[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"vulvar-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:vulvar-carcinoma":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,49,78,107,133],{"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":29,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100644769","phase-2-tisotumab-vedotin-in-squamous-cell-carcinoma-of-the-vulva-100644769",false,"NCT07672782","Tisotumab Vedotin in Squamous Cell Carcinoma of the Vulva","Phase II Study Tisotumab Vedotin in Metastatic or Recurrent Squamous Cell Carcinoma of the Vulva","Inclusion Criteria:\n\n* Age ≥18 years, or considered an adult by local regulations, at time of consent.\n* Must sign an informed consent form (ICF) indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study prior to any other study-related assessments or procedures.\n* Has recurrent or metastatic vulva cancer with squamous cell histology, and:\n\n  1. Has not received more than 2 prior systemic therapy regimens for recurrent and\u002For metastatic vulva cancer. Chemotherapy administered in the adjuvant or neoadjuvant setting, or in combination with radiation therapy, should not be counted as separate systemic therapy regimen.\n  2. Is not a candidate for curative therapy, including but not limited to radiotherapy or exenterative surgery.\n* Measurable disease according to RECIST v1.1 as assessed by the investigator, defined as:\n\n  1. A minimum of one non-nodal lesion ≥10 mm in the longest diameter from a nonirradiated area. If target lesion(s) are located within previously irradiated area only, the participant can be enrolled only if there has been demonstrated progression in the \"in field\" lesion and upon approval of the sponsor's medical monitor.\n\n     OR\n  2. Lymph node lesion ≥15 mm in the shortest diameter from a non-irradiated area.\n* Must demonstrate acceptable screening laboratory values:\n\n  1. Calculated eGFR (MDRD formula): ≥50 mL\u002Fmin\u002F1.73m\\^2\n  2. Alanine aminotransferase (ALT): ≤3× upper limit of normal (ULN) (if liver tumor\u002Fmetastases are present, then ≤5×ULN is allowed)\n  3. Aspartate aminotransferase (AST): ≤3×ULN (if liver tumor\u002Fmetastases are present, then ≤5×ULN is allowed)\n  4. Bilirubin: ≤1.5×ULN (except in participants diagnosed with Gilbert's syndrome, direct bilirubin ≤2×ULN)\n  5. Hemoglobin: ≥5.6 mmol\u002FL (9.0 g\u002FdL)\n  6. Absolute Neutrophil Count (ANC): ≥1500\u002FμL (1.5x10\\^9\u002FL)\n  7. Platelet count: ≥100×10\\^9\u002FL\n  8. For participants NOT on anti-coagulation therapy:\n\n     1. Activated partial thromboplastin time (aPTT): ≤1.5×ULN\n     2. International normalized ratio (INR): ≤1.2\n  9. For participants on anti-coagulation therapy:\n\n     1. aPTT: ≤1.5×ULN\n     2. INR: ≤2.5\n* Has ECOG performance status of 0 or 1 within 28 days prior to registration.\n* Has a negative serum pregnancy test for participants of reproductive potential. Participants that are postmenopausal, permanently sterilized or previously subjected to bilateral oophorectomy, bilateral salpingectomy and\u002For hysterectomy can be considered as not having reproductive potential.\n* Participants of reproductive potential must agree to use adequate contraception during and for 6 months after the last study treatment administration. Adequate contraception is defined as highly effective methods of contraception. Two highly effective methods of contraception must be used in countries where this is required.\n* Must agree not to breastfeed or donate ova, starting at the time of informed consent and continuing through 6 months after receiving the last dose of study drug administration.\n* If required by local health authorities, has negative serology for hepatitis B surface antigen (HBsAg)\u002FHBV DNA, or hepatitis C antibody (HCVAb) or RNA. Active hepatitis C is defined by a known positive HCVAb result and known quantitative HCV RNA results greater than the lower limits of detection of the assay.\n* Must be willing and able to adhere to the prohibitions and restrictions specified in the protocol.