Caba Argentina C1096AAS
    27 Hospital Provincial del Centenario ( Site 0794) Rosario Santa Fe Argentina S2002KDS
    28 Hospital Aleman ( Site 0806) Buenos Aires Argentina C1118AAT
    29 Hospital Italiano ( Site 0793) Buenos Aires Argentina C1181ACH
    30 Hospital Britanico de Buenos Aires ( Site 0792) Buenos Aires Argentina C1280AEB
    31 Clinica de nefrologia urologia y enfermedades cardiovasculares ( Site 0802) Santa Fe Argentina S3000BPJ
    32 Royal Prince Alfred Hospital AW ( Site 0225) Camperdown New South Wales Australia 2050
    33 Liverpool Hospital ( Site 0226) Liverpool New South Wales Australia 2170
    34 Princess Alexandra Hospital ( Site 0228) Woollongabba Queensland Australia 4102
    35 Royal Adelaide Hospital ( Site 0234) Adelaide South Australia Australia 5000
    36 Monash Health ( Site 0233) Clayton Victoria Australia 3168
    37 St Vincents Hospital Melbourne ( Site 0227) Fitzroy Victoria Australia 3065
    38 Alfred Health ( Site 0230) Melbourne Victoria Australia 3004
    39 Royal Perth Hospital ( Site 0229) Perth Western Australia Australia 6000
    40 University Hospital Antwerp (UZA) ( Site 0374) Edegem Antwerpen Belgium 02650
    41 Erasme Hospital ( Site 0376) Bruxelles Bruxelles-Capitale, Region De Belgium 1070
    42 UZ Gent ( Site 0375) Gent Oost-Vlaanderen Belgium 9000
    43 UZ Leuven ( Site 0377) Leuven Vlaams-Brabant Belgium 3000
    44 CIONC - Centro Integrado de Oncologia de Curitiba ( Site 0813) Curitiba Parana Brazil 80810-050
    45 Hospital de Cancer de Pernambuco ( Site 0815) Recife Pernambuco Brazil 50040-000
    46 Hospital de Clinicas de Porto Alegre ( Site 0824) Porto Alegre Rio Grande Do Sul Brazil 90035-903
    47 Clinica de Oncologia Reichow ( Site 0818) Blumenau Santa Catarina Brazil 89010-340
    48 Centro de Novos Tratamentos Itajai - Clinica de Neoplasias Litoral ( Site 0820) Itajai Santa Catarina Brazil 88301-220
    49 Hospital Paulistano ( Site 0829) São Paulo Sao Paulo Brazil 01321-001
    50 Instituto COI de Pesquisa Educacao e Gestao ( Site 0825) Rio de Janeiro Brazil 22793-080
    51 Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0826) Sao Paulo Brazil 01246-000
    52 Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 0828) Sao Paulo Brazil 01321-001
    53 A.C. Camargo Cancer Center ( Site 0827) Sao Paulo Brazil 01509-900
    54 Casa de Saude Santa Marcelina ( Site 0821) Sao Paulo Brazil 08270120
    55 Complex Cancer Center Plovdiv-First Medical Oncology Department ( Site 0982) Plovdiv Bulgaria 4004
    56 Nova Scotia Health Authority QEII-HSC ( Site 0208) Halifax Nova Scotia Canada B3H 2Y9
    57 Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0211) Montreal Quebec Canada H2X 3E4
    58 McGill University Health Centre ( Site 0207) Montreal Quebec Canada H4A 3J1
    59 Anhui Provincil Hospital South District ( Site 0181) Hefei Anhui China 230036
    60 Cancer Hospital Chinese Academy of Medical Sciences ( Site 0156) Beijing Beijing China 100021
    61 Peking University People's Hospital ( Site 0191) Beijing Beijing China 100044
    62 Beijing Cancer Hospital ( Site 0155) Beijing Beijing China 100142
    63 Fujian Provincial Cancer Hospital ( Site 0165) Fuzhou Fujian China 350014
    64 900 Hospital of the Joint ( Site 0197) Fuzhou Fujian China 350025
    65 Guangdong General Hospital ( Site 0166) Guangzhou Guangdong China 510080
