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)

April 3, 2026 updated by: Merck Sharp & Dohme LLC

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)

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

959

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1118AAT
        • Hospital Aleman ( Site 0806)
      • Buenos Aires, Argentina, C1181ACH
        • Hospital Italiano ( Site 0793)
      • Buenos Aires, Argentina, C1280AEB
        • Hospital Britanico de Buenos Aires ( Site 0792)
      • Santa Fe, Argentina, S3000BPJ
        • Clinica de nefrologia urologia y enfermedades cardiovasculares ( Site 0802)
    • Buenos Aires
      • Pilar, Buenos Aires, Argentina, B1629AHJ
        • Hospital Universitario Austral ( Site 0795)
    • Buenos Aires F.D.
      • Buenos Aires, Buenos Aires F.D., Argentina, C1096AAS
        • Fundación favaloro para la Docencia e Investigación Médica ( Site 0808)
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, S2002KDS
        • Hospital Provincial del Centenario ( Site 0794)
  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Royal Prince Alfred Hospital AW ( Site 0225)
      • Liverpool, New South Wales, Australia, 2170
        • Liverpool Hospital ( Site 0226)
    • Queensland
      • Woollongabba, Queensland, Australia, 4102
        • Princess Alexandra Hospital ( Site 0228)
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Royal Adelaide Hospital ( Site 0234)
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Monash Health ( Site 0233)
      • Fitzroy, Victoria, Australia, 3065
        • St Vincents Hospital Melbourne ( Site 0227)
      • Melbourne, Victoria, Australia, 3004
        • Alfred Health ( Site 0230)
    • Western Australia
      • Perth, Western Australia, Australia, 6000
        • Royal Perth Hospital ( Site 0229)
  • Belgium
    • Antwerpen
      • Edegem, Antwerpen, Belgium, 02650
        • University Hospital Antwerp (UZA) ( Site 0374)
    • Bruxelles-Capitale, Region de
      • Brussels, Bruxelles-Capitale, Region de, Belgium, 1070
        • Erasme Hospital ( Site 0376)
    • Oost-Vlaanderen
      • Ghent, Oost-Vlaanderen, Belgium, 9000
        • UZ Gent ( Site 0375)
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • UZ Leuven ( Site 0377)
  • Brazil
      • Rio de Janeiro, Brazil, 22793-080
        • Instituto COI de Pesquisa Educacao e Gestao ( Site 0825)
      • São Paulo, Brazil, 01246-000
        • Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0826)
      • São Paulo, Brazil, 01321-001
        • Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 0828)
      • São Paulo, Brazil, 01509-900
        • A.C. Camargo Cancer Center ( Site 0827)
      • São Paulo, Brazil, 08270120
        • Casa de Saude Santa Marcelina ( Site 0821)
    • Paraná
      • Curitiba, Paraná, Brazil, 80810-050
        • CIONC - Centro Integrado de Oncologia de Curitiba ( Site 0813)
    • Pernambuco
      • Recife, Pernambuco, Brazil, 50040-000
        • Hospital de Cancer de Pernambuco ( Site 0815)
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
        • Hospital de Clinicas de Porto Alegre ( Site 0824)
    • Santa Catarina
      • Blumenau, Santa Catarina, Brazil, 89010-340
        • Clinica de Oncologia Reichow ( Site 0818)
      • Itajaí, Santa Catarina, Brazil, 88301-220
        • Centro de Novos Tratamentos Itajai - Clinica de Neoplasias Litoral ( Site 0820)
    • São Paulo
      • São Paulo, São Paulo, Brazil, 01321-001
        • Hospital Paulistano ( Site 0829)
  • Bulgaria
      • Plovdiv, Bulgaria, 4004
        • Complex Cancer Center Plovdiv-First Medical Oncology Department ( Site 0982)
  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • Nova Scotia Health Authority QEII-HSC ( Site 0208)
    • Quebec
      • Montreal, Quebec, Canada, H2X 3E4
        • Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0211)
      • Montreal, Quebec, Canada, H4A 3J1
        • McGill University Health Centre ( Site 0207)
  • China
    • Anhui
      • Hefei, Anhui, China, 230036
        • Anhui Provincil Hospital South District ( Site 0181)
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100021
        • Cancer Hospital Chinese Academy of Medical Sciences ( Site 0156)
      • Beijing, Beijing Municipality, China, 100044
        • Peking University People's Hospital ( Site 0191)
      • Beijing, Beijing Municipality, China, 100142
        • Beijing Cancer Hospital ( Site 0155)
    • Fujian
      • Fuzhou, Fujian, China, 350014
        • Fujian Provincial Cancer Hospital ( Site 0165)
      • Fuzhou, Fujian, China, 350025
        • 900 Hospital of the Joint ( Site 0197)
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Guangdong General Hospital ( Site 0166)
      • Guangzhou, Guangdong, China, 510515
        • Southern Medical University Nanfang Hospital ( Site 0172)
