[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"carcinoma-in-situ\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:carcinoma-in-situ":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,42,84],{"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":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100580113","phase-2-a-clinical-study-of-intismeran-autogene-v940-and-bcg-in-people-with-bladder-cancer-v940-011interpath-011-100580113",false,"NCT06833073","A Clinical Study of Intismeran Autogene (V940) and BCG in People With Bladder Cancer (V940-011\u002FINTerpath-011)","A Phase 2 Open-label Randomized Study of V940 in Combination With BCG Versus BCG Monotherapy in Participants With High-risk Non-muscle Invasive Bladder Cancer (INTerpath-011)","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n\\- Is an individual whose most recent TURBT was performed within 12 weeks before randomization\u002Fallocation and showed BICR-confirmed high-risk NMIBC histology\n\nCohort A:\n\n* Has high-risk non-muscle invasive (HG Ta, T1, and\u002For CIS) UC of the bladder\n* Is BCG-naïve defined as either having never received BCG or having received BCG more than 2 years before high-risk NMIBC recurrence. Recurrence must be at least 24 months from the last exposure to BCG with evidence of complete response during the 2-year period post BCG\n\nCohort B:\n\n* Has CIS +\u002F-papillary non-muscle invasive UC of the bladder\n* Is ineligible for, or refusing, any IVESIC therapy\n* Is either BCG-naïve (as defined above) or BCG-exposed but did not receive protocol-specified minimum dosing of BCG and experienced recurrence of high-risk NMIBC within 2 years of the last dose of BCG\n* Human immunodeficiency virus (HIV)-infected individuals must have well controlled HIV on antiretroviral therapy (ART)\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has a history of or concurrent locally-advanced (ie, T2, T3, T4) or metastatic UC\n* Has concurrent extravesical (ie, urethra, ureter, renal pelvis) non-muscle invasive UC or a history of extravesical non-muscle invasive UC that recurred within the last 2 years, with certain exceptions\n* Has a known additional malignancy that is progressing or has required active treatment within the last 3 years\n* Has had a myocardial infarction within 6 months of randomization\u002Fallocation\n* Has received any systemic anticancer therapy including investigational agents within 4 weeks before randomization\u002Fallocation\n* Has received prior treatment with a cancer vaccine\n* Has immunodeficiency or is receiving chronic systemic steroid therapy\n* Has active autoimmune disease that has required systemic treatment in the last 2 years\n* Has any contraindication to IV contrast and gadolinium or is otherwise unable to have imaging with either computerized tomography urogram (CTU) or Magnetic resonance urography (MRU)\n\nCohort A:\n\n* Has current active tuberculosis\n* Has a known history of HIV infection\n\nCohort B:\n\n\\- HIV-infected individuals with a history of Kaposi's sarcoma and\u002For Multicentric Castleman's Disease","ALL","18 Years",{"count":19,"type":20},308,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","Researchers are looking for new ways to treat people with high-risk non-muscle invasive bladder cancer (HR NMIBC). NMIBC is cancer in the tissue that lines the inside of the bladder but has not spread to the bladder muscle or outside of the bladder. High-risk means NMIBC may have a high chance of getting worse or coming back after treatment. HR NMIBC can also include carcinoma in situ (CIS). CIS is bladder cancer that appears flat and is only in the inner layer (surface) of the bladder. CIS is not raised and is not growing toward the center of the bladder.\n\nThe standard treatment for HR NMIBC is a procedure to remove the tumor called transurethral resection of the bladder tumor (TURBT) followed by Bacillus Calmette-Guerin (BCG). Standard treatment is something that is considered the first line of treatment for a condition. BCG is an immunotherapy, which is a treatment that helps the immune system fight cancer. However, BCG may not work to treat HR NMIBC in some people. Researchers want to learn if adding intismeran autogene, the study treatment, to standard treatment can help treat HR NMIBC. Intismeran autogene is designed to help a person's immune system attack their specific cancer.