[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cutaneous-squamous-cell-carcinoma-cscc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cutaneous-squamous-cell-carcinoma-cscc":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,15,0,[8,48,79,111,138,169,197,225,258,285,319,344,366,391,422],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"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":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100561073","phase-3-study-of-intralesional-cemiplimab-in-adult-patients-with-early-stage-cutaneous-squamous-cell-carcinoma-100561073",false,"NCT06585410","Study of Intralesional Cemiplimab in Adult Patients With Early Stage Cutaneous Squamous Cell Carcinoma","A Phase 3 Randomized Study of Intralesional Cemiplimab Versus Primary Surgery in Participants With Early Stage Cutaneous Squamous Cell Carcinoma (CSCC)","Key Inclusion Criteria:\n\n1. Participants who have a histologically confirmed invasive CSCC TL, as described in the protocol\n2. Participants who have CSCC TL ≥1 cm and ≤2.0 cm (longest diameter) located in either the Head or Neck (HN), hand, or pre-tibial surface, as described in the protocol\n3. Participants who are judged to be eligible for surgical resection of their CSCC TL and the method of planned surgical resection would be Micrographically oriented histographic surgery (Mohs) or other surgical method of Complete Margin Assessment (CMA). Participants for whom the planned surgery is surgical excision without margin control are not eligible\n4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤1\n5. Adequate hepatic, renal and bone marrow functions, as described in the protocol\n\nKey Exclusion Criteria:\n\n1. Participant in which the TL is a keratoacanthoma (KA), adenosquamous carcinoma, desmoplastic carcinoma, sarcomatoid carcinoma, basal cell carcinoma, basosquamous carcinoma, Bowen's disease, or CSCC in situ without an invasive component. (Note: For participants with invasive CSCC with a minor basaloid component, the patient may be eligible after discussion with the sponsor medical director.)\n2. Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-mediated Adverse Events (imAEs), as described in the protocol\n3. History of non-infectious pneumonitis within the last 5 years\n4. TL (lesion planned for intralesional therapy) or other non-target CSCC lesion in dry red lip (vermillion), oral cavity, or nasal mucosa\n\nNOTE: Other protocol defined inclusion \u002F exclusion criteria apply.","ALL","18 Years",{"count":19,"type":20},369,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","This study will test a study drug called cemiplimab to see if it can help treat early-stage Cutaneous Squamous Cell Carcinoma (CSCC), a type of skin cancer. Cemiplimab works by helping the immune system to kill cancer cells. It binds to a protein called Programmed cell Death-1 (PD-1) on the surface of certain immune cells.\n\nThe main purpose of this study is to compare how well cemiplimab works compared to surgery, when injected into the lesion.\n\nThe study is looking at:\n\n* The side effects cemiplimab might cause\n* How well cemiplimab works compared to surgery",[26],"Cutaneous Squamous Cell Carcinoma (CSCC)",[28,29,30,31,32,33,34],"Dermato-Oncology","Cemiplimab","Early Stage","Skin Cancer","Non-Melanoma Skin Cancer","UV Skin Damage","Chronic Sun Exposure","RECRUITING","2026-06-29",{"date":38,"type":39},"2026-06-30","ACTUAL",{"date":41,"type":39},"2025-01-02",{"date":43,"type":20},"2030-05-03",{"name":45,"class":46},"Regeneron Pharmaceuticals","INDUSTRY",52,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":21,"phases":56,"briefSummary":58,"conditions":59,"keywords":62,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":78},"100614955","early-phase-1-a-randomized-controlled-trial-of-topical-5-niacinamide-for-skin-cancer-prevention-in-transplant-recipients-100614955","NCT07286318","A Randomized Controlled Trial of Topical 5% Niacinamide for Skin Cancer Prevention in Transplant Recipients","Inclusion Criteria:\n\nAge ≥18 History of solid organ transplantation At least 5 AKs in the past year or prior history of skin cancer Participants are willing to continue using SPF30 sunscreen from their own supply\n\nExclusion Criteria:\n\nKnown allergy to niacinamide or sunscreen components Eczema or other skin conditions for which niacinamide is contraindicated",{"count":55,"type":20},20,[57],"EARLY_PHASE1","A Randomized Controlled Trial of Topical 5% Niacinamide for Skin Cancer Prevention in Organ Transplant Recipients\n\nThis study is designed to evaluate whether a topical 5% niacinamide cream can help prevent skin cancer in organ transplant recipients. Individuals who have received an organ transplant have a much higher risk of developing precancerous skin growths and skin cancers because of long-term immune-suppressing medications. Although sunscreen is an important part of sun protection, additional preventive approaches are needed. Early research suggests that niacinamide may help protect the skin, and this trial will examine whether a topical formulation provides benefit in this high-risk group.\n\nThe study will test whether daily use of topical 5% niacinamide reduces the number of actinic keratoses over 6 and 12 months and whether it decreases the development of new keratinocyte cancers when compared with sunscreen alone. The study will also evaluate how well the topical product is tolerated and whether it can be used consistently as part of a daily skin-care routine.\n\nA total of 20 adult organ transplant recipients with a history of multiple actinic keratoses and at least one prior non-melanoma skin cancer will enroll in this 12-month, randomized, controlled trial. Participants will be assigned to receive either daily topical 5% niacinamide plus sunscreen or sunscreen alone. Skin examinations will be performed at 6 and 12 months using standardized mapping methods. Information on treatment tolerability, adherence, and any side effects will be collected through structured surveys, and any lesions suspicious for cancer will be evaluated by a board-certified pathologist.",[31,26,60,61],"Actinic Keratosis (AK)","Organ Transplant Recipient",[63,64,65,66,67],"Niacinamide","Cutaneous squamous cell carcinoma","Basal cell carcinoma","Organ transplant recipient","Actinic keratosis","2026-06-03",{"date":70,"type":39},"2026-06-05",{"date":72,"type":39},"2026-05-01",{"date":74,"type":20},"2027-06-30",{"name":76,"class":77},"Marissa Lobl","OTHER",2,{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":87,"targetDuration":4,"studyType":21,"phases":89,"briefSummary":91,"conditions":92,"keywords":93,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":110},"100592815","phase-2-mohs-surgery-and-short-course-radiation-therapy-with-structured-follow-up-for-head--neck-squamous-cell-skin-cancer-100592815","NCT06998342","MOHs Surgery and Short-Course Radiation Therapy With Structured Follow-Up for Head & Neck Squamous Cell Skin Cancer","MOHs Surgery and Adjuvant Short-course Hypofractionated Radiation Therapy With Structured Surveillance for Cutaneous Head & Neck Squamous Cell Carcinoma: a Phase II Pilot Study (MOHSAHRTSS-Study)","MOHSAHRTSS","Inclusion Criteria:\n\n* Pathologically confirmed cutaneous squamous cell carcinoma of the head \\& neck region, defined as extending from vertex of head to supraclavicular region.\n* Mohs micrographic surgery with or without further surgery following Mohs to achieve negative margins (i.e. R0 margin status) within 70 days prior to registration\n* Appropriate stage for study entry (T1-T3 N0 M0; AJCC 8th ed.) based on the following diagnostic workup:\n\n  * Clinical exam within 60 days prior to registration\n  * CT head \\& neck\u002Fsoft tissue with IV contrast within 60 days prior to registration or MR face and neck with IV contrast. IV contrast may be held if medically contraindicated.\n  * Bilateral neck ultrasound within 60 days prior to registration\n* Risk Factors fitting either the High-Risk or Moderate-Risk Categories:\n\n  * Risk Factor Definitions\n\nMajor Risk Factors: Microscopic Extensive PNI (defined as PNI for \\>3 nerves with all involved nerves either \\>0.1 mm in size and\u002For deeper than the dermis), Gross PNI (defined as perineural spread evidenced on by MRI imaging, with cranial nerve deficit, or both), Size \\>6 cm, or Recurrent disease status post prior Mohs\n\nModerate-Risk Factors: Poor differentiation, 4-6 cm, PNI (defined as \\>0.1 mm in size)\n\nBWH Risk factors: \\>2 cm, poor differentiation, deep invasion, PNI (\\>0.1 mm in size)\n\n• BWH: T2a = 1 risk factor; T2b = 2-3 risk factors, T3 = 4 risk factors\n\nHigh-Risk Group (Group H) Any 1 major OR 2-3 moderate OR BWH T3\n\nModerate-Risk Group (Group M) BWH T2b not meeting criteria for High-Risk.