[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"muscle-invasive-bladder-urothelial-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:muscle-invasive-bladder-urothelial-carcinoma":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,42,70,82,109,131,157,182,209,240,266],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100053221","phase-2-combining-immunotherapy-and-radiation-therapy-to-help-patients-avoid-bladder-removal-after-treatment-shrinks-muscle-invasive-bladder-cancer-bright-trial-100053221",false,"NCT07061964","Combining Immunotherapy and Radiation Therapy to Help Patients Avoid Bladder Removal After Treatment Shrinks Muscle Invasive Bladder Cancer, BRIGHT Trial","Single Arm Phase II Study of Bladder Preservation With Immunoradiotherapy After a Clinically Meaningful Response to Neoadjuvant Therapy in Patients With Muscle Invasive Bladder Cancer (BRIGHT)","Inclusion Criteria:\n\n* Participants must have histologic evidence of cT2-T4aN0M0 muscle invasive urothelial carcinoma of the bladder within 180 days prior to starting neoadjuvant therapy (NAT)\n* Participants must have had CT chest\u002Fabdomen\u002Fpelvis (C\u002FA\u002FP), MRI C\u002FA\u002FP or PET within 60 days prior to starting NAT to determine cT2-T4aN0M0\n* Participants must have undergone TURBT with biopsy of areas of prior disease and systematic biopsies (left and right lateral, dome, posterior wall and trigone) and radiologic staging showing clinically T0-T1 disease within 60 days after the last dose of NAT. At least 4 out of 5 systematic biopsies must be performed\n\n  * NOTE: This TURBT must be within 90 days prior to registration. Registration must be within 90 days after the last dose of NAT\n* Participants must have imaging of the chest, abdomen, and pelvis performed using CT or MRI preferably with contrast. Fludeoxyglucose F-18 (FDG) PET-CT can also be used for staging. If FDG PET-CT is used, then it is at the discretion of the investigator if they want to additionally obtain diagnostic CT or MRI with contrast within 60 days after the last dose of NAT\n* Participants with lymph nodes ≥ 1.0 cm in the shortest cross-sectional diameter on imaging (CT or MRI of abdomen and pelvis) after completion of NAT must have a PET-CT within 70 days prior to registration. A biopsy in the setting of negative PET-CT is not required unless there is strong clinical suspicion for nodal involvement with tumor. Participants with a positive PET are deemed ineligible unless a biopsy is performed and shows no evidence of tumor involvement\n\n  * NOTE: For questions regarding the above eligibility criteria, please contact the study chairs in addition to the Southwest Oncology Group (SWOG) Statistics and Data Management Center (SDMC)\n* Participants must not have evidence of ≥ T2, or N1-3, or M1 disease after NAT\n* Participants must not have the presence of small cell, neuroendocrine carcinoma, plasmacytoid variants on any pathology\n* Participants must not have had urothelial carcinoma or histological variant at any site outside of the urinary bladder within 24 months prior to registration except Ta\u002FT1\u002Fcarcinoma in situ (CIS) of the upper urinary tract, including renal pelvis or ureter if the participant underwent complete nephroureterectomy\n\n  * NOTE: Participants with mixed variant histology will be eligible for the trial if the majority (\\> 50%) of the tumor is urothelial cell carcinoma\n* Participants will be allowed to continue PD-1\u002FL-1 inhibitor therapy received as part of standard of care neoadjuvant therapy while they undergo pre-registration assessments (TURBT and imaging)\n* Participants must have received at least 3 and no more than 6 cycles of Food and Drug Administration (FDA) approved NAT for MIBC. These include cisplatin-based combination chemotherapy (e.g. cisplatin and gemcitabine \\[GC\\] with or without PD-1\u002FL1 inhibitors) dose dense or accelerated methotrexate, vinblastine, doxorubicin and cisplatin (MVAC) or enfortumab vedotin with PD-1\u002FL1 inhibitor\n* Participants must not have had anti-PD-1, anti PD-L1, anti PD-L2 or anti-CTLA4 antibody, any other antibody or drug targeting T-cell co-stimulation, enfortumab vedotin, or any other drug targeting nectin-4 other than for neoadjuvant treatment for MIBC\n\n  * NOTE: Prior intravesical immunotherapy or chemotherapy for non-muscle invasive disease is allowed\n* Participants must not have had prior pelvic radiotherapy\n* Participants must not have received a live attenuated vaccination within 28 days prior to registration\n* Participants with conditions requiring immunosuppressive doses of steroids (\\> 10 mg\u002Fday of prednisone or equivalent) or other immunosuppressive medications must not be taking steroids at time of trial registration\n* Participants must be ≥ 18 years old at the time of registration\n* Participants must have Zubrod performance status of 0-2\n* Participants must have a complete medical history and physical exam within 28 days prior to registration\n* Leukocytes ≥ 3 x 10\\^3\u002FuL (within 28 days prior to registration)\n* Absolute neutrophil count ≥ 1.5 x 10\\^3\u002FuL (within 28 days prior to registration)\n* Platelets ≥ 100 x 10\\^3\u002FuL (within 28 days prior to registration)\n* Total bilirubin ≤ institutional upper limit of normal (ULN) unless history of Gilbert's disease (within 28 days prior to registration)\n\n  * Participants with history of Gilbert's disease must have total bilirubin ≤ 5 x institutional ULN\n* Aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT) ≤ 3 x institutional ULN (within 28 days prior to registration)\n* Participants must have a creatinine ≤ the institutional (I)ULN OR measured OR calculated creatinine clearance ≥ 40 mL\u002Fmin using the following Cockcroft-Gault Formula. This specimen must have been drawn and processed within 28 days prior to registration\n* Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class II or better\n* Participants with a history of human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at registration and have undetectable viral load test on the most recent test results obtained within 6 months prior to registration\n* For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured (defined as undetectable HCV viral load)\n* Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen\n* Participants must not be pregnant or nursing (nursing includes breast milk fed to an infant by any means, including from the breast, milk expressed by hand, or pumped). Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of \"reproductive potential.\" In addition to routine contraceptive methods, \"effective contraception\" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation\u002Focclusion, and vasectomy with testing showing no sperm in the semen\n* Participants must be offered the opportunity to participate in specimen banking\n* Participants who can complete the PRO-CTCAE questionnaire in English or Spanish will be offered the opportunity to participate in the optional patient-reported outcome study\n* NOTE: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system\n\n  * Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines\n  * For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and central institutional review board (CIRB) regulations","ALL","18 Years",{"count":19,"type":20},111,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This phase II trial tests the effect of giving pembrolizumab in combination with radiation therapy after chemotherapy in preventing surgery to remove the bladder in patients with muscle invasive bladder cancer. Standard of care therapy includes chemotherapy before surgery (neoadjuvant) to shrink or get rid of the tumor. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Photon beam radiation therapy is a type of radiation therapy that uses x-rays or gamma rays that come from a special machine called a linear accelerator. The radiation dose is delivered at the surface of the body and goes into the tumor and through the body. Giving pembrolizumab in combination with radiation therapy after neoadjuvant chemotherapy may help prevent surgical removal of the bladder in patients with muscle invasive bladder cancer.",[26,27,28],"Muscle Invasive Bladder Urothelial Carcinoma","Stage II Bladder Cancer AJCC v8","Stage IIIA Bladder Cancer AJCC v8","RECRUITING","2026-07-10",{"date":32,"type":33},"2026-07-13","ACTUAL",{"date":35,"type":33},"2025-11-25",{"date":37,"type":20},"2027-07-31",{"name":39,"class":40},"National Cancer Institute (NCI)","NIH",148,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":21,"phases":51,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":69},"100515110","phase-2-testing-the-role-of-dna-released-from-tumor-cells-into-the-blood-in-guiding-the-use-of-immunotherapy-after-surgical-removal-of-the-bladder-kidney-ureter-and-urethra-for-urothelial-cancer-treatment-modern-study-100515110","NCT05987241","Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study","MODERN: An Integrated Phase 2\u002F3 and Phase 3 Trial of MRD-Based Optimization of ADjuvant ThErapy in URothelial CaNcer","Inclusion Criteria:\n\n* PRE-REGISTRATION (STEP 0): Histologically confirmed muscle-invasive urothelial carcinoma of the urethra, bladder, ureter or renal pelvis\n* PRE-REGISTRATION (STEP 0): Variant histology, including neuroendocrine differentiation, sarcomatoid, micropapillary, glandular, trophoblastic, Mullerian, is allowed if urothelial cancer is predominant histology (any amount of squamous differentiation is allowed provided the tumor is not a pure squamous cell cancer)\n* PRE-REGISTRATION (STEP 0): Radical surgery (cystectomy with lymph node dissection or nephroureterectomy or ureterectomy) must be ≥ 3 weeks and ≤ 12 weeks (central Signatera pathway) or ≤ 16 weeks (commercial Signatera pathwary) prior to pre-registration. Patients who have had a partial cystectomy as definitive therapy are not eligible\n* PRE-REGISTRATION (STEP 0): Patients who have had a partial cystectomy as definitive therapy are not eligible\n* PRE-REGISTRATION (STEP 0): No gross cancer at the surgical margins. Microscopic invasive urothelial carcinoma at the surgical margins (i.e., \"positive margins\") are allowed. Carcinoma in situ (CIS) at margins is considered negative margins\n* PRE-REGISTRATION (STEP 0): No evidence of residual cancer or metastasis after radical cystectomy or nephroureterectomy or ureterectomy (imaging is not required prior to pre-registration but is required prior to registration)\n* PRE-REGISTRATION (STEP 0): Have undergone a radical cystectomy nephroureterectomy, or ureterectomy with pathological evidence of urothelial carcinoma at high risk of recurrence as described in one of the two scenarios below (i or ii). The 7th edition of American Joint Committee on Cancer (AJCC) staging will be utilized.:\n\n  * (i) Patients who have not received neoadjuvant systemic therapy: pT4N0 or pTanyN+ on radical surgery pathology specimen (i.e., cystectomy, nephroureterectomy, or ureterectomy) and are not eligible for adjuvant cisplatin chemotherapy\n\n    * (i) Patients ineligible for cisplatin due to at least one of the following criteria and reason for ineligibility should be documented:\n\n      * (i) Creatinine Clearance (using Cockcroft-Gault): \\\u003C 60 mL\u002Fmin\n      * (i) Common Terminology Criteria for Adverse Events (CTCAE) version 5, grade \\>= 2 audiometric hearing loss\n      * (i) CTCAE version 5, grade \\>= 2 or above peripheral neuropathy\n      * New York Heart Association Class III heart failure\n      * (i) Eastern Cooperative Oncology Group (ECOG) performance status = 2\n    * (i) Patients who are eligible for adjuvant cisplatin may be candidates if they refuse adjuvant cisplatin-based chemotherapy, despite being informed by the investigator about the treatment options. The patient's refusal must be documented.\n\n      * (i) Patients with pT2N0 urothelial cancer on radical surgery specimen (without prior neoadjuvant systemic therapy) with ctDNA(+) Signatera results are eligible only if the result was obtained via commercial testing (central testing is not permitted for this population) (Note: this is distinct from patients with ypT2N0 who are eligible based on ii).\n  * (ii) Patients who received neoadjuvant systemic therapy: ypT2-T4N0 or Nx or ypTanyN+ on radical surgery (i.e., cystectomy. , nephroureterectomy, or ureterectomy) pathology specimen. Neoadjuvant systemic therapy may have included cisplatin-based chemotherapy, cisplatin-based chemotherapy plus PD-1\u002FPD-L1 blockade, or enfortumab vedotin plus PD-1\u002FPD-L1 blockade\n* PRE-REGISTRATION (STEP 0): Patients are required to meet criteria for one of two criteria:\n\n  * 1\\) Commercial Signatera pathway:\n\n    * Available commercial Signatera testing result (i.e., ctDNA+ or ctDNA-) from blood sample obtained ≥ 3 weeks and ≤ 16 weeks from time of radical surgery performed as part of standard care\n\n      * Sites are required to verify that the commercial Signatera report demonstrates a complete 16 target assay design and that the test was designed on exome. This verification is conducted at the site level during the eligibility review. OR\n  * Central Signatera pathway:\n\n    * Pre-registration samples are to be submitted after pre-registration, at ≥ 3 weeks but ≤ 12 weeks from the time of radical surgery\n\n      * Ineligible patients for the commercial pathway must use the central Signatera pathway and provide tumor tissue as part of the A032103 study\n      * For patients who have not had neoadjuvant chemotherapy, tumor tissue is preferred from the radical surgery specimen\n      * For patients who have had neoadjuvant therapy, tissue is preferred from the pre-chemotherapy specimen diagnosing muscle-invasive disease (e.g., transurethral resection of bladder tumor specimen)\n* PRE-REGISTRATION (STEP 0): Age \\>= 18 years\n* PRE-REGISTRATION (STEP 0): ECOG performance status 0-2\n* PRE-REGISTRATION (STEP 0): Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects\n* PRE-REGISTRATION (STEP 0): No postoperative adjuvant systemic therapy after radical surgery\n* PRE-REGISTRATION (STEP 0): No adjuvant radiation after radical surgery\n* PRE-REGISTRATION (STEP 0): No treatment with any other type of investigational agent =\\\u003C 4 weeks before pre-registration\n* PRE-REGISTRATION (STEP 0): No previous treatment with LAG-3 blockade therapy\n* PRE-REGISTRATION (STEP 0): Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* PRE-REGISTRATION (STEP 0): Absolute neutrophil count (ANC) \\>= 1,200\u002Fmm\\^3\n* PRE-REGISTRATION (STEP 0): Platelet count \\>= 100,000\u002Fmm\\^3\n* PRE-REGISTRATION (STEP 0): Hemoglobin \\>= 8 g\u002FdL\n* PRE-REGISTRATION (STEP 0): Creatinine =\\\u003C 1.5 x upper limit of normal (ULN) or calculated (calc.) creatinine clearance \\> 30 mL\u002Fmin (using either Cockcroft-Gault formula or Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation\n* PRE-REGISTRATION (STEP 0): Aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT) =\\\u003C 3 x ULN\n* PRE-REGISTRATION (STEP 0): Total bilirubin =\\\u003C 1.5 x upper limit of normal (ULN) (except in patients with Gilbert Syndrome, who can have total bilirubin \\\u003C 3.0 mg\u002FdL)\n* PRE-REGISTRATION (STEP 0): For women of childbearing potential only: A negative urine or serum pregnancy test done =\\\u003C 14 days prior to pre-registration is required\n* PRE-REGISTRATION (STEP 0): Not currently requiring hemodialysis\n* PRE-REGISTRATION (STEP 0): No current or prior history of myocarditis\n* PRE-REGISTRATION (STEP 0): No history of a grade ≥ 3 immune related adverse event with prior PD-1\u002FPD-L1 blockade in the neoadjuvant setting\n* PRE-REGISTRATION (STEP 0): No active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids. These include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn's, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens- Johnson syndrome, or phospholipid syndrome because of the risk of recurrence or exacerbation of disease.\n* PRE-REGISTRATION (STEP 0): Patients with vitiligo, endocrine deficiencies including type I diabetes mellitus, thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible.\n* PRE-REGISTRATION (STEP 0): Patients with rheumatoid arthritis and other arthropathies, Sjögren's syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible.\n* PRE-REGISTRATION (STEP 0): No current pneumonitis or prior history of non-infectious pneumonitis that required steroids within the previous 5 years.\n* PRE-REGISTRATION (STEP 0): No known active hepatitis B (e.g., hepatitis B surface antigen \\[HBsAg\\] reactive) or hepatitis C (e.g., hepatitis C virus \\[HCV\\] ribonucleic acid \\[RNA\\] \\[qualitative\\] is detected).\n* PRE-REGISTRATION (STEP 0): For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n* PRE-REGISTRATION (STEP 0): Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible.\n* PRE-REGISTRATION (STEP 0): No concurrent antineoplastic therapy including anti-hormonal treatments used for cancer therapy (e.g., leuprolide, antiandrogens)\n* PRE-REGISTRATION (STEP 0): No current immunosuppressive agents (except for corticosteroids as described below).\n* PRE-REGISTRATION (STEP 0): No condition requiring systemic treatment with either corticosteroids (\\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of pre-registration (with the exception of steroid pre-medications for contrast allergies). Inhaled or topical steroids and adrenal replacement doses \\\u003C 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.\n* REGISTRATION (STEP 1): Patient must have had radical cystectomy and lymph node dissection or nephroureterectomy or ureterectomy =\\\u003C 18 weeks prior to registration.\n* REGISTRATION (STEP 1): Must have evaluable ctDNA Signatera assay result (i.e., ctDNA+ or ctDNA-) based on either:\n\n  * Commercial Signatera result OR\n  * Central Signatera testing result (i.e. testing that was performed as part of A032103.)\n* REGISTRATION (STEP 1): All patients must have confirmed disease-free status defined as no measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, or definitive non-measurable radiographic metastatic disease, within 60 days prior to registration. Patients with equivocal lymph nodes less than 15 mm in short axis, or \\\u003C 10 mm in long axis for non-lymph node lesions, not considered by the investigator to represent malignant disease will be eligible. Attempts should be made to resolve the etiology of equivocal lesions with complementary imaging (e.g., PET scan) or biopsy.\n* REGISTRATION (STEP 1): No major surgery =\\\u003C 3 weeks before registration.\n* REGISTRATION (STEP 1): No live vaccine within 30 days prior to registration. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster (chicken pox), yellow fever, rabies, Bacillus Calmette- Guerin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist \\[registered trademark\\]) are live attenuated vaccines and are not allowed. Coronavirus disease 2019 (COVID-19) vaccines are not live vaccines and are allowed\n* REGISTRATION (STEP 1): No change since Step 0 pre-registration in clinical condition and\u002For laboratory tests that would impact the safety of nivolumab +\u002F- relatlimab administration in the opinion of the treating investigator\n* REGISTRATION (STEP 1): No evidence of high grade urothelial cancer in the bladder for patients with primary urothelial cancers of the upper urinary tract\n* RE-REGISTRATION (STEP 2) COHORT B, ARM 4 PATIENTS INITIATING NIVOLUMAB AFTER CONVERSION OF ctDNA ASSAY FROM ctDNA(-) to ctDNA (+):\n\n  * Patient must have converted to ctDNA(+) during serial monitoring performed centrally as part of A032103\n* RE-REGISTRATION (STEP 2) COHORT B, ARM 4 PATIENTS INITIATING NIVOLUMAB AFTER CONVERSION OF ctDNA ASSAY FROM ctDNA(-) to ctDNA (+):\n\n  * No evidence of metastatic disease on the most recent scheduled imaging assessment as outlined in the study calendar (no repeat imaging is necessary specifically at the time of the conversion from ctDNA\\[-\\] to ctDNA\\[+\\]).\n* RE-REGISTRATION (STEP 2) COHORT B, ARM 4 PATIENTS INITIATING NIVOLUMAB AFTER CONVERSION OF ctDNA ASSAY FROM ctDNA(-) to ctDNA (+):\n\n  * In the opinion of the treating investigator, patient clinical condition and laboratory tests would not impact the safety of nivolumab administration in the opinion of the treating investigator",{"count":50,"type":20},992,[23,52],"PHASE3","This phase II\u002FIII trial examines whether patients who have undergone surgical removal of bladder, kidney, ureter or urethra, but require an additional treatment called immunotherapy to help prevent their urinary tract (urothelial) cancer from coming back, can be identified by a blood test. Many types of tumors tend to lose cells or release different types of cellular products including their DNA which is referred to as circulating tumor DNA (ctDNA) into the bloodstream before changes can be seen on scans. Health care providers can measure the level of ctDNA in blood or other bodily fluids to determine which patients are at higher risk for disease progression or relapse. In this study, a blood test is used to measure ctDNA and see if there is still cancer somewhere in the body after surgery and if giving a treatment will help eliminate the cancer. Immunotherapy with monoclonal antibodies, such as nivolumab and relatlimab, can help the body's immune system to attack the cancer, and can interfere with the ability of tumor cells to grow and spread. This trial may help doctors determine if ctDNA measurement in blood can better identify patients that need additional treatment, if treatment with nivolumab prolongs patients' life and whether the additional immunotherapy treatment with relatlimab extends time without disease progression or prolongs life of urothelial cancer patients who have undergone surgical removal of their bladder, kidney, ureter or urethra.",[26,55,56,57,58,59,60],"Muscle Invasive Renal Pelvis Urothelial Carcinoma","Muscle Invasive Ureter Urothelial Carcinoma","Muscle Invasive Urethral Urothelial Carcinoma","Stage II Bladder Urothelial Carcinoma AJCC v6 and v7","Stage III Bladder Urothelial Carcinoma AJCC v6 and v7","Stage IV Bladder Urothelial Carcinoma AJCC