[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Iovance Biotherapeutics, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":277},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,54,91,138,181,206,233,251],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":35,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":4},"100650238","phase-1-a-study-of-iov-5001-in-adults-with-advanced-solid-tumors-100650238",false,"NCT07743723","A Study of IOV-5001 in Adults With Advanced Solid Tumors","A Phase 1\u002F2, Multicenter, Multi-cohort, Open-label Study of an Autologous Tumor-infiltrating Lymphocytes (TIL) Regimen With IOV-5001 in Participants With Previously Treated Advanced Solid Tumors","Inclusion Criteria:\n\n1. Participant must be ≥ 18 years of age at the time of signing the informed consent.\n2. Diagnosis:\n\n   NSCLC: Participant has a histologically or pathologically confirmed diagnosis of metastatic Stage IV NSCLC (squamous, nonsquamous, adenocarcinoma, large cell, or mixed histologies) without epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or ROS proto-oncogene 1 (ROS1) genomic alterations.\n\n   TNBC: Participant has a histologically or pathologically confirmed diagnosis of unresectable or Stage IV breast cancer.\n\n   CRC: Participant has a histologically or pathologically confirmed diagnosis of Stage IV CRC.\n\n   HNSCC: Participant has a histologically or pathologically confirmed diagnosis of Stage III or IV HNSCC not amenable to curative intent treatment.\n3. Radiographic disease progression: Participant has radiographic disease progression after the most recent line of therapy.\n4. Disease-specific criterion:\n\n   NSCLC: Radiographic disease progression occurred:\n   * After having received platinum-based chemotherapy and an immune checkpoint inhibitor, either administered concurrently or sequentially for Stage IV disease.\n   * Within 6 months of completion of the platinum component of platinum-based chemotherapy in the adjuvant or neoadjuvant setting and having progressed after receiving an immune checkpoint inhibitor in the neoadjuvant, adjuvant, or metastatic setting.\n\n   TNBC: Participant has received up to 3 prior lines of therapy. These must include at least one prior line of cytotoxic chemotherapy for unresectable or Stage IV breast cancer, regardless of ER, PR, or HER2 status at the time it was given.\n\n   CRC: Participant has received up to 3 prior lines of therapy. These must include a fluoropyrimidine, oxaliplatin, irinotecan, an anti-VEGF therapy, an anti-EGFR therapy (for RAS\u002Frapidly accelerated fibrosarcoma \\[RAF\\] wild-type disease if the tumor originated in the left side of the colon), and an immune checkpoint inhibitor (for microsatellite instability high \\[MSI-H\\] or deficient mismatch repair \\[dMMR\\] disease.\n\n   HNSCC: Participant has received up to 3 prior lines of therapy. These must include an immune inhibitor and platinum-based chemotherapy unless platinum ineligible due to pre-existing hearing loss, Grade \\>= 2 tinnitus, Grade \\>= 2 peripheral neuropathy, or allergy to platinum.\n5. Disease-specific criterion:\n\n   NSCLC: Participant has received up to 3 lines of prior therapy. These must include an appropriate health authority-approved targeted therapy for participants who have actionable mutations (other than EGFR, ALK, or ROS1 genomic alterations) if eligible and available.\n\n   TNBC: Participant has progressed on or is ineligible for other standard of care therapies including, but not limited to: sacituzumab govitecan, poly(ADP-ribose) polymerase (PARP) inhibitors (if breast cancer gene \\[BRCA\\]1 or BRCA2 mutated), trastuzumab deruxtecan (if HER2low), and pembrolizumab (for PD-L1 combined positive score \\[CPS\\] \\>= 10).\n\n   CRC: Microsatellite instability and\u002For mismatch repair mutational status must have been previously determined based on archival tumor biopsies.\n\n   HNSCC: Participant has documented PD-L1 status.\n6. The participant has an ECOG performance status of 0 or 1 and an estimated life expectancy of \\> 6 months.