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

Part of paid clinical trials in Duarte, California.

Sponsor
Jazz Pharmaceuticals
Study ID
NCT06282575
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Biliary Tract Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Zanidatamab — DRUG
    Administered intravenously (IV)
  • Cisplatin — DRUG
    Administered intravenously (IV)
  • Gemcitabine — DRUG
    Administered intravenously (IV)
  • Pembrolizumab — DRUG
    Administered intravenously (IV)
  • Durvalumab — DRUG
    Administered intravenously (IV)

Study Details

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.

Key Dates

Start date
Jul 19, 2024
Status verified
May 2026
Primary completion
Dec 1, 2028
Completion
Apr 1, 2030

Study Design

Enrollment
286 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Zanidatamab with Standard-of-care Therapy Arm
    Zanidatamab plus standard of care treatment of CisGem with or without a PD-1/L1 inhibitor. PD-1/L1 inhibitor will be physician's choice of either Durvalumab or Pembrolizumab, where approved under local regulations.
  • Active Comparator: Standard-of-care Therapy Arm
    Standard of care treatment of CisGem with or without a PD-1/L1 inhibitor. PD-1/L1 inhibitor will be physician's choice of either Durvalumab or Pembrolizumab, where approved under local regulations.

Primary Outcome Measure

Progression Free Survival (PFS) in participants with Immunohistochemistry (IHC) 3+ tumors [ Time Frame: Up to 52 months ]

Central Contacts

Locations (21)

FacilityCityStateZIPSite coordinators
City of Hope(City of Hope National Medical Center, City of Hope Medical Center)DuarteCalifornia91010-
Rocky Mountain Cancer Centers, LLPLone TreeColorado80124-
AdventHealth Hematology and OncologyOrlandoFlorida32804-
Winship Cancer InstituteAtlantaGeorgia30322-
The University of Kansas Cancer Center - WestwoodWestwoodKansas66205-
Norton Cancer Institute - AudubonLouisvilleKentucky40217-
Ochsner Clinic FoundationNew OrleansLouisiana70121-
Tufts Medical CenterBostonMassachusetts02111-
University of Michigan HospitalAnn ArborMichigan48109-
Henry Ford Health SystemDetroitMichigan48202-
Minnesota Oncology Hematology, P.A.Maple GroveMinnesota55369-
Atlantic Health System/Morristown Medical CenterMorristownNew Jersey07960-
Laura and Isaac Perlmutter Cancer Center at NYU Langone - Ambulatory Care CenterNew YorkNew York10016-
Memorial Sloan Kettering Cancer CentersNew YorkNew York10022-
Oregon Health and Science UniversityPortlandOregon97239-
Saint Francis Cancer CenterGreenvilleSouth Carolina29607-
SCRI Oncology PartnersNashvilleTennessee37203-
Texas Oncology - DFWDallasTexas75246-
University of Texas Southwestern Medical CenterDallasTexas75390-
The Univerrsity of Texas MD Anderson Cancer CenterHoustonTexas77030-
Virginia Commonwealth University, VCU HealthRichmondVirginia23219-

Find similar trials in Duarte, CA

By research site
City of Hope(City of Hope National Medical Center, City of Hope Medical Center)· Duarte, CARocky Mountain Cancer Centers, LLP· Lone Tree, COAdventHealth Hematology and Oncology· Orlando, FLWinship Cancer Institute· Atlanta, GAThe University of Kansas Cancer Center - Westwood· Westwood, KSNorton Cancer Institute - Audubon· Louisville, KY

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