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)
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)
7 other identifiers
interventional
959
31 countries
249
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 hepatocellular-carcinoma
Started May 2019
Typical duration for phase_3 hepatocellular-carcinoma
249 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 6, 2019
CompletedFirst Posted
Study publicly available on registry
March 7, 2019
CompletedStudy Start
First participant enrolled
May 28, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 20, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2025
CompletedResults Posted
Study results publicly available
April 24, 2026
CompletedApril 24, 2026
April 1, 2026
5.8 years
March 6, 2019
February 25, 2026
April 3, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Recurrence-Free Survival (RFS)
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)
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 Outcomes (15)
Number of Participants Who Experienced an Adverse Event (AE)
Up to approximately 26 months
Number of Participants Who Discontinued Study Treatment Due to an AE
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
Baseline and up to approximately 120 weeks
Change From Baseline in EORTC QLQ-C30 Physical Functioning Scale Score
Baseline and up to approximately 120 weeks
Change From Baseline in EORTC QLQ-C30 Role Functioning Scale Score
Baseline and up to approximately 120 weeks
- +10 more secondary outcomes
Study Arms (2)
Pembrolizumab
EXPERIMENTALParticipants receive intravenous (IV) pembrolizumab at 200 mg on Day 1 of each 21-day cycle for up to 17 cycles.
Placebo
PLACEBO COMPARATORParticipants receive IV placebo on Day 1 of each 21-day cycle for up to 17 cycles.
Interventions
IV infusion of Pembrolizumab 200 mg.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (249)
Banner MD Anderson Cancer Center ( Site 0026)
Gilbert, Arizona, 85234, United States
The University of Arizona Cancer Center - North Campus ( Site 0039)
Tucson, Arizona, 85719, United States
City of Hope Medical Center ( Site 0027)
Duarte, California, 91010, United States
Smilow Cancer Hospital at Yale New Haven ( Site 0042)
New Haven, Connecticut, 06510, United States
Regional Cancer Center ( Site 0054)
Fort Myers, Florida, 33905, United States
Indiana University Simon Cancer Center ( Site 0075)
Indianapolis, Indiana, 46202, United States
University of Iowa ( Site 0067)
Iowa City, Iowa, 52242, United States
James Graham Brown Cancer Center ( Site 0088)
Louisville, Kentucky, 40202, United States
University of Louisville ( Site 0059)
Louisville, Kentucky, 40202, United States
University Medical Center New Orleans ( Site 0014)
New Orleans, Louisiana, 70112, United States
Massachusetts General Hospital ( Site 0062)
Boston, Massachusetts, 02114, United States
Boston Medical Center ( Site 0025)
Boston, Massachusetts, 02118, United States
Beth Israel Deaconess Medical Ctr. ( Site 0033)
Boston, Massachusetts, 02215, United States
University of Massachusetts Worcester ( Site 0017)
Worcester, Massachusetts, 01655, United States
Henry Ford Hospital-GI/Hepatology Research ( Site 0047)
Detroit, Michigan, 48202, United States
University of New Mexico ( Site 0041)
Albuquerque, New Mexico, 87131, United States
North Shore-Long Island Jewish Health System ( Site 0068)
Lake Success, New York, 11042, United States
