Recruiting NCT06282575
Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy for Advanced HER2-positive Biliary Tract Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Zanidatamab, Cisplatin, Gemcitabine, Pembrolizumab.
- Who it may be relevant to
- Registry conditions: Biliary Tract Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Argentina, Belgium, Brazil, Canada +20
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
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)
Primary outcome measures
- Progression Free Survival (PFS) in participants with Immunohistochemistry (IHC) 3+ tumors [Time frame: Up to 52 months]
Secondary outcome measures (12)
- Overall survival (OS) in participants with IHC 3+ tumors [Time frame: Up to 68 months]
- Progression Free Survival for all participants [Time frame: Up to 68 months]
- OS for all participants [Time frame: Up to 68 months]
- Number of participants achieving Confirmed objective response rate (cORR) [Time frame: Up to 68 months]
- Duration of response (DOR) [Time frame: Up to 68 months]
- Number of Patients reporting Treatment-Emergent Adverse Events (TEAE) [Time frame: Up to 68 months]
- Maximum serum concentration of Zanidatamab [Time frame: Up to 68 months]
- Number of participants who develop Anti-drug antibodies (ADAs) to Zanidatamab [Time frame: Up to 68 months]
- 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 [Time frame: Up to 68 months]
- TDD for all participants in patient-reported PF domain score as measured by the EORTC QLQ-C30 [Time frame: 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) [Time frame: Up to 68 months]
- TDD for all participants in patient-reported symptoms scores as measured by the EORTC QLQ-BIL21 (Pain, Jaundice, Abdominal Pain, and Pruritis) [Time frame: Up to 68 months]
Eligibility criteria
Inclusion criteria
- Histologically- or cytologically-confirmed Biliary Tract Cancer (BTC), including Gallbladder Cancer (GBC), Intrahepatic Cholangiocarcinoma (ICC), or Extrahepatic Cholangiocarcinoma (ECC).
- Locally advanced unresectable or metastatic BTC and not eligible for curative resection, transplantation, or ablative therapies.
- Received no more than 2 cycles of systemic therapy which is limited to Cisplatin and Gemcitabine (CisGem) with or without a PD-1/L1 inhibitor (physician's choice of durvalumab or pembrolizumab, where approved under local regulations) for advanced unresectable or metastatic disease.
- HER2-positive disease (defined as IHC 3+; or IHC 2+/ ISH+) by IHC and in situ Hybridization (ISH) assay (in participants with IHC 2+ tumors) at a central laboratory on new biopsy tissue or archival tissue from the most recent biopsy.
- Assessable (measurable or non-measurable) disease as defined by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), per investigator assessment.
- Male or female ≥ 18 years or age (or the legal age of adulthood per country-specific regulations).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate organ function
- Females of childbearing potential must have a negative pregnancy test result.
- Females of childbearing potential and males with a partner of childbearing potential must be willing to use 2 methods of birth control.
Exclusion criteria
- Prior treatment with a HER2-targeted agent
- Prior treatment with checkpoint inhibitors, other than durvalumab or pembrolizumab
- The following BTC histologic subtypes are excluded: small cell cancer, neuroendocrine tumors, lymphoma, sarcoma, mixed tumor histology, and mucinous cystic neoplasms detected in the biliary tract region.
- Use of systemic corticosteroids.
- Brain metastases
- Severe chronic or active infections
- History of allogeneic organ transplantation.
- Active or prior autoimmune inflammatory conditions
- History of interstitial lung disease or non-infectious pneumonitis.
- Participation in another clinical trial with an investigational medicinal product within the last 3 months.
- Females who are breastfeeding
- Any other medical, social, or psychosocial factors that, in the opinion of the investigator, could impact safety or compliance with study procedures.
- Use of phenytoin
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 21 centers
- City of Hope(City of Hope National Medical Center, City of Hope Medical Center) — Duarte
- Rocky Mountain Cancer Centers, LLP — Lone Tree
- AdventHealth Hematology and Oncology — Orlando
- Winship Cancer Institute — Atlanta
- The University of Kansas Cancer Center - Westwood — Westwood
- Norton Cancer Institute - Audubon — Louisville
- Ochsner Clinic Foundation — New Orleans
- Tufts Medical Center — Boston
- … and 13 more centers
Japan · 20 centers
Center list to be confirmed — check the primary protocol.
Spain · 12 centers
Center list to be confirmed — check the primary protocol.
