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)

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

959

Participants

Timeline

Start Date

May 28, 2019

Primary Completion Date

March 20, 2025

Study Completion Date

September 30, 2025

Conditions
Hepatocellular Carcinoma
Interventions
BIOLOGICAL

Pembrolizumab

IV infusion of Pembrolizumab 200 mg.

DRUG

Placebo

IV infusion of 0.9% normal saline.

Trial Locations (249)

100

National Taiwan University Hospital ( Site 0330), Taipei

112

Taipei Veterans General Hospital ( Site 0331), Taipei

333

Chang Gung Medical Foundation. Linkou ( Site 0332), Taoyuan District

704

National Cheng Kung University Hospital ( Site 0334), Tainan City

833

Chang Gung Medical Foundation. Kaohsiung Branch ( Site 0335), Kaohsiung City

1011

CHUV (centre hospitalier universitaire vaudois) ( Site 0712), Lausanne

1070

Erasme Hospital ( Site 0376), Brussels

1085

Semmelweis University ( Site 0480), Budapest

1142

Auckland City Hospital ( Site 0246), Auckland

1211

Hopitaux Universitaires de Geneve HUG ( Site 0711), Geneva

2050

Royal Prince Alfred Hospital AW ( Site 0225), Camperdown

2170

Liverpool Hospital ( Site 0226), Liverpool

2730

Herlev Hospital ( Site 0421), Herlev

3000

UZ Leuven ( Site 0377), Leuven

3004

Alfred Health ( Site 0230), Melbourne

3010

Universitaetsspital Bern ( Site 0710), Bern

3065

St Vincents Hospital Melbourne ( Site 0227), Fitzroy

3168

Monash Health ( Site 0233), Clayton

4004

Complex Cancer Center Plovdiv-First Medical Oncology Department ( Site 0982), Plovdiv

4032

Debreceni Egyetem Klinikai Kozpont Onkologiai Tanszek ( Site 0481), Debrecen

4056

University Hospital Basel ( Site 0709), Basel

4102

Princess Alexandra Hospital ( Site 0228), Woollongabba

5000

Royal Adelaide Hospital ( Site 0234), Adelaide

Odense Universitets Hospital ( Site 0422), Odense C

6000

Royal Perth Hospital ( Site 0229), Perth

Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 0483), Kecskemét

6720

SZTE Szent-Gyorgyi Albert Klinikai Kozpont ( Site 0482), Szeged

7400

Somogy Megyei Kaposi Mór Oktató Kórház-Oncology center ( Site 0484), Kaposvár

8011

Christchurch Hospital ( Site 0247), Christchurch

8091

Universitaetsspital Zurich ( Site 0713), Zurich

8200

Aarhus Universitets hospital ( Site 0420), Aarhus N

8401

Kantonsspital Winterthur ( Site 0714), Winterthur

9000

UZ Gent ( Site 0375), Ghent

9007

Kantonsspital St. Gallen ( Site 0708), Sankt Gallen

10050

Gleneagles Penang ( Site 0290), George Town

10350

Penang Adventist Hospital ( Site 0289), George Town

10400

Ramathibodi Hospital. ( Site 0352), Bangkok

10408

National Cancer Center ( Site 0314), Goyang-si

10700

Siriraj Hospital ( Site 0351), Bangkok

11042

North Shore-Long Island Jewish Health System ( Site 0068), Lake Success

13005

Hopital de la Timone ( Site 0442), Marseille

13353

Charite - Campus Virchow Klinikum ( Site 0457), Berlin

13605

Seoul National University Bundang Hospital ( Site 0313), Seongnam-si

15706

Complejo Hospitalario Universitario de Santiago ( Site 0668), Santiago de Compostela