\n7. Participant is assessed as having at least one resectable lesion (or aggregate lesions) with an estimated minimum diameter of 1.5 cm (short axis) for IOV-5001 generation.\n\nExclusion Criteria:\n\n1. Participants with symptomatic untreated brain metastases. Participants with brain metastases may be enrolled with considerations and discussion with medical monitor.\n2. Participant has an active medical illness(es) that, in the opinion of the investigator would pose increased risks for study participation. Participant has evidence of any active viral, bacterial, or fungal infection requiring ongoing systemic treatment or identified during screening.\n3. Participant has any form of primary immunodeficiency (eg, severe combined immunodeficiency disease \\[SCID\\] or AIDS).\n4. Participant has a history of hypersensitivity to any component of the study intervention.\n5. Participant had another primary malignancy within the previous 3 years (except for those that do not require treatment or have been curatively treated \\> 1 year ago, and in the judgment of the investigator does not pose a significant risk of recurrence including, but not limited to: in situ carcinoma of the cervix, early stage skin cancer, including non-melanoma skin cancer, ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS) of the breast, prostate cancer with Gleason score ≤ 6, or superficial bladder cancer).\n6. Participant has a history of allogeneic organ transplant or any form of cell therapy involving prior conditioning chemotherapy within the past 20 years.\n7. Participant requires systemic steroid therapy \\> 10 mg\u002Fday of prednisone or another steroid equivalent dose. Participants receiving steroids as replacement therapy for adrenocortical insufficiency at ≤ 10 mg\u002Fday of prednisone or another steroid equivalent dose may be eligible.\n8. Participant received or will receive a live or attenuated vaccination within 28 days prior to the start of the NMA-LD preparative regimen.\n9. 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.","ALL","18 Years","70 Years",{"count":20,"type":21},106,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","A Phase 1\u002F2, multicenter, multi-cohort, open-label study of an autologous tumor-infiltrating lymphocytes (TIL) regimen with IOV-5001 in participants with previously treated advanced solid tumors",[28,29,30,31,32,33,34],"Advanced Solid Tumors","Non-Small Cell Lung Cancer","Triple Negative Breast Cancer (TNBC)","Colorectal Cancer","Head and Neck Squamous Cell Carcinoma","Metastatic Solid Tumors","Unresectable Solid Tumor",[36,37,28,30,33,38,39,40,41],"TIL","Tumor Infiltrating Lymphocytes","Unresectable Solid Tumors","Non-Small Cell Lung Cancer (NSCLC)","Colorectal Cancer (CRC)","Head and Neck Squamous Cell Carcinoma (HNSCC)","NOT_YET_RECRUITING","2026-08-03",{"date":45,"type":46},"2026-08-06","ACTUAL",{"date":48,"type":21},"2026-08",{"date":50,"type":21},"2044-03",{"name":52,"class":53},"Iovance Biotherapeutics, Inc.","INDUSTRY",{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":11,"sex":16,"minAge":62,"maxAge":18,"enrollmentInfo":63,"targetDuration":4,"studyType":22,"phases":65,"briefSummary":66,"conditions":67,"keywords":73,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":4},"100649901","phase-2-a-study-of-lifileucel-tumor-infiltrating-lymphocytes-in-adults-with-advanced-soft-tissue-sarcoma-100649901","NCT07741877","A Study of Lifileucel (Tumor-infiltrating Lymphocytes) in Adults With Advanced Soft Tissue Sarcoma","A Phase 2, Multicenter, Open-label Study of Lifileucel (Tumor-infiltrating Lymphocytes [TIL]) in Participants With Previously Treated Advanced Soft Tissue Sarcoma","'SARATOGA'","Inclusion Criteria:\n\n* Participant must be ≥ 16 years of age at the time of signing the informed consent and assent.\n* Participants who are \\> 70 years of age may be allowed to enroll after the investigator discusses with the medical monitor.\n* Participant must have a confirmed diagnosis of histologically confirmed unresectable or metastatic UPS (Cohort 1) or DDLPS (Cohort 2), with or without a well-differentiated component, who have received ≥ 1 and a maximum of 3 prior systemic therapies, including ≥ 1 anthracycline-based regimen.