Dose Escalation, Expansion Study of Vofatamab (B-701) in Treatment of Locally Advanced or Metastatic...
Locally Advanced or Metastatic Urothelial Cell CarcinomaUrinary Bladder Disease1 moreThis is a Phase 1/2(b), sequential, dose escalation, open-label, randomized expansion, multicenter, efficacy and safety study of vofatamab alone or in combination with docetaxel, or versus docetaxel in FGFR3 mutant/fusion subjects with Stage IV, locally advanced or metastatic UCC who have relapsed after, or are refractory to at least one prior line of chemotherapy. This study is divided into 3 phases: Phase 1b (Cohort 1), Phase 2 (Cohorts 2 and 3), and Phase 2b (Monotherapy Expansion Phase and Randomized Phase).
A Study of Varlilumab (Anti-CD27) and Sunitinib in Patients With Metastatic Clear Cell Renal Cell...
CarcinomaRenal Cell8 moreThis is a study to determine the clinical benefit (how well the drug works), safety, and tolerability of combining varlilumab and sunitinib. The study will enroll patients with metastatic clear cell renal cell carcinoma.
A Study of B-701 in Combination With Pembrolizumab in Treatment of Locally Advanced or Metastatic...
Locally Advanced or Metastatic Urothelial Cell CarcinomaUrinary Bladder Disease1 moreThis is a Phase 1b/2 multi-center, open-label study to establish the initial safety and to determine a recommended Phase 2 dose of B-701 in combination with pembrolizumab, and to determine safety, tolerability and efficacy of B-701 (vofatamab) plus pembrolizumab in the treatment of subjects with locally advanced or metastatic UCC, who have progressed following platinum-based chemotherapy and who have not received prior immune checkpoint inhibitor therapy.
Opioid Reduction Initiative During Outpatient Pediatric Urologic Procedures Using Exparel
Urologic DiseasesHypospadias4 moreThis study aims to evaluate the utility of long-acting liposomal bupivacaine (Exparel®) in improving pain scores and reducing narcotic pain requirements in pediatric patients following minor urologic procedures.
Effect of Nephrostomy on Relative Function of Obstructed Kidney
Obstructive UropathyUrinary tract obstruction is a serious health problem due to kidney damage. Relative renal function has an important role in the treatment of obstructed kidneys. Nephrectomy can be recommended when the relative renal function is 10% or less in radionuclide examinations. Recently, however, nephron sparing approaches have come to the fore. This indicated the need to evaluate the possibility of recovering the function of the kidney before nephrectomy. The aim of this study is to compare relative functions of obstructed kidneys in technetium 99m dimercaptosuccinic acid scintigraphy (DMSA) before and 2 weeks after nephrostomy tube.
Clinical Feasibility Assessment of Glean Urodynamics System
Urologic DiseasesUrodynamicsThe goal of this prospective observational trial is to assess the safety and reliability of the Glean Urodynamics System (GUS) in adult females with lower urinary tract symptoms. The main question[s] it aims to answer are: • What is GUS's ability to safely and reliably conduct wireless, catheter-free monitoring of vesical pressure compared to the vesical pressures collected with conventional urodynamics? Participants will undergo a conventional urodynamics exam, a simultaneous urodynamics exam with GUS, ambulatory urodynamics with GUS, and extended home monitoring with GUS. Researchers will compare GUS data with that from a conventional urodynamics exam.
Efficacy and Tolerability of Propiverine Hydrochloride in Patients With Neurogenic Detrusor Overactivity...
Neurogenic Urinary Bladder DisorderUrinary Bladder10 moreThe purpose of this clinical study is to compare efficacy and safety of propiverine hydrochloride extended and immediate release formulations in patients suffering from neurogenic detrusor overactivity.
Tamsulosin Phase III Clinical Trial -Double-Blind, Placebo Controlled Study in Male Patients With...
Urinary Tract DiseasesThe purpose of this study is to determine whether Tamusulosin is effective in the treatment of lower urinary tract syndrome with male patients.
Proliposomal Intravesical Paclitaxel for Treatment of Low-Grade, Stage Ta, Non Muscle Invasive Bladder...
Bladder Cancer Cell TransitionalNon-Muscle Invasive Bladder Cancer8 moreThis is a single-arm, phase 1/2a study of formulated paclitaxel in subjects with low-grade, noninvasive papillary carcinoma (stage Ta) of the bladder. Part 1 of the study will enroll 6 subjects (3 per cohort) with low-grade, stage Ta transitional cell carcinoma (TCC) of the bladder who will receive escalating doses of paclitaxel formulated as TSD-001 every 2 weeks for 6 treatments until Dose Limiting Toxicity (or until the Maximum Deliverable Dose) is observed (Maximum Tolerated Dose established). Part 2 of the study will enroll an additional 10 subjects with low-grade, stage Ta (uni-or multifocal) TCC of the bladder who will receive weekly TSD-001 for 6 weeks at the highest nontoxic dose (i.e., MTD) established in part 1 of the study. May meet definition of low grade without histological tissue diagnosis if on cystoscopic assessment they have a solitary papillary tumor. Part 3 of the study will continue to track subjects enrolled in Parts 1 and 2 to determine rates of disease-free survival.
Safety of Pre-TURBT Intravesical Instillation of Escalating Doses of TC-3 Gel and MMC in NMIBC Patients...
Bladder CancerNeoplasms2 moreA prospective, open label, modified 3+3 dose escalation study. This dose-escalation study is designed to carefully assess the safety of successive cohorts of patients (3 patients/cohort), each cohort treated with a fixed dose of TC-3 and MMC Intravesical instillations.