[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"urothelial-carcinoma-recurrent\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:urothelial-carcinoma-recurrent":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,47,79,109,141,166,222],{"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":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100611531","phase-2-phase-ii-study-of-trastuzumab-rezetecan-or-in-combination-with-adebrelimab-in-her2-expressing-locally-advanced-or-metastatic-urothelial-carcinoma-lamuc-100611531",false,"NCT07241793","Phase II Study of Trastuzumab Rezetecan or in Combination With Adebrelimab in HER2-Expressing Locally Advanced or Metastatic Urothelial Carcinoma (la\u002FmUC)","A Phase II Clinical Study of Trastuzumab Rezetecan (SHR-A1811) or in Combination With Adebrelimab (SHR-1316) for HER2-Expressing Locally Advanced or Metastatic Urothelial Carcinoma (la\u002FmUC)","TRAIN-UC-01","Inclusion Criteria:\n\n* Patients included in this study must meet all of the following criteria:\n\n  1. Age ≥ 18 years;\n  2. Histologically or cytologically confirmed HER2-expressing locally advanced unresectable (e.g., T4b, or N2-3) or metastatic urothelial carcinoma (la\u002FmUC), including bladder, ureter, renal pelvis, and urethra. HER2 expression is defined as immunohistochemical (IHC) staining results of 1+ to 3+, and must be confirmed by the pathology department of Sun Yat-sen University Cancer Center according to ASCO\u002FCAP guidelines.\n  3. Cohort 1: Patients who have received at least one prior systemic therapy, or relapsed\u002Fprogressed within 12 months after the last treatment, or who could not tolerate treatment due to adverse events (AEs). Cohort 2: Patients who have not received prior systemic therapy or relapsed\u002Fprogressed more than 12 months after neoadjuvant\u002Fadjuvant therapy, or those who could not tolerate treatment due to AEs. Cohort 3: Patients who have previously received platinum-based chemotherapy (including cisplatin, carboplatin, etc.), immunotherapy (including PD-1, PD-L1 inhibitors), and Disitamab Vedotin ;\n  4. At least one measurable target lesion according to RECIST 1.1 criteria;\n  5. ECOG performance status ≤ 2;\n  6. Adequate bone marrow, renal (calculated creatinine clearance \\> 30 mL\u002Fmin using the CG formula), hepatic, and coagulation function;\n  7. Expected survival ≥ 3 months;\n  8. The patient understands the study procedures and has provided written informed consent to participate in the study;\n  9. Female participants of childbearing potential must have a negative urine or serum pregnancy test within 7 days before the first administration of the study drug (Cycle 1, Day 1). If the urine pregnancy test is inconclusive, a blood pregnancy test is required.\n  10. Both male and female participants must agree to use highly effective contraception (i.e., methods with a failure rate of less than 1% per year) and continue contraception until at least 180 days after the end of study treatment.\n\nExclusion Criteria:\n\n1. Locally advanced patients who are candidates for curative local treatment;\n2. Clinical history of cardiovascular, liver, respiratory, renal, hematological, endocrine, or neurological\u002Fpsychiatric diseases;\n3. Known or untreated spinal cord compression or active central nervous system metastases, except for those who have been treated and stable for at least 1 month and have discontinued corticosteroids for \\> 2 weeks;\n4. Known severe allergic reactions to the study drug's active ingredients and\u002For excipients, or allergy to humanized monoclonal antibody products (e.g., trastuzumab, pertuzumab);\n5. Received antitumor monoclonal antibody treatment within 4 weeks before the study start, or received other antitumor therapy without recovery from adverse events;\n6. Participated in any investigational drug treatment within 4 weeks before the study started;\n7. Known or suspected interstitial lung disease, or moderate to severe pulmonary diseases that might interfere with the evaluation of drug-related pulmonary toxicity, including but not limited to idiopathic pulmonary fibrosis, organizing pneumonia, bronchitis obliterans, pulmonary embolism, severe asthma, COPD, restrictive pulmonary diseases, or any autoimmune, connective tissue or inflammatory lung diseases, such as rheumatoid arthritis, Sjogren's syndrome, sarcoidosis, etc., or a history of total lung resection;\n8. Known hereditary or acquired bleeding disorders (e.g., hemophilia, coagulopathy);\n9. Received spinal cord radiation or has not recovered from radiation-related adverse events within 4 weeks before study start;\n10. Diagnosed with immunodeficiency or received systemic corticosteroid treatment or any other immunosuppressive therapy within 7 days before the first study drug administration. Physiological doses of corticosteroids (≤10 mg\u002Fday of prednisone or equivalent) are allowed;\n11. Active autoimmune diseases requiring systemic treatment within the past 2 years (e.g., requiring disease-modifying drugs, corticosteroids, or immunosuppressants). Replacement therapies (e.g., thyroid hormones, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency) are not considered systemic treatments. A history of non-infectious pneumonia requiring corticosteroid treatment or current interstitial lung disease within 1 year before the first dose is excluded;\n12. History of organ or hematopoietic stem cell transplantation;\n13. Known HIV infection (HIV 1\u002F2 positive);\n14. Untreated active hepatitis B (HBV). Note: Hepatitis B carriers with an HBV viral load \\\u003C 1000 copies\u002FmL (200 IU\u002FmL) before the first dose are eligible, but should receive antiviral therapy during chemotherapy to prevent reactivation.\n\n    For anti-HBc (+), HBsAg (-), anti-HBs (-), and undetectable HBV viral load subjects, preventive antiviral therapy is not required, but close monitoring is necessary.\n15. Active hepatitis C (HCV) infection (HCV antibody positive and HCV RNA level above detection threshold;\n16. Received live vaccines within 30 days before the first dose of the study drug. Note: Inactivated flu vaccines are allowed within 30 days before the first dose, but live attenuated flu vaccines are not permitted.\n17. History of other malignancies within the past 3 years, except for cured non-melanoma skin cancer, cervical carcinoma in situ, or low-risk prostate cancer (T2N0M0, Gleason score \\\u003C7, or undetectable PSA);\n18. Any condition or disease history that may interfere with the study results or hinder the participant's full participation, including abnormal laboratory values, or situations deemed inappropriate by the investigator;\n19. Breastfeeding women.","ALL","18 Years",{"count":20,"type":21},96,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is a multicenter, open-label, Phase II clinical trial to evaluate the efficacy and safety of Trastuzumab Rezetecan (SHR-A1811) or in combination with Adebrelimab (SHR-1316) for HER2-expressing locally advanced or metastatic urothelial carcinoma (la\u002FmUC).",[27,28,29],"Urothelial Carcinoma","Advanced Urothelial Carcinoma","Urothelial Carcinoma Recurrent",[31,32,33],"Urothelial carcinoma","Antibody-Drug Conjugate","immune checkpoint inhibitor","RECRUITING","2026-04-29",{"date":37,"type":38},"2026-04-30","ACTUAL",{"date":40,"type":38},"2025-11-20",{"date":42,"type":21},"2031-07-01",{"name":44,"class":45},"Sun Yat-sen University","OTHER",6,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":59,"conditions":60,"keywords":66,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":46},"100442122","phase-3-evaluating-safety-and-efficacy-of-verity-bcg-in-bcg-nave-patients-with-intermediate-and-high-risk-non-muscle-invasive-bladder-nmibc-100442122","NCT05037279","Evaluating Safety and Efficacy of Verity-BCG in BCG-naïve Patients With Intermediate and High-risk Non-muscle Invasive Bladder (NMIBC)","A Multicenter, Randomized, Double-blind, Controlled Phase III Non-inferiority Study Assessing Efficacy and Safety of VERITY-BCG in Management of Intermediate and High-risk Non-muscle Invasive Bladder Cancer (NMIBC) in BCG-naïve Patients.","EVER","Inclusion Criteria:\n\n* Male or Female\n* 18 years and older\n* Low or high-grade NMIBC as defined by 2004 World Health Organization (WHO)\u002FInternational Society of Urological Pathology (ISUP) classification and Grade 2 or 3 in the 1973 classification, diagnosed within 45 days of registration.\n* Pathologically confirmed and completely resected stage Ta or T1 urothelial cell carcinoma, with or without associated carcinoma in situ (CIS), diagnosed within 45 days of registration.\n\n  1. Patients with T1 disease must have imaging demonstrating no evidence of metastatic disease (based on MRI or CT scan) within (before or after) 90 days of registration, to confirm stage T1N0M0 disease.\n  2. For patients with stage T1 disease, a repeat TURBT must be performed as per standard of care\u002FCUA guidelines. A repeat TURBT may also be required for patients with Ta disease. Repeat TURBT must be performed within 60 days of the initial TURBT and within 45 days of registration. Pathological confirmation is required after the repeat TURBT.\n* Patients may have intermediate or high recurrence risk disease, as indicated by the probability of 2-year recurrence of ≥ 50% based on the EORTC Bladder Cancer risk calculator.\n* ECOG performance status of 0-2\n* Adequate organ and marrow function as defined below:\n\n  * leukocytes ≥3,000\u002FmcL\n  * absolute neutrophil count ≥1,500\u002FmcL\n  * platelets ≥100,000\u002FmcL\n  * total bilirubin ≤ 1.5 × institutional upper limit of normal (ULN)\n  * AST(SGOT)\u002FALT(SGPT) ≤3 × institutional ULN\n  * creatinine ≤ institutional ULN OR glomerular filtration rate (GFR) ≥50 mL\u002Fmin\u002F1.73 m2 unless data exists supporting safe use of BCG at lower kidney function values, no lower than 30 mL\u002Fmin\u002F1.73 m2\n* For women of childbearing potential involved in any sexual intercourse that could lead to pregnancy: Negative pregnancy test and willingness to use contraceptive (consistent with local regulations) during 120 days after the last dose of the study treatment. Note: The use of contraceptive methods does not apply to subjects who are abstinent for at least 4 weeks before Day 1 and will continue to be abstinent from penile-vaginal intercourse 120 days after last dose of study drug treatment. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the participant.\n* Note: A woman of non-childbearing potential is defined as follows:\n\n  * Has had surgical sterilization (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy);\n  * Has had a cessation of menses for at least 12 months without an alternative medical cause, and a follicle-stimulating hormone (FSH) test confirming nonchildbearing potential (refer to laboratory reference ranges for confirmatory levels).\n* Male patients with female partner of childbearing potential must agree to be abstinent or practice an effective method of contraception.\n\nMale patients must agree to refrain from donating sperm during the treatment period and for at least 120 days after the last dose of study treatment.\n\nExclusion Criteria:\n\n* Presence of urothelial carcinoma involving the upper urinary tract or prostatic urethra documented by radiological imaging or biopsy, performed within 12 months of the start of treatment. Should the imaging or biopsy be performed outside the window it will be up to the physicians' discretion to re-scan\u002Fbiopsy. This is considered T4 disease.\n* CIS only disease.\n* Pure squamous cell carcinoma or adenocarcinoma.\n* Presence of micropapillary components.\n* Other prior non-bladder malignancy, except for the following:\n\n  * patients presenting with NMIBC recurrent tumor(s)\n  * adequately treated basal cell or squamous cell skin cancer.\n  * in situ cervical cancer.\n  * adequately treated stage I or II cancer currently in complete remission, or any other cancer from which the patient has been disease free for five years.\n  * patients with localized prostate cancer who are being followed by an active surveillance program are also eligible.\n* Prior intravesical BCG or intradermal BCG, within 5 years of screening, with the exception of tuberculosis vaccination in childhood.\n* Chronic administration of steroids (\\>10 mg prednisone) at the time of randomization.\n* Current or planned concomitant biologic therapy, radiation therapy, hormonal therapy, chemotherapy, surgery, or other cancer therapy while on study.\n* Prior chemoradiation treatment (trimodal therapy or \"TMT\") for bladder cancer.\n* Currently being treated or scheduled to have treatment with any systemic or intravesical chemotherapeutic agent during the study.\n* Receiving any other investigational agents.\n* The presence of an impaired immune response irrespective of whether this impairment is congenital or caused by disease, drugs or other therapy.\n* Known positive HIV serology with detectable viral load.\n* Current diagnosis of AIDS\n* Presence of a urinary tract infection; treatment should be withheld until urine culture is negative and antibiotic therapy is stopped.\n* Trauma to the urinary bladder. In case of gross hematuria, therapy should be stopped or postponed until the hematuria has been successfully treated or has resolved.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to BCG vaccine.\n* Uncontrolled intercurrent illness.\n* Psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Pregnancy: pregnant women are excluded from this study because VERITY-BCG is an agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with VERITY-BCG, breastfeeding should be discontinued if the mother is treated with VERITY-BCG.",{"count":56,"type":21},540,[58],"PHASE3","The aim of this study is to evaluate the effect of Verity-BCG in patients with intermediate and high-risk non-muscle-invasive bladder cancer (NMIBC) and to compare our findings to the standard of care BCG formulation, OncoTICE (BCG) in order to examine our hypothesis that Verity-BCG is at least non-inferior to OncoTICE in achieving 24-month Recurrence Free Survival in NMIBC patients who are at high risk of recurrence and have never been treated with intradermal or intravesical BCG before, with the exception of tuberculosis vaccination in childhood.",[61,62,63,64,29,65],"Bladder Cancer","Bladder Cancer Recurrent","Neoplasm Recurrence","Urothelial Carcinoma Bladder","Non-Invasive Bladder Urothelial Carcinoma",[67,68],"Interventional","Non-inferiority study","2026-03-17",{"date":71,"type":38},"2026-03-20",{"date":73,"type":38},"2024-04-24",{"date":75,"type":21},"2029-02",{"name":77,"class":78},"Verity Pharmaceuticals Inc.","INDUSTRY",{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":87,"targetDuration":4,"studyType":22,"phases":89,"briefSummary":90,"conditions":91,"keywords":95,"overallStatus":99,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":4},"100628630","phase-3-a-study-of-ndv-01-sustained-release-gemcitabine-docetaxel-in-participants-with-non-muscle-invasive-bladder-cancer-100628630","NCT07464145","A Study of NDV-01 (Sustained-release Gemcitabine-docetaxel) in Participants With Non-muscle Invasive Bladder Cancer","A Phase 3 Study Evaluating the Efficacy and Safety of NDV-01 in Participants With Non-muscle Invasive Bladder Cancer (RESCUE)","RESCUE","Cohort 1 Inclusion Criteria:\n\n1. Be ≥18 years of age (or the legal age of majority in the jurisdiction in which the study is taking place) at the time of informed consent.\n2. Have a histologically confirmed diagnosis (within 90 days of randomization) of IR NMIBC based on the AUA\u002FSUO criteria of IR NMIBC (excluding LGT1 tumors).\n3. Participant must be willing to undergo all study procedures (e.g., multiple cystoscopies from Screening through the end of study and TURBT for assessment of recurrence\u002Fprogression) and receive the assigned treatment, including intravesical chemotherapy if randomized into that arm.\n4. Participant must have ≥ 1 IBCG risk factors: 1) multiple tumors, 2) early recurrence (within 1 year), 3) frequent recurrences (\\> 1 per year), 4) tumor size (\\> 3 cm), 5) failure of prior induction intravesical therapy.\n5. Visible papillary disease must be fully resected prior to randomization, and absence of disease must be documented at Screening cystoscopy. The same method for visualizing disease at Screening cystoscopy should be used throughout for the participant (white light versus enhanced cystoscopic method \\[e.g., blue light cystoscopy, narrow-band imaging\\]).\n\n   All pathology specimens must be predominantly urothelial (transitional cell) and have less than 20% variant (e.g., sarcomatoid, squamous component) histology.\n6. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.\n\nCohort 1 Exclusion Criteria:\n\n1. Histologically confirmed stage T1 tumors.\n2. Histologically confirmed diagnosis of HR NMIBC (including CIS) or muscle-invasive bladder cancer (MIBC), locally advanced, nonresectable, or metastatic urothelial carcinoma at any time prior to enrollment.\n3. Has had urothelial carcinoma outside of the urinary bladder (including prostatic urethra, ureter, or renal pelvis) or has a predominant histological variant of urothelial carcinoma (UC). Ta\u002Fany T1, CIS of the upper urinary tract is allowable if treated with complete nephroureterectomy more than 24 months prior to initiating study.\n4. Participant has tumor(s) involving the prostatic urethra (ductal or stromal).\n5. N+ and\u002For M+ per computed tomography (CT)\u002Fmagnetic resonance (MR) urography.\n6. Received an investigational treatment for bladder cancer within 6 months prior to randomization, before the planned first dose of study treatment, or is currently enrolled in an investigational study.\n7. Received adjuvant induction intravesical chemotherapy within 3 months of current diagnosis. Peri-operative instillation of a single dose of intravesical chemotherapy is allowed per institutional guidelines.\n8. Received prior intravesical treatment with immunotherapy, including BCG, within 3 months prior to randomization.\n\nCohort 2 Inclusion Criteria:\n\n1. Cohort 2a: BCG-unresponsive NMIBC with CIS of the bladder, with or without coexisting papillary Ta\u002FT1 tumor(s) who are ineligible for or have elected not to undergo cystectomy at the time of enrollment and have received 1 or 2 lines of therapy after meeting criteria for BCG unresponsiveness and experienced biopsy confirmed CIS disease within 12 months of last treatment, where:\n\n   * Adequate BCG regimen consists of at least 2 courses of BCG, where the first course (induction) must have included at least 5 of 6 doses and the second course may have included a re-induction (at least 2 of 6 treatments) or maintenance (at least 2 of 3 doses). Adequacy of the BCG regimen will be determined by the Investigator in conjunction with the Sponsor.\n   * Treatment after BCG unresponsiveness includes either approved or in development therapy\n   * Post-treatment presence of CIS must be documented or indicated by pathology at screening or within 4 months of screening (provided no therapy for CIS disease was given after the most recent biopsy).\n   * For inclusion, a participant with BCG-unresponsive disease (as defined above) must have received up to two lines of therapy for BCG-unresponsive disease and who are being considered for radical cystectomy. Such therapies may include agents approved or in development (e.g., pembrolizumab, nadofaragene firodenovec, nogapendekin alfa inbakicept-pmln, cretostimogene grenadenorepvec, detalimogene voraplasmid, TARA-002, gemcitabine intravesical system (INLEXZO®), gemcitabine-docetaxel, gemcitabine, MMC, or valrubicin monotherapy. Participant will have demonstrated biopsy-proven recurrence with HG papillary disease (without CIS) after one or two first-line therapy(ies).\n2. Cohort 2b: BCG-unresponsive NMIBC of the bladder, with papillary Ta\u002FT1 tumor(s) and without co-existing CIS, who are ineligible for or have elected not to undergo cystectomy at the time of enrollment and have experienced recurrent Ta\u002FT1 disease within 12 months of treatment with 1 or 2 lines of therapy after BCG-unresponsive status.\n\n   * For inclusion, a participant with BCG-unresponsive disease (as defined above) must have received up to two lines of therapy for BCG-unresponsive disease and who are being considered for radical cystectomy. Such therapies may include agents approved or in development (e.g., pembrolizumab, nadofaragene firodenovec, nogapendekin alfa inbakicept-pmln, cretostimogene grenadenorepvec, detalimogene voraplasmid, TARA-002, gemcitabine intravesical system (INLEXZO®), gemcitabine-docetaxel, gemcitabine, MMC, or valrubicin monotherapy. Participant will have demonstrated biopsy-proven recurrence with HG papillary disease (without CIS) after one or two first-line therapy(ies).\n\nAll Cohort 2\n\n1. A participant with HG T1 may be eligible after repeat-TURBT showing non-invasive (Ta or less) or no disease. Either original or repeat-TURBT must confirm that muscularis propria is present and uninvolved in the specimen.\n2. All specimens must be predominantly urothelial (transitional cell) carcinoma with or without squamous or glandular differentiation. Pure squamous or glandular tumors will not be included. A participant with less than 10% micropapillary histology will be included. All other variant histology (e.g., plasmacytoid, small cell, nested, trophoblastic variants) will not be included.\n\nCohort 2 Exclusion Criteria:\n\n1. Has had urothelial carcinoma outside of the urinary bladder (i.e., urethra, ureter, or renal pelvis) or has a predominant histological variant of UC. Ta\u002Fany T1, CIS of the upper urinary tract is allowable if treated with complete nephroureterectomy more than 24 months prior to initiating study and is considered to be without evidence of recurrent disease.\n\n   * Participants have tumor(s) involving the prostatic urethra (ductal or stromal).\n   * N+ and\u002For M+ per computerized tomography (CT)\u002FMagnetic Resonance Imagery (MR) urography.\n2. History of prior T2\u002FT3 urothelial carcinoma of the bladder.\n3. Concurrent treatment with any chemotherapeutic agent.\n4. Intravesical chemotherapy within 3 months of enrollment (including INLEXZO®, gemcitabine-docetaxel)",{"count":88,"type":21},393,[58],"Study REL-NDV01-303 is a Phase 3, open-label, multi-center study to determine the safety and efficacy of NDV-01 in adult participants with NMIBC. The study will include two cohorts:\n\n* Cohort 1: a randomized, open-label, parallel group, multi-center, Phase 3 study evaluating the efficacy and safety of the NDV-01 versus observation in participants with histologically confirmed IR-NMIBC.\n* Cohort 2: an open-label, multi-center, single-arm Phase 3 study evaluating the efficacy and safety of the NDV-01 in two populations of high-risk NMIBC:\n\n  * Cohort 2a: will include participants with HR-NMIBC who have a biopsy-proven recurrence with CIS ± papillary disease after receiving one or 2 lines of therapy for BCG-unresponsive NMIBC (approved or in development).\n  * Cohort 2b: will include participants with high-risk papillary-only disease (without CIS) NMIBC who have a biopsy-proven recurrence with HG papillary disease after receiving one or 2 lines of therapy for BCG-unresponsive NMIBC (approved or in development).\n\nThis study will evaluate the safety and efficacy of intravesical administration of NDV-01, and its effect on disease recurrence and progression in patients with NMIBC who have IR disease and have recently undergone a TURBT (Cohort 1) and in patients who have HR BCG-unresponsive disease and who have recurred after first-line therapy for BCG-unresponsive patients - both approved and in development - and are unwilling or unable to undergo radical cystectomy (Cohort 2). Both GEM and DOCE have established safety and efficacy across a range of tumor types, including IR and BCG-unresponsive NMIBC. By combining both GEM and DOCE in an intravesical extended-release formulation, Relmada believes that NDV-01 has the potential to be an agent for second-line therapy in patients who have recurred after first-line therapy in BCG-unresponsive disease, thereby avoiding radical cystectomy. This study will serve as a master protocol for all cohorts included in the study.",[92,93,64,29,94],"Bladder (Urothelial, Transitional Cell) Cancer","Bladder (Urothelial, Transitional Cell) Cancer Superficial (Non-Invasive)","Urologic Cancer",[96,97,98],"NMIBC","non-muscle-invasive bladder cancer","bladder cancer","NOT_YET_RECRUITING","2026-03-05",{"date":102,"type":38},"2026-03-11",{"date":104,"type":21},"2026-06",{"date":106,"type":21},"2032-09",{"name":108,"class":78},"Relmada Therapeutics, Inc.",{"id":110,"slug":111,"hasResults":11,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":115,"eligibilityCriteria":116,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":117,"enrollmentInfo":118,"targetDuration":4,"studyType":22,"phases":120,"briefSummary":121,"conditions":122,"keywords":125,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":140},"100591652","phase-2-clinical-trial-of-am80-in-combination-with-gemcitabine-cisplatin-and-nivolumab-in-patients-with-urothelial-carcinoma-100591652","NCT06983210","Clinical Trial of AM80 in Combination With Gemcitabine, Cisplatin, and Nivolumab in Patients With Urothelial Carcinoma","Multi-center, Open-Label, Single Arm Trial for Evaluation of the Efficacy and Safety in the First Line Combination Therapy of Gemcitabine, Cisplatin and Nivolumab With Additional Pretreatment of AM80 for Urothelial Carcinoma Patients","GRAPE","Inclusion Criteria:\n\n1. Patients who have been histologically or cytologically diagnosed with urothelial carcinoma of the renal pelvis, ureter, bladder, or urethra based on the General Rule for Clinical and Pathological Studies on Renal Pelvic, Ureteral and Bladder Cancer, 2nd Edition that cannot be curatively resected or has recurred (diagnosis is not permitted at the site of palliative radiation)\n2. Patients who have not received prior treatment for unresectable or recurrent urothelial carcinoma\n3. Patients with measurable lesions according to RECIST version 1.1 on the CT at screening\n4. Patients with an ECOG PS of 0-1 at screening, who are able to take oral medication\n5. Patients who will be expected to survive for 12 weeks or more from the enrollment\n6. Patients whose major organ functions at screening meet the following criteria\n\n(1)Neutrophil count: 1,500\u002FuL or more (2)Platelet count: 100,000\u002FuL or more (3)Hb: 9.0 g\u002FdL or more (no red blood cell transfusion within 14 days prior to screening examination) (4)T-Bil: 1.5 times or less than 1.5 times the upper limit of the facility standard value (less than 3.0 mg\u002FdL in the case of Gilbert syndrome) (5)AST