Status:
RECRUITING
Perioperative Gemcitabine, Cisplatin, and Pembrolizumab in Potentially Resectable Biliary Tract Cancers
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Billiary Track Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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...
Eligibility Criteria
Inclusion
- Must have a newly diagnosed, biopsy-proven biliary tract cancer (BTC) including gallbladder, intrahepatic, extrahepatic, and hilar cholangiocarcinoma.
- Resectable BTC (biliary tract cancer)
- Measurable disease per RECIST 1.1 as determined by the investigator.
- Age ≥18 years.
- ECOG (Eastern Cooperative Oncology Group) performance status ≤1 or Karnofsky ≥80
- Patients must have adequate organ and marrow function defined by study-specified laboratory tests.
- Patients must have adequate liver function defined by study-specified laboratory tests.
- Patients with chronic or acute HBV or HCV infection must have disease controlled prior to enrollment.
- Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test.
- For both Women and Men, must use acceptable form of birth control while on study.
- Ability to understand and willingness to sign a written informed consent document.
Exclusion
- Receiving, or previously received, any systemic chemotherapy, or investigational agent for BTC.
- Has received prior radiotherapy within 2 weeks of start of study intervention.
- Patients with a history of prior treatment with anti-PD-1 and anti-PD-L1.
- Have been diagnosed with another cancer or myeloproliferative disorder whose natural history or treatment has the potential to interfere with safety or efficacy assessment of this study's investigational drugs.
- Has a known history of Human Immunodeficiency Virus (HIV)/AIDS
- Has active co-infection with HBV and HDV.
- Has a diagnosis of immunodeficiency.
- Has active autoimmune disease that has required systemic treatment in the past 2 years.
- Systemic or topical corticosteroids at immunosuppressive doses.
- Prior allogeneic stem cell transplantation or organ transplantation.
- Prior tissue or organ allograft or allogeneic bone marrow transplantation, including corneal transplants.
- Uncontrolled intercurrent active medical and/or psychiatric illness/social psychosocial problems that that would limit compliance with study requirements.
- Uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, metastatic cancer, or psychiatric illness/social situations that would limit compliance with study requirements.
- Evidence of clinical ascites.
- Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
- Previously identified allergy or hypersensitivity to monoclonal antibodies or any component of the study treatment formulations.
- Pregnant or breastfeeding.
- WOCBP and men with female partners (WOCBP) who are not willing to use contraception.
- Subjects unable to undergo venipuncture and/or tolerate venous access.
- Patient is at the time of signing informed consent a regular user (including "recreational use") of any illicit drugs or had a recent history (within the last year) of substance abuse (including alcohol).
Key Trial Info
Start Date :
July 8 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2028
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT06001658
Start Date
July 8 2024
End Date
June 1 2028
Last Update
December 3 2025
Active Locations (1)
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1
SKCCC Johns Hopkins
Baltimore, Maryland, United States, 21231