Miami Valley Hospital South ( Site 0093)
Centerville, Ohio, 45459, United States
University of Cincinnati Medical Center ( Site 0084)
Cincinnati, Ohio, 45219, United States
ProMedica Flower Hospital ( Site 0090)
Sylvania, Ohio, 43560, United States
Stephenson Cancer Center ( Site 0045)
Oklahoma City, Oklahoma, 73104, United States
Vanderbilt Ingram Cancer Center ( Site 0006)
Nashville, Tennessee, 37232, United States
Baylor Scott & White Medical Center - Temple ( Site 0089)
Temple, Texas, 76508, United States
Virginia Mason Medical Center ( Site 0028)
Seattle, Washington, 98101, United States
Hospital Universitario Austral ( Site 0795)
Pilar, Buenos Aires, B1629AHJ, Argentina
Fundación favaloro para la Docencia e Investigación Médica ( Site 0808)
Buenos Aires, Buenos Aires F.D., C1096AAS, Argentina
Hospital Provincial del Centenario ( Site 0794)
Rosario, Santa Fe Province, S2002KDS, Argentina
Hospital Aleman ( Site 0806)
Buenos Aires, C1118AAT, Argentina
Hospital Italiano ( Site 0793)
Buenos Aires, C1181ACH, Argentina
Hospital Britanico de Buenos Aires ( Site 0792)
Buenos Aires, C1280AEB, Argentina
Clinica de nefrologia urologia y enfermedades cardiovasculares ( Site 0802)
Santa Fe, S3000BPJ, Argentina
Royal Prince Alfred Hospital AW ( Site 0225)
Camperdown, New South Wales, 2050, Australia
Liverpool Hospital ( Site 0226)
Liverpool, New South Wales, 2170, Australia
Princess Alexandra Hospital ( Site 0228)
Woollongabba, Queensland, 4102, Australia
Royal Adelaide Hospital ( Site 0234)
Adelaide, South Australia, 5000, Australia
Monash Health ( Site 0233)
Clayton, Victoria, 3168, Australia
St Vincents Hospital Melbourne ( Site 0227)
Fitzroy, Victoria, 3065, Australia
Alfred Health ( Site 0230)
Melbourne, Victoria, 3004, Australia
Royal Perth Hospital ( Site 0229)
Perth, Western Australia, 6000, Australia
University Hospital Antwerp (UZA) ( Site 0374)
Edegem, Antwerpen, 02650, Belgium
Erasme Hospital ( Site 0376)
Brussels, Bruxelles-Capitale, Region de, 1070, Belgium
UZ Gent ( Site 0375)
Ghent, Oost-Vlaanderen, 9000, Belgium
UZ Leuven ( Site 0377)
Leuven, Vlaams-Brabant, 3000, Belgium
CIONC - Centro Integrado de Oncologia de Curitiba ( Site 0813)
Curitiba, Paraná, 80810-050, Brazil
Hospital de Cancer de Pernambuco ( Site 0815)
Recife, Pernambuco, 50040-000, Brazil
Hospital de Clinicas de Porto Alegre ( Site 0824)
Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
Clinica de Oncologia Reichow ( Site 0818)
Blumenau, Santa Catarina, 89010-340, Brazil
Centro de Novos Tratamentos Itajai - Clinica de Neoplasias Litoral ( Site 0820)
Itajaí, Santa Catarina, 88301-220, Brazil
Hospital Paulistano ( Site 0829)
São Paulo, São Paulo, 01321-001, Brazil
Instituto COI de Pesquisa Educacao e Gestao ( Site 0825)
Rio de Janeiro, 22793-080, Brazil
Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0826)
São Paulo, 01246-000, Brazil
Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 0828)
São Paulo, 01321-001, Brazil
A.C. Camargo Cancer Center ( Site 0827)
São Paulo, 01509-900, Brazil
Casa de Saude Santa Marcelina ( Site 0821)
São Paulo, 08270120, Brazil
Complex Cancer Center Plovdiv-First Medical Oncology Department ( Site 0982)
Plovdiv, 4004, Bulgaria
Nova Scotia Health Authority QEII-HSC ( Site 0208)
Halifax, Nova Scotia, B3H 2Y9, Canada
Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0211)
Montreal, Quebec, H2X 3E4, Canada
McGill University Health Centre ( Site 0207)
