Comparing Zanidatamab with Cisplatin for biliary tract cancer
Official title: 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
- Phase 3
- 2 groups
- Sites in London, Toronto and 1 more city
- Recruiting
Interventions (5)
- Medication
Zanidatamab
Administered intravenously (IV)
- Medication
Cisplatin
Administered intravenously (IV)
- Medication
Gemcitabine
Administered intravenously (IV)
- Medication
Pembrolizumab
Administered intravenously (IV)
- Medication
Durvalumab
Administered intravenously (IV)
Canadian Sites (3)
3 of 3 recruiting
- Recruiting
London Health Sciences Centre
London, Ontario
- Recruiting
Princess Margaret Cancer Centre - University Health Network
Toronto, Ontario
- Recruiting
Centre Hospitalier de l'Universite de Montreal (CHUM)
Montreal, Quebec
Eligibility Criteria
See who this study is looking for37 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +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.
- +Brain metastases
- +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.
- +Assessable (measurable or non-measurable) disease as defined by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), per investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → 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
- +Exclusion CriteriaExclusion criteriaThe things that would prevent someone from taking part.Read more →
- +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.
- +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 trialInterventional studyA study where participants are given something to see what happens.Read more → with an investigational medicinal product within the last 3 months.
- +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
- +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 controlControl groupThe group a new treatment is measured against.Read more →.
- +Females who are breastfeeding
Exclusion
- −Brain metastases
- −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.
- −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 trialInterventional studyA study where participants are given something to see what happens.Read more → with an investigational medicinal product within the last 3 months.
- −Any other medical, social, or psychosocial factors that, in the opinion of the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →, could impact safety or compliance with study procedures.
- −Use of phenytoin
- −Females who are breastfeeding
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A receives Zanidatamab, together with one or more of: Cisplatin, Gemcitabine, Pembrolizumab and Durvalumab.
Registry label: A: Zanidatamab with Standard-of-care Therapy Arm
Group B, the comparison group, receives one or more of: Cisplatin, Gemcitabine, Pembrolizumab and Durvalumab.
Registry label: B: Standard-of-care Therapy Arm
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 286 people.
The study is currently expected to finish around April 2030.
The main measurement is taken over: Up to 52 months.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Progression Free Survival (PFS) in participants with Immunohistochemistry (IHC) 3+ tumors — measured over Up to 52 months.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06282575 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About ZanidatamabDrug
Administered intravenously (IV)
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About CisplatinDrug
Administered intravenously (IV)
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About GemcitabineDrug
Administered intravenously (IV)
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About PembrolizumabDrug
Administered intravenously (IV)
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About DurvalumabDrug
Administered intravenously (IV)
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Up to 52 months.
The study as a whole is currently expected to finish around 2030-04-01.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 286 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 7 locations, including: London, Ontario, Canada; Toronto, Ontario, Canada; Montreal, Quebec, Canada; Ann Arbor, Michigan, United States; Detroit, Michigan, United States; Maple Grove, Minnesota, United States, and 1 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
Other Sites (5)
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
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
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.