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

PHASE2RecruitingINTERVENTIONAL
Enrollment

27

Participants

Timeline

Start Date

July 8, 2024

Primary Completion Date

June 30, 2028

Study Completion Date

June 30, 2028

Conditions
Billiary Track Cancer
Interventions
DRUG

Gemcitabine

Patients will receive treatment on Day 1 and Day 8 of each cycle. Gemcitabine (1000 mg/m2) will be administered IV on Day 1 and Day 8 of each cycle, Q3 weeks with 2 - 4 cycles prior to surgery and then 4-6 cycles after surgery.

DRUG

Cisplatin

Patients will receive treatment on Day 1 and Day 8 of each cycle. Cisplatin (25 mg/m2) will be administered IV on Day 1 and Day 8 of each cycle, Q3 weeks with 2 - 4 cycles prior to surgery and then 4-6 cycles after surgery.

DRUG

Pembrolizumab

Patients will receive treatment on Day 1 of each cycle. Pembrolizumab (200 mg) will be administered IV on Day 1 of each cycle, Q3 weeks with 2 - 4 cycles prior to surgery and then 4-6 cycles after surgery. Pembrolizumab (400 mg) will be administered IV Q6 weeks up to 4 cycles as maintenance.

Trial Locations (1)

21231

RECRUITING

SKCCC Johns Hopkins, Baltimore

All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

lead

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER