Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy for Advanced HER2-positive Biliary Tract Cancer

PHASE3RecruitingINTERVENTIONAL
Enrollment

286

Participants

Timeline

Start Date

July 19, 2024

Primary Completion Date

December 1, 2028

Study Completion Date

April 1, 2030

Conditions
Biliary Tract Cancer
Interventions
DRUG

Zanidatamab

Administered intravenously (IV)

DRUG

Cisplatin

Administered intravenously (IV)

DRUG

Gemcitabine

Administered intravenously (IV)

DRUG

Pembrolizumab

Administered intravenously (IV)

DRUG

Durvalumab

Administered intravenously (IV)

Trial Locations (183)

106

RECRUITING

National Taiwan University Cancer Center, Taipei

180

RECRUITING

Docrates Cancer Center, Helsinki

290

RECRUITING

Comprehensive Cancer Center, Helsinki University Hospital, Helsinki

333

RECRUITING

Chang Gung Memorial Hospital Linkou Branch of the Chang Gung Medical Foundation, Taoyuan District

704

RECRUITING

National Cheng Kung University Hospital, Tainan City

807

RECRUITING

Kaohsiung Medical University - Chung-Ho Memorial Hospital, Kaohsiung City

833

RECRUITING

Chang Gung Memorial Hospital Kaohsiung Branch of the Chang Gung Medical Foundation, Kaohsiung City

935

RECRUITING

Hospital Oncologico, Puerto Rico Medical Center, Rio Piedras

2000

RECRUITING

Hospital Provincial Del Centenario, Rosario

2650

RECRUITING

UZ Antwerpen, Edegem

2820

RECRUITING

Imelda VZW, Bonheiden

2841

RECRUITING

Korea University Anam Hospital, Seoul

3000

RECRUITING

UZ Leuven, Leuven

3080

RECRUITING

Seoul National University Hospital, Seoul

3722

RECRUITING

Severance Hospital, Yonsei University Health System, Seoul

4000

RECRUITING

CAIPO Centro para la Atención Integral del Paciente Oncológico, San Miguel de Tucumán

RECRUITING

Centro Médico en Oncología Clínica EXELSUS S.R.L, San Miguel de Tucumán

4600

RECRUITING

Fundación ARS Médica, San Salvador de Jujuy

4763

WITHDRAWN

Hanyang University Seoul Hospital, Seoul

5505

RECRUITING

Asan Medical Center, Seoul

6351

RECRUITING

Samsung Medical Center, Seoul

8035

RECRUITING

Vall d'Hebron Institute of Oncology/Hospital Universitari de Vall d'Hebron, Barcelona

8308

RECRUITING

Korea University Guro Hospital, Seoul

9042

RECRUITING

Azienda Ospedaliero Universitaria di Cagliari Presidio Ospedaliero Duilio Casula, Monserrato

10016

RECRUITING

Laura and Isaac Perlmutter Cancer Center at NYU Langone - Ambulatory Care Center, New York

10022

RECRUITING

Memorial Sloan Kettering Cancer Centers, New York

10060

RECRUITING

Instituo di Candiolo, Fondazione del Piemonte per l'Oncologia (IRCCS), Candiolo

10408

RECRUITING

National Cancer Center, Ilsandong-gu, Goyang-si

11000

RECRUITING

University Clinical Center of Serbia, Clinic for Gastroenterohepatology, Belgrade

11040

RECRUITING

Military Medical Academy, Clinic for Gastroenterology and Hepatology, Belgrade

13353

RECRUITING

Charité - Universitätsmedizin Berlin - Campus Virchow Klinikum, Medizinische Klinik mit Schwerpunkt Hamatologie und Tumorimmunologie, Berlin

13496

RECRUITING

CHA Bundang Medical Center, CHA University, Bundang-Gu, Seongnam-Si

13620

RECRUITING

Seoul National University Bundang Hospital, Seongnam-si

14004

RECRUITING

Hospital Universitario Reina Sofia, Córdoba

14186

RECRUITING

Cancerstudieenheten Huddinge, Karolinska Universitetssjukhuset Huddinge, Huddinge

15706

RECRUITING

Complejo Hospitalario Universitario de Santiago -Hospital Clinico Universitario de Santiago, Santiago de Compostela