\n\nExclusion Criteria:\n\n* Has primary melanoma, adenocarcinoma, sarcomatoid, or other histologies not mentioned in inclusion criterion 3\n* Has clinically significant bleeding issues or risks:\n\n  1. Known past or current coagulation defects leading to an increased risk of bleeding\n  2. Diffuse alveolar hemorrhage from vasculitis\n  3. Known bleeding diathesis\n  4. Ongoing major bleeding (ie, participant requires a transfusion of \\>2 platelet concentrates within 14 days of the first dose of study treatment)\n  5. Trauma with increased risk of life-threatening bleeding\n  6. History of severe head trauma or intracranial surgery within 8 weeks of study entry\n* Has cardiovascular issues or risks:\n\n  1. Clinically significant cardiac disease, including unstable angina or acute myocardial infarction, 6 months prior to screening\n  2. Any medical history of congestive heart failure (grade III or IV as classified by the New York Heart Association)\n  3. Any medical history of decreased cardiac ejection fraction of \\\u003C45%\n  4. A marked baseline prolongation of QT\u002FQTc interval (eg, repeated demonstration of a QTc interval \\>450 msec)\n  5. A complete left bundle branch block (defined as a QRS interval ≥120 msec in left bundle branch block form) or an incomplete left bundle branch block\n* Central nervous system (CNS): any history of intracerebral arteriovenous malformation, cerebral aneurysm, or stroke (transient ischemic attack \\>28 days prior to screening is allowed).\n* Ophthalmological: Active ocular surface disease or a history of cicatricial conjunctivitis or inflammatory conditions that predispose to cicatrizing conjunctivitis (eg, Wagner syndrome, atopic keratoconjunctivitis, autoimmune disease affecting the eyes), ocular Stevens-Johnson syndrome or toxic epidermal necrolysis, mucus pemphigoid, and participants with penetrating ocular transplants are ineligible. Cataracts alone is not an exclusion criterion.\n* Other cancer: known past or current malignancy other than inclusion diagnosis. Exceptions are malignancies with a negligible risk of metastasis or death (e.g., 5-year OS ≥90%) such as non-invasive basal cell carcinoma, non-invasive superficial bladder cancer, and ductal carcinoma in situ.\n* Brain metastases are allowed if the following criteria are met: definitive therapy (eg, surgery or stereotactic brain radiotherapy) has been completed \\>8 weeks before the first dose of study treatment; no evidence of clinical or radiologic progression of the brain metastases; participant has completed perioperative corticosteroid therapy or steroid taper. NOTE: Chronic steroid therapy is acceptable provided that the dose is stable for 28 days prior to study enrollment.\n* Surgery\u002Fprocedures: major surgery within 4 weeks (28 days) or minor surgery within 7 days prior to the first study treatment administration. Participants must have recovered adequately from the toxicity or complications from the intervention prior to starting study treatment. Participants who have planned major surgery during the treatment period must be excluded from the study.\n* Peripheral neuropathy ≥grade 2.\n* Prior anti-cancer therapy:\n\n  1. Any prior treatment with MMAE-derived drugs (e.g. Brentuximab vedotin, Polatuzumab vedotin, Tisotumab vedotin, Disitamab vedotin).\n  2. Radiotherapy for palliative intent within 21 days prior to the first administration of study treatment. Participants must have recovered from all clinically significant radiation-related toxicities. At least 42 days must have elapsed from the last administration of chemo-radiotherapy to first study treatment.\n  3. Small molecules, chemotherapy, immunotherapy, or monoclonal antibodies within 28 days prior to the first administration of study treatment.\n  4. Currently participating in or has participated in a study of an investigational agent or device and received active treatment within 28 days prior to the first dose of study treatment.\n* Other:\n\n  1. Ongoing significant, uncontrolled medical condition.\n  2. Clinically significant active viral, bacterial, or fungal infection requiring IV or oral treatment with antimicrobial therapy ending \\\u003C7 days prior to first study treatment administration.\n  3. Clinically relevant bilateral hydronephrosis which cannot be alleviated by ureteral stents or percutaneous drainage.\n  4. Participants with clinical symptoms or signs of gastrointestinal obstruction and who require parenteral hydration or nutrition at the time of the first dose of study treatment.\n* Has known seropositivity of human immunodeficiency virus (HIV); known medical history of hepatitis B or C infection. Note: No testing for HIV, hepatitis B, or hepatitis C is required, unless mandated by local health authorities. Exceptions include latent or controlled HIV infection.\n* Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (dose exceeding 10 mg daily of prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of tisotumab vedotin.\n* Is pregnant or intends to conceive children within 6 months of ending study treatment.\n* Is breast feeding and cannot discontinue breast feeding for the duration of the study and ≥6 months after the last study treatment administration.