Montreal, Quebec, H4A 3J1, Canada
Anhui Provincil Hospital South District ( Site 0181)
Hefei, Anhui, 230036, China
Cancer Hospital Chinese Academy of Medical Sciences ( Site 0156)
Beijing, Beijing Municipality, 100021, China
Peking University People's Hospital ( Site 0191)
Beijing, Beijing Municipality, 100044, China
Beijing Cancer Hospital ( Site 0155)
Beijing, Beijing Municipality, 100142, China
Fujian Provincial Cancer Hospital ( Site 0165)
Fuzhou, Fujian, 350014, China
900 Hospital of the Joint ( Site 0197)
Fuzhou, Fujian, 350025, China
Guangdong General Hospital ( Site 0166)
Guangzhou, Guangdong, 510080, China
Southern Medical University Nanfang Hospital ( Site 0172)
Guangzhou, Guangdong, 510515, China
Wuhan Union Hospital ( Site 0173)
Wuhan, Hubei, 430022, China
Hubei Cancer Hospital ( Site 0189)
Wuhan, Hubei, 430079, China
The Third Xiangya Hospital of Central South University ( Site 0167)
Changsha, Hunan, 410000, China
Hunan Provincial People Hospital ( Site 0192)
Changsha, Hunan, 410005, China
Hunan Cancer Hospital ( Site 0168)
Changsha, Hunan, 410013, China
Fudan University Shanghai Cancer Center ( Site 0161)
Shanghai, Shanghai Municipality, 200032, China
Zhongshan Hospital Fudan University ( Site 0193)
Shanghai, Shanghai Municipality, 200032, China
Renji Hospital Shanghai Jiaotong University School of Medicine ( Site 0174)
Shanghai, Shanghai Municipality, 200127, China
Zhongshan Hospital affiliated to Fudan University ( Site 0153)
Shanghai, Shanghai Municipality, 210000, China
The First Affiliated Hospital of Xi an Jiaotong University ( Site 0164)
Xi’an, Shanxi, 710061, China
West China Hospital of Sichuan University ( Site 0162)
Chengdu, Sichuan, 610041, China
Affiliated Tumor Hospital of Xinjiang Medical University ( Site 0157)
Ürümqi, Xinjiang, 830001, China
Zhejiang Cancer Hospital ( Site 0171)
Hangzhou, Zhejiang, 310022, China
Herlev Hospital ( Site 0421)
Herlev, Capital Region, 2730, Denmark
Aarhus Universitets hospital ( Site 0420)
Aarhus N, Central Jutland, 8200, Denmark
Odense Universitets Hospital ( Site 0422)
Odense C, Region Syddanmark, 5000, Denmark
HUS Hopital Hautepierre ( Site 0445)
Strasbourg, Bas-Rhin, 67098, France
Hopital de la Timone ( Site 0442)
Marseille, Bouches-du-Rhone, 13005, France
CHU Bordeaux Haut-Leveque ( Site 0437)
Pessac, Gironde, 33604, France
CHU Rangueil ( Site 0441)
Toulouse, Haute-Garonne, 31059, France
Hopital Beaujon ( Site 0439)
Clichy, Hauts-de-Seine, 92118, France
CHU Montpellier. ( Site 0443)
Montpellier, Herault, 34295, France
Hopital Claude Huriez CHRU LILLE ( Site 0440)
Lille, Nord, 59037, France
Hopital Paul Brousse ( Site 0447)
Villejuif, Val-de-Marne, 94800, France
SLK-Kliniken Heilbronn GmbH ( Site 0460)
Heilbronn, Baden-Wurttemberg, 74078, Germany
Universitaetsklinikum Tuebingen ( Site 0466)
Tübingen, Baden-Wurttemberg, 72076, Germany
Klinikum rechts der Isar der Technischen Universitaet ( Site 0470)
Munich, Bavaria, 81675, Germany
Universitaetsklinikum Wuerzburg ( Site 0468)
Würzburg, Bavaria, 97080, Germany
Krankenhaus Nord-West GmbH ( Site 0472)
Frankfurt am Main, Hesse, 60488, Germany
Universitaetsklinikum Frankfurt ( Site 0467)
Frankfurt am Main, Hesse, 60596, Germany
Medizinische Hochschule Hannover ( Site 0458)
Hanover, Lower Saxony, 30625, Germany
Universitaetsklinikum Koeln ( Site 0463)
Cologne, North Rhine-Westphalia, 50937, Germany
