[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"locally-advanced-cutaneous-squamous-cell-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:locally-advanced-cutaneous-squamous-cell-carcinoma":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":4},"100548263","phase-2-neoadjuvant-pd-1-inhibitor-and-egfr-inhibitor-in-locally-advanced-cutaneous-squamous-cell-carcinoma-100548263",false,"NCT06418724","Neoadjuvant PD-1 Inhibitor and EGFR Inhibitor in Locally Advanced Cutaneous Squamous Cell Carcinoma","NEOPECS","Inclusion Criteria:\n\n1. Male or female \\> 18 years of age and able to comply with treatment, assessment and follow up\n2. Documentation of a locally advanced cutaneous squamous cell carcinoma diagnosis as evidenced by histopathology with available archival tissue. Locally Advanced cutaneous Squamous Cell Carcinoma (LASCC) defined as borderline resectable for surgery due to multiple recurrences, prior radiotherapy, large extension, bone erosion and\u002For deep infiltration beyond the subcutaneous tissue into muscle\u002Fnerve or, where curative resection may lead to unacceptable complications, morbidity or deformity, and ineligible for curative radiotherapy\n3. Measurable disease in accordance with iRECIST criteria OR clinically measurable disease \\>1cm by caliper measurement. Patients with synchronous primary cutaneous squamous cell carcinoma (cSCC) tumours will be eligible.\n4. Adequate bone marrow function with haemoglobin \\>100g\u002FL, absolute neutrophil count \\> 1.5 x 109\u002FL, platelets \\> 100 x 109\u002FL). Blood transfusion is allowable.\n5. Adequate hepatic function with total bilirubin levels \\\u003C1.5 upper limit normal range and Alanine aminotransferase (ALT) and AST levels \\\u003C2.5 level normal range.\n6. Adequate renal function with eGFR estimated with Cockcroft Gault formula \\>50mL\u002Fmin. Serum potassium levels 3.5 - 5.5 mmoL\u002FL, Serum magnesium levels 0.7 - 1.05 mmol\u002FL, Serum corrected calcium levels 2.15 - 2.55 mmol\u002FL\n7. Adequate performance status of Eastern Cooperative Oncology Group (ECOG) 0-1 as assessed by investigator\n8. Life expectancy of \\>6 months\n9. Able to provide written informed consent obtained from patient and ability for patient to comply with the requirements of the trial.\n\nExclusion Criteria:\n\n1. Distant metastatic disease (M1) including visceral or distant nodal metastases\n2. Prior receipt of checkpoint inhibitor therapy or anti-EGFR therapy for LASCC or any other malignancy\n3. Uncontrolled medical\u002Fpsychiatric co-morbidity as per investigator that may jeopardize the ability of the patient to undergo trial procedures with reasonable safety\n4. Uncontrolled autoimmune disease requiring active immune-suppression within 1 year of enrolment\n5. Corticosteroid use of \\>10mg daily of oral prednisone within 2 weeks of Cycle 1 Day 1 (C1D1)\n6. Known history of interstitial lung disease, non-infectious pneumonitis or uncontrolled diseases including pulmonary fibrosis, acute lung diseases.\n7. Uncontrolled infection with human immunodeficiency virus, hepatitis B, or hepatitis C infection; or has a diagnosis of immunodeficiency\n8. Transplant recipient\n9. Hepatitis C virus (HCV) and hepatitis B virus (HBV) testing will be performed at screening\n10. Controlled HIV infection (undetectable viral load (HIV RNA PCR) and Cluster of differentiation 4 (CD4) counts above 350 either spontaneously or on a stable antiviral regimen) is permitted. Monitoring will be performed per local standards.\n11. Controlled hepatitis B antibody positive infection (HBsAg+) is permitted providing a serum hepatitis B virus DNA PCR that is below the limit of detection and patient is receiving anti-viral therapy for hepatitis B. Periodic monitoring of HBV DNA is required. Anti-viral therapy for at least 6 months post the last dose of investigational study drug is required.\n12. Controlled hepatitis C virus antibody positive (HCV Ab+) is permitted (undetectable HCV RNA by PCR either spontaneously or in response to a successful prior course of anti-HCV therapy).\n13. History of another malignancy within 5 years prior to trial registration. A past history of adequately treated carcinoma-in-situ, basal cell carcinoma of skin, or superficial transitional cell carcinoma of the bladder is permitted. Patients with a history of other malignancies are eligible if they have been continuously disease free for at least 3 years after definitive primary treatment and low expected risk of recurrence.