Ignite Creation Date:
2025-12-24 @ 7:55 PM
Ignite Modification Date:
2026-02-17 @ 9:00 PM
Study NCT ID:
NCT05727904
Status:
RECRUITING
Last Update Posted:
2025-07-08
First Post:
2023-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Investigate Lifileucel Regimen Plus Pembrolizumab Compared With Pembrolizumab Alone in Participants With Untreated 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'}, {'id': 'C582435', 'term': 'pembrolizumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 670}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'nctId': 'NCT05398640', 'statusForNctId': 'AVAILABLE', 'hasExpandedAccess': True}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2030-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-07', 'studyFirstSubmitDate': '2023-02-06', 'studyFirstSubmitQcDate': '2023-02-06', 'lastUpdatePostDateStruct': {'date': '2025-07-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective Response Rate and Progression Free Survival', 'timeFrame': '5 years total duration', 'description': 'To compare the efficacy of lifileucel plus pembrolizumab with the efficacy of pembrolizumab alone measured by objective response rate (ORR) and progression-free survival (PFS) assessed by the blinded independent review committee (BIRC) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1'}], 'secondaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': '7 years total duration', 'description': 'To compare the efficacy of lifileucel plus pembrolizumab with the efficacy of pembrolizumab alone measured by overall survival (OS)'}, {'measure': 'Complete Response Rate, Duration of Response and Event Free Survival', 'timeFrame': '5 years total duration', 'description': 'To compare the efficacy of lifileucel plus pembrolizumab with the efficacy of pembrolizumab alone measured by complete response (CR) rate and duration of response (DOR) and event- free survival (EFS) assessed by the BIRC per RECIST v1.1'}, {'measure': 'Objective Response Rate, Progression Free Survival, Complete Response Rate, Duration of Responses, Event Free Survival and PFS2', 'timeFrame': '5 years total duration', 'description': 'To compare the efficacy of lifileucel plus pembrolizumab with the efficacy of pembrolizumab alone measured by ORR, PFS, CR rate, DOR, and EFS assessed by the investigator per RECIST v1.1 and PFS2 assessed by the investigator'}, {'measure': 'Adverse Events', 'timeFrame': '5 years total duration', 'description': 'To characterize the safety and tolerability profile of lifileucel plus pembrolizumab and pembrolizumab alone in participants with unresectable or metastatic melanoma'}]}, 'oversightModule': {'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)', 'Check point inhibitor', 'Melanoma', 'Lifileucel', 'Stage III Melanoma', 'Stage IV Melanoma', 'Skin cancer', 'Skin cancer types', 'Malignant melanoma', 'Autologous Adoptive Cell Therapy', 'Autologous Adoptive Cell Transfer', 'LN-144', 'Pembrolizumab', 'Pembro', 'Adjuvant/Neo-adjuvant', 'BRAF/MEK', 'ICI', 'BRAF v600', 'Immune checkpoint inhibitor', 'Tumor infiltrating T-cells', 'TILVANCE', 'TILVANCE-301'], 'conditions': ['Metastatic Melanoma', 'Unresectable Melanoma', 'Melanoma']}, 'descriptionModule': {'briefSummary': 'This is a Phase 3, multicenter, open-label, randomized, parallel group, treatment study to assess the efficacy and safety of lifileucel in combination with pembrolizumab compared with pembrolizumab alone in participants with untreated, unresectable or metastatic melanoma. Participants randomized to the pembrolizumab monotherapy arm who subsequently have a blinded independent central review- verified confirmed progressive disease (PD) will be offered lifileucel monotherapy in an optional crossover period.', 'detailedDescription': 'The study will enroll participants with unresectable or metastatic melanoma (Stage IIIC, IIID, or IV per the American Joint Committee on Cancer \\[AJCC\\] staging system) who have had no prior therapy for metastatic disease. Previous adjuvant/neoadjuvant therapy with a single line of protooncogene B-Raf (BRAF) inhibitor with or without a mitogen-activated protein kinase (MEK) inhibitor, PD-1 inhibitor, or cytotoxic T-lymphocyte-associated antigen-4 \\[CTLA-4\\] inhibitor is allowed, provided such treatment was completed ≥6 months before progression to metastatic disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Participant has a histologically or pathologically confirmed diagnosis of Stage IIIC, IIID, or IV unresectable or metastatic melanoma.\n2. In the investigator's assessment, the participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and an estimated life expectancy of \\> 6 months.\n3. Participant is assessed as having at least one resectable lesion (or aggregate lesions) for lifileucel generation.\n4. Participant must have at least one measurable disease as defined by RECIST 1.1 following tumor resection.\n5. Participants must have adequate organ function.\n6. Participants of childbearing potential or those with partners of childbearing potential must be willing to practice an approved method of highly effective birth control.\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. Participant has melanoma of uveal/ocular origin.\n2. Participant has symptomatic untreated brain metastases.\n3. Participant received more than 1 prior line of therapy.\n4. Participant received prior therapy for metastatic disease\n5. Participants with a BRAF V600 mutation-positive tumor received prior adjuvant/neoadjuvant ICI therapy only\n6. 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.\n7. Participant has any form of primary or acquired immunodeficiency (eg, SCID or AIDS).\n8. 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.)\n9. Participant has a history of allogeneic cell or organ transplant.\n\nOther protocol defined inclusion/exclusion criteria could apply."}, 'identificationModule': {'nctId': 'NCT05727904', 'briefTitle': 'Study to Investigate Lifileucel Regimen Plus Pembrolizumab Compared With Pembrolizumab Alone in Participants With Untreated Advanced Melanoma.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Iovance Biotherapeutics, Inc.'}, 'officialTitle': 'A Phase 3, Multicenter, Randomized, Open-label, Parallel Group, Treatment Study to Assess the Efficacy and Safety of the Lifileucel (LN-144, Autologous Tumor Infiltrating Lymphocytes [TIL]) Regimen in Combination With Pembrolizumab Compared With Pembrolizumab Monotherapy in Participants With Untreated, Unresectable or Metastatic Melanoma', 'orgStudyIdInfo': {'id': 'IOV-MEL-301'}, 'secondaryIdInfos': [{'id': 'TILVANCE-301', 'type': 'OTHER', 'domain': 'Iovance Biotherapeutics, Inc.'}, {'id': 'TILVANCE', 'type': 'OTHER', 'domain': 'Iovance Biotherapeutics, Inc.'