Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy… (NCT06282575) | Clinical Trial Compass
RecruitingPhase 3
Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy for Advanced HER2-positive Biliary Tract Cancer
United States, Argentina, Belgium286 participantsStarted 2024-07-19
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is specifically measuring how long people with IHC 3+ HER2-positive tumors go without their cancer progressing — do you know my tumor's HER2 IHC score, and would that affect whether this trial might be worth discussing for my situation?
2Since this is a Phase 3 trial testing zanidatamab added on top of standard-of-care therapy, what does that mean for what's already known about its safety and potential benefit compared to standard treatment alone — and how does that weigh against just starting standard care now?
3Zanidatamab is being added to existing standard-of-care chemotherapy regimens — can you help me understand what the combined treatment schedule might look like and how demanding that could be week to week for someone in my situation?
4Because this trial is still actively recruiting, how long might I need to wait to get enrolled and start treatment, and could that delay matter for my particular cancer?
5Are there other HER2-targeted treatment options or trials I should compare this one against, or would standard-of-care chemotherapy alone be a better first step before considering a trial like this?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Progression Free Survival (PFS) in participants with Immunohistochemistry (IHC) 3+ tumors
. 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 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