v7","2026-07-01",{"date":63,"type":33},"2026-07-02",{"date":65,"type":33},"2024-02-02",{"date":67,"type":20},"2030-09-02",{"name":39,"class":40},499,{"id":71,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":72,"targetDuration":4,"studyType":21,"phases":73,"briefSummary":24,"conditions":74,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":79,"leadSponsor":80,"locationsCount":81},"100597705",{"count":19,"type":20},[23],[26,27,28],"2026-06-25",{"date":77,"type":33},"2026-06-26",{"date":35,"type":33},{"date":37,"type":20},{"name":39,"class":40},144,{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":90,"targetDuration":4,"studyType":21,"phases":92,"briefSummary":93,"conditions":94,"keywords":95,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":108},"100618494","phase-2-neoadjuvant-intravesical-nadofaragene-firadenovec-with-gemcitabine-cisplatin-and-durvalumab-for-the-treatment-of-muscle-invasive-bladder-cancer-trifecta-trial-100618494","NCT07332351","Neoadjuvant Intravesical Nadofaragene Firadenovec With Gemcitabine, Cisplatin and Durvalumab for the Treatment of Muscle Invasive Bladder Cancer, TRIFECTA Trial","Intravesical Nadofaragene Firadenovec With Neoadjuvant Chemotherapy and Durvalumab in Patients With Muscle Invasive Bladder Cancer (TRIFECTA)","TRIFECTA","Inclusion Criteria:\n\n* Age ≥ 18 years at the time of screening\n* Ability to understand and willingness to sign the written informed consent document\n* Patients with confirmed muscle-invasive urothelial carcinoma of the bladder (cT2-4a, N0-1, M0 or cT1, N1, M0), who are planning to undergo RC\n* Pure urothelial or mixed histologic subtypes are allowed if urothelial is the primary histology (regardless of the % of conventional urothelial histology)\n* Eligible to receive neoadjuvant cisplatin\u002Fgemcitabine and durvalumab per the patient's medical oncologist's discretion\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1\n* Hemoglobin count ≥ 9 gm\u002FdL\n* Absolute neutrophil count of ≥ 1500 cells\u002FuL\n* Platelet count of ≥ 100,000\u002FuL\n* Alanine and aspartate aminotransferase levels ≤ 2.5 x upper limit of normal (ULN)\n* Total bilirubin ≤ 1.5 x ULN (≤ 2.5 x ULN for Gilbert syndrome)\n* Creatinine clearance or estimated glomerular filtration rate (GFR) ≥ 40ml\u002Fmin (using Chronic Kidney Disease Epidemiology Collaboration Formula \\[CKD-EPI\\] 2021 equation)\n* For patients with evidence of, or history of HIV, chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, the viral load must be undetectable, or the infection must have been treated and cured. Patients are not allowed to be on immunosuppressive agents for HIV, HBV or HCV. Routine testing for HIV, HBV and HCV is not required for patients without such history unless clinically indicated\n* Individuals with a prior malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are allowed to enroll\n\nExclusion Criteria:\n\n* cT4b, N2-3, or M1 stage at time of screening\n* Any known concurrent clinically relevant malignancies\n* Prior systemic therapy for muscle-invasive bladder carcinoma (MIBC) (prior intravenous pembrolizumab for non-muscle invasive bladder carcinoma \\[NMIBC\\] is allowed)\n* Current or prior use of systemic immunosuppressive medication within 14 days before first dose of investigational product. The following are allowed (not systemic route): intranasal, inhaled, intra-articular, topical steroids, local steroid injections\n* Pure non-urothelial histology subtype\u002Fvariant or any neuroendocrine (small or large cell) component\n* Prior treatment with adenovirus-based drugs\n* Known hypersensitivity or allergy to any components of rAd-interferon (IFN)a\u002FSyn3\n* Currently receiving other investigational agent\n* Pregnant or lactating women",{"count":91,"type":20},33,[23],"This phase II trial tests the effect of intravesical nadofaragene firadenovec in combination with gemcitabine, cisplatin and durvalumab before (neoadjuvant) radical cystectomy (RC) in treating patients with muscle invasive bladder cancer. The combination of gemcitabine, cisplatin and durvalumab are already considered standard of care in the treatment of muscle invasive bladder cancer. This trial attempts to determine whether the addition of nadofaragene firadenovec to the current standard regiment is safe and can improve oncological outcomes for those with muscle invasive bladder cancer.\n\nNadofaragene firadenovec, a type of intravesical gene therapy, is a weakened adenovirus that carries a copy of the gene for interferon alfa-2b. This medication gets absorbed by the bladder and stimulates the bladder to naturally create interferon alfa-2b, which is thought to kill bladder cancer. Nadofaragene firadenovec is given in a solution that is placed directly into the bladder (intravesical) using a thin tube called a catheter. It is a medication that is already FDA approved for the treatment of non-muscle invasive bladder cancer. Gemcitabine is a chemotherapy drug that blocks the cells from making deoxyribonucleic acid and may kill tumor cells. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread.",[26,27,28],[96],"Urinary Bladder","NOT_YET_RECRUITING","2026-06-04",{"date":100,"type":33},"2026-06-08",{"date":102,"type":20},"2026-09-01",{"date":104,"type":20},"2027-02-01",{"name":106,"class":107},"University of Washington","OTHER",1,{"id":110,"slug":111,"hasResults":11,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":4,"eligibilityCriteria":115,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":116,"targetDuration":4,"studyType":21,"phases":118,"briefSummary":119,"conditions":120,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":130},"100600411","phase-3-testing-shorter-duration-radiation-therapy-versus-the-usual-radiation-therapy-in-patients-receiving-the-usual-chemotherapy-treatment-for-bladder-cancer-archer-study-100600411","NCT07097142","Testing Shorter Duration Radiation Therapy Versus the Usual Radiation Therapy in Patients Receiving the Usual Chemotherapy Treatment for Bladder Cancer, ARCHER Study","The Phase III Adaptive Radiation and Chemotherapy for Muscle Invasive Bladder Cancer Trial (ARCHER)","Inclusion Criteria:\n\n* Histologically proven, cT2-T3,N0M0 urothelial carcinoma of the bladder prior to randomization.\n\n  * Note: Patients with mixed urothelial carcinoma will be eligible for the trial, but the presence of small cell carcinoma will make a patient ineligible\n* Must undergo a transurethral resection of bladder tumor (TURBT) prior to randomization. Patients may have either completely or partially resected tumors as long as the treating urologist attempted maximal resection\n* Must undergo radiological staging prior to randomization. Imaging of chest, abdomen, and pelvis must be performed using CT or MRI (with or without contrast is acceptable). Patients must not have evidence of T4 or node positive disease. Fluorodeoxyglucose (FDG) PET imaging is acceptable for radiological staging\n* If any lymph nodes ≥ 1.0 cm in shortest cross-sectional diameter are noted on imaging (CT \u002F MRI of abdomen and pelvis), then the patient must have had a biopsy of the enlarged lymph node showing no tumor involvement prior to randomization\n* No diffuse carcinoma in situ (CIS) based on cystoscopy and biopsy\n* No definitive clinical or radiologic evidence of metastatic disease\n* Must not have had urothelial carcinoma or histological variant at any site outside of the urinary bladder within 24 months prior to registration except Ta\u002FT1\u002FCarcinoma in situ (CIS) of the upper urinary tract including renal pelvis and ureter if the patient had undergone complete nephroureterectomy\n* Age ≥ 18\n* Zubrod performance status of ≤ 2\n* Not pregnant and not nursing\n\n  * Negative urine or serum pregnancy test (in persons of childbearing potential) within 14 days prior to registration. Childbearing potential is defined as any person who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal\n* Absolute neutrophil count (ANC) ≥ 1,500 cells\u002Fmm\\^3\n* Platelets ≥ 100,000 cells\u002Fmm\\^3\n* Hemoglobin ≥ 8.0 g\u002Fdl (Note: The use of transfusion or other intervention to achieve hemoglobin \\[Hgb\\]) ≥ 8.0 g\u002Fdl is acceptable)\n* Creatinine clearance (CrCL) of ≥ 30 mL\u002Fmin by the Cockcroft-Gault formula\n* Total bilirubin ≤ 2 x institutional upper limit of normal (ULN)\n* Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \\[SGOT\\]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 3 x institutional ULN\n* All adverse events associated with any prior therapy must have resolved to Common Terminology Criteria for Adverse Events (CTCAE) grade ≤ 3 prior to randomization\n* For patients who have completed neoadjuvant therapy, they are eligible if the pre-neoadjuvant therapy diagnosis (TURBT path) is within 180 days before randomization\n* Must not have had prior pelvic radiation\n* New York Heart Association Functional Classification II or better (NYHA Functional Classification III\u002FIV are not eligible) (Note: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification.)