[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"non-muscle-invasive-bladder-cancer-with-carcinoma-in-situ\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:non-muscle-invasive-bladder-cancer-with-carcinoma-in-situ":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,48,87],{"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":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100629875","phase-3-efficacy-and-safety-of-intravesical-tara-002-compared-with-investigators-choice-of-intravesical-chemotherapy-in-participants-with-bcg-nave-high-grade-non-muscle-invasive-bladder-cancer-100629875",false,"NCT07480356","Efficacy and Safety of Intravesical TARA-002 Compared With Investigator's Choice of Intravesical Chemotherapy in Participants With BCG-naïve High-grade Non-muscle Invasive Bladder Cancer","A Phase 3, Randomized Study to Evaluate the Efficacy and Safety of Intravesical TARA-002 Compared With Investigator's Choice of Intravesical Chemotherapy in Participants With BCG-naïve High-Grade Non-Muscle Invasive Bladder Cancer","ADVANCED-3","Inclusion Criteria:\n\n* Male or female participants 18 years of age or older at the time of signing informed consent\n* Participants who have voluntarily given written informed consent after the nature of the study has been explained according to applicable requirements prior to study entry\n* Central histologic confirmation of high-grade non-muscle invasive CIS (± Ta\u002FT1) with active disease\n* Participants who are BCG naive, or participants who are BCG exposed and have not received intravesical BCG for at least 24 months prior to the most recent CIS diagnosis, or participants who received ≤2 doses of BCG within the 24 months prior to the most recent CIS diagnosis\n\nExclusion Criteria:\n\n* Penicillin allergy (participants with a questionable history of allergy to penicillin will undergo penicillin blood allergy testing via central laboratory\n* Central confirmed variant histology\n* Concomitant prostatic or upper tract urothelial involvement per Investigator's assessment\n* Nodal and metastatic disease are excluded if they existed at any time (whether present or in the past)\n* Any history of ≥ T2 bladder cancer that existed at any point in time in the participant's history\n\nFor more information on eligibility criteria, please contact the Sponsor.","ALL","18 Years",{"count":20,"type":21},284,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","The goal of this clinical trial is to learn if TARA-002 can treat high-grade non-muscle invasive bladder cancer (NMIBC) in BCG-naïve adults 18 years of age or older.\n\nThe main questions it aims to answer are:\n\n* Can the study drug help participants with this type of cancer?\n* Is the study drug safe?\n* What are the side effects of the study drug?\n\nResearchers will compare TARA-002 to chemotherapy to see if TARA-002 works to treat NMIBC.",[27,28,29],"Bladder (Urothelial, Transitional Cell) Cancer","Non-Muscle Invasive Bladder Carcinoma","Non-muscle Invasive Bladder Cancer With Carcinoma in Situ",[31,32,33,34],"BCG-naive","Non-muscle invasive bladder Cancer","bladder cancer","carcinoma in situ","RECRUITING","2026-06-25",{"date":38,"type":39},"2026-06-29","ACTUAL",{"date":41,"type":39},"2026-05-29",{"date":43,"type":21},"2032-11",{"name":45,"class":46},"Protara Therapeutics","INDUSTRY",6,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":86},"100420283","phase-1-legend-study-eg-70-in-nmibc-patients-bcg-unresponsive-and-high-risk-nmibc-incompletely-treated-with-bcg-or-bcg-nave-100420283","NCT04752722","LEGEND Study: EG-70 in NMIBC Patients BCG-Unresponsive and High-Risk NMIBC Incompletely Treated With BCG or BCG-Naïve","A Phase 1\u002F2 Study of EG-70 as an Intravesical Administration to Patients With BCG Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC) and High-Risk NMIBC Patients Who Are BCG Naïve or Received Incomplete BCG Treatment","Inclusion Criteria:\n\nBCG-unresponsive Patients:\n\n1. BCG-unresponsive NMIBC with carcinoma in situ (CIS) with or without coexisting papillary Ta\u002FT1 tumors who are ineligible for or have elected not to undergo cystectomy, and have experienced CIS disease within 12 months of treatment where: adequate BCG regimen consists of at least 2 courses of BCG where the first course (induction) must have included at least 5 or 6 doses and the second course may have included a re-induction (at least 2 treatments) or maintenance (at least 2 doses), and Cis must be documented or indicated by pathology\n\n   Phase 2 Only:\n2. BCG-Naïve or BCG-incompletely treated Patients with CIS or BCG-unresponsive, HG Ta\u002FT1 papillary disease without CIS:\n\n   -NMIBC with current Cis of the bladder, with or without coexisting papillary Ta\u002FT1 NMIBC tumor(s), who are ineligible for or have elected not to undergo cystectomy, where: either: cohort 2a) no treatment with BCG but may have previously been treated with at least 1 dose of intravesical chemotherapy following transurethral resection of bladder tumor (TURBT) and Cis must be documented or cohort 2b) indicated by pathology incomplete BCG treatment (at least 1 dose and less than the 5+2 doses required for adequate dosing per Cohort 1) or cohort 3) patients who are BCG-unresponsive following adequate treatment, with HG Ta\u002FT1 papillary disease without CIS.\n\n   All Patients:\n3. Patients who have previously been treated with a checkpoint inhibitor and failed treatment are eligible for inclusion 30 days post-treatment (Phase 1) or 3 months post-treatment (Phase 2).\n4. Male or non-pregnant, non-lactating female, 18 years or older.\n5. Women of childbearing potential must have a negative pregnancy test at Screening.\n6. Female patients of childbearing potential must be willing to consent to using highly effective birth control methods; Male patients are required to utilize a condom for the duration of the study treatment through 3 months post-dose.\n7. In Phase 2, for patients with T1 lesions may be eligible after repeat TURBT if pathology shows non-invasive (Ta or less) or no disease.\n8. Performance Status: Eastern Cooperative Oncology Group 0, 1, and 2.\n9. Hematologic inclusion: a. Absolute neutrophil count \\>1,500\u002Fmm3. b. Hemoglobin \\>9.0 g\u002FdL. c. Platelet count \\>100,000\u002Fmm3.\n10. Hepatic inclusion: a. Total bilirubin must be ≤1.5 x the upper limit of normal (ULN). b. Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase ≤2.5 x ULN.\n11. Adequate renal function with creatinine clearance \\>30 mL\u002Fmin\n12. Prothrombin time and partial thromboplastin time ≤1.25 x ULN or within the therapeutic range if on anticoagulation therapy.\n13. Must have satisfactory bladder function with ability to retain study drug for 60 minutes.\n\nExclusion Criteria:\n\n1. Active malignancies (i.e., progressing or requiring treatment change in the last 24 months). Exceptions allowed under Sponsor review.\n2. Concurrent treatment with any chemotherapeutic agent.\n3. History of partial cystectomy.\n4. Treatment with last therapeutic agent (including intravesical chemotherapy post-TURBT) within 30 days of Screening (prior to the screening biopsy).\n5. Patients who have received systemic immunosuppressive medication including high-dose corticosteroids.\n6. History of severe asthma or other respiratory diseases.\n7. History of unresolved vesicoureteral reflux or an indwelling urinary stent.\n8. History of unresolved hydronephrosis due to ureteral obstruction.\n9. Participation in any other research protocol involving administration of an investigational agent within 30 Days prior to screening or any prior treatment of NMIBC with any investigational gene or immunotherapy agent.\n10. History of external beam radiation to the pelvis or prostate brachytherapy within the last 12 months.\n11. History of interstitial lung disease and\u002For pneumonitis in patients who have previously received a PD-1 or PD-L1 inhibitor therapy.\n12. Evidence of metastatic disease.\n13. History of difficult catheterization that in the opinion of the Investigator will prevent administration of EG-70.\n14. Active interstitial cystitis on cystoscopy or biopsy.\n15. Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.\n16. Known human immunodeficiency virus, Hepatitis B, or Hepatitis C infection.\n17. Significant cardiovascular risk (e.g., coronary stenting within 8 weeks, myocardial infarction within 6 months).\n18. Hypersensitivity to any of the excipients of the study drug.\n\nExclusionary for Bladder Rinse cohort: known allergy to polidocanol",{"count":56,"type":21},350,[58,59],"PHASE1","PHASE2","This study will evaluate the safety and efficacy of intravesical administration of detalimogene (EG-70) in the bladder and its effect on bladder tumors in patients with NMIBC.\n\nThis study study consists of two phases; a Phase 1 dose-escalation to establish safety and recommended the phase 2 dose, followed by a Phase 2 study to establish how effective the treatment is. The Study will include patients with: NMIBC with CIS for whom BCG therapy is unresponsive, and other high risk patients with NMIBC.\n\nA Substudy will include a surfactant bladder rinse prior to the instillation of detalimogene in patients with NMIBC with CIS for whom BCG therapy is unresponsive.",[62,29],"Superficial Bladder Cancer",[64,65,66,67,68,69,70,71,72,73,74,75,76],"Non-muscle invasive bladder cancer (NMIBC)","Bacillus calmette- guerin (BCG) failure","BCG unresponsive","NMIBC","Bladder Cancer","LEGEND Study","EG-70","High-risk NMIBC","BCG-naïve","Incomplete BCG treatment","Carcinoma in situ (Cis)","BCG-exposed","Surfactant Bladder Rinse","2026-06-18",{"date":79,"type":39},"2026-06-22",{"date":81,"type":39},"2021-04-22",{"date":83,"type":21},"2028-11-30",{"name":85,"class":46},"enGene, Inc.",102,{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":95,"targetDuration":4,"studyType":22,"phases":97,"briefSummary":98,"conditions":99,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":109},"100558041","phase-3-a-trial-to-evaluate-intravesical-nadofaragene-firadenovec-alone-or-in-combination-with-chemotherapy-or-immunotherapy-in-participants-with-high-grade-bcg-unresponsive-non-muscle-invasive-bladder-cancer-100558041","NCT06545955","A Trial to Evaluate Intravesical Nadofaragene Firadenovec Alone or in Combination With Chemotherapy or Immunotherapy in Participants With High-grade BCG Unresponsive Non-muscle Invasive Bladder Cancer","A Phase 3, Randomised, Multi-center, Open Label Trial to Evaluate the Safety and Efficacy of Intravesical Nadofaragene Firadenovec Alone or in Combination With Chemotherapy or Immunotherapy in Participants With High-grade Bacillus Calmette-Guerin Therapy (BCG) Unresponsive Non-muscle Invasive Bladder Cancer (NMIBC)","ABLE-22","Inclusion Criteria:\n\n* Diagnosed, as documented, with carcinoma in situ (CIS) ±Ta\u002FT1 high-grade disease.\n\n  * For T1 disease biopsies should contain muscle fibres.\n* Unresponsive to ≥2 courses of Bacillus Calmette-Guerin (BCG) therapy within the last 12 months. BCG-unresponsive refers to participants with high-grade non-muscle invasive bladder cancer (NMIBC) who are unlikely to benefit from and who will not be receiving further intravesical BCG. The term \"BCG-Unresponsive\" includes participants who did not respond to BCG treatment and have a persistent high-grade recurrence within 12 months after BCG was initiated, and those who despite an initial complete response to BCG, relapse with CIS within 12 months of their last intravesical treatment with BCG or relapse with high-grade Ta\u002FT1 NMIBC within 6 months of their last intravesical treatment with BCG. The following criteria define the participants who may be included in the trial:\n\n  * Have received at least 2 courses of BCG within a 12 month period - defined as at least 5 of 6 induction BCG instillations and at least 2 of 3 instillations of maintenance BCG, or at least 2 of 6 instillations of a second induction course, where maintenance BCG is not given.