AzTrials
AzTrials

Billiary Track CancerPhase 2NCT06001658

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

A Phase 2 study testing Gemcitabine, Cisplatin and Pembrolizumab in people with Billiary Track Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Billiary Track Cancer
What is being tested?
Gemcitabine, Cisplatin and Pembrolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
1 siteUnited States
Study dates
8 Jul 2024to Jun 2028
Phase
Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 11Show fewer
  • 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.

Who cannot join

  • 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.
Show all 20Show fewer
  • 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).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Colleen Apostal, RN contact

410-614-3644

GIClinicalTrials@jhmi.edu

United States1 site, 1 recruiting

  • SKCCC Johns Hopkins

    Baltimore, Maryland, 21231

    Colleen Apostol, RN, 410-614-3644, GIClinicalTrials@jhmi.edu

    Marina Baretti, MD

    Recruiting

Other trials in United States

About this study

Official title: Tumor Microenvironment Features of Response to Perioperative Gemcitabine, Cisplatin, and Pembrolizumab in Potentially Resectable Biliary Tract Cancers

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.

Keywords
Biliary Tract cancer, Pembrolizumab, Gemcitabine, Cisplatin, Immunotherapy, Potentially resectable biliary tract cancer, Anti PD-L1, PD-L1, Carcinoma
Medical subject headings
Biliary Tract Neoplasms, Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GemcitabineDrug

    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.

  • CisplatinDrug

    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.

  • PembrolizumabDrug

    Also called KEYTRUDA; anti-PD-1 mAb

    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.

Study groups in NCT06001658
Study groupRoleWhat they receive
Gemcitabine, Cisplatin and PembrolizumabExperimentalNot described
Receives: Drug: Gemcitabine; Drug: Cisplatin; Drug: Pembrolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    The evaluable population of this endpoint consist of all patients who receive at least one dose of study drug and have TAMs and CD8 T cell measures at the time of surgery. TAMs being evaluated are the following: immunosuppressive TAMs with high Arginase-1 expression (CD68+CD163+Arg-1hiPDL1-/+), immunosuppressive TAMs with low Arginase-1 expression (CD68+CD163+Arg-1lo PDL1-/+), and less immunosuppressive TAMs (CD68+CD163-HLA-DRhi/CD86hi/PDL1hi)

    Measured: 4 years

Secondary outcomes (4)

  1. Number of participants experiencing grade 3 or above drug-related toxicities

    When calculating the incidence of AEs, each AE (as defined by NCI CTCAE v5.0) will be counted only once for a given subject.

    Measured: 4 years

  2. Number of patients proceeding to surgery without an extended treatment-related delay as a measure of feasibility

    Extended treatment delay is defined as a delay of greater than 60 days of the pre-planned surgical evaluation date, or inability to go to surgery due to an adverse event related to study treatment.

    Measured: 144 days

  3. Major pathologic response rate

    The number of participants with a major pathologic response as defined by ≤ 10% residual viable tumor cells in the resection of the primary tumor and lymph nodes.

    Measured: 8-12 weeks

  4. R0 resection rate

    The number of participants with a R0 resection as defined by a microscopically margin-negative resection, in which no tumor (gross or microscopic) remains in the primary tumor bed.

    Measured: 60 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2023
  2. Study start8 Jul 2024
  3. Primary completionJun 2028 (estimated)
  4. Study completionJun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
27 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06001658
Sponsor's protocol ID
J2390
Other IDs
IRB00371087
Status last verified
Dec 2025
First submitted
8 Aug 2023
Last updated
3 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in