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| ID | Type | Description | Link |
|---|---|---|---|
| MK-3475-937 | Other Identifier | MSD Protocol Number | |
| KEYNOTE-937 | Other Identifier | MSD | |
| 194786 | Registry Identifier | JAPAC-CTI | |
| 2022-501971-24-00 | Registry Identifier | EU CT | |
| U1111-1282-6370 | Registry Identifier | UTN | |
| 2018-004800-20 | EudraCT Number |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pembrolizumab | Experimental | Participants receive intravenous (IV) pembrolizumab at 200 mg on Day 1 of each 21-day cycle for up to 17 cycles. |
|
| Placebo | Placebo Comparator | Participants receive IV placebo on Day 1 of each 21-day cycle for up to 17 cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pembrolizumab | Biological | IV infusion of Pembrolizumab 200 mg. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experienced an Adverse Event (AE) | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner MD Anderson Cancer Center ( Site 0026) | Gilbert | Arizona | 85234 | United States | ||
| The University of Arizona Cancer Center - North Campus ( Site 0039) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35421228 | Derived | 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. |
| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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Of 1313 participants screened, 959 participants were randomized 1:1 to receive either pembrolizumab or placebo.
Participants at least 18 years of age with hepatocellular carcinoma (HCC) and who had complete radiological response after surgical resection or local ablation were recruited.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pembrolizumab | Participants received intravenous (IV) pembrolizumab at 200 mg on Day 1 of each 21-day cycle for up to 17 cycles |
| FG001 | Placebo | Participants received IV placebo on Day 1 of each 21-day cycle for up to 17 cycles |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 8, 2022 |
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| Placebo | Drug | IV infusion of 0.9% normal saline. |
|
| Number of Participants Who Discontinued Study Treatment Due to an AE | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 |
| 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) | Malmö | 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 | 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 | Kharkiv 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 |
| Plain Language Summary | View source |
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
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Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Pembrolizumab | Participants received intravenous (IV) pembrolizumab at 200 mg on Day 1 of each 21-day cycle for up to 17 cycles |
| BG001 | Placebo | Participants received IV placebo on Day 1 of each 21-day cycle for up to 17 cycles |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Prior Local Therapy | Prior local therapy (resection versus ablation) was used as a randomization stratification factor. | Count of Participants | Participants |
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| Recurrence Risk Group | Risk of recurrence (intermediate versus high risk versus very high risk) was used as a randomization stratification factor. | Count of Participants | Participants |
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| Alpha Fetoprotein (AFP) at Initial Diagnosis Prior to Resection or Ablation | AFP at initial diagnosis prior to resection or ablation (<200 ng/mL versus ≥200 ng/mL), was used as a randomization stratification factor. | Count of Participants | Participants |
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| Region of Enrolling Site | Geographic region of enrollment site (Asia without Japan versus non-Non-Asia and Japan) was used as a randomization stratification factor. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Number of Participants Who Experienced an Adverse Event (AE) | 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. | The analysis population consisted of all participants who received at least 1 dose of study treatment. | Posted | Count of Participants | Participants | Up to approximately 26 months |
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| Secondary | Number of Participants Who Discontinued Study Treatment Due to an AE | 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. | The analysis population consisted of all participants who received at least 1 dose of study treatment. | Posted | Count of Participants | Participants | Up to approximately 23 months |
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| Secondary | 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 | 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. | The analysis population consisted of all participants who received at least 1 dose of study treatment and had at least one EORTC QLQ-C30 score available. | Posted | Least Squares Mean | 95% Confidence Interval | Score on a Scale | Baseline and up to approximately 120 weeks |
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| Secondary | Change From Baseline in EORTC QLQ-C30 Physical Functioning Scale Score | 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. | The analysis population consisted of all participants who received at least 1 dose of study treatment and had at least one EORTC QLQ-C30 score available. | Posted | Least Squares Mean | 95% Confidence Interval | Score on a Scale | Baseline and up to approximately 120 weeks |
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| Secondary | Change From Baseline in EORTC QLQ-C30 Role Functioning Scale Score | 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. | The analysis population consisted of all participants who received at least 1 dose of study treatment and had at least one EORTC QLQ-C30 score available. | Posted | Least Squares Mean | 95% Confidence Interval | Score on a Scale | Baseline and up to approximately 120 weeks |
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| Secondary | Change From Baseline in EORTC QLQ-Hepatocellular Carcinoma Module (EORTC QLQ-HCC18) Abdominal Swelling Scale Score | 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. | The analysis population consisted of all participants who received at least 1 dose of study treatment and had at least one EORTC QLQ-HCC18 score available. | Posted | Least Squares Mean | 95% Confidence Interval | Score on a Scale | Baseline and up to approximately 120 weeks |