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Wuhan Union Hospital ( Site 0173)
      • Wuhan, Hubei, China, 430079
        • Hubei Cancer Hospital ( Site 0189)
    • Hunan
      • Changsha, Hunan, China, 410000
        • The Third Xiangya Hospital of Central South University ( Site 0167)
      • Changsha, Hunan, China, 410005
        • Hunan Provincial People Hospital ( Site 0192)
      • Changsha, Hunan, China, 410013
        • Hunan Cancer Hospital ( Site 0168)
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200032
        • Fudan University Shanghai Cancer Center ( Site 0161)
      • Shanghai, Shanghai Municipality, China, 200032
        • Zhongshan Hospital Fudan University ( Site 0193)
      • Shanghai, Shanghai Municipality, China, 200127
        • Renji Hospital Shanghai Jiaotong University School of Medicine ( Site 0174)
      • Shanghai, Shanghai Municipality, China, 210000
        • Zhongshan Hospital affiliated to Fudan University ( Site 0153)
    • Shanxi
      • Xi’an, Shanxi, China, 710061
        • The First Affiliated Hospital of Xi an Jiaotong University ( Site 0164)
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • West China Hospital of Sichuan University ( Site 0162)
    • Xinjiang
      • Ürümqi, Xinjiang, China, 830001
        • Affiliated Tumor Hospital of Xinjiang Medical University ( Site 0157)
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Zhejiang Cancer Hospital ( Site 0171)
  • Denmark
    • Capital Region
      • Herlev, Capital Region, Denmark, 2730
        • Herlev Hospital ( Site 0421)
    • Central Jutland
      • Aarhus N, Central Jutland, Denmark, 8200
        • Aarhus Universitets hospital ( Site 0420)
    • Region Syddanmark
      • Odense C, Region Syddanmark, Denmark, 5000
        • Odense Universitets Hospital ( Site 0422)
  • France
    • Bas-Rhin
      • Strasbourg, Bas-Rhin, France, 67098
        • HUS Hopital Hautepierre ( Site 0445)
    • Bouches-du-Rhone
      • Marseille, Bouches-du-Rhone, France, 13005
        • Hopital de la Timone ( Site 0442)
    • Gironde
      • Pessac, Gironde, France, 33604
        • CHU Bordeaux Haut-Leveque ( Site 0437)
    • Haute-Garonne
      • Toulouse, Haute-Garonne, France, 31059
        • CHU Rangueil ( Site 0441)
    • Hauts-de-Seine
      • Clichy, Hauts-de-Seine, France, 92118
        • Hopital Beaujon ( Site 0439)
    • Herault
      • Montpellier, Herault, France, 34295
        • CHU Montpellier. ( Site 0443)
    • Nord
      • Lille, Nord, France, 59037
        • Hopital Claude Huriez CHRU LILLE ( Site 0440)
    • Val-de-Marne
      • Villejuif, Val-de-Marne, France, 94800
        • Hopital Paul Brousse ( Site 0447)
  • Germany
      • Berlin, Germany, 13353
        • Charite - Campus Virchow Klinikum ( Site 0457)
      • Hamburg, Germany, 20246
        • Universitaetsklinikum Hamburg-Eppendorf ( Site 0469)
    • Baden-Wurttemberg
      • Heilbronn, Baden-Wurttemberg, Germany, 74078
        • SLK-Kliniken Heilbronn GmbH ( Site 0460)
      • Tübingen, Baden-Wurttemberg, Germany, 72076
        • Universitaetsklinikum Tuebingen ( Site 0466)
    • Bavaria
      • Munich, Bavaria, Germany, 81675
        • Klinikum rechts der Isar der Technischen Universitaet ( Site 0470)
      • Würzburg, Bavaria, Germany, 97080
        • Universitaetsklinikum Wuerzburg ( Site 0468)
    • Hesse
      • Frankfurt am Main, Hesse, Germany, 60488
        • Krankenhaus Nord-West GmbH ( Site 0472)
      • Frankfurt am Main, Hesse, Germany, 60596
        • Universitaetsklinikum Frankfurt ( Site 0467)
    • Lower Saxony
      • Hanover, Lower Saxony, Germany, 30625
        • Medizinische Hochschule Hannover ( Site 0458)
    • North Rhine-Westphalia
      • Cologne, North Rhine-Westphalia, Germany, 50937
        • Universitaetsklinikum Koeln ( Site 0463)
      • Düsseldorf, North Rhine-Westphalia, Germany, 40225
        • Universitaetsklinikum Duesseldorf ( Site 0461)
    • Saxony
      • Dresden, Saxony, Germany, 01067
        • Staedtisches Klinikum Dresden ( Site 0471)
      • Dresden, Saxony, Germany, 01307
        • Universitatsklinikum Carl Gustav Carus ( Site 0459)
  • Hong Kong
      • Hong Kong, Hong Kong, 000
        • Prince of Wales Hospital ( Site 0268)
      • Hong Kong, Hong Kong
        • Pamela Youde Nethersole Eastern Hospital ( Site 0271)
      • Hong Kong, Hong Kong
        • Queen Mary Hospital ( Site 0267)
      • Tuenmen, Hong Kong
        • Tuen Mun Hospital ( Site 0272)
  • Hungary
      • Budapest, Hungary, 1085
        • Semmelweis University ( Site 0480)
      • Debrecen, Hungary, 4032
        • Debreceni Egyetem Klinikai Kozpont Onkologiai Tanszek ( Site 0481)
    • Bács-Kiskun county
      • Kecskemét, Bács-Kiskun county, Hungary, 6000
        • Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 0483)
    • Csongrád megye
      • Szeged, Csongrád megye, Hungary, 6720
        • SZTE Szent-Gyorgyi Albert Klinikai Kozpont ( Site 0482)
    • Somogy County
      • Kaposvár, Somogy County, Hungary, 7400
        • Somogy Megyei Kaposi Mór Oktató Kórház-Oncology center ( Site 0484)
  • Ireland
      • Dublin, Ireland, D04 T6F4
        • St Vincent's University Hospital ( Site 0498)
      • Dublin, Ireland, D24 NR0A
        • Tallaght University Hospital ( Site 0499)
  • Israel
      • Haifa, Israel, 3109601
        • Rambam Medical Center ( Site 0524)
      • Jerusalem, Israel, 9112001
        • Haddassah Medical Organization - Ein Kerem ( Site 0519)
      • Petah Tikva, Israel, 4941492
        • Rabin Medical Center ( Site 0520)
      • Ramat Gan, Israel, 5262000
        • Chaim Sheba Medical Center ( Site 0523)
      • Tel Aviv, Israel, 6423906
        • Sourasky Medical Center ( Site 0522)
  • Italy
      • Bari, Italy, 70124
        • Istituto Tumori Giovanni Paolo II ( Site 0543)
      • Bologna, Italy, 40138
        • AOU di Bologna Policliico S. Orsola-Malpighi ( Site 0541)
      • Florence, Italy, 50134
        • Azienda Ospedaliero Universitaria Careggi ( Site 0549)
      • Milan, Italy, 20122
        • Fondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico ( Site 0550)
      • Milan, Italy, 20133
        • Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0540)
      • Naples, Italy, 80147
        • Ospedale del Mare ( Site 0545)
      • Pisa, Italy, 56126
        • Azienda Ospedaliero Universitaria Pisana ( Site 0546)
    • Abruzzo
      • Modena, Abruzzo, Italy, 41025
        • A O U Policlinico di Modena ( Site 0548)
    • Piedmont
      • Turin, Piedmont, Italy
        • Azienda Ospedaliera Ordine Mauriziano di Torino ( Site 0542)
    • Sicily
      • Palermo, Sicily, Italy, 90146
        • Azienda Ospedaliera Ospedali Riuniti Villa Sofia-Cervello ( Site 0547)
  • Japan
      • Chiba, Japan, 260-8677
        • Chiba University Hospital ( Site 0103)
      • Fukuoka, Japan, 810-8563
        • National Hospital Organization Kyushu Medical Center ( Site 0118)
      • Hiroshima, Japan, 7348551
        • Hiroshima University Hospital ( Site 0117)
      • Kyoto, Japan, 602-8566
        • University Hospital, Kyoto Prefectural University of Medicine ( Site 0112)
      • Osaka, Japan, 543-8555
        • Japanese Red Cross Osaka Hospital ( Site 0113)
      • Osaka, Japan, 545-8586
        • Osaka Metropolitan University Hospital. ( Site 0114)
      • Saga, Japan, 840-8571
        • Saga-Ken Medical Centre Koseikan ( Site 0120)
      • Tokyo, Japan, 105-8470
        • Toranomon Hospital ( Site 0108)
      • Tokyo, Japan, 113-8655
        • The University of Tokyo Hospital ( Site 0105)
      • Wakayama, Japan, 641-8510
        • Wakayama Medical University Hospital ( Site 0115)
    • Ehime
      • Tōon, Ehime, Japan, 791-0295
        • Ehime University Hospital ( Site 0123)
    • Fukuoka
      • Kurume, Fukuoka, Japan, 830-0011
        • Kurume University Hospital ( Site 0119)
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-0033
        • Hokkaido P.W.F.A.C Sapporo-Kosei General Hospital ( Site 0102)
    • Ishikawa-ken
      • Kanazawa, Ishikawa-ken, Japan, 920-8641
        • Kanazawa University Hospital ( Site 0111)
    • Kagawa-ken
      • Kita-gun, Kagawa-ken, Japan, 761-0793
        • Kagawa University Hospital ( Site 0121)
      • Takamatsu, Kagawa-ken, Japan, 760-8557
        • Kagawa Prefectural Central Hospital ( Site 0122)
    • Kanagawa
      • Kawasaki, Kanagawa, Japan, 213-8587
        • Toranomon Hospital Kajigaya ( Site 0109)
      • Yokohama, Kanagawa, Japan, 232-0024
        • Yokohama City University Medical Center ( Site 0110)
    • Osaka
      • Sayama, Osaka, Japan, 5898511
        • Kindai University Hospital ( Site 0116)
    • Saitama
      • Iruma-gun, Saitama, Japan, 350-0495
        • Saitama Medical University Hospital ( Site 0104)
    • Tokyo
      • Mitaka, Tokyo, Japan, 181-8611
        • Kyorin University Hospital ( Site 0106)
      • Musashino, Tokyo, Japan, 180-8610
        • Musashino Red Cross Hospital ( Site 0107)
  • Malaysia
      • Kuala Lumpur, Malaysia, 59100
        • University Malaya Medical Centre ( Site 0288)
    • Kelantan
      • Kubang Kerian, Kelantan, Malaysia, 16150
        • Hospital Universiti Sains Malaysia ( Site 0295)
    • Pulau Pinang
      • George Town, Pulau Pinang, Malaysia, 10350
        • Penang Adventist Hospital ( Site 0289)
      • George Town, Pulau Pinang, Malaysia, 10050
        • Gleneagles Penang ( Site 0290)
    • Putrajaya
      • Putrajaya Wilayah Persekutuan, Putrajaya, Malaysia, 62250
        • Institut Kanser Negara - National Cancer Institute ( Site 0294)
    • Sarawak
      • Kuching, Sarawak, Malaysia, 93586
