Ignite Creation Date:
2025-12-25 @ 12:08 AM
Ignite Modification Date:
2026-01-02 @ 6:00 AM
Study NCT ID:
NCT06001658
Status:
RECRUITING
Last Update Posted:
2025-12-03
First Post:
2023-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Perioperative Gemcitabine, Cisplatin, and Pembrolizumab in Potentially Resectable Biliary Tract Cancers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001661', 'term': 'Biliary Tract Neoplasms'}, {'id': 'D002277', 'term': 'Carcinoma'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000093542', 'term': 'Gemcitabine'}, {'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'C582435', 'term': 'pembrolizumab'}], 'ancestors': [{'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 27}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2028-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-01', 'studyFirstSubmitDate': '2023-08-08', 'studyFirstSubmitQcDate': '2023-08-16', 'lastUpdatePostDateStruct': {'date': '2025-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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.', 'timeFrame': '4 years', 'description': '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)'}], 'secondaryOutcomes': [{'measure': 'Number of participants experiencing grade 3 or above drug-related toxicities', 'timeFrame': '4 years', 'description': 'When calculating the incidence of AEs, each AE (as defined by NCI CTCAE v5.0) will be counted only once for a given subject.'}, {'measure': 'Number of patients proceeding to surgery without an extended treatment-related delay as a measure of feasibility', 'timeFrame': '144 days', 'description': '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.'}, {'measure': 'Major pathologic response rate', 'timeFrame': '8-12 weeks', 'description': '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.'}, {'measure': 'R0 resection rate', 'timeFrame': '60 days', 'description': '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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Biliary Tract cancer', 'Pembrolizumab', 'Gemcitabine', 'Cisplatin', 'Immunotherapy', 'Potentially resectable biliary tract cancer', 'Anti PD-L1', 'PD-L1', 'Carcinoma'], 'conditions': ['Billiary Track Cancer']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must have a newly diagnosed, biopsy-proven biliary tract cancer (BTC) including gallbladder, intrahepatic, extrahepatic, and hilar cholangiocarcinoma.\n* Resectable BTC (biliary tract cancer)\n* Measurable disease per RECIST 1.1 as determined by the investigator.\n* Age ≥18 years.\n* ECOG (Eastern Cooperative Oncology Group) performance status ≤1 or Karnofsky ≥80\n* Patients must have adequate organ and marrow function defined by study-specified laboratory tests.\n* Patients must have adequate liver function defined by study-specified laboratory tests.\n* Patients with chronic or acute HBV or HCV infection must have disease controlled prior to enrollment.\n* Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test.\n* For both Women and Men, must use acceptable form of birth control while on study.\n* Ability to understand and willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Receiving, or previously received, any systemic chemotherapy, or investigational agent for BTC.\n* Has received prior radiotherapy within 2 weeks of start of study intervention.\n* Patients with a history of prior treatment with anti-PD-1 and anti-PD-L1.\n* 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.\n* Has a known history of Human Immunodeficiency Virus (HIV)/AIDS\n* Has active co-infection with HBV and HDV.\n* Has a diagnosis of immunodeficiency.\n* Has active autoimmune disease that has required systemic treatment in the past 2 years.\n* Systemic or topical corticosteroids at immunosuppressive doses.\n* Prior allogeneic stem cell transplantation or organ transplantation.\n* Prior tissue or organ allograft or allogeneic bone marrow transplantation, including corneal transplants.\n* Uncontrolled intercurrent active medical and/or psychiatric illness/social psychosocial problems that that would limit compliance with study requirements.\n* 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.\n* Evidence of clinical ascites.\n* Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.\n* Previously identified allergy or hypersensitivity to monoclonal antibodies or any component of the study treatment formulations.\n* Pregnant or breastfeeding.\n* WOCBP and men with female partners (WOCBP) who are not willing to use contraception.\n* Subjects unable to undergo venipuncture and/or tolerate venous access.\n* 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).'}, 'identificationModule': {'nctId': 'NCT06001658', 'briefTitle': 'Perioperative Gemcitabine, Cisplatin, and Pembrolizumab in Potentially Resectable Biliary Tract Cancers', 'organization': {'class': 'OTHER', 'fullName': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins'}, 'officialTitle': 'Tumor Microenvironment Features of Response to Perioperative Gemcitabine, Cisplatin, and Pembrolizumab in Potentially Resectable Biliary Tract Cancers', 'orgStudyIdInfo': {'id': 'J2390'}, 'secondaryIdInfos': [{'id': 'IRB00371087', 'type': 'OTHER', 'domain': 'Johns Hopkins Medicine Internal Review Board'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Gemcitabine, Cisplatin and Pembrolizumab', 'interventionNames': ['Drug: Gemcitabine', 'Drug: Cisplatin', 'Drug: Pembrolizumab']}], 'interventions': [{'name': 'Gemcitabine', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Gemcitabine, Cisplatin and Pembrolizumab']}, {'name': 'Cisplatin', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Gemcitabine, Cisplatin and Pembrolizumab']}, {'name': 'Pembrolizumab', 'type': 'DRUG', 'otherNames': ['KEYTRUDA; anti-PD-1 mAb'], 'description': '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.', 'armGroupLabels': ['Gemcitabine, Cisplatin and Pembrolizumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21231', 'city': 'Baltimore', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Colleen Apostol, RN', 'role': 'CONTACT', 'email': 'GIClinicalTrials@jhmi.edu', 'phone': '410-614-3644'}, {'name': 'Marina Baretti, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'SKCCC Johns Hopkins', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'centralContacts': [{'name': 'Colleen Apostal, RN', 'role': 'CONTACT', 'email': 'GIClinicalTrials@jhmi.edu', 'phone': '410-614-3644'}], 'overallOfficials': [{'name': 'Marina Baretti, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'SKCCC Johns Hopkins Medical Institution'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins', 'class': 'OTHER'}, 'collaborators': [{'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}