\n14. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with trial protocol and follow-up schedule, including alcohol and drug abuse.\n15. Pregnancy, lactation or inadequate contraception. Women must be post-menopausal, infertile or willing to use reliable means of contraception. Women of childbearing potential must have a negative pregnancy test done within 7 days prior to registration. Men must have been surgically sterilized or willing to use double barrier contraception.\n16. Sexually active men and women of childbearing potential who are unwilling to practice highly effective contraception prior to the start of the first treatment, during the study, and for at least 6 months after the last dose of investigational drug.","ALL","18 Years",{"count":19,"type":20},27,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","The NEOPECS trial is a phase II prospective, single-arm, non-randomised interventional trial for patients with borderline resectable locally advanced cutaneous squamous cell carcinoma with a 6-participant safety lead in to ensure safety of the combination in the neoadjuvant setting across 3 sites in Australia.",[26],"Locally Advanced Cutaneous Squamous Cell Carcinoma",[28,29,30,31,32,33],"immunotherapy","neoadjuvant therapy","PD-1 inhibitor","EGFR inhibitor","cetuximab","cemiplimab","NOT_YET_RECRUITING","2026-03-23",{"date":37,"type":38},"2026-03-27","ACTUAL",{"date":40,"type":20},"2026-07-30",{"date":42,"type":20},"2030-12-01",{"name":44,"class":45},"Melanoma and Skin Cancer Trials Limited","OTHER",{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":21,"phases":56,"briefSummary":57,"conditions":58,"keywords":59,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":5},"100610504","phase-2-l19il2l19tnf-in-patients-with-cutaneous-squamous-cell-carcinoma-100610504","NCT07228442","L19IL2\u002FL19TNF in Patients With Cutaneous Squamous Cell Carcinoma","A Phase 2 Study of Intratumoral Administration of L19IL2\u002FL19TNF in Locally Advanced Cutaneous Squamous Cell Carcinoma Patients Progressing on or Intolerant to Systemic Treatment","Inclusion Criteria:\n\n* Patients must have histologically documented, locally advanced cSCC.\n* Patients must have at least one injectable and measurable cutaneous or subcutaneous lesion.\n* Patients must have locally advanced cSCC that has progressed on or cannot tolerate ICI treatment (adjuvant or first line) as assessed by a local multidisciplinary tumor board.\n* Patients with nodal, regional or in transit injectable cSCC lesions.\n* Patients must be willing to provide tissue from a core or excisional biopsy of a tumor lesion at screening and for confirmation of Objective Response or Stable Disease.\n* Male or female patients, age 18 - 100 years.\n* ECOG Performance Status\u002FWHO Performance Status ≤ 2.\n* Hemoglobin \\> 10.0 g\u002FdL.\n* Platelets \\> 100 x 109\u002FL.\n* ALT and AST, GGT and Lipase ≤ 1.5 x the upper limit of normal (ULN).\n* Chronically impaired renal function as indicated by creatinine clearance \\\u003C 60 mL\u002Fmin\u002F1.73m2 or for patients older than 65 years without albuminuria or proteinuria, creatinine clearance \\\u003C 45 mL\u002Fmin\u002F1.73m2.\n* All acute toxic effects (excluding alopecia) of any prior therapy must have resolved to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v. 5.0) Grade ≤ 1 unless otherwise specified.\n* Women of childbearing potential (WOCBP) must have negative pregnancy test results at screening. WOCBP must be using, from screening to three months following the last study drug administration, highly effective contraception methods, as defined by the \"Recommendations for contraception and pregnancy testing in clinical trials\" issued by the Head of Medicine Agencies' Clinical Trial Facilitation Group and which include, for instance, progesterone-only or combined (estrogenand progesterone-containing) hormonal contraception associated with inhibition of ovulation, intrauterine devices, intrauterine hormone-releasing systems, bilateral tubal occlusion, vasectomised partner.\n* Male patients with WOCBP partners must agree to use simultaneously two acceptable methods of contraception (i.e. spermicidal gel plus condom) from the screening to three months following the last study drug administration.