RecruitingPhase 3NCT06282575

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

An Open-label Randomized Trial of the Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy Alone for Advanced HER2-positive Biliary Tract Cancer

Sponsor

Jazz Pharmaceuticals

Enrollment

286 participants

Start Date

Jul 19, 2024

Study Type

INTERVENTIONAL

Conditions

Biliary Tract Cancer

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether adding zanidatamab — a drug that targets HER2, a protein found on some cancer cells — to standard chemotherapy improves outcomes for people with advanced HER2-positive biliary tract cancer (cancer of the bile ducts or gallbladder). **You may be eligible if...** - You are 18 years or older - You have been diagnosed with biliary tract cancer (gallbladder cancer, or intrahepatic or extrahepatic cholangiocarcinoma) - Your cancer has tested HER2-positive - Your cancer is locally advanced, unresectable, or has spread (metastatic) and cannot be cured with surgery - You have received no more than 2 cycles of cisplatin and gemcitabine (with or without immunotherapy) for advanced disease - You are in good physical condition (ECOG 0-1) with adequate organ function **You may NOT be eligible if...** - You have received prior HER2-targeted therapy for this cancer - You are pregnant or breastfeeding - You have uncontrolled infections or significant heart problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGZanidatamab

Administered intravenously (IV)

DRUGCisplatin

Administered intravenously (IV)

DRUGGemcitabine

Administered intravenously (IV)

DRUGPembrolizumab

Administered intravenously (IV)

DRUGDurvalumab

Administered intravenously (IV)

Locations(184)

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

Duarte, California, United States

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

Oregon Health and Science University

Portland, Oregon, 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 Province, Argentina

Centro de Investigaciónes Clínicas - Clínica Viedma

Viedma, Río Negro Province, Argentina

Hospital Provincial Del Centenario

Rosario, Santa Fe Province, Argentina

Instituto Médico de la Fundación Estudios Clínicos

Rosario, Santa Fe Province, Argentina

CAIPO Centro para la Atención Integral del Paciente Oncológico

San Miguel de Tucumán, Tucumán Province, Argentina

Centro Médico en Oncología Clínica EXELSUS S.R.L

San Miguel de Tucumán, Tucumán Province, 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

Hospital de Clinicas de Porto Alegre - HCPA

Porto Alegre, Rio Grande do Sul, 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 Doutor Amaral Carvalho - Hospital Amaral Carvalho

Jaú, 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

Instituto Nacional de Cancer - INCA

Rio de Janeiro, Brazil

London Health Sciences Centre

London, Ontario, Canada

Princess Margaret Cancer Centre - University Health Network

Toronto, Ontario, Canada

Centre Hospitalier de l'Universite de Montreal (CHUM)

Montreal, Quebec, Canada

James Lind Centro de Investigacion del Cancer

Temuco, Araucania, Chile

Servicios Médicos URUMED SpA

Rancagua, Libertador Gen Bernardo O Higgins, Chile

Clinica Puerto Montt

Port Montt, Los Lagos Region, Chile

Centro de Investigacion y Especialidades Medicas (CDIEM)