Ignite Creation Date:
2025-12-24 @ 7:34 PM
Ignite Modification Date:
2025-12-24 @ 7:34 PM
Study NCT ID:
NCT07288203
Status:
RECRUITING
Last Update Posted:
2025-12-17
First Post:
2025-12-09
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of Lifileucel (Tumor-infiltrating Lymphocytes) in Adults With Advanced Melanoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008545', 'term': 'Melanoma'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}], 'ancestors': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue 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': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-11-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2033-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-15', 'studyFirstSubmitDate': '2025-12-09', 'studyFirstSubmitQcDate': '2025-12-15', 'lastUpdatePostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2032-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective Response Rate', 'timeFrame': '5 years', 'description': 'To evaluate the efficacy of lifileucel as measured by ORR per RECIST v1.1 as assessed by the IRC'}], 'secondaryOutcomes': [{'measure': 'Complete Response Rate', 'timeFrame': '5 years', 'description': 'To evaluate the efficacy of lifileucel as measured by CR rate per RECIST v1.1 as assessed by the IRC'}, {'measure': 'Duration of Response', 'timeFrame': '5 years', 'description': 'To evaluate the efficacy of lifileucel as measured by DOR per RECIST v1.1 as assessed by the IRC'}, {'measure': 'Disease Control Rate', 'timeFrame': '5 years', 'description': 'To evaluate the efficacy of lifileucel as measured by DCR per RECIST v1.1 as assessed by the IRC'}, {'measure': 'Progression-Free Survival', 'timeFrame': '5 years', 'description': 'To evaluate the efficacy of lifileucel as measured by PFS per RECIST v1.1 as assessed by the IRC'}, {'measure': 'Objective Response Rate', 'timeFrame': '5 years', 'description': 'To evaluate the efficacy of lifileucel as measured by ORR per RECIST v1.1 as assessed by the investigators'}, {'measure': 'Complete Response Rate', 'timeFrame': '5 years', 'description': 'To evaluate the efficacy of lifileucel as measured CR rate per RECIST v1.1 as assessed by the investigators'}, {'measure': 'Duration of Response', 'timeFrame': '5 years', 'description': 'To evaluate the efficacy of lifileucel as measured by DOR per RECIST v1.1 as assessed by the investigators'}, {'measure': 'Disease Control Rate', 'timeFrame': '5 years', 'description': 'To evaluate the efficacy of lifileucel as measured by DCR per RECIST v1.1 as assessed by the investigators'}, {'measure': 'Progression-Free Survival', 'timeFrame': '5 years', 'description': 'To evaluate the efficacy of lifileucel as measured by PFS per RECIST v1.1 as assessed by the investigators'}, {'measure': 'Overall Survival', 'timeFrame': '5 years', 'description': 'To evaluate the efficacy of lifileucel as measured by OS'}, {'measure': 'Adverse Events', 'timeFrame': '5 years', 'description': 'To demonstrate safety and tolerability of lifileucel'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tumor Infiltrating Lymphocytes', 'TIL', 'Metastatic Melanoma', 'Unresectable Melanoma', 'Cell Therapy', 'Cellular Immuno-therapy', 'IL-2', 'Non-myeloablative lymphodepletion (NMALD)', 'Melanoma', 'Lifileucel', 'Skin Cancer', 'LN-144', 'BRAF v600', 'BRAF/MEK'], 'conditions': ['Melanoma (Skin Cancer)', 'Unresectable Melanoma', 'Metastatic Melanoma']}, 'descriptionModule': {'briefSummary': 'This is a Phase 2, multicenter, open-label study of lifileucel (tumor-infiltrating lymphocytes \\[TIL\\]) in participants with previously treated advanced melanoma', 'detailedDescription': 'This is a Phase 2 study of the lifileucel treatment regimen in participants who previously received treatment for unresectable or metastatic (advanced) melanoma with 1 prior line of an anti-programmed cell death protein-1 (PD-1) or anti-programmed death ligand 1 (PD-L1) agent or whose melanoma progressed during and/or within ≤ 12 weeks after adjuvant anti-PD-(L)1 treatment (early relapse). Participants who have BRAF V600 mutation positive melanoma may have received or refused 1 additional prior line treatment with a BRAF inhibitor\n\n± a MEK inhibitor'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant has a histologically or pathologically confirmed diagnosis of Stage IIIC, IIID, or IV unresectable or metastatic melanoma.\n* The participant has an ECOG performance status of 0 or 1 and an estimated life expectancy of \\> 6 months.\n* The participant must have experienced radiographic disease progression on: 1 prior line of an anti-PD-(L)1 treatment (as a monotherapy or as part of a combination) for advanced melanoma and/or during or within ≤ 12 weeks after adjuvant anti-PD-(L)1 treatment (as a monotherapy or as part of a combination). Participants who have BRAF V600 mutation positive melanoma may have received 1 additional prior line of treatment with a BRAF inhibitor ± a MEK inhibitor.\n* Participant is assessed as having at least one resectable lesion (or aggregate lesions) for lifileucel generation.\n* Participant must have at least one measurable disease as defined by RECIST 1.1 following tumor resection.\n* Participants who are \\> 70 years of age may be allowed to enroll after the investigator discusses with the medical monitor.\n* Participants of childbearing potential or those with partners of childbearing potential must be willing to practice an approved method of highly effective birth control.\n* Participants must have adequate organ function.\n* Participant is willing to receive optimal supportive care, including intensive care, from enrollment until the first post-treatment tumor assessment.\n\nExclusion Criteria:\n\n* Participant has melanoma of uveal/ocular origin.\n* Participant has symptomatic untreated brain metastases.\n* Participant has active uveitis that requires active treatment.\n* Participant has an active medical illness(es) that, in the opinion of the investigator, would pose increased risks for study participation, such as systemic infections; seizure disorders; coagulation disorders; or other active major medical illnesses of the cardiovascular, respiratory, or immune systems.\n* Participant has any form of primary or acquired immunodeficiency (eg, SCID or AIDS).\n* Participant had another primary malignancy within the previous 3 years (except for those that do not require treatment or were curatively treated \\>1 year ago, and in the judgment of the investigator do not pose a significant risk of recurrence.)\n* Participant has a history of allogeneic cell or organ transplant.\n* Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.\n\nOther protocol defined inclusion/exclusion criteria could apply.'}, 'identificationModule': {'nctId': 'NCT07288203', 'briefTitle': 'A Study of Lifileucel (Tumor-infiltrating Lymphocytes) in Adults With Advanced Melanoma', '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 Melanoma', 'orgStudyIdInfo': {'id': 'IOV-MEL-202'}, 'secondaryIdInfos': [{'id': '2025-522054-40-00', 'type': 'CTIS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single Arm', 'description': 'Lifileucel', 'interventionNames': ['Biological: Lifileucel']}], 'interventions': [{'name': 'Lifileucel', 'type': 'BIOLOGICAL', 'otherNames': ['LN-144'], 'description': 'A tumor sample is resected from each patient for lifileucel manufacturing. Patients will first receive the preparative non-myeloablative lymphodepletion (NMA-LD) regimen. They will then receive the lifileucel infusion, followed by an abbreviated course of aldesleukin.', 'armGroupLabels': ['Single Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Sarah Cannon Research Institute', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': 'M5G 2M9', 'city': 'Toronto', 'state': 'Ontario, Canada', 'status': 'RECRUITING', 'country': 'Canada', 'facility': 'Princess Margaret Cancer Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H2X 0A9', 'city': 'Montral', 'state': 'Quebec, Canada', 'status': 'RECRUITING', 'country': 'Canada', 'facility': "Centre Hospitalier de l'Universite de Montreal"}, {'zip': 'SW3 6JJ', 'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'Royal Marsden Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'centralContacts': [{'name': 'Iovance Biotherapeutics Study Team', 'role': 'CONTACT', 'email': 'Clinical.Inquiries@iovance.com', 'phone': '844-845-4682'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Iovance Biotherapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}