[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"tumor-recurrence\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:tumor-recurrence":40},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,83],{"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":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":41,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":82},"100517783","phase-1-a-dose-escalation-and-dose-expansion-study-of-intratumoral-onm-501-alone-and-in-combination-with-cemiplimab-in-patients-with-advanced-solid-tumors-and-lymphomas-100517783",false,"NCT06022029","A Dose Escalation and Dose Expansion Study of Intratumoral ONM-501 Alone and in Combination With Cemiplimab in Patients With Advanced Solid Tumors and Lymphomas.","A Phase 1 Dose-Escalation and Expansion Study of Intratumorally Administered ONM-501 Alone and in Combination With Cemiplimab in Patients With Advanced Solid Tumors and Lymphomas","ON-5001","Inclusion Criteria:\n\n1. Ability to understand and willingness to sign written informed consent before performance of any study procedures\n2. Age ≥ 18 years\n3. Participants with solid tumors or lymphomas, confirmed by available histopathology records or current biopsy, that are advanced, nonresectable, or recurrent and progressing since last antitumor therapy, and for which no alternative standard therapy exists.\n4. Participants must have a minimum of one injectable and measurable lesion.\n5. Participants with prior Hepatitis B or C are eligible if they have adequate liver function\n6. Participants with human immunodeficiency virus (HIV) are eligible if on established HAART for a minimum of 4 weeks prior to enrollment, have an HIV viral load \\\u003C400 copies\u002FmL, and have CD4+ T-cell (CD4+) counts ≥ 350 cells\u002FuL\n7. Adequate bone marrow function:\n8. Adequate liver function\n\nExclusion Criteria: Patients will be excluded from this study if they meet any of the following criteria (Part 1a and Part 1b).\n\n1. Other malignancy active within the previous 2 years except for basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast that has completed curative therapy.\n2. Major surgery within 4 weeks before the first dose of study drug.\n3. Brain metastases that are untreated or in the posterior fossa or involve the meninges. Participants with stable or previously treated progressing brain metastases (except in the posterior fossa or involving the meninges) may be permitted in a case-by-case basis at the Sponsor's discretion.\n4. Prolongation of corrected QT (QTc) interval to \\>470 millisecond (ms) for males and females when electrolytes balance is normal.\n5. Females who are breastfeeding or pregnant at screening or baseline\n6. Females of childbearing potential that refuse to use a highly effective method of contraception.\n7. Has uncontrolled or poorly controlled hypertension as defined by a sustained BP \\> 9. Has received prior investigational therapy within 5 half-lives of the agent or 4 weeks before the first administration of study drug, whichever is shorter.\n8. Has had any major cardiovascular event within 6 months prior to study drug 10. Has known hypersensitivity to any component in the formulation of ONM-501\n9. Has an active infection requiring systemic treatment\n10. Is participating in another therapeutic clinical trial\n\nAdditional Exclusion Criteria for ONM-501 in Combination with cemiplimab (Part 1b)\n\n1. Has known hypersensitivity to any component in the formulation of cemiplimab\n2. Has any active or recent history of a known or suspected autoimmune disease or recent history of a syndrome that required systemic corticosteroids (\\>10 mg daily prednisone equivalent)\n3. Has a condition requiring systemic treatment with corticosteroids","ALL","18 Years",{"count":20,"type":21},168,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","A phase 1, multicenter, open label, non-randomized dose escalation and dose expansion study to examine the maximum tolerated dose, (MTD), minimum effective dose (MED) and\u002For recommended dose for expansion (RDE) of intratumoral ONM-501 as monotherapy and in