[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"metastatic-renal-pelvis-and-ureter-urothelial-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:metastatic-renal-pelvis-and-ureter-urothelial-carcinoma":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,46,72],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100599697","phase-2-therapeutic-plasma-exchange-with-enfortumab-vedotin-and-pembrolizumab-for-treatment-of-bladder-cancers-100599697",false,"NCT07087860","Therapeutic Plasma Exchange With Enfortumab Vedotin and Pembrolizumab for Treatment of Bladder Cancers","MC220503 Randomized Phase II Rescuing Cancer Immunotherapy With Plasma Exchange in Bladder Cancer 1 (ReCIPE-B1)","RECIPE-B1","Inclusion Criteria:\n\n* Age ≥ 18 years\n* GROPUS A and B (reCIPE-B1): Histologically proven urothelial carcinoma \\[American Joint Committee on Cancer (AJCC) 2017\\] of the bladder (BCa) or upper urothelial tract (UTUC), that has progressed despite enfortumab vedotin and pembrolizumab treatment\n\n  * NOTE: Primary or secondary progression are allowed, therapies are not required to be concurrent or immediately antecedent to enrollment)\n* COHORT C (CAKE ReCIPE): Histologically proven urothelial carcinoma (AJCC 2017) of the bladder (BCa) or upper urothelial tract (UTUC), that has progressed despite ADC AND is otherwise not a candidate for Groups A and B\n\n  * NOTE: Patients in Groups A and B who have progressed on that treatment are candidates for this cohort. Such patients must be re-consented and re- enrolled\n* Measurable disease per RECIST version (v)1.1\n* Eastern Cooperative Oncology Group (ECOG) performance status grade 0, 1, or 2\n* Hemoglobin \\> 7.0 g\u002FdL (obtained ≤ 30 days prior to registration)\n* Platelet count ≥ 75,000\u002Fmm\\^3 (obtained ≤ 30 days prior to registration)\n* Alanine aminotransferase (ALT) OR aspartate transaminase (AST) ≤ 3.5 x upper limit of normal (ULN) OR total bilirubin ≤ 3 x ULN OR direct bilirubin ≤ 3 x ULN (obtained ≤ 30 days prior to registration)\n* Estimated glomerular filtration rate (GFR) ≥ 15 ml\u002Fmin (obtained ≤ 30 days prior to registration)\n* Negative pregnancy test ≤ 8 days prior to registration, for persons of childbearing potential only\n* Provide written informed consent\n* Ability to complete questionnaire(s) by themselves or with assistance\n* Willingness to undergo treatment as assigned (group A: TPE + EV\u002Fpembro; OR group B: next line standard of care; OR Cohort C TPE + ADC)\n* Willingness to provide mandatory blood and fluid specimens for correlative research\n* Willingness to provide tissue specimens for correlative research\n* Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)\n\nExclusion Criteria:\n\n* Any of the following because this study involves an investigational agent, the genotoxic, mutagenic, and teratogenic effects of which on the developing fetus and newborn are unknown\n\n  * Pregnant persons\n  * Nursing persons\n  * Persons of childbearing potential or able to father a child who are unwilling to employ adequate contraception\n* Any of the following histologic variants\u002Fdivergent differentiation: Any amount of neuroendocrine or signet ring cell features\n* Active malignancies (i.e., progressing or requiring treatment change ≤ 24 months before registration) other than the disease being treated under study\n\n  * EXCEPTIONS:\n\n    * Skin cancer (melanoma or non-melanoma) that is considered completely cured\n    * Non-invasive cervical cancer that is considered completely cured\n    * Breast cancer: adequately treated lobular carcinoma in situ or ductal carcinoma in situ considered to have a very low risk of recurrence\n    * Localized prostate cancer (T1c\u002FT2N0M0):\n\n      * Gleason score 6, treated by either surgery or ablation ≤ 24 months prior to registration or untreated and under active surveillance\n      * Gleason score 3+4 that has been treated (may include surgery or ablation) ≤ 24 months prior to registration and considered to have a very low risk of recurrence (i.e., cT1c or pT2 on prostatectomy specimen)\n* History of uncontrolled cardiovascular disease including any of the following ≤ 6 months prior to registration:\n\n  * Significant cardiovascular disease \\[New York Heart Association (NYHA) class ≥ III\\], symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, myocardial infarction, ventricular fibrillation, Torsades de Pointes, cerebrovascular accident, or transient ischemic attack\n  * Psychiatric illness\u002Fsocial situations (e.g., substance