\n* No active infection requiring IV antibiotics\n* Patients with hydronephrosis are eligible if they have unilateral hydronephrosis and kidney function meet criteria specified",{"count":117,"type":20},486,[52],"This phase III trial compares the effect of decreased number of radiation (ultra-hypofractionated) treatments to the usual radiation number of treatments (hypofractionation) with standard of care chemotherapy, with cisplatin, gemcitabine or mitomycin and 5-fluorouracil for the treatment of patients with muscle invasive bladder cancer. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a short period of time. Ultra-hypofractionated radiation therapy delivers radiation over an even shorter period of time than hypofractionated radiation therapy. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Gemcitabine is a chemotherapy drug that blocks the cells from making DNA and may kill tumor cells. Chemotherapy drugs, such as mitomycin-C and 5-fluorouracil (5-FU), work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ultra-hypofractionated radiation may be equally effective as hypofractionated therapy for patients with muscle invasive bladder cancer.",[26,27,28],"2026-04-28",{"date":123,"type":33},"2026-05-04",{"date":125,"type":33},"2025-10-07",{"date":127,"type":20},"2030-05-31",{"name":129,"class":107},"NRG Oncology",211,{"id":132,"slug":133,"hasResults":11,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":4,"eligibilityCriteria":137,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":138,"targetDuration":4,"studyType":21,"phases":140,"briefSummary":141,"conditions":142,"keywords":143,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":156},"100578272","phase-2-enfortumab-vedotin-plus-pembrolizumab-with-selective-bladder-sparing-for-treatment-of-muscle-invasive-bladder-cancer-100578272","NCT06809140","Enfortumab Vedotin Plus Pembrolizumab With Selective Bladder Sparing for Treatment of Muscle-invasive Bladder Cancer","Phase 2 Trial of Enfortumab Vedotin Plus Pembrolizumab With Selective Bladder Sparing for Treatment of Muscle-invasive Urothelial Cancer of the Bladder","Inclusion Criteria:\n\n1. Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.\n2. Age ≥ 18 years at the time of consent.\n3. ECOG Performance Status of 0-1 within 28 days prior to registration.\n4. Histological evidence of clinically localized muscle-invasive urothelial cancer of the bladder clinical stage T2-3N0M0. Participants with mixed histology are eligible provided the urothelial component is ≥50% with the following exceptions: (a) tumors with any degree of squamous differentiation are eligible provided there is a urothelial cancer component, (b) tumors that contain any component of neuroendocrine histology are not eligible. N0 will be considered as the absence of radiographically enlarged lymph nodes on baseline imaging (i.e., Patients with lymph nodes ≥1 cm in short axis on imaging are not eligible).\n5. Have undergone a standard of care maximal transurethral resection of bladder tumor ≤ 90 days prior C1D1. A maximal TURBT should be performed when feasible and is defined as a macroscopically complete resection of bladder tumor.\n6. All subjects must have adequate transurethral resection of bladder tumor tissue available for submission identified during screening. The specimen must include tumor tissue (i.e., if a restaging maximal TURBT was performed and there was no cancer in the specimen, tissue from the most recent prior TURBT that established the diagnosis of muscle-invasive urothelial cancer of the bladder should be submitted). Tissue from both the restaging TURBT and the prior diagnostic TURBT may be requested. Subjects without available archival tissue must be discussed with the sponsor-investigator.\n7. Be deemed eligible to undergo radical cystectomy and pelvic lymph node dissection\n8. Demonstrate adequate organ function as defined below. All screening labs to be obtained within 28 days prior to registration.\n\n   * Absolute neutrophil count (ANC): ≥ 1.5 x 10\\^9\u002FL\n   * Hemoglobin (Hgb): ≥ 9 g\u002FdL\n   * Platelets: ≥ 100 x 10\\^9\u002FL\n   * Creatinine clearance: ≥ 30 mL\u002Fmin\n   * Bilirubin: ≤ 1.5 ×ULN OR direct bilirubin ≤ ULN for participants with total bilirubin levels \\> 1.5 × ULN\n   * Aspartate aminotransferase (AST): ≤ 2.5 × ULN\n   * Alanine aminotransferase (ALT): ≤ 2.5 × ULN\n   * International normalized ratio (INR) or Prothrombin time (PT) or Partial thromboplastin time (PTT): ≤ 1.5 ×ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range for intended use of anticoagulants\n\n10\\. Females of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to registration. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. WOCBP must agree to use contraception.\n\n11\\. Male participants able to father a child who are sexually active with female of childbearing potential must be willing to use an effective method(s) of contraception.\n\nExclusion Criteria:\n\n1. Pre-existing sensory or motor neuropathy Grade ≥ 2\n2. Ongoing clinically significant toxicity (Grade 2 or higher with the exception of alopecia) associated with prior treatment (including systemic therapy, radiotherapy or surgery).\n3. Prior systemic chemotherapy for muscle-invasive urothelial cancer of the bladder.\n4. Prior malignancy active within the previous 2 years except for locally curable cancers that have been apparently cured. Patients with intermediate or lower risk prostate cancer as defined by the National Comprehensive Cancer Network (NCCN) risk stratification guidelines may be eligible for enrollment.\n5. Prior radiation therapy for bladder cancer.\n6. Hemoglobin A1c ≥ 8% or hemoglobin A1c 7%-\\\u003C8% with associated diabetes symptoms (polyuria or polydipsia) that are not otherwise explained\n7. Active infection requiring systemic therapy.\n8. Known active Hepatitis B or C infection. NOTE: Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody \\[anti-HBc\\] and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.\n9. HIV-infected patients on effective anti-retroviral therapy with an undetectable viral load are eligible.\n10. Has a known history of active TB (Bacillus Tuberculosis).\n11. Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).\n12. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).\n13. Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study drug. Administration of killed vaccines is allowed.\n14. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.\n15. Has severe hypersensitivity (≥ Grade 3) to pembrolizumab or enfortumab vedotin and\u002For any of their excipients.