combination with a PD-1 checkpoint inhibitor in patients with advanced solid tumors and lymphomas.",[27,28,29,30,31,32,33,34,35,36,37,38,39,40],"Triple Negative Breast Cancer","Diffuse Large B Cell Lymphoma","Follicular Lymphoma","Lymphoma, Non-Hodgkin","Mantle Cell Lymphoma","Bladder Cancer","Uveal Melanoma, Recurrent","Cervix Cancer","Carcinoma in Situ","Head and Neck Squamous Cell Carcinoma","Skin Cancer","Metastatic Cancer","Tumor, Solid","Tumor Recurrence",[42,43,44,45,46,47,48,49,37,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64,65,66,67,68,69],"Solid tumors","Lymphoma","ONM-501","STING","Intra-tumoral","HNSCC","Breast Cancer","Melanoma","cemiplimab","Libtayo","DLBCL","bladder cancer","cervical cancer","metastases","immunotherapy","ICI","TNBC","Triple Negative","mTNBC","anti-PD-1 antibody","BRCA1","BRCA2","anti-PD-L1","uveal","NHL","Mantle Zone lymphoma","FL","stimulator of interferon genes","RECRUITING","2025-12-18",{"date":73,"type":74},"2025-12-24","ACTUAL",{"date":76,"type":74},"2023-10-13",{"date":78,"type":21},"2026-08-29",{"name":80,"class":81},"OncoNano Medicine, Inc.","INDUSTRY",16,{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":91,"minAge":18,"maxAge":4,"enrollmentInfo":92,"targetDuration":4,"studyType":22,"phases":94,"briefSummary":96,"conditions":97,"keywords":101,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":116},"100474414","clinical-study-on-the-re-irradiation-of-lateral-pelvic-recurrences-of-gynecological-malignancies-100474414","NCT05457595","Clinical Study on the Re-irradiation of Lateral Pelvic Recurrences of Gynecological Malignancies","Phase II Clinical Study on the Re-irradiation of Lateral Pelvic Recurrences of Gynecological Malignancies","CYCLOPS","Inclusion Criteria:\n\n* Patients ≥ 18 years of age\n* Karnofsky Index ≥ 70\n* Histological or radiological diagnosis of pelvic and groin recurrence\n* Contraindications for radical surgery\n* No other distant progression or stable disease (SD) of known secondarisms (≥6 months)\n* Previous radiation therapy on pelvis\n* Distance ≥ 10mm between tumour and close intestinal tract (small intestine), radiologically evaluated\n* Possibility to perform a surgery to space the intestinal loops, in case of distance \\\u003C 10mm\n* If needed, spacer in biocompatible material (silicon, goretex) or anatomical material (omentum, muscle patch), non-absorbable.\n* DICOM (Digital Imaging and COmmunications in Medicine) images of the previous treatment plan availability\n* Written informed consent\n* Patient's ability to understand the characteristics and consequences of the clinical trial\n\nExclusion Criteria:\n\n* Hip prosthesis, metal prostheses or any other condition that prevents adequate imaging to identify the target volume and calculate the dose in the treatment plan\n\n  * Intestinal infiltration\n  * Bladder infiltration\n  * Vessel infiltration\n  * Previous therapy with anti-angiogenesis drugs\n  * Psychic or other disorders that may prevent informed consent\n  * Previous invasive tumor, with the exception of skin cancer (excluding melanoma) unless disease-free for at least 3 years\n  * Spacer in absorbable material (i.e. vycril)\n  * Distance \\\u003C 10mm between tumour and close intestinal tract (small intestine), radiologically evaluated\n  * Impossibility to assess MRI","FEMALE",{"count":93,"type":21},55,[95],"NA","The study aims to obtain a local control rate in patients with lateral pelvic relapses of gynecologycal cancers previously irradiated. High LET (Linear Energy Transfer) particles as carbon ions can guarantee a biologic advantage compared to photons in radioresistant neoplasms, given to their higher biological efficacy (RBE).",[40,98,99,100],"Malignant Epithelial Neoplasm of Vulva","Malignant Epithelial Tumor of Ovary","Malignant Epithelial Neoplasm",[102,103,104,105],"gynecological cancer","carbon ion radiation therapy","recurrencies","CIRT","2025-08-01",{"date":108,"type":74},"2025-08-06",{"date":110,"type":74},"2021-02-24",{"date":112,"type":21},"2028-02-25",{"name":114,"class":115},"CNAO National Center of Oncological Hadrontherapy","OTHER",1]