\n* Willingness and ability to comply with the scheduled visits, treatment plan, laboratory tests and other study procedures.\n\nExclusion Criteria:\n\n* Presence of concomitant malignancies, with the exception of any cancer curatively treated more than 3 years prior to study entry and of tumors with a negligible risk for metastasis or death, such as adequately treated basal cell carcinoma of the skin (surgically removed at least 4 weeks prior to study entry), ductal carcinoma in situ of the breast, or carcinoma in situ of the cervix, early-stage asymptomatic CLL and not under active treatment (Rai 0, Binet A) will be eligible for the study.\n* Radiation therapy on the tumor sites in the 4 weeks prior to study drug administration.\n* Current topical or systemic chemotherapy, immunotherapy.\n* Presence of visceral metastasis.\n* Presence of active severe bacterial or viral infections or other severe concurrent disease\u002Finfection requiring therapy, including positive tests for human immunodeficiency virus (HIV)-1 or HIV-2 serum antibody, hepatitis B virus (HBV), or hepatitis C virus (HCV). For HBV serology, the determination of HBsAg and anti-HBcAg Ab is required. In patients with serology documenting previous exposure to HBV, negative serum HBV-DNA is required. For HCV, HCV-RNA or HCV antibody test is required. Subjects with a positive test for HCV antibody but no detection of HCV-RNA indicating no current infection are eligible.\n* History within the last year of acute or subacute coronary syndromes including myocardial infarction, unstable or severe stable angina pectoris, inadequately treated cardiac arrhythmias and heart insufficiency (any grade, New York Heart Association (NYHA) criteria).\n* Any abnormalities observed during baseline ECG investigations that are considered clinically significant by the investigator.\n* Known arterial aneurysms.\n* INR \\> 3.\n* Uncontrolled hypertension.\n* Known uncontrolled coagulopathy or bleeding disorder.\n* Known hepatic cirrhosis or severe pre-existing hepatic impairment.\n* Moderate to severe respiratory failure.\n* Active autoimmune disease that has required systemic treatment in past 2 years.\n* Patients have a diagnosis of immunodeficiency or are receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug. Limited use of corticosteroids to treat or prevent acute hypersensitivity reactions and asthma\u002FCOPD is not considered an exclusion criterion.\n* Known history of allergy to IL2, TNF, or other human proteins\u002Fpeptides\u002Fantibodies.\n* Pregnancy or breast-feeding.\n* Ischemic peripheral vascular disease (Grade IIb-IV).\n* Severe diabetic retinopathy.\n* Recovery from major trauma including surgery within 4 weeks prior to enrollment.\n* Solid organ transplant recipient or patient with iatrogenic or pathologic severe immune suppression.\n* Patients with a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.\n* Patients who have received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin, and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed.\n* Any conditions that in the opinion of the investigator could hamper compliance with the study protocol.","100 Years",{"count":55,"type":20},92,[23],"Open-label, single-arm, multicenter study in patients with locally advanced, histologically confirmed Cutaneous Squamous Cell Carcinoma (LacSCC) amenable to intratumoral injection, who have progressed on or are intolerant to Immune Checkpoint Inhibitor (ICI). The primary objective of the study is to evaluate the activity of intratumoral L19IL2\u002FL19TNF, while the secondary objective is to assess the safety and efficacy. The patients will receive multiple intratumoral administrations of combined L19IL2 and L19TNF to all injectable cutaneous and subcutaneous lesions once weekly for up to 4 weeks: for those who have a partial response or stable disease as their best response, a second 4-week course L19IL2\u002FL19TNF of four weekly injections may be administered as per treating physician judgement. Patients will be followed for a maximum of 160 weeks after beginning of treatment.",[26],[60,61,62,63,64],"Cutaneous Squamous Cell Carcinoma","Immune Checkpoint Inhibitor","subcutaneous lesions","locally advanced","cutaneous lesions","2026-03-06",{"date":67,"type":38},"2026-03-09",{"date":69,"type":20},"2026-02",{"date":71,"type":20},"2031-02",{"name":73,"class":74},"Philogen S.p.A.","INDUSTRY"]