[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"recurrent-vulvar-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:recurrent-vulvar-cancer":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,63,100],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":34,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":52,"startDateStruct":55,"completionDateStruct":57,"leadSponsor":59,"locationsCount":62},"100644252","reirradiation-and-total-ablative-strategies-for-recurrent-gynecologic-cancer-100644252",false,"NCT07667192","Reirradiation and Total Ablative Strategies for Recurrent Gynecologic Cancer","REGYNERA(Dia)TION: An Ambispective International Multicenter Patient Registry of Reirradiation and Total Ablative Strategies for Recurrent Gynecologic Malignancies","Regynera-RT","Inclusion Criteria:\n\n* \\- Age 18 years or older at the time of reirradiation or prospective enrollment.\n* Histologically confirmed gynecologic malignancy, including uterine, cervical, vaginal, vulvar, ovarian, fallopian tube, primary peritoneal, or rare gynecologic primary.\n* Documented prior radiotherapy delivered as part of previous treatment.\n* Recurrent or progressive disease for which reirradiation and\u002For total ablative strategy has been delivered, is ongoing, or is planned according to local multidisciplinary decision-making.\n* Recurrence or progression documented by imaging, clinical examination, pathology, and\u002For multidisciplinary tumor board assessment according to institutional practice.\n* Availability of minimum essential data, including prior radiotherapy information, date of reirradiation or planned reirradiation, disease extent at reirradiation, and at least one follow-up, outcome, or survival-status record for retrospective patients.\n* For prospective patients, written informed consent where required by local regulations and ethics approval.\n\nExclusion Criteria:\n\n* No evidence of prior radiotherapy.\n* No reirradiation or clinically meaningful local ablative radiotherapy component delivered or planned.\n* Insufficient minimum data preventing assignment of reirradiation date, disease extent, or survival\u002Ffollow-up status.\n* Exclusively polymetastatic disease with more than 5 active non-regional lesions treated without a meaningful local reirradiation or total ablative component, unless included in an exploratory non-core substudy approved by the steering committee.\n* Prospective refusal of consent when consent is required by local law or ethics approval.","FEMALE","18 Years",{"count":20,"type":21},500,"ESTIMATED","5 Years","OBSERVATIONAL","REGYNERA(dia)TION is an international, multicenter, ambispective observational patient registry of adults with recurrent gynecologic malignancies after prior radiotherapy who are treated or planned for reirradiation and\u002For total ablative strategies as part of routine clinical care. The registry does not assign treatment. Radiotherapy technique, dose, systemic therapy, surgery, metastasis-directed therapy, imaging, and follow-up are selected by the treating multidisciplinary team according to local standards and patient-specific factors. The registry will collect harmonized retrospective and prospective data on disease characteristics, prior radiotherapy, recurrence pattern, reirradiation or ablative treatment exposure, response, progression, survival, severe treatment-related morbidity, fistula events, and patient-reported outcomes where available.",[26,27,28,29,30,31,32,33],"Recurrent Gynecologic Cancer","Recurrent Uterine Cancer","Recurrent Cervical Cancer","Recurrent Vaginal Cancer","Recurrent Vulvar Cancer","Recurrent Ovarian Cancer","Recurrent Fallopian Tube Cancer","Primary Peritoneal Cancer",[35,36,37,38,39,40,41,42,43,44,45,46,47,48,49],"Reirradiation","Radiotherapy","Brachytherapy","External Beam Radiotherapy","Stereotactic Body Radiotherapy","Proton Therapy","Intraoperative Radiotherapy","Total Ablative Strategy","Oligometastatic Recurrence","Metastasis-Directed Therapy","Patient Registry","Radiographic Progression-Free Survival","Treatment-Related Adverse Events","Fistula","Overall survival","RECRUITING","2026-06-20",{"date":53,"type":54},"2026-06-24","ACTUAL",{"date":56,"type":54},"2026-06-11",{"date":58,"type":21},"2036-12",{"name":60,"class":61},"Affidea Nu-med Center of Oncological DIagnostics and Therapy","OTHER",1,{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":71,"targetDuration":4,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":81,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":99},"100508700","phase-2-pembrolizumab-combination-with-lenvatinib-in-pts-with-recurrentpersistentmetastatic-or-locally-advanced-vulvar-cancer-not-amenable-to-curative-surgery-or-radiotherapy-100508700","NCT05903833","Pembrolizumab Combination With Lenvatinib in Pts With Recurrent,Persistent,Metastatic or Locally Advanced Vulvar Cancer Not Amenable to Curative Surgery or Radiotherapy","Pembrolizumab in Combination With Lenvatinib in Pts With Recurrent, Persistent, Metastatic or Locally Advanced Vulvar Cancer Not Amenable to Curative Surgery or Radiotherapy","PIERCE","Inclusion Criteria:\n\n1. Signed written informed consent obtained prior to initiation of any study-specific procedures and treatment as confirmation of the patients awareness and willingness to comply with the study requirements.