        • Sarawak General Hospital ( Site 0293)
  • New Zealand
      • Auckland, New Zealand, 1142
        • Auckland City Hospital ( Site 0246)
    • Canterbury
      • Christchurch, Canterbury, New Zealand, 8011
        • Christchurch Hospital ( Site 0247)
  • Norway
      • Oslo, Norway, 0450
        • Oslo Universitetssykehus HF. Ulleval ( Site 0433)
  • Poland
    • Lower Silesian Voivodeship
      • Szklarska Poręba, Lower Silesian Voivodeship, Poland, 58-580
        • Izerskie Centrum Pulmonologii i Chemioterapii IZER-MED Spolka z o.o. ( Site 0607)
    • Lublin Voivodeship
      • Lublin, Lublin Voivodeship, Poland, 20-081
        • Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie ( Site 0620)
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 02-106
        • MTZ Clinical Research Sp. z o. o. ( Site 0608)
    • Pomeranian Voivodeship
      • Gdansk, Pomeranian Voivodeship, Poland, 80-219
        • Copernicus PL Sp. z o.o. ( Site 0603)
    • Silesian Voivodeship
      • Mysłowice, Silesian Voivodeship, Poland, 41-400
        • ID Clinic ( Site 0619)
    • Warmian-Masurian Voivodeship
      • Olsztyn, Warmian-Masurian Voivodeship, Poland, 10-228
        • SPZOZ MSWIA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie ( Site 0606)
    • West Pomeranian Voivodeship
      • Koszalin, West Pomeranian Voivodeship, Poland, 75-581
        • Szpital Wojewodzki im. Mikolaja Kopernika ( Site 0604)
  • Russia
    • Altayskiy Kray
      • Barnaul, Altayskiy Kray, Russia, 656045
        • Altay Regional Oncology Dispensary ( Site 0919)
    • Krasnoyarsk Krai
      • Krasnoyarsk, Krasnoyarsk Krai, Russia, 660037
        • Siberian Clinical Center of FMBA ( Site 0918)
      • Krasnoyarsk, Krasnoyarsk Krai, Russia, 660133
        • Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0648)
    • Moscow
      • Moscow, Moscow, Russia, 115478
        • Blokhin National Medical Oncology ( Site 0645)
      • Moscow, Moscow, Russia, 119049
        • City Clinical Hospital 1 na. NI. Pirogov ( Site 0662)
      • Moscow, Moscow, Russia, 119881
        • First Moscow State Medical University n.a. I.M.Sechenov ( Site 0661)
      • Moscow, Moscow, Russia, 121205
        • Hadassah Medical-Clinical Research Department ( Site 0920)
      • Moscow, Moscow, Russia, 125284
        • National Medical Research Radiological Centre ( Site 0660)
    • Nizhny Novgorod Oblast
      • Nizhny Novgorod, Nizhny Novgorod Oblast, Russia, 603109
        • Privolzhsky District Medical Center ( Site 0655)
    • Samara Oblast
      • Samara, Samara Oblast, Russia, 443031
        • Samara Regional Clinical Oncology Center ( Site 0656)
    • Sankt-Peterburg
      • Saint Petersburg, Sankt-Peterburg, Russia, 195271
        • Road Hospital JSC Russian railways ( Site 0649)
      • Saint Petersburg, Sankt-Peterburg, Russia, 197758
        • Russian Scientific Center of Radiology and Surgical Technologies ( Site 0665)
      • Saint Petersburg, Sankt-Peterburg, Russia, 198255
        • City Clinical Oncology Center ( Site 0646)
    • Tomsk Oblast
      • Tomsk, Tomsk Oblast, Russia, 634028
        • Tomsk Scientific Research Institute of Oncology ( Site 0657)
  • South Korea
      • Seoul, South Korea, 03080
        • Seoul National University Hospital ( Site 0312)
      • Seoul, South Korea, 03722
        • Severance Hospital Yonsei University Health System ( Site 0309)
      • Seoul, South Korea, 05505
        • Asan Medical Center ( Site 0310)
      • Seoul, South Korea, 06351
        • Samsung Medical Center ( Site 0311)
      • Seoul, South Korea, 06591
        • The Catholic University of Korea. Seoul St. Mary s Hospital ( Site 0315)
    • Kyonggi-do
      • Goyang-si, Kyonggi-do, South Korea, 10408
        • National Cancer Center ( Site 0314)
      • Seongnam-si, Kyonggi-do, South Korea, 13605
        • Seoul National University Bundang Hospital ( Site 0313)
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d Hebron ( Site 0674)
      • Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Maranon ( Site 0676)
      • Madrid, Spain, 28034
        • Hospital Ramon y Cajal ( Site 0673)
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz ( Site 0677)
      • Seville, Spain, 41013
        • Hospital Universitario Virgen del Rocio ( Site 0670)
      • Zaragoza, Spain, 50009
        • Hospital Universitario Miguel Servet-Gastroenterology ( Site 0682)
    • Barcelona
      • Sabadell, Barcelona, Spain, 08208
        • Hospital Universitari Parc Tauli ( Site 0681)
    • Gipuzkoa
      • Donostia / San Sebastian, Gipuzkoa, Spain, 20014
        • Hospital Universitario de Donostia ( Site 0671)
    • La Coruna
      • Santiago de Compostela, La Coruna, Spain, 15706
        • Complejo Hospitalario Universitario de Santiago ( Site 0668)
    • Madrid
      • Majadahonda, Madrid, Spain, 28222