16150

Hospital Universiti Sains Malaysia ( Site 0295), Kubang Kerian

20014

Hospital Universitario de Donostia ( Site 0671), Donostia / San Sebastian

20122

Fondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico ( Site 0550), Milan

20133

Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0540), Milan

20246

Universitaetsklinikum Hamburg-Eppendorf ( Site 0469), Hamburg

28007

Hospital General Universitario Gregorio Maranon ( Site 0676), Madrid

28034

Hospital Ramon y Cajal ( Site 0673), Madrid

28046

Hospital Universitario La Paz ( Site 0677), Madrid

28222

Hospital Universitario Puerta de Hierro ( Site 0678), Majadahonda

30625

Medizinische Hochschule Hannover ( Site 0458), Hanover

31059

CHU Rangueil ( Site 0441), Toulouse

33011

Hospital Central de Asturias ( Site 0667), Oviedo

33440

VM Medical Park Hastanesi ( Site 0739), Mersin

33604

CHU Bordeaux Haut-Leveque ( Site 0437), Pessac

33905

Regional Cancer Center ( Site 0054), Fort Myers

34093

Bezmialem Vakif University School of Medicine ( Site 0732), Istanbul

34295

CHU Montpellier. ( Site 0443), Montpellier

34457

Acıbadem Maslak Hastanesi ( Site 0742), Istanbul

34722

Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 0730), Istanbul

35340

Dokuz Eylul Universitesi ( Site 0740), Izmir

37232

Vanderbilt Ingram Cancer Center ( Site 0006), Nashville

40002

Srinagarind Hospital ( Site 0354), Khon Kaen

40138

AOU di Bologna Policliico S. Orsola-Malpighi ( Site 0541), Bologna

40202

James Graham Brown Cancer Center ( Site 0088), Louisville

University of Louisville ( Site 0059), Louisville

40225

Universitaetsklinikum Duesseldorf ( Site 0461), Düsseldorf

40447

China Medical University Hospital ( Site 0333), Taichung

41013

Hospital Universitario Virgen del Rocio ( Site 0670), Seville

41025

A O U Policlinico di Modena ( Site 0548), Modena

42080

Konya Necmettin Erbakan University Medical Faculty ( Site 0736), Konya

43560

ProMedica Flower Hospital ( Site 0090), Sylvania

44280

Inonu University Faculty of Medicine ( Site 0729), Malatya

45219

University of Cincinnati Medical Center ( Site 0084), Cincinnati

45459

Miami Valley Hospital South ( Site 0093), Centerville

46202

Indiana University Simon Cancer Center ( Site 0075), Indianapolis

48202

Henry Ford Hospital-GI/Hepatology Research ( Site 0047), Detroit

50009

Hospital Universitario Miguel Servet-Gastroenterology ( Site 0682), Zaragoza

50134

Azienda Ospedaliero Universitaria Careggi ( Site 0549), Florence

50200

Maharaj Nakorn Chiangmai Hospital ( Site 0353), Chiang Mai

50937

Universitaetsklinikum Koeln ( Site 0463), Cologne

52242

University of Iowa ( Site 0067), Iowa City

56126

Azienda Ospedaliero Universitaria Pisana ( Site 0546), Pisa

58000

Regional Clinical Onco Dispensary_ State Medical University ( Site 0782), Chernivtsi

59037

Hopital Claude Huriez CHRU LILLE ( Site 0440), Lille

59100

University Malaya Medical Centre ( Site 0288), Kuala Lumpur

Namik Kemal Universitesi Tip Fakultesi ( Site 0738), Tekirdağ

60488

Krankenhaus Nord-West GmbH ( Site 0472), Frankfurt am Main

60596

Universitaetsklinikum Frankfurt ( Site 0467), Frankfurt am Main

61000

Regional Oncology Center of Kharkiv ( Site 0777), Kharkiv

62250

Institut Kanser Negara - National Cancer Institute ( Site 0294), Putrajaya Wilayah Persekutuan

