[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"renal-pelvis-and-ureter-urothelial-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:renal-pelvis-and-ureter-urothelial-carcinoma":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,41,66,90],{"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":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100410765","phase-2-testing-the-addition-of-medi4736-durvalumab-to-chemotherapy-before-surgery-for-patients-with-high-grade-upper-urinary-tract-cancer-100410765",false,"NCT04628767","Testing the Addition of MEDI4736 (Durvalumab) to Chemotherapy Before Surgery for Patients With High-Grade Upper Urinary Tract Cancer","A Phase II\u002FIII Trial of Durvalumab and Chemotherapy for Patients With High Grade Upper Tract Urothelial Cancer Prior to Nephroureterectomy","Inclusion Criteria:\n\n* STEP 1 REGISTRATION AND RANDOMIZATION\n* Patients must be \\>= 18 years of age\n* Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and\u002For family member available will also be considered eligible\n* Patient must have a diagnosis of high grade upper tract urothelial carcinoma expected within 14 weeks (98 days) prior to registration\u002Frandomization with one of the following:\n\n  * Biopsy (gold standard, preferred) and either upper urinary tract mass on cross-sectional imaging or tumor directly visualized during upper urinary tract endoscopy\n  * High grade cytology and clinically estimated invasive upper urinary tract mass on cross-sectional imaging (e.g., including presence of tumor-related hydronephrosis) or tumor directly visualized during upper urinary tract endoscopy\n\n    * NOTE: Universal histologic testing of UTUC with additional studies, such as immunohistochemistry and\u002For microsatellite instability, is strongly recommended to identify patients with high probability of Lynch-related or other germline mutation related cancers whom clinicians should refer for genetic counseling and germline testing (this is not required for eligibility)\n\n      * Due to the anatomy of upper urinary tract and lack of muscularis propria, pathologic evidence of cT2 on biopsy is usually not possible\n* Patients must not have any component of small cell\u002Fneuroendocrine carcinoma. Other histologic subtypes (variants) are permitted provided the half or predominant (\\>= 50%) subtype is conventional urothelial carcinoma\n* Leukocytes \\>= 3,000\u002FmcL (obtained =\\\u003C 14 days prior to registration\u002Frandomization)\n* Platelets \\>= 100,000\u002FmcL (obtained =\\\u003C 14 days prior to registration\u002Frandomization)\n* Total bilirubin =\\\u003C 1.2 mg\u002FdL (or ≤ 2 mg\u002FdLfor patients with Gilbert's disease)\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) =\\\u003C 2 x institutional ULN (obtained =\\\u003C 14 days prior to registration\u002Frandomization)\n* Hemoglobin (Hgb) \\>= 9 g\u002FdL (obtained =\\\u003C 14 days prior to registration\u002Frandomization)\n\n  * NOTE: Packed red blood transfusion is allowed to achieve this parameter as per treating investigator\n* Patients must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. All patients of childbearing potential must have a blood test or urine study within 14 days prior to registration to rule out pregnancy. A patient of childbearing potential is defined as any patient, regardless of whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)\n* Patients of childbearing potential and sexually active patients must not expect to conceive or father children, either by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse from the time of registration, while on study treatment and for at least 6 months after the last dose of protocol treatment\n* Patients must have no evidence of metastatic disease or clinically enlarged regional lymph nodes (\\>= 1.5 cm short axis) on imaging required within 28 days prior to registration (Non-regional findings \\>=1.5 cm short axis that in the opinion of the investigator are not concerning for involvement based on radiographic characteristics, chronicity, avidity on positron emission tomography (PET) scan or other imaging or other criteria can be eligible based on investigator discretion).\n\n  * NOTE: Patients with elevated alkaline phosphatase, calcium or suspicious bone pain\u002Ftenderness can also undergo baseline bone scan to evaluate for bone metastasis at the discretion of local provider.