    66 Southern Medical University Nanfang Hospital ( Site 0172) Guangzhou Guangdong China 510515
    67 Wuhan Union Hospital ( Site 0173) Wuhan Hubei China 430022
    68 Hubei Cancer Hospital ( Site 0189) Wuhan Hubei China 430079
    69 The Third Xiangya Hospital of Central South University ( Site 0167) Changsha Hunan China 410000
    70 Hunan Provincial People Hospital ( Site 0192) Changsha Hunan China 410005
    71 Hunan Cancer Hospital ( Site 0168) Changsha Hunan China 410013
    72 Fudan University Shanghai Cancer Center ( Site 0161) Shanghai Shanghai China 200032
    73 Zhongshan Hospital Fudan University ( Site 0193) Shanghai Shanghai China 200032
    74 Renji Hospital Shanghai Jiaotong University School of Medicine ( Site 0174) Shanghai Shanghai China 200127
    75 Zhongshan Hospital affiliated to Fudan University ( Site 0153) Shanghai Shanghai China 210000
    76 The First Affiliated Hospital of Xi an Jiaotong University ( Site 0164) XI An Shanxi China 710061
    77 West China Hospital of Sichuan University ( Site 0162) Chengdu Sichuan China 610041
    78 Affiliated Tumor Hospital of Xinjiang Medical University ( Site 0157) Urumqi Xinjiang China 830001
    79 Zhejiang Cancer Hospital ( Site 0171) Hangzhou Zhejiang China 310022
    80 Herlev Hospital ( Site 0421) Herlev Hovedstaden Denmark 2730
    81 Aarhus Universitets hospital ( Site 0420) Aarhus N Midtjylland Denmark 8200
    82 Odense Universitets Hospital ( Site 0422) Odense C Syddanmark Denmark 5000
    83 HUS Hopital Hautepierre ( Site 0445) Strasbourg Bas-Rhin France 67098
    84 Hopital de la Timone ( Site 0442) Marseille Bouches-du-Rhone France 13005
    85 CHU Bordeaux Haut-Leveque ( Site 0437) Pessac Gironde France 33604
    86 CHU Rangueil ( Site 0441) Toulouse Haute-Garonne France 31059
    87 Hopital Beaujon ( Site 0439) Clichy Hauts-de-Seine France 92118
    88 CHU Montpellier. ( Site 0443) Montpellier Herault France 34295
    89 Hopital Claude Huriez CHRU LILLE ( Site 0440) Lille Nord France 59037
    90 Hopital Paul Brousse ( Site 0447) Villejuif Val-de-Marne France 94800
    91 SLK-Kliniken Heilbronn GmbH ( Site 0460) Heilbronn Baden-Wurttemberg Germany 74078
    92 Universitaetsklinikum Tuebingen ( Site 0466) Tuebingen Baden-Wurttemberg Germany 72076
    93 Klinikum rechts der Isar der Technischen Universitaet ( Site 0470) Muenchen Bayern Germany 81675
    94 Universitaetsklinikum Wuerzburg ( Site 0468) Wuerzburg Bayern Germany 97080
    95 Krankenhaus Nord-West GmbH ( Site 0472) Frankfurt am Main Hessen Germany 60488
    96 Universitaetsklinikum Frankfurt ( Site 0467) Frankfurt Hessen Germany 60596
    97 Medizinische Hochschule Hannover ( Site 0458) Hannover Niedersachsen Germany 30625
    98 Universitaetsklinikum Duesseldorf ( Site 0461) Duesseldorf Nordrhein-Westfalen Germany 40225
    99 Universitaetsklinikum Koeln ( Site 0463) Koeln Nordrhein-Westfalen Germany 50937
    100 Staedtisches Klinikum Dresden ( Site 0471) Dresden Sachsen Germany 01067
    101 Universitatsklinikum Carl Gustav Carus ( Site 0459) Dresden Sachsen Germany 01307
    102 Charite - Campus Virchow Klinikum ( Site 0457) Berlin Germany 13353
    103 Universitaetsklinikum Hamburg-Eppendorf ( Site 0469) Hamburg Germany 20246
    104 Prince of Wales Hospital ( Site 0268) Hong Kong Hong Kong 000
