[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"vulvar-squamous-cell-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:vulvar-squamous-cell-carcinoma":136},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,59,88,112],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":36,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":47,"lastUpdatePostDateStruct":48,"startDateStruct":51,"completionDateStruct":53,"leadSponsor":55,"locationsCount":58},"100609637",false,"NCT07217171","A Study Evaluating the Safety, Efficacy, and Pharmacokinetics (PK) of EVOLVE104 in Participants With Advanced Urothelial and Squamous Cell Carcinomas","A Phase 1 Dose-Escalation and Expansion Study Evaluating the Safety, Efficacy, and Pharmacokinetics of EVOLVE104 in Subjects With Advanced Urothelial and Squamous Cell Carcinomas","Key Inclusion Criteria:\n\nParticipants must have locally advanced or metastatic cancer with one of the following tumor types: bladder cancer, squamous cell carcinoma of the lung, esophagus, skin, or an anogenital squamous cell carcinoma.\n\n1. Participant must have documented disease progression during or post treatment with standard of care, dependent upon tumor type.\n2. The cancer must be measurable by CT scan or MRI.\n3. Eastern Cooperative Oncology Group (ECOG) performance status score ≤1.\n4. Anticipated life expectancy of at least 3 months.\n5. Adequate organ function, as indicated by standard blood tests.\n6. Able to provide a fresh or archival tumor biopsy.\n7. Male and female participants must agree to use contraception during the study and for 120 days after the last dose of study drug, except for women who are post-menopausal or surgically sterile.\n\nKey Exclusion Criteria:\n\n1. The participant is a candidate for treatment with a targeted agent known to provide a benefit.\n2. Persistent significant toxicities from prior anticancer therapy.\n3. Brain metastases unless previously treated and stable.\n4. Prior severe or life-threatening immunologic reactions to previous therapies.\n5. Significant medical conditions, including but not limited to:\n\n   * History of clinically significant cardiac disease\n   * Severe esophageal disease such as esophageal rupture or severe erosive esophagitis.\n   * Active inflammatory corneal or conjunctival inflammation, erosion, or ulcerations.\n   * History of cirrhosis or significant portal hypertension.\n   * Uncontrolled or significant infection.\n   * History of certain other cancers in the past 3 years.\n   * History of arterial thrombosis, stroke and transient ischemic attack within 6 months.\n   * Active or uncontrolled HIV, HBV or HCV infection.\n   * Autoimmune or other condition requiring chronic systemic immunosuppression.","ALL","18 Years",{"count":18,"type":19},160,"ESTIMATED","INTERVENTIONAL",[22],"PHASE1","The goal of this study is to evaluate the safety and effectiveness of EVOLVE104 in participants with advanced urothelial and squamous cell carcinomas who have previously taken standard treatment options, have declined or have been ineligible for treatment with these medications. Participants with advanced or metastatic cancer who meet all eligibility criteria may be eligible to participate in the study.",[25,26,27,28,29,30,31,32,33,34,35],"Bladder Cancer","Squamous Cell Carcinoma of the Lung","Esophageal Squamous Cell Carcinoma","Tongue Squamous Cell Carcinoma","Cutaneous Squamous Cell Cancer","Penile Squamous Cell Carcinoma","Anal Squamous Cell Carcinoma","Vulvar Squamous Cell Carcinoma","Cervical Squamous Cell Carcinoma","Vaginal Squamous Cell Carcinoma","Urethral Squamous Cell Carcinoma",[37,38,39,40,41,42,43,44,45],"bladder","lung","esophagus","tongue","penile","anal","vulvar","cervical","vaginal","RECRUITING","2026-07-01",{"date":49,"type":50},"2026-07-02","ACTUAL",{"date":52,"type":50},"2025-11-13",{"date":54,"type":19},"2031-01-29",{"name":56,"class":57},"EvolveImmune United, Inc","INDUSTRY",12,{"id":60,"slug":4,"hasResults":10,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":10,"sex":66,"minAge":16,"maxAge":4,"enrollmentInfo":67,"targetDuration":4,"studyType":20,"phases":69,"briefSummary":71,"conditions":72,"keywords":73,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":87},"100645176","NCT07679841","Safety and Efficacy of Nivolumab and Imiquimod Combination in Vulvar Squamous Cell Carcinoma Patients","A Multicentre, Single Arm, Phase 1\u002F2 Study, Aiming to Assess the Safety and Efficacy of Nivolumab and Imiquimod Combination in Vulvar Squamous Cell Carcinoma Patients","COLOMBE","Inclusion Criteria:\n\nI1. Female patient ≥ 18 years of age on day of signing informed consent.