\n\nThe goal of this study are to learn if people who receive V940 with BCG live longer and without the cancer growing, spreading, or coming back compared to people who receive BCG alone.",[26,27,28],"Urinary Bladder Neoplasms","Non-Muscle Invasive Bladder Neoplasms","Carcinoma in Situ","RECRUITING","2026-07-01",{"date":32,"type":33},"2026-07-02","ACTUAL",{"date":35,"type":33},"2025-03-11",{"date":37,"type":20},"2031-09-03",{"name":39,"class":40},"Merck Sharp & Dohme LLC","INDUSTRY",89,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":83},"100239986","project-every-child-for-younger-patients-with-cancer-100239986","NCT02402244","Project: Every Child for Younger Patients With Cancer","The Project: EveryChild Protocol: A Registry, Eligibility Screening, Biology and Outcome Study","Inclusion Criteria:\n\n* Enrollment must occur within 6 months of initial disease presentation OR within 6 months of refractory disease, disease progression, disease recurrence, second or secondary malignancy, or post-mortem\n* Patients previously enrolled on ACCRN07 are eligible to enroll on Tracking Outcome, Registry and Future Contact components of APEC14B1 any time after they reach age of majority\n* Patients with a known or suspected neoplasm that occurs in the pediatric, adolescent or young adult populations are eligible for enrollment as follows:\n\n  * All cancer cases with an International Classification of Diseases for Oncology (ICD-O) histologic behavior code of one \"1\" (borderline), two \"2\" (carcinoma in situ) or three \"3\" (malignant)\n  * All neoplastic lesions of the central nervous system regardless of behavior, i.e., benign, borderline or malignant\n  * All neoplastic lesions of the kidney regardless of behavior, i.e., benign, borderline or malignant\n  * The following other benign\u002Fborderline conditions:\n\n    * Mesoblastic nephroma\n    * Teratomas (mature and immature types)\n    * Myeloproliferative diseases including transient myeloproliferative disease\n    * Langerhans cell histiocytosis\n    * Lymphoproliferative diseases\n    * Desmoid tumors\n    * Gonadal stromal cell tumors\n    * Neuroendocrine tumors including pheochromocytoma\n    * Melanocytic tumors, except clearly benign nevi\n    * Ganglioneuromas\n* Subjects must be =\\\u003C 25 years of age at time of original diagnosis, except for patients who are being screened specifically for eligibility onto a COG (or COG participating National Clinical Trials Network \\[NCTN\\]) therapeutic study, for which there is a higher upper age limit\n* All patients or their parents or legally authorized representatives must sign a written informed consent and agree to participate in at least one component of the study; parents will be asked to sign a separate consent for their own biospecimen submission\n\n  * If patients or their parents or legally authorized representatives have not signed the Part A subject consent form at the time of a diagnostic bone marrow procedure, it is recommended that they initially provide consent for drawing extra bone marrow using the Consent for Collection of Additional Bone Marrow; consent using the Part A subject consent form must be provided prior to any other procedures for eligibility screening or banking under APEC14B1","25 Years",{"count":51,"type":20},75000,"OBSERVATIONAL","This study gathers health information for the Project: Every Child for younger patients with cancer. Gathering health information over time from younger patients with cancer may help doctors find better methods of treatment and on-going care.",[55,56,57,58,59,60,61,62,63,64,65,66,67,68,69,70,71,72],"Adrenal Gland Pheochromocytoma","Carcinoma In Situ","Central Nervous System Neoplasm","Childhood Immature Teratoma","Childhood Kidney Neoplasm","Childhood Langerhans Cell Histiocytosis","Childhood Mature Teratoma","Congenital Mesoblastic Nephroma","Desmoid Fibromatosis","Ganglioneuroma","Lymphoproliferative Disorder","Malignant Neoplasm","Malignant Solid Neoplasm","Melanocytic Neoplasm","Myeloproliferative Neoplasm","Neoplasm of Uncertain Malignant Potential","Neuroendocrine Neoplasm","Stromal Neoplasm","2026-05-01",{"date":75,"type":33},"2026-05-05",{"date":77,"type":33},"2015-11-03",{"date":79,"type":20},"2030-12-31",{"name":81,"class":82},"Children's Oncology Group","NETWORK",278,{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":90,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":92,"targetDuration":4,"studyType":21,"phases":94,"briefSummary":96,"conditions":97,"keywords":111,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":149},"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","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",{"count":93,"type":20},168,[95],"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.",[98,99,100,101,102,103,104,105,28,106,107,108,109,110],"Triple Negative Breast Cancer","Diffuse Large B Cell Lymphoma","Follicular Lymphoma","Lymphoma, Non-Hodgkin","Mantle Cell Lymphoma","Bladder Cancer","Uveal Melanoma, Recurrent","Cervix Cancer","Head and Neck Squamous Cell Carcinoma","Skin Cancer","Metastatic Cancer","Tumor, Solid","Tumor Recurrence",[112,113,114,115,116,117,118,119,107,120,121,122,123,124,125,126,127,128,129,130,131,132,133,134,135,136,137,138,139],"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","2025-12-18",{"date":142,"type":33},"2025-12-24",{"date":144,"type":33},"2023-10-13",{"date":146,"type":20},"2026-08-29",{"name":148,"class":40},"OncoNano Medicine, Inc.",16]