[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"bladder-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:bladder-cancer":32},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,219,0,25,[9,52,85,127,149,175,201,226,247,289,317,348,369,394,418,454,478,498,517,542,568,607,655,682,706],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":34,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100635114","acupuncture-and-exercise-for-ev-pembro-induced-peripheral-neuropathy-100635114",false,"NCT07548476","Acupuncture and Exercise for EV-Pembro-Induced Peripheral Neuropathy","Acupuncture and Exercise for EV-Pembro-Induced Peripheral Neuropathy (ACE)","ACE","Inclusion Criteria:\n\n* Age ≥ 18 years old\n* Diagnosed with pathologically proven urothelial cancer (UC)\n* Have received at least one cycle of EV-Pembro treatment with enrollment occurring after the 1st cycle and prior to the 4th cycle\n* Self-reported ability to walk for 6 minutes and\u002For 2 blocks\n* Deemed acceptable for exercise by their treating provider\n* Sedentary, currently engaging in less than or equal to 60 minutes of moderate or vigorous structured exercise\u002Fweek, as assessed by the Godin Leisure-Time Exercise Questionnaire\n* Willing to adhere to all study-related procedures, including randomization to either treatment group\n* Referrals to physical therapy are allowed during the study if necessary\n* Participants taking any of medications listed below must be on a stable regimen, with no changes in the past three months. Use of these medications may continue while on study.\n* Duloxetine, amitriptyline, nortriptyline, gabapentin, and pregabalin\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety of efficacy assessment of investigational regimen will be eligible.\n\nExclusion Criteria:\n\n* History of documented grade 2 or greater peripheral or motor neuropathy prior to EV-Pembro initiation; may confound assessment of the intervention's preventative effect\n* Patients with uncontrolled medical conditions that would preclude them from participating in moderate-to-vigorous intensity exercise in a virtual setting. Given the exercise environment is virtual, only patients with stable medical conditions should be enrolled to ensure their safety. Physical Activity Readiness Questionnaire (PARQ+) will be used during screening to facilitate conversations about present or historical medical conditions\n* Having continued grade 2 or higher adverse effects of their current treatment (EV-Pembro)\n* Receiving more than 10mg prednisone daily for any condition\n* History of bleeding diathesis (von Willebrand disease, hemophilia A\u002FB)\n* Known history of seizure disorder or taking antiepileptic drugs\n* Participate in more than 60 minutes of moderate or vigorous structured exercise\u002Fweek\n\nInvestigators will not include the following special populations:\n\n* Adults unable to consent\n* Individuals who are not yet adults (infants, children, teenagers \\\u003C 18 years)\n* Pregnant women\n* Prisoners","ALL","18 Years",{"count":21,"type":22},20,"ESTIMATED","INTERVENTIONAL",[25],"NA","The goal of this study is to evaluate the feasibility and preliminary efficacy of a combined acupuncture and exercise intervention for the management of chemotherapy-induced peripheral neuropathy (CIPN) in participants with bladder cancer receiving enfortumab vedotin (EV) and pembrolizumab (Pembro).\n\nThe names of the two study groups in this research study are:\n\n* Acupuncture + Virtual Exercise (AVE)\n* Virtual Exercise Only (VE)",[28,29,30,31,32,33],"Metastatic Bladder Cancer","Peripheral Neuropathy","Advanced Urothelial Cancer","Metastatic Urothelial Cancer","Bladder Cancer","Urothelial Cancer",[35,36,37,38],"Enfortumab Vedotin-Induced Neuropathy","Pembrolizumab-Induced Neuropathy","mUC","UC","RECRUITING","2026-08-19",{"date":42,"type":43},"2026-08-20","ACTUAL",{"date":45,"type":22},"2026-08",{"date":47,"type":22},"2028-08",{"name":49,"class":50},"Dana-Farber Cancer Institute","OTHER",1,{"id":53,"slug":54,"hasResults":12,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":4,"eligibilityCriteria":58,"healthyVolunteers":12,"sex":18,"minAge":59,"maxAge":4,"enrollmentInfo":60,"targetDuration":4,"studyType":23,"phases":62,"briefSummary":63,"conditions":64,"keywords":71,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":78,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":51},"100610399","dosing-physical-activity-among-older-cancer-survivors-who-experience-chronic-pain-a-micro-randomized-trial-100610399","NCT07227077","Dosing Physical Activity Among Older Cancer Survivors Who Experience Chronic Pain: a Micro-randomized Trial","An Adaptive Design for Dosing Physical Activity Among Older Cancer Survivors Who Experience Chronic Pain: a Micro-randomized Trial","Inclusion Criteria:\n\n1. Age greater than or equal to 65 years.\n2. Patients with a history of bladder, breast, cervical, colorectal, endometrial, lung, and prostate cancer diagnosis and treatment.\n3. Fluent in spoken and written English.\n4. Patient has access to smartphone\n5. Ability to understand a written informed consent document, and the willingness to sign it.\n\nExclusion Criteria:\n\n1. Patient has metastatic disease.\n2. Patient has cancer recurrence.","65 Years",{"count":61,"type":22},50,[25],"The purpose of this study is to assess the best time to deliver a message to increase physical activity and how often participants will experience a pain episode in the 24 hours following their receipt of a message to increase physical activity.",[65,66,32,67,68,69,70],"Breast Cancer","Cervical Cancer","Colorectal Cancer","Endometrial Cancer","Lung Cancer","Prostate Cancer",[72,73,74,75,76,77],"Physical Activity","Exercise","Survivorship","Supportive Care","Pain","Symptom Management",{"date":42,"type":43},{"date":80,"type":43},"2026-02-07",{"date":82,"type":22},"2027-05-01",{"name":84,"class":50},"Medical College of Wisconsin",{"id":86,"slug":87,"hasResults":12,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":4,"eligibilityCriteria":91,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":92,"targetDuration":4,"studyType":23,"phases":94,"briefSummary":96,"conditions":97,"keywords":106,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":126},"100529338","a-study-of-her3-dxd-in-subjects-with-locally-advanced-or-metastatic-solid-tumors-100529338","NCT06172478","A Study of HER3-DXd in Subjects With Locally Advanced or Metastatic Solid Tumors","HERTHENA-PanTumor01 (U31402-277): A Phase 2, Multicenter, Multicohort, Open-Label, Proof of Concept Study of Patritumab Deruxtecan (HER3-DXd; U3-1402) in Subjects With Locally Advanced or Metastatic Solid Tumors","Inclusion Criteria\n\nParticipants must meet all of the following criteria to be eligible for enrollment into the study:\n\n1. Sign and date the informed consent form prior to the start of any study-specific qualification procedures. A separate tissue screening consent will be obtained from all subjects to meet the baseline tumor tissue requirement.\n2. Participants aged ≥18 years (follow local regulatory requirements if the legal age of consent for study participation is \\>18 years old).\n3. Has locally advanced unresectable or metastatic disease (not curable by surgery or radiation) as follows:\n\n   Cutaneous (acral and non-acral) melanoma\n   1. Histologically or cytologically confirmed cutaneous (acral or non-acral) melanoma\n   2. Disease progression while on or after having received treatment with ≥1 prior line of anti-programmed cell death protein (PD-1) or anti-programmed death-ligand 1 (PD-L1) based therapy (previous use of other immune checkpoint inhibitors \\[ICIs\\] \\[ie, anti-CTLA4, anti- LAG-3\\] is acceptable). Prior anti-PD-(L)1 therapy in the adjuvant setting is allowed if there is recurrence within 12 weeks of the last dose. If the participant had BRAFm melanoma, they must have had disease progression on BRAF\u002FMEK inhibitor therapy as well.\n\n      Squamous cell carcinomas of the head and neck\n   3. Squamous cell carcinoma of the head and neck (with a primary location of oral cavity,oropharynx, larynx, hypopharynx) that is human papillomavirus (HPV) positive or negative (as determined by local standard). Excludes tumor location in the nasopharynx, nasal cavity, paranasal sinuses, and unknown primary locations.\n   4. Disease progression after having received treatment with ≥1 and \\\u003C3 prior lines of systemic therapy in the unresectable recurrent or metastatic setting.\n\n      Must have had disease progression on anti-PD-(L)1 (either as monotherapy or in combination with chemotherapy or other therapies). Must also have had disease progression on a platinum-based chemotherapy (PBC) regimen either in the recurrent or metastatic setting or in the locally advanced setting with curative intent.\n\n      Gastric or GEJ adenocarcinoma\n   5. Tumor tissue must be confirmed as negative for HER2 expression (immunohistochemistry \\[IHC\\] 0\u002F1+ or IHC 2+\u002Fin situ hybridization negative) as classified by American Society of Clinical Oncology\u002FCollege of American Pathologists (ASCO-CAP) guidelines and determined prior to enrollment by assessment in a local laboratory that is Clinical Laboratory Improvement Amendments certified (US sites) or accredited based on specific country regulations.\n   6. Disease progression after having received treatment with ≥2 prior lines of therapy that include PBC with or without anti-PD-1 therapy.\n\n      Ovarian Carcinoma\n   7. Pathologically documented high-grade serous epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.\n   8. Documented disease progression ≥4 weeks after the last dose of PBC and \\\u003C6 months of last dose of PBC in the advanced or metastatic setting. Prior use of folate reductase alpha targeting antibody-drug conjugate (ADC) (ie, mirvetuximab soravtansine) is allowed.\n\n      Cervical Cancer\n   9. Pathologically or cytologically documented recurrent or persistent squamous, adenosquamous, or adenocarcinoma of the uterine cervix.\n   10. Disease progression after having received ≥1 line of systemic therapy in the recurrent or metastatic setting. This may include prior anti-PD-(L)1 treatment and\u002For tissue factor directed ADC (tisotumab vedotin \\[TV\\]) per regional standard of care.\n\n       Endometrial Cancer\n   11. Pathologically or cytologically documented endometrial cancer (carcinoma of any histological sub-type or endometrial carcinosarcoma), irrespective of microsatellite instability (MSI) or mismatch repair (MMR) status.\n   12. Documented disease progression after having received ≥1 prior line of therapy (maximum of 3) PBC containing systemic treatment and an anti-PD(L)-1 therapy-containing regimen (combined or sequential) in the advanced\u002Fmetastatic setting.\n\n       Bladder Cancer\n   13. Pathologically or cytologically documented locally advanced\u002Funresectable or metastatic urothelial carcinoma of the bladder, renal pelvis, ureter, or urethra. Histological variants are allowed if urothelial histology is predominant. Small cell\u002Fneuroendocrine tumors are not allowed even if mixed histology.\n   14. Relapsed or progressed after treatment with ≥1 prior line of therapy (maximum of 3) that contains anti-PD-(L)1 therapy in the perioperative or metastatic setting. At least 1 line of therapy must also contain one of the following treatment modalities: chemotherapy or enfortumab vedotin. Prior fibroblast growth factor receptor (FGFR)-inhibitor treatment for those who are eligible are allowed.\n\n       * Required treatments can be given in combination or sequentially\n       * Prior cisplatin-based therapy or PD-(L)1 inhibitor therapy given for the treatment of muscle invasive urothelial carcinoma is counted as 1 line of therapy\n       * The same regimen administered twice in different disease settings will be counted as 1 line of prior therapy\n       * Participants in the second-line setting who have previously received enfortumab vedotin and pembrolizumab in combination can be enrolled.\n\n       Esophageal Carcinoma\n   15. Pathologically or cytologically documented esophageal squamous cell carcinoma.\n   16. Must have documented disease progression after having received 2 prior lines of therapy including previous PBC with or without an anti-PD-1 therapy-containing regimen (combined or sequential) in the advanced\u002Fmetastatic setting.\n\n       Pancreatic Carcinoma\n   17. Pathologically or cytologically documented unresectable or metastatic pancreatic adenocarcinoma.\n   18. Relapsed or disease progression after having received 1 prior line of systemic therapy in the locally advanced\u002Fmetastatic setting.\n\n       Prostate Cancer\n   19. Pathologically or cytologically documented unresectable locally advanced or metastatic castration-resistant prostate cancer (CRPC).\n   20. Adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology.\n   21. Surgically or medically castrated, with testosterone levels of \\\u003C50 ng\u002FdL.\n   22. Documented objective progression as determined by radiographic progression for subjects with measurable disease after androgen deprivation.\n   23. Relapsed or disease progression after having received treatment with ≥1 of the following novel hormonal agents: abiraterone, enzalutamide, apalutamide, or darolutamide.\n   24. Relapsed or disease progression after having received ≥1 cytotoxic chemotherapy regimen that included a taxane.\n\n       Gastric Cancer 2L\n   25. Must have had gastric or GEJ adenocarcinoma confirmed as negative for HER2 expression (IHC 0\u002F1+ or IHC 2+\u002Fin situ hybridization negative) as classified by American Society of Clinical Oncology\u002FCollege of American Pathologists (ASCO-CAP) guidelines and determined prior to enrollment by assessment in a local laboratory that is Clinical Laboratory Improvement Amendments certified (US sites) or accredited based on specific country regulations.\n   26. Disease progression after having received treatment with only 1 prior line of systemic anti-cancer therapy that includes 5-FU-based chemotherapy with or without an anti-PD-1 therapy. For subjects whose tumors are claudin (CLDN) 18.2 positive, treatment with 5-FU based chemotherapy with CLDN18.2 directed therapy in the first-line setting is allowed.\n\n   Non-small Cell Lung Cancer aa. Histologically or cytologically documented metastatic or locally advanced nonsquamous NSCLC not amenable to curative surgery or radiation bb. Documentation of absence of actionable driver mutation (ie, ALK rearrangement, BRAF V600E mutation, EGFR-activating mutations \\[exon 19 deletion or L858R mutation\\], EGFR exon 20 insertion mutation, HER2 mutation, KRAS G12C mutation, MET exon 14 skipping mutation, NTRK 1\u002F2\u002F3 gene fusion, RET rearrangement, or ROS1 rearrangement). New testing for these genomic alterations is not required for Screening.\n\n   cc. Relapsed or disease progression after receiving only anti-PD-(L)1 and PBC (ie, platinum doublet) administered in combination or sequentially for metastatic disease.\n\n   Breast Cancer dd. Pathologically documented breast cancer that is assessed as HER2 negative (IHC2+\u002FISH-, IHC1+, or IHC0 per ASCO\u002FCAP guidelines), and HR positive (either ER and\u002For PgR positive \\[ER or PgR ≥1%\\] per ASCO\u002FCAP guidelines). The HER2 and HR results must be from a tumor sample obtained in the metastatic setting.\n\n   ee. Participant must have received one line of chemotherapy for mBC, but not more than one line and must have a clinically or radiologically documented evidence of tumor progression on or after CDK 4\u002F6 inhibitor combined with endocrine therapy; previous treatments with phosphoinositide 3-kinase (PI3K) inhibitors, mammalian target of rapamycin (mTOR) inhibitors, protein kinase B (PKB) inhibitors also known as AKT-inhibitors and poly ADP ribose polymerase (PARP)-inhibitors are allowed.\n4. Has ≥1 measurable lesion on CT or MRI as per RECIST v1.1 by investigator assessment. Prostate cancer participants with bone only disease may be eligible.\n5. Provides a pretreatment tumor tissue sample that meets 1 of the following collection requirements:\n\n   1. Tumor biopsy from ≥1 lesion not previously irradiated and performed since progression with the most recent systemic cancer therapy regimen and prior to signature of the tissue ICF (ARCHIVAL PRETREATMENT sample).\n\n      OR\n   2. Newly obtained pretreatment tumor biopsy from ≥1 lesion not previously irradiated and amenable to sampling, after signature of tissue ICF (FRESH PRETREATMENT sample)\n6. Has Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1 at screening.\n\nExclusion Criteria\n\nParticipants who meet any of the following criteria will be disqualified from entering the study:\n\n1. Has HER2-positive gastric cancer as classified by ASCO-CAP guidelines and determined prior to enrollment by assessment in a local laboratory that is Clinical Laboratory Improvement Amendments certified (US sites) or accredited based on specific country regulations.\n2. Has nasopharyngeal cancer.\n3. Has mucosal or uveal melanoma.\n4. Has a history of (non-infectious) interstitial lung disease (ILD), that required corticosteroids, has current ILD\u002Fpneumonitis, or suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening.\n5. Has clinically severe respiratory compromise (based on the investigator's assessment) resulting from intercurrent pulmonary illnesses\n6. Is receiving chronic systemic corticosteroids dosed at \\>10 mg prednisone daily or equivalent anti-inflammatory activity or any form of immunosuppressive therapy prior to Cycle 1 Day 1.\n\n   Participants who require use of bronchodilators, inhaled or topical steroids, or local steroid injections may be included in the study.\n7. Had prior treatment with an anti-HER3 antibody and\u002For antibody-drug conjugate (ADC) that consists of an exatecan derivative that is a topoisomerase I inhibitor (eg, trastuzumab deruxtecan).\n8. Has history of other active malignancy within 3 years prior to Cycle 1 Day 1, except the following:\n\n   1. Adequately treated nonmelanoma skin cancer\n   2. Adequately treated intraepithelial carcinoma of the cervix\n   3. Any other curatively treated in situ disease\n9. Has any evidence of severe or uncontrolled diseases (eg, active bleeding diatheses, active serious infection) psychiatric illness\u002Fsocial situations, geographical factors, substance abuse, or other factors that, in the investigator's opinion, make it high risk for the subject to participate in the study or that would jeopardize compliance with the protocol\n10. Has previously received topoisomerase-1 inhibitors (e.g., irinotecan) treatment in the advanced or metastatic disease setting.",{"count":93,"type":22},740,[95],"PHASE2","This is a proof-of-concept study designed to investigate HER3-DXd monotherapy in locally advanced unresectable or metastatic solid tumors. The study is enrolling cohorts of participants with melanoma \\[cutaneous\u002Facral\\], squamous cell carcinomas of the head and neck (SCCHN), HER2-negative gastric cancer ovarian carcinoma, cervical cancer, endometrial cancer, bladder cancer, esophageal carcinoma, pancreatic carcinoma, prostate cancer, second-line gastric cancer, lung cancer, and breast cancer.",[98,99,100,101,102,66,68,32,103,104,70,105,69,65],"Advanced Solid Tumor","Melanoma","Head and Neck Cancer","Gastric Cancer","Ovarian Carcinoma","Esophageal Cancer","Pancreatic Carcinoma","Non-small Cell Lung Cancer (NSCLC)",[98,99,100,101,107,108,109,110,111,112,113,114,115,116,69,65],"Ovarian carcinoma","Cervical cancer","Endometrial cancer","Bladder cancer","Esophageal carcinoma","Pancreatic carcinoma","Prostate cancer","Patritumab Deruxtecan","HER3-DXd","U3-1402",{"date":118,"type":43},"2026-08-21",{"date":120,"type":43},"2024-02-26",{"date":122,"type":22},"2028-10-10",{"name":124,"class":125},"Daiichi Sankyo","INDUSTRY",86,{"id":128,"slug":129,"hasResults":12,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":4,"eligibilityCriteria":133,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":134,"targetDuration":4,"studyType":23,"phases":136,"briefSummary":137,"conditions":138,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":142,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":51},"100519224","a-home-based-prehabilitation-exercise-intervention-for-improving-physical-function-in-patients-with-bladder-cancer-and-upper-tract-urothelial-cancer-get-moving-trial-100519224","NCT06040762","A Home-Based Prehabilitation Exercise Intervention for Improving Physical Function in Patients With Bladder Cancer and Upper Tract Urothelial Cancer, Get Moving Trial","The \"Get Moving Trial\": A Phase I\u002FII RCT of Home-Based (P)Rehabilitation With ExerciseRx in Bladder Cancer and Upper Tract Urothelial Cancer","Inclusion Criteria:\n\n* 18 years of age or older\n* English-speaking\n* Planned treatment with radical cystectomy or radical nephroureterectomy\u002Fureterectomy with or without preceding systemic therapy as indicated by the patient's surgeon with enough time to complete a minimum of 4 weeks of exercises before surgery if enrolled in the (P)REHAB arm\n* Willing and able to participate in trial activities\n\nExclusion Criteria:\n\n* Cognitive\u002Fmental impairment that will preclude ability to participate in routine exercise activities. Significant cognitive or memory impairment or baseline dementia that would preclude a patient's ability to follow instructions or reproduce exercises\n* Immobility, inability\u002Funwillingness to perform personalized exercise program. Inability to perform exercises safely from seated or standing position at home or recent falls or high fall risk. Neurologic or orthopedic condition(s) that restricts participation in unsupervised home exercises, such as prior stroke with neurologic impairment, weight-bearing precautions, or unwillingness to participate in exercises\n* Participants who have nonmuscle-invasive urothelial cancer of the bladder\u002Fupper tract anticipating undergoing organ-preserving treatments, or radiographic evidence of metastatic disease involving other organs including brain metastases.\n* Patients with predominant histology other than urothelial carcinoma of the bladder or upper tracts (e.g. metastasis from another cancer) who would not otherwise be considered candidates for standard definitive or consolidative surgeries (radical cystectomy, ureterectomy, radical nephroureterectomy) with\u002Fwithout treatment with preoperative\u002Fneoadjuvant systemic therapy.\n* Uncontrolled or concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Pregnant women are excluded from this study\n* Inability to understand or read English\n* Lack of access or lack of sufficient facility to use an Android or iOS smart device with the minimum criteria for using ExerciseRx\n* Not receiving surgery at UWMC\n* Participation in a clinical trial that does not permit enrollment in the Get Moving trial",{"count":135,"type":22},128,[25],"Prehabilitation refers to the process of improving a patient's functional capabilities prior to a surgical procedure with the goal of decreasing post-surgical inactivity and physical decline. This clinical trial evaluates the utility of a personalized home-based prehabilitation exercise intervention for the improvement of physical function and surgical outcomes in patients with urothelial carcinoma undergoing definitive or consolidative surgery of the bladder (radical cystectomy) or upper tract (nephroureterectomy, ureterectomy) with or without preceding neoadjuvant\u002Fsystemic therapy. The exercise intervention includes at-home exercise sessions focused on the improvement of core strength and balance as well as personalized step count goals, delivered to patients remotely via a smart-device-based application (ExerciseRx). Encouraging physical activity before surgery may improve physical function and surgical outcomes in patients who are scheduled to undergo surgery for their bladder or urothelial cancer.",[32,139,140,141],"Urothelial Carcinoma","Upper Tract Urothelial Carcinoma","Renal Pelvis and Ureter Urothelial Carcinoma",{"date":42,"type":43},{"date":144,"type":43},"2023-12-19",{"date":146,"type":22},"2027-04-30",{"name":148,"class":50},"University of Washington",{"id":150,"slug":151,"hasResults":12,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":4,"eligibilityCriteria":155,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":156,"targetDuration":4,"studyType":23,"phases":158,"briefSummary":160,"conditions":161,"keywords":162,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":174},"100602936","phase-2-study-of-datopotamab-deruxtecan-plus-carboplatin-or-cisplatin-versus-gemcitabine-plus-carboplatin-or-cisplatin-in-participants-with-locally-advanced-or-metastatic-urothelial-carcinoma-100602936","NCT07129993","Study of Datopotamab Deruxtecan Plus Carboplatin or Cisplatin Versus Gemcitabine Plus Carboplatin or Cisplatin in Participants With Locally Advanced or Metastatic Urothelial Carcinoma","A Randomized, Open-Label, Phase 2\u002F3 Study of Datopotamab Deruxtecan (Dato-DXd) Plus Carboplatin or Cisplatin Versus Gemcitabine Plus Carboplatin or Cisplatin in Participants With Locally Advanced or Metastatic Urothelial Carcinoma (la\u002FmUC) Who Progressed During or After Enfortumab Vedotin (EV) Plus Pembrolizumab Combination Treatment TROPION-Urothelial03 (TU03)","Key Inclusion Criteria:\n\n* Adult ≥18 years at the time the ICF is signed (if the legal age of consent is \\> 18 years old, then follow the local regulatory requirements).\n* Histologically or cytologically confirmed unresectable or locally advanced (T4b, any N; or any T, N 2-3) or metastatic (any T, any N, M1) urothelial carcinoma of the bladder, renal pelvis, ureter, or urethra. Participants with urothelial carcinoma (transitional cell) with squamous differentiation or mixed cell types are eligible if the histology is predominantly urothelial as specified in the protocol.\n* Must provide tumor tissue sample from archival tissue or newly obtained pretreatment biopsy for exploratory biomarker testing. Tumor tissue sample should not be collected from a lesion that was irradiated unless documentation can be provided confirming that the tumor tissue was collected at least 3 months after radiation and the lesion increased\u002Fappeared since radiation occurred. Tumor tissue must be of sufficient quantity (as defined in the Laboratory Manual).\n* Archival tissue collected after the most recent anticancer treatment and within 12 months before the informed consent date is preferred.\n* Must be considered eligible to receive cisplatin- or carboplatin-containing chemotherapy, in the investigator's judgment. Participants eligible for cisplatin will receive cisplatin. If a participant received gemcitabine, carboplatin, or cisplatin for early UC in the adjuvant\u002Fneoadjuvant setting, the decision to rechallenge the participant with platinum therapy will be at the discretion of the investigator. Participants only receive carboplatin if they are ineligible for cisplatin. Participants are cisplatin-ineligible if they meet any of the following criteria: a. GFR \\\u003C60 mL\u002Fmin (GFR may be estimated by calculated CrCl using the Cockcroft-Gault formula, Modification of Diet in Renal Disease, or 24-hour urine)\n\nFor Phase 2 part:\n\n* Participants with a GFR \\\u003C60 mL\u002Fmin but ≥50 mL\u002Fmin but have no other cisplatin ineligibility criteria (items b, c, and d) may be considered cisplatin-eligible based on the investigator's clinical judgment.\n\nFor Phase 3 Part:\n\n* Participants with borderline renal function CrCl ≥40 mL\u002Fmin to \\\u003C60 mL\u002Fmin who have no other cisplatin ineligibility criteria (items b, c, and d) may receive cisplatin using a split-dose regimen, administered as cisplatin 35 mg\u002Fm\\^2 on Days 1 and 8 of each 21-day cycle, for a maximum of 4 to 6 cycles.\n* In participants with CrCl ≥50 mL\u002Fmin to \\\u003C60 mL\u002Fmin, full-dose cisplatin may also be administered at the investigator's discretion, based on the overall clinical assessment.\n\nThe dosing schedule and dose level for Dato-DXd or gemcitabine are not altered when combined with either split-dose or full-dose cisplatin.\n\nFor both Phase 2 and Phase 3:\n\nb. NCI-CTCAE Grade ≥2 audiometric hearing loss c. NCI-CTCAE Grade ≥2 peripheral neuropathy d. NYHA Class III heart failure\n\n• Must have experienced radiographic progression or relapse during or after 1L of EV (or other agents with a vedotin payload) and pembrolizumab (or other PD-1\u002FPD-L1 inhibitors).\n\nParticipants who discontinued EV (or other agents with a vedotin payload) and pembrolizumab (or other PD-1\u002FPD-L1 inhibitors) in 1L due to toxicity are eligible if they have experienced disease progression following discontinuation. Participant who received EV (or other agents with a vedotin payload) plus pembrolizumab (or other PD-1\u002FPD-L1) inhibitors in a neoadjuvant\u002Fadjuvant setting and progressed during treatment or within 12 months of treatment completion will also be considered for enrollment, after approval by the Sponsor's Medical Monitor or Sponsor's designee.\n\nKey Exclusion Criteria:\n\n* Has had prior systemic therapy other than the combination of EV and pembrolizumab for la\u002FmUC. The following participants may be considered eligible after approval by the Sponsor's Medical Monitor or Sponsor's designee.\n* Participant who progressed during or after treatments with assets that include either anti-Nectin 4 or vedotin payload (MMAE or other microtubule inhibitors) combined with PD1\u002FPD-L1 inhibitors in 1L la\u002FmUC.\n* Treatment with any of the following:\n\n  1. History of an allogeneic bone marrow or solid organ transplant.\n  2. Concomitant treatment with any prohibited medications in this protocol.\n  3. Prior TROP2 directed ADC therapy.\n* Uncontrolled or significant cardiovascular disease, including:\n\nQTcF interval \\>470 ms based on the average of triplicate 12-lead (ECG per local read) at screening.\n\n1. Screening myocardial infarction within 6 months prior to randomization.\n2. Uncontrolled angina pectoris within 6 months prior to randomization.\n3. NYHA Class 3 or 4 congestive heart failure at screening.\n4. Uncontrolled hypertension (resting systolic blood pressure \\>160 mmHg or diastolic blood pressure \\>100 mmHg within 28 days before randomization that is not resolved despite maximal medical therapy).\n\n   * Has a history of non-infectious ILD\u002Fpneumonitis including radiation pneumonitis that required steroids, has current ILD\u002Fpneumonitis, or has suspected ILD\u002Fpneumonitis that cannot be ruled out by imaging at screening.\n   * Has clinically severe pulmonary compromise as judged by the investigator resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (eg, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, etc.) or any autoimmune, connective tissue, or inflammatory disorders with pulmonary involvement (eg, rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, etc.), or prior complete pneumonectomy.\n   * Toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet improved to NCI-CTCAE version 5.0 Grade ≤1 or baseline. Note: Participants may be enrolled with chronic, stable Grade 2 toxicities (defined as no worsening to Grade \\>2 for at least 3 months prior to randomization and managed with standard of care treatment) which the investigator deems related to previous anticancer therapy, comprised of (including but not limited to):\n\na. Anticancer therapy-induced neuropathy b. Residual toxicities from prior immunotherapy treatment: Grade 1 or Grade 2 endocrinopathies which may include:\n\n* Hypothyroidism\u002F hyperthyroidism\n* Type I diabetes\n* Hyperglycemia\n* Adrenal insufficiency\n* Adrenalitis c. Skin hypopigmentation (vitiligo)",{"count":157,"type":22},630,[95,159],"PHASE3","This is a global, multicenter, randomized, open-label, Phase 2\u002F3 study of Dato-DXd plus carboplatin or cisplatin versus gemcitabine plus carboplatin or cisplatin in participants with la\u002FmUC who progressed during or after EV plus pembrolizumab combination treatment.\n\nThis trial will start with part A, Phase 2. During part A, Phase 2, preliminary efficacy and safety will be assessed, and the recommended Phase 3 dose (RP3D) will be identified when the data allow sufficient assessment of activity, safety, and tolerability. The Phase 3 part will start contingent upon the assessment in the Phase 2 part, taking into consideration the totality of information.",[33,32],[139,163,164,165,166],"Dato-DXd","TROPION","DS-1062a","Datopotamab Deruxtecan","2026-08-18",{"date":42,"type":43},{"date":170,"type":43},"2025-09-26",{"date":172,"type":22},"2030-01-22",{"name":124,"class":125},100,{"id":176,"slug":177,"hasResults":12,"nctId":178,"briefTitle":179,"officialTitle":180,"acronym":4,"eligibilityCriteria":181,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":182,"enrollmentInfo":183,"targetDuration":4,"studyType":184,"phases":4,"briefSummary":185,"conditions":186,"keywords":187,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":193,"startDateStruct":194,"completionDateStruct":196,"leadSponsor":198,"locationsCount":51},"100380605","en-bloc-transurethral-resection-of-bladder-tumor-en-bloc-turbt-specimens-using-a-redesigned-surgical-resectoscope-device-100380605","NCT04235764","En-bloc Transurethral Resection of Bladder Tumor (En-bloc TURBT) Specimens Using a Redesigned Surgical Resectoscope Device","Ex-Vivo Trial of En-bloc Transurethral Resection of Bladder Tumor (En-bloc TURBT) Specimens Using a Redesigned Surgical Resectoscope Device","* INCLUSION CRITERIA:\n* Patients requiring surgical removal of the bladder at the NIH Clinical Center.\n\nNOTE: Reasons for need for surgical removal of bladder include cancer or benign condition for which a surgeon determined surgical removal of the bladder is recommended. Patient's with invasive bladder cancer requiring cystectomy are eligible for enrollment. Bladder cancer remains the most common reason for cystectomy. Patients with clinical advanced disease and having other treatments\u002For participating in other trials remain eligible for enrollment in this study.\n\n* Men and women\n* Age greater than or less than 18 years\n* Deemed clinically appropriate for the planned surgical procedure.\n* Ability of subject to understand and the willingness to sign a written informed consent document.\n* Subjects will be asked to co-enroll in 15-C-0087, \"Care of the Urothelial Cancer Patient and Prospective Collection of Biospecimens from Healthy Volunteers and Urothelial Cancer Patients.\" NOTE: Most participants are expected to already be enrolled in 15-C-0087 prior to entry in this study.\n\nEXCLUSION CRITERIA:\n\n\\- Cystectomy during pregnancy would subject the fetus to significant risk of miscarriage or premature labor. For this reason, pregnant women are ineligible for this study.","120 Years",{"count":7,"type":22},"OBSERVATIONAL","Background:\n\nBladder cancer is the sixth most common cancer in the United States. The way that doctors remove tumors in bladder surgeries may leave some cancer . Also, many people have their tumors return or progress after surgery. Researchers want to test a modified device. It might tell doctors more about bladder tumors.\n\nObjective:\n\nTo see if using a modified standard device with bladder surgery can provide better information about tumors in bladder specimens.\n\nEligibility:\n\nPeople ages 18 and older who need to have their bladder removed at the NIH.\n\nDesign:\n\nParticipants will be screened with:\n\nMedical and prior surgical history\n\nReview of existing MRI, x-ray, or CT scans\n\nReview of existing specimens and reports\n\nPregnancy test for women of childbearing age\n\nCT or MRI: Participants will lie in a machine. The machine will take pictures of their body.\n\nParticipants will have bladder surgery. This will occur in the same way as if they did not take part in this study. A member of the research team will cut the removed bladder using the modified device. This will most likely be done on a separate back table in the operating room. The bladder and samples after cutting will be sent out for review. The will occur just as it would if the participants were not in this study. The only difference is the way that the specimen is prepared for review.\n\nParticipants follow-up care will occur per standard of care. Or it will occur as part of any other study in which they might also be enrolled.",[32],[188,189,190,191,192],"TURBT","Transurethral Resection of Bladder Tumors","Cystectomy","Modified Resectoscope","Natural History",{"date":40,"type":43},{"date":195,"type":43},"2020-09-09",{"date":197,"type":22},"2027-09-30",{"name":199,"class":200},"National Cancer Institute (NCI)","NIH",{"id":202,"slug":203,"hasResults":12,"nctId":204,"briefTitle":205,"officialTitle":205,"acronym":4,"eligibilityCriteria":206,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":207,"targetDuration":209,"studyType":184,"phases":4,"briefSummary":210,"conditions":211,"keywords":212,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":218,"startDateStruct":219,"completionDateStruct":221,"leadSponsor":223,"locationsCount":225},"100300661","measuring-surgical-recovery-after-radical-cystectomy-100300661","NCT03193970","Measuring Surgical Recovery After Radical Cystectomy","Inclusion Criteria:\n\n1\\. Bladder cancer patients undergoing radical cystectomy at the MD Anderson Cancer Center and the collaborating centers.\n\nExclusion Criteria:\n\nN\u002FA",{"count":208,"type":22},2000,"3 Months","The intent of this study is to establish a registry of post-surgical outcomes in patients undergoing radical cystectomy at MD Anderson Cancer Center and the collaborating institutions. The goals of this initiative are to obtain a detailed baseline of multiple patient-reported outcomes (PRO) and clinician-reported outcomes (CRO) as well as various presenting conditions associated with them, so that future quality improvement interventions can be evaluated accurately as to their relative contribution to improved outcomes.",[32],[32,213,214,215,216,217],"Registry","Post-surgical outcomes","Radical cystectomy","MD Anderson Symptom inventory","MDASI",{"date":40,"type":43},{"date":220,"type":43},"2015-04-30",{"date":222,"type":22},"2034-12-31",{"name":224,"class":50},"M.D. Anderson Cancer Center",10,{"id":227,"slug":228,"hasResults":12,"nctId":229,"briefTitle":230,"officialTitle":230,"acronym":4,"eligibilityCriteria":231,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":232,"targetDuration":4,"studyType":184,"phases":4,"briefSummary":234,"conditions":235,"keywords":237,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":242,"lastUpdatePostDateStruct":243,"startDateStruct":244,"completionDateStruct":4,"leadSponsor":246,"locationsCount":51},"100054764","evaluation-for-nci-surgery-branch-clinical-research-protocols-100054764","NCT00001823","Evaluation for NCI Surgery Branch Clinical Research Protocols","* INCLUSION CRITERIA:\n\nAge \\>= 18 years.\n\nPatient suspected of having, or with biopsy proven, malignant disease.\n\nPatient is able to understand and willing to sign a written informed consent document.\n\nPatient is being evaluated for treatment on an NCI-SB protocols.\n\nEXCLUSION CRITERIA:\n\nWomen of child-bearing potential who are pregnant or plan to become pregnant because of the potentially dangerous effects of some of the screening procedures (e.g., nuclear medicine or other imaging scans) on the fetus.",{"count":233,"type":22},7000,"Background:\n\nThe National Cancer Institute Surgery Branch (NCI-SB) has developed experimental therapies that involve taking white blood cells from patients' tumor or from their blood, growing them in the laboratory in large numbers, and then giving the cells back to the patient.\n\nObjective:\n\nThis study will allow patients to under screening and evaluation for participation in NC-SB Protocols.\n\nEligibility:\n\nPatients 18 years or older must meet the minimum eligibility criteria for an NCI-SB treatment protocol.\n\nDesign\n\nPatients will undergo testing and evaluations as required by the appropriate NCI-SB treatment protocol.\n\n...",[236,99,67,69,32],"Synovial Cell Cancer",[238,239,240,241],"Cancer","Gene Therapy","Immunotherapy","Clinical Trial","2026-08-15",{"date":167,"type":43},{"date":245,"type":43},"1999-07-11",{"name":199,"class":200},{"id":248,"slug":249,"hasResults":12,"nctId":250,"briefTitle":251,"officialTitle":252,"acronym":4,"eligibilityCriteria":253,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":254,"targetDuration":4,"studyType":23,"phases":256,"briefSummary":258,"conditions":259,"keywords":270,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":280,"lastUpdatePostDateStruct":281,"startDateStruct":282,"completionDateStruct":284,"leadSponsor":286,"locationsCount":288},"100609637","phase-1-a-study-evaluating-the-safety-efficacy-and-pharmacokinetics-pk-of-evolve104-in-participants-with-advanced-urothelial-and-squamous-cell-carcinomas-100609637","NCT07217171","A Study Evaluating the Safety, Efficacy, and Pharmacokinetics (PK) of EVOLVE104 in Participants With Advanced Urothelial and Squamous Cell Carcinomas","A Phase 1 Dose-Escalation and Expansion Study Evaluating the Safety, Efficacy, and Pharmacokinetics of EVOLVE104 in Subjects With Advanced Urothelial and Squamous Cell Carcinomas","Key Inclusion Criteria:\n\nParticipants must have locally advanced or metastatic cancer with one of the following tumor types: bladder cancer, squamous cell carcinoma of the lung, esophagus, skin, or an anogenital squamous cell carcinoma.\n\n1. Participant must have documented disease progression during or post treatment with standard of care, dependent upon tumor type.\n2. The cancer must be measurable by CT scan or MRI.\n3. Eastern Cooperative Oncology Group (ECOG) performance status score ≤1.\n4. Anticipated life expectancy of at least 3 months.\n5. Adequate organ function, as indicated by standard blood tests.\n6. Able to provide a fresh or archival tumor biopsy.\n7. Male and female participants must agree to use contraception during the study and for 120 days after the last dose of study drug, except for women who are post-menopausal or surgically sterile.\n\nKey Exclusion Criteria:\n\n1. The participant is a candidate for treatment with a targeted agent known to provide a benefit.\n2. Persistent significant toxicities from prior anticancer therapy.\n3. Brain metastases unless previously treated and stable.\n4. Prior severe or life-threatening immunologic reactions to previous therapies.\n5. Significant medical conditions, including but not limited to:\n\n   * History of clinically significant cardiac disease\n   * Severe esophageal disease such as esophageal rupture or severe erosive esophagitis.\n   * Active inflammatory corneal or conjunctival inflammation, erosion, or ulcerations.\n   * History of cirrhosis or significant portal hypertension.\n   * Uncontrolled or significant infection.\n   * History of certain other cancers in the past 3 years.\n   * History of arterial thrombosis, stroke and transient ischemic attack within 6 months.\n   * Active or uncontrolled HIV, HBV or HCV infection.\n   * Autoimmune or other condition requiring chronic systemic immunosuppression.",{"count":255,"type":22},160,[257],"PHASE1","The goal of this study is to evaluate the safety and effectiveness of EVOLVE104 in participants with advanced urothelial and squamous cell carcinomas who have previously taken standard treatment options, have declined or have been ineligible for treatment with these medications. Participants with advanced or metastatic cancer who meet all eligibility criteria may be eligible to participate in the study.",[32,260,261,262,263,264,265,266,267,268,269],"Squamous Cell Carcinoma of the Lung","Esophageal Squamous Cell Carcinoma","Tongue Squamous Cell Carcinoma","Cutaneous Squamous Cell Cancer","Penile Squamous Cell Carcinoma","Anal Squamous Cell Carcinoma","Vulvar Squamous Cell Carcinoma","Cervical Squamous Cell Carcinoma","Vaginal Squamous Cell Carcinoma","Urethral Squamous Cell Carcinoma",[271,272,273,274,275,276,277,278,279],"bladder","lung","esophagus","tongue","penile","anal","vulvar","cervical","vaginal","2026-08-14",{"date":167,"type":43},{"date":283,"type":43},"2025-11-13",{"date":285,"type":22},"2031-01-29",{"name":287,"class":125},"EvolveImmune United, Inc",15,{"id":290,"slug":291,"hasResults":12,"nctId":292,"briefTitle":293,"officialTitle":294,"acronym":4,"eligibilityCriteria":295,"healthyVolunteers":296,"sex":18,"minAge":297,"maxAge":4,"enrollmentInfo":298,"targetDuration":4,"studyType":184,"phases":4,"briefSummary":300,"conditions":301,"keywords":306,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":280,"lastUpdatePostDateStruct":312,"startDateStruct":314,"completionDateStruct":4,"leadSponsor":316,"locationsCount":51},"100060106","collection-of-serum-and-tissue-samples-from-patients-with-biopsy-proved-or-suspected-malignant-disease-100060106","NCT00026884","Collection of Serum and Tissue Samples From Patients With Biopsy-Proved or Suspected Malignant Disease","Collection of Serum and Tissue Samples From Patients With Biopsy-Proved or Suspected Malignant Diseases","* INCLUSION CRITERIA:\n* Individuals with biopsy-proven malignant disease\n* Individuals suspected of having a malignant disease\n* Individuals who have or are suspected of having an inherited genitourinary malignant disorder\n* Participants must be \\>= 2 years of age\n* A relative (related by blood) of an individual with a confirmed or suspected diagnosis of a malignant disease or an inherited genitourinary malignant disorder.\n* All participants and parents\u002Fguardians, for children younger than 18 years of age, must sign an informed consent document indicating their understanding of the investigational nature and the risks of this study before any protocol related studies are performed.\n\nEXCLUSION CRITERIA:\n\n-Individuals whose co-morbidities preclude surgical intervention.",true,"2 Years",{"count":299,"type":22},5950,"Selected individuals suspected of having or with prior biopsy proof of malignant disease will be seen in the Urologic Oncology Branch, NCI. Blood samples may be collected at the time of the initial visit and at periodic intervals during the course of the disease. These samples will be stored in the tissue bank of the Urologic Oncology Branch. Aliquots of malignant and normal tissue will be collected at the time of surgery and stored in the tissue bank, Urologic Oncology Branch, NCI. These materials will be used in the research efforts of the Urologic Oncology Branch, NCI.",[302,303,304,305,32],"Malignant Neoplasms","Hereditary Neoplastic Syndromes","Kidney Cancer","Renal Cancer",[307,308,309,310,311,192],"Serum","Collection of Tissue","Malignant Disease","Molecular Basis","Genome Sequencing",{"date":313,"type":43},"2026-08-17",{"date":315,"type":43},"1998-03-12",{"name":199,"class":200},{"id":318,"slug":319,"hasResults":12,"nctId":320,"briefTitle":321,"officialTitle":322,"acronym":323,"eligibilityCriteria":324,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":325,"targetDuration":4,"studyType":23,"phases":327,"briefSummary":328,"conditions":329,"keywords":331,"overallStatus":338,"whyStopped":4,"lastUpdateSubmitDate":339,"lastUpdatePostDateStruct":340,"startDateStruct":341,"completionDateStruct":343,"leadSponsor":345,"locationsCount":347},"100651700","retrieval-of-transurethrally-resected-intact-en-bloc-vesical-tumors-using-a-retrieval-device-for-bladder-tumors-100651700","NCT07762820","REtrieval of Transurethrally Resected Intact En-bloc Vesical Tumors Using a Retrieval Device for Bladder Tumors","REtrieval of Transurethrally Resected Intact En-bloc Vesical Tumors Using a Retrieval Device for Bladder Tumors - A Prospective Multicenter Feasibility Study","RETRIEVE-BT","Inclusion Criteria:\n\n* Age ≥18 years at the time of enrollment\n* Suspected primary non-muscle invasive bladder cancer (NMIBC; stage pTa or pT1) based on cystoscopic assessment, with no radiological or clinical evidence of muscle-invasive disease\n* Solitary or multiple bladder tumors with an estimated largest diameter of ≤50 mm based on flexible or rigid cystoscopic assessment (or cross-sectional imaging if available)\n* Clinical indication for elective transurethral resection of the bladder tumor, planned to be performed as en-bloc resection\n* Written informed consent obtained prior to any study-related procedure\n* Ability to understand the study procedures and willingness to comply with study requirements\n\nExclusion Criteria:\n\n* Known or clinically suspected muscle-invasive bladder cancer (MIBC; cT2 or higher) based on cystoscopy or imaging\n* Recurrent bladder tumor (prior history of bladder tumor resection within the past 24 months)\n* Active untreated urinary tract infection at the time of surgery (requiring postponement and re-evaluation)\n* Uncorrectable coagulopathy or anticoagulation that cannot be safely paused perioperatively\n* Severe urethral stricture precluding standard resectoscope passage\n* Inability to provide written informed consent (e.g., due to cognitive impairment or language barrier without translation support)",{"count":326,"type":22},75,[25],"Bladder cancer is the most common malignancy of the urinary tract, and approximately 75% of cases are non-muscle invasive (NMIBC) at diagnosis. The standard treatment is transurethral resection of the bladder tumor (TURBT). En bloc resection (EBR-T), in which the tumor is removed in one intact piece rather than fragmented, offers superior pathological specimen quality and may reduce the need for repeat resections. However, extracting the intact specimen from the bladder through the urethra remains a critical technical challenge, particularly for larger tumors.\n\nCURTIS (Urotech GmbH) is a CE-marked retrieval device consisting of a hydrophilic-coated bag that can be opened and closed via a handpiece, enabling controlled capture and safe transurethral extraction of the resected tumor specimen.\n\nThis study aims to evaluate the technical feasibility of CURTIS-assisted intact specimen retrieval following en bloc transurethral resection of primary NMIBC. The central question the study seeks to answer is: in what proportion of cases can CURTIS successfully retrieve an intact en bloc resected bladder tumor, and what is the maximum tumor size for which intact retrieval remains feasible?",[32,330],"Bladder Cancer TNM Staging Primary Tumor (T) T1",[332,333,334,335,336,337],"bladder cancer","urothelial cell cancer","en-bloc","retrieval","transurethral resection of bladder tumor","TUR-BT","NOT_YET_RECRUITING","2026-08-13",{"date":313,"type":43},{"date":342,"type":22},"2026-09-01",{"date":344,"type":22},"2027-03-31",{"name":346,"class":50},"Ludwig-Maximilians - University of Munich",9,{"id":349,"slug":350,"hasResults":12,"nctId":351,"briefTitle":352,"officialTitle":353,"acronym":354,"eligibilityCriteria":355,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":356,"targetDuration":4,"studyType":23,"phases":358,"briefSummary":359,"conditions":360,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":339,"lastUpdatePostDateStruct":361,"startDateStruct":362,"completionDateStruct":364,"leadSponsor":366,"locationsCount":368},"100625181","phase-3-a-clinical-trial-of-sacituzumab-tirumotecan-sac-tmt-mk-2870-to-treat-urothelial-cancer-mk-2870-031-100625181","NCT07419295","A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) to Treat Urothelial Cancer (MK-2870-031)","A Phase 3, Randomized, Open-label Study of Sacituzumab Tirumotecan (MK-2870) Versus Investigator's Choice of Non-platinum Chemotherapy in Participants With Pretreated Locally Advanced\u002FMetastatic Urothelial Carcinoma","TroFuse-031","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has histologically documented locally advanced\u002Fmetastatic urothelial cancer. Locally advanced disease must not be amenable to resection or radiation with curative intent per investigator assessment\n* Has measurable disease per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) as assessed by the investigator\n* Has received treatment with anti-programmed cell death \\[ligand\\] 1 (anti-PD-\\[L\\]1) therapy, platinum-based chemotherapy, and enfortumab vedotin (EV)\n* Prior therapy with disitamab vedotin (DV) is allowed but will not meet the requirement for prior treatment with EV, except in China, where participants may have received DV instead of EV before study entry\n* Has received a maximum of 2 prior lines of therapy\n* Has experienced radiographic disease progression on or after the immediate prior line of therapy before study entry\n* Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed within 7 days of randomization\n* Is eligible to receive at least one of the control arm nonplatinum chemotherapy options (paclitaxel, docetaxel, or vinflunine)\n* Is able to provide archival tumor tissue sample or newly obtained biopsy of a tumor lesion not previously irradiated\n* If human immunodeficiency virus (HIV) positive, has well-controlled HIV on antiretroviral therapy (ART)\n* If hepatitis B surface antigen (HBsAg) positive, has received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and has undetectable HBV viral load\n* If history of hepatitis C virus (HCV) infection, has undetectable HCV viral load\n* Has adequate organ function\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has history of documented severe dry eye syndrome, severe Meibomian gland disease and\u002For blepharitis, or severe corneal disease that prevents\u002Fdelays corneal healing\n* Has uncontrolled, significant cardiovascular disease or cerebrovascular disease\n* Has a history of (noninfectious) interstitial lung disease (ILD)\u002Fpneumonitis that required steroids, has current ILD\u002Fpneumonitis, or has suspected ILD or pneumonitis that cannot be ruled out by standard diagnostic assessments at Screening\n* HIV-infected participants with a history of Kaposi's sarcoma and\u002For Multicentric Castleman's Disease\n* Has received prior systemic anticancer therapy within 4 weeks or 5 half-lives (whichever is shorter) and has not recovered to grade ≤ 1 or baseline from adverse event (AE) associated with anticancer therapy\n* Has received prior therapy with trophoblast cell-surface antigen 2 (TROP2)-targeted antibody drug conjugate (ADC)\n* Has received prior therapy with a topoisomerase 1 inhibitor-containing ADC\n* Has completed prior external radiotherapy within 6 weeks or stereotactic radiotherapy within 4 weeks of start of study intervention, or has radiation related toxicities, requiring corticosteroids\n* Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed\n* Has received prior chemotherapy for urothelial cancer with any of the study therapies in the control arm (paclitaxel, docetaxel, and vinflunine)\n* Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention\n* Has a known additional malignancy that is progressing or has required active treatment within the past 3 years\n* Has a current or past history of central nervous system (CNS) metastases and\u002For carcinomatous meningitis\n* Has an active infection requiring systemic therapy other than those permitted per protocol\n* Has a history of stem cell\u002Fsolid organ transplant\n* Has not adequately recovered from major surgery, or has ongoing surgical complications",{"count":357,"type":22},590,[159],"Researchers are looking for new ways to treat locally advanced or metastatic urothelial cancer (UC). Current treatments for locally advanced or metastatic UC include chemotherapy, immunotherapy, and targeted therapy.\n\nResearchers want to know if giving sacituzumab tirumotecan (sac-TMT), the trial medicine, can treat locally advanced or metastatic UC that got worse after certain treatments. The goal of this trial is to learn if people who receive sac-TMT live longer than those who receive certain non-platinum chemotherapies.",[32],{"date":280,"type":43},{"date":363,"type":43},"2026-04-23",{"date":365,"type":22},"2030-04-23",{"name":367,"class":125},"Merck Sharp & Dohme LLC",80,{"id":370,"slug":371,"hasResults":12,"nctId":372,"briefTitle":373,"officialTitle":374,"acronym":4,"eligibilityCriteria":375,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":376,"targetDuration":4,"studyType":23,"phases":378,"briefSummary":379,"conditions":380,"keywords":383,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":339,"lastUpdatePostDateStruct":386,"startDateStruct":387,"completionDateStruct":389,"leadSponsor":391,"locationsCount":393},"100607367","guiding-value-of-urinary-tumor-dna-testing-in-repeat-transurethral-resection-of-non-muscle-invasive-bladder-cancer-100607367","NCT07187635","Guiding Value of Urinary Tumor DNA Testing in Repeat Transurethral Resection of Non-Muscle-Invasive Bladder Cancer","The Guiding Value of Urinary Tumor DNA Testing in Repeat Transurethral Resection of Non-Muscle-Invasive Bladder Cancer: An Open-Label, Randomized Controlled, Multi-Center Clinical Study (Truce-LB01)","Inclusion Criteria:\n\nParticipants must meet all of the following criteria to be eligible for the study:\n\n1. Male or female, aged 18 years or older.\n2. Histologically confirmed non-muscle-invasive bladder tumor, with no evidence of muscle-invasive bladder cancer or metastatic disease.\n3. Histologically confirmed urothelial carcinoma of the bladder or bladder tumor with urothelial carcinoma as the predominant component (\\>50%).\n4. At least one of the following conditions:\n\n   1. Incomplete initial transurethral resection of bladder tumor (TURBT) or suspected incomplete resection.\n   2. Absence of detrusor muscle in the initial TURBT pathological specimen (except for low-grade Ta stage tumors or carcinoma in situ \\[CIS\\]).\n   3. T1 stage tumor.\n5. Willingness to provide a 50 mL urine sample between 2-6 weeks after the initial TURBT and prior to re-TURBT.\n6. Willingness to provide tumor tissue samples for pathological examination.\n7. Willingness to undergo genetic testing required for the trial.\n\nExclusion Criteria:\n\n1. Contraindications to transurethral resection of bladder tumor (TURBT).\n2. Concurrent malignancy of the upper urinary tract (ureter or renal pelvis).",{"count":377,"type":22},196,[25],"Non-muscle-invasive bladder cancer (NMIBC) accounts for approximately 75% of newly diagnosed bladder cancers and is characterized by a high risk of recurrence and progression. Current guidelines recommend that patients with stage T1 NMIBC undergo a second transurethral resection of bladder tumor (re-TURBT) within 2-6 weeks after the initial surgery to remove residual tumor, confirm staging, and obtain additional pathological information. However, the benefits of routine re-TURBT for all high-risk patients remain controversial, as many patients may not have residual disease, while the procedure carries surgical and anesthetic risks, physical and psychological burden, and additional healthcare costs.\n\nUrine tumor DNA (utDNA) refers to DNA fragments shed by tumor cells into urine. It can be detected using molecular assays with high sensitivity and specificity, offering a non-invasive method for bladder cancer diagnosis and surveillance. Previous studies have shown that positive utDNA results after initial TURBT may be associated with residual disease and higher recurrence risk.\n\nThis multicenter, randomized controlled trial aims to evaluate whether utDNA testing can accurately identify NMIBC patients who are most likely to benefit from re-TURBT, thereby guiding the decision to perform the procedure. The goal is to optimize patient selection for re-TURBT, reduce unnecessary surgeries, and improve patient quality of life while maintaining oncologic safety.",[32,381,382],"Liquid Biopsy","Repeat Transurethral Resection of Bladder Tumor",[332,384,385],"liquid biopsy","second transurethral resection of bladder tumor",{"date":280,"type":43},{"date":388,"type":43},"2025-09-28",{"date":390,"type":22},"2027-11-01",{"name":392,"class":50},"Tianjin Medical University Second Hospital",7,{"id":395,"slug":396,"hasResults":12,"nctId":397,"briefTitle":398,"officialTitle":398,"acronym":399,"eligibilityCriteria":400,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":401,"targetDuration":4,"studyType":184,"phases":4,"briefSummary":403,"conditions":404,"keywords":406,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":409,"lastUpdatePostDateStruct":410,"startDateStruct":411,"completionDateStruct":413,"leadSponsor":415,"locationsCount":417},"100604038","exploration-of-novel-ai-enabled-blue-light-enhanced-cystoscopy-100604038","NCT07144319","Exploration of Novel AI-enabled Blue Light Enhanced Cystoscopy","ENAiBLE","Inclusion Criteria:\n\n* Age 18 or older\n* Written informed consent, approved by relevant IRB\u002FIEC, signed\n* Hexvix\u002FCysview has been prescribed in the usual manner in accordance with the terms of the marketing authorization (see Appendix B)\n* Physician has planned to do a blue light cystoscopy on the patient and to obtain biopsies, if clinically indicated, of suspicious lesions with video confirmation.\n* Patient has not previously taken part in this study\n\nExclusion Criteria:\n\n* None",{"count":402,"type":22},500,"Blue light cystoscopy (BLC) is a diagnostic procedure in bladder cancer where the inside of the bladder is observed with a camera to detect bladder lesions. Unlike regular white light cystoscopy, blue light cystoscopy makes use of a drug that induces fluorescence under blue light preferentially in neoplastic and malignant cells that helps visualize bladder lesions during the cystoscopic procedure. Blue light cystoscopy has shown to improve detection of bladder cancer.\n\nCystoscopy, including blue light cystoscopy, is a procedure involving assessment of the visual appearance of the bladder surface, leading to decisions of taking biopsies, remove suspicious areas and assign treatment options. The assessment is subjective and has a large operator variability. These shortcomings show an opportunity for computer aided detection (CADe) medical device to add value to both clinicians and patients.\n\nThe objective of this data collection study is to build a high-quality, diverse data set of video, image recordings and relevant clinical data from BLC procedures performed as part of routine clinical practice to train a computer-aided detection (CADe) algorithm for real- time lesion detection during cystoscopy. The data will be used to support the training, non-clinical technical development and testing of such AI algorithms for use during cystoscopy and to provide documentation needed for training of such algorithms and to assist in guiding future validation of such algorithms.\n\nExploratory purposes of the study is to use data to explore future AI algorithms in bladder cancer, such as computer-aided diagnosis (CADx) AI algorithms, image enhancement and cystoscopy improvement algorithms, including bladder mapping, tumor visualization, cystoscopy documentation, and combination models of image and clinical data including risk assessment, clinical outcomes, and disease modeling",[32,405],"Non-muscle Invasive Bladder Cancer",[332,407,408],"artificial intelligence","cystoscopy","2026-08-12",{"date":280,"type":43},{"date":412,"type":43},"2026-03-25",{"date":414,"type":22},"2027-12",{"name":416,"class":125},"Photocure",5,{"id":419,"slug":420,"hasResults":12,"nctId":421,"briefTitle":422,"officialTitle":423,"acronym":4,"eligibilityCriteria":424,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":425,"targetDuration":4,"studyType":23,"phases":427,"briefSummary":428,"conditions":429,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":444,"lastUpdatePostDateStruct":445,"startDateStruct":447,"completionDateStruct":449,"leadSponsor":451,"locationsCount":453},"100534718","phase-1-a-study-of-mgc026-in-participants-with-advanced-solid-tumors-100534718","NCT06242470","A Study of MGC026 in Participants With Advanced Solid Tumors","A Phase 1\u002F1b First-in-Human, Open Label, Dose Escalation and Cohort Expansion Study of MGC026 in Participants With Advanced Solid Tumors","Inclusion Criteria:\n\n* Adults ≥ 18 years old, able to provide informed consent\n* Adequate performance and laboratory parameters\n* Availability of archival or formalin-fixed paraffin-embedded tumor tissue sample. Participants may undergo a fresh tumor biopsy to obtain a specimen for testing if an archival tumor sample is not available. Participants with no available archival tissue sample who cannot safely undergo a fresh biopsy as determined by consultation between the sponsor and investigator are eligible\n* Unresectable, locally advanced or metastatic solid tumors including: squamous cell cancer (SCC) of the head and neck, esophageal SCC, squamous and non-squamous non-small cell lung cancer, small cell lung cancer, bladder cancer, sarcoma, endometrial cancer, melanoma, castration resistant prostate cancer, breast cancer, ovarian cancer, cervical cancer, colorectal cancer gastric or gastroesophageal cancer, pancreatic carcinoma, clear cell renal cell cancer or hepatocellular cancer.\n* Measurable disease per RECIST v1.1. Participants with metastatic CRPC without measurable disease are eligible.\n* Must be willing to use highly effective methods of birth control from the time of consent through 7 months after discontinuation of MGC026.\n* Not pregnant or breastfeeding.\n\nExclusion Criteria:\n\n* Any underlying medical or psychiatric condition impairing participant's ability to receive, tolerate, or comply with the planned treatment or study procedures.\n* Another cancer that required treatment within the past 2 years, with the exception of those with low risk of cancer spreading or death such as adequately treated non melanomatous skin cancer, localized prostate cancer (Gleason Score \\\u003C 6), or carcinoma in situ.\n* Patients with history of prior central nervous system (CNS) metastasis must have been treated, be asymptomatic, and not have concurrent treatment for CNS disease, progression of CNS metastases on magnetic resonance imaging, computed tomography or positron emission tomography, or history of leptomeningeal disease or cord compression at the time of enrollment.\n* Treatment with surgery, systemic cancer therapy, immunotherapy, chimeric antigen receptor-T therapy, or anti-hormonal within protocol specified intervals.\n* Prior treatment with any B7-H3 targeted agent for cancer or any ADC with a topoisomerase payload.\n* Prior autologous or allogeneic stem cell or solid organ transplant.\n* Clinically significant cardiovascular, pulmonary, or gastrointestinal disorders.\n* Active viral, bacterial, or systemic fungal infection requiring parenteral treatment within 1 week of first study drug administration.\n* Known history of hepatitis B or C infection or known positive test for hepatitis B surface antigen or core antigen, or hepatitis C polymerase chain reaction.\n* Known positive testing for human immunodeficiency virus or history of acquired immune deficiency syndrome.\n* History of primary immunodeficiency.\n* Major trauma or major surgery within 4 weeks of first study drug administration.\n* Known hypersensitivity to recombinant proteins.",{"count":426,"type":22},250,[257],"The study is designed to understand the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor activity of MGC026 in participants with relapsed or refractory, unresectable, locally advanced or metastatic solid tumors The study has a dose escalation portion and a cohort expansion portion of the study.\n\nParticipants will receive MGC026 by intravenous (IV) infusion. The dose of MGC026 will be assigned at the time of enrollment. Participants may receive up to 35 treatments if there are no severe side effects and as long as the cancer does not get worse. Participants will be monitored for side effects, and progression of cancer, have blood samples collected for routing laboratory work, and blood samples collected for research purposes.",[98,430,431,432,433,434,32,435,68,99,436,66,67,101,437,438,439,440,441,65,442,443],"Advanced Cancer","Metastatic Cancer","Squamous Cell Carcinoma of Head and Neck","Non Small Cell Lung Cancer","Small-cell Lung Cancer","Sarcoma","Castration Resistant Prostatic Cancer","Gastro-esophageal Cancer","Pancreas Cancer","Clear Cell Renal Cell Carcinoma","Hepatocellular Carcinoma","Platinum-resistant Ovarian Cancer","Ovarian Cancer","Esophageal Squamous Cell Cancer (SCC)","2026-08-10",{"date":446,"type":43},"2026-08-11",{"date":448,"type":43},"2024-03-06",{"date":450,"type":22},"2028-10",{"name":452,"class":125},"MacroGenics",12,{"id":455,"slug":456,"hasResults":12,"nctId":457,"briefTitle":458,"officialTitle":459,"acronym":4,"eligibilityCriteria":460,"healthyVolunteers":296,"sex":18,"minAge":19,"maxAge":182,"enrollmentInfo":461,"targetDuration":4,"studyType":184,"phases":4,"briefSummary":462,"conditions":463,"keywords":466,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":471,"lastUpdatePostDateStruct":472,"startDateStruct":473,"completionDateStruct":475,"leadSponsor":477,"locationsCount":51},"100238234","care-of-the-urothelial-cancer-patient-and-prospective-procurement-of-urothelial-cancer-tissue-100238234","NCT02379429","Care of the Urothelial Cancer Patient and Prospective Procurement of Urothelial Cancer Tissue","Care of the Urothelial Cancer Patient and Prospective Collection of Biospecimens From Healthy Volunteers and Urothelial Cancer Patients","* INCLUSION CRITERIA FOR UROTHELIAL CANCER PARTICIPANTS:\n* Adults (\\>= 18 years of age) with biopsy-proven or suspected urothelial cancer who require and are willing to undergo diagnostic or therapeutic intervention as part of their diagnosis, standard of care treatment, or follow-up\u002Fsurveillance for their neoplasm.\n* ECOG performance status of 0-3.\n* Must be willing and able to provide informed consent.\n\nEXCLUSION CRITERIA:\n\n* Subjects who are pregnant.\n* Subjects co-morbidities preclude diagnostic or therapeutic intervention. Co-morbidities include:\n\n  --Ongoing treatment for another non-skin malignancy.\n* History of hepatitis B\u002FC or HIV. Patients who are HIV positive are excluded from this study because treatment with immunomodulatory agents for immunosuppressed patients would affect sample analysis and skew the data.\n\nELIGIBILITY CRITERIA FOR HEALTHY VOLUNTEERS\n\nINCLUSION CRITERIA:\n\n-Adults (greater than or equal to 18 years of age) and able to give informed consent.\n\nEXCLUSION CRITERIA:\n\n* Subjects who are pregnant.\n* Diagnosis of cancer requiring treatment other than minor resection of basal cell or squamous cell skin cancers.\n* Heart, lung, kidney disease, or other medical conditions as per Principal Investigator discretion.\n* History of acute or chronic hepatitis B\u002FC or HIV infection. Patients who are HIV positive are excluded from this study because treatment with immunomodulatory agents for immunosuppressed patients would affect sample analysis and skew the data.\n* Healthy volunteers who are family members with germline mutations.",{"count":402,"type":22},"Background:\n\nUrothelial cancer is cancer of the bladder, ureter, and urethra. Researchers want to better understand what changes in a person s cells and genes cause this cancer to form. This may help them find new ways to treat it.\n\nObjective:\n\n\\- To perform DNA sequencing to help researchers learn the differences between normal tissue and tumor tissue. Also, to learn how molecular changes - including gene changes - might help predict the course of disease and how people respond to therapy.\n\nEligibility:\n\n\\- Adults age 18 and older who have or are suspected of having urothelial cancer or an inherited disorder that raises their risk of getting bladder cancer.\n\nDesign:\n\n* Participants will be screened with a physical exam. Their medical records and tissue samples will be reviewed.\n* Eligible participants will give tissue blocks of their original tumor. The blocks will be put in a tissue bank.\n* Participants medical records may be reviewed.\n* Participants may have a medical history and physical exam.\n* Participants may have blood and urine tests. They may have imaging scans. They may give urine, blood, and saliva samples. These samples may be used in future research.\n* If participants need surgery for their cancer, researchers will keep some of the tissue (both tumor and normal tissue). The tissue may be used in future research.\n* Participants will go back to the Clinical Center in 6 months. They may give saliva, urine, and blood samples. After 6 months, they will be seen by their local doctor for standard post-surgical visits.\n* Participants will be called every 6 months to give health updates.",[32,464,33,465],"Urinary Tract Cancer","Healthy Volunteers",[467,468,469,470,192],"Specimen Collection","Urine","Blood","Saliva","2026-08-08",{"date":446,"type":43},{"date":474,"type":43},"2015-11-10",{"date":476,"type":22},"2028-01-01",{"name":199,"class":200},{"id":479,"slug":480,"hasResults":12,"nctId":481,"briefTitle":482,"officialTitle":482,"acronym":4,"eligibilityCriteria":483,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":484,"enrollmentInfo":485,"targetDuration":4,"studyType":23,"phases":487,"briefSummary":488,"conditions":489,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":490,"lastUpdatePostDateStruct":491,"startDateStruct":492,"completionDateStruct":494,"leadSponsor":496,"locationsCount":51},"100651591","phase-2-luminal-bladder-cancer-effective-response-to-neoadjuvant-chemotherapy-lumber-nac-100651591","NCT07762586","Luminal Bladder Cancer Effective Response to Neoadjuvant Chemotherapy (LUMBER-NAC)","Inclusion Criteria:\n\n* ▪ Inclusion Criteria\n\n  * Willing and able to provide informed consent\n  * Age ≥18 years old\n  * Eligible to receive standard of care systemic neoadjuvant therapy\n  * Eastern Cooperative Group (ECOG) performance status of 0-1\n  * Documented histologically confirmed urothelial muscle-invasive bladder cancer\n  * cT2N0M0 bladder cancer based on pre-TURBT bimanual exam and cross-sectional imaging performed within 8 weeks of surgery or initiation of NAT.\n  * Willing to undergo RC with urinary diversion\n  * No signs of extravesical disease on pre-TURBT conventional imaging\n  * Variant histology is allowed so long as the tumor is predominantly urothelial carcinoma.\n  * No presence of LVI on TURBT\n  * Decipher Bladder GSC test result\n  * Ineligible for or refusing TMT\n  * No cN+\n  * The population is adult men or women of any ethnicity diagnosed with muscle-invasive bladder cancer.\n\nExclusion Criteria:\n\n* Patients under 18 years old. Considering the minimal incidence of bladder cancer among the pediatric population, children are not eligible for this study.\n* Not willing or unable to give informed consent.\n* Clinical or pathological evidence of metastatic disease, including, non-regional lymph nodes, visceral lesions, and bone lesions.\n* Significant hepatic impairment (Serum bilirubin \\> 1.5x upper limit of normal).\n* Significant renal impairment (creatinine clearance \\\u003C30 ml\u002Fmin).\n* Predominant variant histology (i.e. nested, micropapillary, sarcomatoid, plasmacytoid, small cell)6\n* cT3 bladder cancer on pre-TURBT bimanual exam or with hydronephrosis on cross-sectional imaging performed within 8 weeks of surgery or initiation of NAT\n* TURBT specimen with lymphovascular invasion (LVI) cT4 or unresectable bladder cancer\n* Concurrent diagnoses of other, non-urothelial, malignancies or prior malignancy diagnoses within the past three years. Exceptions, determined at the discretion of the principal investigator, include squamous cell carcinoma, basal cell carcinoma, or other low-grade cancer not expected to progress or require surgical\u002Fsystemic therapy.\n* Prior history of systemic treatment for non-urothelial malignancies in the past three years, including chemotherapy and immunotherapy.\n* Prior diagnosis or evidence of psychiatric or medical conditions that may prevent patients from giving full and properly informed consent.\n* Any medical, familial, psychiatric, or geographic considerations that may prevent patients from study participation or follow-up required by the study protocol\n* Patients (cN+) are excluded from participation and are not eligible for enrollment.\n* Prisoners, Individuals without Decisional Capacity, and Pregnant Women will be excluded.","90 Years",{"count":486,"type":22},60,[95],"This study is a two-arm phase II randomized trial investigating patients with luminal subtype muscle-invasive bladder cancer (MIBC) receiving neoadjuvant therapy (NAT) followed by cystectomy compared to those receiving upfront cystectomy.",[32],"2026-08-07",{"date":339,"type":43},{"date":493,"type":43},"2026-07-10",{"date":495,"type":22},"2029-07",{"name":497,"class":50},"Rutgers, The State University of New Jersey",{"id":499,"slug":500,"hasResults":12,"nctId":501,"briefTitle":502,"officialTitle":503,"acronym":504,"eligibilityCriteria":505,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":506,"targetDuration":4,"studyType":184,"phases":4,"briefSummary":508,"conditions":509,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":490,"lastUpdatePostDateStruct":510,"startDateStruct":511,"completionDateStruct":513,"leadSponsor":515,"locationsCount":21},"100595936","treatment-approaches-and-biomarkers-prevalence-in-bladder-cancer-in-russian-federation-100595936","NCT07038928","TReatment Approaches and bIomarkers preValence in bladdEr Cancer in RuSsian Federation","A Multicentre Observational Study on Treatment Approaches and HER2 Positive Status Prevalence in Different Stages of Bladder Cancer and PD-L1-positive Status in Metastatic Bladder Cancer in Russian Federation","RIVERS","Inclusion Criteria:\n\n* Age ≥ 18 years;\n* Signed ICF, including consent for FFPE tumor tissue sample testing;\n* Confirmed diagnosis of urothelial bladder cancer at NMIBC, MIBC, or mBC stage at study entry;\n* For patients with NMIBC: 1. TURBT performed at least 1 month but not more than 12 months prior to study entry; 2. Presence of ≥1 high-risk feature:\n\n  * T1 tumor\n  * High grade\u002FG3 tumor\n  * CIS (carcinoma in situ)\n  * Multiple and recurrent and large (with diameter of largest tumor ≥3 cm) tumors (all conditions must be met in this point);\n* For patients with MIBC: Сystectomy performed at least 2 months but not more than 12 months prior to study entry;\n* For patients with mBC: mBC diagnosed during 12 months prior to study entry;\n* Availability of medical history data;\n* Availability of FFPE tumour tissue sample obtained during biopsy and\u002For surgery.\n\nExclusion Criteria:\n\n• Participation in any interventional trial since the urothelial bladder cancer diagnosis.",{"count":507,"type":22},600,"A multicentre observational study on treatment approaches and HER2 positive status prevalence in different stages of bladder cancer and PD-L1-positive status in metastatic bladder cancer in Russian Federation",[32],{"date":444,"type":43},{"date":512,"type":43},"2025-06-30",{"date":514,"type":22},"2026-12-31",{"name":516,"class":125},"AstraZeneca",{"id":518,"slug":519,"hasResults":12,"nctId":520,"briefTitle":521,"officialTitle":521,"acronym":4,"eligibilityCriteria":522,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":523,"targetDuration":4,"studyType":184,"phases":4,"briefSummary":525,"conditions":526,"keywords":530,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":490,"lastUpdatePostDateStruct":536,"startDateStruct":537,"completionDateStruct":539,"leadSponsor":541,"locationsCount":51},"100433365","a-multi-center-natural-history-of-urothelial-cancer-and-rare-genitourinary-tract-malignancies-100433365","NCT04923178","A Multi-Center Natural History of Urothelial Cancer and Rare Genitourinary Tract Malignancies","* INCLUSION CRITERIA:\n* Participants must have histologically or cytologically confirmed urothelial or rare genitourinary cancer including but not limited to the following: small cell carcinoma of the bladder; adenocarcinoma of the bladder; squamous cell carcinoma of the bladder; plasmacytoid urothelial carcinoma; any penile cancer; any testicular cancer, sarcomatoid renal cell carcinoma; sarcomatoid urothelial carcinoma; renal medullary carcinoma or other miscellaneous histologic variants of the urothelial carcinoma, such as, but not limited to micropapillary, giant cell, lipid-rich, clear cell and nested variants, large cell neuroendocrine carcinoma, lymphoepithelioma-like carcinoma and mixed patterns will be considered, as well as small cell neuroendocrine prostate cancer, testicular Sertoli or Leydig cell tumors. Any genitourinary cancer can be included at the principal investigator's discretion.\n* Age \\>=18 years.\n* Ability of participant to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n-None",{"count":524,"type":22},1100,"Background:\n\nTumors in the genitourinary tracts can occur in the kidney, bladder, prostate, and testicles and can have common and rare histologies. Some cancers that occur along the genitourinary (GU) tract are rare. Some GU tumors are so rare that they are not included in treatment studies or tissue banks. This makes it hard for researchers to determine standards of care. Researchers want to learn more about common and rare GU tumors.\n\nObjective:\n\nTo learn more about urinary tract cancers.\n\nEligibility:\n\nPeople ages 18 and older with urinary tract or GU cancer such as bladder, kidney, testicular, prostate, penis, or neuroendocrine cancer.\n\nDesign:\n\nParticipants will be screened with questions about their medical history. Their medical records will be reviewed.\n\nParticipants will have a physical exam. They will give blood and urine samples. They will complete a survey about their family cancer history. Clinical photographs will be taken to document skin lesions.\n\nParticipants may have imaging scans of their chest, abdomen, and pelvis. They may have a contrast agent injected into their arm.\n\nParticipants will get recommendations about how to best manage and treat their cancer. They can ask as many questions as they would like.\n\nParticipants will provide existing tumor samples if available. They may have optional tumor biopsies up to twice a year. For needle biopsies, the biopsy area will be numbed and they will get a sedative. A needle will be inserted through their skin to collect a tumor sample. For skin biopsies, their skin will be numbed. A small circle of skin will be removed.\n\nSome blood and tumor samples may be used for genetic tests.\n\nParticipants will have frequent follow-up visits. If they cannot visit NIH, their home doctor will be contacted. They will be followed on this study for life....",[33,32,527,528,529],"Genitourinary Cancer","Urogenital Neoplasms","Urogenital Cancer",[531,532,533,534,535,192],"bladder\u002Furachal adenocarcinoma","renal tumors","penile cancers","small cell neuroendocrine carcinoma of the prostate","Renal Cell Carcinoma",{"date":444,"type":43},{"date":538,"type":43},"2022-10-24",{"date":540,"type":22},"2042-12-01",{"name":199,"class":200},{"id":543,"slug":544,"hasResults":12,"nctId":545,"briefTitle":546,"officialTitle":547,"acronym":4,"eligibilityCriteria":548,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":549,"targetDuration":4,"studyType":23,"phases":551,"briefSummary":552,"conditions":553,"keywords":556,"overallStatus":338,"whyStopped":4,"lastUpdateSubmitDate":561,"lastUpdatePostDateStruct":562,"startDateStruct":563,"completionDateStruct":565,"leadSponsor":567,"locationsCount":51},"100651068","bladder-sparing-treatment-with-disitamab-vedotin-and-toripalimab-with-or-without-pelvic-lymph-node-dissection-in-bladder-cancer-100651068","NCT07756008","Bladder-Sparing Treatment With Disitamab Vedotin and Toripalimab With or Without Pelvic Lymph Node Dissection in Bladder Cancer","A Prospective, Multicenter, Randomized Controlled Study of Disitamab Vedotin Plus Toripalimab With or Without Pelvic Lymph Node Dissection for Bladder-Sparing Treatment in Patients With cT2-3N0M0 Bladder Urothelial Carcinoma","Inclusion Criteria:\n\n1. Male or female participants aged 18 years or older.\n2. Histologically confirmed bladder urothelial carcinoma.\n3. Clinical stage cT2-3N0M0 according to the AJCC 8th edition TNM staging system.\n4. HER2 expression of IHC 2+ or higher.\n5. Participants who decline radical cystectomy as assessed by the investigator.\n6. Adequate organ function as defined in the study protocol.\n7. Ability to understand and willingness to sign written informed consent.\n\nExclusion Criteria:\n\n1. Known allergy or hypersensitivity to disitamab vedotin, toripalimab, their excipients, or other monoclonal antibodies.\n2. Prior radiotherapy for bladder cancer.\n3. Prior anticancer treatment that may affect efficacy assessment, as defined in the study protocol.\n4. Pregnant or breastfeeding women.\n5. Any serious uncontrolled disease or medical condition that, in the investigator's judgment, would make participation inappropriate.\n6. Participation in another interventional clinical trial that may interfere with this study.",{"count":550,"type":22},114,[95,159],"This is a prospective, multicenter, randomized controlled superiority study designed to evaluate whether the addition of pelvic lymph node dissection improves bladder-intact event-free survival in patients with cT2-3N0M0 bladder urothelial carcinoma receiving bladder-sparing treatment. Eligible patients with HER2 expression of IHC 2+ or higher who decline radical cystectomy will be randomized 1:1 to receive maximal transurethral resection of bladder tumor followed by disitamab vedotin plus toripalimab with or without standardized pelvic lymph node dissection. The primary endpoint is the 2-year bladder-intact event-free survival rate. Secondary endpoints include clinical complete response, partial response, disease progression, overall survival, quality of life, safety, treatment cost, and exploratory biomarker analyses.",[554,555,32],"Bladder Urothelial Carcinoma","Muscle-invasive Bladder Cancer",[557,558,559,560],"Bladder-sparing therapy","Disitamab vedotin","Toripalimab","Pelvic lymph node dissection","2026-08-04",{"date":444,"type":43},{"date":564,"type":22},"2026-08-01",{"date":566,"type":22},"2031-06-20",{"name":392,"class":50},{"id":569,"slug":570,"hasResults":12,"nctId":571,"briefTitle":572,"officialTitle":573,"acronym":574,"eligibilityCriteria":575,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":576,"targetDuration":4,"studyType":23,"phases":578,"briefSummary":579,"conditions":580,"keywords":589,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":561,"lastUpdatePostDateStruct":598,"startDateStruct":600,"completionDateStruct":602,"leadSponsor":604,"locationsCount":606},"100551821","phase-1-a-study-of-ly4052031-in-participants-with-advanced-or-metastatic-urothelial-cancer-or-other-solid-tumors-100551821","NCT06465069","A Study of LY4052031 in Participants With Advanced or Metastatic Urothelial Cancer or Other Solid Tumors","A Phase 1a\u002F1b Study of LY4052031, an Antibody-Drug Conjugate Targeting Nectin-4, in Participants With Advanced or Metastatic Urothelial Carcinoma or Other Solid Tumors","NEXUS-01","Inclusion Criteria:\n\n* Have one of the following solid tumor cancers:\n\n  * Cohort A1: urothelial carcinoma, triple negative breast cancer, non-small cell lung cancer, esophageal cancer, pancreatic cancer, ovarian cancer, cervical cancer (squamous cell carcinoma), head and neck squamous cell carcinoma or prostate cancer\n  * Cohort A2\u002FB1\u002FB2: urothelial carcinoma\n  * Cohort C: triple negative breast cancer, non-small cell lung cancer, ovarian cancer, cervical cancer, HNSCC (head and neck squamous cell carcinoma), esophageal cancer, pancreatic cancer, or prostate cancer\n* Prior Systemic Therapy Criteria:\n\n  * Cohort A1\u002FC: Individual has received all standard therapies for which the participant was deemed to be an appropriate candidate by the treating investigator; OR there is no standard therapy available for the disease. There is no restriction on number of prior therapies\n  * Cohort A2\u002FB1\u002FB2: Individual must have received at least one prior regimen in the advanced or metastatic setting. There is no restriction on number of prior therapies.\n* Prior enfortumab vedotin specific requirements:\n\n  * Cohorts A1\u002FA2\u002FC: prior treatment with enfortumab vedotin is allowed, but not required\n  * Cohort B1: individual must be enfortumab vedotin naive in the advanced\u002Fmetastatic setting\n  * Cohort B2: individual must have received enfortumab vedotin in the metastatic\u002Fadvanced setting.\n* Measurability of disease\n\n  * Cohort A1: measurable or non-measurable disease as defined by Response Evaluation Criteria in Solid Tumors v1.1 (RECIST 1.1)\n  * Measurable disease is required as defined by Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1) for all Cohorts. Cohort A1 may permit non-measurable disease as defined by RECIST v1.1\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Have adequate archival tumor tissue sample available or undergo a screening biopsy if allowed per country specific regulations\n\nExclusion Criteria:\n\n* Individual with known or suspected uncontrolled CNS metastases\n* Individual with uncontrolled hypercalcemia\n* Individual with uncontrolled diabetes\n* Individual with evidence of corneal keratopathy or keratitis, and history of corneal transplant\n* Any serious unresolved toxicities from prior therapy\n* Significant cardiovascular disease\n* Recent thromboembolic event and\u002For clinically significant bleeding disorder\n* Prolongation of QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥ 470 ms\n* History of pneumonitis\u002Finterstitial lung disease\n* History of Grade ≥3 skin toxicity when receiving enfortumab vedotin\n* Individuals who are pregnant, breastfeeding or plan to breastfeed during study or within 30 days of last dose of study intervention",{"count":577,"type":22},420,[257],"The purpose of this study is to find out whether the study drug, LY4052031, is safe, tolerable and effective in participants with advanced, or metastatic solid tumors including urothelial cancer. The study is conducted in two parts - phase Ia (dose-escalation, dose-optimization) and phase Ib (dose-expansion). The study will last up to approximately 4 years.",[581,582,98,583,584,585,103,586,442,66,587,70,588,32],"Metastatic Solid Tumor","Recurrent Solid Tumor","Urinary Bladder Neoplasm","Triple Negative Breast Cancer","Non-small Cell Lung Cancer","Pancreatic Cancer","Head and Neck Squamous Cell Carcinoma","Renal Pelvis Cancer",[32,590,554,591,464,592,588,593,594,595,596,105,597],"Bladder Neoplasm","Urinary Bladder Cancer","Urothelial Neoplasms","Ureter Cancer","Nectin-4","Antibody Drug Conjugate (ADC)","Triple Negative Breast Cancer (TNBC)","Head and Neck Squamous Cell Carcinoma (HNSCC)",{"date":599,"type":43},"2026-08-05",{"date":601,"type":43},"2024-07-01",{"date":603,"type":22},"2027-05",{"name":605,"class":125},"Eli Lilly and Company",39,{"id":608,"slug":609,"hasResults":12,"nctId":610,"briefTitle":611,"officialTitle":612,"acronym":4,"eligibilityCriteria":613,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":614,"targetDuration":4,"studyType":23,"phases":616,"briefSummary":617,"conditions":618,"keywords":630,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":646,"lastUpdatePostDateStruct":647,"startDateStruct":648,"completionDateStruct":650,"leadSponsor":652,"locationsCount":654},"100614270","phase-1-a-study-of-ide892-as-monotherapy-and-combination-in-mtap-deleted-advanced-solid-tumors-100614270","NCT07277413","A Study of IDE892 as Monotherapy and Combination in MTAP-deleted Advanced Solid Tumors","A Multicenter Study Evaluating the Safety, Efficacy, and Pharmacokinetics of IDE892 as Monotherapy and Combination Therapy in Participants With MTAP-Deleted Advanced Solid Tumors","Inclusion Criteria:\n\n* Are ≥ 18 years of age (or the minimum age of consent in accordance with local regulations) at the time of signing the ICF.\n* Have a histologically confirmed diagnosis of a locally advanced recurrent or metastatic solid tumor type of interest with MTAP deletion (for dose escalation: mesothelioma \\[pleural or peritoneal\\], gastroesophageal cancers \\[squamous and adenocarcinoma of esophagus, gastric adenocarcinoma, gastroesophageal junction cancers\\], pancreatic adenocarcinoma and biliary tract carcinomas (intrahepatic and extrahepatic cholangiocarcinoma, and gallbladder cancer), NSCLC \\[adenocarcinoma, squamous cell carcinoma, and adeno-squamous\\] or UC \\[including mixed urothelial-squamous histology\\]; for dose expansion: NSCLC that has progressed on at least one prior line of treatment and for which additional effective standard therapy is not available or for which the participant is not a candidate due to intolerance).\n* Are willing and able to provide blood\u002Ftumor tissue samples for biomarker testing. An archival tumor tissue specimen must be provided for central confirmation of MTAP loss.\n* Must be willing and able to provide the blood\u002Fserum\u002Fplasma samples\n* Have evidence of homozygous loss of MTAP or MTAP deletion (pre-screening available after signing pre-screening ICF)\n* Have at least 1 measurable lesion according to RECIST version 1.1\n* Have Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1\n* Have life expectancy \\> 3 months\n* Have adequate bone marrow and organ function\n* Able to swallow and retain orally administered study drug\u002FIMP.\n* Are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures\n* Male and female: willing to use contraception\n\nExclusion Criteria:\n\n* Known symptomatic brain metastases requiring supraphysiologic doses of systemic corticosteroids\n* Have a known primary central nervous system (CNS) malignancy\n* Have had other malignancies within 2 years prior to the first dose, with some exceptions\n* Impaired cardiac function or clinically significant cardiac diseases\n* Have presence of uncontrolled pleural, peritoneal, or pericardial effusion within 2 weeks before the first study dose, requiring recurrent drainage procedures or an indwelling drainage catheter\n* Have a history of severe infections within 4 weeks prior to the start of study treatment\n* Hypertension (e.g., \\> 150\u002F100 mmHg) that cannot be controlled by medications despite optimal medical therapy\n* Other acute or chronic medical or psychiatric condition\n* Have a history of immunodeficiency, with a positive human immunodeficiency virus(HIV) test at screening\n* Known or suspected viral hepatitis with a positive test at screening\n* Had an adverse reaction to a previous antitumor treatment that has not recovered to CTCAE Grade ≤ 1\n* Have received chemotherapy within 4 weeks of the first dose of IMP; immunotherapy or biologic targeted antitumor treatments within 2 weeks before the first dose of IMP; small molecule inhibitors within 2 weeks before the first dose of IMP, or other investigational products within 4 weeks\n* Current radiation-related toxicity or radiation therapy within 2 weeks before the first dose of IMP\n* Administration of any of the following within 2 weeks before the first dose of IDE892 as a monotherapy: Strong inhibitors or inducers of cytochrome P450, Strong inhibitors of P-glycoprotein, Narrow therapeutic index and sensitive substrates of multidrug and toxin extrusion (MATE)1 and MATE2-K, Narrow therapeutic index and sensitive substrates of P-gp and breast cancer resistance protein\n* Administration of any of the following within 2 weeks before the first dose of IDE892: Strong inhibitors or inducers of CYP3A4\u002F5, Strong inhibitors of P-gp and\u002For BCRP, Narrow therapeutic index and sensitive substrates of MATE1 and MATE2-K, Narrow therapeutic index and sensitive substrates of P-gp and BCRP\n* Use of proton pump inhibitors (PPIs) within 7 days prior to the first dose of IMP or planned use during the study\n* Use of drugs with known risk for QT prolongation within 2 weeks prior to the first dose of IDE892\n* Previous treatment with a Amethionine adenosyltransferase 2A (MAT2A) inhibitor and\u002For Protein arginine N-methyltransferase (PRMT) inhibitor\n* Major surgery within 4 weeks before study entry\n* Prior irradiation to \\> 25% of the bone marrow\n* Known or suspected hypersensitivity to IDE892\n\nDisease-Specific Eligibility Criteria Eligibility Criteria for Participants with NSCLC (All Parts)\n\n* Must have histologically confirmed diagnosis of advanced or metastatic NSCLC that has progressed after prior treatment with platinum chemotherapy and a PD-1\u002FPD-L1 inhibitor (unless contraindicated or participant developed intolerance) in the metastatic setting\n* Treatment with no more than 3 prior lines in the setting of advanced or metastatic disease.\n* If considered standard of care and available, participants whose cancers have proven targetable oncogene alterations must have had disease progression on (unless contraindicated or participant developed intolerance) at least 1 prior line containing appropriate targeted therapy.\n\nEligibility Criteria for Participants with Urothelial Cancer (Bladder and Upper Urinary Tract), Mesothelioma (Pleural or Peritoneal), Pancreatic Adenocarcinoma or Biliary Tract Carcinomas (Intrahepatic and Extrahepatic Cholangiocarcinoma, and Gallbladder Cancer) (Parts 1 and 3)\n\n* Must have histologically confirmed diagnosis of advanced or metastatic UC, mesothelioma, gastroesophageal cancer or pancreatic and biliary tract tumors\n* Must have progressed following at least 1 prior line of therapy\n* Treatment with no more than 3 prior lines in the setting of advanced or metastatic disease",{"count":615,"type":22},260,[257],"This is a multicenter clinical study to evaluate the safety, efficacy, and Pharmacokinetics (PK) of IDE892 as monotherapy and in combination with other agents including IDE397 in participants with methylthioadenosine phosphorylase (MTAP)-deleted advanced solid tumors within indications of interest.",[619,620,621,622,623,624,32,625,626,627,628,586,629],"NSCLC Adenocarcinoma","Gastroesophageal Cancer (GC)","Gastric Adenocarcinoma","Adenocarcinoma of Esophagus","Squamous Cell Car. - Esophagus","Urothelial Carcinoma (UC)","Mesothelioma","Pleural Mesothelioma","Peritoneal Mesothelioma","Non-Small Cell Lung Cancer NSCLC","Biliary Tract Carcinoma",[631,632,633,634,635,636,637,638,639,640,641,642,643,644,645],"MTAP deletion","MTAP loss","MTAP-deficient tumors","homozygous MTAP loss","IDE892","IDE397","MAT2A inhibitor","PRMT5","advanced solid tumors","metastatic cancer","recurrent cancer","dose escalation","dose expansion","phase 1 clinical trial","ctDNA","2026-08-03",{"date":599,"type":43},{"date":649,"type":43},"2026-03-04",{"date":651,"type":22},"2028-04-30",{"name":653,"class":125},"IDEAYA Biosciences",17,{"id":656,"slug":657,"hasResults":12,"nctId":658,"briefTitle":659,"officialTitle":660,"acronym":4,"eligibilityCriteria":661,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":662,"targetDuration":4,"studyType":23,"phases":664,"briefSummary":665,"conditions":666,"keywords":670,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":646,"lastUpdatePostDateStruct":675,"startDateStruct":676,"completionDateStruct":678,"leadSponsor":680,"locationsCount":417},"100586075","phase-1-idov-immune-for-advanced-solid-tumors-100586075","NCT06910657","IDOV-Immune for Advanced Solid Tumors","A First-in-human, Phase I, Multi-center, Open-label, Dose-escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Evidence of Antitumor Activity of IDOV-Immune in Adult Participants With Advanced Solid Tumors","Key Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Histologically or cytologically confirmed advanced solid tumors that have progressed despite standard therapy, or for which no standard therapy exists.\n* ECOG performance status ≤ 1.\n* Measurable disease per RECIST v1.1.\n* Adequate organ and bone marrow function.\n* At least 28 days since major surgery, prior immunotherapy, or radiotherapy (with exceptions for minor procedures).\n* Negative pregnancy test for women of childbearing potential.\n* Agreement to use effective contraception during treatment and for 3 months after.\n* Ability to provide informed consent and comply with study requirements.\n\nKey Exclusion Criteria:\n\n* Prior treatment with an oncolytic virus.\n* Active or recent vaccinia virus infection or smallpox\u002Fmonkeypox vaccination within 10 years.\n* Active uncontrolled infection requiring systemic treatment.\n* History of hepatitis B, hepatitis C, or HIV (unless meeting protocol-specific criteria).\n* Unresolved ≥ Grade 2 toxicities from prior therapies (except hair loss or stable chronic conditions).\n* Active or symptomatic autoimmune disease requiring systemic therapy.\n* Active or untreated CNS metastases (unless stable per protocol).\n* Significant cardiac disease (e.g., NYHA Class III\u002FIV heart failure).\n* Interstitial lung disease or prior pneumonitis requiring steroids.\n* Conditions requiring chronic immunosuppressive therapy.\n* Severe skin disorders or history of pancreatitis.\n* Bleeding disorders or history of recent serious thromboembolic events.\n* Any medical or psychiatric condition that could interfere with study participation.",{"count":663,"type":22},78,[257],"This is a Phase I clinical trial evaluating an investigational treatment called IDOV-Immune, a type of oncolytic virus therapy, for adults with advanced solid tumors that have not responded to standard treatments. Oncolytic viruses are designed to infect and destroy cancer cells and have the potential to stimulate the immune system to fight the tumor.\n\nThe purpose of this study is to determine the safety of IDOV-Immune, how well it is tolerated, and to identify the highest dose that can be safely given. Researchers will also study how the drug behaves in the body, how the immune system responds to it, and whether it shows any signs of shrinking tumors.\n\nParticipants will receive a single intravenous (IV) infusion of IDOV-Immune and will be closely monitored for side effects and any changes in their cancer.\n\nThis study is being conducted at multiple sites in the United States and Australia.",[67,586,99,442,101,103,440,535,65,435,32,69,70,667,668,669],"Cervical Cancers","Head and Neck Cancers","Adrenal Gland Tumors",[671,672,431,673,240,674],"Oncolytic Virus Therapy","Advanced Solid Tumors","Refractory Cancer","Vaccinia Virus",{"date":599,"type":43},{"date":677,"type":43},"2025-08-25",{"date":679,"type":22},"2027-05-31",{"name":681,"class":125},"ViroMissile, Inc.",{"id":683,"slug":684,"hasResults":12,"nctId":685,"briefTitle":686,"officialTitle":687,"acronym":4,"eligibilityCriteria":688,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":689,"targetDuration":4,"studyType":23,"phases":691,"briefSummary":692,"conditions":693,"keywords":695,"overallStatus":338,"whyStopped":4,"lastUpdateSubmitDate":699,"lastUpdatePostDateStruct":700,"startDateStruct":702,"completionDateStruct":703,"leadSponsor":705,"locationsCount":417},"100650602","active-surveillance-versus-adjuvant-intravesical-chemotherapy-in-liquid-biopsy-defined-low-shedding-intermediate-risk-nmibc-100650602","NCT07749924","Active Surveillance Versus Adjuvant Intravesical Chemotherapy in Liquid Biopsy-Defined Low-Shedding Intermediate-Risk NMIBC","A Prospective, Multicenter, Randomized, Open-Label, Non-Inferiority Trial of Active Surveillance Versus Adjuvant Intravesical Chemotherapy After Complete Transurethral Resection in Patients With Preoperative Liquid Biopsy-Negative, Intermediate-Risk Non-Muscle-Invasive Bladder Cancer","Inclusion Criteria:\n\n1. Age ≥18 years.\n2. Histologically confirmed urothelial carcinoma of the urinary bladder, including tumors with divergent differentiation, provided that the urothelial carcinoma component accounts for \\>50% of the tumor\n3. Non-muscle-invasive bladder cancer classified as intermediate-risk according to the 2021 European Association of Urology (EAU) NMIBC prognostic risk-group definition. Intermediate-risk disease is defined as NMIBC without concomitant carcinoma in situ that does not meet the criteria for the EAU low-, high-, or very-high-risk groups.\n4. Complete transurethral resection of all visible bladder tumors performed within 6 weeks before randomization, with no macroscopically visible residual disease.\n5. Negative multi-urinary liquid biopsy results after complete TURBT and before randomization.\n6. Eastern Cooperative Oncology Group performance status of 0-2.\n7. Adequate clinical condition to undergo protocol-specified intravesical therapy, cystoscopic surveillance, and study-related procedures.\n8. Ability to understand the study requirements and provide written informed consent.\n\nExclusion Criteria:\n\n1. EAU low-risk, high-risk, or very-high-risk NMIBC.\n2. Any current or previous concomitant carcinoma in situ associated with the qualifying tumor episode.\n3. Muscle-invasive bladder cancer, locally advanced urothelial carcinoma, lymph-node involvement, or metastatic urothelial carcinoma.\n\n   Incomplete TURBT, macroscopically visible residual tumor, or inability to achieve complete endoscopic resection before randomization.\n4. Urothelial carcinoma involving the prostatic stroma or prostatic ducts, or carcinoma in situ of the prostatic urethra.\n5. Severe lower urinary tract dysfunction, bladder capacity considered insufficient for intravesical treatment, or another clinically significant urological condition that may interfere with treatment or outcome assessment.\n6. Another active malignancy requiring systemic treatment or likely to interfere with the assessment of study endpoints, except adequately treated non-melanoma skin cancer, localized prostate cancer under surveillance, or another malignancy with a negligible risk of recurrence, as determined by the investigator.\n7. Pregnant or breastfeeding women.\n8. Any serious uncontrolled medical, psychiatric, or social condition that, in the investigator's judgment, would compromise participant safety, protocol adherence, or interpretation of study results.",{"count":690,"type":22},670,[25],"This study will evaluate whether adjuvant intravesical chemotherapy can be safely omitted under active surveillance after complete transurethral resection in selected patients with EAU intermediate-risk non-muscle-invasive bladder cancer.\n\nPatients with intermediate-risk non-muscle-invasive bladder cancer are commonly treated with transurethral resection followed by adjuvant intravesical chemotherapy to reduce the risk of recurrence. However, not all patients may derive the same benefit from additional intravesical treatment. Some tumors may have a low-shedding phenotype, meaning that they show no detectable tumor-associated signals in urine despite the presence of visible bladder tumors.\n\nIn this study, preoperative urine-based liquid biopsy will be used to identify patients with a low-shedding profile. This profile is defined by negative results across urine cytology, NMP22, urinary DNA methylation, and urinary tumor DNA testing before transurethral resection.\n\nEligible patients with EAU intermediate-risk non-muscle-invasive bladder cancer, a negative preoperative urine-based liquid biopsy profile, and complete tumor resection will be randomly assigned to active surveillance or standard adjuvant intravesical chemotherapy. The study will compare recurrence-free survival between the two groups and assess whether active surveillance can avoid immediate intravesical chemotherapy without compromising oncologic safety. Secondary outcomes will include high-grade recurrence, disease progression, need for subsequent bladder cancer treatment, safety, patient-reported outcomes.",[32,694],"Non-Muscle-Invasive Bladder Cancer (NMIBC)",[696,697,698],"Non-muscle-invasive bladder cancer (NMIBC)","Active surveillance","Liquid biopsy","2026-08-02",{"date":701,"type":43},"2026-08-06",{"date":444,"type":22},{"date":704,"type":22},"2032-03-01",{"name":392,"class":50},{"id":707,"slug":708,"hasResults":12,"nctId":709,"briefTitle":710,"officialTitle":711,"acronym":4,"eligibilityCriteria":712,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":713,"targetDuration":4,"studyType":23,"phases":715,"briefSummary":716,"conditions":717,"keywords":4,"overallStatus":338,"whyStopped":4,"lastUpdateSubmitDate":718,"lastUpdatePostDateStruct":719,"startDateStruct":720,"completionDateStruct":722,"leadSponsor":724,"locationsCount":726},"100648648","role-of-erbt-plus-intravesical-bcg-in-intermediate-risk-or-high-risk-nmbc-100648648","NCT07724886","Role of ERBT Plus Intravesical BCG in Intermediate-Risk or High-Risk NMBC","A Randomised Trial Investigating the Role of Transurethral En Bloc Resection of Bladder Tumour Plus Intravesical Bacillus Calmette-Guerin Therapy, in Patients With Intermediate-Risk or High-Risk Non-Muscle-Invasive Bladder Cancer","Inclusion Criteria:\n\n* Age 18 years or above\n* Fulfil any one of the following three criteria:\n\n  1. Recurrent bladder tumour\n  2. Multiple bladder tumours\n  3. Any bladder tumour size of \\>1cm\n\nExclusion Criteria:\n\n* EAU low-risk NIMBC as intravesical BCG therapy should not be offered (5)\n* EAU very high-risk NMIBC as upfront radical cystectomy should be offered (5)\n* Any prior use of intravesical BCG therapy\n* Presence or prior history of upper urinary tract malignancy\n* Presence of clinically significant cardiovascular disease (History of acute myocardial infarction, presence of uncontrolled angina within 3 months before screening, New York Heart Association Class III or IV congestive heart failure, presence of ventricular arrhythmias, or presence of second-degree or third-degree heart block) (16)\n* Presence of GOLD Stage III or IV chronic obstructive pulmonary disease\n* ECOG performance status ≥ 2 (Ambulatory and capable of all self-care but unable to carry our any work activities) (18)\n* History of bleeding disorder or use of anti-coagulants\n* Pregnancy\n* Presence of other active malignancy",{"count":714,"type":22},732,[25],"This is a prospective, multi-centre randomised trial comparing between cTURBT plus 1-year BCG therapy, and ERBT plus 1-year BCG therapy, in patients with intermediate-risk or high-risk NMIBC.",[32],"2026-07-31",{"date":646,"type":43},{"date":721,"type":22},"2026-07-01",{"date":723,"type":22},"2030-03-31",{"name":725,"class":50},"Chinese University of Hong Kong",2]