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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: Recruiting Phase 3 study of Biliary Tract Cancer, sponsored by Jazz Pharmaceuticals.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
PFS is defined as the time from the date of randomization to the date of documented disease progression, or death from any cause.
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 |
What NCT06282575 shows while recruiting
NCT06282575 is an interventional study that assigns participants to a tested intervention. The registered 286 participants enrollment target is mid-sized for trials with a published cap, above the 231-participant average among 36 other Biliary Tract Cancer trials with a reported enrollment target (24% higher).
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 names 20 study sites across 16 states, led by 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
Similar trials for Biliary Tract Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06282575's enrollment target sits among peer trials
286 9th of 36 higher than 28 of 36 other Biliary Tract Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Biliary Tract Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Study of Rilvegostomig or Durvalumab Plus Chemotherapy for First-Line Treatment of Biliary Tract Cancer (ARTEMIDE-Biliary02)
RECRUITING · Phase 3
-
Phase 3 Study of T-DXd and Rilvegostomig Versus SoC in Advanced HER2-expressing Biliary Tract Cancer
RECRUITING · Phase 3
-
Rilvegostomig + Chemotherapy as Adjuvant Therapy for Biliary Tract Cancer After Resection (ARTEMIDE-Biliary01)
ACTIVE NOT RECRUITING · Phase 3
-
Durvalumab With Chemotherapy as First Line Treatment in Patients With Advanced Biliary Tract Cancers (aBTCs)
ACTIVE NOT RECRUITING · Phase 3
-
Phase 1 Trial of ZM008 as Single Agent and in Combination With Pembrolizumab in Patients With Advanced Solid Tumors
RECRUITING · Phase 1
-
Adoptive Transfer of Tumor Infiltrating Lymphocytes for Biliary Tract Cancers
RECRUITING · Phase 2
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