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| Secondary | Change From Baseline in EORTC QLQ-HCC18 Fatigue Scale Score | 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. | The analysis population consisted of all participants who received at least 1 dose of study treatment and had at least one EORTC QLQ-HCC18 score available. | Posted | Least Squares Mean | 95% Confidence Interval | Score on a Scale | Baseline and up to approximately 120 weeks |
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| Secondary | Change From Baseline in EORTC QLQ-HCC18 Pain Scale Score | 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. | The analysis population consisted of all participants who received at least 1 dose of study treatment and had at least one EORTC QLQ-HCC18 score available. | Posted | Least Squares Mean | 95% Confidence Interval | Score on a Scale | Baseline and up to approximately 120 weeks |
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| Secondary | 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 | 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). | The analysis population consisted of all participants who received at least 1 dose of study treatment and had at least one EQ-5D-5L score available. | Posted | Least Squares Mean | 95% Confidence Interval | Score on a Scale | Baseline and up to approximately 120 weeks |
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| Secondary | Time to Deterioration (TTD) in the EORTC QLQ-C30 Combined GHS / QoL Scale Score | 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. | The analysis population consisted of all participants who received at least 1 dose of study treatment and had at least one EORTC QLQ-C30 score available at baseline. | Posted | Median | 95% Confidence Interval | Months | Baseline and up to approximately 120 weeks |
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| Secondary | TTD in the EORTC QLQ-C30 Physical Functioning Scale Score | 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. | The analysis population consisted of all participants who received at least 1 dose of study treatment and had at least one EORTC QLQ-C30 score available at baseline. | Posted | Median | 95% Confidence Interval | Months | Baseline and up to approximately 120 weeks |
| ||||||||||||||||||||||||||||||
| Secondary | TTD in the EORTC QLQ-C30 Role Functioning Scale Score | 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. | The analysis population consisted of all participants who received at least 1 dose of study treatment and had at least one EORTC QLQ-C30 score available at baseline. | Posted | Median | 95% Confidence Interval | Months | Baseline and up to approximately 120 weeks |
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| Secondary | TTD in the EORTC QLQ-HCC18 Abdominal Swelling Scale Score | 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. | The analysis population consisted of all participants who received at least 1 dose of study treatment and had at least one EORTC QLQ-HCC18 score available at baseline. | Posted | Median | 95% Confidence Interval | Months | Baseline and up to approximately 120 weeks |
|
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| Secondary | TTD in the EORTC QLQ-HCC18 Fatigue Scale Score | 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. | The analysis population consisted of all participants who received at least 1 dose of study treatment and had at least one EORTC QLQ-HCC18 score available at baseline. | Posted | Median | 95% Confidence Interval | Months | Baseline and up to approximately 120 weeks |
|
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| Secondary | TTD in the EORTC QLQ-HCC18 Pain Scale Score | 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. | The analysis population consisted of all participants who received at least 1 dose of study treatment and had at least one EORTC QLQ-HCC18 score available at baseline. | Posted | Median | 95% Confidence Interval | Months | Baseline and up to approximately 120 weeks |
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| Primary | 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. | All randomized participants were analyzed. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 69 months |
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| Primary | Overall Survival (OS) | OS was defined as the time from randomization to death due to any cause. OS was reported for each arm. | All randomized participants were analyzed. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 69 months |
|
|
Up to approximately 74 months
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pembrolizumab | Participants received intravenous (IV) pembrolizumab at 200 mg on Day 1 of each 21-day cycle for up to 17 cycles | 109 | 476 | 103 | 471 | 350 | 471 |
| EG001 | Placebo | Participants received IV placebo on Day 1 of each 21-day cycle for up to 17 cycles | 109 | 483 | 59 | 482 | 278 | 482 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Atrioventricular block complete | Cardiac disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Cardiomyopathy | Cardiac disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Coronary artery stenosis | Cardiac disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Immune-mediated myocarditis | Cardiac disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Left ventricular failure | Cardiac disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 28.0 | Systematic Assessment |
