Clinical trials: Intermediate Risk Non-Muscle Invasive Bladder Cancer
Non Muscle Invasive Bladder Cancer
Celecoxib for the Treatment of Non-muscle Invasive Bladder Cancer
The treatment of non-muscle invasive bladder cancer (NMIBC) is problematic given the variable natural history of the disease. Although contemporary treatment options are limited, new targets and new approaches are under…
- Trial name
- NCT02343614
- Testing
- Celecoxib
- Volunteers
- 58 people
- Sponsor
- Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Non-muscle Invasive Bladder Cancer
Safety and Efficacy of APL-1202 in Combination With Epirubicin Hydrochloride Versus Epirubicin Hydrochloride Alone in Intermediate and High-risk Chemo-refractory Non-muscle Invasive Bladder Cancer (NMIBC) Patients
To evaluate the clinical efficacy (median event-free survival) of APL-1202 in combination with Epirubicin hydrochloride versus Epirubicin hydrochloride alone in intermediate and high-risk chemo-refractory non-muscle invasive…
- Trial name
- ACCRUE (NCT04490993)
- Testing
- APL-1202 in combination with Epirubicin
- Where
- China
- Volunteers
- 359 people
- Sponsor
- Jiangsu Yahong Meditech Co., Ltd aka Asieris
Low-grade NMIBC, FGFR Gene Amplification
Efficacy and Safety of TYRA-300 in Participants With FGFR3 Altered Low Grade, Intermediate Risk Non-Muscle Invasive Bladder Cancer
Phase 2 Study of TYRA-300 in FGFR3 Altered Low Grade, Intermediate Risk NMIBC
- Conditions
- Low-grade NMIBC, FGFR Gene Amplification, FGFR Gene Alterations, FGFR3 Gene Alteration
- Trial name
- SURF302 (NCT06995677)
- Testing
- TYRA-300 60mg, TYRA-300 50mg, TYRA-300 Dose 70 mg
- Where
- 48 sites in United States, Australia and 2 more
- Volunteers
- 90 people
- Sponsor
- Tyra Biosciences, Inc
Non-Muscle-Invasive Bladder Cancer (NMIBC)
Disitamab Vedotin Plus Intravesical Mitomycin C in HER2-Expressing Intermediate- to High-Risk Non-Muscle-Invasive Bladder Cancer
This study aims to evaluate the efficacy and safety of intravenous administration of vedacitinib combined with intravesical instillation of mitomycin in treating patients with high-risk NMIBC with HER2 expression.
- Trial name
- NCT07646145
- Testing
- Disitamab Vedotin, Mitomycin C (MMC)
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Shanxi Province Cancer Hospital
Bladder Cancer
Assessement of the Concordance of Genomic Alterations Between Urine and Tissue in High-Risk NMIBC Patients
The analysis of cell-free tumor DNA (cfDNA) in plasma has emerged as a clinically relevant predictive and prognostic biomarker in several metastatic solid malignancies, and even now represents standard-of-care for prescription of…
- Trial name
- ALU (NCT04412070)
- Where
- France
- Volunteers
- 20 people
- Sponsor
- Hopital Foch
Bladder Cancer Stage 0, Bladder Cancer Stage I
Efficacy and Safety of Obturator Nerve Block During Transurethral Resection on Non-muscle Invasive Intermediate and High Risk Lateral Wall Bladder Tumours
In this prospective randomized controlled study, the effects of obturator nerve block (ONB) on obturator reflex, incomplete resection, perforation, tumor recurrence and progression, presence of muscle tissue in the specimen, need…
- Trial name
- NCT04885309
- Testing
- Nerve Stimulator-guided Obturator Nerve Block
- Where
- Turkey (Türkiye)
- Volunteers
- 104 people
- Sponsor
- Ankara Training and Research Hospital
Bladder Cancer
Optimal Adjuvant Intravesical Therapy for Intermediate Risk Non Muscle Invasive Bladder Cancer: A Randomized Controlled Trial
The objective of this prospective, single-center randomized controlled trial is to identify the optimal adjuvant intravesical therapy in patients with intermediate risk (IR) non muscle invasive bladder cancer by comparing two…
- Trial name
- NCT05146635
- Testing
- Intravesical Bcg, Intravesical chemotherapy (epirubicin)
- Where
- Egypt
- Volunteers
- 110 people
- Sponsor
- Mansoura University
Bladder Cancer, Urothelial Carcinoma
A Phase 3 Single-Arm Study of UGN-102 for Treatment of Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer
This Phase 3, multinational, single-arm study was designed to evaluate the efficacy and safety of UGN-102 as primary chemoablative therapy in patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer…
- Conditions
- Bladder Cancer, Urothelial Carcinoma, Urothelial Carcinoma Bladder
- Trial name
- ENVISION (NCT05243550)
- Testing
- UGN-102
- Where
- 65 sites in United States, Austria and 8 more
- Volunteers
- 240 people
- Sponsor
- UroGen Pharma Ltd.