65055

MI Odessa Regional Oncological Centre ( Site 0776), Odesa

67098

HUS Hopital Hautepierre ( Site 0445), Strasbourg

69032

CI City Clinical Hospital # 3 ( Site 0783), Zaporizhzhia

70112

University Medical Center New Orleans ( Site 0014), New Orleans

70124

Istituto Tumori Giovanni Paolo II ( Site 0543), Bari

72076

Universitaetsklinikum Tuebingen ( Site 0466), Tübingen

73104

Stephenson Cancer Center ( Site 0045), Oklahoma City

74078

SLK-Kliniken Heilbronn GmbH ( Site 0460), Heilbronn

76508

Baylor Scott & White Medical Center - Temple ( Site 0089), Temple

80147

Ospedale del Mare ( Site 0545), Napoli

81675

Klinikum rechts der Isar der Technischen Universitaet ( Site 0470), Munich

85234

Banner MD Anderson Cancer Center ( Site 0026), Gilbert

85719

The University of Arizona Cancer Center - North Campus ( Site 0039), Tucson

87131

University of New Mexico ( Site 0041), Albuquerque

90146

Azienda Ospedaliera Ospedali Riuniti Villa Sofia-Cervello ( Site 0547), Palermo

91010

City of Hope Medical Center ( Site 0027), Duarte

92118

Hopital Beaujon ( Site 0439), Clichy

93586

Sarawak General Hospital ( Site 0293), Kuching

94800

Hopital Paul Brousse ( Site 0447), Villejuif

97080

Universitaetsklinikum Wuerzburg ( Site 0468), Würzburg

98101

Virginia Mason Medical Center ( Site 0028), Seattle

100021

Cancer Hospital Chinese Academy of Medical Sciences ( Site 0156), Beijing

100044

Peking University People's Hospital ( Site 0191), Beijing

100142

Beijing Cancer Hospital ( Site 0155), Beijing

115478

Blokhin National Medical Oncology ( Site 0645), Moscow

119049

City Clinical Hospital 1 na. NI. Pirogov ( Site 0662), Moscow

119881

First Moscow State Medical University n.a. I.M.Sechenov ( Site 0661), Moscow

121205

Hadassah Medical-Clinical Research Department ( Site 0920), Moscow

125284

National Medical Research Radiological Centre ( Site 0660), Moscow

195271

Road Hospital JSC Russian railways ( Site 0649), Saint Petersburg

197758

Russian Scientific Center of Radiology and Surgical Technologies ( Site 0665), Saint Petersburg

198255

City Clinical Oncology Center ( Site 0646), Saint Petersburg

200032

Fudan University Shanghai Cancer Center ( Site 0161), Shanghai

Zhongshan Hospital Fudan University ( Site 0193), Shanghai

200127

Renji Hospital Shanghai Jiaotong University School of Medicine ( Site 0174), Shanghai

