[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"stage-i-bladder-cancer-ajcc-v8\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:stage-i-bladder-cancer-ajcc-v8":151},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,42,67,91,115,133],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":10,"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},"100592949",false,"NCT07000084","Testing the Addition of an Anti-Cancer Drug, Gemcitabine, to Usual Treatment (BCG Alone) in People Whose Non-Muscle Invasive Bladder Cancer (NMIBC) Came Back After Prior BCG Therapy","GAIN-BCG: Gemcitabine Alternating With INtravesical BCG Randomized Against BCG Alone for Patients With Recurrent High Grade Non-Muscle Invasive Bladder Cancer","GAIN-BCG","Inclusion Criteria:\n\n* Documentation of Disease: Histologic confirmation of urothelial carcinoma that is high grade Ta, high grade T1, or Tis (Tis\u002Fcarcinoma in situ \\[CIS\\] only disease) within 120 days prior to randomization\n* Any component of neuroendocrine carcinoma (i.e., small cell or large cell) is not allowed. Other histologic subtypes\u002Fvariant histologies are allowed so long as there is a predominantly urothelial component.\n\n  \\* Note: Pure squamous cell carcinoma or pure adenocarcinoma without a urothelial component are not allowed\n* All visible papillary lesions must be macroscopically resected by TURBT within 90 days of randomization. (Residual CIS is permitted).\n\n  \\* If the treating urologist did not perform the TURBT, the treating urologist must perform a cystoscopy within 45 days prior to randomization to confirm the absence of visible papillary disease\n* All patients with high grade T1 must undergo a restaging TURBT within 90 days of randomization. Patients who undergo a restaging TURBT that shows no residual cancer in the specimen are still eligible for trial based on prior TURBT\n* Patients must have BCG-Exposed non muscle invasive bladder carcinoma (NMIBC), defined as recurrent high grade NMIBC within 24 months of last BCG exposure but not meeting the definition of BCG unresponsive disease\n\n  * Note: Up to 26 months from the last BCG instillation is allowed for the treating physician to perform a transurethral resection of bladder tumor (TURBT) so long as there is evidence\u002Fsuspicion of recurrent disease (by positive cytology, imaging, or cystoscopy) within 24 months of last exposure to BCG.\n  * Note: A patient who previously met the definition of BCG unresponsive NMIBC but no longer currently meets unresponsive criteria may still enroll in this trial so long as the treating urologist believes re-treatment with BCG is a reasonable treatment option for that patient.\n  * BCG-exposed NMIBC criteria is defined as:\n\n    * Any high grade NMIBC recurrence within 24 months of induction only BCG, or\n    * A high grade papillary NMIBC (Ta\u002FT1) recurrence between 6-24 months of last exposure to induction + maintenance BCG, or\n    * A high-grade CIS (with or without Ta\u002FT1 papillary disease) recurrence within 12-24 months of last exposure to induction + maintenance BCG.\n  * Patient must not have BCG-unresponsive NMIBC, defined as:\n\n    * Persistent or recurrent high-grade papillary NMIBC (Ta\u002FT1) \\\u003C 6 months of \"adequate\" BCG, or\n    * A high-grade CIS (with or without Ta\u002FT1 papillary disease) recurrence \\\u003C 12 months of \"adequate\" BCG, or\n    * A high grade T1 recurrence at the first 3-month assessment from induction BCG\n    * \"Adequate\" BCG is defined as ≥5 of 6 doses of induction BCG therapy with either\n\n      * ≥ 2 of 3 doses of maintenance BCG, or\n      * ≥ 2 of planned 6 instillations of repeat induction BCG given within a 6 month time period\n* More than one prior induction course of BCG and\u002For prior maintenance BCG is allowed so long as the patient does not currently met the definition of BCG unresponsive disease\n* Prior treatment with any intravesical chemotherapy (both perioperative and induction course) for NMIBC is allowed, including gemcitabine either alone or in combination (ie. gemcitabine plus docetaxel) or gemcitabine delivered through a intravesical delivery system (ie. TAR-200)\n* Prior treatment with any systemic or intravesical agents for NMIBC is allowed, regardless of whether it is given either alone or in prior combination with BCG (ie. Prior treatment with pembrolizumab, other immune checkpoint