\n2. Female patients who are at least 18 years of age on the day signing informed consent\n3. Histologically confirmed locally advanced, recurrent, persistent and\u002For metastatic VSCC not amenable for salvage surgery or definitive (chemo)radiation (additive palliative radiotherapy for symptom control is allowed)\n4. ≤2 previous lines of chemotherapy for recurrent or metastatic disease\n5. Measurable disease (investigator assessed RECIST 1.1). Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.\n6. Have an eastern cooperative oncology group (ECOG) performance status of 0-1. Evaluation of ECOG is to be performed within 7 days prior to the first dose of study intervention.\n7. No pregnancy (as documented by a positive beta-human chorionic gonadotropin \\[ß-hCG\\] or human chorionic gonadotropin \\[hCG\\]) test with a minimum sensitivity of 25 IU\u002FL or equivalent units of ß-hCG \\[or hCG\\]), no breastfeeding, and at least one of the following conditions applies:\n\n   1. Not a woman of childbearing potential (WOCBP) as defined in Appendix 3 OR\n   2. A WOCBP who agrees to follow the contraception and pregnancy testing recommendations for investigational medicinal products (IMPs) with demonstrated or suspected human teratogenicity\u002F fetotoxicity in early pregnancy of the CTFG-guideline in Appendix 3 during the treatment period and for at least 4 months (corresponding to time needed to eliminate pembrolizumab) after the last dose of study treatment. In addition to the described highly effective oral\u002Ftransdermal contraception methods a barrier method must be used.\n\n   A WOCBP should not become pregnant during the treatment and for at least 4 months.\n8. Available archival tumor tissue sample and\u002For newly obtained core or excisional biopsy of a tumor lesion ideally not previously irradiated. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides.\n9. Adequate organ function as defined in Table 3 of study protocol. Specimens must be collected within 10 days prior to the start of study treatment.\n\nExclusion Criteria:\n\n1. Non squamous cell histology\n2. Contraindications regarding treatment with pembrolizumab:\n\n   allergy or hypersensitivity to pembrolizumab or one of the components.\n3. Contraindications regarding treatment with lenvatinib: allergy or hypersensitivity to lenvatinib or one of the components or:\n\n   1. Pre-existing ≥Grade 3 gastrointestinal or nongastrointestinal fistula\n   2. Radiographic evidence of major blood vessel infiltration\n4. Bradyarrhythmia\n5. Arterial dissection\u002Faneurysm\n6. Long QT Syndrome\n7. Significant cardiovascular impairment: history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, myocardial infarction or stroke within 12 months of the first dose of study drug, or cardiac arrhythmia requiring medical treatment at screening.\n8. History or evidence of major thrombotic (e.g. symptomatic pulmonary embolism) or hemorrhagic disorders within 6 months prior to day 1, cycle 1. The degree of tumor invasion\u002Finfiltration of major blood vessels (e.g. carotid artery) should be considered because of the potential risk of severe haemorrhage associated with tumor shrinkage\u002Fnecrosis following lenvatinib therapy.\n9. Allogenic tissue\u002Fsolid organ transplant.\n10. Diagnosis of immunodeficiency\n11. Active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed.\n12. History of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years (time requirement does not apply for definitively treated early endometrial cancer (FIGO IA\u002FB), in-situ carcinomas \\[e.g. breast, cervix, bladder\\], or basal or squamous cell carcinoma of the skin).\n13. Gastrointestinal malabsorption, gastrointestinal anastomosis, or any other condition that might affect the absorption of lenvatinib.\n14. Active CNS metastases and\u002For carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are radiologically stable, i.e. without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study intervention.\n15. History of (non-infectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease.\n16. Major active infection requiring systematic therapy.\n17. Has active hemoptysis within 3 weeks prior to the first dose of study intervention or tumor bleeding within 2 weeks prior randomization.\n18. Known history of Human Immunodeficiency Virus (HIV) infection\n19. History of Hepatitis B (defined as Hepatitis B surface antigen \\[HBsAg\\] reactive) or known active Hepatitis C virus (defined as HCV RNA \\[qualitative\\] is detected) infection.\n20. Known history of active TB (Bacillus tuberculosis).\n21. Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n22. History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.\n23. Pregnancy\n24. Breastfeeding Prior\u002F Concomitant Therapy\n25. Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).\n26. Systemic use of corticosteroids or immunosuppressive drugs within 7 days prior start of study treatment (see EC 11.)\n\n    * Systemic corticosteroids (at dose higher than 10 mg\u002Fday equivalent prednisone); if systemic corticoid use, corticoid must be stopped at least 7 days before study treatment start\n    * Interferons\n    * Interleukins\n    * Live vaccine\n\n    Note: Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster, yellow fever, rabies, BCG, and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed as other killed vaccines, if done at least 2 weeks prior the first dose of study drug; however, intranasal influenza vaccines (e.g. FluMist®) are live attenuated vaccines and are not allowed.