Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy for Advanced HER2-positive Biliary Tract Cancer
- Conditions
- Biliary Tract Cancer
- Interventions
- Registration Number
- NCT06282575
- Lead Sponsor
- Jazz Pharmaceuticals
- Brief Summary
The purpose of this study is to evaluate the efficacy and safety of Zanidatamab plus CisGem (Cisplatin and Gemcitabine) with or without the addition of a programmed death protein 1/ligand-1 (PD-1/L1) inhibitor (physician's choice of either Durvalumab or Pembrolizumab, where approved under local regulations) as first line of treatment for participants with human epidermal growth factor receptor 2 (HER2)-positive biliary tract cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 286
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Zanidatamab with Standard-of-care Therapy Arm Zanidatamab Zanidatamab plus standard of care treatment of CisGem with or without a PD-1/L1 inhibitor. PD-1/L1 inhibitor will be physician's choice of either Durvalumab or Pembrolizumab, where approved under local regulations. Zanidatamab with Standard-of-care Therapy Arm Cisplatin Zanidatamab plus standard of care treatment of CisGem with or without a PD-1/L1 inhibitor. PD-1/L1 inhibitor will be physician's choice of either Durvalumab or Pembrolizumab, where approved under local regulations. Zanidatamab with Standard-of-care Therapy Arm Gemcitabine Zanidatamab plus standard of care treatment of CisGem with or without a PD-1/L1 inhibitor. PD-1/L1 inhibitor will be physician's choice of either Durvalumab or Pembrolizumab, where approved under local regulations. Zanidatamab with Standard-of-care Therapy Arm Pembrolizumab Zanidatamab plus standard of care treatment of CisGem with or without a PD-1/L1 inhibitor. PD-1/L1 inhibitor will be physician's choice of either Durvalumab or Pembrolizumab, where approved under local regulations. Zanidatamab with Standard-of-care Therapy Arm Durvalumab Zanidatamab plus standard of care treatment of CisGem with or without a PD-1/L1 inhibitor. PD-1/L1 inhibitor will be physician's choice of either Durvalumab or Pembrolizumab, where approved under local regulations. Standard-of-care Therapy Arm Cisplatin Standard of care treatment of CisGem with or without a PD-1/L1 inhibitor. PD-1/L1 inhibitor will be physician's choice of either Durvalumab or Pembrolizumab, where approved under local regulations. Standard-of-care Therapy Arm Gemcitabine Standard of care treatment of CisGem with or without a PD-1/L1 inhibitor. PD-1/L1 inhibitor will be physician's choice of either Durvalumab or Pembrolizumab, where approved under local regulations. Standard-of-care Therapy Arm Pembrolizumab Standard of care treatment of CisGem with or without a PD-1/L1 inhibitor. PD-1/L1 inhibitor will be physician's choice of either Durvalumab or Pembrolizumab, where approved under local regulations. Standard-of-care Therapy Arm Durvalumab Standard of care treatment of CisGem with or without a PD-1/L1 inhibitor. PD-1/L1 inhibitor will be physician's choice of either Durvalumab or Pembrolizumab, where approved under local regulations.
- Primary Outcome Measures
Name Time Method Progression Free Survival (PFS) in participants with Immunohistochemistry (IHC) 3+ tumors Up to 52 months PFS is defined as the time from the date of randomization to the date of documented disease progression, or death from any cause.
- Secondary Outcome Measures
Name Time Method Number of participants achieving Confirmed objective response rate (cORR) Up to 68 months Confirmed objective response rate is defined as achieving a confirmed best overall response of Complete Response (CR) or Partial Response (PR)
Overall survival (OS) in participants with IHC 3+ tumors Up to 68 months OS is defined as the time from randomization to death, due to any cause.
OS for all participants Up to 68 months OS is defined as the time from randomization to death, due to any cause.
Progression Free Survival for all participants Up to 68 months PFS is defined as the time from the date of randomization to the date of documented disease progression, or death from any cause.
Duration of response (DOR) Up to 68 months Duration of response is defined as the time from the first objective response (CR or PR) to documented Progressive Disease (PD) or death, from any cause.