\n\nExclusion Criteria:\n\n* Patients receiving any other investigational agents.\n\nPatients pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.\n\nSerious medical comorbidities that, in the opinion of the radiation oncologist, would prevent participation in this study.\n\nPrior systemic chemotherapy for the study cancer; note that prior chemotherapy for different cancer(s) is allowable\n\nPrior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields\n\nActively receiving systemic cytotoxic chemotherapy, immunosuppressive, anti-monocyte or immunomodulatory therapy.",{"count":88,"type":20},24,[90],"PHASE2","The goal of this clinical trial is to evaluate if short-course radiation therapy (SCRT) can effectively treat high-risk cutaneous squamous cell carcinoma (cSCC) and if active surveillance is a safe alternative to radiation for moderate-risk cSCC in adults with head and neck cSCC who have undergone surgery.\n\nThe main questions it aims to answer are:\n\nDoes short-course radiation therapy (5 treatments over 2 weeks) effectively prevent cancer recurrence in high-risk patients? Can moderate-risk patients be safely monitored with active surveillance instead of receiving radiation?\n\nResearchers will compare:\n\nShort-course radiation therapy (SCRT) for high-risk patients to historical data on long-course radiation to determine effectiveness.\n\nActive surveillance for moderate-risk patients to expected recurrence rates to assess safety.\n\nParticipants will:\n\nHigh-Risk Group (SCRT): Receive short-course radiation therapy and attend follow-up visits.\n\nModerate-Risk Group (Active Surveillance): Have regular check-ups, including clinical exams and imaging, to monitor for cancer recurrence.\n\nOptionally provide blood samples for future biomarker research.",[26],[94,95,96,97,98,99,100],"Cutaneous Squamous Cell Carcinoma","Head and Neck Cancer","Neoadjuvant Therapy","Immunotherapy","Surgical Oncology","Clinical Trial","Radiation","2026-05-20",{"date":103,"type":39},"2026-05-26",{"date":105,"type":39},"2025-06-04",{"date":107,"type":20},"2031-05",{"name":109,"class":77},"University of Vermont Medical Center",1,{"id":112,"slug":113,"hasResults":11,"nctId":114,"briefTitle":115,"officialTitle":115,"acronym":116,"eligibilityCriteria":117,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":118,"targetDuration":120,"studyType":121,"phases":4,"briefSummary":122,"conditions":123,"keywords":124,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":137},"100637369","follow-up-of-a-french-national-cohort-of-patients-with-cutaneous-squamous-cell-carcinoma-requiring-systemic-treatment-100637369","NCT07606508","Follow-up of a French National Cohort of Patients With Cutaneous Squamous Cell Carcinoma Requiring Systemic Treatment.","CAREPI","Inclusion Criteria:\n\n* Patients with a diagnosis of primary cutaneous squamous cell carcinoma initiating first-line systemic therapy, whether administered with curative, adjuvant, or neoadjuvant intent.\n\n  * Male or female patients.\n  * Age ≥18 years.\n  * No documented objection to participation in the study.\n\nExclusion Criteria:\n\n* Patients who refuse to participate in the study or who object to the collection or processing of their personal data.\n* Initiation of systemic therapy prior to 2020.\n* Patients not requiring systemic therapy.\n* More than one line of systemic therapy at the time of inclusion.\n* Patients under legal guardianship or curatorship.\n* Individuals deprived of liberty.\n* lack of health insurance coverage.",{"count":119,"type":20},1500,"5 Years","OBSERVATIONAL","In the context where advanced cutaneous squamous cell carcinoma (cSCC) is currently a public health issue due to its increasing incidence and where its management is rapidly evolving, it is essential to characterize and monitor changes in therapeutic strategies for patients requiring systemic treatment with adjuvant\u002Fneoadjuvant or curative setting.\n\nThe overall objective of this study is to describe the long-term, real-life management of patients with cSCC requiring systemic therapy, including their clinical characteristics as well as treatment effectiveness and safety. To achieve this aim, the project is based on the establishment of a French national database of patients with cSCC receiving systemic therapy. This is a non-interventional multicenter study involving approximately 30 centers from the French Cutaneous Oncology Group (GCC), including a retrospective phase (from January 2020 for initiation of first-line systemic therapy) followed by a prospective phase.\n\nTime perspective is Retrospective and Prospective",[26],[26,125,126,127,128],"skin","Adjuvant Treatment","Neoadjuvant treatment","Curative treament","2026-05-18",{"date":103,"type":39},{"date":132,"type":39},"2021-07-09",{"date":134,"type":20},"2036-07-15",{"name":136,"class":77},"University Hospital, Lille",29,{"id":139,"slug":140,"hasResults":11,"nctId":141,"briefTitle":142,"officialTitle":142,"acronym":4,"eligibilityCriteria":143,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":144,"targetDuration":4,"studyType":21,"phases":146,"briefSummary":148,"conditions":149,"keywords":154,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":78},"100640027","phase-1-a-first-in-human-study-to-evaluate-the-safety-pharmacokinetics-and-pharmacodynamics-of-kup-101a-in-patients-with-selected-advanced-solid-tumors-100640027","NCT07600476","A First-in-Human Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of KUP-101A in Patients With Selected Advanced Solid Tumors","Inclusion Criteria:\n\n* Histologically confirmed cancer with evidence of advanced disease for which no other standard treatment is available\n* ECOG Performance status of 0 to 2\n* Adequate hematological, renal, and hepatic organ function\n\nExclusion Criteria:\n\n* Previous systemic treatment with TLR agonists, with the exception of TLR agonists used as vaccine adjuvants.\n* Known additional malignancy that is progressing or requires active treatment\n* Diagnosis of immunodeficiency\n* Active autoimmune disease not caused by prior anticancer treatment that required systemic immunosuppressive treatment in the past 2 years\n* Active autoimmune disease caused by prior anticancer treatment, unless currently controlled by replacement therapy only.\n* Any kind of leukemia\n* Previously received an organ transplant (other than corneal transplants) or hematopoietic stem cell transplantation\n* Known active central nervous system metastases and\u002For carcinomatous meningitis\n* Cerebral vascular event within 6 months before Screening\n* Unstable cardiopulmonary status defined by uncontrolled congestive heart failure of New York Heart Association Grade III or IV, unstable angina, or myocardial infarction within 6 months before Screening\n* High grade ocular disease such as uncontrolled glaucoma",{"count":145,"type":20},21,[147],"PHASE1","The purpose of this trial is to find the maximum tolerated and recommended Phase 2 dose of KUP-101A and to evaluate its safety and tolerability. Additionally, pharmacokinetics and pharmacodynamics will be assessed, and first data on KUP-101A's efficacy in patients with advanced solid tumors will be obtained.",[150,151,26,152,153],"Cutaneous Melanoma","Mucosal Melanoma","Merkel Cell Carcinoma of Skin","Basal Cell Carcinoma of Skin",[155,156,157,158,159,160],"TLR4 agonist","TLR7 agonist","TLR4\u002F7 agonist","skin cancer","innate immunity","immunotherapy","2026-05-13",{"date":101,"type":39},{"date":164,"type":20},"2026-04",{"date":166,"type":20},"2028-12",{"name":168,"class":46},"Kupando GmbH",{"id":170,"slug":171,"hasResults":11,"nctId":172,"briefTitle":173,"officialTitle":174,"acronym":175,"eligibilityCriteria":176,"healthyVolunteers":11,"sex":16,"minAge":177,"maxAge":4,"enrollmentInfo":178,"targetDuration":4,"studyType":21,"phases":180,"briefSummary":181,"conditions":182,"keywords":184,"overallStatus":187,"whyStopped":4,"lastUpdateSubmitDate":188,"lastUpdatePostDateStruct":189,"startDateStruct":191,"completionDateStruct":193,"leadSponsor":195,"locationsCount":110},"100627953","phase-2-flash-radiotherapy-for-skin-cancer-100627953","NCT07455331","Flash Radiotherapy for Skin Cancer","Randomized Phase II Selection Trial of FLASH Versus Conventional Radiotherapy for Participants With Localized Cutaneous Squamous Cell Carcinoma or Basal Cell Carcinoma","LANCE","Inclusion Criteria:\n\n1. Signed study Informed Consent Form\n2. Karnofsky Performance Status (KPS) ≥ 60\n3. Age ≥ 60 years\n4. Participants with histologically proven cSCC; or participants with BCC either histologically proven or proven by non-invasive imaging: either OCT, LC-OCT or RCM\n5. Participants requiring radiotherapy treatment according to the dermato-oncology tumor board: participants who cannot undergo surgical procedure or participants who decline surgical resection, and\u002For anatomical locations where surgery can compromise function or cosmesis.\n6. T1-N0 lesions (TNM UICC, 8th Edition)\n7. Lesions should be at least 4 cm apart if treated with 2 different modalities (including surgical treatment of lesions). Lesions should not be located on the face, except on the forehead, above a line situated 1 cm above the eyebrows. Lesions located on the scalp can be treated\n8. In cases of prior intervention within the target area, the treated lesion must be located at a distance of \\> 4 cm from the previous site.\n\nExclusion Criteria:\n\n1. Previous radiotherapy in the treated area or a history of radiation therapy within 4 cm of the lesion to be treated\n2. Concomitant auto-immune disease with skin lesions\n3. Concomitant use of radio-sensitizer drug\n4. Cognitive disorders not compatible with the signature of informed consent or that may compromise compliance with the requirements of the study\n5. Current, recent (within 10 days prior to start of study treatment), or planned participation in an experimental drug study (before EOT visit)\n6. Concomitant use of systemic or immunochemotherapy for skin cancer(s)\n7. Concomitant use of systemic chemotherapy for a cancer other than the skin cancer(s)\n8. Topical antitumoral treatment is prohibited within the radiation field except after a mandatory 4-weeks washout period.\n9. Any active cutaneous infection within the irradiation field (except if completely resolved prior to the initiation of radiotherapy).\n10. Uncontrolled intercurrent comorbidities that may impair wound healing including Diabetes Mellitus (HbA1c \\> 8.5% or evidence of active diabetic ulceration), Chronic Venous Insufficiency with active venous ulcers, or severe (Grade 3+) oedema in the treatment field.","60 Years",{"count":179,"type":20},60,[90],"The goal of this clinical investigation is to describe and compare the toxicity and efficacy of an experimental radiotherapy, named FLASH therapy, to conventional radiotherapy for subjects suffering from localized Cutaneous Squamous Cell Carcinoma (cSCC) and Basal Cell Carcinoma (BCC). FLASH therapy can deliver the irradiation dose within milliseconds instead of the minutes commonly required in conventional radiotherapy, with the aim of providing a curative dose while minimizing side effects on healthy tissue.\n\nThis is a phase II selection and monocentric clinical investigation with a 1 to 1 randomization. This clinical investigation will include approximately 60 participants aged ≥ 60 years old with one or more localized cSCC and BCC who either cannot undergo surgery or decline surgical resection.\n\nThe study design is the following:\n\n* On day 1, either a single dose FLASH radiotherapy (22 Gy) will be delivered or a single dose conventional radiotherapy (22 Gy) will be delivered to the selected localized cSCC or BCC lesion(s) (up to maximum 3 per participant; all lesions distant of at least 4 cm from one-another).\n* The surveillance period will be of 6 weeks post irradiation.\n* Follow-up visits will take place at 3, 6, and 12 months post-treatment.",[26,183],"Basal Cell Carcinoma (BCC)",[185,186,158],"radiotherapy","FLASH","NOT_YET_RECRUITING","2026-05-06",{"date":190,"type":39},"2026-05-11",{"date":192,"type":20},"2026-06-23",{"date":194,"type":20},"2030-12-23",{"name":196,"class":77},"Jules Bordet Institute",{"id":198,"slug":199,"hasResults":11,"nctId":200,"briefTitle":201,"officialTitle":202,"acronym":203,"eligibilityCriteria":204,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":205,"targetDuration":4,"studyType":21,"phases":207,"briefSummary":208,"conditions":209,"keywords":210,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":215,"lastUpdatePostDateStruct":216,"startDateStruct":218,"completionDateStruct":220,"leadSponsor":222,"locationsCount":224},"100569308","phase-3-study-of-a-strategy-integrating-adjuvant-radiation-therapy-versus-strategy-based-on-monitoring-in-the-treatment-of-carcinomas-spinocellular-with-high-risk-of-recurrence-100569308","NCT06692556","Study of a Strategy Integrating Adjuvant Radiation Therapy Versus Strategy Based on Monitoring in the Treatment of Carcinomas Spinocellular With High Risk of Recurrence","Randomized Comparative Multicenter Phase III Study of a Strategy Integrating Adjuvant Radiation Therapy Versus Strategy Based on Monitoring in the Treatment of Carcinomas Spinocellular With High Risk of Recurrence","SPINO-RT","Inclusion Criteria:\n\nI1. Patients aged ≥ 18 years at the time of signing the informed consent form; I2. Patients with histologically confirmed localized cutaneous squamous cell carcinoma;\n\nNote: Patients with carcinoma of the external auditory canal may be included in the study;\n\nI3. Patients treated with complete surgical excision (R0), regardless of the margin (submillimeter or supramillimeter);\n\nI4. Disease with a high risk of recurrence defined by one of the following scenarios:\n\n* presence of microscopic EPN without any other risk factors;\n* presence of microscopic EPN with a single other risk factor;\n* presence of 2 risk factors other than microscopic EPN;\n* presence of 3 risk factors other than microscopic EPN;\n\nNote: The risk factors considered are immunosuppression (limited to untreated hematologic disease), a tumor diameter \\>20 mm (longest axis, measured preferably clinically, or, failing that, histologically), a specific location (lip\u002Fear\u002Ftemple), deep invasion (tumor thickness \\>6 mm (Breslow) or invasion beyond the subcutaneous fat), poor differentiation, or desmoplasia;\n\nI5. Patient informed and having signed a consent form to participate in the study; I6. Patient enrolled in a health insurance plan (or beneficiary of such a plan).\n\nExclusion Criteria:\n\nNI1. Patients with in situ or mixed CEC; NI2. History of CEC with a high risk of recurrence in the same lymphatic drainage area (head and neck, trunk, or limb) within 2 years prior to the randomization date; NI3. History of CEC treated with systemic therapy; NI4. Patients with SCC localized to the endonasal, intraoral, anogenital, or vulvar mucosa;\n\nNI5. Patients with recurrent SCC or SCC at very high risk of recurrence defined by one of the following criteria:\n\n* EPN with ≥ 2 other risk factors,\n* \\> 3 risk factors,\n* bone invasion,\n* immunosuppression due to immunosuppressive treatments (regardless of the reason). NI6. Patients with CEC presenting a single risk factor other than EPN; NI7. Patient with CEC and lymph node or distant metastasis; NI8. Patient with a history of cancer undergoing systemic and\u002For locoregional anticancer treatment;\n\nNote: Local treatment of cutaneous keratoses with fluoropyrimidines is permitted outside the theoretical radiation field);\n\nNI9. Patient with a contraindication to radiation therapy; NI10. Patient with a history of radiation therapy to the site of the lesion; NI11. Participation in another clinical trial that may interfere with the assessment of the primary endpoint; NI12. Patient under legal guardianship or conservatorship, or deprived of liberty; NI13. Pregnant or breastfeeding woman.",{"count":206,"type":20},266,[23],"The goal of this clinical trial is to evaluate a strategy integrating adjuvant radiation therapy versus strategy based on monitoring in the treatment of carcinomas spinocellular with high risk of recurrence (SCC).\n\nThe investigators will compare the disease-free survival (DFS) of patients treated with adjuvant radiation therapy versus surveillance in high risk of recurrence SCC.