Recruiting

Phase 2

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

Sponsor:

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Code:

NCT06001658

Conditions

Billiary Track Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Gemcitabine

Cisplatin

Pembrolizumab

Study Details

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 ID

NCT06001658

Start date

Jul 8, 2024

Status verified date

Dec, 2025

Completion date

Jun, 2028

Anticipated

Primary completion date

Jun, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

27 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Gemcitabine, Cisplatin and Pembrolizumab

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.

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.

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.

Primary outcome measure

Average minimum Euclidean distance from CD8+ T cells to immunosuppressive tumor-associated macrophages (TAMs) at the per-cell level in patients with a major pathologic response versus pathologic non-responders. [ Time Frame: 4 years ]

Central Contacts and Locations

Central contacts

Colleen Apostal, RN

410-614-3644 GIClinicalTrials@jhmi.edu

Locations

SKCCC Johns Hopkins

Recruiting

Baltimore, Maryland, United States, 21231

Contacts

Colleen Apostol, RN

410-614-3644 GIClinicalTrials@jhmi.edu

Principal Investigator:

Marina Baretti, MD

More Information

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Last update posted

Dec 3, 2025

Last verified

Dec, 2025

Keywords

Biliary Tract cancer
Pembrolizumab
Gemcitabine
Cisplatin
Immunotherapy
Potentially resectable biliary tract cancer
Anti PD-L1
PD-L1
Carcinoma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins on 2025-12-03.