\n\n    o Exception: those who have T1 high-grade disease at 1st evaluation after induction BCG alone (at least 5 of 6 doses) may qualify in the absence of disease progression\n  * At the time of tumour recurrence, participants with CIS alone or high-grade Ta\u002FT1 with CIS should be within 12 months of last exposure to BCG\n  * No maximum limit to the amount of BCG administered\n  * All visible papillary tumours must be resected and those with persistent T1 disease on transurethral resection of bladder tumour (TURBT) should undergo an additional re-TURBT within 14 to 70 days prior to beginning trial treatment. Obvious areas of CIS should also be fulgurated\n* Eastern Cooperative Oncology Group (ECOG) status ≤2\n* Aged ≥18 years at the time of consent\n* Available for the whole duration of the trial\n* Life expectancy \\>2 years, in the opinion of the investigator\n* Absence of concomitant upper tract urothelial carcinoma or urothelial carcinoma within the prostatic urethra. Freedom from upper tract disease (if clinically indicated) as indicated by no evidence of upper tract tumour by either intravenous pyelogram, retrograde pyelogram, computed tomography (CT) scan with or without urogram, or magnetic resonance imaging (MRI) with or without urogram performed within 6 months of enrolment. Absence of locally advanced disease as assessed by CT scan or MRI\n* Participants who elect not to undergo cystectomy\n* Participants with prostate cancer on active surveillance at low risk for progression are permitted to be included into the trial at the discretion of the investigator\n* Females of reproductive potential must have a negative highly sensitive urine or serum pregnancy test upon entry into this trial and be willing to use highly effective contraception during treatment with the investigational medicinal product and for 6 months following the last dose. Otherwise, female participants must be post-menopausal (no menstrual period for a minimum of 12 months, as confirmed by follicle-stimulating hormone levels) or surgically sterile\n* Male subjects must be willing to use a male condom and effective contraception during sex throughout the treatment period and for 3 months following the last dose.\n\nExclusion Criteria:\n\n* Current or previous evidence of muscle-invasive (muscularis propria) or metastatic disease presented at the screening visit. Examples of increased risk of muscle-invasive disease include but are not limited to:\n\n  * Presence of lymphovascular invasion and \u002F or micropapillary, sarcomatoid, plasmacytoid and \u002F or neuroendocrine disease as shown in the histology of the biopsy sample\n  * Participants with CIS+T1 disease accompanied by the presence of hydronephrosis secondary to the primary tumour\n* Current systemic therapy for bladder cancer other than investigational medicinal products used in randomisation arm\n* Current or prior investigational treatment for BCG-unresponsive NMIBC or any other investigational drug (drug used in a clinical trial, i.e drug used in a Ferring sponsored non interventional study does not apply) within 1 month prior to screening\n* Current or prior pelvic external beam radiotherapy within 2 years of screening\n* Prior treatment with nadofaragene firadenovec at any time\n* Prior systemic therapy for bladder cancer at any time\n* Prior intravesical chemotherapy for the treatment of BCG-unresponsive NMIBC",{"count":96,"type":21},250,[24],"The pivotal phase 3 trial (rAd-IFN-CS 003) evaluating the efficacy of nadofaragene firadenovec showed that 55 (53.4%) of 103 subjects with CIS ± high-grade Ta\u002FT1 achieved a complete response (CR) at 3 months. In this trial, the safety and efficacy of intravesical instillation of nadofaragene firadenovec alone or in combination with chemotherapy or immunotherapy will be evaluated in participants with NMIBC CIS (± high-grade Ta\u002FT1).",[29],"2026-06-15",{"date":102,"type":39},"2026-06-17",{"date":104,"type":39},"2024-10-01",{"date":106,"type":21},"2030-12-31",{"name":108,"class":46},"Ferring Pharmaceuticals",75]