\n16. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed.\n17. Has a history of (non-infectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease.\n18. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.\n19. Has had an allogenic tissue\u002Fsolid organ transplant.\n20. Is currently receiving an investigational agent or has received an investigational agent or used an investigational device within 28 days of study registration.",{"count":139,"type":20},47,[23],"Patients with MIBC will receive 3 cycles (C1-C3) of induction enfortumab vedotin plus pembrolizumab followed by restaging including MRI of the bladder, urine cytology, and cystoscopy with TURBT of any visible tumor and\u002For resection site plus random biopsies using a recommended template. Patients achieving a stringently defined cCR (clinical complete response) will receive 14 cycles of \"maintenance\" treatment. Enfortumab vedotin will be administered during the first 6 cycles (C4-C9) of \"maintenance\" treatment and pembrolizumab will be given all 14 cycles (C4-C14). Patients with any residual disease at clinical restaging (i.e., \\>cTa disease) will undergo cystectomy.",[26],[144,145,146],"MIBC","Pembrolizumab","Enfortumab vedotin","2026-02-19",{"date":149,"type":33},"2026-02-23",{"date":151,"type":33},"2025-04-07",{"date":153,"type":20},"2029-11",{"name":155,"class":107},"Matthew Galsky",5,{"id":158,"slug":159,"hasResults":11,"nctId":160,"briefTitle":161,"officialTitle":162,"acronym":4,"eligibilityCriteria":163,"healthyVolunteers":164,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":165,"targetDuration":4,"studyType":21,"phases":167,"briefSummary":168,"conditions":169,"keywords":171,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":174,"startDateStruct":176,"completionDateStruct":178,"leadSponsor":180,"locationsCount":4},"100614438","phase-2-a-phase-ii-study-of-toripalimab-plus-rc48-adc-with-radiotherapy-for-bladder-preservation-in-her2-positive-muscle-invasive-bladder-cancer-100614438","NCT07279597","A Phase II Study of Toripalimab Plus RC48-ADC With Radiotherapy for Bladder Preservation in HER2-Positive Muscle-Invasive Bladder Cancer","An Open, Single-arm Clinical Study on the Efficacy and Safety of Toripalimab Combined With RC48-ADC in Radiotherapy for HER-2 Positive Muscle-invasive Bladder Cancer (MIBC) Patients for Bladder Preservation Treatment After Chemotherapy Induction","Inclusion Criteria:\n\n* Patients who meet all of the following criteria are eligible to participate in the trial:\n\n  1. Male or female ≥18 years of age;\n  2. ECOG Performance Status: 0-1;\n  3. Patients must have undergone pathological biopsy and imaging diagnosis, and be judged by the investigator to have muscle-invasive bladder urothelial carcinoma (urothelial carcinoma as the main pathological component \\>50%);\n  4. Clinical stage T2-T4a N0 M0 (CT\u002FMRI ± PET\u002FCT);\n  5. HER2 immunohistochemistry 1+, 2+, or 3+;\n  6. Expected survival ≥3 months;\n  7. Normal function of major organs (within 14 days before enrollment), meeting the following standards:\n\n  \u003C!-- -->\n\n  1. Hematological criteria must be met (no blood transfusion or granulocyte colony-stimulating factor treatment within 14 days before enrollment):\n\n     HB ≥90 g\u002FL; ANC ≥1.5×10\\^9 \u002FL; PLT ≥100×10\\^9 \u002FL;\n  2. No functional organic disease, meeting the following standards:\n\nT-BIL ≤1.5×ULN (Upper Limit of Normal); ALT and AST ≤2.5×ULN; if liver metastases are present, then ALT and AST ≤5×ULN; Serum creatinine ≤ 2×ULN, or creatinine clearance \\>30 ml\u002Fmin (Cockcroft-Gault formula);International Normalized Ratio (INR), Activated Partial Thromboplastin Time (aPTT): ≤1.5× ULN (this criterion applies only to patients not receiving anticoagulant therapy; patients receiving anticoagulant therapy should have their anticoagulant within the therapeutic range); 8. No systemic corticosteroid treatment within 4 weeks prior to therapy; 9. Men of reproductive potential or women with childbearing potential must use highly effective contraception methods (e.g., oral contraceptives, intrauterine device, sexual abstinence, or barrier contraception combined with spermicide) during the trial and continue contraception for 12 months after the end of treatment; 10. Women with childbearing potential must have a negative urine pregnancy test result within 7 days before treatment; 11. Subjects voluntarily join the study, sign the informed consent form, have good compliance, and cooperate with follow-up.\n\nExclusion Criteria:\n\n* Patients presenting with any of the following conditions will be excluded from the trial:\n\n  1. Previous treatment with anti-PD-1, anti-PD-L1, or anti-PD-L2 therapy, including during the adjuvant therapy phase;\n  2. Known allergy to recombinant humanized anti-PD-1 monoclonal antibody drugs or their components;\n  3. Received other anti-tumor therapy (including corticosteroid therapy, immunotherapy) or participated in other clinical studies within 4 weeks before the start of study treatment, or have not recovered from previous toxicity (except for Grade 2 alopecia and Grade 1 neurotoxicity);\n  4. Pregnant or lactating women;\n  5. Positive HIV test result;\n  6. Patients with active Hepatitis B or Hepatitis C: HBsAg or HBcAb positive with concurrently positive HBV DNA copy number (quantitative detection limit of 500 IU\u002Fml, or reaching the positive copy number value detected by the research center); HBV DNA must be tested during study screening for these patients; Patients with positive HCV antibody test results can only be enrolled in this study if the PCR test result for HCV RNA is negative.\n  7. History of definite active tuberculosis;\n  8. Active autoimmune disease requiring systemic treatment in the past 2 years (e.g., using disease-modifying drugs, corticosteroids, or immunosuppressive drugs). Related replacement therapy (e.g., thyroxine, insulin, or physiological corticosteroid replacement for renal or pituitary insufficiency) is allowed;\n  9. Other severe, uncontrolled concomitant diseases that may affect protocol compliance or interfere with result interpretation, including active opportunistic infections or advanced (severe) infections, uncontrolled diabetes, cardiovascular diseases (Class III or IV heart failure as defined by the New York Heart Association classification, second-degree or higher heart block, myocardial infarction within the past 6 months, unstable arrhythmia or unstable angina, cerebral infarction within 3 months, etc.) or pulmonary diseases (interstitial pneumonia, obstructive pulmonary disease, and history of symptomatic bronchospasm);\n  10. Received live vaccination within 4 weeks before the start of treatment;\n  11. Previous allogeneic hematopoietic stem cell transplantation or solid organ transplantation;\n  12. Underwent major surgical procedures (excluding diagnostic surgery) within 4 weeks before the start of treatment;\n  13. History of psychotropic drug abuse and inability to abstain, or history of mental disorders;\n  14. Presence of clinically symptomatic large pleural effusion or ascites requiring symptomatic treatment;\n  15. History of other malignancies within the past 5 years that have not been cured, excluding malignancies that are considered clearly cured or curable cancers, such as basal cell or squamous cell skin cancer, localized low-risk prostate cancer, carcinoma in situ of the cervix, or carcinoma in situ of the breast; Note: Localized low-risk prostate cancer (defined as stage ≤T2b, Gleason