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)
Study Details
Study Description
Brief Summary
This study will evaluate the safety and efficacy of pembrolizumab (MK-3475) versus placebo as adjuvant therapy in participants with hepatocellular carcinoma (HCC) and complete radiological response after surgical resection or local ablation. The primary hypotheses of this study are that adjuvant pembrolizumab is superior to placebo with respect to: 1) recurrence-free survival (RFS) as assessed by blinded independent central review (BICR); and 2) overall survival (OS).
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Pembrolizumab Participants receive intravenous (IV) pembrolizumab at 200 mg on Day 1 of each 21-day cycle for up to 17 cycles. |
Biological: Pembrolizumab
IV infusion of Pembrolizumab 200 mg.
Other Names:
|
Placebo Comparator: Placebo Participants receive IV placebo on Day 1 of each 21-day cycle for up to 17 cycles. |
Drug: Placebo
IV infusion of 0.9% normal saline.
|
Outcome Measures
Primary Outcome Measures
- Recurrence-Free Survival (RFS) [Up to ~4 years]
RFS is defined as the time from randomization to first documentation of disease recurrence (local, regional, or distant) as assessed by BICR or by pathology consistent with HCC if required per the site's standard of care, or death due to any cause (both cancer and non-cancer causes of death), whichever occurs first.
- Overall Survival (OS) [Up to ~6 years]
OS is defined as the time from randomization to death due to any cause.
Secondary Outcome Measures
- Percentage of Participants who Experience an Adverse Event (AE) [Up to ~6 years]
An AE is defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy can be determined.
- Percentage of Participants who Discontinue Study Treatment Due to an AE [Up to ~1 year]
An AE is defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy can be determined.
- Change from Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Combined Global Health Status (GHS) / Quality of Life (QoL) Scale Score [Baseline and time of last patient reported outcome (PRO) assessment (up to ~7 years)]
The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients, including a combined GHS/QoL (Items 29 and 30) scale. Per protocol, the change from baseline in the combined GHS/QoL score (range: 0-100) will be reported. Higher overall GHS/QoL scores indicate higher GHS/QoL.
- Change from Baseline in EORTC QLQ-Hepatocellular Carcinoma Module (EORTC QLQ-HCC18) Scale Score [Baseline and time of last PRO assessment (up to ~7 years)]
The EORTC QLQ-HCC18 is an HCC-specific questionnaire, administered in addition to the EORTC QLQ-C30, with scores ranging from 0-100. Higher scores indicate more severe symptoms/problems. Change from baseline in the EORTC QLQ-HCC18 scale score will be reported.
- Change from Baseline in European Quality of Life (EuroQoL)-5 Dimensions, 5-level Questionnaire (EQ-5D-5L) Health Utility Score [Baseline and time of last PRO assessment (up to ~7 years)]
The EQ-5D-5L measured health-related outcomes, assessing 5 health state dimensions (mobility, selfcare, usual activities, pain/discomfort, and anxiety/depression) on a 5-point scale from 1 (no problem) to 5 (extreme problems). The EQ-5D-5L also includes a graded (0 to 100) vertical visual analog scale on which the participant rates their general state of health.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Has a diagnosis of HCC by radiological criteria and/or pathological confirmation.
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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.
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Has no radiologic evidence of disease prior to enrollment.
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Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days prior to Cycle 1, Day 1.
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Has a Child-Pugh class A liver score (5 to 6 points) within 7 days prior to Cycle 1, Day 1.
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Has alpha fetoprotein (AFP) concentration lower than 400 ng/mL within 28 days prior to Cycle 1, Day 1.
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Has controlled hepatitis B (Hep B).
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Has recovered adequately from toxicity and/or complications from the local intervention (surgical resection or local ablation) prior to starting study treatment.
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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).
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If undergoing surgical resection, has submitted a tumor tissue sample during Screening.
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Has adequate organ function.
Exclusion Criteria:
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Has a known additional malignancy that is progressing or has required active antineoplastic treatment (including hormonal) or surgery within the past 3 years.
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Has had esophageal or gastric variceal bleeding within the last 6 months.
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Has clinically apparent ascites on physical examination.
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Has had clinically diagnosed hepatic encephalopathy in the last 6 months.
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Has received local therapy to liver ablation other than with radiofrequency or microwave ablation.
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Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
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Has an active infection requiring systemic therapy.
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Has dual active Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV) infection at study entry.
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Has a known history of human immunodeficiency virus (HIV) infection.