abuse) that would limit compliance with study requirements\n* Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participants (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments","ALL","18 Years",{"count":20,"type":21},70,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This phase II trial compares therapeutic plasma exchange followed by enfortumab vedotin and pembrolizumab to standard of care next-line therapy for the treatment of patients with bladder or upper urinary tract cancers that have spread from where they first started (primary site) to other places in the body (metastatic) and that have not responded to previous treatment (refractory). TPE is a process that slowly removes a patient's blood through an intravenous or central line. The blood is sent through a machine that separates the plasma (the liquid part of blood) from other blood components (red cells, white cells, platelets). The plasma is then removed. The remaining blood components are combined with replacement fluid and returned to the patient's bloodstream through the intravenous or central line. Enfortumab vedotin is a monoclonal antibody, enfortumab, linked to an anticancer drug called vedotin. It works by helping the immune system to slow or stop the growth of cancer cells. Enfortumab attaches to a protein called nectin-4 on cancer cells in a targeted way and delivers vedotin to kill them. It is a type of antibody-drug conjugate. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Treatment with enfortumab vedotin and pembrolizumab is already approved by the Food and Drug Administration for the treatment of bladder cancer, but TPE is not. Combining TPE with enfortumab vedotin and pembrolizumab may work better than standard of care options for treating metastatic and refractory bladder and urinary tract cancers. This study also evaluates the effect of TPE with standard of care antibody drug conjugates (ADCs) in treating patients with refractory metastatic bladder cancer. ADC therapy is treatment with a monoclonal antibody linked to a chemotherapy drug. It is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of tumor cells, and delivers chemotherapy to kill them. Giving TPE with standard of care ADC therapy may be effective in treating patients with refractory metastatic bladder cancer.",[27,28,29,30,31,32],"Metastatic Bladder Urothelial Carcinoma","Metastatic Renal Pelvis and Ureter Urothelial Carcinoma","Refractory Bladder Urothelial Carcinoma","Refractory Renal Pelvis and Ureter Urothelial Carcinoma","Stage IV Bladder Cancer AJCC v7","Stage IV Renal Pelvis and Ureter Cancer AJCC v7","RECRUITING","2026-05-06",{"date":36,"type":37},"2026-05-08","ACTUAL",{"date":39,"type":37},"2025-08-01",{"date":41,"type":21},"2028-08-07",{"name":43,"class":44},"Mayo Clinic","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":45},"100574808","phase-4-enfortumab-vedotin-and-pembrolizumab-with-cystectomy-andor-ureterectomy-for-locally-advanced-or-metastatic-bladder-and-upper-urothelial-tract-cancer-cast-ai-trial-100574808","NCT06764095","Enfortumab Vedotin and Pembrolizumab With Cystectomy and\u002For Ureterectomy for Locally Advanced or Metastatic Bladder and Upper Urothelial Tract Cancer, CAST-AI Trial","CAST-AI: Cystectomy After Systemic Therapy With ADC and Immunotherapy","Inclusion Criteria:\n\n* 18 years of age or older at the time of informed consent\n* Histologically proven urothelial carcinoma \\[American Joint Committee on Cancer (AJCC) 2017\\] of the bladder (BCa) or upper urothelial tract (UTUC), N+ and\u002For M+. Initial diagnosis must be within 90 days of planned date for treatment initiation\n\n  * The following variant histologic subtypes are permitted in any amount\n\n    * Urothelial with squamous differentiation\n    * Urothelial with sarcomatoid differentiation\n  * Mixed variant histologic subtypes are permitted if urothelial differentiation is predominant (e.g., \\\u003C 50% variant histologic subtype)\n* Willing to undergo cytoreductive cystectomy (CC) or ureterectomy (U) and deemed clinically a surgical candidate (presuming good response) by the attending urologist\n* Eastern Cooperative Oncology Group (ECOG) performance status grade 0, 1, or 2\n* Hemoglobin ≥ 8.0 g\u002FdL (obtained ≤ 28 days prior to registration)\n* Absolute neutrophil count (ANC) ≥ 1500\u002Fmm\\^3 (obtained ≤ 28 days prior to registration)\n* Platelet count ≥ 80,000\u002Fmm\\^3 (obtained ≤ 28 days prior to registration)\n* Alanine aminotransferase (ALT) OR aspartate transaminase (AST) ≤ 