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

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
Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Standard-of-care Therapy ArmCisplatinStandard 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 ArmGemcitabineZanidatamab 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 ArmGemcitabineStandard 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 ArmZanidatamabZanidatamab 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 ArmDurvalumabZanidatamab 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 ArmCisplatinZanidatamab 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 ArmPembrolizumabZanidatamab 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 ArmPembrolizumabStandard 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 ArmDurvalumabStandard 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
NameTimeMethod
Progression Free Survival (PFS) in participants with Immunohistochemistry (IHC) 3+ tumorsUp 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
NameTimeMethod
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+ tumorsUp to 68 months

OS is defined as the time from randomization to death, due to any cause.

OS for all participantsUp to 68 months

OS is defined as the time from randomization to death, due to any cause.

Progression Free Survival for all participantsUp 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 ZanidatamabUp to 68 months
Number of participants who develop Anti-drug antibodies (ADAs) to ZanidatamabUp 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-C30Up 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-C30Up 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

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