\n\nThe main question it aims to answer is:\n\nIs DFS different between the \"adjuvant radiotherapy\" group and the \"surveillance\" group?\n\nParticipants will:\n\n* be distributed in one of the two arms\n* will be followed up every 4 months for 2 years, then every 6 months (clinical examination, identification of concomitant treatments, imaging, quality-of-life questionnaire)\n* followed up until their death or their progression whether local, regional or metastatic",[26],[211,212,213,214],"Squamous cell carcinomas at high risk of recurrence","Adjuvant radiotherapy","Surveillance","Peri Nervous System Sheathing","2026-04-21",{"date":217,"type":39},"2026-04-24",{"date":219,"type":39},"2025-02-21",{"date":221,"type":20},"2031-06",{"name":223,"class":77},"Centre Leon Berard",28,{"id":226,"slug":227,"hasResults":11,"nctId":228,"briefTitle":229,"officialTitle":230,"acronym":231,"eligibilityCriteria":232,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":233,"targetDuration":4,"studyType":21,"phases":234,"briefSummary":235,"conditions":236,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":248,"lastUpdatePostDateStruct":249,"startDateStruct":251,"completionDateStruct":253,"leadSponsor":255,"locationsCount":257},"100550264","phase-1-a-study-of-vet3-tgi-in-patients-with-solid-tumors-100550264","NCT06444815","A Study of VET3-TGI in Patients With Solid Tumors","A Phase 1\u002F1b Study of VET3-TGI Administered Alone and in Combination With Atezolizumab in Patients With Advanced Solid Tumors","STEALTH-001","Key Inclusion Criteria:\n\n* Have pathologically confirmed, advanced, unresectable, or metastatic solid tumors. Preferred indications include, but are not limited to, breast carcinoma, bladder carcinoma, cervical squamous carcinoma, colorectal carcinoma, esophageal carcinoma, head and neck squamous carcinoma, renal cell carcinoma, ovarian carcinoma, sarcoma, thymoma, and uterine carcinoma.\n* Failed, intolerant to, or refused potentially curative treatment options, including but not limited to, standard of care molecularly targeted agents, immunotherapy (e.g., anti -pembrolizumab\u002FPDL1 antibodies), and chemotherapy\n* Measurable disease as per RECIST 1.1 criteria\n* At least one tumor amenable to safe ITu injections and\u002For biopsies\n* ECOG performance status 0 or 1\n* Demonstrate adequate organ function\n* Must be willing to comply with all protocol procedures and adhere to post-treatment care instructions\n\nAdditional Inclusion criteria exist\n\nKey Exclusion Criteria:\n\n* Prior systemic therapy washout (dependent upon the therapy)\n* Requires use of anti-platelet or anti-coagulant therapy that cannot be safely suspended for per protocol biopsies or intra-tumoral injections.\n* CNS metastases and\u002For carcinomatous meningitis that have not been completely resected or completely irradiated.\n* Prior history of myocarditis\n* Known HIV\u002FAIDS, active HBV or HCV infection.\n* Receiving high dose immunosuppressive medication or has a significant immunodeficiency (e.g. transplant recipient, etc).\n\nAdditional Exclusion criteria exist",{"count":179,"type":20},[147],"VET3-TGI is an oncolytic immunotherapy designed to treat advanced cancers. VET3-TGI has not been given to human patients yet, and the current study is designed to find a safe and effective dose of VET3-TGI when administered by direct injection into tumor(s) (called an intratumoral injection) or when given intravenously (into the vein) both alone and in combination with atezolizumab in patients with solid tumors (STEALTH-001).",[237,238,239,240,241,242,243,152,244,245,26,246,247],"Solid Tumor, Adult","Microsatellite Stable Colorectal Cancer","Head and Neck Squamous Cell Carcinoma","Cervical Cancer","Kidney Cancer","Renal Cell Carcinoma","Melanoma Stage IV","Mesothelioma","Non-small Cell Lung Cancer","Urothelial Carcinoma Bladder","Squamous Cell Carcinoma","2026-04-01",{"date":250,"type":39},"2026-04-07",{"date":252,"type":39},"2024-09-16",{"date":254,"type":20},"2027-12-31",{"name":256,"class":46},"KaliVir Immunotherapeutics",7,{"id":259,"slug":260,"hasResults":11,"nctId":261,"briefTitle":262,"officialTitle":263,"acronym":4,"eligibilityCriteria":264,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":265,"enrollmentInfo":266,"targetDuration":4,"studyType":21,"phases":268,"briefSummary":269,"conditions":270,"keywords":271,"overallStatus":187,"whyStopped":4,"lastUpdateSubmitDate":276,"lastUpdatePostDateStruct":277,"startDateStruct":279,"completionDateStruct":281,"leadSponsor":283,"locationsCount":110},"100623254","phase-2-pucotenlimab-combined-with-becotatug-vedotin-in-advanced-cutaneous-squamous-cell-carcinoma-100623254","NCT07394244","Pucotenlimab Combined With Becotatug Vedotin in Advanced Cutaneous Squamous Cell Carcinoma","Pucotenlimab Combined With Becotatug Vedotin in Advanced Cutaneous Squamous Cell Carcinoma: A Single-Arm, Multicenter, Prospective Phase II Clinical Trial","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form and agree to comply with the protocol requirements.\n2. Age ≥18 years and ≤80 years on the day of signing the informed consent form, regardless of gender.\n3. Life expectancy ≥12 weeks.\n4. Histopathologically confirmed cutaneous squamous cell carcinoma (cSCC), which is either locally advanced and inoperable (including recurrence after ≥2 prior surgeries, or deemed unresectable by a surgeon, or where surgery may lead to severe complications or deformity) or metastatic.\n5. Have received 0-1 prior lines of systemic chemotherapy for advanced cSCC, and have experienced disease progression during or after the most recent treatment (relapse within 6 months after completing adjuvant therapy is considered as one line of therapy).\n6. Able to provide tumor tissue specimens (paraffin blocks, paraffin-embedded sections, or fresh tissue sections) from a primary or metastatic site for pathological testing. The most recent archived tumor tissue specimen should be used. If archived tissue is unavailable, a new biopsy must be performed.\n7. Have at least one measurable lesion at baseline according to RECIST 1.1 criteria (the longest diameter ≥10 mm on CT scan, or short axis ≥15 mm for lymph nodes; measurable lesions should not have been irradiated, unless progression has been demonstrated within a prior radiation field or after local therapy). Digital photography may be used for superficial lesions.\n8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days prior to treatment initiation.\n9. No severe cardiac dysfunction, with left ventricular ejection fraction (LVEF) ≥50% within 28 days prior to treatment initiation.\n10. Adequate organ function within 7 days prior to treatment initiation, defined as:\n\n(1)Bone Marrow Function: Absolute neutrophil count (ANC) ≥1.5×10⁹\u002FL, platelet count ≥100×10⁹\u002FL, hemoglobin ≥90 g\u002FL; and no transfusion or blood product administration within 14 days prior to the first dose, and no treatment with biologic response modifiers (e.g., G-CSF, erythropoietin) within 7 days prior to the first dose.\n\n(2)Liver Function: For patients without liver metastases: total bilirubin (TBIL) ≤1.5 × upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × ULN. For patients with liver metastases: TBIL ≤1.5 × ULN, ALT and AST ≤5 × ULN.\n\n(3)Renal Function: Serum creatinine (Cr) ≤1.5 × ULN, or creatinine clearance (Ccr) ≥50 mL\u002Fmin (calculated using the Cockcroft-Gault formula) (4)Coagulation Function: International normalized ratio (INR) ≤1.5 × ULN and activated partial thromboplastin time (APTT) ≤1.5 × ULN (unless the patient is receiving therapeutic anticoagulation).\n\n11.Men and women of childbearing potential must agree to use effective contraception from the time of signing the informed consent form until 6 months after the last dose of the investigational product. Women of childbearing potential include premenopausal women and women within 2 years of menopause. A negative serum pregnancy test result is required for women of childbearing potential within ≤7 days before the first dose of the investigational product.\n\nExclusion Criteria:\n\n1. History of other malignancies within the past five years, except for cured cervical carcinoma in situ, thyroid cancer, or cutaneous basal cell carcinoma.