Universitaetsklinikum Duesseldorf ( Site 0461)
Düsseldorf, North Rhine-Westphalia, 40225, Germany
Staedtisches Klinikum Dresden ( Site 0471)
Dresden, Saxony, 01067, Germany
Universitatsklinikum Carl Gustav Carus ( Site 0459)
Dresden, Saxony, 01307, Germany
Charite - Campus Virchow Klinikum ( Site 0457)
Berlin, 13353, Germany
Universitaetsklinikum Hamburg-Eppendorf ( Site 0469)
Hamburg, 20246, Germany
Prince of Wales Hospital ( Site 0268)
Hong Kong, 000, Hong Kong
Pamela Youde Nethersole Eastern Hospital ( Site 0271)
Hong Kong, Hong Kong
Queen Mary Hospital ( Site 0267)
Hong Kong, Hong Kong
Tuen Mun Hospital ( Site 0272)
Tuenmen, Hong Kong
Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 0483)
Kecskemét, Bács-Kiskun county, 6000, Hungary
SZTE Szent-Gyorgyi Albert Klinikai Kozpont ( Site 0482)
Szeged, Csongrád megye, 6720, Hungary
Somogy Megyei Kaposi Mór Oktató Kórház-Oncology center ( Site 0484)
Kaposvár, Somogy County, 7400, Hungary
Semmelweis University ( Site 0480)
Budapest, 1085, Hungary
Debreceni Egyetem Klinikai Kozpont Onkologiai Tanszek ( Site 0481)
Debrecen, 4032, Hungary
St Vincent's University Hospital ( Site 0498)
Dublin, D04 T6F4, Ireland
Tallaght University Hospital ( Site 0499)
Dublin, D24 NR0A, Ireland
Rambam Medical Center ( Site 0524)
Haifa, 3109601, Israel
Haddassah Medical Organization - Ein Kerem ( Site 0519)
Jerusalem, 9112001, Israel
Rabin Medical Center ( Site 0520)
Petah Tikva, 4941492, Israel
Chaim Sheba Medical Center ( Site 0523)
Ramat Gan, 5262000, Israel
Sourasky Medical Center ( Site 0522)
Tel Aviv, 6423906, Israel
A O U Policlinico di Modena ( Site 0548)
Modena, Abruzzo, 41025, Italy
Azienda Ospedaliera Ordine Mauriziano di Torino ( Site 0542)
Turin, Piedmont, Italy
Azienda Ospedaliera Ospedali Riuniti Villa Sofia-Cervello ( Site 0547)
Palermo, Sicily, 90146, Italy
Istituto Tumori Giovanni Paolo II ( Site 0543)
Bari, 70124, Italy
AOU di Bologna Policliico S. Orsola-Malpighi ( Site 0541)
Bologna, 40138, Italy
Azienda Ospedaliero Universitaria Careggi ( Site 0549)
Florence, 50134, Italy
Fondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico ( Site 0550)
Milan, 20122, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0540)
Milan, 20133, Italy
Ospedale del Mare ( Site 0545)
Naples, 80147, Italy
Azienda Ospedaliero Universitaria Pisana ( Site 0546)
Pisa, 56126, Italy
Ehime University Hospital ( Site 0123)
Tōon, Ehime, 791-0295, Japan
Kurume University Hospital ( Site 0119)
Kurume, Fukuoka, 830-0011, Japan
Hokkaido P.W.F.A.C Sapporo-Kosei General Hospital ( Site 0102)
Sapporo, Hokkaido, 060-0033, Japan
Kanazawa University Hospital ( Site 0111)
Kanazawa, Ishikawa-ken, 920-8641, Japan
Kagawa University Hospital ( Site 0121)
Kita-gun, Kagawa-ken, 761-0793, Japan
Kagawa Prefectural Central Hospital ( Site 0122)
Takamatsu, Kagawa-ken, 760-8557, Japan
Toranomon Hospital Kajigaya ( Site 0109)
Kawasaki, Kanagawa, 213-8587, Japan
Yokohama City University Medical Center ( Site 0110)
Yokohama, Kanagawa, 232-0024, Japan
Kindai University Hospital ( Site 0116)
Sayama, Osaka, 5898511, Japan
Saitama Medical University Hospital ( Site 0104)
Iruma-gun, Saitama, 350-0495, Japan
Kyorin University Hospital ( Site 0106)
Mitaka, Tokyo, 181-8611, Japan
Musashino Red Cross Hospital ( Site 0107)
Musashino, Tokyo, 180-8610, Japan
Chiba University Hospital ( Site 0103)
Chiba, 260-8677, Japan
National Hospital Organization Kyushu Medical Center ( Site 0118)