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A', 'description': 'Lifileucel plus Pembrolizumab', 'interventionNames': ['Biological: Lifileucel plus Pembrolizumab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm B', 'description': 'Pembrolizumab alone with Optional Crossover Period', 'interventionNames': ['Biological: Pembrolizumab with Optional Crossover Period']}], 'interventions': [{'name': 'Lifileucel plus Pembrolizumab', 'type': 'BIOLOGICAL', 'otherNames': ['LN-144', 'Pembrolizumab'], 'description': 'A tumor sample is resected from each patient for Lifileucel manufacturing. Patients then receive Pembrolizumab followed by the lifileucel regimen which consists of non-myeloablative lymphodepletion, lifileucel infusion followed by IL-2. Patients will then continue to receive Pembrolizumab every 6 weeks until disease progression.', 'armGroupLabels': ['Arm A']}, {'name': 'Pembrolizumab with Optional Crossover Period', 'type': 'BIOLOGICAL', 'description': 'Patient will receive Pembrolizumab monotherapy every 6 weeks until disease progression. Upon verified confirmed disease progression by the blinded independent review central committee, patients may proceed to lifileucel monotherapy during an optional crossover period if they meet eligibility criteria.\n\nOptional crossover: A tumor sample is resected from each patient for Lifileucel manufacturing. Patients then receive the lifileucel regimen which consists of non-myeloablative lymphodepletion, lifileucel infusion followed by IL-2.', 'armGroupLabels': ['Arm B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of Alabama at Birmingham: The Kirklin Clinic', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '91010', 'city': 'Duarte', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'City of Hope', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '90007', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'USC Norris Comprehensive Cancer Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94107', 'city': 'San Francisco', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'California Pacific Medical Center', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of Colorado Cancer Center', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Orlando Health Cancer Institute', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of Illinois Hospital & Health Sciences System', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '66205', 'city': 'Kansas City', 'state': 'Kansas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of Kansas', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of Louisville - James Graham Brown Cancer Center', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '20814', 'city': 'Bethesda', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'National Cancer Institute', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Barbara Ann Karmanos Cancer Hospital dba Karmanos Cancer Center', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Henry Ford Health', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '03756', 'city': 'Lebanon', 'state': 'New Hampshire', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Dartmouth-Hitchcock Medical Center (DHMC) - Norris Cotton Cancer Center', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}, {'zip': '08103', 'city': 'Camden', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'MD Anderson Cancer Center at Cooper', 'geoPoint': {'lat': 39.92595, 'lon': -75.11962}}, {'zip': '45226', 'city': 'Cincinnati', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Oncology Hematology Care', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '43201', 'city': 'Columbus', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Ohio State University', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '18045', 'city': 'Easton', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'facility': "St. Luke's Cancer Center - 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Hospital Duran i Reynals", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '28007', 'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital General Universitario Gregorio Maranon', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28041', 'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital 12 de Octubre', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28050', 'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Universitario Madrid Sanchinarro - CIOCC', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28223', 'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Universitario Quirónsalud Madrid', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Universitario Ramon y Cajal', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '31008', 'city': 'Pamplona', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Clínica Universitaria de Navarra', 'geoPoint': {'lat': 42.81687, 'lon': -1.64323}}, {'zip': '41009', 'city': 'Seville', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Universitario Virgen Macarena', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '46014', 'city': 'Valencia', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Consorcio Hospital General Universitario de Valencia', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': 'SE-41346', 'city': 'Gothenburg', 'state': 'Västra Götaland County', 'status': 'RECRUITING', 'country': 'Sweden', 'facility': 'Sahlgrenska Universitetssjukhuset', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}, {'zip': '1011', 'city': 'Lausanne', 'status': 'RECRUITING', 'country': 'Switzerland', 'facility': 'Centre Hospitalier Universitaire Vaudois Lausanne', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}, {'zip': 'B15 2GW', 'city': 'Birmingham', 'state': 'England', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'Queen Elizabeth Hospital Birmingham', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'zip': 'NE7 7DN', 'city': 'Newcastle upon Tyne', 'state': 'England', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'Freeman Hospital', 'geoPoint': {'lat': 54.97328, 'lon': -1.61396}}, {'zip': 'SW3 6JJ', 'city': 'Chelsea', 'state': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'Royal Marsden Hospital', 'geoPoint': {'lat': 51.48755, 'lon': -0.16936}}, {'zip': 'G120YN', 'city': 'Glasgow', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'Beaston West of Scotland Canter Centre', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'zip': 'SE1 9RT', 'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': "Guy's Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'W1G 6AD', 'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'Sarah Cannon Research Institute UK', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'centralContacts': [{'name': 'Iovance Biotherapeutics https://www.tilvance-301.com', 'role': 'CONTACT', 'email': 'Clinical.Inquiries@iovance.com', 'phone': '1-844-845-4682'}, {'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'}}}}