and ALT: 3 times or less than 3 times the upper limit of the facility standard value (6)CrCl 50 mL\u002Fmin or more 7.Patients who have given consent to be treated if any of the following applies:\n\n1. Female patients of childbearing potential who can prevent contraception for 30 days prior to enrollment and for 2 years after the end of AM80 treatment\n2. Male patients with partners of childbearing potential, who can use contraception from the start of AM80 administration until 7 months after the end of administration and refrain from donating sperm during the above period 8.Patients aged 18-79 years at the time of consent (regardless of sex) 9.Patients who have received a thorough explanation of this clinical trial and have voluntarily given their written informed consent\n\nExclusion Criteria:\n\n1. Patients who have previously been treated with drugs such as antibodies targeting PD-1, PD-L1, PD-L2, CTLA-4, OX-40, or CD137\n2. Patients who have received any of the following t reatments for urothelial carcinoma:\n\n(1)Perioperative adjuvant therapy for curative resection completed less than 12 months prior to enrollment (2)Intravesical therapy within 28 days prior to enrollment (3)Palliative radiation therapy for measurable lesions within 14 days prior to enrollment 3.Patients who have not recovered from toxicity (Grade 1 or 0 or at baseline) from prior treatment at the time of enrollment; however, enrollment is permitted for those with \\\u003C= Grade 2 fatigue and alopecia 4.Patients who have participated in other clinical trials within 28 days prior to enrollment (enrollment is permitted if the drug or medical device used in the clinical trial are similar to approved indications, dosage, and administration and do not affect the evalu ation) and who have received their last dose of a drug or other substance used in the current clinical research within the last 28 days 5.Patients with metastasis to the central nervous system or a history or complication of carcinomatous meningitis 6.Patients with multiple cancers whose disease-free interval at the time of registration is less than 3 years (excluding gastrointestinal cancer that was completely resected via endoscopic mucosal resection, completely resected intraepithelial neoplasia of the cervix, localized or presumably cured prostate cancer, completely resected basal\u002Fsquamous cell carcinoma of the skin, and solid cancers similar to these that have undergone curative treatment and are presumed to be cured) 7.Patients who are taking vitamin A agents or vitam in A-containing supplements at the time of enrollment 8.Patients who have undergone surgery under general anesthesia (excluding diagnostic biopsies) or severe trauma within 28 days prior to enrollment 9.Patients known to have a bleeding tendency or coagulation disorder (e.g., patients with significant in tratumoral bleeding, thromboembolism, or a history or comorbidity of bleeding disorders), and those who require administration of anticoagulants or antiplatelet drugs 10.Patients with active infections requiring systemic administration of antibiotics, antifungals, or antivirals 11.Patients who test positive for hepatitis B surface (HBs) antigen, hepatitis C virus (HCV) antibody and RNA, or HIV antigen or antibody. However, even if the patient is negative to HBs antigen, if the patient is positive to HBs antibody or hepatitis B core (HBc) antibody, the possibility of inclusion should be considered in consultation with a gastroenterologist, if necessary, based on Document 3 of the latest Hepatitis B Treatment Guidelines.\n\n12.Patients with a history of or comorbidity of interstitial lung disease evident on imaging, or those with active non-infectious pneumonitis 13.Patients with autoimmune disease, a history of chronic or recurrent autoimmune disease, or those who have required high-dose systemic corticosteroids (prednisolone equivalent of more than 10 mg\u002Fday) or immunosuppressants within 14 days prior to enrollment 14.Patients who require treatment for tuberculosis 15.Patients with clinical symptoms or findings indicating intestinal obstruction requiring intravenous or total parenteral nutrition, and those with risk factors for intestinal perforation (e.g., acute diverticulitis, in traperitoneal abscess, gastrointestinal obstruction, history of abdominal tumor, etc.).\n\n16.Patients with gastrointestinal disorders that may affect the absorption of AM80 17.Patients with a history of severe hypersensitivity or anaphylactic reactions to components of the drugs used in the clinical trial or antibody preparations 18.Patients who received live or attenuated vaccines within 30 days prior to enrollment 19.Patients with serious complications (liver disease , kidney disease, heart disease, lung disease, blood disease, brain disease, etc.) 20.Patients with uncontrolled adrenal insufficiency, Grade 2 or higher hearing impairment, or Grade 2 or higher neuropathy 21.Patients with hypervitaminosis A 22.Lactating female patients (excluding those who agreed to discontinue breastfeeding during the study period and for 6 months after the final dose of A M80) 23.Female patients who are pregnant or have positive pregnancy test results (female patients who have had a period within 12 months prior to enrollment and may be pregnant will be subjected to a pregnancy test. Female patients who have not had a period within 12 months but whose pregnancy cannot be ruled out due to reasons such as chemical menopause will also be subjected to a pregnancy test) 24.Patients who are otherwise deemed inappropriate for participation in this clinical trial by the principal investigator or sub-investigator","79 Years",{"count":119,"type":21},43,[24],"【Treatment of Urothelial Carcinoma】 Treatment for urothelial carcinoma includes surgery, chemotherapy (anticancer drugs), and radiation therapy. Chemotherapy is generally used when metastasis has already occurred at diagnosis and surgery is not curative (metastatic urothelial carcinoma) or when the cancer recurs after local therapy such as surgery or radiation therapy (recurrent urothelial carcinoma).\n\nAlthough there are several recommended treatments for urothelial carcinoma, the options are often limited by side effects and other factors, and these treatments may not be fully effective. Therefore, the development of safer and more effective treatments is desired.\n\n【About the Drugs to be Used in this Clinical Trial】 In this clinical trial, the investigational drug MIKE-1 will be used in combination with nivolumab plus GC (cisplatin gemcitabine), one of the recommended chemotherapy regimens, and subsequently with nivolumab monotherapy for patients with unresectable metastatic or recurrent urothelial cancer. Nivolumab, cisplatin, and gemcitabine are injectable (intravenous infusion), while MIKE-1 is oral.\n\n【Purpose of the Clinical Trial】 The purpose of this clinical trial is to evaluate the efficacy (how much the cancer shrinks or slows down) and safety of the investigational drug MIKE-1 in combination with nivolumab and gemcitabine and cisplatin therapy in patients with untreated unresectable or recurrent urothelial cancer.",[64,123,124,29],"Urothelial Carcinoma of the Renal Pelvis and Ureter","Urothelial Carcinoma Urethra",[126,127,98,128,129,130],"urothelial carcinoma","Gemcitabine, Cisplatin and Nivolumab","renal pelvis cancer","ureteral cancer","urethral cancer","2025-08-09",{"date":133,"type":38},"2025-08-14",{"date":135,"type":38},"2025-05-01",{"date":137,"type":21},"2029-03-01",{"name":139,"class":45},"Nagoya University",1,{"id":142,"slug":143,"hasResults":11,"nctId":144,"briefTitle":145,"officialTitle":146,"acronym":4,"eligibilityCriteria":147,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":148,"enrollmentInfo":149,"targetDuration":4,"studyType":22,"phases":151,"briefSummary":152,"conditions":153,"keywords":154,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":165},"100579371","phase-2-9mw2821--toripalimab-vs-9mw2821-for-1st-line-locally-advanced-or-metastatic-urothelial-carcinoma-100579371","NCT06823427","9MW2821 + Toripalimab vs 9MW2821 for 1st Line Locally Advanced or Metastatic Urothelial Carcinoma","A Randomized Phase II Trial to Evaluate 9MW2821 in Combination With Toripalimab Compared With 9MW2821 Monotherapy for the 1st Line Treatment of Locally Advanced or Metastatic Urothelial Carcinoma","Inclusion Criteria:\n\n* Voluntary participation\n* Age 18-80\n* ECOG 0-1\n* Histologically confirmed inoperable locally advanced or metastatic urothelial carcinoma (including bladder, renal pelvis and ureter). Mixed histology with squamous or adenomatous differentiation is allowed if urothelial carcinoma differentiation is \\>50%.\n* Has not received any systemic treatment for locally advanced or metastatic urothelial carcinoma\n* At least 1 measurable target lesion that satisfies RECIST v1.1 definition. If the patient has received radiotherapy, the target lesion needs to be outside the radiation field or has demonstrated clear progression after radiotherapy.\n* Life expectancy over 12 weeks\n* Appropriate hematological and organ functions\n* Agree to contraceptive measures until 180 days after the last dose of study drug administration\n* Able to understand and follow study visits, treatment, laboratory assessment and other procedures\n\nExclusion Criteria:\n\n* Other concurrent malignancy within 3 years prior to randomization\n* Active autoimmune disease requiring systemic treatment within 2 years prior to randomization. Having received high dose corticosteroid (\\>10mg\u002Fday prednisolone equivalent) or other immunosuppressive agents.\n* Severe cardiovascular or cerebral vascular thrombo-embolic events within 6 months prior to randomization\n* Major surgery within 28 days prior to randomization, except for minor procedures that the PI considers not to impact study participation. Live vaccine within 28 days prior to randomization or planning to take live vaccine during the study. Radiotherapy or bladder infusion therapy within 21 days prior to randomization. Use of strong CYP3A4 inhibitors within 14 days prior to randomization.\n* Lung effusion or ascites that require treatment within 14 days prior to randomization. Cancer-related severe uncontrolled bone pain or spinal cord compression within 14 days prior to randomization. Active infection that requires systemic antibiotic treatment within 7 days prior to randomization.\n* Have received prior treatment with anti-PD-1, anti-PD-L1\u002FPD-L2 or anti-CTLA-4 therapies. Have received prior treatment with Nectin-4 targeted therapy or ADC with MMAE as payload. Have received allogeneic hematological stem cell transplantation or solid organ transplant.\n* Toxicities from previous cancer treatment (radiotherapy, chemotherapy or surgery) that have not recovered to grade 0-1 according to CTCAE v5.0, except for alopecia and skin hyperpigmentation.\n* Severe dry eyes, active keratitis, corneal ulceration or other risk factors for corneal diseases where the PI judges to be not suited for this study\n* Preexisting grade ≥ 2 neuropathy prior to randomization\n* Other uncontrolled serious illness\n* Brain metastasis or meningeal carcinomatosis\n* HBsAg positive, and HBV-DNA copy number positive ; HCV-Ab positive and HCV-RNA positive; HIV-Ab positive\n* Known allergy to the study drug or components of the study drug\n* Drug abuse or psychiatric disorder that would impact study compliance\n* Other circumstances that the PI judges to be not suitable for the study","80 Years",{"count":150,"type":21},60,[24],"This study will compare the efficacy of 9MW2821+toripalimab versus 9MW2821 monotherapy in locally advanced or metastatic urothelial carcinoma patients who have not received any systemic treatment in the metastatic or advanced setting.",[27,64,29,123],[155],"9MW2821","2025-03-20",{"date":158,"type":38},"2025-03-21",{"date":160,"type":38},"2025-01-17",{"date":162,"type":21},"2027-06",{"name":164,"class":78},"Mabwell (Shanghai) Bioscience Co., Ltd.",2,{"id":167,"slug":168,"hasResults":11,"nctId":169,"briefTitle":170,"officialTitle":171,"acronym":172,"eligibilityCriteria":173,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":174,"targetDuration":176,"studyType":177,"phases":4,"briefSummary":178,"conditions":179,"keywords":185,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":213,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":221},"100506479","utract-jelmyto-registry-a-registry-of-patients-with-upper-tract-urothelial-cancer-utuc-treated-with-jelmyto-100506479","NCT05874921","uTRACT Jelmyto Registry: A Registry of Patients With Upper Tract Urothelial Cancer (UTUC) Treated With Jelmyto","uTRACT Jelmyto Registry: A Multicenter, Prospective and Retrospective Registry to Evaluate Real World Experience and Outcomes of Patients With Upper Tract Urothelial Cancer (UTUC) Treated With Jelmyto","uTRACT","Inclusion Criteria:\n\n* Adults \\>18 years old and capable of giving informed consent.\n* Diagnosis of UTUC.\n* Receipt of at least 1 dose of JELMYTO after FDA approval (15 Apr 2020).\n\nExclusion Criteria:\n\n* Incapable of giving informed consent (e.g., incarcerated individuals, individuals with dementia).\n* Receipt of 1 or more doses of JELMYTO (also referred to as UGN-101 or Mitogel in clinical development) before FDA approval (on or before 15 Apr 2020).\n* Pregnancy or lactation.\n* Unable to comply with protocol requirements (for prospective data capture).\n* Any medical or mental condition(s) that makes participation in the Registry inadvisable in the opinion of the Investigator (for prospective data capture).",{"count":175,"type":21},400,"3 Years","OBSERVATIONAL","The purpose of this registry is to evaluate real world experience and outcomes of patients with Upper Tract Urothelial Cancer (UTUC) treated with Jelmyto in the United States.",[27,29,180,181,182,123,183,184],"Urothelial Carcinoma Ureter","Urothelial Carcinoma Ureter Recurrent","Urothelial Cancer of Renal Pelvis","Carcinoma, Transitional Cell","Transitional Cell Carcinoma of Renal Pelvis",[186,187,188,189,190,191,192,193,194,195,196,197,198,199,200,201,202,203,204,205,206,207,208,209,210,211],"Upper Tract Urothelial Cancer","UTUC","UGN-101","Mitomycin C","TCC","Ureteral","Upper Tract","Carcinoma","Kidney","Renal","Gel","Local","Prolonged Release","Slow Release","Kidney Sparing","Recurrence","Neoplasms by Histologic Type","Neoplasms","Urologic Neoplasms","Urogenital Neoplasms","Neoplasms by Site","Antibiotics, Antineoplastic","Antineoplastic Agents","Alkylating Agents","Nucleic Acid Synthesis Inhibitors","Enzyme Inhibitors","2025-02-25",{"date":214,"type":38},"2025-02-28",{"date":216,"type":38},"2023-11-17",{"date":218,"type":21},"2028-01",{"name":220,"class":78},"UroGen Pharma Ltd.",22,{"id":223,"slug":224,"hasResults":11,"nctId":225,"briefTitle":226,"officialTitle":4,"acronym":4,"eligibilityCriteria":227,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":228,"phases":4,"briefSummary":229,"conditions":230,"keywords":231,"overallStatus":235,"whyStopped":4,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":236,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":237,"locationsCount":4},"100477242","named-patient-program-for-mitomycin-for-pyelocalyceal-solution-100477242","NCT05494411","Named Patient Program for Mitomycin for Pyelocalyceal Solution","Inclusion Criteria:\n\n* Patients who are suitable to receive JELMYTO and for whom there is reasonable expectation that JELMYTO may provide clinical benefit based on the medical judgment of their prescribing physician.","EXPANDED_ACCESS","This program provides controlled, pre-approval access to JELMYTO in response to unsolicited requests by physicians, hospitals, pharmacies, distributors, ministries of health or other parties on behalf of specific, or named patients, in select countries where JELMYTO has not yet received a marketing authorization and in situations when patients have exhausted all available treatment options.",[182,123,180,181,27,29],[232,233,188,234],"Low-grade Upper Tract Urothelial Cancer","LG-UTUC","Mitomycin","AVAILABLE",{"date":214,"type":38},{"name":220,"class":78}]