\n27. Antiarrhythmics of classes Ia and III and other QT-interval prolongation drugs\n28. Prior systemic anti-cancer therapy including investigational agents within 4 weeks \\[could consider shorter interval for kinase inhibitors or other short half-life drugs\\] prior to allocation.\n29. Prior radiotherapy within 2 weeks of start of study intervention. Patients must have recovered from radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease.\n30. Not recovered adequately from any toxicity from other anticancer treatment regimens and\u002For complications from major surgery prior to starting therapy. Note: Withhold lenvatinib for at least 1 week prior to elective surgery. Do not administer for at least 2 weeks following major surgery and until adequate wound healing.\n31. Administration of a live, attenuated vaccine within 30 days prior first dose of study drug. Diagnostic Assessments\n32. Uncontrolled blood pressure (Systolic BP \\>140 mmHg or diastolic BP \\>90 mmHg) in spite of an optimized regimen of antihypertensive medication.\n33. Change of anti-HTN (hypertension) medical regimen within 1 week prior to randomization\n34. Prolongation of corrected QT interval (QTc interval) \\>480 ms\n35. Left ventricular ejection fraction (LVEF) below the institutional normal range as determined by multigated acquisition scan (MUGA) or echocardiogram (ECHO).\n36. Electrolyte abnormalities that have not been corrected.\n37. Subjects having \\>1+ proteinuria on urine dipstick testing unless a 24-hour urine collection for quantitative assessment indicates that the urine protein is \\\u003C1 g\u002F24 hours. Prior\u002FConcurrent Study Experience\n38. Prior enrolment on a clinical study evaluating pembrolizumab and lenvatinib for a carcinoma, regardless of treatment received.\n39. Currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention. Note: Patients who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent.",{"count":72,"type":21},42,"INTERVENTIONAL",[75],"PHASE2","Evaluation of efficacy and safety of pembrolizumab in combination with lenvatinib in patients with recurrent, persistent, metastatic or locally advanced vulva cancer.",[30,78,79,80],"Persistent Vulvar Cancer","Metastatic Vulva Cancer","Locally Advanced Vulvar Cancer",[82,83,84,85,86,87,88],"Advanced vulvar cancer","Recurrent vulvar cancer","Persistent vulvar canser","Metastatic vulvar cancer","Locally advanced vulvar cancer","Pembrolizumab","Lenvatinib","2026-05-06",{"date":91,"type":54},"2026-05-11",{"date":93,"type":54},"2025-06-24",{"date":95,"type":21},"2029-10-30",{"name":97,"class":98},"AGO Research GmbH","INDUSTRY",15,{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":4,"eligibilityCriteria":106,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":107,"targetDuration":4,"studyType":73,"phases":109,"briefSummary":110,"conditions":111,"keywords":113,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":62},"100627041","phase-2-electrochemotherapy-for-recurrent-vulvar-cancer-100627041","NCT07443475","Electrochemotherapy for Recurrent Vulvar Cancer","Use of Electrochemotherapy in Women With Vulvar Cancer","Inclusion Criteria:\n\n* Local recurrence of vulvar cancer\n* Age ≥ 18 years\n* Expected life expectancy \\> 3 months\n* Karnofsky performance status ≥ 70 or WHO performance status ≤ 2\n* At least 2 weeks since last treatment\n* Ability to understand the procedure and possible adverse effects\n* Ability to provide written informed consent\n* Patient discussed at multidisciplinary tumor board before enrollment\n* Fit for anesthesia\n\nExclusion Criteria:\n\n* Life-threatening infection and\u002For severe cardiac, hepatic, or other systemic disease\n* Significantly reduced lung function requiring DLCO testing (patients with abnormal DLCO are excluded)\n* Age \\\u003C 18 years\n* Major coagulation disorders not responding to standard therapy\n* Prior cumulative bleomycin dose ≥ 400 mg\u002Fm²\n* Chronic renal impairment (creatinine \\> 150 µmol\u002FL)\n* Epilepsy\n* Pregnancy\n* Inability to understand the study or refusal to participate",{"count":108,"type":21},13,[75],"This phase I\u002FII interventional study evaluates the effectiveness and safety of electrochemotherapy (ECT) as neoadjuvant treatment for local recurrence of vulvar cancer. Electrochemotherapy combines intravenous administration of bleomycin with delivery of electric pulses to the tumor area, increasing drug uptake into cancer cells. The main goal is to assess tumor response and reduce the need for mutilating surgical procedures, thereby improving quality of life in women with recurrent vulvar cancer. Participants will be followed prospectively and treatment outcomes will be evaluated using RECIST criteria and adverse events using CTCAE v5.0.",[112,30],"Vulvar Cancer",[114,115,116],"Electrochemotherapy","Bleomycin","Vulvar carcinoma","2026-02-27",{"date":119,"type":54},"2026-03-02",{"date":121,"type":54},"2021-09-01",{"date":123,"type":21},"2026-08-31",{"name":125,"class":61},"Institute of Oncology Ljubljana"]