    105 Pamela Youde Nethersole Eastern Hospital ( Site 0271) Hong Kong Hong Kong
    106 Queen Mary Hospital ( Site 0267) Hong Kong Hong Kong
    107 Tuen Mun Hospital ( Site 0272) Tuen Mun Hong Kong
    108 Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 0483) Kecskemét Bacs-Kiskun Hungary 6000
    109 SZTE Szent-Gyorgyi Albert Klinikai Kozpont ( Site 0482) Szeged Csongrad Hungary 6720
    110 Somogy Megyei Kaposi Mór Oktató Kórház-Oncology center ( Site 0484) Kaposvár Somogy Hungary 7400
    111 Semmelweis University ( Site 0480) Budapest Hungary 1085
    112 Debreceni Egyetem Klinikai Kozpont Onkologiai Tanszek ( Site 0481) Debrecen Hungary 4032
    113 St Vincent's University Hospital ( Site 0498) Dublin Ireland D04 T6F4
    114 Tallaght University Hospital ( Site 0499) Dublin Ireland D24 NR0A
    115 Rambam Medical Center ( Site 0524) Haifa Israel 3109601
    116 Haddassah Medical Organization - Ein Kerem ( Site 0519) Jerusalem Israel 9112001
    117 Rabin Medical Center ( Site 0520) Petah Tikva Israel 4941492
    118 Chaim Sheba Medical Center ( Site 0523) Ramat Gan Israel 5262000
    119 Sourasky Medical Center ( Site 0522) Tel Aviv Israel 6423906
    120 A O U Policlinico di Modena ( Site 0548) Modena Abruzzo Italy 41025
    121 Azienda Ospedaliera Ordine Mauriziano di Torino ( Site 0542) Torino Piemonte Italy
    122 Azienda Ospedaliera Ospedali Riuniti Villa Sofia-Cervello ( Site 0547) Palermo Sicilia Italy 90146
    123 Istituto Tumori Giovanni Paolo II ( Site 0543) Bari Italy 70124
    124 AOU di Bologna Policliico S. Orsola-Malpighi ( Site 0541) Bologna Italy 40138
    125 Azienda Ospedaliero Universitaria Careggi ( Site 0549) Firenze Italy 50134
    126 Fondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico ( Site 0550) Milano Italy 20122
    127 Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0540) Milano Italy 20133
    128 Ospedale del Mare ( Site 0545) Napoli Italy 80147
    129 Azienda Ospedaliero Universitaria Pisana ( Site 0546) Pisa Italy 56126
    130 Ehime University Hospital ( Site 0123) Toon Ehime Japan 791-0295
    131 Kurume University Hospital ( Site 0119) Kurume Fukuoka Japan 830-0011
    132 Hokkaido P.W.F.A.C Sapporo-Kosei General Hospital ( Site 0102) Sapporo Hokkaido Japan 060-0033
    133 Kanazawa University Hospital ( Site 0111) Kanazawa Ishikawa Japan 920-8641
    134 Kagawa University Hospital ( Site 0121) Kita-gun Kagawa Japan 761-0793
    135 Kagawa Prefectural Central Hospital ( Site 0122) Takamatsu Kagawa Japan 760-8557
    136 Toranomon Hospital Kajigaya ( Site 0109) Kawasaki Kanagawa Japan 213-8587
    137 Yokohama City University Medical Center ( Site 0110) Yokohama Kanagawa Japan 232-0024
    138 Kindai University Hospital ( Site 0116) Osakasayama Osaka Japan 5898511
    139 Saitama Medical University Hospital ( Site 0104) Iruma-gun Saitama Japan 350-0495
    140 Kyorin University Hospital ( Site 0106) Mitaka Tokyo Japan 181-8611
    141 Musashino Red Cross Hospital ( Site 0107) Musashino Tokyo Japan 180-8610
    142 Chiba University Hospital ( Site 0103) Chiba Japan 260-8677
    143 National Hospital Organization Kyushu Medical Center ( Site 0118) Fukuoka Japan 810-8563
    144 Hiroshima University Hospital ( Site 0117) Hiroshima Japan 7348551
    145 University Hospital, Kyoto Prefectural University of Medicine ( Site 0112) Kyoto Japan 602-8566