\n2. Prior receipt of any of the following treatments:\n\n   1. Any prior therapy targeting anti-PD-1, anti-PD-L1, PD-L2, CD137, CTLA-4 antibodies, or any other antibodies\u002Fdrugs specifically targeting T-cell costimulation or immune checkpoint pathways;\n   2. Any prior EGFR monoclonal antibody therapy;\n   3. Investigational drug administration within 28 days before the first dose;\n   4. Anticancer chemotherapy within 21 days before the first dose (washout period ≥14 days for oral fluoropyrimidines, leucovorin, or weekly paclitaxel chemotherapy; ≥42 days for nitrosoureas or mitomycin);\n   5. Radiotherapy within 28 days before the first dose, or palliative radiotherapy for bone metastases within 2 weeks;\n   6. Major surgery within 28 days before the first dose without full recovery, or planned major surgery within the first 12 weeks after receiving the study drug.\n3. Symptomatic brain or leptomeningeal metastases (unless treated \\>6 months prior, with negative imaging within 4 weeks before enrollment, and stable neurological status without steroid therapy).\n4. Any severe or uncontrolled systemic disease per investigator's judgment, including poorly controlled hypertension (systolic BP \\>160 mmHg or diastolic BP \\>100 mmHg), uncontrolled diabetes, or active bleeding signs.\n5. Poorly controlled cardiac diseases, including NYHA Class II or higher heart failure, unstable angina, myocardial infarction within 1 year, or clinically significant supraventricular\u002Fventricular arrhythmias requiring treatment.\n6. Active infections, including:\n\n   Hepatitis B (HBsAg-positive AND HBV DNA ≥2000 IU\u002FmL, excluding drug-induced or other non-viral hepatitis);\n\n   Hepatitis C (anti-HCV antibody-positive AND HCV RNA above the lower limit of detection);\n\n   HIV infection; or uncontrolled active bacterial, viral, fungal, rickettsial, or parasitic infections (unless treated and resolved before study drug initiation).\n7. History of hypersensitivity to any component of Pucotenlimab or Vebreltus (e.g., histidine, histidine hydrochloride, sucrose, mannitol, polysorbate 80), or ≥Grade 3 allergic reactions to macromolecular protein preparations\u002Fmonoclonal antibodies.\n8. Primary immunodeficiency history or active autoimmune disease requiring immunosuppressants or systemic glucocorticoids (dose ≥10 mg\u002Fday prednisone or equivalent within 2 weeks before enrollment).\n\n   Note: Patients with type I diabetes, stable hypothyroidism on hormone replacement, psoriasis\u002Feczema not requiring systemic therapy, or vitiligo may be enrolled. Topical\u002Finhaled corticosteroids or short-term (≤7 days) glucocorticoid use for non-autoimmune conditions are exempted.\n9. History or presence of interstitial lung disease, radiation pneumonitis, severe chronic obstructive pulmonary disease, severe respiratory insufficiency, or symptomatic bronchospasm.\n10. Positive serum pregnancy test, lactation, or unwillingness to use adequate contraception during the study and for 6 months after the last dose.\n11. Other conditions deemed inappropriate for participation by the investigator (e.g., alcohol\u002Fdrug abuse).","80 Years",{"count":267,"type":20},38,[90],"Study Design The study plans to enroll 38 patients. A Simon's two-stage design is employed. Based on historical data, the objective response rate (ORR) for patients meeting the inclusion criteria and receiving PD-1 inhibitor monotherapy is approximately 30%. The expected ORR for the combination of Pucotenlimab and Vebreltus is 55%. With a one-sided α=0.05 and 80% power, 9 patients will be enrolled in the first stage. If ≥2 patients achieve a partial response (PR) or complete response (CR), the study will proceed to the second stage. An additional 25 patients will be enrolled in the second stage, resulting in a total of 34 patients. If ≥15 patients in the total population achieve a PR, the study endpoint is considered met. Accounting for a 10% dropout rate, a total of 38 patients will be enrolled.\n\nStudy Procedures After providing full informed consent and passing screening, eligible subjects will receive treatment with Vebreltus 2.0 mg\u002Fkg and Pucotenlimab 200 mg. On the first day of each treatment cycle, patients will receive an intravenous infusion of Pucotenlimab (infusion duration: 60 min ± 15 min, with the first cycle infusion lasting no less than 60 minutes). At least 30 minutes after the completion of the Pucotenlimab infusion, the Vebreltus infusion will commence (infusion duration: 60 min ± 15 min, with the first cycle infusion lasting no less than 60 minutes). Patients will receive the combination therapy once every 3 weeks until completion of 2 years of treatment or until the occurrence of a protocol-defined treatment discontinuation event. Following the end of treatment, each subject will undergo a 30-day (+7 days) safety follow-up to monitor adverse events and clinically relevant events. Post-treatment survival follow-up will be conducted every 12 weeks (±7 days). For subjects who discontinue treatment for reasons other than disease progression\u002Fdeath and do not initiate new anti-cancer therapy, tumor imaging assessments will continue per the original schedule until disease progression, initiation of new anti-cancer therapy, withdrawal of consent, loss to follow-up, or death, whichever occurs first.\n\nAfter enrollment, tumor response will be assessed according to RECIST v1.1 and iRECIST criteria. Imaging evaluations will be performed every 6 weeks (±7 days) from the first dose for the first 54 weeks, and then every 9 weeks (±7 days) thereafter (regardless of any delays in study drug administration), until iRECIST-confirmed progressive disease (iPD), initiation of new anti-cancer therapy, withdrawal of informed consent, loss to follow-up, or death, whichever occurs first.\n\nExploratory Analysis This study will analyze the correlation between biomarkers in patient tumor tissue\u002Fblood samples (e.g., EGFR expression, PD-L1 CPS score, TILs) collected before and after treatment and clinical efficacy endpoints (e.g., ORR, PFS, DoR).",[26],[272,273,274,275],"Becotatug Vedotin","Pucotenlimab","CSCC","EGFR-ADC","2026-02-01",{"date":278,"type":39},"2026-02-06",{"date":280,"type":20},"2026-01-09",{"date":282,"type":20},"2028-12-31",{"name":284,"class":77},"Fudan University",{"id":286,"slug":287,"hasResults":11,"nctId":288,"briefTitle":289,"officialTitle":290,"acronym":291,"eligibilityCriteria":292,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":293,"targetDuration":4,"studyType":121,"phases":4,"briefSummary":295,"conditions":296,"keywords":301,"overallStatus":187,"whyStopped":4,"lastUpdateSubmitDate":309,"lastUpdatePostDateStruct":310,"startDateStruct":312,"completionDateStruct":314,"leadSponsor":316,"locationsCount":110},"100620749","impact-of-preoperative-high-frequency-ultrasound-cutaneous-lesion-extent-assessment-on-excision-margin-positivity-in-head-and-neck-skin-cancer-and-the-relationship-between-preoperative-assessment-methods-inadequate-excision-margins-and-tumor-recurrence-100620749","NCT07361666","Impact of Preoperative High-Frequency Ultrasound Cutaneous Lesion Extent Assessment on Excision Margin Positivity in Head and Neck Skin Cancer, and the Relationship Between Preoperative Assessment Methods, Inadequate Excision Margins, and Tumor Recurrence","Impact of Preoperative High-Frequency Ultrasound Cutaneous Lesion Extent Assessment on Excision Margin Positivity in Head and Neck Skin Cancer, and the Relationship Between Preoperative Assessment Methods, Inadequate Excision Margins, and Tumor Recurrence (HFUS-CLEAR)","HFUS-CLEAR","Inclusion Criteria:\n\n* Cutaneous lesion located in the head and neck region with a preoperative diagnosis of basal cell carcinoma (BCC) or squamous cell carcinoma (SCC), established by dermoscopy or biopsy, and qualified for surgical excision with curative intent.\n* patient age of 18 years or older.\n* Ability of patient to provide voluntary, informed, written consent for participation in the study.\n* Confirmation that the patient has read and understood the Patient Information Sheet.\n\nExclusion Criteria:\n\n* Excisional biopsies without radical intent.\n* Lack of histopathologic confirmation of BCC or SCC in the postoperative specimen (incorrect dermoscopic qualification).\n* Inability to perform radical surgical excision due to excessive tumor extent, poor general condition of the patient, or lack of patient consent for surgery.