score ≤7, and PSA ≤20 ng\u002FmL at diagnosis if measured) treated with curative intent and without biochemical recurrence of prostate-specific antigen (PSA) may participate in this study;\n  16. Concurrent upper urinary tract urothelial carcinoma (renal pelvis, ureter urothelial carcinoma);\n  17. Other severe, acute, or chronic medical or psychiatric conditions or laboratory abnormalities that, in the investigator's opinion, may increase the risk associated with study participation or may interfere with the interpretation of study results.",true,{"count":166,"type":20},45,[23],"This is a prospective, open-label, single-center, single-arm clinical study. Plans to enroll 45 MIBC patients with clinical stage T2-T4aN0M0 and HER2-positive (IHC 1+\u002F2+\u002F3+) status. Treatment Flow: Post maximal Transurethral Resection of Bladder Tumor (TURBT); 2 cycles of Gemcitabine + Cisplatin chemotherapy; 4 cycles of RC48-ADC + Toripalimab targeted therapy; Radiotherapy (60-64 Gy) with concurrent Toripalimab treatment; Continue with 6 cycles of RC48-ADC + Toripalimab after radiotherapy completion; Patients achieving CR will receive maintenance therapy with Toripalimab for 1 year.",[170],"Muscle-invasive Bladder Urothelial Carcinoma",[172],"Bladder-preserving","2025-12-12",{"date":175,"type":33},"2025-12-19",{"date":177,"type":20},"2025-12-10",{"date":179,"type":20},"2028-08-01",{"name":181,"class":107},"Tongji Hospital",{"id":183,"slug":184,"hasResults":11,"nctId":185,"briefTitle":186,"officialTitle":187,"acronym":188,"eligibilityCriteria":189,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":190,"targetDuration":4,"studyType":192,"phases":4,"briefSummary":193,"conditions":194,"keywords":197,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":200,"startDateStruct":202,"completionDateStruct":204,"leadSponsor":206,"locationsCount":208},"100546560","increasing-pre-surgical-identification-of-muscle-invasive-tumor-evaluations-prior-to-planned-cystectomy-insite-100546560","NCT06396533","Increasing Pre-Surgical Identification of Muscle Invasive Tumor Evaluations Prior to Planned Cystectomy (INSITE)","Increasing Pre-Surgical Identification of Muscle Invasive Tumor Evaluations Prior to Planned Cystectomy","INSITE","Inclusion Criteria:\n\n1. Properly counselled patients with high grade T1 disease who elect for cystectomy\n2. Properly counselled patients with non-muscle invasive high grade Ta urothelial carcinoma or carcinoma in situ who are unresponsive to intravesical therapy and have elected cystectomy\n3. cT2-T3 muscle invasive urothelial carcinoma for planned cystectomy\n4. Patient who have received prior intravesical therapy or multiple TURBTs can be enrolled (data regarding number of previous TURBTs and type of intravesical therapy will be collected).\n5. Male or female patients age \\>=18 years at the time of consent.\n6. Able and willing to comply with study requirements.\n7. Patients must have a non-contrast phase component for CT scans of chest\u002Fabdomen\u002Fpelvis either pre-existing (prior to accrual) or obtained during the screening process.\n8. Patients who undergo neoadjuvant systemic therapy for muscle invasive disease must be enrolled before starting systemic therapy.\n9. Ability to understand and willingness to sign a written informed consent and HIPAA authorization document.\n\nExclusion Criteria:\n\n1. Patients who undergo cystectomy with non-curative intent will be excluded.\n2. Patients who have undergone previous definitive pelvic radiation for the purpose of treating bladder malignancy.\n3. Patients who are pregnant or nursing.",{"count":191,"type":20},92,"OBSERVATIONAL","This trial aims at investigating the diagnostic ability of a combined diagnostic panel including systematic endoscopic evaluation (SEE), blood-based ctDNA assay, and urine-based cfDNA assay to predict the presence of residual tumor remaining in the bladder at cystectomy.\n\nPatients who are planned for cystectomy due to bladder cancer will be considered for enrollment based on inclusion and exclusion criteria.",[195,26,196],"Urothelial Carcinoma","Non-Muscle Invasive Bladder Urothelial Carcinoma",[198],"cystectomy","2025-10-30",{"date":201,"type":33},"2025-10-31",{"date":203,"type":33},"2024-08-13",{"date":205,"type":20},"2029-02-23",{"name":207,"class":107},"Fox Chase Cancer Center",2,{"id":210,"slug":211,"hasResults":11,"nctId":212,"briefTitle":213,"officialTitle":214,"acronym":4,"eligibilityCriteria":215,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":216,"targetDuration":4,"studyType":192,"phases":4,"briefSummary":218,"conditions":219,"keywords":226,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":230,"lastUpdatePostDateStruct":231,"startDateStruct":233,"completionDateStruct":235,"leadSponsor":237,"locationsCount":208},"100562610","pan-tumor-mrd-study-100562610","NCT06605404","Pan-tumor MRD Study","Molecular Residual Disease in Solid Tumors: A Prospective Study to Collect Clinical Data and Biospecimens to Support Discovery and Development of Cancer Biomarkers","Eligibility Criteria:\n\n1. Age 18 years or older.\n2. Confirmed histological or cytological diagnosis of a malignant solid tumor that is either specified in one of the pre-defined tumor cohorts or meets the enrollment criteria for the Mix of Solid Tumors (MOST) cohort (Table 1).\n3. Eligible for curative intent therapy, with surgical resection of cancer planned.\n\n   a. If surgical resection has occurred, enrollment should occur within 3 months of surgical resection and before initiation of adjuvant therapy.\n4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2.\n5. No systemic therapy for current cancer diagnosis administered before enrollment.\n6. Willing and able to comply with required study procedures, including blood sample collection and primary tumor tissue submission from diagnostic biopsy or surgical excision.\n7. Has completed all therapy (including endocrine therapy) 3 or more years ago for any previous invasive solid organ malignancy (with exception of nonmelanoma skin cancers) or hematologic malignancy. Individuals with a prior history of noninvasive (in situ) carcinomas may participate if they have received definitive treatment (no washout period required).\n8. No concurrent diagnosis of another invasive cancer, except for nonmelanoma skin cancers.\n9. No prior allogeneic hematopoietic stem cell transplant.\n10. Able and willing to provide informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for the release of personal health information.\n\n    Cohort Specific Criteria\n11. Muscle-invasive urothelial carcinoma of the bladder and Melanoma Cohorts: Stage II or operable III cancer:\n12. Esophageal, Gastric\u002FGEJ, and NSCLC Cohorts: Stage I, II, or operable III cancer.\n13. Pancreatic Cohort: Stage I, II or operable III cancer, exocrine only disease.\n14. MOST cohort: Stage II or operable stage III solid tumor diagnosis that meets eligibility criteria and is not included in the other cohorts.\n\nThe following tumor types are excluded:\n\n1. Central nervous system (CNS) malignancies\n2. Colorectal cancer\n3. Breast cancer\n4. Squamous cell skin cancer\n5. Basal cell carcinoma\n6. Gastrointestinal stromal tumors (GIST)\n7. Thyroid cancer\n8. Uveal melanoma\n9. Low or intermediate grade neuroendocrine tumors\n\n   ■ Eligible tumor types: High-grade neuroendocrine tumors, including neuroendocrine carcinomas, Merkel cell carcinomas, and small cell lung cancer are permissible\n10. Hematologic cancers including multiple myeloma or other plasma cell dyscrasias, Hodgkin\\'s lymphoma, non-Hodgkin\\'s lymphoma, acute or chronic leukemias including chronic lymphocytic leukemia \u002F small lymphocytic leukemia",{"count":217,"type":20},1350,"The purpose of this observational study is to collect clinical information, blood, and tumor tissue samples from participants diagnosed with stage I, stage II, or operable stage III cancer in select solid tumors. The information collected will be used to develop tests to better understand cancer, for example, to improve cancer detection and to assess the risk of cancer coming back.