    146 Japanese Red Cross Osaka Hospital ( Site 0113) Osaka Japan 543-8555
    147 Osaka Metropolitan University Hospital. ( Site 0114) Osaka Japan 545-8586
    148 Saga-Ken Medical Centre Koseikan ( Site 0120) Saga Japan 840-8571
    149 Toranomon Hospital ( Site 0108) Tokyo Japan 105-8470
    150 The University of Tokyo Hospital ( Site 0105) Tokyo Japan 113-8655
    151 Wakayama Medical University Hospital ( Site 0115) Wakayama Japan 641-8510
    152 National Cancer Center ( Site 0314) Goyang-si Kyonggi-do Korea, Republic of 10408
    153 Seoul National University Bundang Hospital ( Site 0313) Seongnam-si Kyonggi-do Korea, Republic of 13605
    154 Seoul National University Hospital ( Site 0312) Seoul Korea, Republic of 03080
    155 Severance Hospital Yonsei University Health System ( Site 0309) Seoul Korea, Republic of 03722
    156 Asan Medical Center ( Site 0310) Seoul Korea, Republic of 05505
    157 Samsung Medical Center ( Site 0311) Seoul Korea, Republic of 06351
    158 The Catholic University of Korea. Seoul St. Mary s Hospital ( Site 0315) Seoul Korea, Republic of 06591
    159 Hospital Universiti Sains Malaysia ( Site 0295) Kubang Kerian Kelantan Malaysia 16150
    160 Penang Adventist Hospital ( Site 0289) George Town Pulau Pinang Malaysia 10350
    161 Gleneagles Penang ( Site 0290) Penang Pulau Pinang Malaysia 10050
    162 Sarawak General Hospital ( Site 0293) Kuching Sarawak Malaysia 93586
    163 Institut Kanser Negara - National Cancer Institute ( Site 0294) Putrajaya Wilayah Persekutuan Wilayah Persekutuan Putrajaya Malaysia 62250
    164 University Malaya Medical Centre ( Site 0288) Kuala Lumpur Malaysia 59100
    165 Christchurch Hospital ( Site 0247) Christchurch Canterbury New Zealand 8011
    166 Auckland City Hospital ( Site 0246) Auckland New Zealand 1142
    167 Oslo Universitetssykehus HF. Ulleval ( Site 0433) Oslo Norway 0450
    168 Izerskie Centrum Pulmonologii i Chemioterapii IZER-MED Spolka z o.o. ( Site 0607) Szklarska Poreba Dolnoslaskie Poland 58-580
    169 Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie ( Site 0620) Lublin Lubelskie Poland 20-081
    170 MTZ Clinical Research Sp. z o. o. ( Site 0608) Warsaw Mazowieckie Poland 02-106
    171 Copernicus PL Sp. z o.o. ( Site 0603) Gdansk Pomorskie Poland 80-219
    172 ID Clinic ( Site 0619) Myslowice Slaskie Poland 41-400
    173 SPZOZ MSWIA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie ( Site 0606) Olsztyn Warminsko-mazurskie Poland 10-228
    174 Szpital Wojewodzki im. Mikolaja Kopernika ( Site 0604) Koszalin Zachodniopomorskie Poland 75-581
    175 Altay Regional Oncology Dispensary ( Site 0919) Barnaul Altayskiy Kray Russian Federation 656045
    176 Siberian Clinical Center of FMBA ( Site 0918) Krasnoyarsk Krasnoyarskiy Kray Russian Federation 660037
    177 Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0648) Krasnoyarsk Krasnoyarskiy Kray Russian Federation 660133
    178 Blokhin National Medical Oncology ( Site 0645) Moscow Moskva Russian Federation 115478
    179 City Clinical Hospital 1 na. NI. Pirogov ( Site 0662) Moscow Moskva Russian Federation 119049
    180 First Moscow State Medical University n.a. I.M.Sechenov ( Site 0661) Moscow Moskva Russian Federation 119881
    181 Hadassah Medical-Clinical Research Department ( Site 0920) Moscow Moskva Russian Federation 121205