3.5 x upper limit of normal (ULN) (obtained ≤ 28 days prior to registration)\n* Total bilirubin ≤ 3 x ULN OR direct bilirubin ≤ 3 x ULN (obtained ≤ 28 days prior to registration)\n* Estimated glomerular filtration rate ≥ 15 ml\u002Fmin (obtained ≤ 28 days prior to registration)\n* Prior systemic chemotherapy for indications other than urothelial cell carcinoma of the bladder is permitted, but interval between this treatment and study enrollment must exceed 24 months\n* All adverse events associated with any prior surgery must have resolved to CTCAE version 5.0 grade \\\u003C 2 prior to registration\n* Must sign an informed consent form (ICF) indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study and agree to store samples when applicable\n* Ability to complete questionnaire(s) by themselves or with assistance\n* Willingness to provide mandatory blood specimens for correlative research\n* Willingness to provide tissue specimens for correlative research\n* Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)\n\nExclusion Criteria:\n\n* The following histologic variants\u002Fdivergent differentiation are excluded from trial participation:\n\n  * Presence of urothelial carcinoma with histologic variants comprising \\> 50% of histology\n  * Any amount: neuroendocrine, micropapillary, or signet ring cell features\n* Prior systemic chemotherapy for urothelial cell carcinoma of the bladder at any time (excluding intravesicular therapies)\n* Known active malignancies (i.e., progressing or requiring treatment change in the last 24 months) other than the disease being treated under study. The only allowed exceptions are:\n\n  * Skin cancer (non-melanoma or melanoma) that is considered completely cured\n  * Non-invasive cervical cancer treated that is considered completely cured\n  * Breast cancer:\n\n    * Adequately treated lobular carcinoma in situ or ductal carcinoma in situ considered to have a very low risk of recurrence\n  * Localized prostate cancer (T1c\u002FT2N0M0):\n\n    * Gleason score 6, treated by either surgery or ablation within the last 24 months or untreated and under active surveillance\n    * Gleason score 3+4 that has been treated (may include surgery or ablation) within the last 24 months and considered to have a very low risk of recurrence (i.e., cT1c or pT2 on prostatectomy specimen)\n* Received prior systemic chemotherapy or targeted small molecule therapy (excluding hormonal therapy) within 2 years prior to starting study treatment\n* History of uncontrolled adrenal insufficiency\n* History of uncontrolled cardiovascular disease including any of the following in the preceding 6 months: unstable angina, myocardial infarction, ventricular fibrillation, Torsades de Pointes, cardiac arrest, or known congestive New York Heart Association class III-IV heart failure, cerebrovascular accident, or transient ischemic attack; pulmonary embolism or other venous thromboembolism\n* Known active tuberculosis\n* Is receiving immunosuppression for an allogeneic tissue\u002Fsolid organ transplant\n* Participants with an active autoimmune disease requiring systemic treatment. Participants with autoimmune disorders not requiring systemic treatment (eg, skin conditions such as vitiligo or alopecia) or conditions requiring hormonal replacement therapies such as type 1 diabetes mellitus or hypothyroidism are permitted to enroll\n* Known clinically significant liver disease that precludes participant treatment regimens prescribed on the study (including, but not limited to active viral, alcoholic, or other autoimmune hepatitis, cirrhosis, or inherited liver disease)\n* Known human immunodeficiency virus (HIV) infection, unless the participant has been on a stable antiretroviral therapy regimen for the last 6 months or more and has had no opportunistic infections and a CD4 count of \\> 350 in the last 6 months\n* Known active hepatitis B or C infection \\[however, participants with history of hepatitis C infection but normal hepatitis C virus polymerase chain reaction test and participants with hepatitis B with positive hepatitis B surface antigen (HBsAg) antibody are allowed\\]\n* Known urinary tract infection (UTI), defined as a symptomatic infection with a positive urine culture with a bacterial count of ≥ 10\\^5 colony forming units (CFU)\u002FmL in urine voided from women, or \\> 104 CFU\u002FmL in urine voided from men, or in straight catheter urine from women. Symptoms may include dysuria, urgency, frequency, and\u002For systemic symptoms such as