Urinary Bladder Neoplasms, Urologic Neoplasms
A Study of Vepugratinib (LY3866288) in Adults With Non-Muscle Invasive Bladder Cancer and Upper Tract Urothelial Cancer
The main purpose of this study is to see how well vepugratinib works in adults with low grade, intermediate risk, non-muscle invasive bladder cancer (LG IR NMIBC) or low-grade upper tract urothelial carcinoma (LG UTUC).
- Conditions
- Urinary Bladder Neoplasms, Urologic Neoplasms, Receptor, Fibroblast Growth Factor, Type 3
- Trial name
- FORAY (NCT07827612)
- Testing
- Vepugratinib
- Where
- United States
- Volunteers
- 161 people
- Sponsor
- Eli Lilly and Company
Superficial Bladder Cancer
A Randomized Study Comparing Single Agent Gemcitabine Intravesical Therapy Versus Mitomycin C in Patients With Intermediate Risk Superficial Bladder Cancer
Gemcitabine has been shown to be highly effective and well tolerated in the first and second line therapy, as a single agent or in combination therapy for treatment of metastatic transitional cell carcinoma.
- Trial name
- NCT00192049
- Testing
- Gemcitabine, mitomycin C
- Where
- 5 sites in Israel
- Volunteers
- 90 people
- Sponsor
- Eli Lilly and Company
NMIBC, MIBC
Outcomes for IR and High Risk (HR) Non-muscle Invasive Bladder Cancer (NMIBC) and ctDNA-based Biomarkers for Response and Recurrence in Muscle Invasive Bladder Cancer (MIBC)
This study aims to better understand how treatment choices impact outcomes for patients with intermediate- and high-risk non-muscle-invasive bladder cancer (NMIBC), as well as the factors that influence treatment decisions made…
- Conditions
- NMIBC, MIBC, Muscle Invasive Bladder Cancer (MIBC), Non Muscle Invasive Bladder Cancer
- Trial name
- BLAST (NCT07893509)
- Testing
- This is a non-interventional, observational, prospective study.
- Where
- United States
- Volunteers
- 1,400 people
- Sponsor
- Bladder Cancer Advocacy Network
Bladder Cancer, Urothelial Carcinoma
Feasibility of Home Instillation of UGN-102 for Treatment of Low-Grade (LG) Non-Muscle Invasive Bladder Cancer (NMIBC)
This study aims to demonstrate that home instillation of UGN-102 is a feasible alternative to instillation in a clinical setting, which might mitigate patient challenges (logistical, expense, and comfort) when receiving treatment…
- Conditions
- Bladder Cancer, Urothelial Carcinoma, Urothelial Carcinoma Bladder
- Trial name
- NCT05136898
- Testing
- UGN-102
- Where
- 5 sites in United States
- Volunteers
- 8 people
- Sponsor
- UroGen Pharma Ltd.
Non-muscle Invasive Bladder Cancer (NMIBC)
A Study to Evaluate the Efficacy and Safety of RAG-01 as Monotherapy and in Combination With Chemotherapy in Patients With Non-muscle Invasive Bladder Cancer (NMIBC).
This is a randomized, controlled, multicenter clinical study to evaluate the efficacy and safety of RAG-01 monotherapy and in combination with chemotherapy in patients with NMIBC.
- Trial name
- NCT07777848
- Testing
- RAG-01, Chemotherapy agent
- Where
- China
- Volunteers
- 114 people
- Sponsor
- Ractigen Therapeutics.
Intermediate and High-risk Non-muscle Invasive Bladder Cancer
A Phase I Clinical Study of SHR-2005 Intravesical Instillation in the Treatment of Intermediate and High-risk Non-muscle Invasive Bladder Cancer (NMIBC)
This study is an open-label, multicenter Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-2005 for Intravesical perfusion in patients with intermediate and high-risk non-muscle…
- Trial name
- NCT06108492
- Testing
- SHR-2005
- Where
- China
- Volunteers
- 170 people
- Sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.
Non-Muscle Invasive Bladder Cancer
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Patients With Bladder Cancer (MK-2870-027)
The goal of the study is to learn about the safety of Sacituzumab Tirumotecan and if people can tolerate it when given in the bladder and find the highest dose that people can take without having certain problems.
- Trial name
- TroFuse-027 (NCT06637423)
- Testing
- Sacituzumab tirumotecan, Rescue medication, Supportive care measures
- Where
- 13 sites in United States, Canada and 4 more
- Volunteers
- 32 people
- Sponsor
- Merck Sharp & Dohme LLC
Bladder Cancer
Efficacy and Safety of Multi-Instillations of Apaziquone in Patients With Non-Muscle Invasive Bladder Cancer
This is an international, multicenter, double-blind, placebo-controlled, randomized study. All eligible patients entering the open label phase of the study will receive a single immediate instillation of apaziquone (4 mg in 40 mL…
- Trial name
- NCT01410565
- Testing
- Apaziquone
- Where
- 47 sites in United States, Canada
- Volunteers
- 66 people
- Sponsor
- Spectrum Pharmaceuticals, Inc
Non-muscle-invasive Bladder Cancer
A Multi-National Study In Bladder Cancer Patients to Detect Recurrences After TURB (Trans-urethral Resection of the Bladder) Earlier With the Xpert Bladder Cancer Monitor Assay (ANTICIPATE X)
Bladder cancer is the 5th most common cancer in Europe, with more than 151,000 new cases diagnosed in 2012 (4% of the total). Bladder cancer has the highest recurrence rate of any malignancy, often as high as 70% within 5 years…
- Trial name
- ANTICIPATE X (NCT03664258)
- Testing
- Xpert Bladder Cancer Monitor
- Where
- 13 sites in Austria, Czechia and 7 more
- Volunteers
- 852 people
- Sponsor
- Cepheid
Bladder Cancer
Surveillance for Low and Low-Intermediate Risk Non-muscle Invasive Bladder Cancer: A Pilot Study
This is a two-arm, randomized-controlled pilot study with 2 year duration. The "intervention" refers to surveillance based on the European Association of Urology (EAU) guidelines and the "control" refers to surveillance based on…
- Trial name
- NCT02298998
- Testing
- Intervention, Control
- Where
- United States
- Volunteers
- 41 people
- Sponsor
- The University of Texas Health Science Center at San Antonio
Non-muscle-invasive Bladder Cancer
Artificial Intelligence Prediction Tool in Non-muscle Invasive Bladder Cancer (NMIBC)
This is a multi-center study and the aim is to develop and validate an Artificial Intelligence (AI) -based histologic analysis tool to predict responsiveness to intravesical Bacillus Calmette-Guérin (BCG) and intravesical…
- Trial name
- NCT05825950
- Where
- 2 sites in United States
- Volunteers
- 600 people
- Sponsor
- University of Texas Southwestern Medical Center
Bladder Cancer
Hyperthermic Intra-Vesical Chemotherapy
The purpose of the HIVEC II trial is to find out if the combination of the new technology called hyperthermia (the use of heat) and a drug called mitomycin is more effective than mitomycin alone which is the standard treatment…
- Trial name
- HIVECII (NCT06768346)
- Testing
- Hyperthermia will be delivered in combination with each instillation using the Combat BRS system
- Where
- 14 sites in United Kingdom
- Volunteers
- 259 people
- Sponsor
- Queen Mary University of London