    182 National Medical Research Radiological Centre ( Site 0660) Moscow Moskva Russian Federation 125284
    183 Privolzhsky District Medical Center ( Site 0655) Nizhniy Novgorod Nizhegorodskaya Oblast Russian Federation 603109
    184 Samara Regional Clinical Oncology Center ( Site 0656) Samara Samarskaya Oblast Russian Federation 443031
    185 Road Hospital JSC Russian railways ( Site 0649) Saint Petersburg Sankt-Peterburg Russian Federation 195271
    186 Russian Scientific Center of Radiology and Surgical Technologies ( Site 0665) Saint Petersburg Sankt-Peterburg Russian Federation 197758
    187 City Clinical Oncology Center ( Site 0646) Saint Petersburg Sankt-Peterburg Russian Federation 198255
    188 Tomsk Scientific Research Institute of Oncology ( Site 0657) Tomsk Tomskaya Oblast Russian Federation 634028
    189 Hospital Central de Asturias ( Site 0667) Oviedo Asturias Spain 33011
    190 Hospital Universitari Parc Tauli ( Site 0681) Sabadell Barcelona Spain 08208
    191 Hospital Universitario de Donostia ( Site 0671) San Sebastian Gipuzkoa Spain 20014
    192 Complejo Hospitalario Universitario de Santiago ( Site 0668) Santiago de Compostela La Coruna Spain 15706
    193 Hospital Universitario Puerta de Hierro ( Site 0678) Majadahonda Madrid Spain 28222
    194 Hospital Universitari Vall d Hebron ( Site 0674) Barcelona Spain 08035
    195 Hospital General Universitario Gregorio Maranon ( Site 0676) Madrid Spain 28007
    196 Hospital Ramon y Cajal ( Site 0673) Madrid Spain 28034
    197 Hospital Universitario La Paz ( Site 0677) Madrid Spain 28046
    198 Hospital Universitario Virgen del Rocio ( Site 0670) Sevilla Spain 41013
    199 Hospital Universitario Miguel Servet-Gastroenterology ( Site 0682) Zaragoza Spain 50009
    200 Skane University Hospital ( Site 0692) Malmo Skane Lan Sweden 205 02
    201 Karolinska Universitetssjukhuset, Huddinge ( Site 0689) Stockholm Stockholms Lan Sweden 141 86
    202 Norrlands Universitetssjukhus ( Site 0687) Umea Vasterbottens Lan Sweden 901 85
    203 Sahlgrenska Universitetssjukhuset ( Site 0691) Goteborg Vastra Gotalands Lan Sweden 413 46
    204 Universitaetsspital Bern ( Site 0710) Bern Aargau Switzerland 3010
    205 University Hospital Basel ( Site 0709) Basel Basel-Stadt Switzerland 4056
    206 Kantonsspital St. Gallen ( Site 0708) St. Gallen Sankt Gallen Switzerland 9007
    207 CHUV (centre hospitalier universitaire vaudois) ( Site 0712) Lausanne Vaud Switzerland 1011
    208 Kantonsspital Winterthur ( Site 0714) Winterthur Zurich Switzerland 8401
    209 Hopitaux Universitaires de Geneve HUG ( Site 0711) Geneve Switzerland 1211
    210 Universitaetsspital Zurich ( Site 0713) Zurich Switzerland 8091
    211 Chang Gung Medical Foundation. Kaohsiung Branch ( Site 0335) Kaohsiung Taiwan 833
    212 China Medical University Hospital ( Site 0333) Taichung Taiwan 40447
    213 National Cheng Kung University Hospital ( Site 0334) Tainan Taiwan 704
    214 National Taiwan University Hospital ( Site 0330) Taipei Taiwan 100
    215 Taipei Veterans General Hospital ( Site 0331) Taipei Taiwan 112
    216 Chang Gung Medical Foundation. Linkou ( Site 0332) Taoyuan Taiwan 333
    217 Ramathibodi Hospital. ( Site 0352) Bangkok Krung Thep Maha Nakhon Thailand 10400
    218 Siriraj Hospital ( Site 0351) Bangkok Krung Thep Maha Nakhon Thailand 10700