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Has known active tuberculosis (TB; Bacillus tuberculosis).
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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).
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Has received prior systemic anti-cancer therapy for HCC including investigational agents.
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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.
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Has received a live vaccine within 30 days prior to the first dose of study treatment.
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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.
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Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to Cycle 1, Day 1.
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Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
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Has an active autoimmune disease that has required systemic treatment in past 2 years.
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Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study.
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Has had an allogenic tissue/solid organ transplant.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Banner MD Anderson Cancer Center ( Site 0026) | Gilbert | Arizona | United States | 85234 |
2 | The University of Arizona Cancer Center - North Campus ( Site 0039) | Tucson | Arizona | United States | 85719 |
3 | City of Hope Medical Center ( Site 0027) | Duarte | California | United States | 91010 |
4 | Smilow Cancer Hospital at Yale New Haven ( Site 0042) | New Haven | Connecticut | United States | 06510 |
5 | Regional Cancer Center ( Site 0054) | Fort Myers | Florida | United States | 33905 |
6 | Indiana University Simon Cancer Center ( Site 0075) | Indianapolis | Indiana | United States | 46202 |
7 | University of Iowa ( Site 0067) | Iowa City | Iowa | United States | 52242 |
8 | James Graham Brown Cancer Center ( Site 0088) | Louisville | Kentucky | United States | 40202 |
9 | University of Louisville ( Site 0059) | Louisville | Kentucky | United States | 40202 |
10 | University Medical Center New Orleans ( Site 0014) | New Orleans | Louisiana | United States | 70112 |
11 | Massachusetts General Hospital ( Site 0062) | Boston | Massachusetts | United States | 02114 |
12 | Boston Medical Center ( Site 0025) | Boston | Massachusetts | United States | 02118 |
13 | Beth Israel Deaconess Medical Ctr. ( Site 0033) | Boston | Massachusetts | United States | 02215 |
14 | University of Massachusetts Worcester ( Site 0017) | Worcester | Massachusetts | United States | 01655 |
15 | Henry Ford Hospital-GI/Hepatology Research ( Site 0047) | Detroit | Michigan | United States | 48202 |
16 | University of New Mexico ( Site 0041) | Albuquerque | New Mexico | United States | 87131 |
17 | North Shore-Long Island Jewish Health System ( Site 0068) | Lake Success | New York | United States | 11042 |
18 | Miami Valley Hospital South ( Site 0093) | Centerville | Ohio | United States | 45459 |
19 | University of Cincinnati Medical Center ( Site 0084) | Cincinnati | Ohio | United States | 45219 |
20 | ProMedica Flower Hospital ( Site 0090) | Sylvania | Ohio | United States | 43560 |
21 | Stephenson Cancer Center ( Site 0045) | Oklahoma City | Oklahoma | United States | 73104 |
22 | Vanderbilt Ingram Cancer Center ( Site 0006) | Nashville | Tennessee | United States | 37232 |
23 | Baylor Scott & White Medical Center - Temple ( Site 0089) | Temple | Texas | United States | 76508 |
