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 States286 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 range18 Years
SexALL
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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
Exclusion criteria
✕. Prior treatment with a HER2-targeted agent
✕. Prior treatment with checkpoint inhibitors, other than durvalumab or pembrolizumab
What they're measuring
1
Progression Free Survival (PFS) in participants with Immunohistochemistry (IHC) 3+ tumors
✕. 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