\n* Patient must meet below criteria for prior\u002Fcurrent malignancy history:\n\n  * Non-urothelial cancer malignancy history:\n\n    * Patient must not have another active (or within two years) second malignancy other than resected non-melanoma skin cancers, resected in situ breast, cervical or other in situ carcinoma, and either clinically insignificant per the investigator (e.g. =\\\u003C Gleason 3+4) on active surveillance (or watchful waiting) or previously treated prostate cancer with no rising prostate specific antigen (PSA) and no plan to treat\n\n      * NOTE: Patients with 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    * Urothelial cancer malignancy history:\n\n      * Patient may have a history of resectable urothelial cancer as long as patients meet one of the following:\n      * T0, Ta or Tis at any time\n      * T1-4a N0 and no evidence of disease (NED) for more than 2 years from the latest therapy \\[e.g., radical surgery, transurethral resection of bladder tumor (TURBT), radiation, chemotherapy (neoadjuvant or adjuvant, or with radiation)\\]. Prior systemic immune checkpoint inhibitor is not allowed.\n      * Patient with history of \\>= pT4b, N+, and\u002For M1 UC is not eligible.\n      * NOTE: Patients in whom concomitant or prior bladder\u002Furethra predominant (\\>= 50%) urothelial carcinoma have been surgically resected and demonstrated to be only Ta or carcinoma in situ (CIS) (\\\u003C cT1 N0) are eligible regardless of time elapsed\n* Patient must not have any uncontrolled illness including, but not limited to, ongoing or active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis testing in line with local practice), symptomatic congestive heart failure (CHF), myocardial infarction (MI) or unstable angina pectoris, significant uncontrolled cardiac arrhythmia, clinically relevant liver cirrhosis, interstitial lung disease, or psychiatric illness\u002Fsocial situations in the three months prior to registration that would limit compliance with study requirements\n* Patient must not have received prior radiation therapy to \\>= 25% of the bone marrow for other diseases\n* Patient must not have received prior systemic anthracycline therapy\n\n  * NOTE: Patients who have received prior intravesical therapy at any time for non-muscle invasive urothelial carcinoma of the bladder are eligible\n* Patient must not have either history of or active autoimmune disease requiring immunosuppressive therapy within 2 years prior to registration\u002Frandomization or any history of inflammatory bowel disease (inflammatory bowel disease \\[IBD\\], e.g. ulcerative colitis, or Crohn's disease), neuromuscular autoimmune condition, immune-related pneumonitis or interstitial lung disease. Patients with well-controlled hyper\u002Fhypothyroidism, celiac controlled by diet alone, diabetes mellitus type I, vitiligo, alopecia, psoriasis, eczema, lichen planus, or similar skin\u002Fmucosa condition are eligible\n* Patient must not be on or have used immunosuppressive medication within 14 days prior to the first dose of durvalumab. The following are exceptions to this criterion and are allowed:\n\n  * Intranasal, inhaled, intra-auricular, topical steroids, or local steroid injections (e.g. intra-articular injection\n  * Systemic corticosteroids at physiologic doses not to exceed 10 mg\u002Fday of prednisone or its equivalent at the time of enrollment\n  * Steroids as pre-medications for hypersensitivity reactions (e.g. computed tomography \\[CT\\] pre-medication)\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration\u002Frandomization are eligible for this trial\n\n  * NOTE: These patients must be stable on their anti-retroviral regimen with evidence of at least two undetectable viral loads within the past 6 months on the same regimen; the most recent undetectable viral load must be within the past 12 weeks. They must have a CD4 count of greater than 250 cells\u002FmcL over the past 6 months on this same anti-retroviral regimen and must not have had a CD4 count \\\u003C 200 cells\u002FmcL over the past 2 years, unless it was deemed related to the cancer and\u002For chemotherapy induced bone marrow suppression. They must not be currently receiving prophylactic therapy for an opportunistic infection and must not have had an opportunistic infection within the past 6 months\n  * NOTE: For patients who have received chemotherapy in the past 6 months, a CD4 count \\\u003C 250 cells\u002FmcL during chemotherapy is permitted as long as viral loads were undetectable during this same chemotherapy. They must have an undetectable viral load and a CD4 count \\>= 250 cells\u002FmcL within 7 days of registration\u002Frandomization\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n\n  * NOTE: Testing for HIV, hepatitis B or hepatitis C is not required unless clinically indicated\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and have undetectable viral load. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* 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. To be eligible for this trial, patients should be class 2B or better\n* Patient must not have received live attenuated vaccine within 30 days prior to the first dose of durvalumab, while on protocol treatment and within 30 days after the last dose of durvalumab\n* Patient must not have had a major surgical procedure within 28 days prior to registration\u002Frandomization\n\n  * NOTE: Cystoscopy\u002Fureteroscopy\u002FTURBT, stent placement or nephrostomy tube is not considered major surgery\n* Patient must not have history of allogenic organ transplantation\n* Patient must have a body weight of \\> 30 kg\n* Patient must have life expectancy of \\>= 12 weeks\n* Patient must have creatinine clearance \\> 15 ml\u002Fmin as estimated by Cockcroft-Gault formula or glomerular filtration rate (GFR) \\> 15 ml\u002Fmin\u002F1.73m\\^2 within 28 days prior to registration\u002Frandomization\n\n  * NOTE: Patients will be assigned to cisplatin-ineligible and cisplatin-eligible cohorts based on their creatinine clearance, Eastern Cooperative Oncology Group (ECOG) performance status, and grade (if any) of peripheral neuropathy and\u002For hearing loss in keeping with recommended cisplatin contraindications. Patients who are cisplatin-eligible will be randomized to either Arm A or Arm B and patients who are cisplatin-ineligible will be registered to Arm C\n\n    * Patients that meet any of the following four criteria will be registered to the cisplatin-ineligible Arm C if they meet other eligibility criteria:\n\n      * Creatinine clearance \\> 15 ml\u002Fmin and =\\\u003C 50 ml\u002Fmin (estimated by Cockcroft-Gault formula) or GFR \\> 15ml\u002Fmin\u002F1.73m\\^2 and ≤ 50 ml\u002Fmin\u002F1.73 m\\^2\n      * Hearing loss \\>= 3\n      * Neuropathy \\>= 2\n      * ECOG performance status 2\n    * In addition, the patient must have an absolute neutrophil count (ANC) \\>= 1,000\u002FmcL obtained =\\\u003C 14 days prior to registration\n    * Patients that meet all of the following four criteria will be randomized to the cisplatin-eligible Arm A or Arm B:\n\n      * Creatinine clearance \\> 50ml\u002Fmin (estimated by Cockcroft-Gault formula) or GFR \\> 50ml\u002Fmin\u002F1.73m\\^2\n      * ECOG performance status 0-1\n      * Hearing loss grade 0-2\n      * Neuropathy 0-1\n    * In addition, the patient must have an absolute neutrophil count (ANC) \\>= 1,500\u002FmcL obtained =\\\u003C 14 days prior to randomization\n    * Also, the patient must have left ventricular ejection fraction (LVEF) \\>= 50% by (either multigated acquisition scan \\[MUGA\\] or 2-D echocardiogram) obtained within obtained within 28 days prior to randomization","ALL","18 Years",{"count":19,"type":20},131,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE2","PHASE3","This phase II\u002FIII trial compares the effect of adding durvalumab to chemotherapy versus chemotherapy alone before surgery in treating patients with upper urinary tract cancer. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as methotrexate, vinblastine, doxorubicin, cisplatin, and gemcitabine 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. Durvalumab in combination with chemotherapy before surgery may enhance the shrinking of the tumor compared to chemotherapy alone.",[27],"Renal Pelvis and Ureter Urothelial Carcinoma","RECRUITING","2026-06-27",{"date":31,"type":32},"2026-06-30","ACTUAL",{"date":34,"type":32},"2021-11-12",{"date":36,"type":20},"2027-09-30",{"name":38,"class":39},"National Cancer Institute (NCI)","NIH",258,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":65},"100639280","office-based-ureteroscopy-utilizing-a-single-use-digital-flexible-ureteroscope-for-upper-tract-urothelial-carcinoma-100639280","NCT07630155","Office-Based Ureteroscopy Utilizing a Single Use Digital, Flexible Ureteroscope for Upper Tract Urothelial Carcinoma","A Prospective Clinical Assessment of Office-Based Ureteroscopy for Upper Tract Urothelial Carcinoma Utilizing a 6.3 French Single Use Digital Flexible Ureteroscope","Inclusion Criteria:\n\n* Provision of signed and dated informed consent form\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n* Male or female, aged ≥ 18 year. Both sexes are included to reflect the patient population with upper tract urothelial carcinoma (UTUC) already being followed at the University of Michigan and allow exploration of potential differences in tolerability of awake ureteroscopy based on sex\n* History of endoscopically managed UTUC at any time, or a suspected diagnosis of UTUC based on pre-procedure imaging, and is already planned for office-based ureteroscopic assessment\n* Ability and willingness to complete and adhere to survey questions and responses throughout study duration\n\nExclusion Criteria:\n\n* Known ureteral strictures\n* Active urinary tract infection\n* Need for general anesthesia due to patient or procedural factors\n* History