inhibitors, nadofaragene firadenovec, nogapendekin alfa inbakicept, cretostimogene grenadenorepvec, etc. are all allowed)\n* Patients must not have a history of intolerance to BCG (ie needing to stop BCG induction or maintenance due to toxicity) or intolerance to any other intravesical therapies\n* Patients must not have compromised bladder function such that they are unlikely to tolerate further intravesical therapies\n* Patient must not have any prior history or current evidence of muscle-invasive (i.e., T2, T3, T4), locally advanced unresectable, or metastatic urothelial carcinoma as assessed on radiographic imaging obtained within 120 days prior to randomization.\n\n  \\* The radiographic imaging includes a CT Scan or MRI of the abdomen\u002Fpelvis with intravenous contrast, with a CT or MRI urogram preferred. If a patient is unable to receive intravenous contrast due to renal function or allergy, then either a CT scan or MRI of the abdomen\u002Fpelvis without intravenous contrast is acceptable\n* Patients with a history of upper tract urothelial carcinoma are allowed so long as they had localized non-muscle invasive (Ta, T1, Tis) that has been definitively treated with surgery (nephroureterectomy or ureterectomy) with at least one post-treatment disease assessment imaging study that demonstrates no evidence of residual upper tract disease\n* Patients with a history of, or current evidence of, non-invasive (Ta\u002FTis) urothelial carcinoma of the prostatic urethra are eligible so long as a transurethral resection of prostate (TURP) is performed before enrollment and there is prostatic glandular tissue without evidence of lamina propria invasion or prostatic stromal invasion\n* HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* Age ≥ 18 years\n* 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* Not pregnant and not nursing, Patient 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 randomization to rule out pregnancy. A patient of childbearing potential is defined as anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria:\n\n  * has achieved menarche at some point\n  * has not undergone a hysterectomy or bilateral oophorectomy\n  * 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)","ALL","18 Years",{"count":19,"type":20},330,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","This phase III trial compares the effect of adding gemcitabine to intravesical Bacillus Calmette Guerin (BCG) versus intravesical BCG alone in patients with non-muscle invasive bladder cancer that has come back after a period of improvement (recurrent). Gemcitabine is a chemotherapy drug that blocks the cells from making deoxyribonucleic acid (DNA) and may kill cancer cells. Intravesical BCG is a solution containing the live BCG bacteria that is placed in the bladder via a catheter (intravesical). When the solution comes into direct contact with the bladder wall, it stimulates the body's immune system which kills tumor cells. Giving gemcitabine with intravesical BCG may kill more tumor cells in patients with recurrent non-muscle invasive bladder cancer.",[26,27,28],"Recurrent Non-Muscle Invasive Bladder Carcinoma","Stage 0a Bladder Cancer AJCC v8","Stage I Bladder Cancer AJCC v8","RECRUITING","2026-07-01",{"date":32,"type":33},"2026-07-02","ACTUAL",{"date":35,"type":33},"2025-07-17",{"date":37,"type":20},"2028-12-05",{"name":39,"class":40},"Alliance for Clinical Trials in Oncology","OTHER",58,{"id":43,"slug":4,"hasResults":10,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":66},"100575307","NCT06770582","Testing the Addition of the Immunotherapy Drug, Pembrolizumab, to Radiation Therapy Compared to the Usual Chemotherapy Treatment During Radiation Therapy for Bladder Cancer, PARRC Trial","Randomized Phase II Trial of Pembrolizumab and Radiation vs. Radiation and Concurrent Chemotherapy for High-Grade T1 Bladder Cancer (PARRC Trial)","Inclusion Criteria:\n\n* Pathologically (histologically) proven diagnosis of T1 high-grade non-muscle invasive urothelial carcinoma of the bladder without radiographic evidence of regional nodal disease or metastatic disease (N0, M0) on CT, MRI, or positron emission tomography (PET)\u002FCT scan who would otherwise be treated with cystectomy off-trial. Patients should have cystectomy recommended disease but do not need to be medically operable for a cystectomy to be eligible for the trial.\n\n  * NOTE: Patients with nodal disease ≥ 1 cm on short-axis or with suspicious nodes that are PET-avid of any size are not eligible\n* High grade T1 disease history that must meet at least ONE of the three criteria below:\n\n  * Histologically confirmed recurrence with high-grade T1 urothelial carcinoma (+\u002F- focal carcinoma in situ \\[CIS\\]) in the bladder following initial transurethral resection of bladder tumor (TURBT) and at least one induction course of intravesical therapy. Adequate induction course is defined as ≥ 5 doses of intravesical Bacillus Calmette-Guerin (BCG) or intravesical chemotherapy when BCG is not available.\n  * T1 with pathologic high-risk features (lymphovascular invasion \\[LVI\\] or variant histology of micropapillary, sarcomatoid, or plasmacytoid features) post initial TURBT. (No prior intravesical therapy required)\n  * Persistent high-grade T1 urothelial carcinoma at repeat TURBT (+\u002F- focal CIS) in the bladder. (No prior intravesical therapy required)\n* Restaging TURBT must be performed and must meet ALL of the following criteria below:\n\n  * If there is absence of muscularis propria in the initial TURBT, there must be uninvolved muscularis propria in the restaging TURBT.\n  * All grossly visible papillary tumors must be removed\n\n    * Note: If the restaging TURBT is performed outside of the enrolling institution, an office cystoscopy should be performed by a Urologist who will be following the patient as part of the clinical trial\n* No pure squamous cell carcinoma or adenocarcinoma of the bladder\n* No neuroendocrine (small or large cell) features\n* No diffuse carcinoma in situ determined on cystoscopy and biopsy (i.e. extensive carcinoma in situ that is not just tumor-associated CIS in the opinion of the site investigator)\n* No prostatic urethral involvement\n* Age ≥ 18\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2\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), tubal ligation or who is not postmenopausal\n* Absolute neutrophil count (ANC) ≥ 1,500 cells\u002Fmm\\^3\n* Platelets ≥ 100,000 cells\u002Fmm\\^3\n* Hemoglobin ≥ 9 g\u002Fdl (Note: The use of transfusion or other intervention to achieve hemoglobin \\[Hgb\\] ≥ 9 g\u002Fdl is acceptable)\n* Adequate renal function defined as creatinine clearance (CrCL) of ≥ 30 mL\u002Fmin by the Cockcroft-Gault formula, ≤ 1.5 × upper limit of normal (ULN) or creatinine levels \\> 1.5 × institutional ULN\n* Total bilirubin ≤ institutional upper limit of normal (ULN) (Not applicable to patients with known Gilbert's syndrome)\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 of their most recent therapy\u002Fintervention must have resolved to \\\u003C grade 3 or returned to baseline prior to registration\n* No history of pelvic radiation therapy\n* No prior systemic chemotherapy or immunotherapy for urothelial carcinoma. Prior treatment with local intravesical therapy including BCG or chemotherapy is allowed\n* No prior treatment with anti-PD-1, anti PD-L1, anti PD-L2 or anti-CTLA4 antibody or any other antibody or drug targeting T-cell co-stimulation\n* No live vaccine administered within 30 days of registration. All non live vaccines (including the coronavirus disease \\[COVID\\] vaccine) are allowed at any time during the study. Timing should minimize confusion with drug-related toxicities where possible\n* Patients must have recovered from acute cardiac illness\n* New York Heart Association Functional Classification II or better (New York Heart Association \\[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* No active autoimmune disease that required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment\n* No history of idiopathic pulmonary fibrosis, organizing pneumonia, (non-infectious) pneumonitis that required steroids or current pneumonitis\n* No history of allogeneic bone marrow transplant or prior solid organ transplant\n* No active tuberculosis\n* No evidence of hydronephrosis\n* No history of upper tract urothelial carcinoma within 24 months of registration\n* No patients with a prior diagnosis of prostate cancer who have not received definitive treatment for their prostate cancer (e.g. on active surveillance)\n* 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* No glucocorticoids except physiologic doses are allowed. The use of doses of corticosteroids (defined as 10 mg prednisone or equivalent) is acceptable\n* No history of allergic reaction to the drug excipients",{"count":49,"type":20},160,[51],"PHASE2","This phase II trial compares the use of pembrolizumab and radiation therapy to chemotherapy with cisplatin, gemcitabine, 5-fluorouracil or mitomycin-C and radiation therapy for the treatment of non-muscle invasive bladder 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. Chemotherapy drugs, such as cisplatin, gemcitabine, 5-fluorouracil or mitomycin-C, 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. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Giving pembrolizumab with radiation may kill more tumor cells than chemotherapy with radiation therapy in patients with non-muscle invasive bladder cancer.",[54,55,28],"Non-Muscle Invasive Bladder Urothelial Carcinoma","Recurrent Non-Muscle Invasive Bladder Urothelial Carcinoma","2026-06-19",{"date":58,"type":33},"2026-06-23",{"date":60,"type":33},"2025-06-03",{"date":62,"type":20},"2032-02-01",{"name":64,"class":65},"National Cancer Institute (NCI)","NIH",134,{"id":68,"slug":4,"hasResults":10,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":4,"eligibilityCriteria":72,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":73,"targetDuration":4,"studyType":21,"phases":75,"briefSummary":77,"conditions":78,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":90},"100570203","NCT06704191","In-home Intravesical Chemotherapy for the Treatment of Bladder Cancer, INVITE Trial","MC240502: Cancer CARE (Connected Access and Remote Expertise) Beyond Walls In-home iNtraVesIcal ThErapy (INVITE) Study - A Phase Ib\u002FII, Single-Arm Trial of Delivering Intravesical Therapy for Bladder Cancer in Patients' Homes","Inclusion Criteria:\n\n* PHASE IB ONLY: Female or male patients with histologically confirmed non-muscle invasive bladder cancer (stage Ta, Tis, or T1) who are currently receiving induction therapy with one of the following eligible intravesical treatment regimens\n\n  * Gemcitabine\n  * Sequential gemcitabine\u002Fdocetaxel\n  * Bacillus Calmette-Guerin\n  * Mitomycin C\n* PHASE II ONLY: Female or male patients with histologically confirmed non-muscle invasive bladder cancer (stage Ta, Tis or T1) who are receiving maintenance therapy with an eligible regimen\n* PHASE IB ONLY: Able to be successfully catheterized and able to tolerate first dost of intravesical therapy in the outpatient clinic\n* Residing within the area serviced by supplier network\n* Residence either has Wi-Fi or cellular data network connection for virtual telehealth visits\n* Age ≥ 18 years at time of registration\n* Signed informed consent form by patient\n* Willing and able to comply with the study protocol in the investigator's judgment\n* Ability to complete questionnaire(s) by themselves or with assistance\n* Willingness to follow birth control requirements for females and males of reproductive potential\n\nExclusion Criteria:\n\n* Receiving any other investigational or standard of care agent which would be considered as a treatment for non-muscle invasive bladder cancer and is not part of the eligible treatment regimens\n* Actively receiving any other treatment for cancer (except hormone therapy for breast or prostate cancer, or treatment for non-invasive skin cancer)\n* Requiring 24\u002F7 assistance with activities of daily living (ADLs)\n* Current inpatient hospitalization (excluding admission to the Advanced Care at Home program)\n* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens\n* Uncontrolled intercurrent illness including, but not limited to:\n\n  * Ongoing or active infection\n  * Symptomatic congestive heart failure\n  * Unstable angina pectoris\n  * Cardiac arrhythmia\n  * Myocardial infarction ≤ 6 months\n  * Wound healing disorder\n  * Psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Anticipation of the need for major surgery during the course of study treatment\n* Known allergy or previous intolerance to drug regimens\n* Pregnancy or breastfeeding\n* Hypersensitivity or allergy to polysorbate 80 or paclitaxel",{"count":74,"type":20},40,[76,51],"PHASE1","This phase Ib\u002FII trial compares the safety, tolerability and acceptability of intravesical chemotherapy given at home to in-clinic administration in patients with non-muscle invasive bladder cancer. Chemotherapy drugs, such as bacillus Calmette-Guerin (BCG), gemcitabine, docetaxel, and mitomycin C, 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. Standard