\n* Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (eg, compromise well-being) or that could prevent, limit, or confound the protocol-specified assessments.\n* Known allergies, hypersensitivity, or intolerance to study treatment or its excipients (refer to the Investigator's Brochure for further information on tisotumab vedotin).\n* Has known psychiatric or substance abuse disorders that would interfere with cooperating with the requirements of the study.","FEMALE","18 Years",{"count":19,"type":20},28,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This is an open-label, single arm, phase 2 study designed to evaluate the efficacy of tisotumab vedotin in participants with recurrent or metastatic squamous cell carcinoma of the vulva by estimating the objective response rate.\n\nPatients will receive tisotumab vedotin every 3 weeks (21 days plus or minus 3 days). Treatment will continue until either unacceptable toxicity, progression of disease, or investigator\u002Fpatient request for withdrawal.",[26,27,28],"Vulvar Carcinoma","Recurrent or Metastatic Vulvar Cancer","Squamous Cell Carcinoma Vulva",[30,31,32,33,34,35],"Metastatic","Recurrent","Squamous Cell Carcinoma","Vulva","Advanced","Vulvar Cancer","NOT_YET_RECRUITING","2026-06-22",{"date":39,"type":40},"2026-06-29","ACTUAL",{"date":42,"type":20},"2026-11",{"date":44,"type":20},"2029-12",{"name":46,"class":47},"GOG Foundation","NETWORK",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":56,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":21,"phases":59,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":48},"100624285","phase-2-vaginal-dhea-to-improve-vaginal-health-after-radiation-for-women-with-gynecologic-anal-or-rectal-cancer-100624285","NCT07407647","Vaginal DHEA to Improve Vaginal Health After Radiation for Women With Gynecologic, Anal or Rectal Cancer","Vaginal DHEA for Women With Gynecologic and Gastrointestinal Cancer After Radiation","Inclusion Criteria:\n\n* Any patient with anal, rectal, cervical, vaginal, or vulvar cancer receiving external beam radiation alone, or both external beam radiation and brachytherapy with curative intent (Participants will be consented and enrolled prior to starting treatment but will not receive intervention till after treatment is completed)\n* Concurrent or prior chemotherapy is allowed\n* Any prior gynecologic surgery is permitted\n* Rectal surgery, including lower anterior resection and abdominoperineal resection, is permitted\n* Subject must be menopausal, which is defined as age \\> 50 with no menses for 12 months or bilateral oophorectomy\n\nExclusion Criteria:\n\n* Patients with scleroderma, mixed connective tissue disorder, and lupus will be excluded\n* Patients who have received prior pelvic radiation\n* Undiagnosed abnormal genital bleeding (unrelated to current diagnosis or treatment related toxicity)\n* Endometrial cancer or endometrial hyperplasia\n* Use of estrogen alone injectable or progestin implant therapy with 3 months before study entry\n* Use of estrogen pellet or progestin injectable drug within 6 months before study entry\n* Use of oral estrogen, progestin, or DHEA or intrauterine progestin within 8 weeks before study entry\n* Use of vaginal estrogen (rings, creams, tablets, or gels), transdermal estrogen +\u002F- progestin, vaginal hyaluronic acid, or pro-estrogenic herbal treatments such as black cohosh in the 4 weeks before study entry. Intravaginal moisturizers and lubricants prior to enrollment are permitted\n* History of breast cancer\n* Patients receiving palliative radiation therapy\n* Patients who do not meet criteria for menopause","50 Years",{"count":58,"type":20},25,[23],"This phase II trial tests the feasibility and side effects of vaginal DHEA to improve vaginal health after radiation for women with gynecologic, anal or rectal cancer. Treatment of cancers with radiation to the abdomen can influence the vaginal microbiome (any bacteria, virus, or other organisms found in the vagina). Both menopause and radiation cause a decrease in lubrication and elasticity of the vagina and symptoms including vaginal dryness, vaginal burning and itching, vaginal bleeding, pain or burning during urination, and pain during sexual intercourse. DHEA is a type of hormone replacement therapy. It is use to improve symptoms in women during menopause and may be effective in treating these symptoms for women who have received radiation.",[62,63,64,65,66,26],"Anal Carcinoma","Cervical Carcinoma","Malignant Female Reproductive System Neoplasm","Rectal Carcinoma","Vaginal Carcinoma","RECRUITING","2026-04-16",{"date":70,"type":40},"2026-04-21",{"date":72,"type":40},"2026-03-12",{"date":74,"type":20},"2026-12-31",{"name":76,"class":77},"Ohio State University Comprehensive