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| Adrenal insufficiency | Endocrine disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Graves' disease | Endocrine disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hypophysitis | Endocrine disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hypopituitarism | Endocrine disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Inappropriate antidiuretic hormone secretion | Endocrine disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Uveitis | Eye disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Vitreous haemorrhage | Eye disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hernial eventration | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Obstruction gastric | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Oedematous pancreatitis | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Oesophageal varices haemorrhage | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Varices oesophageal | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Bile duct stenosis | Hepatobiliary disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hepatic mass | Hepatobiliary disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hypertransaminasaemia | Hepatobiliary disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Immune-mediated hepatitis | Hepatobiliary disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Portal vein embolism | Hepatobiliary disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Abdominal infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Cytomegalovirus infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Hepatitis B reactivation | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Hepatitis C | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Hepatitis E | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Leptospirosis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Perirectal abscess | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Post-acute COVID-19 syndrome | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Renal abscess | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Craniocerebral injury | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
| |
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
| |
| Tooth fracture | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Liver function test increased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Immune-mediated arthritis | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Myositis | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Spinal disorder | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Adenocarcinoma of colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 28.0 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 28.0 | Systematic Assessment |
| |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 28.0 | Systematic Assessment |
| |
| Bladder transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 28.0 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 28.0 | Systematic Assessment |
| |
| Cholangiocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 28.0 | Systematic Assessment |
| |
| Gastrointestinal tract adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 28.0 | Systematic Assessment |
| |
| Lip and/or oral cavity cancer recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 28.0 | Systematic Assessment |
| |
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 28.0 | Systematic Assessment |
| |
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 28.0 | Systematic Assessment |
| |
| Plasma cell myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 28.0 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 28.0 | Systematic Assessment |
| |
| Transitional cell carcinoma recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 28.0 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Demyelination | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Facial paralysis | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Guillain-Barre syndrome | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hepatic encephalopathy | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Intracranial aneurysm | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Metabolic encephalopathy | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Myasthenia gravis | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Vertebrobasilar insufficiency | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Foetal death | Pregnancy, puerperium and perinatal conditions | MedDRA 28.0 | Systematic Assessment |
| |
| Adjustment disorder with depressed mood | Psychiatric disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Cystitis interstitial | Renal and urinary disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Prerenal failure | Renal and urinary disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Bronchitis chronic | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Obstructive sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 28.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 28.0 | Systematic Assessment |
|
The Sponsor will comply with the requirements for publication of study results. In accordance with standard editorial and ethical practice, the Sponsor will generally support publication of multicenter studies only in their entirety and not as individual site data. In this case, a coordinating investigator will be designated by mutual agreement. If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme LLC | 1-800-672-6372 | ClinicalTrialsDisclosure@msd.com |
| Feb 25, 2026 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| C565324 | Parkinson Disease 4, Autosomal Dominant Lewy Body |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C582435 | pembrolizumab |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Ablation |
|
| High |
|
| Very High |
|
| <200 ng/mL |
|
| Missing |
|
| Non-Asia and Japan |
|
|
|
|
|
| Counts |
|---|
| Participants |
|
|
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| Participants |
|
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| Participants |
|
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| Participants |
|
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| Participants |
|
|
|
|
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| Units | Counts |
|---|---|
| Participants |
|
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|
| Units | Counts |
|---|
| Participants |
|
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
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| Participants |
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| Participants |
|
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| Participants |
|
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|
|
|
|