        • Hospital Universitario Puerta de Hierro ( Site 0678)
    • Principality of Asturias
      • Oviedo, Principality of Asturias, Spain, 33011
        • Hospital Central de Asturias ( Site 0667)
  • Sweden
    • Skåne County
      • Malmo, Skåne County, Sweden, 205 02
        • Skane University Hospital ( Site 0692)
    • Stockholm County
      • Stockholm, Stockholm County, Sweden, 141 86
        • Karolinska Universitetssjukhuset, Huddinge ( Site 0689)
    • Västerbotten County
      • Umeå, Västerbotten County, Sweden, 901 85
        • Norrlands Universitetssjukhus ( Site 0687)
    • Västra Götaland County
      • Gothenburg, Västra Götaland County, Sweden, 413 46
        • Sahlgrenska Universitetssjukhuset ( Site 0691)
  • Switzerland
      • Geneva, Switzerland, 1211
        • Hopitaux Universitaires de Geneve HUG ( Site 0711)
      • Zurich, Switzerland, 8091
        • Universitaetsspital Zurich ( Site 0713)
    • Canton of Aargau
      • Bern, Canton of Aargau, Switzerland, 3010
        • Universitaetsspital Bern ( Site 0710)
    • Canton of Basel-City
      • Basel, Canton of Basel-City, Switzerland, 4056
        • University Hospital Basel ( Site 0709)
    • Canton of St. Gallen
      • Sankt Gallen, Canton of St. Gallen, Switzerland, 9007
        • Kantonsspital St. Gallen ( Site 0708)
    • Canton of Vaud
      • Lausanne, Canton of Vaud, Switzerland, 1011
        • CHUV (centre hospitalier universitaire vaudois) ( Site 0712)
    • Canton of Zurich
      • Winterthur, Canton of Zurich, Switzerland, 8401
        • Kantonsspital Winterthur ( Site 0714)
  • Taiwan
      • Kaohsiung City, Taiwan, 833
        • Chang Gung Medical Foundation. Kaohsiung Branch ( Site 0335)
      • Taichung, Taiwan, 40447
        • China Medical University Hospital ( Site 0333)
      • Tainan, Taiwan, 704
        • National Cheng Kung University Hospital ( Site 0334)
      • Taipei, Taiwan, 100
        • National Taiwan University Hospital ( Site 0330)
      • Taipei, Taiwan, 112
        • Taipei Veterans General Hospital ( Site 0331)
      • Taoyuan District, Taiwan, 333
        • Chang Gung Medical Foundation. Linkou ( Site 0332)
  • Thailand
      • Chiang Mai, Thailand, 50200
        • Maharaj Nakorn Chiangmai Hospital ( Site 0353)
      • Khon Kaen, Thailand, 40002
        • Srinagarind Hospital ( Site 0354)
    • Bangkok
      • Bangkok, Bangkok, Thailand, 10400
        • Ramathibodi Hospital. ( Site 0352)
      • Bangkok, Bangkok, Thailand, 10700
        • Siriraj Hospital ( Site 0351)
  • Turkey (Türkiye)
      • Adana, Turkey (Türkiye), 01120
        • Baskent Unv. Adana Uyg. ve Arast. Hastanesi ( Site 0733)
      • Ankara, Turkey (Türkiye), 06010
        • Gulhane Egitim ve Arastirma Hastanesi ( Site 0741)
      • Ankara, Turkey (Türkiye), 06800
        • Ankara Sehir Hastanesi ( Site 0731)
      • Aydin, Turkey (Türkiye), 09010
        • Adnan Menderes University Medical Faculty ( Site 0737)
      • Istanbul, Turkey (Türkiye), 34093
        • Bezmialem Vakif University School of Medicine ( Site 0732)
      • Istanbul, Turkey (Türkiye), 34457
        • Acıbadem Maslak Hastanesi ( Site 0742)
      • Istanbul, Turkey (Türkiye), 34722
        • Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 0730)
      • Izmir, Turkey (Türkiye), 35340
        • Dokuz Eylul Universitesi ( Site 0740)
      • Konya, Turkey (Türkiye), 42080
        • Konya Necmettin Erbakan University Medical Faculty ( Site 0736)
      • Malatya, Turkey (Türkiye), 44280
        • Inonu University Faculty of Medicine ( Site 0729)
      • Mersin, Turkey (Türkiye), 33440
        • VM Medical Park Hastanesi ( Site 0739)
    • Tekirdas
      • Tekirdağ, Tekirdas, Turkey (Türkiye), 59100
        • Namik Kemal Universitesi Tip Fakultesi ( Site 0738)
  • Ukraine
      • Kyiv, Ukraine, 03057
        • Universal Clinic Oberig-Oncology Center ( Site 0786)
      • Kyiv, Ukraine, 03151
        • Medical Center Dobrobut Clinic ( Site 0785)
    • Chernivetska Oblast
      • Chernivtsi, Chernivetska Oblast, Ukraine, 58000
        • Regional Clinical Onco Dispensary_ State Medical University ( Site 0782)
    • Kharkivs’ka Oblast’
      • Kharkiv, Kharkivs’ka Oblast’, Ukraine, 61000
        • Regional Oncology Center of Kharkiv ( Site 0777)
    • Kyivska Oblast
      • Kyiv, Kyivska Oblast, Ukraine, 03022
        • National Cancer Institute of the MoH of Ukraine ( Site 0779)
      • Kyiv, Kyivska Oblast, Ukraine, 03126
        • Shalimov s NI of Surgery and Transplantation ( Site 0781)
    • Odesa Oblast
      • Odesa, Odesa Oblast, Ukraine, 65055
        • MI Odessa Regional Oncological Centre ( Site 0776)
    • Zaporizhzhia Oblast
      • Zaporizhzhia, Zaporizhzhia Oblast, Ukraine, 69032
        • CI City Clinical Hospital # 3 ( Site 0783)
  • United Kingdom
