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NCT06282575 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy for Advanced HER2-positive Biliary Tract Cancer
A Phase 3 study of Biliary Tract Cancer, sponsored by Jazz Pharmaceuticals.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 286
- Enrollment target
- 20
- Study locations
NCT06282575 is a Phase 3 study of Biliary Tract Cancer that is actively recruiting participants, run by Jazz Pharmaceuticals. The registered enrollment target is 286 participants, above the 231-participant average among 36 other Biliary Tract Cancer trials with a reported enrollment target (24% higher). The trial reports 20 study locations across 16 states.
The verdict
NCT06282575, a Phase 3 study of Biliary Tract Cancer, is actively recruiting participants, sponsored by Jazz Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 286 participants
- Enrollment target
- 20
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG Cisplatin
- DRUG Gemcitabine
- DRUG Zanidatamab
- DRUG Durvalumab
Study Locations (20)
Texas
- Texas Oncology - DFW - Dallas
- University of Texas Southwestern Medical Center - Dallas
- The Univerrsity of Texas MD Anderson Cancer Center - Houston
Michigan
- University of Michigan Hospital - Ann Arbor
- Henry Ford Health System - Detroit
New York
- Laura and Isaac Perlmutter Cancer Center at NYU Langone - Ambulatory Care Center - New York
- Memorial Sloan Kettering Cancer Centers - New York
California
- City of Hope(City of Hope National Medical Center, City of Hope Medical Center) - Duarte
Colorado
- Rocky Mountain Cancer Centers, LLP - Lone Tree
Florida
- AdventHealth Hematology and Oncology - Orlando
Georgia
- Winship Cancer Institute - Atlanta
Kansas
- The University of Kansas Cancer Center - Westwood - Westwood
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 286 participants |
| Start Date | 2024-07-19 |
| Est. Completion | 2030-04-01 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06282575
The ClinicalTrials.gov registry entry for NCT06282575 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 286 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 231-participant average among 36 other Biliary Tract Cancer trials with a reported enrollment target (24% higher). The listed sponsor is Jazz Pharmaceuticals, which has 128 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Biliary Tract Cancer appearing as the primary indexed condition, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT06282575 reports 20 study locations spanning 16 distinct geographic areas - top geographies include Texas, Michigan, New York.
Frequently Asked Questions
What is clinical trial NCT06282575 about?
NCT06282575 is a clinical study titled "Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy for Advanced HER2-positive Biliary Tract Cancer". 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 regu...
What is the current status of trial NCT06282575?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 286 participants. The study started on 2024-07-19. Estimated completion is 2030-04-01.
What conditions does trial NCT06282575 study?
This clinical trial studies the following conditions: Biliary Tract Cancer.
What interventions are being tested in trial NCT06282575?
The interventions under investigation include: Pembrolizumab (DRUG), Cisplatin (DRUG), Gemcitabine (DRUG), Zanidatamab (DRUG), Durvalumab (DRUG).
Who is sponsoring clinical trial NCT06282575?
This trial is sponsored by Jazz Pharmaceuticals, which has 128 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06282575 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Georgia, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.