\n\nI2. Histologically confirmed primary VSCC, with all of the following characteristics:\n\n* At least 1 lesion that can be measured in at least 1 dimension with ≥ 10 mm in largest diameter\n* Clinically stage FIGO I-III (2021 FIGO staging)\n* Eligible for primary tumour surgery\n* Surgical complexity due to either bulky tumors \\> 4 cm OR multifocal tumor (defined as the presence of two or more foci of cancer on the vulva), the largest lesion must be ≥ 10 mm and all lesions ≥ 10 mm are designated as \"target\" lesion(s) for all subsequent tumor evaluations OR any tumor for which a surgical excision would have anatomical or functional consequences deemed significant by the treating surgeon\n\nI3. Availability of a representative formalin-fixed paraffin-embedded (FFPE) sample of the primary tumor tissue (biopsy) with an associated pathology report. This tumor sample must meet the following quality\u002Fquantity control criteria: ≥30 % of tumor cells and a tumor surface area ≥ 5mm2\n\nI4. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 2\n\nI5. Patients with adequate organ function:\n\n* Absolute Neutrophil Count (ANC) ≥ 1 10\\^9\u002FL\n* Platelets ≥ 100 10\\^9\u002FL (without transfusion for platelets within 7 days)\n* Hemoglobin ≥ 9 g\u002FdL\n* Creatinine clearance according to CKD-EPI ≥ 30 mL\u002Fmin\n* Serum total bilirubin ≤ 1.5 x ULN (except for patients with Gilbert disease for whom a total serum bilirubin ≤ 3 x ULN is acceptable)\n* AST and ALT ≤ 3 x ULN\n\nI6. Women of child-bearing potential (WOCBP) must have a negative serum pregnancy test within 7 days prior to C1D1 and must agree to use effective forms of contraception from the time of the negative pregnancy test up to 5 months after the last dose of nivolumab.\n\nI7. Patient should understand, sign, and date the written voluntary informed consent form at the screening visit prior to any protocol-specific procedures performed. Patient should be able and willing to comply with study visits and procedures as per protocol.\n\nI8. Patients must be covered by a medical insurance.\n\nExclusion Criteria:\n\nE1. Patients participating in another clinical trial with therapeutic intent.\n\nE2. Patients previously treated with any anti-cancer treatment including anti-PD-1, anti-PDL1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T cell receptor (e.g., CTLA-4, OX 40, CD37).\n\nE3. Patients not respecting the minimal washout period or receiving or anticipation of need during the study of the following medications\u002Fprocedure:\n\n* Major surgery: 2 weeks\n* Live vaccines: 4 weeks\n* Systemic corticosteroids (in dosing exceeding 10 mg daily of prednisone or equivalent) or any other form of immunosuppressive therapy: 1 week\n\nE4. Patients with known additional malignancy that is progressing or has required active treatment within the past 3 years.\n\nNote: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin on a location other than the vulva, or carcinoma in situ (e.g. of the breast, cervix or bladder) that have undergone potentially curative therapy are not excluded.\n\nE5. Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.\n\nE6. Patients with evidence of significant uncontrolled infection or concomitant disease, or psychiatric illness\u002Fsocial situations that could affect compliance with the protocol or interpretation of results.\n\nE7. Patients with prior organ or bone marrow transplant.\n\nE8. Patients with known active hepatitis B, C, or HIV infection or any active infection requiring systemic therapy.\n\nE9. Patients with known or suspected active autoimmune disease. Note: Patients with skin disorders (such as vitiligo, psoriasis or alopecia), type I diabetes mellitus, hypothyroidism only requiring hormone replacement or conditions not expected to recur in the absence of an external trigger are eligible.