\n* Pregnancy.",{"count":294,"type":20},400,"Non-melanoma skin cancers (NMSC), particularly basal cell carcinoma (BCC) and cutaneous squamous cell carcinoma (cSCC), are the most common malignancies in Caucasians, with the majority of tumors located in the head and neck due to chronic ultraviolet exposure. Although BCC has very low metastatic potential, while cSCC carries a higher risk of nodal spread, both can cause significant local tissue destruction and functional and cosmetic impairment. Complete excision with histologically clear margins remains the standard treatment; however, incomplete or close excision margins are reported in a substantial proportion of cases and are associated with increased risk of local recurrence, need for additional treatment, and higher healthcare costs.\n\nPreoperative dermoscopy improves delineation of lateral tumor borders but does not assess depth of invasion. High-frequency ultrasound (HFUS) is a rapid, non-invasive imaging modality that can visualize superficial skin structures and estimate tumor thickness. Previous studies have suggested good agreement between HFUS and histopathologic depth of invasion, but results are not fully consistent, and HFUS has not yet been incorporated into major guideline recommendations for preoperative assessment of NMSC. Further prospective data are needed to clarify whether HFUS can improve surgical planning and margin control.\n\nThis prospective study is designed to assess the impact of adding preoperative HFUS to standard dermoscopic evaluation in head and neck BCC and cSCC. The primary objectives are: (1) to compare the frequency of positive or inadequate (\\\u003C1 mm) histopathologic excision margins between lesions assessed with dermoscopy alone and those assessed with both dermoscopy and HFUS; and (2) to evaluate 5-year local recurrence rates in relation to preoperative assessment method, histopathologic margin status, and subsequent management of inadequate margins (observation, non-surgical treatment, or scar excision). Secondary and additional objectives include: assessing concordance between HFUS-measured and histopathologic depth of invasion; determining the frequency of residual tumor in scars excised after inadequate margins; evaluating recurrence rate according to the site of inadequate margins (lateral vs deep); and identifying patient-related, tumor-related, surgical, and histopathologic predictors of inadequate margins and recurrence. Approximately 400 lesions (BCC or cSCC of the head and neck) qualified for curative surgical excision will be included. Each lesion will constitute an independent study case. All lesions will undergo preoperative assessment, including clinical evaluation with detailed medical history and dermoscopy; in one cohort, lesions will additionally be evaluated with HFUS. HFUS will be performed with an 18-MHz linear probe, using superficial B-mode and color Doppler. Maximum tumor depth will be recorded from the epidermal surface (or granular layer) to the deepest hypoechoic point, with assessment of potential infiltration of deeper structures when visible. Surgical excision and postoperative care will follow standard clinical practice. Postoperative histopathologic assessment of FFPE tumor samples will record tumor histologic type and subtype, margin status, width, depth of invasion, differentiation, inflammation, elastosis, perineural or vascular invasion, and other routinely assessed diagnostic features. In the event of positive or inadequate excision margins, patients will be referred, after consultation with a dermatologist, for further management (observation, non-surgical treatment, or scar excision), depending on clinical indications and patient preferences. Participation in the study will not influence the primary surgical treatment or any decisions regarding subsequent management.\n\nPatients will be followed for at least 5 years according to current clinical guidelines, with dermoscopic skin examination and documentation of local recurrence and its management. The study aims to determine whether incorporating HFUS into preoperative assessment can reduce the frequency of inadequate histologic margins and improve long-term local control in head and neck NMSC.",[153,26,297,298,183,299,300],"Cutaneous Squamous Cell Carcinoma in Situ (CSCCis)","Cutaneous Squamous Cell Carcinoma of the Head and Neck","Basal Cell Carcinoma of the Head and Neck","Non-Melanoma Skin Cancer (NMSC)",[302,247,31,303,304,305,306,307,308],"Basal Cell Carcinoma","Skin Neoplasms","Margins of Excision","Positive Surgical Margins","Recurrence","high-frequency ultrasound","HFUS","2026-01-15",{"date":311,"type":39},"2026-01-23",{"date":313,"type":20},"2025-12-23",{"date":315,"type":20},"2033-11-30",{"name":317,"class":318},"Państwowy Instytut Medyczny Ministerstwa Spraw Wewnętrznych i Administracji","OTHER_GOV",{"id":320,"slug":321,"hasResults":11,"nctId":322,"briefTitle":323,"officialTitle":324,"acronym":4,"eligibilityCriteria":325,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":326,"targetDuration":4,"studyType":121,"phases":4,"briefSummary":328,"conditions":329,"keywords":333,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":335,"lastUpdatePostDateStruct":336,"startDateStruct":338,"completionDateStruct":340,"leadSponsor":342,"locationsCount":110},"100562658","tumor-informed-ctdna-testing-for-mrd-following-treatment-of-squamous-cell-carcinoma-100562658","NCT06606028","Tumor-Informed ctDNA Testing for MRD Following Treatment of Squamous Cell Carcinoma","Tumor-informed ctDNA Testing for Minimal Residual Disease Monitoring Following Curative-intent Treatment of Squamous Cell Carcinoma of the Head and Neck.","Inclusion Criteria:\n\n1. Participants must have histologically or cytologically confirmed squamous cell carcinoma of the head and neck mucosa and skin.\n2. Participants must be age \\>=18 years.\n3. Participants must be planning to receive curative-intent surgery or radiation-based treatment as part of standard of care treatment.\n4. Participants must have the ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n1\\. Contraindication to phlebotomy for removal of 20 mL of peripheral blood each time point (up to 300 mL total over 15 time points).",{"count":327,"type":20},250,"This is a single-center, non-interventional, observational study that evaluates the correlation of circulating tumor DNA (ctDNA) testing to cancer relapse for participants with squamous cell carcinomas (HNC) of the head and neck mucosa and skin after curative-intent primary radiation or surgery.",[330,331,332,26],"Squamous Cell Carcinoma of Head and Neck","Squamous Cell Carcinoma Head and Neck Cancer (HNSCC)","Squamous Cell Carcinoma of Skin",[334],"ctDNA","2025-12-04",{"date":337,"type":39},"2025-12-12",{"date":339,"type":39},"2024-10-09",{"date":341,"type":20},"2029-12-30",{"name":343,"class":77},"University of California, San Francisco",{"id":345,"slug":346,"hasResults":11,"nctId":347,"briefTitle":348,"officialTitle":348,"acronym":4,"eligibilityCriteria":349,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":350,"targetDuration":4,"studyType":21,"phases":352,"briefSummary":353,"conditions":354,"keywords":356,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":357,"lastUpdatePostDateStruct":358,"startDateStruct":360,"completionDateStruct":362,"leadSponsor":364,"locationsCount":78},"100567128","early-phase-1-a-phase-0-window-of-opportunity-trial-of-intratumoral-seasonal-influenza-immunization-in-cutaneous-squamous-cell-carcinoma-cscc-patients-awaiting-curative-excision-100567128","NCT06664151","A Phase 0 Window of Opportunity Trial of Intratumoral Seasonal Influenza Immunization in Cutaneous Squamous Cell Carcinoma (CSCC) Patients Awaiting Curative Excision","Inclusion Criteria:\n\n* Participants must have a diagnosis of cutaneous squamous cell carcinoma that has been biopsied and confirmed histologically. Mixed histology (such as basosquamous carcinoma, sarcomatous carcinoma) is allowed.\n* Participants must have a skin tumor that measures 10 - 39 mm (not less than 10 mm and not more than 39 mm) in longest dimension by clinical exam. (Participants may have more than one untreated CSCC at the time of enrollment, but only one CSCC may be treated with the study agent.)\n* Participants must be candidates for treatment (excision) by Mohs micrographic surgery.