RECRUITING

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

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Conditions

Pancreatic CancerBiliary Tract cancerPembrolizumabGemcitabineCisplatinImmunotherapyPotentially resectable biliary tract cancerAnti PD-L1PD-L1Carcinoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-07-08
Study Completion:2028-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06001658

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Must have a newly diagnosed, biopsy-proven biliary tract cancer (BTC) including gallbladder, intrahepatic, extrahepatic, and hilar cholangiocarcinoma.
  2. * Resectable BTC (biliary tract cancer)
  3. * Measurable disease per RECIST 1.1 as determined by the investigator.
  4. * Age ≥18 years.
  5. * ECOG (Eastern Cooperative Oncology Group) performance status ≤1 or Karnofsky ≥80
  6. * Patients must have adequate organ and marrow function defined by study-specified laboratory tests.
  7. * Patients must have adequate liver function defined by study-specified laboratory tests.
  8. * Patients with chronic or acute HBV or HCV infection must have disease controlled prior to enrollment.
  9. * Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test.
  10. * For both Women and Men, must use acceptable form of birth control while on study.
  11. * Ability to understand and willingness to sign a written informed consent document.
  1. * Receiving, or previously received, any systemic chemotherapy, or investigational agent for BTC.
  2. * Has received prior radiotherapy within 2 weeks of start of study intervention.
  3. * Patients with a history of prior treatment with anti-PD-1 and anti-PD-L1.
  4. * 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.
  5. * Has a known history of Human Immunodeficiency Virus (HIV)/AIDS
  6. * Has active co-infection with HBV and HDV.
  7. * Has a diagnosis of immunodeficiency.
  8. * Has active autoimmune disease that has required systemic treatment in the past 2 years.
  9. * Systemic or topical corticosteroids at immunosuppressive doses.
  10. * Prior allogeneic stem cell transplantation or organ transplantation.
  11. * Prior tissue or organ allograft or allogeneic bone marrow transplantation, including corneal transplants.
  12. * Uncontrolled intercurrent active medical and/or psychiatric illness/social psychosocial problems that that would limit compliance with study requirements.
  13. * 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.
  14. * Evidence of clinical ascites.
  15. * Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
  16. * Previously identified allergy or hypersensitivity to monoclonal antibodies or any component of the study treatment formulations.
  17. * Pregnant or breastfeeding.
  18. * WOCBP and men with female partners (WOCBP) who are not willing to use contraception.
  19. * Subjects unable to undergo venipuncture and/or tolerate venous access.
  20. * 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).

Contacts and Locations

Study Contact

Colleen Apostal, RN
CONTACT
410-614-3644
GIClinicalTrials@jhmi.edu
Joann Santmyer, RN
CONTACT
410-614-3644
GIClinicalTrials@jhmi.edu

Principal Investigator

Marina Baretti, M.D.
PRINCIPAL_INVESTIGATOR
SKCCC Johns Hopkins Medical Institution

Study Locations (Sites)

SKCCC Johns Hopkins
Baltimore, Maryland, 21231
United States

Collaborators and Investigators

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

  • Marina Baretti, M.D., PRINCIPAL_INVESTIGATOR, SKCCC Johns Hopkins Medical Institution

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-08
Study Completion Date2028-06

Study Record Updates

Study Start Date2024-07-08
Study Completion Date2028-06

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Pancreatic Cancer