\n* Participant has demonstrated progressive disease on or after the last line of therapy.\n* Participant is assessed as having at least one resectable lesion (or aggregate lesions) with an estimated minimum diameter of 1.5 cm (short axis) for lifileucel generation.\n* Following tumor resection for lifileucel generation, the participant will have at least one measurable lesion, as defined by RECIST v1.1 at Baseline.\n* Participant is expected to achieve washout from investigational or anticancer therapy(ies).\n* If the participant has preplanned surgical procedure(s), the procedure will take place at least 14 days (for major operative procedures) prior to the tumor resection. Wound healing will have occurred, and all complications will have resolved at the time of tumor resection.\n* Participant has recovered from all prior anticancer treatment-related AEs to Grade ≤ 1(per NCI-CTCAE), except for peripheral neuropathy, alopecia, or vitiligo.\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 symptomatic untreated brain metastases.\n* The participant has an ECOG performance status of ≥ 2, a need for urgent therapy due to rapidly progressive disease or tumor mass effect, or an estimated life expectancy of\\\u003C 6 months.\n* Participant has an active medical illness(es) that, in the opinion of the investigator, would pose increased risks for study participation.\n* Participant has any form of primary immunodeficiency (eg, severe combined immunodeficiency disease \\[SCID\\] or AIDS).\n* Participant has a history of hypersensitivity to any component of the study intervention.\n* Participant had another primary malignancy within the previous 3 years (except for those that do not require treatment or have been curatively treated \\> 1 year ago, and in the judgment of the investigator does not pose a significant risk of recurrence.\n\nOther protocol defined inclusion\u002Fexclusion criteria could apply.","16 Years",{"count":64,"type":21},80,[25],"A study of lifileucel (tumor-infiltrating lymphocytes) in adults with advanced soft tissue sarcoma ('SARATOGA')",[68,69,70,71,72],"Sarcoma","Soft Tissue Sarcoma (STS)","Advanced Soft Tissue Sarcoma","Undifferentiated Pleomorphic Sarcoma (UPS)","Dedifferentiated Liposarcoma (DDLPS)",[36,37,74,75,76,77,68,78,70,79,80,81,82,83],"Cell Therapy","Cellular Immuno-therapy","IL2","Lifileucel","Soft Tissue Sarcoma","LN-145","Non-myeloablative lymphodepletion (NMALD)","SARATOGA","Undifferentiated pleomorphic sarcoma (UPS)","Dedifferentiated liposarcoma (DDLPS)","2026-07-30",{"date":43,"type":46},{"date":87,"type":21},"2026-09-01",{"date":89,"type":21},"2034-09-01",{"name":52,"class":53},{"id":92,"slug":93,"hasResults":11,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":4,"eligibilityCriteria":97,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":98,"targetDuration":4,"studyType":22,"phases":100,"briefSummary":101,"conditions":102,"keywords":104,"overallStatus":128,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":137},"100409639","phase-2-autologous-ln-145-in-patients-with-metastatic-non-small-cell-lung-cancer-100409639","NCT04614103","Autologous LN-145 in Patients With Metastatic Non-Small-Cell Lung Cancer","A Phase 2 Multicenter Study of Autologous Tumor Infiltrating Lymphocytes (TIL or LN-145) in Patients With Metastatic Non-Small-Cell Lung Cancer","Inclusion Criteria:\n\n* Patients who are over 70 years of age may be allowed to enroll after discussion with the Medical Monitor.\n* Have historically or pathologically confirmed diagnosis of metastatic Stage IV NSCLC without EGFR, ALK, or ROS1 genomic alterations.\n* For patients who have actionable mutations (other than EGFR, ALK, or ROS1 genomic alterations), 1 additional line of therapy with the appropriate health authority approved targeted therapy is required.\n* Patients must have documented radiographic disease progression on or after the first-line therapy, including concurrent or sequential ICI and platinum-based chemotherapy ± bevacizumab. No more than 1 prior line is allowed if ICI and platinum-based chemotherapy were administered concurrently and no more than 2 prior lines are allowed for sequential administration of platinum-based chemotherapy and ICI as 2 separate lines.\n* LN-145 manufacture is allowed for patients who have residual resectable disease after completion of the platinum-based chemotherapy component of the front-line ICI and platinum-based chemotherapy combination and meet all eligibility criteria except documented disease progression. These patients must intend to receive TIL therapy after disease progression\n* Prior systemic therapy in the adjuvant or neoadjuvant setting, or as part of definitive chemoradiotherapy, will count as a line of therapy if the patient had disease progression during or within 12 months after the completion of such therapy.\n* At least 1 resectable lesion for TIL production and at least one remaining measurable lesion, as defined by RECIST v1.1\n* Have adequate organ function\n* LVEF \\> 45%, NYHA Class 1\n* Have adequate pulmonary function\n* ECOG performance status of 0 or 1\n* Patients of childbearing potential or those with partners of childbearing potential must be willing to practice an approved method of highly effective birth control during treatment and up to 12 months after all protocol-related therapy\n\nExclusion Criteria:\n\n* Patients who have EGFR, ALK or ROS1 driver mutations\n* Patients who have symptomatic, untreated brain metastases.\n* Patients who have had allogeneic organ transplant or prior cell therapy within the past 20 years\n* Patients who have any form of primary immunodeficiency\n* Patients who are on systemic steroid therapy ≥ 10 mg\u002Fday of prednisone or equivalent.\n* Patients who have received a live or attenuated vaccination within 28 days prior to the start of treatment\n* Patients who have had another primary malignancy within the previous 3 years\n* Participation in another interventional clinical study within 21 days",{"count":99,"type":21},170,[25],"This is a prospective, open-label, multi-cohort, non-randomized, multicenter phase 2 study evaluating LN-145 in patients with metastatic non-small-cell lung cancer",[103],"Metastatic Non Small Cell Lung Cancer",[79,74,105,75,37,36,106,107,108,109,110,111,112,113,103,114,115,116,117,118,119,120,121,122,123,124,125,126,127],"Autologous Adoptive Cell Therapy","IL-2","Non Small Cell Lung Cancer","NSCLC","Second line Lung Cancer","Bronchial Neoplasms","Carcinoma","Lung Disease","Metastatic Lung Cancer","Metastatic NSCLC","Lung Carcinoma","PD-L1","Stage IV Lung Cancer","Stage IV Non-Small Cell Lung Cancer","Stage IV NSCLC","Systemic Therapy","2nd line therapy","Second line therapy","CPI","Immune checkpoint inhibitor (ICI)","NSCLC Recurrent","Recurrent Lung Cancer","Recurrent Lung Carcinoma","RECRUITING","2026-06-24",{"date":131,"type":46},"2026-06-26",{"date":133,"type":46},"2021-05-07",{"date":135,"type":21},"2031-12",{"name":52,"class":53},71,{"id":139,"slug":140,"hasResults":11,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":4,"eligibilityCriteria":144,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":145,"targetDuration":4,"studyType":22,"phases":147,"briefSummary":149,"conditions":150,"keywords":154,"overallStatus":128,"whyStopped":4,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":174,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":179,"locationsCount":180},"100495186","phase-3-study-to-investigate-lifileucel-regimen-plus-pembrolizumab-compared-with-pembrolizumab-alone-in-participants-with-untreated-advanced-melanoma-100495186","NCT05727904","Study to Investigate Lifileucel Regimen Plus Pembrolizumab Compared With Pembrolizumab Alone in Participants With Untreated Advanced Melanoma.","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","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\u002Focular 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\u002Fneoadjuvant 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\u002Fexclusion criteria could apply.",{"count":146,"type":21},670,[148],"PHASE3","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.",[151,152,153],"Metastatic Melanoma","Unresectable Melanoma","Melanoma",[37,36,151,152,74,75,106,80,155,153,77,156,157,158,159,160,105,161,162,163,164,165,166,167,168,169,170,171,172],"Check point inhibitor","Stage III Melanoma","Stage IV Melanoma","Skin cancer","Skin cancer types","Malignant melanoma","Autologous Adoptive Cell Transfer","LN-144","Pembrolizumab","Pembro","Adjuvant\u002FNeo-adjuvant","BRAF\u002FMEK","ICI","BRAF v600","Immune checkpoint inhibitor","Tumor infiltrating T-cells","TILVANCE","TILVANCE-301","2026-06-23",{"date":131,"type":46},{"date":176,"type":46},"2023-03-30",{"date":178,"type":21},"2030-03-01",{"name":52,"class":53},81,{"id":182,"slug":183,"hasResults":11,"nctId":184,"briefTitle":185,"officialTitle":186,"acronym":4,"eligibilityCriteria":187,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":188,"targetDuration":4,"studyType":22,"phases":190,"briefSummary":191,"conditions":192,"keywords":194,"overallStatus":128,"whyStopped":4,"lastUpdateSubmitDate":197,"lastUpdatePostDateStruct":198,"startDateStruct":200,"completionDateStruct":202,"leadSponsor":204,"locationsCount":205},"100588387","phase-1-a-study-to-investigate-the-safety-and-efficacy-of-iov-3001-in-adults-with-advanced-melanoma-who-will-receive-lifileucel-100588387","NCT06940739","A Study to Investigate the Safety and Efficacy of IOV-3001 in Adults With Advanced Melanoma Who Will Receive Lifileucel","A Phase 1\u002F2, Open-label Study of a Modified Interleukin-2 Fusion Protein (IOV-3001) in Participants With Previously Treated, Unresectable or Metastatic Melanoma Who Will Receive Lifileucel","Inclusion Criteria:\n\n1. Participant must be ≥ 18 years of age at the time of signing the informed consent.\n2. Participant has unresectable or metastatic melanoma.\n3. Participant has melanoma not of uveal\u002Focular origin and experienced documented radiographic disease progression during systemic therapy with a PD-1\u002FPD-L1 blocking antibody or within 12 weeks after the last dose of the PD-1\u002FPD-L1 blocking antibody. If the tumor is BRAF V600 mutation positive, the participant also received or refused a BRAF inhibitor with or without a MEK inhibitor.\n\n   OR Phase 1, Part 1 only: For participants with uveal melanoma, tebentafusp must have been received if available as standard of care (human leukocyte antigen \\[HLA\\]-A\\*02:01 positive participant and approved by local authorities for uveal melanoma) or refused.\n4. Participant has an ECOG performance status of 0 or 1 and, in the investigator's opinion, an estimated life expectancy of \\> 6 months.\n5. Phase 1, Part 2 only: Following tumor resection for lifileucel generation, the participant will have at least one remaining measurable lesion, as defined by RECIST v1.1.\n6. Participant has recovered from all prior anticancer treatment-related AEs\n\nExclusion Criteria:\n\n1. Participant has symptomatic untreated brain metastases.\n2. Participant is at an increased risk for systemic infections; seizure disorders; coagulation disorders; or other active major medical illnesses of the cardiovascular, respiratory, or immune systems.\n3. Participant has active uveitis that requires active treatment.\n4. Participant has any form of primary immunodeficiency (e.g., severe combined immunodeficiency disease \\[SCID\\] or AIDS).\n5. Participant has a history of hypersensitivity to any component of the study intervention.\n6. Participant had another primary malignancy within the previous 3 years.\n7. Participants who require systemic steroid therapy 10 mg\u002Fday prednisone or another steroid equivalent dose.\n8. 