      • Coventry, United Kingdom, CV3 2DX
        • University Hospital Coventry and Warwickshire NHS Trust ( Site 0754)
      • Leeds, United Kingdom, LS9 7TF
        • Leeds Teaching Hospitals NHS Trust ( Site 0751)
      • Nottingham, United Kingdom, NG5 1PB
        • Nottingham University Hospitals NHS Trust ( Site 0756)
    • Cambridgeshire
      • Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
        • Cambridge University Hospitals NHS Trust ( Site 0755)
    • Derbyshire
      • Sheffield, Derbyshire, United Kingdom, S10 2SJ
        • Weston Park Hospital ( Site 0753)
    • Glasgow City
      • Glasgow, Glasgow City, United Kingdom, G12 0YN
        • The Beatson West of Scotland Cancer Centre ( Site 0750)
    • London, City of
      • London, London, City of, United Kingdom, SE5 9RS
        • Kings College Hospital NHS Foundation Trust ( Site 0758)
    • Northern Ireland
      • Belfast, Northern Ireland, United Kingdom, BT9 7AB
        • Belfast City Hospital ( Site 0752)
    • Wirral
      • Birkenhead, Wirral, United Kingdom, CH63 4JY
        • The Clatterbridge Cancer Centre NHS Foundation Trust ( Site 0757)
  • United States
    • Arizona
      • Gilbert, Arizona, United States, 85234
        • Banner MD Anderson Cancer Center ( Site 0026)
      • Tucson, Arizona, United States, 85719
        • The University of Arizona Cancer Center - North Campus ( Site 0039)
    • California
      • Duarte, California, United States, 91010
        • City of Hope Medical Center ( Site 0027)
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Smilow Cancer Hospital at Yale New Haven ( Site 0042)
    • Florida
      • Fort Myers, Florida, United States, 33905
        • Regional Cancer Center ( Site 0054)
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Simon Cancer Center ( Site 0075)
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa ( Site 0067)
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • James Graham Brown Cancer Center ( Site 0088)
      • Louisville, Kentucky, United States, 40202
        • University of Louisville ( Site 0059)
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • University Medical Center New Orleans ( Site 0014)
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital ( Site 0062)
      • Boston, Massachusetts, United States, 02118
        • Boston Medical Center ( Site 0025)
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Ctr. ( Site 0033)
      • Worcester, Massachusetts, United States, 01655
        • University of Massachusetts Worcester ( Site 0017)
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital-GI/Hepatology Research ( Site 0047)
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • University of New Mexico ( Site 0041)
    • New York
      • Lake Success, New York, United States, 11042
        • North Shore-Long Island Jewish Health System ( Site 0068)
    • Ohio
      • Centerville, Ohio, United States, 45459
        • Miami Valley Hospital South ( Site 0093)
      • Cincinnati, Ohio, United States, 45219
        • University of Cincinnati Medical Center ( Site 0084)
      • Sylvania, Ohio, United States, 43560
        • ProMedica Flower Hospital ( Site 0090)
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Stephenson Cancer Center ( Site 0045)
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt Ingram Cancer Center ( Site 0006)
    • Texas
      • Temple, Texas, United States, 76508
        • Baylor Scott & White Medical Center - Temple ( Site 0089)
    • Washington
      • Seattle, Washington, United States, 98101
        • Virginia Mason Medical Center ( Site 0028)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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:
  • MK-3475
  • KEYTRUDA®
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence-Free Survival (RFS)
Time Frame: Up to approximately 69 months
RFS was defined as the time from randomization to first documentation of disease recurrence (local, regional, or distant) as assessed by blinded independent central review (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 occurred first. RFS was reported for each arm.
Up to approximately 69 months
Overall Survival (OS)
Time Frame: Up to approximately 69 months
OS was defined as the time from randomization to death due to any cause. OS was reported for each arm.
Up to approximately 69 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Who Experienced an Adverse Event (AE)
Time Frame: Up to approximately 26 months
An AE was 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 was determined. The number of participants who experienced an AE were reported.
Up to approximately 26 months
Number of Participants Who Discontinued Study Treatment Due to an AE
Time Frame: Up to approximately 23 months
An AE was 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 was determined. The number of participants who discontinued study treatment due to an AE were reported.
Up to approximately 23 months
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
Time Frame: Baseline and up to approximately 120 weeks
The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participants responded to the questions regarding Global Health Status (GHS; "How would you rate your overall health during the past week?") and Quality of Life ("How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) was computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. A higher score indicated a better outcome. The change from baseline in GHS (EORTC QLQ-C30 Item 29) and QoL (EORTC QLQ-C30 Item 30) combined score was reported.
Baseline and up to approximately 120 weeks
Change From Baseline in EORTC QLQ-C30 Physical Functioning Scale Score
Time Frame: Baseline and up to approximately 120 weeks
The EORTC QLQ-C30 is a cancer specific health-related quality of life questionnaire. Participants responded to 5 questions about their physical functioning (Items 1-5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. Higher scores indicated better physical functioning. The change from baseline in EORTC QLQ-C30 Physical Functioning (Items 1-5) combined score was reported.
Baseline and up to approximately 120 weeks
Change From Baseline in EORTC QLQ-C30 Role Functioning Scale Score
Time Frame: Baseline and up to approximately 120 weeks
The EORTC QLQ-C30 is a cancer specific health-related quality of life questionnaire. The role functioning score was based on participant responses to questions scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score was computed by averaging the raw scores of Items 6 and 7 and then applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. Higher scores indicated better role functioning. The change from baseline in EORTC QLQ-C30 Role Functioning (Items 6 and 7) combined score was reported.
Baseline and up to approximately 120 weeks
Change From Baseline in EORTC QLQ-Hepatocellular Carcinoma Module (EORTC QLQ-HCC18) Abdominal Swelling Scale Score
Time Frame: Baseline and up to approximately 120 weeks
The EORTC QLQ-HCC18 is an HCC-specific questionnaire, administered in addition to the EORTC QLQ-C30. The abdominal swelling scale score was based on participant responses to questions scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores were standardized, so that scores range from 0-100. Higher scores indicated more severe symptoms/problems. Change from baseline in the EORTC QLQ-HCC18 abdominal swelling scale score was reported.
Baseline and up to approximately 120 weeks
Change From Baseline in EORTC QLQ-HCC18 Fatigue Scale Score
Time Frame: Baseline and up to approximately 120 weeks
The EORTC QLQ-HCC18 is an HCC-specific questionnaire, administered in addition to the EORTC QLQ-C30. The fatigue scale score was based on participant responses to questions scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score was computed by averaging the raw scores of the items and then applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. Higher scores indicated more severe symptoms/problems. Change from baseline in the EORTC QLQ-HCC18 fatigue scale score was reported.
Baseline and up to approximately 120 weeks
Change From Baseline in EORTC QLQ-HCC18 Pain Scale Score
Time Frame: Baseline and up to approximately 120 weeks
The EORTC QLQ-HCC18 is an HCC-specific questionnaire, administered in addition to the EORTC QLQ-C30. The pain scale score was based on participant responses to questions scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score was computed by averaging the raw scores of the items and then applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. Higher scores indicated more severe symptoms/problems. Change from baseline in the EORTC QLQ-HCC18 pain scale score was reported.
Baseline and up to approximately 120 weeks
Change From Baseline in Visual Analogue Scale (VAS) Score on the European Quality of Life (EuroQoL)-5 Dimensions, 5-level Questionnaire (EQ-5D-5L) Health Utility Score
Time Frame: Baseline and up to approximately 120 weeks
The EQ-5D-5L is a standardized instrument for use as a measure of health outcome. The VAS is a component of the EQ-5D-5L that asked participants to rate their overall health on a vertical visual analogue scale, with the scale's ends labelled 'The best health you can imagine' (equivalent to a score of 0) and 'The worst health you can imagine' (equivalent to a score of 100).
Baseline and up to approximately 120 weeks
Time to Deterioration (TTD) in the EORTC QLQ-C30 Combined GHS / QoL Scale Score
Time Frame: Baseline and up to approximately 120 weeks
