Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy for Advanced HER2-positive Biliary Tract Cancer
- Conditions
- 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 hu...
- 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 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. 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. 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. 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 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. 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 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. 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 (104)
The University of Kansas Cancer Center - Westwood
🇺🇸Westwood, Kansas, 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
Saint Francis Cancer Center
🇺🇸Greenville, South Carolina, United States
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 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
Institut de Cancérologie de l'Ouest
🇫🇷Saint-Herblain Cedex, France
Azienda Ospedaliero Universitaria di Cagliari Presidio Ospedaliero Duilio Casula
🇮🇹Monserrato, Cagliari, Italy
AOU dell'Universit~ degli Studi della Campania Luigi Vanvitelli
🇮🇹Napoli, 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
Hokkaido University Hospital
🇯🇵Sapporo-Shi, Hokkaidô, Japan
Kanagawa Cancer Center
🇯🇵Yokohama-shi, Kanagawa, Japan
Mie University Hospital
🇯🇵Tsu-Shi, Mie, Japan
The University of Tokyo Hospital
🇯🇵Bunkyo-ku, Tokyo, Japan
The Cancer Institute Hospital of Japanese Foundation For Cancer Research
🇯🇵Koto-Ku, Tokyo, Japan
Pusan National University Hospital
🇰🇷Busan, Korea, Republic of
Champalimaud Clinical Center
🇵🇹Lisboa, Portugal
Institutul Clinic Fundeni
🇷🇴Bucharest, Romania
Centrul de Oncologie Euroclinic SRL
🇷🇴Iasi, Romania
Military Medical Academy, Clinic for Gastroenterology and Hepatology
🇷🇸Belgrade, Serbia
Onkologiska mottagningen, Sahlgrenska Universitetssjukhuset
🇸🇪Göteborg, Sweden
Cancerstudieenheten Huddinge, Karolinska Universitetssjukhuset Huddinge
🇸🇪Huddinge, Sweden
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
Norton Cancer Institute - Audubon
🇺🇸Louisville, Kentucky, United States
Ochsner Clinic Foundation
🇺🇸New Orleans, Louisiana, 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
Memorial Sloan Kettering Cancer Centers
🇺🇸New York, New York, United States
SCRI Oncology Partners
🇺🇸Nashville, Tennessee, United States
Texas Oncology - DFW
🇺🇸Dallas, Texas, United States
The Univerrsity of Texas MD Anderson Cancer Center
🇺🇸Houston, Texas, 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
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
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
KLES Dr Prabhakar Kore Hospital and Medical Research Centre
🇮🇳Belagavi, Karnataka, 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
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
Instituo di Candiolo, Fondazione del Piemonte per l'Oncologia (IRCCS)
🇮🇹Candiolo, Torino, Italy
IRCCS Ospedale Policlinico San Martino
🇮🇹Genova, Italy
Chiba Cancer Center
🇯🇵Chiba-shi, Chiba, Japan
Osaka Prefectural Hospital Organization Osaka International Cancer Institute
🇯🇵Osaka-shi, Osaka, Japan
Yamaguchi University Hospital
🇯🇵Ube-Shi, Yamaguchi, 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
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
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
Instituto Português de Oncologia Do Porto Francisco Gentil, EPE
🇵🇹Porto, Portugal
Hospital Oncologico, Puerto Rico Medical Center
🇵🇷Rio Piedras, Puerto Rico
University Clinical Center of Serbia, Clinic for Gastroenterohepatology
🇷🇸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
Kaohsiung Medical University - Chung-Ho Memorial Hospital
🇨🇳Kaohsiung, Taiwan
National Cheng Kung University Hospital
🇨🇳Tainan, Taiwan
National Taiwan University Cancer Center
🇨🇳Taipei, Taiwan