fever, chills, elevated white blood cell, and\u002For abdominal\u002Fflank pain. Participants free from symptoms for 7 days with no culture evidence of ≥ 10\\^5 CFUs may be eligible\n* Known active, uncontrolled urogenital bacterial, viral or fungal infections, including UTI. Skin\u002Fnail fungal infections are not exclusionary. Participants with active shingles (varicella zoster infection) will be excluded from the study\n* Evidence of interstitial lung disease or active non-infectious pneumonitis\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, unstable angina pectoris, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Participants who have had a history of acute diverticulitis, intra-abdominal abscess, gastrointestinal obstruction and abdominal carcinomatosis which are known risk factors for bowel perforation\n* Known history of impaired wound healing capacity defined as skin\u002Fdecubitus ulcers, chronic leg ulcers, known gastric ulcers, or unhealed incisions\n* Pelvic radiotherapy administered at any time\n* Received a live virus vaccine within 30 days of planned start of study treatment\n* Active autoimmune disease that has required systemic treatment in the past 2 years\n* Active infection requiring systemic intravenous therapy within 30 days prior to planned treatment initiation\n* Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-cytotoxic T-lymphocyte antigen-4 (CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways\n* Participants with a history of grade ≥ 3 toxic effects when using anti-tumor necrosis factor (TNF) or anti-interleukin (IL)-6 agents are excluded\n* Participants still recovering from toxicity of prior anticancer therapy which was received more than 24 months prior to enrollment (except toxicities which are not clinically significant such as alopecia, skin discoloration)\n* Participants who require immunosuppressive medications including but not limited to systemic corticosteroid at doses \\> 10 mg\u002Fday of prednisone or its equivalence, methotrexate, cyclosporine, azathioprine, and TNF alpha blockers. Use of immunosuppressive medications for the management of immune related adverse events, infusion related reactions, or in participants with contrast allergies is acceptable. Use of inhaled, topical, and intranasal corticosteroids are permitted\n* Participants with a history of allergy to protein-based therapies and participants with a history of any significant drug allergy (such as anaphylaxis, hepatotoxicity, or immune mediated thrombocytopenia or anemia) are excluded\n* Currently participating or has participated in a study of an investigational agent and received study therapy or investigational device within 4 weeks prior to enrollment\n* Participants who have not recovered from the effects of major surgery or significant traumatic injury at least 14 days before registration \\[transurethral resection of bladder tumor (TURBT) is not considered major surgery\\]. Note: Participants with planned surgical procedures to be conducted under local anesthesia may participate\n* Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown\n\n  * Pregnant persons\n  * Nursing persons\n  * Persons of childbearing potential or able to father a child who are unwilling to employ adequate contraception\n* Any condition for which, in the opinion of the Investigator, participation would not be in the best interest of the participants (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments\n* The participant is unable to comply with the requirements of this protocol, including any factors that are likely to affect the participant's return for scheduled visits and follow-up",{"count":54,"type":21},75,[56],"PHASE4","This phase IV trial tests the impact of standard of care enfortumab vedotin and pembrolizumab followed by removal of all or part of the bladder (cytoreductive cystectomy) and\u002For removal of all or part of the tube that carriers urine from the kidneys to the bladder (ureterectomy) on outcomes in patients with bladder and upper urothelial tract that has spread to nearby tissue or lymph nodes (locally advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). Enfortumab vedotin is a monoclonal antibody, enfortumab, linked to an anticancer drug called vedotin. It works by helping the immune system to slow or stop the growth of tumor cells. Enfortumab attaches to a protein called nectin-4 on tumor cells in a targeted way and delivers vedotin to kill them. It is a type of antibody-drug conjugate. 