Cancer Center","OTHER",{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":85,"targetDuration":4,"studyType":87,"phases":4,"briefSummary":88,"conditions":89,"keywords":94,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":106},"100613529","contribution-of-oncovascular-surgery-in-the-treatment-of-gynecological-advanced-malignant-diseases-100613529","NCT07267780","Contribution of Oncovascular Surgery in the Treatment of Gynecological Advanced Malignant Diseases.","The Contribution of Oncovascular Surgery in the Treatment of Gynecological Advanced Malignant Diseases: a Prospective and Retrospective Multicenter Study","Inclusion Criteria:\n\n\\- Retrospective Arm:\n\n1. Diagnosis of advanced or recurrent gynecologic cancer with vascular involvement requiring resection and\u002For reconstruction of major blood vessels, including:\n\n   * Ovarian carcinoma\n   * Cervical carcinoma\n   * Endometrial carcinoma\n   * Vulvar carcinoma\n   * Uterine or other types of sarcomas with vascular involvement\n2. Documented major vascular invasion, confirmed by preoperative imaging or intraoperative description.\n3. Patients who underwent onco-vascular surgery for advanced or recurrent gynecologic cancers between January 1, 2017, and August 31, 2025.\n4. Data Protection Impact Assessment (DPIA) approved for the management of retrospective data. (Deceased or untraceable patients will also be included to avoid selection bias, in accordance with Article 110 bis, paragraph 4 of the Italian Privacy Code. A DPIA will be produced and published on the Sponsor's website before study initiation, and patients who explicitly objected before death will not be included.)\n\nProspective Arm:\n\n1. Age ≥18 years\n2. Patients eligible for onco-vascular surgery for advanced or recurrent gynecologic cancers with vascular involvement, including:\n\n   * Ovarian carcinoma\n   * Cervical carcinoma\n   * Endometrial carcinoma\n   * Vulvar carcinoma\n   * Uterine or other types of sarcomas\n3. Documented major vascular invasion, confirmed by preoperative imaging or intraoperative description.\n4. Signed informed consent.\n\nExclusion Criteria:\n\n1. Patients younger than 18 years of age\n2. Patients with early-stage gynecologic cancers not eligible for onco-vascular surgery\n3. Patients undergoing vascular resection due to accidental injury of blood vessels not directly related to tumor infiltration.\n4. Patients who have previously undergone vascular surgery for reasons unrelated to the study, to avoid data overlap.",{"count":86,"type":20},130,"OBSERVATIONAL","Multicenter ambispective observational study (prospective\u002Fretrospective)",[90,63,91,26,92,93],"Ovarian Carcinoma","Endometrial Carcinoma","Uterine Sarcoma","Gynecologic Tumor",[95,96],"Advanced or recurrent gynecologic tumor","Vascular infiltration","2025-11-25",{"date":99,"type":40},"2025-12-05",{"date":101,"type":20},"2025-12",{"date":103,"type":20},"2035-12",{"name":105,"class":77},"National Cancer Institute, Naples",2,{"id":108,"slug":109,"hasResults":11,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":4,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":114,"targetDuration":4,"studyType":21,"phases":116,"briefSummary":117,"conditions":118,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":132},"100553898","phase-2-cryocompression-with-or-without-cilostazol-for-the-prevention-of-paclitaxel-induced-neuropathy-in-patients-with-gynecological-cancers-100553898","NCT06492070","Cryocompression With or Without Cilostazol for the Prevention of Paclitaxel-induced Neuropathy in Patients With Gynecological Cancers","Prevention of Paclitaxel-Induced Peripheral Neuropathy: Randomized Trial of Cryocompression With or Without Cilostazol","Inclusion Criteria:\n\n* INCLUSION CRITERIA FOR ARMS A and B:\n* Age 18 years or older\n* Diagnosis of uterine, ovarian\u002Ffallopian tube\u002Fprimary peritoneal, cervical, or vulvar cancer and planned chemotherapy regimen of 6-9 cycles of paclitaxel and carboplatin or cisplatin with or without VEGF inhibition, with or without immunotherapy, and with or without HER2-directed therapy\n* Eastern Cooperative Oncology Group performance status from 0 to 2\n* ARM C: Age 18 years or older\n* ARM C: Diagnosis of uterine, ovarian\u002Ffallopian tube\u002Fprimary peritoneal, cervical, or vulvar cancer and completion of 6-9 cycles of a chemotherapy regimen consisting of paclitaxel and carboplatin or cisplatin with or without VEGF inhibition, with or without immunotherapy, and with or without HER2-directed therapy within the last 3 months\n* ARM C: Eastern Cooperative Oncology Group performance status from 0 to 2\n\nExclusion Criteria:\n\n* EXCLUSION CRITERIA