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Perioperative Gemcitabine, Cisplatin, and Pembrolizumab in Potentially Resectable Biliary Tract Cancers

StatusRecruiting
PhasePhase 2
Started2024-07-08
View on ClinicalTrials.gov ↗

Amendment history

2025-12-01
minor
Study Status, Contacts/Locations v7
Study sitescontacts updated at 1 of 1 site
2025-03-31
minor
Study Status, Conditions v6
Re-verified, no change to tracked fields
2024-07-24
minor
Study Status v5
Start dateestimated 2024-07→confirmed 2024-07-08
2024-06-24
minor
Study Status v4
Primary completion date2028-05→2028-06
Completion date2028-05→2028-06
Start date2024-05→2024-07
2024-05-02
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Study sitesdetails revised at 1 of 1 site
Show 2 earlier versions
2024-04-01
minor
Study Status v2
Primary completion date2028-02→2028-05
Completion date2028-02→2028-05
Start date2024-02-29→2024-05
2024-01-03
minor
Study Status v1
Primary completion date2027-12→2028-02
Completion date2027-12→2028-02
Start date2023-12→2024-02-29
2023-08-16
minor
Original filing
The purpose of this study is to determine the safety of peri-operative gemcitabine, cisplatin, and pembrolizumab in patients with BTC, as well as whether the combination of gemcitabine, cisplatin, and pembrolizumab (gem/cis/pembro) is feasible and lead to pathologic responses.
Trial Details
NCT Number NCT06001658
Lead Sponsor Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators: Merck Sharp & Dohme LLC
Conditions Billiary Track Cancer
Enrollment 27 participants
Start Date 2024-07-08
Primary Completion 2028-06 (estimated)
Study Completion 2028-06 (estimated)
Updated on ClinicalTrials.gov 2025-12-03