\n* Age ≥18 years. Because CSCC is exceptionally rare in patients \\\u003C18 years of age, children are excluded from this study.\n* ECOG performance status ≤3 (Karnofsky ≥40%, see Appendix A).\n* Ability to understand and the willingness to sign a written informed consent document.\n* For participants with a past medical history of Human immunodeficiency virus (HIV), they must be on effective anti-retroviral therapy with undetectable viral load measured within the 6 months prior to enrollment.\n* For participants with a past medical history of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n* For participants with a past medical history of hepatitis C virus (HCV) infection, they must have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n\nExclusion Criteria:\n\n* CSCC with the following high-risk features including peri-neural invasion of \\>0.1 mm caliber, and invasion of tissue beyond the subcutaneous fat, and a diameter \\> 3.9 cm.\n* Evidence of in-transit\u002Fsatellite, nodal, or distant metastases from CSCC, in the present or in the past medical history, including evidence from physical exam of primary site and draining lymph node basin.\n* History of solid organ transplant or allogeneic bone marrow transplant.\n* History of allergic reactions attributed to the seasonal flu vaccine.\n* History of Guillain-Barré syndrome.\n* Participants with any uncontrolled intercurrent illness, including uncontrolled cardiac disease (New York Heart Association Class III or IV heart failure, myocardial infarction in the 6 months prior to enrollment, unstable angina).\n* Participants who are receiving any other investigational agents for treatment of cancer.\n* Participants with a past medical history of another malignancy whose natural history or treatment is likely to interfere with the safety or efficacy assessment of the investigational regimen, according to the treating investigator.\n* Participants with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of intratumoral flu vaccine administration. Patients who do not agree to comply with these precautions are ineligible.\n* Pregnant or nursing (breast-feeding) women are excluded from this study because there is an unknown but potential risk to multiple injections of flu vaccine in pregnant or nursing women.\n* Note: Previous treatment with flu vaccination is not an exclusion criterion. Routine intramuscular seasonal influenza vaccination is not required nor prohibited.",{"count":351,"type":20},25,[57],"This study is investigating the effects on immune cells of injecting the influenza vaccine (also known as \"flu shot\") into cutaneous squamous cell carcinoma (CSCC) tumors prior to having standard-of-care Mohs excision surgery. The study will help understand if the addition of the influenza vaccine could improve the immune system response against the cancer.\n\nThe names of the study drug involved in this study is:\n\n-Fluzone Influenza vaccine (flu shot)",[31,26,355],"Cutaneous Squamous Cell Cancer",[31,94,355],"2025-10-01",{"date":359,"type":39},"2025-10-02",{"date":361,"type":39},"2024-11-26",{"date":363,"type":20},"2026-08-30",{"name":365,"class":77},"Dana-Farber Cancer Institute",{"id":367,"slug":368,"hasResults":11,"nctId":369,"briefTitle":370,"officialTitle":371,"acronym":372,"eligibilityCriteria":373,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":374,"targetDuration":376,"studyType":121,"phases":4,"briefSummary":377,"conditions":378,"keywords":379,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":382,"lastUpdatePostDateStruct":383,"startDateStruct":385,"completionDateStruct":387,"leadSponsor":389,"locationsCount":110},"100597887","next-gen-flow-cytometry-to-find-immune-profiles-treatment-response-and-toxicity-markers-in-skin-cancer-patients-treated-with-cemiplimab-100597887","NCT07064330","Next-gen Flow Cytometry to Find Immune Profiles, Treatment Response, and Toxicity Markers in Skin Cancer Patients Treated With Cemiplimab.","Next Generation Flow Cytometry for Global Immunological Profile, Response And Toxicity Biomarker Signatures in Cutaneous Squamous Cell Carcinoma Under CEmiplimab Treatment.","NGF-GRACE","\\- Inclusion criteria At least 18 years old\n\nHepatic function:\n\n1. Total bilirubin ≤1.5x upper limit of normal (ULN) (or ≤3x ULN, if liver metastases).\n2. Patients with Gilbert's Disease and total bilirubin up to 3x ULN may be eligible after communication with and approval from the medical monitor\n3. Transaminases ≤3x ULN (or ≤5x ULN, if liver metastases)\n4. Alkaline phosphatase (ALP) ≤2.5x ULN (or ≤5x ULN, if liver or bone metastases) Renal function: Serum creatinine ≤2x ULN or estimated creatinine clearance \\>35 mL\u002Fmin (according the method of Cockcroft and Gault) Creatine phosphokinase (CPK) (also known as CK \\[creatine kinase\\]) elevation ≤ grade 2\n\nBone marrow function:\n\na. Hemoglobin ≥9.0 g\u002FdL b. Absolute neutrophil count (ANC) ≥1.5 x 109\u002FL c. Platelet count ≥75 x 109\u002FL Anticipated life expectancy \\>12 weeks\n\n\\- Exclusion criteria:\n\n1. \\- Patient who refuses to participate in the study.\n2. Being unsuitable for cemiplimab treatment\n3. Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-related adverse events (irAEs). The following are not exclusionary: vitiligo, childhood asthma that has resolved, type 1 diabetes, residual hypothyroidism requiring only hormone replacement, or psoriasis that does not require systemic treatment.\n4. Untreated brain metastasis(es) that may be considered active.\n\n   a. Note in clarification: Patients with previously treated brain metastases may participate provided that the lesion(s) is (are) stable (without evidence of progression for at least 6 weeks on imaging obtained in the screening period), and there is no evidence of new or enlarging brain metastases, and the patients do not require any immunosuppressive doses of systemic corticosteroids for management of brain metastasis(es) within 28 days of the first dose of REGN2810cemiplimab.\n5. Immunosuppressive corticosteroid doses (\\>10 mg prednisone daily or equivalent) within 4 weeks prior to the first dose of REGN2810cemiplimab\n\n   a. Note in clarification: Patients who require brief courses of steroids (eg, as prophylaxis for imaging studies due to hypersensitivity to contrast agents) are not excluded\n6. Active infection 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)\n7. History of pneumonitis within the last 5 years\n8. Any anticancer treatment other than radiation therapy (chemotherapy, targeted systemic therapy, imiquimod, photodynamic therapy), investigational or standard of care, within 30 days of the initial administration of REGN2810 cemiplimab or planned to occur during the study period\n9. History of documented allergic reactions or acute hypersensitivity reaction attributed to antibody treatments\n10. Patients with allergy or hypersensitivity to REGN2810 cemiplimab or to any of the excipients must be excluded.\n11. Patients with a history of solid organ transplant (patients with prior corneal transplants may be allowed to enroll after discussion with and approval from the medical monitor)\n12. Breastfeeding\n13. Positive serum pregnancy test (a false positive pregnancy test, if demonstrated by serial measurements and negative ultrasound, will not be exclusionary, upon communication with and approval from the medical monitor)\n14. Receipt of live vaccines (including attenuated) within 30 days of first study treatment\n15. Women of childbearing potential (WOCBP)\\*, or sexually active men, who are unwilling to practice highly effective contraception prior to the initial dose\u002Fstart of the first treatment prior to the start of the first treatment, during the study, and for at least 6 months after the last dose.\n\n    Optional criteria, depending on the therapy being investigated:\n16. Prior treatment with an agent that blocks the PD-1\u002FPD-L1 pathway (If a study is addressing prior unsuccessful treatment with PD-1\u002FPD-L1 inhibitor, it is suggested to exclude patients who had suffered from ≥grade 3 irAE during previous treatment)\n17. Prior treatment with other systemic immune-modulating agents within fewer than 28 days prior to the first dose of REGN2810cemiplimab. Examples of immune-modulating agents include therapeutic vaccines, cytokine treatments, or agents that target cytotoxic T-lymphocyte antigen 4 (CTLA-4), 4-1BB (CD137), or OX-40.