Actively Recruiting
Perioperative Gemcitabine, Cisplatin, and Pembrolizumab in Potentially Resectable Biliary Tract Cancers
Led by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Updated on 2025-12-03
27
Participants Needed
1
Research Sites
203 weeks
Total Duration
On this page
Sponsors
S
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Perioperative Gemcitabine, Cisplatin, and Pembrolizumab in Potentially Resectable Biliary Tract Cancers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newly diagnosed, biopsy-proven biliary tract cancer including gallbladder, intrahepatic, extrahepatic, and hilar cholangiocarcinoma
- Resectable biliary tract cancer
- Measurable disease per RECIST 1.1 as determined by the investigator
- Age 18 years or older
- ECOG performance status 1 or lower or Karnofsky score 80 or higher
- Adequate organ and marrow function per study laboratory tests
- Adequate liver function per study laboratory tests
- Controlled chronic or acute HBV or HCV infection before enrollment
- Women of childbearing potential must have a negative pregnancy test
- Both women and men must use acceptable birth control during the study
- Ability to understand and willingness to sign informed consent
You will not qualify if you...
- Receiving or previously received systemic chemotherapy or investigational agents for biliary tract cancer
- Prior radiotherapy within 2 weeks before starting study treatment
- Prior treatment with anti-PD-1 or anti-PD-L1 agents
- Diagnosis of another cancer or myeloproliferative disorder that could interfere with study assessments
- Known history of HIV/AIDS
- Active co-infection with HBV and HDV
- Diagnosis of immunodeficiency
- Active autoimmune disease requiring systemic treatment in the past 2 years
- Use of systemic or topical corticosteroids at immunosuppressive doses
- Prior allogeneic stem cell or organ transplantation
- Prior tissue or organ allograft or allogeneic bone marrow transplantation including corneal transplants
- Uncontrolled active medical, psychiatric, or social conditions limiting study compliance
- Evidence of clinical ascites
- History or current pneumonitis or interstitial lung disease requiring steroids
- Allergy or hypersensitivity to monoclonal antibodies or study treatment components
- Pregnant or breastfeeding
- Women of childbearing potential and men with female partners not willing to use contraception
- Unable to tolerate venous access or venipuncture
- Current regular use or recent history (within 1 year) of illicit drug or substance abuse including alcohol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
SKCCC Johns Hopkins
Baltimore, Maryland, United States, 21231
Actively Recruiting
Research Team
C
Colleen Apostal, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here