of inability to tolerate ureteroscopy under local anesthetic\n* Anticipated need for laser ablation during the surveillance procedure\n* Pregnancy",{"count":49,"type":20},10,[51],"NA","This clinical trial tests how well office based ureteroscopy utilizing a single use digital, flexible ureteroscope works for the assessment of upper tract urothelial carcinoma. Ureteroscopy is a procedure in which a thin camera called a ureteroscope is used to assess patients with a known or suspected diagnosis of upper tract urothelial carcinoma. Ureteroscopy is traditionally performed in an operating room under general anesthesia. In this study, patients undergo ureteroscopy in the doctor's office using an ultra-thin ureteroscope, which is the narrowest instrument of its kind. Because of its small size, researchers believe this procedure can be completed in the office with minimal discomfort and high patient satisfaction, which may eliminate the risks of general anesthesia and reduce delays to diagnosis. Office based ureteroscopy utilizing a single use digital, flexible ureteroscope may be effective for the assessment of upper tract urothelial carcinoma.",[27],"NOT_YET_RECRUITING","2026-06-01",{"date":57,"type":32},"2026-06-05",{"date":59,"type":20},"2026-07-18",{"date":61,"type":20},"2027-07",{"name":63,"class":64},"University of Michigan Rogel Cancer Center","OTHER",1,{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":4,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":73,"targetDuration":4,"studyType":21,"phases":75,"briefSummary":76,"conditions":77,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":65},"100519224","a-home-based-prehabilitation-exercise-intervention-for-improving-physical-function-in-patients-with-bladder-cancer-and-upper-tract-urothelial-cancer-get-moving-trial-100519224","NCT06040762","A Home-Based Prehabilitation Exercise Intervention for Improving Physical Function in Patients With Bladder Cancer and Upper Tract Urothelial Cancer, Get Moving Trial","The \"Get Moving Trial\": A Phase I\u002FII RCT of Home-Based (P)Rehabilitation With ExerciseRx in Bladder Cancer and Upper Tract Urothelial Cancer","Inclusion Criteria:\n\n* 18 years of age or older\n* English-speaking\n* Planned treatment with radical cystectomy or radical nephroureterectomy\u002Fureterectomy with or without preceding systemic therapy as indicated by the patient's surgeon with enough time to complete a minimum of 4 weeks of exercises before surgery if enrolled in the (P)REHAB arm\n* Willing and able to participate in trial activities\n\nExclusion Criteria:\n\n* Cognitive\u002Fmental impairment that will preclude ability to participate in routine exercise activities. Significant cognitive or memory impairment or baseline dementia that would preclude a patient's ability to follow instructions or reproduce exercises\n* Immobility, inability\u002Funwillingness to perform personalized exercise program. Inability to perform exercises safely from seated or standing position at home or recent falls or high fall risk. Neurologic or orthopedic condition(s) that restricts participation in unsupervised home exercises, such as prior stroke with neurologic impairment, weight-bearing precautions, or unwillingness to participate in exercises\n* Participants who have nonmuscle-invasive urothelial cancer of the bladder\u002Fupper tract anticipating undergoing organ-preserving treatments, or radiographic evidence of metastatic disease involving other organs including brain metastases.\n* Patients with predominant histology other than urothelial carcinoma of the bladder or upper tracts (e.g. metastasis from another cancer) who would not otherwise be considered candidates for standard definitive or consolidative surgeries (radical cystectomy, ureterectomy, radical nephroureterectomy) with\u002Fwithout treatment with preoperative\u002Fneoadjuvant systemic therapy.\n* Uncontrolled or concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Pregnant women are excluded from this study\n* Inability to understand or read English\n* Lack of access or lack of sufficient facility to use an Android or iOS smart device with the minimum criteria for using ExerciseRx\n* Not receiving surgery at UWMC\n* Participation in a clinical trial that does not permit enrollment in the Get Moving trial",{"count":74,"type":20},128,[51],"Prehabilitation refers to the process of improving a patient's functional capabilities prior to a surgical procedure with the goal of decreasing post-surgical inactivity and physical decline. This clinical trial evaluates the utility of a personalized home-based prehabilitation exercise intervention for the improvement of physical function and surgical outcomes in patients with urothelial carcinoma undergoing definitive or consolidative surgery of the bladder (radical cystectomy) or upper tract (nephroureterectomy, ureterectomy) with or without preceding neoadjuvant\u002Fsystemic therapy. The exercise intervention includes at-home exercise sessions focused on the improvement of core strength and balance as well as personalized step count goals, delivered to patients remotely via a smart-device-based application (ExerciseRx). Encouraging physical activity before surgery may improve physical function and surgical outcomes in patients who are scheduled to undergo surgery for their bladder or urothelial cancer.",[78,79,80,27],"Bladder Cancer","Urothelial Carcinoma","Upper Tract Urothelial Carcinoma","2026-02-26",{"date":83,"type":32},"2026-03-02",{"date":85,"type":32},"2023-12-19",{"date":87,"type":20},"2027-04-30",{"name":89,"class":64},"University of Washington",{"id":91,"slug":92,"hasResults":11,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":4,"eligibilityCriteria":96,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":97,"targetDuration":4,"studyType":21,"phases":99,"briefSummary":100,"conditions":101,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":65},"100498839","phase-2-pembrolizumab-and-enfortumab-vedotin-with-pembrolizumab-prior-to-and-after-radical-nephroureterectomy-for-high-risk-upper-tract-urothelial-cancer-100498839","NCT05775471","Pembrolizumab and Enfortumab Vedotin With Pembrolizumab Prior to and After Radical Nephroureterectomy for High-Risk Upper Tract Urothelial Cancer","Neoadjuvant Combination Pembrolizumab \u002F Enfortumab Vedotin With Adjuvant Pembrolizumab Prior to and After Radical Nephroureterectomy for High-Risk Upper Tract Urothelial Carcinoma","Inclusion Criteria:\n\n* Male\u002Ffemale participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of high-risk upper tract urothelial carcinoma will be enrolled in this study\n* Male participants: A male participant must agree to use a contraception during the treatment period and for at least 6 months after the last dose of study treatment and refrain from donating sperm during this period\n* Female participants: A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:\n\n  * Not a woman of childbearing potential (WOCBP) OR\n  * A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 6 months after the last dose of study treatment\n* Have provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archived tissue\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Evaluation of ECOG is to be performed within 7 days prior to the first dose of study intervention\n* Absolute neutrophil count (ANC) \\>= 1500\u002FuL (Specimens must be collected within 10 days prior to the start of study intervention)\n* Platelets \\>= 100000\u002FuL (Specimens must be collected within 10 days prior to the start of study intervention)\n* Hemoglobin \\>= 9.0 g\u002FdL or \\>= 5.6 mmol\u002FL (Specimens must be collected within 10 days prior to the start of study intervention)\n* Creatinine =\\\u003C 1.5 x upper limit of normal (ULN) OR measured or calculated creatinine clearance (glomerular filtration rate (GFR) can also be used in place of creatinine or creatinine clearance \\[CrCl\\]) (Specimens must be collected within 10 days prior to the start of study intervention) \\>= 30 mL\u002Fmin for participant with creatinine levels \\> 1.5 x institutional ULN\n* Total bilirubin =\\\u003C1.5 ×ULN OR direct bilirubin =\\\u003C ULN for participants with total bilirubin levels \\> 1.5 × ULN (Specimens must be collected within 10 days prior to the start of study intervention)\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\]) and alanine aminotransferase (ALT) (serum glutamic-pyruvic transaminase \\[SGPT\\]) =\\\u003C 2.5 x ULN (=\\\u003C 5 x ULN for participants with liver metastases) (Specimens must be collected within 10 days prior to the start of study intervention)\n* International normalized ratio (INR) OR prothrombin time (PT) activated partial thromboplastin time (aPTT) =\\\u003C 1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants (Specimens must be collected within 10 days prior to the start of study intervention)\n\nExclusion Criteria:\n\n* A WOCBP who has a positive urine pregnancy test within 72 hours prior to allocation. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n\n  * Note: in the event that 72 hours have elapsed between the screening pregnancy test and the first dose of study treatment, another pregnancy test (urine or serum) must be performed and must be negative in order for subject to start receiving study medication\n* 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)\n* Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks \\[could consider shorter interval for kinase inhibitors or other short half-life drugs\\] prior to allocation\n\n  * Note: Participants must have recovered from all adverse events (AEs) due to previous therapies to =\\\u003C grade 1 or baseline. Participants with =\\\u003C grade 2 neuropathy may be eligible. Participants with endocrine-related AEs grade =\\\u003C 2 requiring treatment or hormone replacement may be eligible\n  * Note: If the participant had major surgery, the participant must have recovered adequately from the procedure and\u002For any complications from the surgery prior to starting study intervention\n* Has received prior radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (=\\\u003C 2 weeks of radiotherapy) to non-central nervous system (CNS) disease\n* Has received a live vaccine within 30 days prior to the first dose of study drug. 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 (eg, FluMist registered trademark) are live attenuated vaccines and are not allowed\n* Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention\n* 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\n* Has a known additional malignancy that is progressing or has required active treatment within the past 2 years. Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (eg, breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded\n* Has known active CNS metastases and\u002For carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e. without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study intervention\n* Has severe hypersensitivity (\\>= grade 3) to pembrolizumab and\u002For any of its excipients\n* 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\n* Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis\n* Has an active infection requiring systemic therapy\n* Has a known history of Human Immunodeficiency Virus (HIV) infection. However, subjects who are on anti-retroviral therapy, have a viral load \\\u003C 200 copies\u002Fmilliliter, and CD4 count \\> 200\u002Fmicroliter, with a low risk of acquired immunodeficiency syndrome (AIDS)-related outcomes will be considered for enrollment.\n\n  * Note: No HIV testing is required unless mandated by local health authority\n* Has a known history of Hepatitis B (defined as Hepatitis B surface antigen \\[HBsAg\\] reactive) or known active Hepatitis C virus (defined as HCV ribonucleic acid \\[RNA\\] is detected) infection. Subjects who have underwent treatment with stable hepatitis B (defined as HBV deoxyribonucleic acid \\[DNA\\] \\\u003C 500 IU\u002FmL) are eligible. Patients with prior curative treatment of Hepatitis C virus are allowed if previously treated \\> 2 weeks prior to treatment initiation and HCV RNA undetectable by established laboratory values. Note: no testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator\n* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial\n* Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment\n* Has had an allogenic tissue\u002Fsolid organ transplant\n* Subjects who have previously received enfortumab vedotin or other MMAE-based ADCs\n* Subjects with an estimated life expectancy \\\u003C 12 weeks\n* Subjects with known severe (\\>= grade 3) hypersensitivity to any enfortumab vedotin excipient contained in the drug formulation of enfortumab vedotin (including histidine, trehalose dihydrate, and polysorbate 20). Subjects with known severe (\\>= grade 3) hypersensitivity to any pembrolizumab excipient contained in the drug formulations of pembrolizumab\n* Subjects with another underlying medical condition that, in the opinion of the investigator, would impair the ability of the subject to receive or tolerate the planned treatment and follow-up; any known psychiatric or substance abuse disorders that would interfere with cooperating with the requirements of the study\n* Subjects with active keratitis or corneal ulcerations. Subjects with superficial punctate keratitis are allowed if the disorder is being adequately treated in the opinion of the investigator",{"count":98,"type":20},21,[23],"This phase II clinical trial tests how well pembrolizumab plus enfortumab vedotin prior to and after radical nephroureterectomy works in treating patients with high-risk upper tract urothelial cancer. 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. Enfortumab vedotin (EV) 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. Radical nephroureterectomy (RNU) is the surgical removal of a kidney and its ureter. Giving pembrolizumab plus enfortumab vedotin before surgery may make the tumor smaller and may reduce the amount of normal tissue that needs to be removed and giving pembrolizumab after surgery may kill any remaining cancer cells.",[27],"2026-02-03",{"date":104,"type":32},"2026-02-05",{"date":106,"type":32},"2024-06-26",{"date":108,"type":20},"2028-12-01",{"name":110,"class":64},"Jonsson Comprehensive Cancer Center"]