24 | Virginia Mason Medical Center ( Site 0028) | Seattle | Washington | United States | 98101 |
25 | Hospital Universitario Austral ( Site 0795) | Pilar | Buenos Aires | Argentina | B1629AHJ |
26 | Fundación favaloro para la Docencia e Investigación Médica ( Site 0808) | Buenos Aires | Caba | Argentina | C1096AAS |
27 | Hospital Provincial del Centenario ( Site 0794) | Rosario | Santa Fe | Argentina | S2002KDS |
28 | Hospital Aleman ( Site 0806) | Buenos Aires | Argentina | C1118AAT | |
29 | Hospital Italiano ( Site 0793) | Buenos Aires | Argentina | C1181ACH | |
30 | Hospital Britanico de Buenos Aires ( Site 0792) | Buenos Aires | Argentina | C1280AEB | |
31 | Clinica de nefrologia urologia y enfermedades cardiovasculares ( Site 0802) | Santa Fe | Argentina | S3000BPJ | |
32 | Royal Prince Alfred Hospital AW ( Site 0225) | Camperdown | New South Wales | Australia | 2050 |
33 | Liverpool Hospital ( Site 0226) | Liverpool | New South Wales | Australia | 2170 |
34 | Princess Alexandra Hospital ( Site 0228) | Woollongabba | Queensland | Australia | 4102 |
35 | Royal Adelaide Hospital ( Site 0234) | Adelaide | South Australia | Australia | 5000 |
36 | Monash Health ( Site 0233) | Clayton | Victoria | Australia | 3168 |
37 | St Vincents Hospital Melbourne ( Site 0227) | Fitzroy | Victoria | Australia | 3065 |
38 | Alfred Health ( Site 0230) | Melbourne | Victoria | Australia | 3004 |
39 | Royal Perth Hospital ( Site 0229) | Perth | Western Australia | Australia | 6000 |
40 | University Hospital Antwerp (UZA) ( Site 0374) | Edegem | Antwerpen | Belgium | 02650 |
41 | Erasme Hospital ( Site 0376) | Bruxelles | Bruxelles-Capitale, Region De | Belgium | 1070 |
42 | UZ Gent ( Site 0375) | Gent | Oost-Vlaanderen | Belgium | 9000 |
43 | UZ Leuven ( Site 0377) | Leuven | Vlaams-Brabant | Belgium | 3000 |
44 | CIONC - Centro Integrado de Oncologia de Curitiba ( Site 0813) | Curitiba | Parana | Brazil | 80810-050 |
45 | Hospital de Cancer de Pernambuco ( Site 0815) | Recife | Pernambuco | Brazil | 50040-000 |
46 | Hospital de Clinicas de Porto Alegre ( Site 0824) | Porto Alegre | Rio Grande Do Sul | Brazil | 90035-903 |
47 | Clinica de Oncologia Reichow ( Site 0818) | Blumenau | Santa Catarina | Brazil | 89010-340 |
48 | Centro de Novos Tratamentos Itajai - Clinica de Neoplasias Litoral ( Site 0820) | Itajai | Santa Catarina | Brazil | 88301-220 |
49 | Hospital Paulistano ( Site 0829) | São Paulo | Sao Paulo | Brazil | 01321-001 |
50 | Instituto COI de Pesquisa Educacao e Gestao ( Site 0825) | Rio de Janeiro | Brazil | 22793-080 | |
51 | Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0826) | Sao Paulo | Brazil | 01246-000 | |
52 | Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 0828) | Sao Paulo | Brazil | 01321-001 | |
53 | A.C. Camargo Cancer Center ( Site 0827) | Sao Paulo | Brazil | 01509-900 | |
54 | Casa de Saude Santa Marcelina ( Site 0821) | Sao Paulo | Brazil | 08270120 | |
55 | Complex Cancer Center Plovdiv-First Medical Oncology Department ( Site 0982) | Plovdiv | Bulgaria | 4004 | |
56 | Nova Scotia Health Authority QEII-HSC ( Site 0208) | Halifax | Nova Scotia | Canada | B3H 2Y9 |
57 | Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0211) | Montreal | Quebec | Canada | H2X 3E4 |
58 | McGill University Health Centre ( Site 0207) | Montreal | Quebec | Canada | H4A 3J1 |
59 | Anhui Provincil Hospital South District ( Site 0181) | Hefei | Anhui | China | 230036 |
60 | Cancer Hospital Chinese Academy of Medical Sciences ( Site 0156) | Beijing | Beijing | China | 100021 |
61 | Peking University People's Hospital ( Site 0191) | Beijing | Beijing | China | 100044 |