Fukuoka, 810-8563, Japan
Hiroshima University Hospital ( Site 0117)
Hiroshima, 7348551, Japan
University Hospital, Kyoto Prefectural University of Medicine ( Site 0112)
Kyoto, 602-8566, Japan
Japanese Red Cross Osaka Hospital ( Site 0113)
Osaka, 543-8555, Japan
Osaka Metropolitan University Hospital. ( Site 0114)
Osaka, 545-8586, Japan
Saga-Ken Medical Centre Koseikan ( Site 0120)
Saga, 840-8571, Japan
Toranomon Hospital ( Site 0108)
Tokyo, 105-8470, Japan
The University of Tokyo Hospital ( Site 0105)
Tokyo, 113-8655, Japan
Wakayama Medical University Hospital ( Site 0115)
Wakayama, 641-8510, Japan
Hospital Universiti Sains Malaysia ( Site 0295)
Kubang Kerian, Kelantan, 16150, Malaysia
Gleneagles Penang ( Site 0290)
George Town, Pulau Pinang, 10050, Malaysia
Penang Adventist Hospital ( Site 0289)
George Town, Pulau Pinang, 10350, Malaysia
Institut Kanser Negara - National Cancer Institute ( Site 0294)
Putrajaya Wilayah Persekutuan, Putrajaya, 62250, Malaysia
Sarawak General Hospital ( Site 0293)
Kuching, Sarawak, 93586, Malaysia
University Malaya Medical Centre ( Site 0288)
Kuala Lumpur, 59100, Malaysia
Christchurch Hospital ( Site 0247)
Christchurch, Canterbury, 8011, New Zealand
Auckland City Hospital ( Site 0246)
Auckland, 1142, New Zealand
Oslo Universitetssykehus HF. Ulleval ( Site 0433)
Oslo, 0450, Norway
Izerskie Centrum Pulmonologii i Chemioterapii IZER-MED Spolka z o.o. ( Site 0607)
Szklarska Poręba, Lower Silesian Voivodeship, 58-580, Poland
Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie ( Site 0620)
Lublin, Lublin Voivodeship, 20-081, Poland
MTZ Clinical Research Sp. z o. o. ( Site 0608)
Warsaw, Masovian Voivodeship, 02-106, Poland
Copernicus PL Sp. z o.o. ( Site 0603)
Gdansk, Pomeranian Voivodeship, 80-219, Poland
ID Clinic ( Site 0619)
Mysłowice, Silesian Voivodeship, 41-400, Poland
SPZOZ MSWIA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie ( Site 0606)
Olsztyn, Warmian-Masurian Voivodeship, 10-228, Poland
Szpital Wojewodzki im. Mikolaja Kopernika ( Site 0604)
Koszalin, West Pomeranian Voivodeship, 75-581, Poland
Altay Regional Oncology Dispensary ( Site 0919)
Barnaul, Altayskiy Kray, 656045, Russia
Siberian Clinical Center of FMBA ( Site 0918)
Krasnoyarsk, Krasnoyarsk Krai, 660037, Russia
Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0648)
Krasnoyarsk, Krasnoyarsk Krai, 660133, Russia
Blokhin National Medical Oncology ( Site 0645)
Moscow, Moscow, 115478, Russia
City Clinical Hospital 1 na. NI. Pirogov ( Site 0662)
Moscow, Moscow, 119049, Russia
First Moscow State Medical University n.a. I.M.Sechenov ( Site 0661)
Moscow, Moscow, 119881, Russia
Hadassah Medical-Clinical Research Department ( Site 0920)
Moscow, Moscow, 121205, Russia
National Medical Research Radiological Centre ( Site 0660)
Moscow, Moscow, 125284, Russia
Privolzhsky District Medical Center ( Site 0655)
Nizhny Novgorod, Nizhny Novgorod Oblast, 603109, Russia
Samara Regional Clinical Oncology Center ( Site 0656)
Samara, Samara Oblast, 443031, Russia
Road Hospital JSC Russian railways ( Site 0649)
Saint Petersburg, Sankt-Peterburg, 195271, Russia
Russian Scientific Center of Radiology and Surgical Technologies ( Site 0665)
Saint Petersburg, Sankt-Peterburg, 197758, Russia
City Clinical Oncology Center ( Site 0646)
Saint Petersburg, Sankt-Peterburg, 198255, Russia
Tomsk Scientific Research Institute of Oncology ( Site 0657)