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. Giving standard of care enfortumab vedotin and pembrolizumab followed by cytoreductive cystectomy and\u002For ureterectomy (CC\u002FU) may improve outcomes in patients with locally advanced or metastatic bladder or upper urothelial tract cancer.",[59,60,27,28,61,62,63],"Locally Advanced Bladder Urothelial Carcinoma","Locally Advanced Renal Pelvis and Ureter Urothelial Carcinoma","Stage III Bladder Cancer AJCC v8","Stage IV Bladder Cancer AJCC v8","Stage IV Renal Pelvis and Ureter Cancer AJCC v8","2026-02-10",{"date":66,"type":37},"2026-02-12",{"date":68,"type":37},"2025-01-08",{"date":70,"type":21},"2034-12-31",{"name":43,"class":44},{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":79,"sex":80,"minAge":18,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":83,"phases":4,"briefSummary":84,"conditions":85,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":45},"100136749","collecting-and-studying-blood-and-tissue-samples-from-patients-with-locally-recurrent-or-metastatic-prostate-or-bladderurothelial-cancer-100136749","NCT01050504","Collecting and Studying Blood and Tissue Samples From Patients With Locally Recurrent or Metastatic Prostate or Bladder\u002FUrothelial Cancer","Molecular Correlates of Sensitivity and Resistance to Therapy in Genitourinary Malignancy","Inclusion Criteria:\n\n* Patients with localized and\u002For metastatic bladder\u002Furothelial or prostate cancer who have disease in the primary organ, biopsy accessible bone metastases (collaborating radiologists will determine if bone metastasis is appropriate for biopsy) or soft tissue metastases are eligible; men and women without cancer are eligible to have blood or normal tissue collected if acquired as part of non-research procedures (e.g. transurethral resection of the prostate or bladder); in patients without malignancy, no additional tissue beyond that necessary for care will be procured\n* Ability to adequately understand and give informed consent\n* Local or metastatic disease to soft tissue or bone at sites accessible to biopsy with minimal risk of complications Or the ability to obtain tissue with minimal risk of complication from a surgical procedure being conducted as a part of another research study Or for standard of care purposes or patients who have archival tissue collected for research or standard of care who are willing to donate archival tissue for this study\n* Alternatively, men and women without cancer or who are at risk of developing cancer are eligible to have blood or normal tissue collected if acquired; tissue will only be acquired as part of non-research procedures (e.g. transurethral resection of the prostate or bladder; in patients without malignancy, no additional tissue beyond that necessary for care will be procured\n* Platelet count \\> 50,000\n* White blood cell (WBC) \\> 1,500\n* Hemoglobin (Hgb) \\> 8.0\n* International normalized ratio (INR) \\\u003C 1.5\n* Partial thromboplastin time (PTT) \\\u003C 45\n* No history of excessive unexplained bleeding from previous surgery\n\nExclusion Criteria:\n\n* Patients unable to stop chronic anticoagulation with warfarin or Lovenox for less than 3 days\n* Serious or uncontrolled infection\n* Treatment with a vascular endothelial growth factor (VEGF) inhibitor (such as Avastin) within the past 28 days",true,"MALE",{"count":82,"type":21},1500,"OBSERVATIONAL","This study collects and studies tissue and blood samples from patients with prostate or bladder\u002Furothelial cancer that has recurred (come back) at or near the same place as the original (primary) tumor or has spread to other parts of the body. Studying samples of blood and tissue samples from patients with prostate or bladder\u002Furothelial cancer in the laboratory may help doctors learn more about new biomarkers, potential drug targets, and resistance developing in response to treatment. It may also help doctors find better ways to treat the cancer.",[86,87,88,89,28,90,91,92,31,93,94],"Localized Renal Pelvis and Ureter Urothelial Carcinoma","Malignant Solid Neoplasm","Metastatic Malignant Neoplasm in the Bone","Metastatic Malignant Neoplasm in the Soft Tissues","Recurrent Bladder Carcinoma","Recurrent Prostate Carcinoma","Recurrent Renal Pelvis and Ureter Urothelial Carcinoma","Stage IV Bladder Urothelial Carcinoma AJCC v7","Stage IV Prostate Cancer AJCC v7","2026-01-13",{"date":97,"type":37},"2026-01-15",{"date":99,"type":4},"2009-08",{"date":101,"type":21},"2029-01-31",{"name":103,"class":44},"University of Washington"]