France · 11 centers
- CHU de Toulouse- (Toulouse University Hospital Center) — Toulouse
- CHU Besancon — Besançon
- CHU de Bordeaux - Hôpital Haut Leveque — Pessac
- CHU Brest Hôpital de la Cavale Blanche — Brest
- CHU Estaing — Clermont-Ferrand
- Hospital Beaujon University — Clichy
- Hopital Henri Mondor — Créteil
- CHU Montepellier - Hôpital Saint Eloi — Montpellier
- … and 3 more centers
Italy · 11 centers
Center list to be confirmed — check the primary protocol.
South Korea · 11 centers
Center list to be confirmed — check the primary protocol.
China · 10 centers
- The First Affiliated Hospital of USTC(Anhui Provincial Hospital) — Hefei
- Beijing Cancer Hospital — Beijing
- The First Hospital of Lanzhou University — Lanzhou
- Harbin Medical University Cancer Hospital — Harbin
- Hunan Provincial People's Hospital — Changsha
- Jilin Cancer Hospital — Changchun
- Shandong Provincial Third Hospital — Jinan
- Sichuan Cancer Hospital — Chengdu
- … and 2 more centers
Germany · 10 centers
- Universitätsklinikum Freiburg - Klinik für Innere Medizin II, — Freiburg im Breisgau
- Nationales Centrum für Tumorerkrankungen (NCT) Heidelberg — Heidelberg
- … and 8 more centers
Argentina · 8 centers
- Hospital Italiano de Buenos Aires — Ciudad Autónoma de Buenos Aires (caba)
- Fundación ARS Médica — San Salvador de Jujuy
- Centro de Investigaciónes Clínicas - Clínica Viedma — Viedma
- Hospital Provincial Del Centenario — Rosario
- Instituto Médico de la Fundación Estudios Clínicos — Rosario
- CAIPO Centro para la Atención Integral del Paciente Oncológico — San Miguel de Tucumán
- Centro Médico en Oncología Clínica EXELSUS S.R.L — San Miguel de Tucumán
- Centro Médico Privado CEMAIC — Córdoba
Brazil · 8 centers
- Liga Norte Riograndense Contra O Cancer — Natal
- Hospital de Clinicas de Porto Alegre - HCPA — Porto Alegre
- Irmandade Da Santa Casa de Misericordia de Porto Alegre - ISCMPA — Porto Alegrev
- Fundação Pio XII Hospital de Amor de Barretos — Barretos
- Fundação Doutor Amaral Carvalho - Hospital Amaral Carvalho — Jaú
- Fundação Faculdade Regional de Medicina de São José do Rio Preto (FUNFARME) — São José do Rio Preto
- Hospital Nossa Senhora Da Conceição/Centro Integrado de Pesquisa em Oncologia CIPO-GHC — Porto Alegre
- Instituto Nacional de Cancer - INCA — Rio de Janeiro
Chile · 8 centers
- James Lind Centro de Investigacion del Cancer — Temuco
- Servicios Médicos URUMED SpA — Rancagua
- Clinica Puerto Montt — Port Montt
- Centro de Investigacion y Especialidades Medicas (CDIEM) — Santiago
- Fundación Arturo López Pérez (FALP) — Santiago
- Oncovida — Santiago
- Biocinetic Ltda — Santiago
- Hospital Clinico Universidad de Chile — Santiago
India · 8 centers
Center list to be confirmed — check the primary protocol.
Israel · 5 centers
Center list to be confirmed — check the primary protocol.
Portugal · 5 centers
Center list to be confirmed — check the primary protocol.
Taiwan · 5 centers
Center list to be confirmed — check the primary protocol.
United Kingdom · 5 centers
Center list to be confirmed — check the primary protocol.
Romania · 4 centers
Center list to be confirmed — check the primary protocol.
Turkey (Türkiye) · 4 centers
Center list to be confirmed — check the primary protocol.
Belgium · 3 centers
- Imelda VZW — Bonheiden
- UZ Antwerpen — Edegem
- UZ Leuven — Leuven
Canada · 3 centers
- London Health Sciences Centre — London
- Princess Margaret Cancer Centre - University Health Network — Toronto
- Centre Hospitalier de l'Universite de Montreal (CHUM) — Montreal
Czechia · 3 centers
- Fakultní nemocnice Brno, Interní hematologická a onkologická klinika — Brno
- Fakultni nemocnice Hradec Kralove, Klinika onkologie a radioterapie — Hradec Králové
- Fakultni nemocnice v Motole, Onkologicka klinika — Prague
Finland · 3 centers
- Docrates Cancer Center — Helsinki
- Comprehensive Cancer Center, Helsinki University Hospital — Helsinki
- Kuopio University Hospital — Kuopio
Serbia · 3 centers
Center list to be confirmed — check the primary protocol.
Sweden · 3 centers
Center list to be confirmed — check the primary protocol.
Puerto Rico · 1 center
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06282575 · JZP598-302 · 2023-508219-21-00