16132

RECRUITING

IRCCS Ospedale Policlinico San Martino, Genova

20089

RECRUITING

Istituto Clinico Humanitas, Rozzano

20133

RECRUITING

Fondazione IRCCS Istituto Nazionale per lo studio e la cura dei Tumori, Milan

21204

RECRUITING

Oncology Institute of Vojvodina, Internal Oncology Clinic, Kamenitz

22030

RECRUITING

Trakya University Faculty of Medicine, Edirne

22328

RECRUITING

Institutul Clinic Fundeni, Bucharest

22763

RECRUITING

Asklepios Tumorzentrum Hamburg, Asklepios Klinik Altona - Onkologie und Palliativmedizin mit Sektionen Hamatologie und Rheumatologie, Hamburg

23219

RECRUITING

Virginia Commonwealth University, VCU Health, Richmond

23562

RECRUITING

Universitätsklinikum Schleswig-Holstein - Campus Lübeck, Medizinische Klinik I (MKI), Lübeck

25030

RECRUITING

CHU Besancon, Besançon

28040

RECRUITING

Hospital Universitario Fundacion Jimenez Diaz, Madrid

28041

RECRUITING

Hospital Universitario 12 de Octubre, Madrid

28048

RECRUITING

Hospital Universitario La Paz, Madrid

29010

RECRUITING

Hospital Regional Universitario de Malaga, Málaga

29200

RECRUITING

CHU Brest Hôpital de la Cavale Blanche, Brest

29607

RECRUITING

Saint Francis Cancer Center, Greenville

30322

RECRUITING

Winship Cancer Institute, Atlanta

30625

RECRUITING

Medizinische Hochschule Hannover - Klinik Fur Gastroenterologie, Hepatologie, Infektiologie und Endokrinologie, Hanover

31008

RECRUITING

Clinica Universidad de Navarra, Pamplona

31059

RECRUITING

CHU de Toulouse- (Toulouse University Hospital Center), Toulouse

32804

RECRUITING

AdventHealth Hematology and Oncology, Orlando

33100

RECRUITING

Azienda Sanitaria Universitaria Friuli Centrale - P.O. S. Maria della Misericordia, Udine

33604

RECRUITING

CHU de Bordeaux - Hôpital Haut Leveque, Pessac

34000

RECRUITING

CHU Montepellier - Hôpital Saint Eloi, Montpellier

34096

RECRUITING

Istanbul University Cerrahpasa Medical Faculty Hospital/Clinical Research Center, Istanbul

35128

RECRUITING

Veneto Institute of Oncology IOV - I.R.C.C.S., Padua

37134

RECRUITING

Azienda Ospedaliera Universitaria Integrata Verona, Verona

37203

RECRUITING

SCRI Oncology Partners, Nashville

40217

RECRUITING

Norton Cancer Institute - Audubon, Louisville

41009

RECRUITING

Hospital Universitario Virgen Macarena, Seville

44805

RECRUITING

Institut de Cancérologie de l'Ouest, Saint-Herblain

46026

RECRUITING

Hospital Universitario y Politecnico La Fe, Valencia

48109

RECRUITING

University of Michigan Hospital, Ann Arbor

48202

RECRUITING

Henry Ford Health System, Detroit

49100

RECRUITING

Rabin Medical Center, Bellinson Hospital, Petah Tikva

49241

RECRUITING

Pusan National University Hospital, Busan

50005

RECRUITING

Fakultni nemocnice Hradec Kralove, Klinika onkologie a radioterapie, Hradec Králové

50009

RECRUITING

Hospital Universitario Miguel Servet, Zaragoza

55369

RECRUITING

Minnesota Oncology Hematology, P.A., Maple Grove

56126

RECRUITING

Azienda Ospedaliero - Universitaria Pisana, Pisa

60488

RECRUITING

Krankenhaus Nordwest - Institut für Klinisch-Onkologische Forschung (IFK), Frankfurt am Main

63100

RECRUITING

CHU Estaing, Clermont-Ferrand

66205

RECRUITING

The University of Kansas Cancer Center - Westwood, Westwood

69120

RECRUITING

Nationales Centrum für Tumorerkrankungen (NCT) Heidelberg, Heidelberg

70029

RECRUITING

Kuopio University Hospital, Kuopio

70121

RECRUITING

Ochsner Clinic Foundation, New Orleans

72076

RECRUITING

Universitätsklinikum Tübingen - Medizinische Universitätsklinik, Innere Medizin I, Tübingen

75246

RECRUITING

Texas Oncology - DFW, Dallas

75390

RECRUITING

University of Texas Southwestern Medical Center, Dallas

77030

RECRUITING

The Univerrsity of Texas MD Anderson Cancer Center, Houston

79106

RECRUITING

Universitätsklinikum Freiburg - Klinik für Innere Medizin II,, Freiburg im Breisgau

80124

RECRUITING

Rocky Mountain Cancer Centers, LLP, Lone Tree

80131

RECRUITING

AOU dell'Universit~ degli Studi della Campania Luigi Vanvitelli, Napoli

81377

RECRUITING

LMU Universitätsklinikum München, Campus Großhadern, Medizinische Klinik und Poliklinik III - Hämatologie und Onkologie, München

86000

RECRUITING

CHU Poitiers, Poitiers

91010

RECRUITING

City of Hope(City of Hope National Medical Center, City of Hope Medical Center), Duarte

91120

RECRUITING

The Hadassah University Medical Center, Ein Kerem Hospital, Jerusalem

92110

RECRUITING

Hospital Beaujon University, Clichy

94010

RECRUITING

Hopital Henri Mondor, Créteil

94805

RECRUITING

Gustave Roussy, Villejuif

100142

RECRUITING

Beijing Cancer Hospital, Beijing

110017

RECRUITING

Max Super Speciality Hospital - Saket (a unit of Devki Devi foundation), New Delhi

110085

RECRUITING

Rajiv Gandhi Cancer Institute And Research Centre, New Delhi

130000

RECRUITING

Jilin Cancer Hospital, Changchun

150086

RECRUITING

Harbin Medical University Cancer Hospital, Harbin

200032

RECRUITING

Zhongshan Hospital Fudan University, Shanghai

200542

RECRUITING

"Centrul De Oncologie SF. Nectarie S.R.L.", Craiova

221005

RECRUITING

Mahamana Pandit Madan Mohan Malviya Cancer Centre, Varanasi

230036

RECRUITING

The First Affiliated Hospital of USTC(Anhui Provincial Hospital), Hefei

250000

RECRUITING

Shandong Provincial Third Hospital, Jinan

410016

RECRUITING

Hunan Provincial People's Hospital, Changsha

410169

RECRUITING

Spital Clinic Judetean de Urgenta Bihor, Oradea

422005

RECRUITING

Chopda Medicare & Research Centre Pvt. Ltd - Magnum Heart Institute, Nashik

500032

RECRUITING

AIG Hospitals (A Unit of Asian Institute of Gastroenterology), Hyderabad

RECRUITING

Pi Health Cancer Hospital, Hyderabad

590010

RECRUITING

KLES Dr Prabhakar Kore Hospital and Medical Research Centre, Belagavi

610041

RECRUITING

Sichuan Cancer Hospital, Chengdu

RECRUITING

West China Hospital Sichuan University, Chengdu

700106

RECRUITING

Centrul de Oncologie Euroclinic SRL, Iași

730000

RECRUITING

The First Hospital of Lanzhou University, Lanzhou

2820000

RECRUITING

Servicios Médicos URUMED SpA, Rancagua

3109601

RECRUITING

Rambam Health Care Campus, Haifa

4000012

RECRUITING

Tata Memorial Hospital, Mumbai

4800827

RECRUITING

James Lind Centro de Investigacion del Cancer, Temuco

5265601

RECRUITING

The Chaim Sheba Medical Center, Tel Hashomer, Ramat Gan, HaMerkaz

5507642

RECRUITING

Clinica Puerto Montt, Port Montt

6423906

RECRUITING

Tel Aviv Sourasky Medical Center (Ichilov), Tel Aviv

7500859

RECRUITING

Centro de Investigacion y Especialidades Medicas (CDIEM), Santiago

7500921

RECRUITING

Fundación Arturo López Pérez (FALP), Santiago

7500994

RECRUITING

Oncovida, Santiago

8320000

RECRUITING

Biocinetic Ltda, Santiago

8380494

RECRUITING

Hospital Clinico Universidad de Chile, Santiago

9208641

RECRUITING

Kanazawa University Hospital, Kanazawa

02111

RECRUITING

Tufts Medical Center, Boston

07960

RECRUITING

Atlantic Health System/Morristown Medical Center, Morristown

C1199ABB

RECRUITING

Hospital Italiano de Buenos Aires, Ciudad Autónoma de Buenos Aires (caba)

R8500ACE

RECRUITING

Centro de Investigaciónes Clínicas - Clínica Viedma, Viedma

S2013DTC

RECRUITING

Instituto Médico de la Fundación Estudios Clínicos, Rosario

X5008HHW

RECRUITING

Centro Médico Privado CEMAIC, Córdoba

59062-000

RECRUITING

Liga Norte Riograndense Contra O Cancer, Natal

90035-903

RECRUITING

Hospital de Clinicas de Porto Alegre - HCPA, Porto Alegre

90020-170

RECRUITING

Irmandade Da Santa Casa de Misericordia de Porto Alegre - ISCMPA, Porto Alegrev

14.784-400

RECRUITING

Fundação Pio XII Hospital de Amor de Barretos, Barretos

17210-080

RECRUITING

Fundação Doutor Amaral Carvalho - Hospital Amaral Carvalho, Jaú

15090-000

RECRUITING

Fundação Faculdade Regional de Medicina de São José do Rio Preto (FUNFARME), São José do Rio Preto