\n\n    1. Note in clarification: Prior treatment with imiquimod or other topical or intralesional immune modulators will not be exclusionary",{"count":375,"type":20},30,"24 Months","Cutaneous squamous cell carcinoma (CSCC) is the second most frequent cancer in humans, it exhibits a high tumor mutational burden and is more common in immunocompromised patients, which aimed to explore the impact of immunotherapy in this cancer. CSCC shows good response to anti-PD1 immunotherapy, and cemiplimab is the first FDA-approved and the only EMA-approved treatment for this tumor. However, 50% of patients won't respond to anti-PD1 and to date there is little evidence on the reasons for such a lack of effectiveness. Also, anti-PD1 immunotherapy is very safe, but some patients will develop adverse events, and anticipating severe adverse events might help in patients' management. The NGF-GRACE project aims to find biomarkers of response and toxicity, both in the blood and the tumor, using advanced technologies. The goal is to move towards more personalized treatments, better select patients, predict side effects, and improve our understanding of the immune system in CSCC.",[26],[29,380,381],"Rhapsody Single Cell System","Tumor Microenvironment","2025-09-03",{"date":384,"type":39},"2025-09-10",{"date":386,"type":39},"2025-07-17",{"date":388,"type":20},"2027-06",{"name":390,"class":77},"Instituto de Investigación Biomédica de Salamanca",{"id":392,"slug":393,"hasResults":11,"nctId":394,"briefTitle":395,"officialTitle":396,"acronym":397,"eligibilityCriteria":398,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":399,"targetDuration":4,"studyType":21,"phases":401,"briefSummary":402,"conditions":403,"keywords":404,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":412,"lastUpdatePostDateStruct":413,"startDateStruct":415,"completionDateStruct":417,"leadSponsor":419,"locationsCount":421},"100579375","phase-2-towards-cure-via-only-ultra-short-icb-in-cscc-100579375","NCT06823479","Towards Cure Via Only Ultra-short ICB in CSCC","Towards Organ Preservation and Cure Via Immunotherapy in Cutaneous Squamous Cell Carcinoma Patients, Normally Undergoing Morbid Curative Surgery and Radiotherapy. The MATISSE 2 Trial, an Investigator-initiated Multicentre Phase 2 Trial","MATISSE 2","Inclusion Criteria:\n\n* 18 years of age or older\n* UV-related stage I to IVa CSCC with an indication for extensive or disfiguring surgery\n* Stage III-IVa CSCC (T3-4N0-3M0 or T0N1-3M0) or multi-focal stage I-II CSCC\n* Primary tumour site: vermillion border lip (C00.0, C00.1, C00.2), skin of lip NOS (C44.0), external ear (C44.2), skin face unspecified (ao: external lip and vestibulum nasi) (C44.3), skin scalp and neck (C44.4), overlapping lesion of skin (C44.8), primary site eyelid (C44.1), other body sites: CSCC outside head and neck area, but not vulva, anus or penis.\n* World Health Organisation (WHO) performance status of 0-2\n* Indication for SOC surgery with curative intent ± RT\n* Screening laboratory values must meet the following criteria: WBC ≥ 2.0x109\u002FL, Neutrophils ≥1.5x109 \u002FL, Platelets ≥100 x109 \u002FL, Haemoglobin ≥5.5 mmol\u002FL, Creatinine ≤1.5x upper limit of normal (ULN), AST ≤ 1.5 x ULN, ALT ≤ 1.5 x ULN, Bilirubin ≤1.5 X ULN (except patients with Gilbert Syndrome, who are eligible when total bilirubin \\\u003C 3.0 mg\u002FdL).\n* Women of child-bearing potential (WOCBP) must use appropriate method(s) of contraception. They should use an adequate method to avoid pregnancy for 23 weeks (30 days plus the time required time for nivolumab to undergo five x T1\u002F2) after the last dose of the IMP.\n* WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25IU\u002FL or equivalent units of HCG) prior to the start of ICB.\n* Patients willing and able to understand the Dutch study information and protocol requirements and comply with the treatment\u002Fintervention schedule, scheduled visits, and other requirements of the study.\n\nExclusion Criteria:\n\n* Distantly metastasized (stadium IVb) CSCC\n* SCC localized in a mucosal surface (i.e. anus, vulva, penis or mucosal portion of lip)\n* Patients for whom standard of care treatment consists of definitive (brachy)radiotherapy\n* Primary or recurrent CSCC appearing in an area that has been previously irradiated\n* Prior systemic therapy or immunotherapy.\n* Active human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)\n* Positive test for hepatitis B virus surface antigen (HBsAg) or hepatitis C antibody (HCV Ab)\n* Subjects with any active autoimmune disease or a documented history of autoimmune disease, except: subjects with vitiligo, resolved childhood asthma\u002Fatopy, residual hypothyroidism due to an autoimmune condition requiring only hormone replacement, psoriasis not requiring systemic treatment, any condition not expected to recur in the absence of an external trigger.\n* Underlying medical conditions that, in the investigator's opinion, will make the administration of the study drug hazardous or obscure the interpretation of toxicity or AEs\n* Concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic or absorbable topical corticosteroids (up to 5 mg of prednisone per day is allowed)\n* Patients who are pregnant or breastfeeding\n* History of allergy to study drug components and\u002For history of severe hypersensitivity to any monoclonal antibody\n* Use of other investigational drugs 30 days before study drug administration and 5 half times before study inclusion.",{"count":400,"type":20},41,[90],"The goal of this clinical trial is to determine whether cutaneous squamous cell carcinoma patients can be cured using only immunotherapy, without surgery or radiotherapy.",[26,355,298,94],[405,406,407,408,160,409,410,411],"nivolumab","opdivo","ipilimumab","yervoy","intravenous","checkpoint inhibitors","neoadjuvant","2025-05-22",{"date":414,"type":39},"2025-05-29",{"date":416,"type":39},"2025-05-14",{"date":418,"type":20},"2029-02",{"name":420,"class":77},"The Netherlands Cancer Institute",5,{"id":423,"slug":424,"hasResults":11,"nctId":425,"briefTitle":426,"officialTitle":426,"acronym":427,"eligibilityCriteria":428,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":429,"targetDuration":4,"studyType":121,"phases":4,"briefSummary":431,"conditions":432,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":433,"lastUpdatePostDateStruct":434,"startDateStruct":436,"completionDateStruct":438,"leadSponsor":439,"locationsCount":110},"100583718","usefulness-of-post-operative-radiotherapy-in-high-grade-cutaneous-squamous-cell-carcinoma-an-observational-study-100583718","NCT06879964","Usefulness of Post-Operative Radiotherapy in High-grade Cutaneous Squamous Cell Carcinoma: an Observational Study","PORTSCC","Inclusion Criteria:\n\n* diagnosis of high-grade cutaneous squamous cell carcinoma\n* patients eligible for post-operative radiotherapy\n* minimum follow-up of 24 months\n\nExclusion Criteria:\n\n* lack of clinical of histological data\n* impossibility of a proper follow-up\n* occurrence of intermediate events (i.e., pregnancy)",{"count":430,"type":20},120,"Post-operative radiotherapy (PORT) is currently considered as the second most important therapy to treat high-grade cutaneous squamous cell carcinoma. Nonetheless, only few studies evaluate its impact on recurrence rate and the major part of those ones do not include a proper control group of patients.\n\nMost recent guide lines from NCCN, Sidemast and British associations of dermatologists suggest clinicians to offer or consider PORT in selected patients but class nor level of evidence of those guide lines are provided.\n\nThis project evaluates impact of post-operative radiotherapy on recurrence rate and overall survival by comparing two cohort of patients, the former who accepted PORT and the latter who, nonetheless its necessity, decided to not undergo it.\n\nThe hypothesis which this project will answer concerns the effectiveness of post-operative radiotherapy in preventing local and regional recurrences. We expect a significant decrease of recurrence rate in patients who undergo this therapeutic option as compared to those with clinical indication but do not undergo PORT.",[26],"2025-03-11",{"date":435,"type":39},"2025-03-17",{"date":437,"type":39},"2023-11-17",{"date":166,"type":20},{"name":440,"class":77},"Fondazione IRCCS Policlinico San Matteo di Pavia"]