[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"high-risk-non-muscle-invasive-bladder-urothelial-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:high-risk-non-muscle-invasive-bladder-urothelial-carcinoma":68},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100504066","phase-1-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-100504066",false,"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","ALL","18 Years",{"count":19,"type":20},30,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","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.",[26,27,28,29],"High Risk Non-Muscle Invasive Bladder Urothelial Carcinoma","Stage 0a Bladder Cancer AJCC v8","Stage 0is Bladder Cancer AJCC v8","Stage I Bladder Cancer AJCC v8","RECRUITING","2026-03-11",{"date":33,"type":34},"2026-03-13","ACTUAL",{"date":36,"type":34},"2023-04-19",{"date":38,"type":20},"2026-12",{"name":40,"class":41},"University of California, Davis","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":21,"phases":53,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":42},"100513213","phase-4-vesical-imaging-reporting-and-data-system-vi-rads-followed-by-photodynamic-trans-urethral-resection-of-bladder-tumours-pdd-turbt-to-avoid-secondary-resections-re-turbt-in-non-muscle-invasive-bladder-cancers-nmibcs-100513213","NCT05962541","Vesical Imaging-Reporting and Data System (VI-RADS) Followed by Photodynamic Trans-urethral Resection of Bladder Tumours (PDD-TURBT) to Avoid Secondary Resections (Re-TURBT) in Non-Muscle Invasive Bladder Cancers (NMIBCs)","Non-inferiority, Phase IV, Open-label, Randomized Controlled Trial of Vesical Imaging- Reporting and Data System (VI-RADS) Followed by Primary Photodynamic Trans-urethral Resection of Bladder Tumours (PDD-TURBT) Versus Conventional White-light TURBT Plus Repeated-TURBT (Re-TURBT) in Non-Muscle Invasive Bladder Cancers (NMIBCs) Candidate for Second Look and Resection","CUT-less","Inclusion Criteria:\n\n1. Female and Male patients at least 18 years old referred for clinical suspicion of primary or recurrent BCa who have been advised to undergo TURBT.\n2. Patients with a TUR-confirmed diagnosis of NMIBC and candidate for second look and resection (Re-TURBT) according to EAU Guidelines \\[6\\].\n3. No imaging evidence (i.e., mpMRI\u002FVI-RADS score 1 or 2) of muscle-invasive, locally advanced, or metastatic BCa (i.e., only confirmed CIS, Ta, T1, N0, M0 will be considered eligible).\n4. Patients who did or did not receive previous BCG immunotherapy (i.e., BCG naïve and non-naïve patients).\n5. Fit to undergo all procedures listed in protocol.\n6. Able to provide written informed consent.\n\nExclusion Criteria:\n\n1. Contraindication to TURBT and\u002For Re-TURBT.\n2. Initial TURBT diagnosis of MIBC (i.e., T2) or locally advanced BCa (i.e., T3-T4).\n3. Preoperative evidence of metastatic disease (i.e., cN1 - N3 and\u002For cM1).\n4. Visual evidence of low-risk NMIBC (solitary tumor, \\\u003C 1 cm) before initial TURBT.\n5. Visual evidence of MIBC on preliminary cystoscopy (i.e., non-papillary or sessile mass attached directly by its base without a stalk).\n6. TURBT diagnosis of NMIBCs not eligible for Re-TURBT according to EAU Guidelines (i.e., Ta-LG; Ta-HG with detrusor muscle in the specimen; primary CIS) \\[6\\].\n7. Concomitant Upper tract (kidney or ureteric) tumours on imaging.\n8. Contraindication to adjuvant intravesical BCG immunotherapy.\n9. Unfit to undergo any procedures listed in protocol.",{"count":52,"type":20},327,[54],"PHASE4","Background: In European Association of Urology (EAU) Guidelines, the vast majority of non-muscle-invasive bladder cancers (NMIBCs) undergo a primary transurethral resection of the bladder tumor (TURBT) followed by a repeat TURBT (Re-TURBT). The Re-TURBT is recommended due to the possibility of residual bladder cancer but is unnecessary in many cases by constituting overtreatment. Currently, no diagnostic strategy or predictive tools have been implemented to further stratify who does or does not benefit from Re-TURBT. Recently, an MRI-based Vesical Imaging Reporting and Data System (VI-RADS) score has been developed to stage as to the preoperative probability of muscle invasion, which could potentially exclude those who do not require a Re-TURBT when a primary high-quality resection is delivered. As such, performing TURBT with standard white light (WL) cystoscopy is known to miss many bladder tumours, which may be poorly visible, and a technique known as with photodynamic diagnosis (PDD) results in lower residual tumor and lower early intravesical recurrence rates. PDD is performed using violet light to improve the detection of these lesions not easily visible with WL cystoscopy.\n\nMethods\u002FAims: The investigators propose an Italian, single-center, phase IV, open-label, non-inferiority, randomized controlled trial, in which participants (n=112) who had already received a mpMRI\u002FVI-RADS score, are randomized to receive PDD-TURBT, no Re-TURBT versus standard of care represented by conventional WL-TURBT followed by WL-Re-TURBT. The primary outcome is proportions of early recurrence in the urinary bladder. Secondary outcomes will include proportions of late BCa recurrence, late disease-free interval, time to progression to MIBC, patient's quality of life assessment, and cost-analysis.\n\nPerspective: The CUT-less trial aims to respond to this unmet need through a non-inferiority randomized clinical study potentially shaping the perspective for a paradigm shift towards a more personalized, socially, and economically sustainable updated NMIBC therapeutic pathway.\n\nImplications: The current clinical trial proposal is aiming to achieve a paradigm shift in the oncological and socio-economical management of urothelial malignancies of the urinary bladder. Our first concern is indeed to guarantee a safe and ground-breaking strategy to manage the pathway of such patients in order to guarantee the non-inferior oncologic safety (and possibly superiority) when compared to the current standard of care.\n\nAdditionally, if our hypotheses are confirmed, the investigators will be able to significantly relieve these patients from the oncologic burden of an already invasive and arduous bladder cancer care path. Finally, safely avoiding an unnecessary, expensive surgical procedure will bring significant social and economic benefits to the EU healthcare system and possibly worldwide.",[57,58,26],"Non-muscle-invasive Bladder Cancer","Non-Muscle Invasive Bladder Urothelial Carcinoma","2025-12-26",{"date":61,"type":34},"2025-12-31",{"date":63,"type":34},"2025-12-22",{"date":65,"type":20},"2031-12",{"name":67,"class":41},"University of Roma La Sapienza","High-Risk, Non-Muscle Invasive Bladder Urothelial Carcinoma"]