FOR ARMS A and B:\n* Any patient unable and\u002For unwilling to cooperate with all study protocols\n* Previous treatment with paclitaxel\n* Patients with baseline pre-chemotherapy neuropathy requiring pharmacologic treatment\n* Diabetes mellitus with hemoglobin A1c \\>7.0\n* Hepatic impairment, moderate to severe (Class B \\& C by Child-Pugh score)\n\n  * Slight or moderate malignant ascites alone will not be considered indicative of hepatic impairment in the absence of other evidence of hepatic disease\n* Raynaud's phenomenon\n* Active wounds on the hands or feet\n* High risk uncontrolled arrhythmias\n* Ischemic heart disease\n* Inadequate bone marrow function with white blood count \\\u003C 4,000\u002Fmm\\^3 and platelet count \\\u003C 100,000\u002Fmm\\^3\n* Inadequate liver function with serum total bilirubin \\>= 1.5mg\u002FdL\n* Inadequate renal function with serum creatinine \\>= 1.5mg\u002FdL\n* On one or more antiplatelet therapies excluding acetylsalicylic acid\n* Hypersensitivity (e.g. anaphylaxis, angioedema) to cilostazol or any components of cilostazol\n* Pregnant and nursing patients\n\n  * Patients enrolled in this study who have the potential to become pregnant (have an intact uterus, ovary(ies), and fallopian tube(s), have not entered menopause, and have regular menses) are required to utilize reliable contraception such as celibacy, hormonal contraception (oral pills, implant, injection, ring or patch), intrauterine device (IUD), condom and\u002For diaphragm with spermicide\n* Incarcerated patients\n* Patients unable to consent for themselves, due to cognitive impairment or other reason\n* Patients with contraindications to cilostazol\n* Any patient who does not meet criteria to receive chemotherapy\n* ARM C: Any patient unable and\u002For unwilling to cooperate with all study protocols\n* ARM C: Previous treatment with paclitaxel\n* ARM C: Patients with baseline pre-chemotherapy neuropathy requiring pharmacologic treatment\n* ARM C: Diabetes mellitus with hemoglobin A1c \\>7.0\n* ARM C: Pregnant patients\n* ARM C: Incarcerated patients\n* ARM C: Patients unable to consent for themselves, due to cognitive impairment or other reason",{"count":115,"type":20},70,[23],"The phase II trial evaluates the effectiveness of cryocompression therapy alone or in combination with cilostazol in preventing paclitaxel-induced peripheral neuropathy (numbness, pain or tingling in the feet and hands) for patients with gynecologic cancers. Peripheral neuropathy is a common side effect of many chemotherapeutic agents, including paclitaxel. Paclitaxel is in a class of medications called antimicrotubule agents. It stops cancer cells from growing and dividing and may kill them. Cryocompression is a therapy that combines compression garments or dressings with cooling of the treated area. Cilostazol is in a class of medications called platelet-aggregation inhibitors (antiplatelet medications). It works by improving blood flow to the legs. Giving cilostazol together with cryocompression may be safe and tolerable in treating patients with gynecological cancers.",[63,119,120,121,90,122,26],"Fallopian Tube Carcinoma","Malignant Solid Neoplasm","Malignant Uterine Neoplasm","Primary Peritoneal Carcinoma","2025-08-20",{"date":125,"type":40},"2025-08-27",{"date":127,"type":40},"2024-08-01",{"date":129,"type":20},"2027-12-31",{"name":131,"class":77},"Emory University",3,{"id":134,"slug":135,"hasResults":11,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":139,"eligibilityCriteria":140,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":141,"enrollmentInfo":142,"targetDuration":4,"studyType":21,"phases":144,"briefSummary":145,"conditions":146,"keywords":148,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":106},"100568808","phase-2-hpv-vaccine-imiquimod-and-metformin-combination-trial-100568808","NCT06686043","HPV Vaccine, Imiquimod, and Metformin Combination Trial","A Phase 2 Study of HPV L1 Vaccine in Combination With Imiquimod and Metformin in Cervical, Vaginal, and Vulvar Cancers","HPV-VIM","Inclusion Criteria:\n\n* Participants must have histologically confirmed locally advanced or metastatic cervical carcinoma (Stage IB2-IVB), vaginal, or vulvar carcinoma (Stage II-IVB), AND not be considered a primary surgical candidate. Patients offered neoadjuvant therapy may be enrolled if they respond and receive chemoradiation.\n* Participants must have measurable disease, per Recist criteria. See Section 12 (Measurement of Effect) for the evaluation of measurable disease. Radiological evaluation shall occur within approximately 30 days prior to enrollment initiation and start of radiation.