JOURNAL ONKOLOGIE – STUDIE
Safety and Efficacy of Lenvatinib (E7080/MK-7902) With Pembrolizumab (MK-3475) in Combination With Transarterial Chemoembolization (TACE) in Participants With Incurable/Non-metastatic Hepatocellular Carcinoma (MK-7902-012/E7080-G000-318/LEAP-012)
Rekrutierend
NCT-Nummer:
NCT04246177
Studienbeginn:
Mai 2020
Letztes Update:
22.01.2021
Wirkstoff:
Lenvatinib, Pembrolizumab, Oral Placebo, IV Placebo
Indikation (Clinical Trials):
Carcinoma, Carcinoma, Hepatocellular
Geschlecht:
Alle
Altersgruppe:
Erwachsene (18+)
Phase:
Phase 3
Sponsor:
Merck Sharp & Dohme Corp.
Collaborator:
Eisai Inc.
Studienleiter
Study Director
Merck Sharp & Dohme Corp.
Kontakt
Kontakt:
Phone: 1-888-577-8839
E-Mail: Trialsites@merck.com» Kontaktdaten anzeigen
Studienlocations (3 von 133)
Krankenhaus Nord-West GmbH ( Site 0208)
60488 Frankfurt am Main
(Hessen)
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Phone: +496976014187» Ansprechpartner anzeigenArizona Oncology Associates PC- HOPE ( Site 0770)
85711 Tucson
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90033 Los Angeles
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Study Coordinator
Phone: 323-865-3000» Ansprechpartner anzeigen
60488 Frankfurt am Main
(Hessen)
GermanyRekrutierend» Google-Maps
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Phone: +496976014187» Ansprechpartner anzeigenArizona Oncology Associates PC- HOPE ( Site 0770)
85711 Tucson
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90033 Los Angeles
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UCLA Hematology/Oncology - Santa Monica ( Site 0720)
90404 Los Angeles
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92868 Orange
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33606 Tampa
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Ansprechpartner:
Study Coordinator
Phone: +34911916025» Ansprechpartner anzeigenHospital General Universitario de Valencia ( Site 0595)
46014 Valencia
SpainRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +34685738410» Ansprechpartner anzeigenHospital General Universitario Gregorio Maranon ( Site 0598)
28007 Madrid
SpainRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +34915868308» Ansprechpartner anzeigenHospital Ramon y Cajal ( Site 0593)
28034 Madrid
SpainRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +34913368589» Ansprechpartner anzeigenHospital Clinico San Carlos ( Site 0597)
28040 Madrid
SpainRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +349133030007545» Ansprechpartner anzeigenHospital Virgen del Rocio ( Site 0591)
41013 Sevilla
SpainRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +34955012065» Ansprechpartner anzeigenNational Cheng Kung University Hospital ( Site 0608)
70457 Tainan
TaiwanRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: 886623535353587» Ansprechpartner anzeigenChang Gung Medical Foundation. Kaohsiung Branch ( Site 0609)
833 Kaohsiung City
TaiwanRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +88677317123» Ansprechpartner anzeigenNational Taiwan University Hospital ( Site 0606)
10002 Taipei
TaiwanRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: 886223123456» Ansprechpartner anzeigenChang Gung Medical Foundation. Linkou ( Site 0607)
333 Taoyuan
TaiwanRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: 88633281200 x3366» Ansprechpartner anzeigenChulalongkorn University ( Site 0627)
10330 Bangkok
ThailandRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +6622564533» Ansprechpartner anzeigenFaculty of Medicine Siriraj Hospital ( Site 0629)
10700 Bangkok
ThailandRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +6624194488» Ansprechpartner anzeigenKonya Necmettin Erbakan University Medical Faculty ( Site 0652)
42080 Konya
TurkeyRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +905322679838» Ansprechpartner anzeigenHacettepe University Medical Faculty ( Site 0653)
06230 Ankara
TurkeyRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +903123052910» Ansprechpartner anzeigenTrakya University Medical Faculty Balkan Oncology Hospital ( Site 0648)
22030 Edirne
TurkeyRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +905322480988» Ansprechpartner anzeigenEge University Medical Faculty Tulay Aktas Oncology Hospital ( Site 0654)
35100 Izmir
TurkeyRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +902323903911» Ansprechpartner anzeigenIzmir Medical Park Hospital Department of Medical Oncology ( Site 0649)
35520 Izmir
TurkeyRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +905052642353» Ansprechpartner anzeigenInonu Universitesi Medical Fakultesi ( Site 0650)
44280 Malatya
TurkeyRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +905326441884» Ansprechpartner anzeigenGrigoriev Institute for medical Radiology NAMS of Ukraine ( Site 0673)
61024 Kharkiv
UkraineRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +380675970506» Ansprechpartner anzeigenCommunal non profit enterprise Regional Clinical Oncology Center ( Site 0669)
61070 Kharkiv
UkraineRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +380503439026» Ansprechpartner anzeigenShalimov s NI of Surgery and Transplantation ( Site 0671)
03126 Kyiv
UkraineRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +380939720596» Ansprechpartner anzeigen
Alle anzeigen 90404 Los Angeles
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: (310) 633-8400 x 20126» Ansprechpartner anzeigenUC Irvine Health ( Site 0718)
92868 Orange
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: 714-509-2450» Ansprechpartner anzeigenTampa General Hospital ( Site 0764)
33606 Tampa
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: 813-844-2673» Ansprechpartner anzeigenMountain States Tumor Institute ( Site 0773)
83712 Boise
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: 208-381-2711» Ansprechpartner anzeigenUniversity of Iowa Hospital and Clinics ( Site 0729)
52242 Iowa City
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: 319-335-3500» Ansprechpartner anzeigenUniversity of Kansas Cancer Center ( Site 0731)
66205 Westwood
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: 913-588-5000» Ansprechpartner anzeigenUniversity of Louisville ( Site 0757)
40202 Louisville
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: 502-562-4673» Ansprechpartner anzeigenTulane Medical Center ( Site 0787)
70112 New Orleans
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: 504-988-3047» Ansprechpartner anzeigenUniversity Medical Center New Orleans ( Site 0733)
70112 New Orleans
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: 504-702-3141» Ansprechpartner anzeigenHenry Ford Health System ( Site 0735)
48202 Detroit
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: 313-916-1973» Ansprechpartner anzeigenWake Forest Baptist Health ( Site 0741)
27157 Winston-Salem
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: 336-713-5440» Ansprechpartner anzeigenUniversity of Cincinnati Medical Center ( Site 0791)
45219 Cincinnati
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: 513-584-7698» Ansprechpartner anzeigenThe Ohio State University Wexner Medical Center ( Site 0759)
43210 Columbus
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: 614-685-2039» Ansprechpartner anzeigenStephenson Cancer Center ( Site 0745)
73104 Oklahoma City
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: 405-271-8001» Ansprechpartner anzeigenOHSU Center for Health & Healing ( Site 0746)
97239 Portland
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: 503-494-1080» Ansprechpartner anzeigenPenn State Hershey Medical Center ( Site 0766)
17033 Hershey
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: 717-531-4300» Ansprechpartner anzeigenHouston Methodist Research Institute ( Site 0784)
77030 Houston
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: 713-441-6232» Ansprechpartner anzeigenSt George Hospital ( Site 0005)
2217 Kogarah
AustraliaRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +61291131487» Ansprechpartner anzeigenPrincess Alexandra Hospital ( Site 0006)
4102 Brisbane
AustraliaRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +61731762111» Ansprechpartner anzeigenAustin Health ( Site 0008)
3084 Heidelberg
AustraliaRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +61394963577» Ansprechpartner anzeigenAlfred Health ( Site 0004)
3004 Melbourne
AustraliaRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +61439633775» Ansprechpartner anzeigenRoyal Perth Hospital ( Site 0002)
6000 Perth
AustraliaRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +612892242179» Ansprechpartner anzeigenClinica de Oncologia Reichow ( Site 0052)
89010-340 Blumenau
BrazilRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +554733805890» Ansprechpartner anzeigenReal e Benemerita Associacao Portuguesa de Beneficencia ( Site 0046)
01323-900 Sao Paulo
BrazilRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +551135056829» Ansprechpartner anzeigenSociedad de Investigaciones Medicas Limitadas ( Site 0064)