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.",{"count":189,"type":21},42,[24,25],"A Phase 1\u002F2, open-label study of a modified interleukin-2 fusion protein (IOV 3001) in participants with previously treated, unresectable or metastatic melanoma who will receive lifileucel.",[152,151,193],"Ocular Melanoma",[37,36,152,151,74,105,75,106,161,153,77,157,195,196],"Malignant Melanoma","Uveal Melanoma","2026-06-11",{"date":199,"type":46},"2026-06-15",{"date":201,"type":46},"2025-03-11",{"date":203,"type":21},"2032-07",{"name":52,"class":53},5,{"id":207,"slug":208,"hasResults":11,"nctId":209,"briefTitle":210,"officialTitle":211,"acronym":4,"eligibilityCriteria":212,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":213,"targetDuration":4,"studyType":22,"phases":215,"briefSummary":216,"conditions":217,"keywords":220,"overallStatus":128,"whyStopped":4,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":226,"startDateStruct":227,"completionDateStruct":229,"leadSponsor":231,"locationsCount":232},"100467009","phase-1-a-study-to-investigate-the-efficacy-and-safety-of-an-infusion-of-iov-4001-in-adult-participants-with-unresectable-or-metastatic-melanoma-or-stage-iii-or-iv-non-small-cell-lung-cancer-100467009","NCT05361174","A Study to Investigate the Efficacy and Safety of an Infusion of IOV-4001 in Adult Participants With Unresectable or Metastatic Melanoma or Stage III or IV Non-small-cell Lung Cancer","A Phase 1\u002F2, Open-label Study of PD-1 Knockout Tumor-infiltrating Lymphocytes (IOV-4001) in Participants With Unresectable or Metastatic Melanoma or Stage III or IV Non-small-cell Lung Cancer","Inclusion Criteria:\n\n1. Participants must have a confirmed diagnosis of Stage IIIC, IIID, or IV unresectable or metastatic melanoma or Stage III or IV NSCLC.\n2. Participants who have received the following previous therapy:\n\n   1. Cohort 1 (Melanoma): Participants who have progressed within 12 weeks of last dose of anti-PD-1\u002FPD-L1 blocking antibody and received BRAF\u002FMEK inhibitor in those with BRAF mutations.\n   2. Cohort 2 (NSCLC): Participants who should have received no more than 3 prior lines of therapy and:\n\n      * those without oncogene-driven tumors: Have progressed within 12 weeks after last dose of anti-PD-1\u002FPD-L1 blocking antibody\n      * those with oncogene-driven tumors: Have progressed during\u002Fafter ≥1 targeted therapy AND either:\n\n        * platinum doublet chemotherapy\n        * Or within 12 weeks after last dose of anti-PD-1\u002FPD-L1 blocking antibody\n3. Participants who have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n4. Participants who is assessed as having at least one resectable lesion.\n5. Participants who have at least one measurable lesion, following resection of the lesion for IOV-4001 generation.\n6. Participants who have adequate organ function.\n7. Cardiac function test required.\n8. Pulmonary function test may be required.\n9. Participants of childbearing potential or those with partners of childbearing potential must be willing to practice an approved method of highly effective birth control during treatment and up to 12 months.\n10. 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 melanoma of uveal\u002Focular origin.\n2. Participants who have symptomatic untreated brain metastases.\n3. 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.\n4. Participants who require systemic steroid therapy 10 mg\u002Fday prednisone or another steroid equivalent dose.\n5. Participants who have any form of primary immunodeficiency.\n6. Participants who have another primary malignancy within the previous 3 years.\n7. Participants who have received or will receive a live or attenuated vaccination within 28 days prior to the start of the NMA-LD.",{"count":214,"type":21},53,[24,25],"This is a study to investigate the efficacy and safety of an infusion of IOV-4001 in adult participants with unresectable or metastatic melanoma or advanced non-small-cell lung cancer (NSCLC).",[152,151,218,219],"Stage III Non-small Cell Lung Cancer","Stage IV Non-small Cell Lung Cancer",[37,36,152,151,221,222,223,74,105,75,106,107,108,109,110,111,112,113,103,115,116,224,117,119,120,121,122,123,155,114,125,126,127,161,153,77,156,157,158,159,160],"Stage III Non-small-cell lung cancer","Stage IV Non-small-cell lung cancer","PD-1 Knockout","Stage IV Cancer","2026-06-10",{"date":197,"type":46},{"date":228,"type":46},"2022-07-20",{"date":230,"type":21},"2029-09",{"name":52,"class":53},11,{"id":234,"slug":235,"hasResults":11,"nctId":236,"briefTitle":237,"officialTitle":237,"acronym":4,"eligibilityCriteria":238,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":239,"phases":4,"briefSummary":240,"conditions":241,"keywords":242,"overallStatus":245,"whyStopped":4,"lastUpdateSubmitDate":246,"lastUpdatePostDateStruct":247,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":249,"locationsCount":250},"100469886","expanded-access-program-of-amtagvi-that-is-out-of-specification-for-commercial-release-100469886","NCT05398640","Expanded Access Program of AMTAGVI That is Out of Specification for Commercial Release","Inclusion Criteria:\n\n1. Eligible for treatment with AMTAGVI per United States Prescribing Information (USPI)\n2. Have an AMTAGVI product manufactured for commercial treatment; however, the final manufactured product did not meet commercial release criteria but was deemed safe and acceptable for release after risk\u002Fbenefit assessment\n3. Patients of childbearing potential or those with partners of childbearing potential must be willing to practice an approved method of highly effective birth control during treatment and for 12 months after receiving the last protocol-related therapy\n\nExclusion Criteria:\n\n1. History of hypersensitivity to cyclophosphamide, mesna, fludarabine, or any component of lifileucel cryopreservation medium\n2. Ongoing systemic infection\n3. Cardiopulmonary or renal disorder which may make patient ineligible for treatment with cyclophosphamide, fludarabine or IL-2, at the discretion of the Treating Physician\n4. Experience a significant worsening in clinical status that would, in the opinion of the Treating Physician, increase the risk of toxicities from treatment with lymphodepleting chemotherapy, AMTAGVI product that is out of specification, or IL-2\n5. Any other condition, laboratory abnormality and\u002For pre-treatment assessment that places patient at unacceptable risk if they were to participate in the EAP based on the Treating Physician's judgment\n6. Pregnant or breastfeeding","EXPANDED_ACCESS","The objective of this expanded access protocol is to provide access to Out Of Specification (OOS) AMTAGVI treatment to patients.",[152,151],[162,77,243,74,37,36,244],"Adoptive Cell Therapy","Immunotherapy","AVAILABLE","2026-04-16",{"date":248,"type":46},"2026-04-20",{"name":52,"class":53},48,{"id":252,"slug":253,"hasResults":11,"nctId":254,"briefTitle":255,"officialTitle":256,"acronym":4,"eligibilityCriteria":257,"healthyVolunteers":11,"sex":258,"minAge":17,"maxAge":18,"enrollmentInfo":259,"targetDuration":4,"studyType":22,"phases":261,"briefSummary":262,"conditions":263,"keywords":265,"overallStatus":128,"whyStopped":4,"lastUpdateSubmitDate":268,"lastUpdatePostDateStruct":269,"startDateStruct":271,"completionDateStruct":273,"leadSponsor":275,"locationsCount":276},"100553092","phase-2-a-study-of-lifileucel-tumor-infiltrating-lymphocytes-in-adults-with-advanced-endometrial-cancer-100553092","NCT06481592","A Study of Lifileucel (Tumor-infiltrating Lymphocytes) in Adults With Advanced Endometrial Cancer.","A Phase 2, Multicenter, Open-label Study of Lifileucel (Tumor-infiltrating Lymphocytes [TIL]) in Participants With Previously Treated Advanced Endometrial Cancer.","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\u002FPD-L1 therapy.\n   * Participants who declined platinum-based chemotherapy regimen and\u002For an anti-PD-1\u002FPD-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\u002Fphysician 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\u002Fday 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.","FEMALE",{"count":260,"type":21},60,[25],"The purpose of this study is to investigate the efficacy and safety of the lifileucel regimen in participants with previously treated endometrial cancer.",[264],"Endometrial Cancer",[37,36,264,266,74,267,106,80],"Endometrial","Cellular Immunotherapy","2025-10-29",{"date":270,"type":46},"2025-10-30",{"date":272,"type":46},"2024-10-29",{"date":274,"type":21},"2029-11",{"name":52,"class":53},12,""]