\n* Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2\n* Participants must be ≥ 18 years of age\n* Participants must have adequate organ function within 28 days of registration, defined as follows: - Absolute neutrophil count ≥ 1,500\u002FµL - Platelets ≥ 100,000\u002FµL - Hemoglobin ≥ 9 g\u002FdL - Serum creatinine ≤ 1.5 x upper limit of normal (ULN) - Total bilirubin ≤ 1.5 x ULN (≤2.0 in patients with known Gilberts syndrome) OR direct bilirubin ≤ 1 x ULN - Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x ULN unless liver metastases are present, in which case they must be ≤ 5 x ULN\n* Participants receiving corticosteroids may continue as long as their dose is stable for at least 4 weeks prior to initiating protocol therapy.\n* Participant must agree to not donate blood during the study or for 90 days after the last dose of study treatment.\n* Female participants of childbearing potential must have a negative serum pregnancy test within 14 days prior to registration. Females of non-childbearing potential is defined as follows (by other than medical reasons): - ≥45 years of age and has not had menses for \\>1 year, post-hysterectomy, post-bilateral oophorectomy, post external beam radiation of 6 Gy to the pelvis, or post-tubal ligation.\n* Participants must agree to not breastfeed during the study.\n* Participants must be able to understand the study procedures and agree to participate in the study by providing written informed consent\n* Participants must be eligible for chemoradiation treatment in the opinion of the treating investigator.\n* Participants who are HIV+ must have CD4 counts \\>200\u002FdL and demonstrate documented Highly active antiretroviral therapy (HAART) compliance m. Participant must have CT (chest\u002Fabdomen\u002Fpelvis) or PET-CT, within 56 days of registration.\n* Participants must be newly diagnosed.\n* Standard chemoradiation using external beam radiation therapy (EBRT) and brachytherapy is permitted for cervical or vaginal carcinoma, and chemoradiation with EBRT for vulvar carcinoma. A lesion must be readily accessible for intratumoral tumor injection.\n* ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A).\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n* Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression.\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n\nExclusion Criteria:\n\n* Patients who are receiving any other investigational agents.\n* Patients who have untreated, new or progressive brain metastases or leptomeningeal disease.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to agents used in study.\n* Patients with uncontrolled intercurrent illness.\n* Patients with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Pregnant women are excluded from this study because cervical carcinoma or vulva carcinoma patients have undergone treatment rendering the patient infertile. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with cervical carcinoma or vulva carcinoma, breastfeeding should be discontinued.","64 Years",{"count":143,"type":20},85,[23],"The goal of this clinical trial is to explore whether additional treatments can help strengthen the participant's immune system to fight cancer caused by the Human Papillomavirus (HPV), a virus spread through intimate skin-to-skin contact. The trial will also monitor the safety of these treatments. The main questions it aims to answer are:\n\nDoes the combination of treatments help the participant's body fight the cancer more effectively when used alongside standard therapy? What side effects or medical issues arise when using these experimental treatments? Researchers will use three experimental therapies along with the participant's standard treatment to find out if these therapies work better together than standard treatment alone.\n\nParticipants will:\n\nReceive HPV vaccinations during the 2nd and 4th week of radiation, and again at weeks 8, 10, 12, and 16 after completing radiation.\n\nHave blood samples taken, tumor cells brushed from the surface, and imiquimod cream applied during each visit.\n\nTake a daily metformin pill and apply an imiquimod suppository three times a week for two weeks after each visit.",[63,66,26,147],"HPV (Human Papillomavirus)-Associated Carcinoma",[149,150,151,152,153,154,155,156,157,158,159,160,161,162,163],"metformin","HPV","Imiquimod","Human Papillomavirus 9-valent Vaccine","Recombinant","Cytobrush","cervical cancer","vaginal cancer","vulvar cancer","chemoradiation","tumor","immunotherapy","metastatic","intratumoral","Endometrial cancer","2024-11-11",{"date":166,"type":40},"2024-11-13",{"date":168,"type":40},"2024-08-23",{"date":170,"type":20},"2028-08-23",{"name":172,"class":77},"Baylor College of Medicine"]