210000

Zhongshan Hospital affiliated to Fudan University ( Site 0153), Shanghai

230036

Anhui Provincil Hospital South District ( Site 0181), Hefei

310022

Zhejiang Cancer Hospital ( Site 0171), Hangzhou

350014

Fujian Provincial Cancer Hospital ( Site 0165), Fuzhou

350025

900 Hospital of the Joint ( Site 0197), Fuzhou

410000

The Third Xiangya Hospital of Central South University ( Site 0167), Changsha

410005

Hunan Provincial People Hospital ( Site 0192), Changsha

410013

Hunan Cancer Hospital ( Site 0168), Changsha

430022

Wuhan Union Hospital ( Site 0173), Wuhan

430079

Hubei Cancer Hospital ( Site 0189), Wuhan

443031

Samara Regional Clinical Oncology Center ( Site 0656), Samara

510080

Guangdong General Hospital ( Site 0166), Guangzhou

510515

Southern Medical University Nanfang Hospital ( Site 0172), Guangzhou

603109

Privolzhsky District Medical Center ( Site 0655), Nizhny Novgorod

610041

West China Hospital of Sichuan University ( Site 0162), Chengdu

634028

Tomsk Scientific Research Institute of Oncology ( Site 0657), Tomsk

656045

Altay Regional Oncology Dispensary ( Site 0919), Barnaul

660037

Siberian Clinical Center of FMBA ( Site 0918), Krasnoyarsk

660133

Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0648), Krasnoyarsk

710061

The First Affiliated Hospital of Xi an Jiaotong University ( Site 0164), Xi’an

830001

Affiliated Tumor Hospital of Xinjiang Medical University ( Site 0157), Ürümqi

3109601

Rambam Medical Center ( Site 0524), Haifa

4941492

Rabin Medical Center ( Site 0520), Petah Tikva

5262000

Chaim Sheba Medical Center ( Site 0523), Ramat Gan

5898511

Kindai University Hospital ( Site 0116), Sayama

6423906

Sourasky Medical Center ( Site 0522), Tel Aviv

7348551

Hiroshima University Hospital ( Site 0117), Hiroshima

9112001

Haddassah Medical Organization - Ein Kerem ( Site 0519), Jerusalem

06510

Smilow Cancer Hospital at Yale New Haven ( Site 0042), New Haven

02114

Massachusetts General Hospital ( Site 0062), Boston

02118

Boston Medical Center ( Site 0025), Boston

02215

Beth Israel Deaconess Medical Ctr. ( Site 0033), Boston

01655

University of Massachusetts Worcester ( Site 0017), Worcester

B1629AHJ

Hospital Universitario Austral ( Site 0795), Pilar

C1096AAS

Fundación favaloro para la Docencia e Investigación Médica ( Site 0808), Buenos Aires

S2002KDS

Hospital Provincial del Centenario ( Site 0794), Rosario

C1118AAT

Hospital Aleman ( Site 0806), Buenos Aires

C1181ACH

Hospital Italiano ( Site 0793), Buenos Aires

C1280AEB

Hospital Britanico de Buenos Aires ( Site 0792), Buenos Aires

S3000BPJ

Clinica de nefrologia urologia y enfermedades cardiovasculares ( Site 0802), Santa Fe

02650

University Hospital Antwerp (UZA) ( Site 0374), Edegem

80810-050

CIONC - Centro Integrado de Oncologia de Curitiba ( Site 0813), Curitiba

50040-000

Hospital de Cancer de Pernambuco ( Site 0815), Recife

90035-903

Hospital de Clinicas de Porto Alegre ( Site 0824), Porto Alegre

89010-340

Clinica de Oncologia Reichow ( Site 0818), Blumenau

88301-220

Centro de Novos Tratamentos Itajai - Clinica de Neoplasias Litoral ( Site 0820), Itajaí

01321-001

Hospital Paulistano ( Site 0829), São Paulo

Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 0828), São Paulo

22793-080

Instituto COI de Pesquisa Educacao e Gestao ( Site 0825), Rio de Janeiro

01246-000

Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0826), São Paulo

01509-900

A.C. Camargo Cancer Center ( Site 0827), São Paulo

08270120

Casa de Saude Santa Marcelina ( Site 0821), São Paulo

B3H 2Y9

Nova Scotia Health Authority QEII-HSC ( Site 0208), Halifax

H2X 3E4

Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0211), Montreal

H4A 3J1

McGill University Health Centre ( Site 0207), Montreal

01067

Staedtisches Klinikum Dresden ( Site 0471), Dresden

01307

Universitatsklinikum Carl Gustav Carus ( Site 0459), Dresden

000

Prince of Wales Hospital ( Site 0268), Hong Kong

Unknown

Pamela Youde Nethersole Eastern Hospital ( Site 0271), Hong Kong

Queen Mary Hospital ( Site 0267), Hong Kong

Tuen Mun Hospital ( Site 0272), Tuenmen

Azienda Ospedaliera Ordine Mauriziano di Torino ( Site 0542), Turin

D04 T6F4

St Vincent's University Hospital ( Site 0498), Dublin

D24 NR0A

Tallaght University Hospital ( Site 0499), Dublin

791-0295

Ehime University Hospital ( Site 0123), Tōon

830-0011

Kurume University Hospital ( Site 0119), Kurume

060-0033

Hokkaido P.W.F.A.C Sapporo-Kosei General Hospital ( Site 0102), Sapporo

920-8641

Kanazawa University Hospital ( Site 0111), Kanazawa

761-0793

Kagawa University Hospital ( Site 0121), Kita-gun

760-8557

Kagawa Prefectural Central Hospital ( Site 0122), Takamatsu

213-8587

Toranomon Hospital Kajigaya ( Site 0109), Kawasaki

232-0024

Yokohama City University Medical Center ( Site 0110), Yokohama

350-0495

Saitama Medical University Hospital ( Site 0104), Iruma-gun

181-8611

Kyorin University Hospital ( Site 0106), Mitaka

180-8610

Musashino Red Cross Hospital ( Site 0107), Musashino

260-8677

Chiba University Hospital ( Site 0103), Chiba

810-8563

National Hospital Organization Kyushu Medical Center ( Site 0118), Fukuoka

602-8566

University Hospital, Kyoto Prefectural University of Medicine ( Site 0112), Kyoto