\n\nE10. Pregnant or breastfeeding women.","FEMALE",{"count":68,"type":19},50,[22,70],"PHASE2","COLOMBE is a multicenter, single arm, phase 1\u002F2 trial designed to evaluate the safety and efficacy of imiquimod cream with IV low dose nivolumab in primary resectable vulvar squamous cell carcinoma patients prior to surgery, leveraging the preoperative \"window of opportunity\" period, an unavoidable interval due to surgical scheduling.",[32],[74,75,76],"vulvar squamous cell carcinoma","nivolumab","imiquimod","NOT_YET_RECRUITING","2026-06-25",{"date":47,"type":50},{"date":81,"type":19},"2026-09",{"date":83,"type":19},"2029-09",{"name":85,"class":86},"Centre Leon Berard","OTHER",3,{"id":89,"slug":4,"hasResults":10,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":10,"sex":66,"minAge":16,"maxAge":4,"enrollmentInfo":95,"targetDuration":4,"studyType":20,"phases":97,"briefSummary":99,"conditions":100,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":111},"100543638","NCT06358469","STRatIfication of Vulvar SCC by HPV and p53 Status to Guide Excision","STRatIfication of Vulvar Squamous Cell Carcinoma by HPV and p53 Status to Guide Excision","STRIVE","Inclusion Criteria:\n\n* Histologically confirmed diagnosis of vulvar squamous cell carcinoma (VSCC)\n* Surgically staged FIGO I-II VSCC as per FIGO 2021 guidelines\n* Vulvar resection according to standard of care guidelines\n* Post-operative margin assessment of tumour clearance, dVIN and p53 status.\n* Participants' age must be ≥ 18 years old\n* Participant is able (i.e. sufficiently fluent) and willing to complete the quality of life and\u002For health utility questionnaires in either English or French\n* Participant's consent must be appropriately obtained in accordance with applicable local and regulatory requirements\n\nExclusion Criteria:\n\n* Recurrent vulvar squamous cell carcinoma\n* Non-squamous cell carcinoma histotypes\n* Participants referred for\u002Freceiving\u002For previously received adjuvant vulvar radiation or chemotherapy\n* Primary tumour HPV-I p53 wild-type VSCC\n* Surgical margins positive for invasive cancer.\n* Participants with a history of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≥ 5 years\n* Lymph node positive VSCC or lymph nodes with isolated tumour cells.",{"count":96,"type":19},249,[98],"NA","This study is being done to answer the following question: Are there types of early-stage vulvar cancer that require either less or more treatment than the usual approach?",[32],"2026-05-11",{"date":103,"type":50},"2026-05-12",{"date":105,"type":50},"2024-12-10",{"date":107,"type":19},"2031-11-30",{"name":109,"class":110},"Canadian Cancer Trials Group","NETWORK",11,{"id":113,"slug":4,"hasResults":10,"nctId":114,"briefTitle":115,"officialTitle":115,"acronym":116,"eligibilityCriteria":117,"healthyVolunteers":10,"sex":66,"minAge":16,"maxAge":4,"enrollmentInfo":118,"targetDuration":4,"studyType":120,"phases":4,"briefSummary":121,"conditions":122,"keywords":123,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":135},"100586163","NCT06911801","In Vitro Study of [18F]F-FAPI-74 Feasibility in Vulvar Cancer","FAPI_VULVA_1","Inclusion Criteria:\n\n* Patients with histologically confirmed diagnosis of invasive vulvar cancer with squamous cell histotype, both from primary tumour site and excised metastatic LNs.\n* Availability of both FFPE and OCT stored samples from each primary tumour site and (when available) from the corresponding metastatic groin lymph nodes.\n* Samples stored in sufficient quantity not to be completely exhausted by their use for this study.\n* Optimal stored sample\n* Available clinical and histopathological data\n\nExclusion Criteria:\n\n\\- Coexistence of primary tumours other than vulvar cancer",{"count":119,"type":19},90,"OBSERVATIONAL","This study aims to investigate the expression of FAP by phosphor imaging in invasive vulvar squamous cell carcinoma specimens. This in vitro study will include all consecutive tumour specimens stored both in optimal cutting temperature (OCT) compound and formalin-fixed paraffin-embedded (FFPE) from patients with a first diagnosis of vulvar squamous cell carcinoma who underwent surgery at Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.",[32],[32,124,125],"FAPI","Phosphor imaging","2025-04-03",{"date":128,"type":50},"2025-04-04",{"date":130,"type":19},"2025-04",{"date":132,"type":19},"2026-11",{"name":134,"class":86},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS",1,""]