Number of Patients reporting Treatment-Emergent Adverse Events (TEAE) Up to 68 months Maximum serum concentration of Zanidatamab Up to 68 months Number of participants who develop Anti-drug antibodies (ADAs) to Zanidatamab Up to 68 months TDD for participants with IHC 3+ tumors in patient-reported symptoms scores as measured by the EORTC QLQ-BIL21 (Pain, Jaundice, Abdominal Pain and Pruritis) Up to 68 months TDD is defined as the time from randomization to the first confirmed clinical meaningful deterioration or death. EORTC Quality of Life Questionnaire - Cholangiocarcinoma and Gallbladder Cancer module (QLQ-BIL21) (Pain, Jaundice, Abdominal Pain, and Pruritis) final scores range from 0 to 100, where higher scores reflect better functioning.
TDD for all participants in patient-reported symptoms scores as measured by the EORTC QLQ-BIL21 (Pain, Jaundice, Abdominal Pain, and Pruritis) Up to 68 months TDD is defined as the time from randomization to the first confirmed clinical meaningful deterioration or death. EORTC QLQ-BIL21 (Pain, Jaundice, Abdominal Pain, and Pruritis) final scores range from 0 to 100, where higher scores reflect better functioning.
Time to definitive deterioration (TDD) for participants with IHC 3+ tumors in patient-reported Physical Functioning (PF) domain score as measured by the EORTC QLQ-C30 Up to 68 months TDD is defined as the time from randomization to the first confirmed clinical meaningful deterioration or death. European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) final scores range from 0 to 100, where higher scores reflect better functioning
TDD for all participants in patient-reported PF domain score as measured by the EORTC QLQ-C30 Up to 68 months TDD is defined as the time from randomization to the first confirmed clinical meaningful deterioration or death. EORTC QLQ-C30 final scores range from 0 to 100, where higher scores reflect better functioning.
Trial Locations
- Locations (163)
Champalimaud Clinical Center
🇵🇹Lisboa, Portugal
Instituto Português de Oncologia Do Porto Francisco Gentil, EPE
🇵🇹Porto, Portugal
Centrul de Oncologie Euroclinic SRL
🇷🇴Iasi, Romania
University Clinical Center of Serbia, Clinic for Gastroenterohepatology
🇷🇸Belgrade, Serbia
Rocky Mountain Cancer Centers, LLP
🇺🇸Lone Tree, Colorado, United States
AdventHealth Hematology and Oncology
🇺🇸Orlando, Florida, United States
Winship Cancer Institute
🇺🇸Atlanta, Georgia, United States
The University of Kansas Cancer Center - Westwood
🇺🇸Westwood, Kansas, United States
Norton Cancer Institute - Audubon
🇺🇸Louisville, Kentucky, United States
Ochsner Clinic Foundation
🇺🇸New Orleans, Louisiana, United States
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States
University of Michigan Hospital
🇺🇸Ann Arbor, Michigan, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Minnesota Oncology Hematology, P.A.
🇺🇸Maple Grove, Minnesota, United States
Atlantic Health System/Morristown Medical Center
🇺🇸Morristown, New Jersey, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone - Ambulatory Care Center
🇺🇸New York, New York, United States
Memorial Sloan Kettering Cancer Centers
🇺🇸New York, New York, United States
Saint Francis Cancer Center
🇺🇸Greenville, South Carolina, United States
SCRI Oncology Partners
🇺🇸Nashville, Tennessee, United States
Texas Oncology - DFW
🇺🇸Dallas, Texas, United States
University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States