543-8555

Japanese Red Cross Osaka Hospital ( Site 0113), Osaka

545-8586

Osaka Metropolitan University Hospital. ( Site 0114), Osaka

840-8571

Saga-Ken Medical Centre Koseikan ( Site 0120), Saga

105-8470

Toranomon Hospital ( Site 0108), Tokyo

113-8655

The University of Tokyo Hospital ( Site 0105), Tokyo

641-8510

Wakayama Medical University Hospital ( Site 0115), Wakayama

0450

Oslo Universitetssykehus HF. Ulleval ( Site 0433), Oslo

58-580

Izerskie Centrum Pulmonologii i Chemioterapii IZER-MED Spolka z o.o. ( Site 0607), Szklarska Poręba

20-081

Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie ( Site 0620), Lublin

02-106

MTZ Clinical Research Sp. z o. o. ( Site 0608), Warsaw

80-219

Copernicus PL Sp. z o.o. ( Site 0603), Gdansk

41-400

ID Clinic ( Site 0619), Mysłowice

10-228

SPZOZ MSWIA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie ( Site 0606), Olsztyn

75-581

Szpital Wojewodzki im. Mikolaja Kopernika ( Site 0604), Koszalin

03080

Seoul National University Hospital ( Site 0312), Seoul

03722

Severance Hospital Yonsei University Health System ( Site 0309), Seoul

05505

Asan Medical Center ( Site 0310), Seoul

06351

Samsung Medical Center ( Site 0311), Seoul

06591

The Catholic University of Korea. Seoul St. Mary s Hospital ( Site 0315), Seoul

08208

Hospital Universitari Parc Tauli ( Site 0681), Sabadell

08035

Hospital Universitari Vall d Hebron ( Site 0674), Barcelona

205 02

Skane University Hospital ( Site 0692), Malmo

141 86

Karolinska Universitetssjukhuset, Huddinge ( Site 0689), Stockholm

901 85

Norrlands Universitetssjukhus ( Site 0687), Umeå

413 46

Sahlgrenska Universitetssjukhuset ( Site 0691), Gothenburg

01120

Baskent Unv. Adana Uyg. ve Arast. Hastanesi ( Site 0733), Adana

06010

Gulhane Egitim ve Arastirma Hastanesi ( Site 0741), Ankara

06800

Ankara Sehir Hastanesi ( Site 0731), Ankara

09010

Adnan Menderes University Medical Faculty ( Site 0737), Aydin

03022

National Cancer Institute of the MoH of Ukraine ( Site 0779), Kyiv

03126

Shalimov s NI of Surgery and Transplantation ( Site 0781), Kyiv

03057

Universal Clinic Oberig-Oncology Center ( Site 0786), Kyiv

03151

Medical Center Dobrobut Clinic ( Site 0785), Kyiv

CB2 0QQ

Cambridge University Hospitals NHS Trust ( Site 0755), Cambridge

S10 2SJ

Weston Park Hospital ( Site 0753), Sheffield

G12 0YN

The Beatson West of Scotland Cancer Centre ( Site 0750), Glasgow

SE5 9RS

Kings College Hospital NHS Foundation Trust ( Site 0758), London

BT9 7AB

Belfast City Hospital ( Site 0752), Belfast

CH63 4JY

The Clatterbridge Cancer Centre NHS Foundation Trust ( Site 0757), Birkenhead

CV3 2DX

University Hospital Coventry and Warwickshire NHS Trust ( Site 0754), Coventry

LS9 7TF

Leeds Teaching Hospitals NHS Trust ( Site 0751), Leeds

NG5 1PB

Nottingham University Hospitals NHS Trust ( Site 0756), Nottingham

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT03867084 - 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) | Biotech Hunter | Biotech Hunter