Tomsk, Tomsk Oblast, 634028, Russia
National Cancer Center ( Site 0314)
Goyang-si, Kyonggi-do, 10408, South Korea
Seoul National University Bundang Hospital ( Site 0313)
Seongnam-si, Kyonggi-do, 13605, South Korea
Seoul National University Hospital ( Site 0312)
Seoul, 03080, South Korea
Severance Hospital Yonsei University Health System ( Site 0309)
Seoul, 03722, South Korea
Asan Medical Center ( Site 0310)
Seoul, 05505, South Korea
Samsung Medical Center ( Site 0311)
Seoul, 06351, South Korea
The Catholic University of Korea. Seoul St. Mary s Hospital ( Site 0315)
Seoul, 06591, South Korea
Hospital Universitari Parc Tauli ( Site 0681)
Sabadell, Barcelona, 08208, Spain
Hospital Universitario de Donostia ( Site 0671)
Donostia / San Sebastian, Gipuzkoa, 20014, Spain
Complejo Hospitalario Universitario de Santiago ( Site 0668)
Santiago de Compostela, La Coruna, 15706, Spain
Hospital Universitario Puerta de Hierro ( Site 0678)
Majadahonda, Madrid, 28222, Spain
Hospital Central de Asturias ( Site 0667)
Oviedo, Principality of Asturias, 33011, Spain
Hospital Universitari Vall d Hebron ( Site 0674)
Barcelona, 08035, Spain
Hospital General Universitario Gregorio Maranon ( Site 0676)
Madrid, 28007, Spain
Hospital Ramon y Cajal ( Site 0673)
Madrid, 28034, Spain
Hospital Universitario La Paz ( Site 0677)
Madrid, 28046, Spain
Hospital Universitario Virgen del Rocio ( Site 0670)
Seville, 41013, Spain
Hospital Universitario Miguel Servet-Gastroenterology ( Site 0682)
Zaragoza, 50009, Spain
Skane University Hospital ( Site 0692)
Malmo, Skåne County, 205 02, Sweden
Karolinska Universitetssjukhuset, Huddinge ( Site 0689)
Stockholm, Stockholm County, 141 86, Sweden
Norrlands Universitetssjukhus ( Site 0687)
Umeå, Västerbotten County, 901 85, Sweden
Sahlgrenska Universitetssjukhuset ( Site 0691)
Gothenburg, Västra Götaland County, 413 46, Sweden
Universitaetsspital Bern ( Site 0710)
Bern, Canton of Aargau, 3010, Switzerland
University Hospital Basel ( Site 0709)
Basel, Canton of Basel-City, 4056, Switzerland
Kantonsspital St. Gallen ( Site 0708)
Sankt Gallen, Canton of St. Gallen, 9007, Switzerland
CHUV (centre hospitalier universitaire vaudois) ( Site 0712)
Lausanne, Canton of Vaud, 1011, Switzerland
Kantonsspital Winterthur ( Site 0714)
Winterthur, Canton of Zurich, 8401, Switzerland
Hopitaux Universitaires de Geneve HUG ( Site 0711)
Geneva, 1211, Switzerland
Universitaetsspital Zurich ( Site 0713)
Zurich, 8091, Switzerland
Chang Gung Medical Foundation. Kaohsiung Branch ( Site 0335)
Kaohsiung City, 833, Taiwan
China Medical University Hospital ( Site 0333)
Taichung, 40447, Taiwan
National Cheng Kung University Hospital ( Site 0334)
Tainan, 704, Taiwan
National Taiwan University Hospital ( Site 0330)
Taipei, 100, Taiwan
Taipei Veterans General Hospital ( Site 0331)
Taipei, 112, Taiwan
Chang Gung Medical Foundation. Linkou ( Site 0332)
Taoyuan District, 333, Taiwan
Ramathibodi Hospital. ( Site 0352)
Bangkok, Bangkok, 10400, Thailand
Siriraj Hospital ( Site 0351)
Bangkok, Bangkok, 10700, Thailand
Maharaj Nakorn Chiangmai Hospital ( Site 0353)
Chiang Mai, 50200, Thailand
Srinagarind Hospital ( Site 0354)
Khon Kaen, 40002, Thailand
Namik Kemal Universitesi Tip Fakultesi ( Site 0738)
Tekirdağ, Tekirdas, 59100, Turkey (Türkiye)
Baskent Unv. Adana Uyg. ve Arast. Hastanesi ( Site 0733)
Adana, 01120, Turkey (Türkiye)
Gulhane Egitim ve Arastirma Hastanesi ( Site 0741)