The Univerrsity of Texas MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Virginia Commonwealth University, VCU Health
🇺🇸Richmond, Virginia, United States
Hospital Italiano de Buenos Aires
🇦🇷Ciudad Autónoma de Buenos Aires (CABA), Buenos Altes, Argentina
Fundación ARS Médica
🇦🇷San Salvador De Jujuy, Jujuy, Argentina
Centro de Investigaciónes Clínicas - Clínica Viedma
🇦🇷Viedma, Río Negro, Argentina
Hospital Provincial Del Centenario
🇦🇷Rosario, Santa Fe, Argentina
Instituto Médico de la Fundación Estudios Clínicos
🇦🇷Rosario, Santa Fe, Argentina
CAIPO Centro para la Atención Integral del Paciente Oncológico
🇦🇷San Miguel De Tucumán, Tucumán, Argentina
Centro Médico en Oncología Clínica EXELSUS S.R.L
🇦🇷San Miguel De Tucumán, Tucumán, Argentina
Centro Médico Privado CEMAIC
🇦🇷Córdoba, Argentina
Imelda VZW
🇧🇪Bonheiden, Antwerpen, Belgium
UZ Antwerpen
🇧🇪Edegem, Antwerpen, Belgium
UZ Leuven
🇧🇪Leuven, Vlaams-Brabant, Belgium
Liga Norte Riograndense Contra O Cancer
🇧🇷Natal, Rio Grande Do Norte, Brazil
Irmandade Da Santa Casa de Misericordia de Porto Alegre - ISCMPA
🇧🇷Porto Alegrev, Rio Grande Do Sul, Brazil
Fundação Pio XII Hospital de Amor de Barretos
🇧🇷Barretos, São Paulo, Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto (FUNFARME)
🇧🇷São José do Rio Preto, São Paulo, Brazil
Hospital Nossa Senhora Da Conceição/Centro Integrado de Pesquisa em Oncologia CIPO-GHC
🇧🇷Porto Alegre, Brazil
London Health Sciences Centre
🇨🇦LondonO, Ontario, Canada
Princess Margaret Cancer Centre - University Health Network
🇨🇦Toronto, Ontario, Canada
James Lind Centro de Investigacion del Cancer
🇨🇱Temuco, Araucanía, Chile
Servicios Médicos URUMED SpA
🇨🇱Rancagua, Libertador Gen Bernardo O Higgins, Chile
Clinica Puerto Montt
🇨🇱Puerto Montt, Los Lagos, Chile
Fundación Arturo López Pérez (FALP)
🇨🇱Santiago, Metropolitana, Chile
Oncovida
🇨🇱Santiago, Metropolitana, Chile
Hospital Clinico Universidad de Chile
🇨🇱Santiago, Region Metropolitana, Chile
Centro de Investigacion y Especialidades Medicas (CDIEM)
🇨🇱Santiago, Región-Metropolitana, Chile
Biocinetic Ltda
🇨🇱Santiago, Región-Metropolitana, Chile
Fakultní nemocnice Brno, Interní hematologická a onkologická klinika
🇨🇿Brno, Czechia
Fakultni nemocnice Hradec Kralove, Klinika onkologie a radioterapie
🇨🇿Hradec Kralove, Czechia
Fakultni nemocnice v Motole, Onkologicka klinika
🇨🇿Praha 5, Czechia
Docrates Cancer Center
🇫🇮Helsinki, Finland
Comprehensive Cancer Center, Helsinki University Hospital
🇫🇮Helsinki, Finland
Kuopio University Hospital
🇫🇮Kuopio, Finland
CHU de Toulouse- (Toulouse University Hospital Center)
🇫🇷Toulouse, Cedex 9, France
CHU Besancon
🇫🇷Besançon, Cedex, France
CHU de Bordeaux - Hôpital Haut Leveque
🇫🇷Pessac, Cedex, France
CHU Brest Hôpital de la Cavale Blanche
🇫🇷Brest, France
CHU Estaing
🇫🇷Clermont-Ferrand, France
Hospital Beaujon University
🇫🇷Clichy, France
Hopital Henri Mondor
🇫🇷Créteil, France
CHU Montepellier - Hôpital Saint Eloi
🇫🇷Montpellier, France
CHU Poitiers
🇫🇷Poitiers, France
Institut de Cancérologie de l'Ouest
🇫🇷Saint-Herblain Cedex, France
Gustave Roussy
🇫🇷Villejuif Cedex, France
Universitätsklinikum Tübingen - Medizinische Universitätsklinik, Innere Medizin I
🇩🇪Tuebingen, Baden-Wuttemberg, Germany
Nationales Centrum für Tumorerkrankungen (NCT) Heidelberg
🇩🇪Heidelberg, Baden-Württemberg, Germany
LMU Universitätsklinikum München, Campus Großhadern, Medizinische Klinik und Poliklinik III - Hämatologie und Onkologie