4810469 Temuco
ChileRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +56994443272» Ansprechpartner anzeigenCentro de Cancer Nuestra Senora de la Esperanza ( Site 0065)
8330024 Santiago
ChileRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +56991612199» Ansprechpartner anzeigenBradford Hill Centro de Investigaciones Clinicas ( Site 0066)
8420383 Santiago
ChileRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +56224076288» Ansprechpartner anzeigenAnhui Provincial Hospital ( Site 0092)
230001 Heifei
ChinaRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +8613855168588» Ansprechpartner anzeigenBeijing Cancer Hospital ( Site 0099)
100142 Beijing
ChinaRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +8613911501185» Ansprechpartner anzeigenBeijing Cancer Hospital ( Site 0105)
100142 Beijing
ChinaRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +8613501146178» Ansprechpartner anzeigenPeking Union Medical College Hospital ( Site 0087)
100730 Beijing
ChinaRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +8613901246374» Ansprechpartner anzeigenMengchao Hepatobiliary Hospital of Fujian Medical University ( Site 0121)
350001 Fuzhou
ChinaRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: 13899812351» Ansprechpartner anzeigenFujian Provincial Cancer Hospital ( Site 0085)
350014 Fuzhou
ChinaRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: 8613850171973» Ansprechpartner anzeigenThe First Affiliated Hospital of Fujian Medical University ( Site 0089)
350014 Fuzhou
ChinaRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +8613950233535» Ansprechpartner anzeigenGuangdong Provincial People s Hospital ( Site 0100)
510080 Guangzhou
ChinaRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +8613902497476» Ansprechpartner anzeigenZhujiang Hospital of Southern Medical University ( Site 0115)
510280 Guangzhou
ChinaRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +8618922345399» Ansprechpartner anzeigenNanfang Hospital of Southern Medical University ( Site 0088)
510515 Guangzhou
ChinaRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +862062786845» Ansprechpartner anzeigenHainan General Hospital ( Site 0112)
570311 Haikou
ChinaRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +8613907571082» Ansprechpartner anzeigenHarbin Medical University Cancer Hospital ( Site 0090)
150081 Harbin
ChinaRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +8613945095085» Ansprechpartner anzeigenHenan Cancer Hospital ( Site 0114)
450008 Zhengzhou
ChinaRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +8613903861969» Ansprechpartner anzeigenHubei Cancer Hospital ( Site 0101)
430079 Wuhan
ChinaRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +8602787670003» Ansprechpartner anzeigenHunan Cancer Hospital ( Site 0096)
410006 Changsha
ChinaRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +8673189762510» Ansprechpartner anzeigenHunan Provincial People's Hospital ( Site 0113)
415005 Changsha
ChinaRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +8657382278256» Ansprechpartner anzeigenZhongshan Hospital Fudan University ( Site 0084)
200032 Shanghai
ChinaRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +8613681971302» Ansprechpartner anzeigenThe First Affiliated Hospital of Xi an Jiaotong University ( Site 0108)
710048 XI An
ChinaRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +8613609195898» Ansprechpartner anzeigenWest China Hospital of Sichuan University ( Site 0119)
610041 Chengdu
ChinaRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +8618980606853» Ansprechpartner anzeigenTianjin Medical University Cancer Institute & Hospital ( Site 0098)
300060 Tianjin
ChinaRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +8618622221077» Ansprechpartner anzeigenThe First Hospital of Kunming ( Site 0124)
650200 Kunming
ChinaRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +8615877991051» Ansprechpartner anzeigen2nd Affil Hosp of Zhejiang University College of Medicine ( Site 0110)
310009 Hangzhou
ChinaRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +8613606642087» Ansprechpartner anzeigenSir Run Run Shaw Hospital ( Site 0094)
310018 Hangzhou
ChinaRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +8657186436673» Ansprechpartner anzeigenZhejiang Cancer Hospital ( Site 0103)
310022 Hangzhou
ChinaRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +8613958183472» Ansprechpartner anzeigenAdministradora Country S.A. ( Site 0137)
110221 Bogota
ColombiaRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +57 1 5300470 ext. 2909-2908-1» Ansprechpartner anzeigenFundacion Cardiovascular de Colombia ( Site 0136)
680003 Bucaramanca
ColombiaRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +573215433439» Ansprechpartner anzeigenFundacion Valle del Lili ( Site 0140)
760032 Cali
ColombiaRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +573148883972» Ansprechpartner anzeigenHerlev Hospital ( Site 0170)
2730 Herlev
DenmarkRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +4538683868» Ansprechpartner anzeigenOdense Universitetshospital ( Site 0160)
5000 Odense
DenmarkRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +4566113333» Ansprechpartner anzeigenHopital de la Croix-Rousse ( Site 0193)
69004 Lyon
FranceRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: 33426732716» Ansprechpartner anzeigenHopital de la Timone ( Site 0188)
13005 Marseille
FranceRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +33491388659» Ansprechpartner anzeigenCHU Bordeaux Haut-Leveque Centre Francois Magendie ( Site 0185)
33604 Pessac Cedex
FranceRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: 33557656439» Ansprechpartner anzeigenC.H.U. de Nancy. Hopital de Brabois Adultes ( Site 0180)
54500 Vandoeuvre les Nancy
FranceRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +33383153364» Ansprechpartner anzeigenA.P.H. Paris, Hopital Henri Mondor ( Site 0179)
94000 Creteil
FranceRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +33149812373» Ansprechpartner anzeigenHopital Paul Brousse ( Site 0182)
94800 Villejuif
FranceRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +33142175691» Ansprechpartner anzeigenSemmelweis Egyetem ( Site 0264)
1088 Budapest
HungaryRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +36» Ansprechpartner anzeigenZala Megyei Szent Rafael Korhaz ( Site 0265)
8900 Zalaegerszeg
HungaryRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +36» Ansprechpartner anzeigenHadassah Ein Karem Jerusalem ( Site 0303)
9112001 Jerusaelm
IsraelRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +97226777957» Ansprechpartner anzeigenRambam Medical Center ( Site 0305)
3109601 Haifa
IsraelRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +97247771258» Ansprechpartner anzeigenRabin Medical Center ( Site 0304)
4941492 Petah Tikva
IsraelRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +97239378076» Ansprechpartner anzeigenSourasky Medical Center ( Site 0306)
6423906 Tel Aviv
IsraelRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +97236973082» Ansprechpartner anzeigenPoliclinico Universitario -Agostino Gemelli ( Site 0328)
00168 Roma
ItalyRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +390630156265» Ansprechpartner anzeigenNational Cancer Center Hospital East ( Site 0347)
277-8577 Kashiwa
JapanRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +81-4-7133-1111» Ansprechpartner anzeigenEhime University Hospital ( Site 0368)
791-0295 Toon
JapanRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +81-89-964-5111» Ansprechpartner anzeigenKurume University Hospital ( Site 0362)
830-0011 Kurume
JapanRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +81-942-35-3311» Ansprechpartner anzeigenHokkaido P.W.F.A.C Sapporo-Kosei General Hospital ( Site 0345)
060-0033 Sapporo
JapanRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +81-11-261-5331» Ansprechpartner anzeigenKanazawa University Hospital ( Site 0354)
920-8641 Kanazawa
JapanRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +81-76-265-2000» Ansprechpartner anzeigenKagawa Prefectural Central Hospital ( Site 0364)
760-8557 Takamatsu
JapanRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +81-87-811-3333» Ansprechpartner anzeigenToranomon Hospital Kajigaya ( Site 0369)
213-8587 Kawasaki
JapanRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +81-44-877-5111» Ansprechpartner anzeigenYokohama City University Medical Center ( Site 0351)
232-0024 Yokohama
JapanRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +81-45-261-5656» Ansprechpartner anzeigenKanagawa Cancer Center ( Site 0352)
241-8515 Yokohama
JapanRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +81-45-520-2222» Ansprechpartner anzeigenNara Medical University Hospital ( Site 0359)
634-8522 Kashihara
JapanRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +81-744-22-3051» Ansprechpartner anzeigenKindai University Hospital ( Site 0358)
589-8511 Osakasayama
JapanRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +81-72-366-0221» Ansprechpartner anzeigenShizuoka Cancer Center Hospital and Research Institute ( Site 0365)
411-8777 Sunto-gun
JapanRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +81-55-989-5222» Ansprechpartner anzeigenJichi Medical University Hospital ( Site 0353)
329-0498 Shimotsuke
JapanRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +81-285-44-2111» Ansprechpartner anzeigenChiba University Hospital ( Site 0346)
260-8677 Chiba
JapanRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +81-43-222-7171» Ansprechpartner anzeigenNational Hospital Organization Kyushu Medical Center ( Site 0361)
810-8563 Fukuoka
JapanRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +81-92-852-0700» Ansprechpartner anzeigenHiroshima University Hospital ( Site 0360)
734-8551 Hiroshima
JapanRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +81-82-257-5555» Ansprechpartner anzeigenUniversity Hospital, Kyoto Prefectural University of Medicine ( Site 0367)
602-8566 Kyoto
JapanRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +81-75-251-5111» Ansprechpartner anzeigenOsaka International Cancer Institute ( Site 0357)
541-8567 Osaka
JapanRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +81-6-6945-1181» Ansprechpartner anzeigenJapanese Red Cross Osaka Hospital ( Site 0356)
543-8555 Osaka
JapanRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +81-6-6774-5111» Ansprechpartner anzeigenSaga-Ken Medical Centre Koseikan ( Site 0363)
840-8571 Saga
JapanRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +81-952-24-2171» Ansprechpartner anzeigenToranomon Hospital ( Site 0349)
105-8470 Tokyo
JapanRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +81-3-3588-1111» Ansprechpartner anzeigenThe University of Tokyo Hospital ( Site 0348)
113-8655 Tokyo
JapanRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +81-3-3815-5411» Ansprechpartner anzeigenChonnam National University Hwasun Hospital ( Site 0572)
58128 Hwasun
Korea, Republic ofRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +82 61 379 7604» Ansprechpartner anzeigenSeoul National University Bundang Hospital ( Site 0570)
13620 Seongnam-si
Korea, Republic ofRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +821092649119» Ansprechpartner anzeigenKyungpook National University Hospital ( Site 0569)
41944 Daegu
Korea, Republic ofRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +821026359427» Ansprechpartner anzeigenSeoul National University Hospital ( Site 0567)
03080 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +82220722228» Ansprechpartner anzeigenSeverance Hospital Yonsei University Health System ( Site 0564)
03722 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +82222288138» Ansprechpartner anzeigenAsan Medical Center ( Site 0565)
05505 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +82 2 3010 5812» Ansprechpartner anzeigenSamsung Medical Center ( Site 0566)
06351 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +82234103878» Ansprechpartner anzeigenThe Catholic University of Korea St. Mary s Hospital ( Site 0571)
06591 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +82 2 2258 7533» Ansprechpartner anzeigenKorea University Guro Hospital ( Site 0573)
08308 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +821055415092» Ansprechpartner anzeigenMaastricht University Medical Centre ( Site 0440)
6229 HX Maastricht
NetherlandsRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +31433872001» Ansprechpartner anzeigenErasmus University Medical Center ( Site 0439)
3015 EA Rotterdam
NetherlandsRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +31205662096» Ansprechpartner anzeigenAuckland City Hospital ( Site 0459)
1023 Auckland
New ZealandRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +6493074949» Ansprechpartner anzeigenCentro Hospitalar de Lisboa Central, EPE - Hosp St. Ant dos Capuchos ( Site 0505)
1169-050 Lisboa
PortugalRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +351217924000» Ansprechpartner anzeigenCentro Hospitalar do Porto, E.P.E. - Hospital Geral de Sto. Antonio ( Site 0504)
4099-001 Porto
PortugalRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +351222077500» Ansprechpartner anzeigenAd-Vance Medical Research LLC ( Site 0527)
00717 Ponce
Puerto RicoRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: 7876516697» Ansprechpartner anzeigenPuerto Rico Medical Research Center LLC ( Site 0523)
00918 San Juan
Puerto RicoRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: 7879005661» Ansprechpartner anzeigenVA Caribbean Healthcare System ( Site 0524)
00921-3201 San Juan
Puerto RicoRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: 7876417582X31530» Ansprechpartner anzeigenFundacion de Investigacion de Diego ( Site 0522)
00927 San Juan
Puerto RicoRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +7877221248» Ansprechpartner anzeigenHospital Universitario Puerta de Hierro ( Site 0596)
28222 Majadahonda
SpainRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +34911916025» Ansprechpartner anzeigenHospital General Universitario de Valencia ( Site 0595)
46014 Valencia
SpainRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +34685738410» Ansprechpartner anzeigenHospital General Universitario Gregorio Maranon ( Site 0598)
28007 Madrid
SpainRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +34915868308» Ansprechpartner anzeigenHospital Ramon y Cajal ( Site 0593)
28034 Madrid
SpainRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +34913368589» Ansprechpartner anzeigenHospital Clinico San Carlos ( Site 0597)
28040 Madrid
SpainRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +349133030007545» Ansprechpartner anzeigenHospital Virgen del Rocio ( Site 0591)
41013 Sevilla
SpainRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +34955012065» Ansprechpartner anzeigenNational Cheng Kung University Hospital ( Site 0608)
70457 Tainan
TaiwanRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: 886623535353587» Ansprechpartner anzeigenChang Gung Medical Foundation. Kaohsiung Branch ( Site 0609)
833 Kaohsiung City
TaiwanRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +88677317123» Ansprechpartner anzeigenNational Taiwan University Hospital ( Site 0606)
10002 Taipei
TaiwanRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: 886223123456» Ansprechpartner anzeigenChang Gung Medical Foundation. Linkou ( Site 0607)
333 Taoyuan
TaiwanRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: 88633281200 x3366» Ansprechpartner anzeigenChulalongkorn University ( Site 0627)
10330 Bangkok
ThailandRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +6622564533» Ansprechpartner anzeigenFaculty of Medicine Siriraj Hospital ( Site 0629)
10700 Bangkok
ThailandRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +6624194488» Ansprechpartner anzeigenKonya Necmettin Erbakan University Medical Faculty ( Site 0652)
42080 Konya
TurkeyRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +905322679838» Ansprechpartner anzeigenHacettepe University Medical Faculty ( Site 0653)
06230 Ankara
TurkeyRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +903123052910» Ansprechpartner anzeigenTrakya University Medical Faculty Balkan Oncology Hospital ( Site 0648)
22030 Edirne
TurkeyRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +905322480988» Ansprechpartner anzeigenEge University Medical Faculty Tulay Aktas Oncology Hospital ( Site 0654)
35100 Izmir
TurkeyRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +902323903911» Ansprechpartner anzeigenIzmir Medical Park Hospital Department of Medical Oncology ( Site 0649)
35520 Izmir
TurkeyRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +905052642353» Ansprechpartner anzeigenInonu Universitesi Medical Fakultesi ( Site 0650)
44280 Malatya
TurkeyRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +905326441884» Ansprechpartner anzeigenGrigoriev Institute for medical Radiology NAMS of Ukraine ( Site 0673)
61024 Kharkiv
UkraineRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +380675970506» Ansprechpartner anzeigenCommunal non profit enterprise Regional Clinical Oncology Center ( Site 0669)
61070 Kharkiv
UkraineRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +380503439026» Ansprechpartner anzeigenShalimov s NI of Surgery and Transplantation ( Site 0671)
03126 Kyiv
UkraineRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +380939720596» Ansprechpartner anzeigen
Studien-Informationen
Brief Summary:The purpose of this study is to evaluate the efficacy and safety of lenvatinib and
pembrolizumab in combination with TACE versus TACE plus oral and intravenous (IV) placebos in
participants with incurable, non-metastatic hepatocellular carcinoma (HCC). The primary
hypotheses are that pembrolizumab plus lenvatinib in combination with TACE is superior to
placebo plus TACE with respect to progression-free survival (PFS) and overall survival (OS).
Ein-/Ausschlusskriterien
Inclusion Criteria:- Has a diagnosis of HCC confirmed by radiology, histology, or cytology
- Has HCC localized to the liver and not amenable to curative treatment
- Participants with Hepatitis C virus (HCV) are eligible if treatment was completed at
least 1 month prior to starting study intervention
- Participants with Hepatitis B virus (HBV) are eligible as long as their virus is well
controlled
- Has adequately controlled blood pressure with or without antihypertensive medications
- Has adequate organ function
Exclusion Criteria:
- Is currently a candidate for liver transplantation
- Has had gastric bleeding within the last 6 months
- Has ascites that is not controlled with medication
- Has significant cardiovascular impairment within 12 months of the first dose of study
intervention such as congestive heart failure
- Has a serious nonhealing wound, ulcer, or bone fracture
Studien-Rationale
Primary outcome:1. Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) (Time Frame - Up to ~5 years):
PFS is defined as the time from randomization to the first documented progressive disease or death due to any cause, whichever occurs first. Responses are according to RECIST 1.1 as assessed by blinded independent central review (BICR).
2. Overall Survival (OS) (Time Frame - Up to ~5 years):
OS is defined as the time from randomization to death due to any cause.
Secondary outcome:
1. PFS per Modified Response Evaluation Criteria in Solid Tumors (mRECIST) (Time Frame - Up to ~5 years):
PFS is defined as the time from randomization to the first documented progressive disease or death due to any cause, whichever occurs first. Responses are according to mRECIST as assessed by BICR.
2. Objective Response Rate (ORR) per mRECIST (Time Frame - Up to ~5 years):
ORR is defined as the percentage of participants who have a confirmed complete response (CR: disappearance of any intratumoral arterial enhancement in all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of viable [enhancement in the arterial phase] target lesions, taking as reference the baseline sum of the diameters of target lesions). Responses are according to mRECIST as assessed by BICR.
3. Disease Control Rate (DCR) per mRECIST (Time Frame - Up to ~5 years):
DCR is defined as the percentage of participants who have a best overall response of CR (disappearance of any intratumoral arterial enhancement in all target lesions), PR (at least a 30% decrease in the sum of diameters of viable [enhancement in the arterial phase] target lesions, taking as reference the baseline sum of the diameters of target lesions), or stable disease (SD). Responses are according to mRECIST as assessed by BICR.
4. Duration of Response (DOR) per mRECIST (Time Frame - Up to ~5 years):
DOR is determined by disease assessment and is defined as the time from the first documented evidence of a response of CR (disappearance of any intratumoral arterial enhancement in all target lesions) or PR (at least a 30% decrease in the sum of diameters of viable [enhancement in the arterial phase] target lesions, taking as reference the baseline sum of the diameters of target lesions) until the first documented disease progression or death due to any cause, whichever occurs first. Responses are according to mRECIST as assessed by BICR.
5. Time to Progression (TTP) per mRECIST (Time Frame - Up to ~5 years):
TTP is defined as the time from randomization to the first documented disease progression. Responses are according to mRECIST as assessed by BICR.
6. Percentage of Participants Who Experience At Least One Adverse Event (AE) (Time Frame - Up to ~5 years):
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who experience at least one AE will be reported.
7. Percentage of Participants Who Experience At Least One Serious Adverse Event (SAE) (Time Frame - Up to ~5 years):
An SAE is an AE that results in death, is life threatening, requires or prolongs a hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, is a cancer, is associated with an overdose, or is another important medical event. The percentage of participants who experience at least one SAE will be reported.
8. Percentage of Participants Who Experience At Least One Hepatic Event of Clinical Interest (ECI) (Time Frame - Up to ~5 years):
Percentage of participants with Hepatic ECIs not due to disease progression or TACE as assessed by the investigator will be reported.
9. Percentage of Participants Who Discontinue Study Drug Due to an AE (Time Frame - Up to ~5 years):
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who discontinue study drug due to an AE will be reported.
10. ORR per RESCIST 1.1 (Time Frame - Up to ~5 years):
ORR is defined as the percentage of participants who have a confirmed complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters). Responses are according to RECIST 1.1 as assessed by BICR.
11. DCR per RECIST 1.1 (Time Frame - Up to ~5 years):
DCR is defined as the percentage of participants who have a best overall response of CR (disappearance of all target lesions), PR (at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters), or SD. Responses are according to RECIST 1.1 as assessed by BICR.
12. DOR per RECIST 1.1 (Time Frame - Up to ~5 years):
DOR is determined by disease assessment and is defined as the time from the first documented evidence of a response of CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters) until the first documented disease progression or death due to any cause, whichever occurs first. Responses are according to RECIST 1.1 as assessed by BICR.
13. TTP per RECIST 1.1 (Time Frame - Up to ~5 years):
TTP is defined as the time from randomization to the first documented disease progression. Responses are according to RECIST 1.1 as assessed by BICR.
Studien-Arme
- Experimental: Lenvatinib plus Pembrolizumab plus TACE
Participants will receive a combination of lenvatinib, pembrolizumab, and TACE. Lenvatinib will be administered at a dose of 12 mg (for participants with screening body weight ≥60 kg) or 8 mg (for participants with screening body weight <60 kg) orally once a day during each 21-day cycle until progressive disease or unacceptable toxicity (up to 2 years [~35 cycles] or longer with Sponsor approval). Pembrolizumab will be administered via IV infusion at a dose of 400 mg once every 6 weeks (Q6W) for up to 2 years (~17 doses). Participants will undergo TACE as a background procedure of chemotherapeutic and embolic agent(s). - Active Comparator: Oral Placebo plus IV Placebo plus TACE
Participants will receive a combination of lenvatinib-matching oral placebo, pembrolizumab-matching IV placebo, and TACE. Lenvatinib-matching oral placebo will be administered once a day during each 21-day cycle for up to 2 years (~35 cycles) or longer with Sponsor approval and pembrolizumab-matching IV placebo will be administered once every 6 weeks (Q6W) for up to 2 years (~17 doses). Participants will undergo TACE as a background procedure of chemotherapeutic and embolic agent(s).
Geprüfte Regime
- Lenvatinib (MK-7902 / E7080 / LENVIMA® / ):
Administered at a dose of 12 mg (for participants with screening body weight ≥60 kg) or 8 mg (for participants with screening body weight <60 kg) via oral capsules once a day during each 21-day cycle. - Pembrolizumab (MK-3475 / KEYTRUDA® / ):
Administered via IV infusion at a dose of 400 mg once every 6 weeks (Q6W). - Oral Placebo:
Lenvatinib-matching placebo administered via oral capsules once a day during each 21-day cycle. - IV Placebo:
Pembrolizumab-matching placebo administered via IV infusion once every 6 weeks (Q6W). - TACE:
Conducted as a background procedure of chemotherapeutic and embolic agent(s).
Quelle: ClinicalTrials.gov