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

NCT ID: NCT06001658

Last Updated: 2025-12-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-08
• Study Completion Date: 2028-06-30

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

Conditions

Billiary Track Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Gemcitabine, Cisplatin and Pembrolizumab

Group Type: EXPERIMENTAL

Gemcitabine

Intervention Type: DRUG

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.

Cisplatin

Intervention Type: DRUG

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.

Pembrolizumab

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

KEYTRUDA; anti-PD-1 mAb

Eligibility 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marina Baretti, M.D.

Role: PRINCIPAL_INVESTIGATOR

SKCCC Johns Hopkins Medical Institution

Locations

SKCCC Johns Hopkins

Baltimore, Maryland, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Colleen Apostal, RN

Role: CONTACT

GIClinicalTrials@jhmi.edu

410-614-3644

Facility Contacts

Colleen Apostol, RN

Role: primary

GIClinicalTrials@jhmi.edu

410-614-3644

Other Identifiers

IRB00371087

Identifier Type: OTHER

Identifier Source: secondary_id

J2390

Identifier Type: -

Identifier Source: org_study_id