🇩🇪München, Bayern, Germany
Krankenhaus Nordwest - Institut für Klinisch-Onkologische Forschung (IFK)
🇩🇪Frankfurt, Hessen, Germany
Medizinische Hochschule Hannover - Klinik Fur Gastroenterologie, Hepatologie, Infektiologie und Endokrinologie
🇩🇪Hannover, Nieder-Sachsen, Germany
Universitätsklinikum Schleswig-Holstein - Campus Lübeck, Medizinische Klinik I (MKI)
🇩🇪Lubeck, Schleswig-Holstein, Germany
Charité - Universitätsmedizin Berlin - Campus Virchow Klinikum, Medizinische Klinik mit Schwerpunkt Hamatologie und Tumorimmunologie
🇩🇪Berlin, Germany
Asklepios Tumorzentrum Hamburg, Asklepios Klinik Altona - Onkologie und Palliativmedizin mit Sektionen Hamatologie und Rheumatologie
🇩🇪Hamburg, Germany
KLES Dr Prabhakar Kore Hospital and Medical Research Centre
🇮🇳Belagavi, Karnataka, India
Tata Memorial Hospital
🇮🇳Mumbai, Maharashtra, India
Chopda Medicare & Research Centre Pvt. Ltd - Magnum Heart Institute
🇮🇳Nashik, Maharashtra, India
AIG Hospitals (A Unit of Asian Institute of Gastroenterology)
🇮🇳Hyderabad, Telangana, India
Pi Health Cancer Hospital
🇮🇳Hyderabad, Telangana, India
Mahamana Pandit Madan Mohan Malviya Cancer Centre
🇮🇳Varanasi, Uttar Pradesh, India
Max Super Speciality Hospital - Saket (a unit of Devki Devi foundation)
🇮🇳New Delhi, India
Rajiv Gandhi Cancer Institute And Research Centre
🇮🇳New Delhi, India
Rambam Health Care Campus
🇮🇱Haifa, Israel
The Hadassah University Medical Center, Ein Kerem Hospital
🇮🇱Jerusalem, Israel
Rabin Medical Center, Bellinson Hospital
🇮🇱Petah-Tikva, Israel
The Chaim Sheba Medical Center, Tel Hashomer
🇮🇱Ramat Gan, HaMerkaz, Israel
Tel Aviv Sourasky Medical Center (Ichilov)
🇮🇱Tel Aviv, Israel
Azienda Ospedaliero Universitaria di Cagliari Presidio Ospedaliero Duilio Casula
🇮🇹Monserrato, Cagliari, Italy
Instituo di Candiolo, Fondazione del Piemonte per l'Oncologia (IRCCS)
🇮🇹Candiolo, Torino, Italy
IRCCS Ospedale Policlinico San Martino
🇮🇹Genova, Italy
Fondazione IRCCS Istituto Nazionale per lo studio e la cura dei Tumori
🇮🇹Milano, Italy
AOU dell'Universit~ degli Studi della Campania Luigi Vanvitelli
🇮🇹Napoli, Italy
Veneto Institute of Oncology IOV - I.R.C.C.S.
🇮🇹Padova, Italy
Azienda Ospedaliero - Universitaria Pisana
🇮🇹Pisa, Italy
Istituto Clinico Humanitas
🇮🇹Rozzano, Italy
Azienda Sanitaria Universitaria Friuli Centrale - P.O. S. Maria della Misericordia
🇮🇹Udine, Italy
Azienda Ospedaliera Universitaria Integrata Verona
🇮🇹Verona, Italy
Aichi Cancer Center
🇯🇵Nagoya-shi, Aichi, Japan
Chiba Cancer Center
🇯🇵Chiba-shi, Chiba, Japan
National Cancer Center Hospital East
🇯🇵Kashiwa, Chiba, Japan
National Hospital Organization Shikoku Cancer Center
🇯🇵Matsuyama-Shi, Ehime, Japan
National Hospital Organization Kyushu Cancer Center
🇯🇵Fukuoka-shi, Fukuoka, Japan
Hokkaido University Hospital
🇯🇵Sapporo-Shi, Hokkaidô, Japan
Kanazawa University Hospital
🇯🇵Kanazawa-shi, Isikawa, Japan
Kagoshima University Hospital
🇯🇵Kagoshima-shi, Kagoshima, Japan
Kanagawa Cancer Center
🇯🇵Yokohama-shi, Kanagawa, Japan
Kyoto University Hospital
🇯🇵Kyoto City, Kyôto, Japan
Mie University Hospital
🇯🇵Tsu-Shi, Mie, Japan
Tohoku University Hospital
🇯🇵Sendai-Shi, Miyagi, Japan
Niigata University Medical and Dental Hospital
🇯🇵Niigata-shi, Niigata, Japan
Osaka Prefectural Hospital Organization Osaka International Cancer Institute
🇯🇵Osaka-shi, Osaka, Japan
The University of Tokyo Hospital
🇯🇵Bunkyo-ku, Tokyo, Japan