EORTC QLQ-C30 is a questionnaire to assess QoL of cancer patients. Participants responded to questions on GHS ("How would you rate your overall health during the past week?") and QoL ("How would you rate your overall QoL during the past week?") were scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) was computed by averaging raw scores of the 2 items and applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. A higher score indicated a better outcome. TTD was defined as the time from baseline to first onset of ≥10-point negative change (decrease) from baseline in GHS-QoL combined score. A longer TTD indicated a better outcome.
Baseline and up to approximately 120 weeks
TTD in the EORTC QLQ-C30 Physical Functioning Scale Score
Time Frame: Baseline and up to approximately 120 weeks
EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participants responded to 5 questions about their physical functioning (Items 1 to 5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. A higher score indicated a better outcome. TTD was defined as the time from baseline to first onset of ≥10-point negative change (decrease) from baseline in physical functioning (Items 1 to 5). A longer TTD indicated a better outcome.
Baseline and up to approximately 120 weeks
TTD in the EORTC QLQ-C30 Role Functioning Scale Score
Time Frame: Baseline and up to approximately 120 weeks
EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participants responded to questions about their role functioning (Items 6 and 7) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of Items 6 and 7 was computed by averaging the raw scores of the items and then applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. A higher score indicated a better outcome. TTD was defined as the time from baseline to first onset of ≥10-point negative change (decrease) from baseline in physical functioning (Items 6 and 7). A longer TTD indicated a better outcome.
Baseline and up to approximately 120 weeks
TTD in the EORTC QLQ-HCC18 Abdominal Swelling Scale Score
Time Frame: Baseline and up to approximately 120 weeks
The EORTC QLQ-HCC18 is an HCC-specific questionnaire, administered in addition to the EORTC QLQ-C30. The abdominal swelling scale score was based on participant responses to questions scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores were standardized, so that scores range from 0-100. Higher scores indicated more severe symptoms/problems. The TTD in EORTC QLQ-HCC18 abdominal swelling scale score was reported, defined as the time to first onset of a ≥10 point decrease from baseline.
Baseline and up to approximately 120 weeks
TTD in the EORTC QLQ-HCC18 Fatigue Scale Score
Time Frame: Baseline and up to approximately 120 weeks
The EORTC QLQ-HCC18 is an HCC-specific questionnaire, administered in addition to the EORTC QLQ-C30. The fatigue scale score was based on participant responses to questions scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score was computed by averaging the raw scores of the items and then applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. Higher scores indicated more severe symptoms/problems. The TTD in EORTC QLQ-HCC18 fatigue scale score was reported, defined as the time to first onset of a ≥10 point decrease from baseline.
Baseline and up to approximately 120 weeks
TTD in the EORTC QLQ-HCC18 Pain Scale Score
Time Frame: Baseline and up to approximately 120 weeks
The EORTC QLQ-HCC18 is an HCC-specific questionnaire, administered in addition to the EORTC QLQ-C30. The pain scale score was based on participant responses to questions scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score was computed by averaging the raw scores of the items and then applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. Higher scores indicated more severe symptoms/problems. The TTD in EORTC QLQ-HCC18 pain scale score was reported, defined as the time to first onset of a ≥10 point decrease from baseline.
Baseline and up to approximately 120 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 28, 2019

Primary Completion (Actual)

March 20, 2025

Study Completion (Actual)

September 30, 2025

Study Registration Dates

First Submitted

March 6, 2019

First Submitted That Met QC Criteria

March 6, 2019

First Posted (Actual)

March 7, 2019

Study Record Updates

Last Update Posted (Actual)

April 24, 2026

Last Update Submitted That Met QC Criteria

April 3, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3475-937
  • MK-3475-937 (Other Identifier: MSD Protocol Number)
  • KEYNOTE-937 (Other Identifier: MSD)
  • 194786 (Registry Identifier: JAPAC-CTI)
  • 2018-004800-20 (EudraCT Number)
  • 2022-501971-24-00 (Registry Identifier: EU CT)
  • U1111-1282-6370 (Registry Identifier: UTN)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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