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

• Status: Recruiting
• Trial end date: 2028-05-01
• Target enrollment: 0
• Participant gender: All

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 pembrolizumab (gem/cis/pembro) is feasible and lead to pathologic responses.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborator: Merck Sharp & Dohme LLC
• Treatments: Gemcitabine; Pembrolizumab

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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).