62 | Beijing Cancer Hospital ( Site 0155) | Beijing | Beijing | China | 100142 |
63 | Fujian Provincial Cancer Hospital ( Site 0165) | Fuzhou | Fujian | China | 350014 |
64 | 900 Hospital of the Joint ( Site 0197) | Fuzhou | Fujian | China | 350025 |
65 | Guangdong General Hospital ( Site 0166) | Guangzhou | Guangdong | China | 510080 |
66 | Southern Medical University Nanfang Hospital ( Site 0172) | Guangzhou | Guangdong | China | 510515 |
67 | Wuhan Union Hospital ( Site 0173) | Wuhan | Hubei | China | 430022 |
68 | Hubei Cancer Hospital ( Site 0189) | Wuhan | Hubei | China | 430079 |
69 | The Third Xiangya Hospital of Central South University ( Site 0167) | Changsha | Hunan | China | 410000 |
70 | Hunan Provincial People Hospital ( Site 0192) | Changsha | Hunan | China | 410005 |
71 | Hunan Cancer Hospital ( Site 0168) | Changsha | Hunan | China | 410013 |
72 | Fudan University Shanghai Cancer Center ( Site 0161) | Shanghai | Shanghai | China | 200032 |
73 | Zhongshan Hospital Fudan University ( Site 0193) | Shanghai | Shanghai | China | 200032 |
74 | Renji Hospital Shanghai Jiaotong University School of Medicine ( Site 0174) | Shanghai | Shanghai | China | 200127 |
75 | Zhongshan Hospital affiliated to Fudan University ( Site 0153) | Shanghai | Shanghai | China | 210000 |
76 | The First Affiliated Hospital of Xi an Jiaotong University ( Site 0164) | XI An | Shanxi | China | 710061 |
77 | West China Hospital of Sichuan University ( Site 0162) | Chengdu | Sichuan | China | 610041 |
78 | Affiliated Tumor Hospital of Xinjiang Medical University ( Site 0157) | Urumqi | Xinjiang | China | 830001 |
79 | Zhejiang Cancer Hospital ( Site 0171) | Hangzhou | Zhejiang | China | 310022 |
80 | Herlev Hospital ( Site 0421) | Herlev | Hovedstaden | Denmark | 2730 |
81 | Aarhus Universitets hospital ( Site 0420) | Aarhus N | Midtjylland | Denmark | 8200 |
82 | Odense Universitets Hospital ( Site 0422) | Odense C | Syddanmark | Denmark | 5000 |
83 | HUS Hopital Hautepierre ( Site 0445) | Strasbourg | Bas-Rhin | France | 67098 |
84 | Hopital de la Timone ( Site 0442) | Marseille | Bouches-du-Rhone | France | 13005 |
85 | CHU Bordeaux Haut-Leveque ( Site 0437) | Pessac | Gironde | France | 33604 |
86 | CHU Rangueil ( Site 0441) | Toulouse | Haute-Garonne | France | 31059 |
87 | Hopital Beaujon ( Site 0439) | Clichy | Hauts-de-Seine | France | 92118 |
88 | CHU Montpellier. ( Site 0443) | Montpellier | Herault | France | 34295 |
89 | Hopital Claude Huriez CHRU LILLE ( Site 0440) | Lille | Nord | France | 59037 |
90 | Hopital Paul Brousse ( Site 0447) | Villejuif | Val-de-Marne | France | 94800 |
91 | SLK-Kliniken Heilbronn GmbH ( Site 0460) | Heilbronn | Baden-Wurttemberg | Germany | 74078 |
92 | Universitaetsklinikum Tuebingen ( Site 0466) | Tuebingen | Baden-Wurttemberg | Germany | 72076 |
93 | Klinikum rechts der Isar der Technischen Universitaet ( Site 0470) | Muenchen | Bayern | Germany | 81675 |
94 | Universitaetsklinikum Wuerzburg ( Site 0468) | Wuerzburg | Bayern | Germany | 97080 |
95 | Krankenhaus Nord-West GmbH ( Site 0472) | Frankfurt am Main | Hessen | Germany | 60488 |
96 | Universitaetsklinikum Frankfurt ( Site 0467) | Frankfurt | Hessen | Germany | 60596 |
97 | Medizinische Hochschule Hannover ( Site 0458) | Hannover | Niedersachsen | Germany | 30625 |
98 | Universitaetsklinikum Duesseldorf ( Site 0461) | Duesseldorf | Nordrhein-Westfalen | Germany | 40225 |
99 | Universitaetsklinikum Koeln ( Site 0463) | Koeln | Nordrhein-Westfalen | Germany | 50937 |
100 | Staedtisches Klinikum Dresden ( Site 0471) | Dresden | Sachsen | Germany | 01067 |
101 | Universitatsklinikum Carl Gustav Carus ( Site 0459) | Dresden | Sachsen | Germany | 01307 |
102 | Charite - Campus Virchow Klinikum ( Site 0457) | Berlin | Germany | 13353 | |
103 | Universitaetsklinikum Hamburg-Eppendorf ( Site 0469) | Hamburg | Germany | 20246 | |
104 | Prince of Wales Hospital ( Site 0268) | Hong Kong | Hong Kong | 000 | |
105 | Pamela Youde Nethersole Eastern Hospital ( Site 0271) | Hong Kong | Hong Kong | ||
106 | Queen Mary Hospital ( Site 0267) | Hong Kong | Hong Kong | ||
107 | Tuen Mun Hospital ( Site 0272) | Tuen Mun | Hong Kong | ||
108 | Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 0483) | Kecskemét | Bacs-Kiskun | Hungary | 6000 |
109 | SZTE Szent-Gyorgyi Albert Klinikai Kozpont ( Site 0482) | Szeged | Csongrad | Hungary | 6720 |
110 | Somogy Megyei Kaposi Mór Oktató Kórház-Oncology center ( Site 0484) | Kaposvár | Somogy | Hungary | 7400 |
111 | Semmelweis University ( Site 0480) | Budapest | Hungary | 1085 | |
112 | Debreceni Egyetem Klinikai Kozpont Onkologiai Tanszek ( Site 0481) | Debrecen | Hungary | 4032 | |
113 | St Vincent's University Hospital ( Site 0498) | Dublin | Ireland | D04 T6F4 | |
114 | Tallaght University Hospital ( Site 0499) | Dublin | Ireland | D24 NR0A | |
115 | Rambam Medical Center ( Site 0524) | Haifa | Israel | 3109601 | |
116 | Haddassah Medical Organization - Ein Kerem ( Site 0519) | Jerusalem | Israel | 9112001 | |
117 | Rabin Medical Center ( Site 0520) | Petah Tikva | Israel | 4941492 | |
118 | Chaim Sheba Medical Center ( Site 0523) | Ramat Gan | Israel | 5262000 | |
119 | Sourasky Medical Center ( Site 0522) | Tel Aviv | Israel | 6423906 | |
120 | A O U Policlinico di Modena ( Site 0548) | Modena | Abruzzo | Italy | 41025 |
121 | Azienda Ospedaliera Ordine Mauriziano di Torino ( Site 0542) | Torino | Piemonte | Italy | |
122 | Azienda Ospedaliera Ospedali Riuniti Villa Sofia-Cervello ( Site 0547) | Palermo | Sicilia | Italy | 90146 |
123 | Istituto Tumori Giovanni Paolo II ( Site 0543) | Bari | Italy | 70124 | |
124 | AOU di Bologna Policliico S. Orsola-Malpighi ( Site 0541) | Bologna | Italy | 40138 | |
125 | Azienda Ospedaliero Universitaria Careggi ( Site 0549) | Firenze | Italy | 50134 | |
126 | Fondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico ( Site 0550) | Milano | Italy | 20122 | |
127 | Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0540) | Milano | Italy | 20133 | |
128 | Ospedale del Mare ( Site 0545) | Napoli | Italy | 80147 | |
129 | Azienda Ospedaliero Universitaria Pisana ( Site 0546) | Pisa | Italy | 56126 | |
130 | Ehime University Hospital ( Site 0123) | Toon | Ehime | Japan | 791-0295 |
131 | Kurume University Hospital ( Site 0119) | Kurume | Fukuoka | Japan | 830-0011 |
132 | Hokkaido P.W.F.A.C Sapporo-Kosei General Hospital ( Site 0102) | Sapporo | Hokkaido | Japan | 060-0033 |
133 | Kanazawa University Hospital ( Site 0111) | Kanazawa | Ishikawa | Japan | 920-8641 |
134 | Kagawa University Hospital ( Site 0121) | Kita-gun | Kagawa | Japan | 761-0793 |
135 | Kagawa Prefectural Central Hospital ( Site 0122) | Takamatsu | Kagawa | Japan | 760-8557 |
136 | Toranomon Hospital Kajigaya ( Site 0109) | Kawasaki | Kanagawa | Japan | 213-8587 |
137 | Yokohama City University Medical Center ( Site 0110) | Yokohama | Kanagawa | Japan | 232-0024 |
138 | Kindai University Hospital ( Site 0116) | Osakasayama | Osaka | Japan | 5898511 |
139 | Saitama Medical University Hospital ( Site 0104) | Iruma-gun | Saitama | Japan | 350-0495 |
140 | Kyorin University Hospital ( Site 0106) | Mitaka | Tokyo | Japan | 181-8611 |
141 | Musashino Red Cross Hospital ( Site 0107) | Musashino | Tokyo | Japan | 180-8610 |
142 | Chiba University Hospital ( Site 0103) | Chiba | Japan | 260-8677 | |
143 | National Hospital Organization Kyushu Medical Center ( Site 0118) | Fukuoka | Japan | 810-8563 | |
144 | Hiroshima University Hospital ( Site 0117) | Hiroshima | Japan | 7348551 | |
145 | University Hospital, Kyoto Prefectural University of Medicine ( Site 0112) | Kyoto | Japan | 602-8566 | |
146 | Japanese Red Cross Osaka Hospital ( Site 0113) | Osaka | Japan | 543-8555 | |
147 | Osaka Metropolitan University Hospital. ( Site 0114) | Osaka | Japan | 545-8586 | |
148 | Saga-Ken Medical Centre Koseikan ( Site 0120) | Saga | Japan | 840-8571 | |
149 | Toranomon Hospital ( Site 0108) | Tokyo | Japan | 105-8470 | |
150 | The University of Tokyo Hospital ( Site 0105) | Tokyo | Japan | 113-8655 | |
151 | Wakayama Medical University Hospital ( Site 0115) | Wakayama | Japan | 641-8510 | |
152 | National Cancer Center ( Site 0314) | Goyang-si | Kyonggi-do | Korea, Republic of | 10408 |
153 | Seoul National University Bundang Hospital ( Site 0313) | Seongnam-si | Kyonggi-do | Korea, Republic of | 13605 |
154 | Seoul National University Hospital ( Site 0312) | Seoul | Korea, Republic of | 03080 | |
155 | Severance Hospital Yonsei University Health System ( Site 0309) | Seoul | Korea, Republic of | 03722 | |
156 | Asan Medical Center ( Site 0310) | Seoul | Korea, Republic of | 05505 | |
157 | Samsung Medical Center ( Site 0311) | Seoul | Korea, Republic of | 06351 | |
158 | The Catholic University of Korea. Seoul St. Mary s Hospital ( Site 0315) | Seoul | Korea, Republic of | 06591 | |
159 | Hospital Universiti Sains Malaysia ( Site 0295) | Kubang Kerian | Kelantan | Malaysia | 16150 |
160 | Penang Adventist Hospital ( Site 0289) | George Town | Pulau Pinang | Malaysia | 10350 |
161 | Gleneagles Penang ( Site 0290) | Penang | Pulau Pinang | Malaysia | 10050 |
162 | Sarawak General Hospital ( Site 0293) | Kuching | Sarawak | Malaysia | 93586 |
163 | Institut Kanser Negara - National Cancer Institute ( Site 0294) | Putrajaya Wilayah Persekutuan | Wilayah Persekutuan Putrajaya | Malaysia | 62250 |
164 | University Malaya Medical Centre ( Site 0288) | Kuala Lumpur | Malaysia | 59100 | |
165 | Christchurch Hospital ( Site 0247) | Christchurch | Canterbury | New Zealand | 8011 |
166 | Auckland City Hospital ( Site 0246) | Auckland | New Zealand | 1142 | |
167 | Oslo Universitetssykehus HF. Ulleval ( Site 0433) | Oslo | Norway | 0450 | |
168 | Izerskie Centrum Pulmonologii i Chemioterapii IZER-MED Spolka z o.o. ( Site 0607) | Szklarska Poreba | Dolnoslaskie | Poland | 58-580 |
169 | Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie ( Site 0620) | Lublin | Lubelskie | Poland | 20-081 |
170 | MTZ Clinical Research Sp. z o. o. ( Site 0608) | Warsaw | Mazowieckie | Poland | 02-106 |
171 | Copernicus PL Sp. z o.o. ( Site 0603) | Gdansk | Pomorskie | Poland | 80-219 |
172 | ID Clinic ( Site 0619) | Myslowice | Slaskie | Poland | 41-400 |
173 | SPZOZ MSWIA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie ( Site 0606) | Olsztyn | Warminsko-mazurskie | Poland | 10-228 |
174 | Szpital Wojewodzki im. Mikolaja Kopernika ( Site 0604) | Koszalin | Zachodniopomorskie | Poland | 75-581 |
175 | Altay Regional Oncology Dispensary ( Site 0919) | Barnaul | Altayskiy Kray | Russian Federation | 656045 |
176 | Siberian Clinical Center of FMBA ( Site 0918) | Krasnoyarsk | Krasnoyarskiy Kray | Russian Federation | 660037 |
177 | Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0648) | Krasnoyarsk | Krasnoyarskiy Kray | Russian Federation | 660133 |
178 | Blokhin National Medical Oncology ( Site 0645) | Moscow | Moskva | Russian Federation | 115478 |
179 | City Clinical Hospital 1 na. NI. Pirogov ( Site 0662) | Moscow | Moskva | Russian Federation | 119049 |
180 | First Moscow State Medical University n.a. I.M.Sechenov ( Site 0661) | Moscow | Moskva | Russian Federation | 119881 |
181 | Hadassah Medical-Clinical Research Department ( Site 0920) | Moscow | Moskva | Russian Federation | 121205 |
182 | National Medical Research Radiological Centre ( Site 0660) | Moscow | Moskva | Russian Federation | 125284 |
183 | Privolzhsky District Medical Center ( Site 0655) | Nizhniy Novgorod | Nizhegorodskaya Oblast | Russian Federation | 603109 |
184 | Samara Regional Clinical Oncology Center ( Site 0656) | Samara | Samarskaya Oblast | Russian Federation | 443031 |
185 | Road Hospital JSC Russian railways ( Site 0649) | Saint Petersburg | Sankt-Peterburg | Russian Federation | 195271 |
186 | Russian Scientific Center of Radiology and Surgical Technologies ( Site 0665) | Saint Petersburg | Sankt-Peterburg | Russian Federation | 197758 |
187 | City Clinical Oncology Center ( Site 0646) | Saint Petersburg | Sankt-Peterburg | Russian Federation | 198255 |
188 | Tomsk Scientific Research Institute of Oncology ( Site 0657) | Tomsk | Tomskaya Oblast | Russian Federation | 634028 |
189 | Hospital Central de Asturias ( Site 0667) | Oviedo | Asturias | Spain | 33011 |
190 | Hospital Universitari Parc Tauli ( Site 0681) | Sabadell | Barcelona | Spain | 08208 |
191 | Hospital Universitario de Donostia ( Site 0671) | San Sebastian | Gipuzkoa | Spain | 20014 |
192 | Complejo Hospitalario Universitario de Santiago ( Site 0668) | Santiago de Compostela | La Coruna | Spain | 15706 |
193 | Hospital Universitario Puerta de Hierro ( Site 0678) | Majadahonda | Madrid | Spain | 28222 |
194 | Hospital Universitari Vall d Hebron ( Site 0674) | Barcelona | Spain | 08035 | |
195 | Hospital General Universitario Gregorio Maranon ( Site 0676) | Madrid | Spain | 28007 | |
196 | Hospital Ramon y Cajal ( Site 0673) | Madrid | Spain | 28034 | |
197 | Hospital Universitario La Paz ( Site 0677) | Madrid | Spain | 28046 | |
198 | Hospital Universitario Virgen del Rocio ( Site 0670) | Sevilla | Spain | 41013 | |
199 | Hospital Universitario Miguel Servet-Gastroenterology ( Site 0682) | Zaragoza | Spain | 50009 | |
200 | Skane University Hospital ( Site 0692) | Malmo | Skane Lan | Sweden | 205 02 |
201 | Karolinska Universitetssjukhuset, Huddinge ( Site 0689) | Stockholm | Stockholms Lan | Sweden | 141 86 |
202 | Norrlands Universitetssjukhus ( Site 0687) | Umea | Vasterbottens Lan | Sweden | 901 85 |
203 | Sahlgrenska Universitetssjukhuset ( Site 0691) | Goteborg | Vastra Gotalands Lan | Sweden | 413 46 |
204 | Universitaetsspital Bern ( Site 0710) | Bern | Aargau | Switzerland | 3010 |
205 | University Hospital Basel ( Site 0709) | Basel | Basel-Stadt | Switzerland | 4056 |
206 | Kantonsspital St. Gallen ( Site 0708) | St. Gallen | Sankt Gallen | Switzerland | 9007 |
207 | CHUV (centre hospitalier universitaire vaudois) ( Site 0712) | Lausanne | Vaud | Switzerland | 1011 |
208 | Kantonsspital Winterthur ( Site 0714) | Winterthur | Zurich | Switzerland | 8401 |
209 | Hopitaux Universitaires de Geneve HUG ( Site 0711) | Geneve | Switzerland | 1211 | |
210 | Universitaetsspital Zurich ( Site 0713) | Zurich | Switzerland | 8091 | |
211 | Chang Gung Medical Foundation. Kaohsiung Branch ( Site 0335) | Kaohsiung | Taiwan | 833 | |
212 | China Medical University Hospital ( Site 0333) | Taichung | Taiwan | 40447 | |
213 | National Cheng Kung University Hospital ( Site 0334) | Tainan | Taiwan | 704 | |
214 | National Taiwan University Hospital ( Site 0330) | Taipei | Taiwan | 100 | |
215 | Taipei Veterans General Hospital ( Site 0331) | Taipei | Taiwan | 112 | |
216 | Chang Gung Medical Foundation. Linkou ( Site 0332) | Taoyuan | Taiwan | 333 | |
217 | Ramathibodi Hospital. ( Site 0352) | Bangkok | Krung Thep Maha Nakhon | Thailand | 10400 |
218 | Siriraj Hospital ( Site 0351) | Bangkok | Krung Thep Maha Nakhon | Thailand | 10700 |
219 | Maharaj Nakorn Chiangmai Hospital ( Site 0353) | Chiang Mai | Thailand | 50200 | |
220 | Srinagarind Hospital ( Site 0354) | Khon Kaen | Thailand | 40002 | |
221 | Namik Kemal Universitesi Tip Fakultesi ( Site 0738) | Tekirdag | Tekirdas | Turkey | 59100 |
222 | Baskent Unv. Adana Uyg. ve Arast. Hastanesi ( Site 0733) | Adana | Turkey | 01120 | |
223 | Gulhane Egitim ve Arastirma Hastanesi ( Site 0741) | Ankara | Turkey | 06010 | |
224 | Ankara Sehir Hastanesi ( Site 0731) | Ankara | Turkey | 06800 | |
225 | Adnan Menderes University Medical Faculty ( Site 0737) | Aydin | Turkey | 09010 | |
226 | Bezmialem Vakif University School of Medicine ( Site 0732) | Istanbul | Turkey | 34093 | |
227 | Acıbadem Maslak Hastanesi ( Site 0742) | Istanbul | Turkey | 34457 | |
228 | Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 0730) | Istanbul | Turkey | 34722 | |
229 | Dokuz Eylul Universitesi ( Site 0740) | Izmir | Turkey | 35340 | |
230 | Konya Necmettin Erbakan University Medical Faculty ( Site 0736) | Konya | Turkey | 42080 | |
231 | Inonu University Faculty of Medicine ( Site 0729) | Malatya | Turkey | 44280 | |
232 | VM Medical Park Hastanesi ( Site 0739) | Mersin | Turkey | 33440 | |
233 | Regional Clinical Onco Dispensary_ State Medical University ( Site 0782) | Chernivtsi | Chernivetska Oblast | Ukraine | 58000 |
234 | Regional Oncology Center of Kharkiv ( Site 0777) | Kharkiv | Kharkivska Oblast | Ukraine | 61000 |
235 | National Cancer Institute of the MoH of Ukraine ( Site 0779) | Kyiv | Kyivska Oblast | Ukraine | 03022 |
236 | Shalimov s NI of Surgery and Transplantation ( Site 0781) | Kyiv | Kyivska Oblast | Ukraine | 03126 |
237 | MI Odessa Regional Oncological Centre ( Site 0776) | Odesa | Odeska Oblast | Ukraine | 65055 |
238 | CI City Clinical Hospital # 3 ( Site 0783) | Zaporizhzhia | Zaporizka Oblast | Ukraine | 69032 |
239 | Universal Clinic Oberig-Oncology Center ( Site 0786) | Kyiv | Ukraine | 03057 | |
240 | Medical Center Dobrobut Clinic ( Site 0785) | Kyiv | Ukraine | 03151 | |
241 | Cambridge University Hospitals NHS Trust ( Site 0755) | Cambridge | Cambridgeshire | United Kingdom | CB2 0QQ |
242 | Weston Park Hospital ( Site 0753) | Sheffield | Derbyshire | United Kingdom | S10 2SJ |
243 | The Beatson West of Scotland Cancer Centre ( Site 0750) | Glasgow | Glasgow City | United Kingdom | G12 0YN |
244 | Kings College Hospital NHS Foundation Trust ( Site 0758) | London | London, City Of | United Kingdom | SE5 9RS |
245 | Belfast City Hospital ( Site 0752) | Belfast | Northern Ireland | United Kingdom | BT9 7AB |
246 | The Clatterbridge Cancer Centre NHS Foundation Trust ( Site 0757) | Birkenhead | Wirral | United Kingdom | CH63 4JY |
247 | University Hospital Coventry and Warwickshire NHS Trust ( Site 0754) | Coventry | United Kingdom | CV3 2DX | |
248 | Leeds Teaching Hospitals NHS Trust ( Site 0751) | Leeds | United Kingdom | LS9 7TF | |
249 | Nottingham University Hospitals NHS Trust ( Site 0756) | Nottingham | United Kingdom | NG5 1PB |
Sponsors and Collaborators
- Merck Sharp & Dohme LLC
Investigators
- Study Director: Medical Director, Merck Sharp & Dohme LLC
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 3475-937
- MK-3475-937
- KEYNOTE-937
- 194786
- 2018-004800-20