of care chemotherapy for non-invasive bladder cancer is usually given directly into the bladder through a catheter (intravesical). This process requires numerous visits and can be disruptive to the lives of patients and caregivers. Bringing cancer care to the patients with in-home intravesical therapy may help reduce the disruption to daily lives. In-home intravesical chemotherapy may be safe and tolerable and may also be preferable to in-clinic administration in patients with non-muscle invasive bladder cancer.",[79,27,28,80],"Non-Muscle Invasive Bladder Carcinoma","Stage 0is Bladder Cancer AJCC v8","2026-03-24",{"date":83,"type":33},"2026-03-30",{"date":85,"type":33},"2025-04-21",{"date":87,"type":20},"2026-12-31",{"name":89,"class":40},"Mayo Clinic",1,{"id":92,"slug":4,"hasResults":10,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":96,"eligibilityCriteria":97,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":98,"targetDuration":4,"studyType":21,"phases":100,"briefSummary":102,"conditions":103,"keywords":105,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":111,"leadSponsor":113,"locationsCount":90},"100616178","NCT07302230","Home-Based Physical Activity Program With Digital App Versus Health Education Group for Improving Physical Activity Among Patients With Non-muscle Invasive Bladder Cancer, The EMPOWER Trial","The EMPOWER Trial: Evaluating a Home-Based Physical Activity Program (PAP) With the ExerciseRx™ Digital Platform vs. Health Education Group (HEG) in People With Non-Muscle Invasive Bladder Cancer","EMPOWER","Inclusion Criteria:\n\n* Adults (age \\>= 18 years)\n* Prior diagnosis of non-muscle invasive bladder cancer (NMIBC), currently on surveillance or receiving maintenance intravesical therapy (including intravesical chemotherapy, immunotherapy)\n* Classified as insufficiently active on the Physical Activity as a Vital Sign (PAVS) assessment\n* Has an Android or Apple Smartphone\u002FTablet\n* Ambulatory\n* English-speaking\n* Willing and able to participate in study activities and sign the informed consent form\n\nExclusion Criteria:\n\n* Severe cognitive or memory impairment\u002Fdementia precluding ability to follow instructions or participate in survey assessments\n* Inability to read or understand English\n* Lack of access or lack of sufficient facility to use an Android or iOS smart device with the minimum criteria to run the ExerciseRx app\n* Not receiving treatment at University of Washington (UW)\n* Orthopedic, neurologic, or other problems that prevent safe ambulation and protocol adherence. Information on prior falls and other recent orthopedic or neurologic problems will be used to make judgment about protocol eligibility\n* Inability\u002FUnwillingness to participate in a personalized exercise program\n* Current diagnosis with muscle-invasive or metastatic bladder cancer\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* Lack of access or lack of sufficient facility to use an Android or iOS smart device with the minimum criteria for using the ExerciseRx app\n* Participation in a clinical trial that does not permit enrollment in the EMPOWER trial",{"count":99,"type":20},100,[101],"NA","This clinical trial compares how well a home-based personalized physical activity program (PAP) that is delivered by a digital application (app) (the ExerciseRx app) works compared to health education in improving physical activity for patients with bladder cancer that has not reached the muscle wall of the bladder (non-muscle invasive). For people who are not physically active, previous studies have shown that increasing step counts can reduce incidence of death, reduce frailty, and reduce healthcare costs. The ExerciseRx app tracks adherence to home exercise, adapts step count goals based on the patient's progress, and provides encouraging feedback and motivation from the healthcare team. Additional features include activity summaries, progress towards current goal, nudges, helpful facts about the benefits of activity, and ideas for how to incorporate daily movement. A home-based PAP using the ExerciseRx app may work better in increasing physical activity among patients with non-muscle invasive bladder cancer compared to a health education only group.",[104,27,80,28],"Localized Non-Muscle Invasive Bladder Urothelial Carcinoma",[106],"Urinary Bladder","2026-03-11",{"date":109,"type":33},"2026-03-13",{"date":107,"type":33},{"date":112,"type":20},"2027-05-31",{"name":114,"class":40},"University of Washington",{"id":116,"slug":4,"hasResults":10,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":4,"eligibilityCriteria":120,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":121,"targetDuration":4,"studyType":21,"phases":123,"briefSummary":124,"conditions":125,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":126,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":90},"100529405","NCT06173349","PLZ4-Coated Paclitaxel-Loaded Micelles for the Treatment of Patients With Recurrent or Refractory Non-Muscle Invasive Bladder Cancer","A Phase I Microtrial With PLZ4-Coated Paclitaxel-Loaded Micelles (PPM) in Patients With Recurrent or Refractory Non-Myoinvasive Bladder Cancer","Inclusion Criteria:\n\n* Histologically confirmed non muscle invasive bladder cancer (NMIBC), defined as noninvasive papillary carcinoma (Ta), carcinoma in situ (CIS) or carcinoma invading the subepithelial connective tissue (T1), determined via transurethral resection of bladder tumor (TURBT) within 3 months of enrollment\n* Participant must have Bacillus Calmette Guerin (BCG)-unresponsive NMIBC or intolerance of treatment with BCG. BCG-unresponsive disease is defined as being at least one of the following:\n\n  * Persistent or recurrent CIS alone or with recurrent Ta\u002FT1 (noninvasive papillary disease\u002Ftumor invades the subepithelial connective tissue) disease within 12 months of completion of adequate BCG therapy\n  * Recurrent high-grade Ta\u002FT1 disease within 12 months of completion of adequate BCG therapy\n  * T1 high-grade disease at the first evaluation following an induction BCG course. In this context, adequate BCG therapy is defined as at least one of the following:\n\n    * At least five of six doses of an initial induction course plus at least two of three doses of maintenance therapy\n    * At least five of six doses of an initial induction course plus at least two of six doses of a second induction course\n* Refuse or intolerant of a radical cystectomy recommended by the treating urologist as the standard next therapy per American Urological Association (AUA) guideline\n* Age ≥ 18 years at time of consent\n* Performance status: Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2\n* Patient with life expectancy greater than 24 months\n* No concurrent radiotherapy, chemotherapy, or other immunotherapy for bladder cancer. No BCG or other intravesical treatment within 4 weeks\n* No scheduled radiotherapy, chemotherapy, other immunotherapy, or surgery before the scheduled response evaluation\n* Recovery from prior treatment side effects that might interfere with the study treatment, in the judgment of the investigator\n* Absolute neutrophil count (absolute granulocyte count \\[AGC\\]\u002Fabsolute neutrophil count \\[ANC\\]) ≥ 1,500\u002FµL\n* Platelets ≥ 100,000\u002FµL (Patients may be transfused to meet this requirement)\n* Hemoglobin ≥ 8 g\u002FdL (Patients may be transfused to meet this requirement)\n* Calculated glomerular filtration rate (GFR) ≥ 30 mL\u002Fmin\n* Total bilirubin ≤ 2.0 × institutional upper limit of normal (ULN) (\\\u003C 3 × ULN for patients with Gilbert's syndrome)\n* Aspartate transaminase (AST), alanine transaminase (ALT), alkaline phosphatase (ALP) ≤ 3.0 × institutional ULN\n* Adequate pulmonary function by clinical assessment with no clinical signs of severe pulmonary dysfunction\n* Participants of childbearing potential must agree to using adequate contraception (e.g., hormonal or barrier method of birth control; abstinence, an intrauterine device) for the duration of study participation (including dosing interruptions) and up to 3 months after last study treatment; or be surgically sterilized (e.g., hysterectomy, tubal ligation, or vasectomy)\n* Ability to understand and willingness to sign an informed consent form\n* Ability and willingness to adhere to the study visit schedule and other protocol requirements\n\nExclusion Criteria:\n\n* Existence of cancer at the upper urinary tract\n* Concurrent use of other investigational agents\n* Evidence of regional and\u002For distant metastasis\n* NYHA (New York Heart Association) class III or IV heart failure, uncontrollable supraventricular arrhythmias, any history of a ventricular arrhythmia, or other clinical signs of severe cardiac dysfunction\n* Symptomatic congestive heart failure (CHF), severe\u002Funstable angina pectoris, or myocardial infarction within 6 months prior to study entry\n* Patient has an intractable bleeding disorder (e.g., coagulation factors deficiencies, Von Willebrand Disease)\n* Patient taking medications that affect coagulation, such as aspirin (though, aspirin 81 mg oral once daily is allowed), Coumadin\u002FWarfarin, heparin, low molecular weight heparin, direct thrombin inhibitors, and direct factor Xa inhibitors. Other nonsteroidal antiinflammatory drugs (NSAIDs) are allowed as long as they are discontinued the day before therapy\n* History or evidence of uncontrollable central nervous system (CNS) disease\n* Active systemic infection requiring parenteral antibiotic therapy\n* Women who are pregnant or breast feeding\n* Any other malignancy diagnosed within 3 years of trial entry with the exception of the following:\n\n  * Basal or squamous cell skin cancers, or\n  * Noninvasive cancer of the cervix, or\n  * Any other cancer deemed to be of low-risk for progression or patient morbidity during trial period, such as localized prostate cancer after definitive treatment and prostate-specific antigen (PSA) less than 0.2 ng\u002FmL\n* Any condition that would prohibit the understanding or rendering of informed consent\n* Any condition that in the opinion of the investigator would interfere with the participant's safety or compliance while on trial",{"count":122,"type":20},12,[76],"This phase I trial tests the safety, tolerability and effectiveness of PLZ4-coated paclitacel-loaded micelles (PPM) in treating patients with non-muscle invasive bladder cancer that has come back after a period of improvement (recurrent) or that does not respond to treatment (refractory). PPM is a bladder cancer-specific nanoparticle that can specifically target and deliver treatment to the tumor cells in the bladder. PPM contains paclitaxel, which is a drug that kills tumor cells or keeps them from growing.",[26,27,80,28],{"date":109,"type":33},{"date":128,"type":33},"2023-11-22",{"date":130,"type":20},"2027-06",{"name":132,"class":40},"University of California, Davis",{"id":134,"slug":4,"hasResults":10,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":4,"eligibilityCriteria":138,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":139,"targetDuration":4,"studyType":21,"phases":141,"briefSummary":142,"conditions":143,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":145,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":90},"100504066","NCT05843448","IDO and PD-L1 Peptide Based Immune-Modulatory Therapeutic (IO102-IO103) in Combination With Pembrolizumab for BCG-Unresponsive or Intolerant, Non-Muscle Invasive Bladder Cancer","Pilot Study of an IDO and PD-L1 Peptide Based Immune-Modulatory Therapeutic (IO102-IO103) in Combination With Pembrolizumab for BCG-Unresponsive or Intolerant, Non-Muscle Invasive Bladder Cancer","Inclusion Criteria:\n\n* Adults \\>= 18 years of age\n* Histologically confirmed high-risk NMIBC (T1, high-grade Ta, or carcinoma in situ \\[CIS\\]\u002FTis). Mixed histologies are allowed if predominantly transitional cell histology. Archival tissue or planned cystoscopy within 28 day of planned initiation of treatment\n* Maximally resected tumor on study entry\n* Cystectomy ineligible or declined\n* Two induction courses of BCG attempted, regardless of exact doses received\n* ECOG (Eastern Cooperative Oncology Group) performance status score of 0 - 2\n* Life expectancy \\>= 6 months\n* Absolute neutrophil count (ANC) \\> 1000 cells\u002FuL (=\\\u003C 14 days of the first study treatment)\n* Platelet count \\> 50,000\u002FuL (=\\\u003C 14 days of the first study treatment)\n* Hemoglobin \\> 8 g\u002FdL (=\\\u003C 14 days of the first study treatment)\n* Aspartate aminotransferase (AST)\u002Fserum glutamic-oxaloacetic transaminase (SGOT), alanine aminotransferase (ALT)\u002Fserum glutamate pyruvate transaminase (SGPT) =\\\u003C 5 x upper limit of normal (ULN) (=\\\u003C 14 days of the first study treatment)\n* Alkaline phosphatase =\\\u003C 5 x upper limit of normal (ULN) (=\\\u003C 14 days of the first study treatment)\n* Total bilirubin =\\\u003C 2 x ULN (=\\\u003C 14 days of the first study treatment)\n* Creatinine clearance \\> 30 mL\u002Fmin as measured using Cockcroft-Gault equation or the estimated glomerular filtration rate from the Modification of Diet in Renal Disease Study (=\\\u003C 14 days of the first study treatment)\n* International normalized ratio (INR) or activated partial thromboplastin time (aPTT) =\\\u003C 1.5 X ULN unless the subject is receiving anticoagulant therapy. Individuals on anticoagulant therapy should have a prothrombin time (PT) or partial thromboplastin time (PTT) within therapeutic range of intended use and no history of severe hemorrhage\n* Ability to understand and willingness to sign an informed consent document\n* Ability to adhere to the study visit schedule and other protocol requirements\n* For female patients of childbearing potential and male patients with partners of childbearing potential, agreement (by patient and\u002For partner) to use methods of contraception\n\nExclusion Criteria:\n\n* Patients with a prior or concurrent malignancy whose natural history or treatment may, in the opinion of the investigator, have the potential to interfere with the safety or efficacy assessment of the investigational regimen\n* Uncontrolled concomitant disease that in the opinion of the investigator would interfere with the patient's safety or compliance on trial\n* Known history of positive test for human immunodeficiency virus (HIV) with CD4 \\\u003C 200 or acquired immunodeficiency syndrome (AIDS)-defining condition\n* Known active tuberculosis\n* Active infection requiring systemic therapy, including active or intractable urinary tract infection (UTI)\n* Previous treatment with checkpoint inhibitors targeting either PD-(L)1 or CTLA-4\n* Prior exposure to IO102 or IO103\n* Received systemic chemotherapy, targeted small molecule therapy, or radiotherapy =\\\u003C 2 weeks before study treatment initiation\n* Any adverse events from prior cancer therapy have resolved to grade =\\\u003C 1 according to Common Terminology Criteria for Adverse Events (CTCAE) version 5\n* Congestive heart failure (as defined by New York Heart Association Functional Classification III or IV), unstable angina, serious uncontrolled cardiac arrhythmia, a myocardial infarction within 6 months prior to study entry or a history of myocarditis\n* Any medical condition requiring systemic steroid equivalent to prednisone \\> 10 mg daily or immunosuppressive therapy within 14 days or 5 half-lives prior to first dose of trial therapy. Patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone are eligible. Patients who have adrenal insufficiency and hypophysitis from prior immunotherapy if they are on stable medical replacement doses are eligible\n* Received a live or live-attenuated vaccine =\\\u003C 30 days before the first dose of study treatment. Administration of killed vaccines, messenger ribonucleic acid (mRNA) based vaccines (e.g., COVID-19), and vector based vaccines are allowed\n* Pregnant and\u002For breast feeding women. If a urine pregnancy test is positive or cannot be confirmed as negative, a serum pregnancy test will be required =\\\u003C 24 hours prior to planned treatment initiation\n* Evidence of active interstitial lung disease or history of non-infectious pneumonitis requiring systemic steroids\n* Known allergy or reaction to any component of either study drug formulation\n* Any condition that would prohibit the understanding or rendering of informed consent\n* Any condition that in the opinion of the investigator would interfere with the patient's safety or compliance while on trial",{"count":140,"type":20},30,[76],"This phase I trial tests the safety and side effects of a PD-L1\u002FIDO peptide vaccine (IO102-IO103) in combination with pembrolizumab in treating patients with non-muscle invasive bladder cancer. IO102-IO103 is a novel IDO and PD-L1 peptide based immune-modulatory therapeutic. It is designed to activate the patient's own immune cells (called T-cells) to fight the tumor and stop the tumor cells escaping from the body's immune system. IO102-IO103 works to directly kill tumor cells and remove the body's immune suppressive cells, which are cells that prevent the immune system from fighting the tumor. 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. Giving IO102-IO103 in combination with pembrolizumab may make tumor cells more visible\u002Frecognizable to the immune system.",[144,27,80,28],"High Risk Non-Muscle Invasive Bladder Urothelial Carcinoma",{"date":109,"type":33},{"date":147,"type":33},"2023-04-19",{"date":149,"type":20},"2026-12",{"name":132,"class":40},""]