National Cancer Center Hospital
🇯🇵Chuo-Ku, Tokyo, Japan
The Cancer Institute Hospital of Japanese Foundation For Cancer Research
🇯🇵Koto-Ku, Tokyo, Japan
Kyorin University Hospital
🇯🇵Mitaka-shi, Tokyo, Japan
Yamaguchi University Hospital
🇯🇵Ube-Shi, Yamaguchi, Japan
Osaka University Hospital
🇯🇵Suita-Shi, Ôsaka, Japan
CHA Bundang Medical Center, CHA University
🇰🇷Bundang-Gu, Seongnam-Si, Gyeonggi-do, Korea, Republic of
National Cancer Center
🇰🇷Ilsandong-gu, Goyang-si, Gyeonggi-do, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Seongnam-si, Gyeonggi-do, Korea, Republic of
Pusan National University Hospital
🇰🇷Busan, Korea, Republic of
Korea University Anam Hospital
🇰🇷Seoul, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Severance Hospital, Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
Hanyang University Seoul Hospital
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of
Unidade Local de Saude de Almada-Seixal, E.P.E. - Hospital Garcia de Orta
🇵🇹Almada, Portugal
Unidade Local de Saude de Coimbra, EPE - Hospitais da Universidade de Coimbra
🇵🇹Coimbra, Portugal
Unidade Local de Saúde de São José - Hospital de Santo António dos Capuchos
🇵🇹Lisboa, Portugal
Hospital Oncologico, Puerto Rico Medical Center
🇵🇷Rio Piedras, Puerto Rico
Spital Clinic Judetean de Urgenta Bihor
🇷🇴Oradea, Bihor, Romania
Centrul De Oncologie "SF. Nectarie" S.R.L.
🇷🇴Craiova, Dolj, Romania
Institutul Clinic Fundeni
🇷🇴Bucharest, Romania
Military Medical Academy, Clinic for Gastroenterology and Hepatology
🇷🇸Belgrade, Serbia
Oncology Institute of Vojvodina, Internal Oncology Clinic
🇷🇸Sremska Kamenica, Serbia
Complejo Hospitalario Universitario de Santiago -Hospital Clinico Universitario de Santiago
🇪🇸Santiago de Compostela, A Coruna, Spain
Vall d'Hebron Institute of Oncology/Hospital Universitari de Vall d'Hebron
🇪🇸Barcelona, Spain
Hospital Universitario Reina Sofia
🇪🇸Cordoba, Spain
Hospital Universitario Fundacion Jimenez Diaz
🇪🇸Madrid, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Hospital Regional Universitario de Malaga
🇪🇸Malaga, Spain
Clinica Universidad de Navarra
🇪🇸Pamplona, Spain
Hospital Universitario Virgen Macarena
🇪🇸Sevilla, Spain
Hospital Universitario y Politecnico La Fe
🇪🇸Valencia, Spain
Hospital Universitario Miguel Servet
🇪🇸Zaragoza, Spain
Onkologiska mottagningen, Sahlgrenska Universitetssjukhuset
🇸🇪Göteborg, Sweden
Cancerstudieenheten Huddinge, Karolinska Universitetssjukhuset Huddinge
🇸🇪Huddinge, Sweden
Onkologiska mottagningen, Skånes Universitetssjukhus Malmö
🇸🇪Malmö, Sweden
Kaohsiung Medical University - Chung-Ho Memorial Hospital
🇨🇳Kaohsiung, Taiwan
Chang Gung Memorial Hospital Kaohsiung Branch of the Chang Gung Medical Foundation
🇨🇳Kaohsiung, Taiwan
National Cheng Kung University Hospital
🇨🇳Tainan, Taiwan
National Taiwan University Cancer Center
🇨🇳Taipei, Taiwan
Chang Gung Memorial Hospital Linkou Branch of the Chang Gung Medical Foundation
🇨🇳Taoyuan, Taiwan
Hacettepe University Cancer Institute
🇹🇷Ankara, Sihhiye, Turkey
Trakya University Faculty of Medicine
🇹🇷Edirne, Turkey
Mount Vernon Cancer Centre
🇬🇧London, England, United Kingdom
NHS Foundation Trust Royal Marsden Hospital
🇬🇧London, England, United Kingdom
The Christie NHS Foundation Trust
🇬🇧Manchester, England, United Kingdom
Royal Marsden Hospital NHS Foundation Trust
🇬🇧Surrey, England, United Kingdom
Western General Hospital, Edinburgh Cancer Centre
🇬🇧Edinburgh, Scotland, United Kingdom