\n\nParticipants will receive routine standard of care from their doctor and their involvement is expected to last for approximately five and a half (5.5) years.",[26,220,221,222,223,224,225],"Esophageal Cancer","Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma","Melanoma (Skin Cancer)","NSCLC (Non-small Cell Lung Cancer)","Pancreatic (Exocrine Only)","Mix of Solid Tumors (MOST)",[227,228,229],"observational","biospecimen","routine care","2025-08-13",{"date":232,"type":33},"2025-08-14",{"date":234,"type":33},"2025-01-08",{"date":236,"type":20},"2032-04",{"name":238,"class":239},"Paradigm Health","INDUSTRY",{"id":241,"slug":242,"hasResults":11,"nctId":243,"briefTitle":244,"officialTitle":245,"acronym":4,"eligibilityCriteria":246,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":247,"enrollmentInfo":248,"targetDuration":4,"studyType":21,"phases":250,"briefSummary":251,"conditions":252,"keywords":254,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":258,"lastUpdatePostDateStruct":259,"startDateStruct":261,"completionDateStruct":262,"leadSponsor":264,"locationsCount":108},"100535837","phase-2-surveillance-of-the-genetic-signature-in-circulating-tumor-dna-for-guiding-adjuvant-chemotherapy-in-urothelial-carcinoma-100535837","NCT06257017","Surveillance of the Genetic Signature in Circulating Tumor DNA for Guiding Adjuvant Chemotherapy in Urothelial Carcinoma","Surveillance of the Genetic Signature in Circulating Tumor DNA for Guiding Adjuvant Chemotherapy in Urothelial Carcinoma: A Pilot Randomized Controlled Trial","Inclusion Criteria:\n\n1. aged 18-70 years old;\n2. a score of ≤1 for the Eastern Cooperative Oncology Group (ECOG) Performance Status;\n3. receiving radical cystectomy (with lymph node dissection) or nephroureterectomy;\n4. histologically confirmed (surgical specimen) muscle invasive urothelial carcinoma, and the major histological type should be transitional cell carcinoma;\n5. Classification of tumour, node and metastasis (TNM): pT2-4a N0-2M0;\n6. absence of microscopic (i.e., positive margin) or gross residual of the tumor (R0 resection) and absence of metastasis, confirmed by a negative CT or MRI scan of pelvis, abdomen and chest within 4 weeks prior to enrolment;\n7. adequate hematologic and end-organ function, defined by the following laboratory results obtained within 28 days prior to the first study treatment:\n\n   * ANC≥1500 cells\u002FμL (without granulocyte colony-stimulating factor support within 2 weeks prior to Cycle 1, Day 1)\n   * WBC counts \\> 2500 cells\u002FμL\n   * Lymphocyte count ≥ 300 cells\u002FμL\n   * Platelet count ≥ 100,000 cells\u002FμL (without transfusion within 2 weeks prior to Cycle 1, Day 1)\n   * Hemoglobin ≥ 9.0 g\u002FdL\n   * AST, ALT, and alkaline phosphatase ≤ 2.5 × the upper limit of normal (ULN),\n   * PTT ≤ 1.5 × ULN\n   * PT ≤ 1.5 × ULN or INR \\\u003C 1.7\n   * Calculated creatinine clearance ≥ 30 mL\u002Fmin (Cockcroft-Gault formula)\n8. able to understand and provide written informed consent, and agree to receive the treatment arrangement and study procedures stated in the informed consent\n\nExclusion Criteria:\n\n1. receiving any approved anti-cancer treatment within 3 weeks prior to study enrolment;\n2. participation in another clinical trial with therapeutic intent within 28 days prior to enrolment;\n3. suffering from malignancies other than urothelial carcinoma within 5 years prior to study enrolment;\n4. conditions that contraindicate chemotherapy, such as renal impairment with creatinine clearance rate (CCr) \\\u003C50 mL\u002Fmin, hearing impairment, and inadequate marrow function;\n5. anaphylactic or hypersensitivity reactions or other contraindication to cisplatin and gemcitabine;\n6. active or uncontrolled infections, including human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), or tuberculosis;\n7. pregnancy or breastfeeding.","70 Years",{"count":249,"type":20},20,[23],"Urothelial carcinomas are one of the most commonly diagnosed cancers worldwide. Postoperative patients carry a poor prognosis with an estimated five-year disease-specific survival rate of 50%. To improve overall survival and reduce the recurrent risk, chemotherapy is recommended as a standard of care. However, currently in Hong Kong, neoadjuvant (preoperational) chemotherapy and adjuvant (postoperative) chemotherapy are not commonly or regularly provided due to the concern of the potential harm from both physicians and patients. Recently, genetic signature from circulating tumor DNA (ctDNA) is emerging as a pivotal biomarker for detecting caner in early stage and molecular residual disease (MRD). With strengths of non-invasive and superior sensitivity, ctDNA is hopefully to serve as a cancer-agnostic surrogate analyte for risk stratification of tumor recurrence, thereby guiding individually tailored treatment. Therefore, this study is proposed to exploratively assess the benefit of ctDNA-guided approach for postoperative adjuvant therapy.",[26,253],"Muscle-Invasive Bladder Carcinoma",[255,256,257],"circulating tumor DNA","ctDNA","molecular residual disease","2025-04-01",{"date":260,"type":33},"2025-04-04",{"date":65,"type":33},{"date":263,"type":20},"2025-12-30",{"name":265,"class":107},"Yung NA",{"id":267,"slug":268,"hasResults":11,"nctId":269,"briefTitle":270,"officialTitle":271,"acronym":4,"eligibilityCriteria":272,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":273,"targetDuration":4,"studyType":192,"phases":4,"briefSummary":275,"conditions":276,"keywords":292,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":293,"lastUpdatePostDateStruct":294,"startDateStruct":296,"completionDateStruct":298,"leadSponsor":300,"locationsCount":108},"100529161","study-on-the-quality-of-life-and-pathological-state-in-patients-who-underwent-radical-cystectomy-100529161","NCT06170177","Study on the Quality of Life and Pathological State in Patients Who Underwent Radical Cystectomy","Bladder Archive: Observational Study on the Quality of Life and Pathological State in Patients Who Underwent Radical Cystectomy","Inclusion Criteria:\n\n* subjects underwent radical cystectomy\n* \\> 18 years old\n* Ability to read and sign the informed consent\n\nExclusion Criteria:\n\n* Age \\\u003C18 years\n* Inability to read and sign the informed consent",{"count":274,"type":20},4000,"Observational study on the quality of life and pathological state of patients underwent radical cystectomy.",[253,26,277,278,279,280,281,282,283,284,285,286,287,288,289,290,291],"Bladder Cancer TNM Staging","Bladder Cancer Stage IIa","Bladder Cancer Stage IIb","Bladder Cancer Stage IV","Bladder Leiomyosarcoma","Bladder Cancer","Bladder Cancer Stage II","Bladder Cancer Stage IIIa","Bladder Cancer Stage IIIb","Bladder Cancer Stage IIIc","Bladder Urothelial Carcinoma","Progression, Disease","Urinary Diversion","Neobladder","Radical Cystectomy",[291],"2023-12-06",{"date":295,"type":33},"2023-12-14",{"date":297,"type":33},"2013-02-04",{"date":299,"type":20},"2063-02",{"name":301,"class":107},"IRCCS San Raffaele"]