    219 Maharaj Nakorn Chiangmai Hospital ( Site 0353) Chiang Mai Thailand 50200
    220 Srinagarind Hospital ( Site 0354) Khon Kaen Thailand 40002
    221 Namik Kemal Universitesi Tip Fakultesi ( Site 0738) Tekirdag Tekirdas Turkey 59100
    222 Baskent Unv. Adana Uyg. ve Arast. Hastanesi ( Site 0733) Adana Turkey 01120
    223 Gulhane Egitim ve Arastirma Hastanesi ( Site 0741) Ankara Turkey 06010
    224 Ankara Sehir Hastanesi ( Site 0731) Ankara Turkey 06800
    225 Adnan Menderes University Medical Faculty ( Site 0737) Aydin Turkey 09010
    226 Bezmialem Vakif University School of Medicine ( Site 0732) Istanbul Turkey 34093
    227 Acıbadem Maslak Hastanesi ( Site 0742) Istanbul Turkey 34457
    228 Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 0730) Istanbul Turkey 34722
    229 Dokuz Eylul Universitesi ( Site 0740) Izmir Turkey 35340
    230 Konya Necmettin Erbakan University Medical Faculty ( Site 0736) Konya Turkey 42080
    231 Inonu University Faculty of Medicine ( Site 0729) Malatya Turkey 44280
    232 VM Medical Park Hastanesi ( Site 0739) Mersin Turkey 33440
    233 Regional Clinical Onco Dispensary_ State Medical University ( Site 0782) Chernivtsi Chernivetska Oblast Ukraine 58000
    234 Regional Oncology Center of Kharkiv ( Site 0777) Kharkiv Kharkivska Oblast Ukraine 61000
    235 National Cancer Institute of the MoH of Ukraine ( Site 0779) Kyiv Kyivska Oblast Ukraine 03022
    236 Shalimov s NI of Surgery and Transplantation ( Site 0781) Kyiv Kyivska Oblast Ukraine 03126
    237 MI Odessa Regional Oncological Centre ( Site 0776) Odesa Odeska Oblast Ukraine 65055
    238 CI City Clinical Hospital # 3 ( Site 0783) Zaporizhzhia Zaporizka Oblast Ukraine 69032
    239 Universal Clinic Oberig-Oncology Center ( Site 0786) Kyiv Ukraine 03057
    240 Medical Center Dobrobut Clinic ( Site 0785) Kyiv Ukraine 03151
    241 Cambridge University Hospitals NHS Trust ( Site 0755) Cambridge Cambridgeshire United Kingdom CB2 0QQ
    242 Weston Park Hospital ( Site 0753) Sheffield Derbyshire United Kingdom S10 2SJ
    243 The Beatson West of Scotland Cancer Centre ( Site 0750) Glasgow Glasgow City United Kingdom G12 0YN
    244 Kings College Hospital NHS Foundation Trust ( Site 0758) London London, City Of United Kingdom SE5 9RS
    245 Belfast City Hospital ( Site 0752) Belfast Northern Ireland United Kingdom BT9 7AB
    246 The Clatterbridge Cancer Centre NHS Foundation Trust ( Site 0757) Birkenhead Wirral United Kingdom CH63 4JY
    247 University Hospital Coventry and Warwickshire NHS Trust ( Site 0754) Coventry United Kingdom CV3 2DX
    248 Leeds Teaching Hospitals NHS Trust ( Site 0751) Leeds United Kingdom LS9 7TF
    249 Nottingham University Hospitals NHS Trust ( Site 0756) Nottingham United Kingdom NG5 1PB

    Sponsors and Collaborators

    • Merck Sharp & Dohme LLC

    Investigators

    • Study Director: Medical Director, Merck Sharp & Dohme LLC

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Merck Sharp & Dohme LLC
    ClinicalTrials.gov Identifier:
    NCT03867084
    Other Study ID Numbers:
    • 3475-937
    • MK-3475-937
    • KEYNOTE-937
    • 194786
    • 2018-004800-20
    First Posted:
    Mar 7, 2019
    Last Update Posted:
    Aug 11, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Merck Sharp & Dohme LLC
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 11, 2022