Ignite Creation Date:
2025-12-24 @ 3:35 PM
Ignite Modification Date:
2026-01-18 @ 8:26 AM
Study NCT ID:
NCT06481592
Status:
RECRUITING
Last Update Posted:
2025-10-30
First Post:
2024-06-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Lifileucel (Tumor-infiltrating Lymphocytes) in Adults With Advanced Endometrial Cancer.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016889', 'term': 'Endometrial Neoplasms'}], 'ancestors': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000730287', 'term': 'lifileucel'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2029-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-29', 'studyFirstSubmitDate': '2024-06-25', 'studyFirstSubmitQcDate': '2024-06-25', 'lastUpdatePostDateStruct': {'date': '2025-10-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective Response Rate', 'timeFrame': 'Up to 5 Years', 'description': 'To evaluate the proportion of participants who have a confirmed complete response (CR) or partial response (PR) per RECIST v1.1.'}], 'secondaryOutcomes': [{'measure': 'Complete Response Rate', 'timeFrame': 'Up to 5 Years', 'description': 'To evaluate the proportion of participants who have a confirmed complete response (CR) per RECIST v1.1.'}, {'measure': 'Duration of Response', 'timeFrame': 'Up to 5 Years', 'description': 'To measure from the first time that criteria are met for complete response (CR) or partial response (PR) per RECIST v1.1.'}, {'measure': 'Disease Control Rate', 'timeFrame': 'Up to 5 Years', 'description': 'To measure by the percentage of participants with best overall confirmed response of complete response (CR) or partial response (PR) at any time or stable disease (SD) for at least 4 weeks per RICIST v1.1.'}, {'measure': 'Progression-Free Survival', 'timeFrame': 'Up to 5 Years', 'description': 'To evaluate the time from the date of the lifileucel infusion until disease progression per RECIST v1.1.'}, {'measure': 'Overall Survival', 'timeFrame': 'Up to 5 Years', 'description': 'To measure the time from the date of lifileucel infusion to death due to any cause.'}, {'measure': 'Adverse Events', 'timeFrame': 'Up to 5 Years', 'description': 'To characterize the safety and tolerability profile of lifileucel in participants with advanced endometrial cancer.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tumor Infiltrating Lymphocytes', 'TIL', 'Endometrial Cancer', 'Endometrial', 'Cell Therapy', 'Cellular Immunotherapy', 'IL-2', 'Non-myeloablative lymphodepletion (NMALD)'], 'conditions': ['Endometrial Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the efficacy and safety of the lifileucel regimen in participants with previously treated endometrial cancer.', 'detailedDescription': 'The study will enroll participants with advanced endometrial cancer who previously received treatment with platinum-based chemotherapy and an anti-programmed cell death protein-1 (PD-1)/programmed death ligand 1 (PD-L1) agent in a recurrent or advanced setting, either sequentially or in combination.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Participants must have a histologically confirmed diagnosis of endometrial carcinoma. All histologies, including carcinosarcoma, will be allowed. Uterine sarcoma will not be allowed.\n2. Participants who have received the following previous therapies:\n\n * At least 1 but no more than 4 lines of prior systemic therapy with no more than 2 lines of chemotherapy in any setting (ie, neoadjuvant or adjuvant setting as well as for recurrent, metastatic, or primary unresectable disease. .\n * Participants have received platinum-based chemotherapy and anti-PD-1/PD-L1 therapy.\n * Participants who declined platinum-based chemotherapy regimen and/or an anti-PD-1/PD-L1 therapy or were deemed ineligible for such therapies by the investigator may be considered after discussion with the medical monitor.\n * Systemic therapy counting towards lines of therapy includes chemotherapy, targeted therapy, immunotherapy, and antibody drug conjugates, given alone or in combination. Hormonal therapy does not count as a line of therapy.\n * Participants must have either (i) documented radiographic disease progression during or after the last line of therapy or (ii) discontinued their last line of therapy because of treatment intolerance or toxicity or (iii) with medical monitor discussion, participant/physician decision in the context of stable disease with evidence of tumor growth.\n3. Participants who have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and estimated life expectancy of \\>6 months.\n4. Participants having at least one resectable lesion and at least one measurable lesion, following resection of the lesion for TIL generation.\n5. Participants who have adequate organ function, including adequate cardiopulmonary function.\n6. Participants of childbearing potential must be willing to practice an approved method of highly effective birth control during treatment and up to 12 months after the last dose of study intervention.\n7. Participants who are \\>70 years of age may be allowed to enroll after the investigator discusses with the medical monitor.\n\nExclusion Criteria:\n\n1. Participants who have symptomatic untreated brain metastases.\n2. Participants who have had a history of allogeneic organ transplant or any form of cell therapy involving prior conditioning chemotherapy within the past 20 years.\n3. Participants who require systemic steroid therapy \\> 10 mg/day prednisone or another steroid equivalent dose.\n4. Participants who have any form of primary immunodeficiency.\n5. Participants who have another primary malignancy within the previous 3 years.\n6. Participants who have received or will receive a live or attenuated vaccination within 28 days prior to the start of the NMALD.'}, 'identificationModule': {'nctId': 'NCT06481592', 'briefTitle': 'A Study of Lifileucel (Tumor-infiltrating Lymphocytes) in Adults With Advanced Endometrial Cancer.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Iovance Biotherapeutics, Inc.'}, 'officialTitle': 'A Phase 2, Multicenter, Open-label Study of Lifileucel (Tumor-infiltrating Lymphocytes [TIL]) in Participants With Previously Treated Advanced Endometrial Cancer.', 'orgStudyIdInfo': {'id': 'IOV-END-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients with Endometrial Cancer', 'interventionNames': ['Biological: Lifileucel']}], 'interventions': [{'name': 'Lifileucel', 'type': 'BIOLOGICAL', 'otherNames': ['Tumor-Infiltrating Lymphocytes', 'TIL'], 'description': 'A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. After lymphodepleting chemotherapy including cyclophosphamide and fludarabine, participant is infused with lifileucel, followed by IL-2.', 'armGroupLabels': ['Patients with Endometrial Cancer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85016', 'city': 'Phoenix', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Honor Health', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '90007', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of Southern California', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Orlando Health', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'H. Lee Moffitt Cancer Center and Research Institute, Inc.', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30912', 'city': 'Augusta', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Augusta University', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'UofL Health - Brown Cancer Center', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Barbara Ann Karmanos Cancer Hospital', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '14203', 'city': 'Buffalo', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Roswell Park Cancer Institute', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '73117', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of Oklahoma', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '15524', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Allegheny Health', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '57105', 'city': 'Sioux Falls', 'state': 'South Dakota', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Avera Medical Group Oncology', 'geoPoint': {'lat': 43.54369, 'lon': -96.72796}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'MD Anderson Cancer Center - U of Texas', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Iovance Biotherapeutics Study Team', 'role': 'CONTACT', 'email': 'Clinical.Inquiries@iovance.com', 'phone': '1-844-845-4682'}], 'overallOfficials': [{'name': 'Iovance Biotherapeutics Study Team', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Iovance Biotherapeutics'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Iovance Biotherapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}