91350-200

RECRUITING

Hospital Nossa Senhora Da Conceição/Centro Integrado de Pesquisa em Oncologia CIPO-GHC, Porto Alegre

20230-130

RECRUITING

Instituto Nacional de Cancer - INCA, Rio de Janeiro

NGA 5W9

RECRUITING

London Health Sciences Centre, London

M5G 2M9

RECRUITING

Princess Margaret Cancer Centre - University Health Network, Toronto

H2X 0C1

RECRUITING

Centre Hospitalier de l'Universite de Montreal (CHUM), Montreal

625 00

RECRUITING

Fakultní nemocnice Brno, Interní hematologická a onkologická klinika, Brno

150 00

RECRUITING

Fakultni nemocnice v Motole, Onkologicka klinika, Prague

01307

RECRUITING

Technische Universität Dresden Medizinische Fakultät Carl Gustav Carus, Dresden

00168

RECRUITING

Fondazione Policlinico Universitario Gemelli-IRCCS, Roma

464-8681

RECRUITING

Aichi Cancer Center, Nagoya

260-8717

RECRUITING

Chiba Cancer Center, Chiba

277-8577

RECRUITING

National Cancer Center Hospital East, Kashiwa

791-0280

RECRUITING

National Hospital Organization Shikoku Cancer Center, Matsuyama

811-1395

RECRUITING

National Hospital Organization Kyushu Cancer Center, Fukuoka

060-8648

RECRUITING

Hokkaido University Hospital, Sapporo

890-8520

RECRUITING

Kagoshima University Hospital, Kagoshima

241-8515

RECRUITING

Kanagawa Cancer Center, Yokohama

606-8507

RECRUITING

Kyoto University Hospital, Kyoto

514-8507

RECRUITING

Mie University Hospital, Tsu

980-8574

RECRUITING

Tohoku University Hospital, Sendai

951-8520

RECRUITING

Niigata University Medical and Dental Hospital, Niigata

541-8567

RECRUITING

Osaka Prefectural Hospital Organization Osaka International Cancer Institute, Osaka

113-8655

RECRUITING

The University of Tokyo Hospital, Bunkyo-ku

104-0045

RECRUITING

National Cancer Center Hospital, Chuo-Ku

135-8550

RECRUITING

The Cancer Institute Hospital of Japanese Foundation For Cancer Research, Koto-Ku

181-8611

RECRUITING

Kyorin University Hospital, Mitaka-shi

755-8505

RECRUITING

Yamaguchi University Hospital, Ube-Shi

565-0871

RECRUITING

Osaka University Hospital, Suita-Shi

2805-267

RECRUITING

Unidade Local de Saude de Almada-Seixal, E.P.E. - Hospital Garcia de Orta, Almada

3004-561

RECRUITING

Unidade Local de Saude de Coimbra, EPE - Hospitais da Universidade de Coimbra, Coimbra

1150-314

RECRUITING

Unidade Local de Saúde de São José - Hospital de Santo António dos Capuchos, Lisbon

1400-038

RECRUITING

Champalimaud Clinical Center, Lisbon

4200-072

RECRUITING

Instituto Português de Oncologia Do Porto Francisco Gentil, EPE, Porto

413 45

RECRUITING

Onkologiska mottagningen, Sahlgrenska Universitetssjukhuset, Gothenburg

205 02

RECRUITING

Onkologiska mottagningen, Skånes Universitetssjukhus Malmö, Malmo

06230

RECRUITING

Hacettepe University Cancer Institute, Ankara

07070

RECRUITING

Akdeniz University Medical Faculty Hospital, Antalya

HA 6 2RN

RECRUITING

Mount Vernon Cancer Centre, London

SW3 6JJ

RECRUITING

NHS Foundation Trust Royal Marsden Hospital, London

M20 4BX

RECRUITING

The Christie NHS Foundation Trust, Manchester

SM2 5PT

RECRUITING

Royal Marsden Hospital NHS Foundation Trust, Surrey

EH4 2XU

RECRUITING

Western General Hospital, Edinburgh Cancer Centre, Edinburgh

Sponsors
All Listed Sponsors
lead

Jazz Pharmaceuticals

INDUSTRY