Ignite Creation Date:
2025-12-24 @ 7:01 PM
Ignite Modification Date:
2025-12-29 @ 8:31 PM
Study NCT ID:
NCT04601857
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-03-04
First Post:
2020-10-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Futibatinib and Pembrolizumab Combination in the Treatment of Advanced or Metastatic Urothelial Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'releaseDate': '2025-12-10'}], 'estimatedResultsFirstSubmitDate': '2025-12-10'}}, 'interventionBrowseModule': {'meshes': [{'id': 'C000713257', 'term': 'futibatinib'}, {'id': 'C582435', 'term': 'pembrolizumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-01-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'dispFirstSubmitDate': '2025-03-03', 'completionDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-03', 'studyFirstSubmitDate': '2020-10-15', 'studyFirstSubmitQcDate': '2020-10-22', 'dispFirstPostDateStruct': {'date': '2025-03-04', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective response rate (ORR)', 'timeFrame': 'Approximately 12 months', 'description': 'Objective response rate (ORR), defined as the proportion of patients experiencing a best overall response of partial response (PR) or complete response (CR).'}], 'secondaryOutcomes': [{'measure': 'Disease control rate (DCR)', 'timeFrame': 'Approximately 8 months', 'description': 'DCR defined as the proportion of patients experiencing a best overall response of stable disease (SD), PR, or CR.'}, {'measure': 'Duration of response (DOR)', 'timeFrame': 'Approximately 8 months', 'description': 'DOR defined as the time from the first documentation of response (CR or PR) to the first documentation of objective tumor progression or death due to any cause, whichever occurs first.'}, {'measure': 'Progression-free survival (PFS)', 'timeFrame': 'Approximately 8 months', 'description': 'PFS defined as the time from the first dose of study therapy to the date of death (any cause) or disease progression, whichever occurs first.'}, {'measure': 'Overall survival (OS)', 'timeFrame': 'Approximately 18 months', 'description': 'OS defined as the time from the date of the first dose to the death date.'}, {'measure': 'Incidence of treatment-emergent Adverse Events (AE)[Safety and Tolerability]', 'timeFrame': 'Approximately 8 months', 'description': 'Safety and tolerability of the futibatinib and pembolizumab combination therapy based on reported AEs, graded according to the NCI-CTCAE, Version 5.0'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Futibatinib', 'Pembrolizumab', 'Urothelial cancer', 'FGFR', 'TAS120', 'MK3475 B04'], 'conditions': ['Advanced and Metastatic Urothelial Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of the trial is to evaluate the antitumor activity and confirm the safety for the combination of Fibroblast Growth Factor Receptor (FGFR) inhibitor futibatinib and anti-programmed cell death-1 (PD-1) antibody pembrolizumab in patients with advanced or metastatic urothelial cancer who are not candidates to receive a platinum-based treatment regimens.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Willing and able to provide written informed consent for the trial.\n2. Age ≥ 18 years of age\n3. Histologically confirmed advanced or metastatic urothelial carcinoma who have not received systemic treatment for advanced metastatic disease.\n\n 1. Cohort A: must have an FGFR3 mutation or FGFR1-4 fusion/rearrangement.\n 2. Cohort B: all other patients with UC (including patients with other FGFR or non-FGFR genetic aberrations and patients with wild-type \\[non-mutated\\] tumors)\n4. Unfit for or intolerant to standard platinum-based chemotherapy.\n5. Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 1.\n6. Adequate organ function.\n7. Have a measurable disease per RECIST 1.1\n\nExclusion Criteria:\n\n1. Have received prior therapy with anti-PD-1, anti-PD-L1/L2 agent or FGFR inhibitor.\n2. History and/or current evidence of any of the following disorders:\n\n 1. Non-tumor related alteration of the calcium-phosphorus homeostasis that is considered clinically significant in the opinion of the Investigator.\n 2. Ectopic mineralization/calcification considered clinically significant in the opinion of the Investigator.\n 3. Retinal or corneal disorder considered clinically significant in the opinion of the Investigator.\n3. Has received a live vaccine within 30 days prior to the first dose of study drug.\n4. Have an active autoimmune disease that has required systemic treatment in the past 2 years.\n5. Have a history of (noninfectious) pneumonitis that required steroids or has current pneumonitis.\n6. Have had an allogenic tissue/ organ transplant.\n7. Has known human immunodeficiency virus (HIV) and/or history of Hepatitis B or C infections, or known to be positive for Hepatitis B antigen (HBsAg)/ Hepatitis B virus (HBV) DNA or Hepatitis C Antibody or RNA.\n8. Have known active central nervous system metastases and/or carcinomatous meningitis.\n9. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy.\n10. Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.'}, 'identificationModule': {'nctId': 'NCT04601857', 'briefTitle': 'Futibatinib and Pembrolizumab Combination in the Treatment of Advanced or Metastatic Urothelial Carcinoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Taiho Oncology, Inc.'}, 'officialTitle': 'A Phase 2 Study Evaluating Futibatinib (TAS 120) Plus Pembrolizumab in the Treatment of Advanced or Metastatic Urothelial Carcinoma', 'orgStudyIdInfo': {'id': 'TAS-120-203'}, 'secondaryIdInfos': [{'id': '2020-000945-15', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'futibatinib and pembrolizumab (Cohort A)', 'description': 'Patients with UC and FGFR3 mutation or FGFR1-4 fusion/rearrangement.', 'interventionNames': ['Drug: futibatinib and pembrolizumab (KEYTRUDA®))']}, {'type': 'EXPERIMENTAL', 'label': 'futibatinib and pembrolizumab (Cohort B)', 'description': 'All other patients than in Cohort A with UC (including patients with other FGFR or non-FGFR genetic aberrations and patients with wild-type \\[non-mutated\\] tumors).', 'interventionNames': ['Drug: futibatinib and pembrolizumab (KEYTRUDA®))']}], 'interventions': [{'name': 'futibatinib and pembrolizumab (KEYTRUDA®))', 'type': 'DRUG', 'otherNames': ['TAS120 and MK-3475-B04'], 'description': 'Patients will receive futibatinib at an oral dose of 20 mg daily and pembrolizumab at an intravenous dose of 200 mg every 3 weeks', 'armGroupLabels': ['futibatinib and pembrolizumab (Cohort A)', 'futibatinib and pembrolizumab (Cohort B)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94158', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF Helen Diller Family Comprehensive Cancer Center', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Hospital', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '89148', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Comprehensive Care Centers of Nevada', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '67200', 'city': 'Strasbourg', 'state': 'Bas-Rhin', 'country': 'France', 'facility': 'ICANS - Institut de cancérologie de Strasbourg Europe', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '13273', 'city': 'Marseille', 'state': 'Bouches-du-Rhône', 'country': 'France', 'facility': 'Institut Paoli Calmettes - Hôpital de jour', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '21079', 'city': 'Dijon', 'state': "Côte d'Or", 'country': 'France', 'facility': 'Centre Georges-François Leclerc', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '69373', 'city': 'Lyon', 'state': 'Rhone', 'country': 'France', 'facility': "Centre Leon Berard - departement d'oncologie medicale", 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '54500', 'city': 'Vandœuvre-lès-Nancy', 'country': 'France', 'facility': 'Centre Regional de Lutte Contre le Cancer de Lorraine', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}, {'zip': '94805', 'city': 'Villejuif', 'country': 'France', 'facility': 'Institut De Cancerologie Gustave Roussy', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}, {'zip': '8243', 'city': 'Manresa', 'state': 'Brcelona', 'country': 'Spain', 'facility': 'ALTHAIA, Xarxa Assistencial Universitària de Manresa', 'geoPoint': {'lat': 41.72815, 'lon': 1.82399}}, {'zip': '08036', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Clinic de Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '8025', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital de La Santa Creu i Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '8035', 'city': 'Barcelona', 'country': 'Spain', 'facility': "Hospital Universitario Vall d'Hebrón", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '14004', 'city': 'Córdoba', 'country': 'Spain', 'facility': 'Hospital Universitario Reina Sofia', 'geoPoint': {'lat': 37.89155, 'lon': -4.77275}}, {'zip': '28050', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario HMN Sanchinarro', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '39008', 'city': 'Santander', 'country': 'Spain', 'facility': 'Hospital Universitario Marqués de Valdecilla', 'geoPoint': {'lat': 43.46589, 'lon': -3.80493}}, {'zip': '46026', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Hospital la Fe', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taiho Oncology, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}