Ankara, 06010, Turkey (Türkiye)
Ankara Sehir Hastanesi ( Site 0731)
Ankara, 06800, Turkey (Türkiye)
Adnan Menderes University Medical Faculty ( Site 0737)
Aydin, 09010, Turkey (Türkiye)
Bezmialem Vakif University School of Medicine ( Site 0732)
Istanbul, 34093, Turkey (Türkiye)
Acıbadem Maslak Hastanesi ( Site 0742)
Istanbul, 34457, Turkey (Türkiye)
Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 0730)
Istanbul, 34722, Turkey (Türkiye)
Dokuz Eylul Universitesi ( Site 0740)
Izmir, 35340, Turkey (Türkiye)
Konya Necmettin Erbakan University Medical Faculty ( Site 0736)
Konya, 42080, Turkey (Türkiye)
Inonu University Faculty of Medicine ( Site 0729)
Malatya, 44280, Turkey (Türkiye)
VM Medical Park Hastanesi ( Site 0739)
Mersin, 33440, Turkey (Türkiye)
Regional Clinical Onco Dispensary_ State Medical University ( Site 0782)
Chernivtsi, Chernivetska Oblast, 58000, Ukraine
Regional Oncology Center of Kharkiv ( Site 0777)
Kharkiv, Kharkivs’ka Oblast’, 61000, Ukraine
National Cancer Institute of the MoH of Ukraine ( Site 0779)
Kyiv, Kyivska Oblast, 03022, Ukraine
Shalimov s NI of Surgery and Transplantation ( Site 0781)
Kyiv, Kyivska Oblast, 03126, Ukraine
MI Odessa Regional Oncological Centre ( Site 0776)
Odesa, Odesa Oblast, 65055, Ukraine
CI City Clinical Hospital # 3 ( Site 0783)
Zaporizhzhia, Zaporizhzhia Oblast, 69032, Ukraine
Universal Clinic Oberig-Oncology Center ( Site 0786)
Kyiv, 03057, Ukraine
Medical Center Dobrobut Clinic ( Site 0785)
Kyiv, 03151, Ukraine
Cambridge University Hospitals NHS Trust ( Site 0755)
Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom
Weston Park Hospital ( Site 0753)
Sheffield, Derbyshire, S10 2SJ, United Kingdom
The Beatson West of Scotland Cancer Centre ( Site 0750)
Glasgow, Glasgow City, G12 0YN, United Kingdom
Kings College Hospital NHS Foundation Trust ( Site 0758)
London, London, City of, SE5 9RS, United Kingdom
Belfast City Hospital ( Site 0752)
Belfast, Northern Ireland, BT9 7AB, United Kingdom
The Clatterbridge Cancer Centre NHS Foundation Trust ( Site 0757)
Birkenhead, Wirral, CH63 4JY, United Kingdom
University Hospital Coventry and Warwickshire NHS Trust ( Site 0754)
Coventry, CV3 2DX, United Kingdom
Leeds Teaching Hospitals NHS Trust ( Site 0751)
Leeds, LS9 7TF, United Kingdom
Nottingham University Hospitals NHS Trust ( Site 0756)
Nottingham, NG5 1PB, United Kingdom
Related Publications (1)
Verset G, Borbath I, Karwal M, Verslype C, Van Vlierberghe H, Kardosh A, Zagonel V, Stal P, Sarker D, Palmer DH, Vogel A, Edeline J, Cattan S, Kudo M, Cheng AL, Ogasawara S, Daniele B, Chan SL, Knox JJ, Qin S, Siegel AB, Chisamore M, Hatogai K, Wang A, Finn RS, Zhu AX. Pembrolizumab Monotherapy for Previously Untreated Advanced Hepatocellular Carcinoma: Data from the Open-Label, Phase II KEYNOTE-224 Trial. Clin Cancer Res. 2022 Jun 13;28(12):2547-2554. doi: 10.1158/1078-0432.CCR-21-3807.
PMID: 35421228DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Vice President, Global Clinical Development
- Organization
- Merck Sharp & Dohme LLC
Study Officials
- STUDY DIRECTOR
Medical Director
Merck Sharp & Dohme LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 6, 2019
First Posted
March 7, 2019
Study Start
May 28, 2019
Primary Completion
March 20, 2025
Study Completion
September 30, 2025
Last Updated
April 24, 2026
Results First Posted
April 24, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf