Clinical trials: Muscle Invasive Bladder Urothelial Carcinoma
Bladder (Urothelial, Transitional Cell) Cancer, Bladder Cancer Requiring Cystectomy
Treatment Expedition With MRI Processing and Optimization for Muscle Invasive Bladder Cancer
The TEMPO-MIBC trial is a phase III, single-center, two-arm, randomized, controlled trial. Its primary objective is to evaluate the efficacy of a simplified diagnostic and treatment pathway for muscle-invasive bladder cancer…
- Conditions
- Bladder (Urothelial, Transitional Cell) Cancer, Bladder Cancer Requiring Cystectomy, Bladder Carcinoma, Bladder Neoplasm
- Trial name
- TEMPO-MIBC (NCT07067749)
- Testing
- multiparametric magnetic resonance imaging (mpMRI) of the bladder, Transurethral resection of bladder tumour (TURBt), Circulating tumour DNA levels assessment
- Where
- Italy
- Volunteers
- 92 people
- Sponsor
- University of Rome Tor Vergata
Urinary Bladder Neoplasms
Prospective Sample Collection for Cancer of Bladder
The goal of the Flemish Databank for Urothelial Cancer is to collect clinical and pathological data of patients treated for urothelial cancer (UC).
- Trial name
- ProCaB (NCT03973671)
- Where
- Belgium
- Volunteers
- 300 people
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
Muscle Invasive Bladder Cancer, Urothelial Carcinoma
Perioperative Tislelizumab Combined With Nab-Paclitaxel for Muscle-invasive Urothelial Bladder Carcinoma
This is a phase II study to determine the safety and efficacy of tislelizumab when given in combination with nab-paclitaxel as perioperative treatment in patients with muscle-invasive bladder cancer (MIBC) prior to cystectomy or…
- Trial name
- NCT04730219
- Testing
- Tislelizumab, Nab paclitaxel
- Where
- China
- Volunteers
- 48 people
- Sponsor
- Tianjin Medical University Second Hospital
Non-Muscle Invasive Bladder Cancer, Urothelial Carcinoma
An Expanded Access Program of Cretostimogene Grenadenorepvec for Treatment of NMIBC for Patients Unresponsive to BCG
This is an open-label, expanded access trial designed to provide access to cretostimogene in patients with NMIBC (specifically CIS with or without HG Ta/T1) unresponsive to BCG.
- Conditions
- Non-Muscle Invasive Bladder Cancer, Urothelial Carcinoma, Urologic Cancer, Bladder Cancer
- Trial name
- NCT06443944
- Testing
- Cretostimogene Grenadenorepvec, n-dodecyl-B-D-maltoside
- Where
- 27 sites in United States
- Sponsor
- CG Oncology, Inc.
Urinary Bladder Diseases, Urinary Bladder Neoplasms
Hyperthermia Treatment in Conjunction With Mitomycin C Versus Bacillus Calmette-Guérin Immunotherapy (BCG) for Superficial Bladder Cancer
The study is designed to compare the efficacy and safety of 2 treatment types for the prevention of tumor recurrence of superficial bladder cancer: 1. A combination of bladder wall heating and local chemotherapy (Synergo) 2.
- Conditions
- Urinary Bladder Diseases, Urinary Bladder Neoplasms, Urinary Bladder Cancer, Malignant Tumor of Urinary Bladder
- Trial name
- NCT00384891
- Testing
- Synergo + MMC, Bacillus Calmette-Guérin
- Where
- 8 sites in Austria, Israel and 2 more
- Volunteers
- 190 people
- Sponsor
- Medical Enterprises Europe B.V.
Bladder Cancer TNM Staging Primary Tumor (T) T2, Bladder Cancer TNM Staging Primary Tumor (T) T2A
Safety and Tolerability of TAR-200 and Nivolumab in Subjects With Muscle-Invasive Bladder Cancer
The purpose of this study is to determine if TAR-200, an investigational drug delivery system, in combination with nivolumab is safe and tolerable in patients with muscle-invasive bladder cancer (MIBC) who are scheduled for…
- Conditions
- Bladder Cancer TNM Staging Primary Tumor (T) T2, Bladder Cancer TNM Staging Primary Tumor (T) T2A, Bladder Cancer TNM Staging Primary Tumor (T) T2B, Bladder Cancer TNM Staging Primary Tumor (T) T3
- Trial name
- NCT03518320
- Testing
- Gemcitabine-Releasing Intravesical System (GemRIS)/TAR-200, Nivolumab Injection [Opdivo]
- Where
- 6 sites in United States
- Volunteers
- 13 people
- Sponsor
- Taris Biomedical LLC
Stage 0 Bladder Urothelial Carcinoma, Stage 0is Bladder Urothelial Carcinoma
S1602: Different Strains of BCG With or Without Vaccine in High Grade Non- Muscle Invasive Bladder Cancer
This randomized phase III trial studies Tokyo-172 strain bacillus Calmette-Guerin (BCG) solution with or without a vaccination using Tokyo-172 strain BCG to see how well it works compared with TICE BCG solution in treating…
- Conditions
- Stage 0 Bladder Urothelial Carcinoma, Stage 0is Bladder Urothelial Carcinoma, Stage I Bladder Urothelial Carcinoma
- Trial name
- NCT03091660
- Testing
- BCG Solution, BCG Tokyo-172 Strain Solution, BCG Tokyo-172 Strain Vaccine
- Where
- 174 sites in United States
- Volunteers
- 1,000 people
- Sponsor
- SWOG Cancer Research Network
High-risk Muscle Invasive Urothelial Carcinoma
An Open-label Study to Investigate the Efficacy and Safety of Dato-DXd + Rilvegostomig vs SoC in Adult Participants With High-risk MIUC
Purpose: to assess efficacy and safety of Dato-DXd + rilvegostomig as adjuvant therapy versus SoC in MIUC participants with high-risk residual disease after radical resection.
- Trial name
- TU-04 (NCT07720284)
- Testing
- Dato-DXd, Rilvegostomig, Durvalumab
- Where
- 160 sites in United States, Australia and 14 more
- Volunteers
- 915 people
- Sponsor
- AstraZeneca
Urinary Bladder Cancer
Safety and Tolerability of GemRIS 225 mg in Subjects With Muscle-Invasive Bladder Cancer
The purpose of this study is to determine if TAR-200, an investigational drug-delivery system, is safe and tolerable in patients with muscle-invasive bladder cancer (MIBC) between diagnosis and radical cystectomy (RC).
- Trial name
- NCT02722538
- Testing
- Gemcitabine-Releasing Intravesical System (GemRIS)/TAR-200
- Where
- 6 sites in United States, Netherlands
- Volunteers
- 23 people
- Sponsor
- Taris Biomedical LLC
Bladder Flat Urothelial Carcinoma In Situ, Non-Muscle Invasive Bladder Urothelial Carcinoma
Testing the Addition of an Anti-cancer Drug, Pembrolizumab, to the Usual Intravesical Chemotherapy Treatment (Gemcitabine) for the Treatment of BCG-Unresponsive Non-muscle Invasive Bladder Cancer
This phase II trial studies the effect of adding pembrolizumab to gemcitabine in treating patients with non-muscle invasive bladder cancer whose cancer does not respond to Bacillus Calmette-Guerin (BCG) treatment.
- Conditions
- Bladder Flat Urothelial Carcinoma In Situ, Non-Muscle Invasive Bladder Urothelial Carcinoma, Stage 0a Bladder Cancer AJCC v8, Stage 0is Bladder Cancer AJCC v8
- Trial name
- NCT04164082
- Testing
- Biopsy Procedure, Biospecimen Collection, Computed Tomography
- Where
- 390 sites in United States, Guam and 1 more
- Volunteers
- 161 people
- Sponsor
- National Cancer Institute (NCI)
Muscle-invasive Bladder Cancer
Pembrolizumab-Epacadostat Combination to Treat Muscle-invasive Bladder UrotheLIAl canceR: PECULIAR Study
An open label, monocenter, single-arm, phase 2 study of neoadjuvant pembrolizumab and epacadostat, preceding radical cystectomy, for patients with muscle-invasive bladder cancer.
- Trial name
- PECULIAR (NCT03832673)
- Testing
- Pembrolizumab, Epacadostat
- Where
- Italy
- Sponsor
- Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Bladder (Urothelial, Transitional Cell) Cancer, NMIBC
DV+BCG in HER2-Expressing, BCG-Naïve High-Risk NMIBC
The purpose of this study is to learn about the safety and effects of the study medicine (Disitamab Vedotin) in people with non-muscle invasive bladder cancer.
- Trial name
- HERO (NCT07207824)
- Testing
- Active Comparator: BCG induction and maintenance, DV + BCG induction and maintenance
- Where
- China
- Volunteers
- 182 people
- Sponsor
- Fudan University
Muscle-invasive Urothelial Carcinoma of the Bladder
Pembrolizumab-Sacituzumab Govitecan Combination to Treat High-risk, Localized Bladder Cancer
This is a Phase 2, single-center, open-label, non-randomized study in patients with MIBC who cannot receive or refuse to receive cisplatin-based chemotherapy. Patients will be consecutively enrolled and treated.
- Trial name
- SURE-02 (NCT05535218)
- Testing
- Sacituzumab govitecan is a humanized mAb with a hydrolysable linker through which SN-38 is conjugated to the humanized mAb hRS7 IgG1κ to enhance the delivery of SN-38 to Trop-2- expressing tumors, whi
- Where
- Italy
- Volunteers
- 48 people
- Sponsor
- Claudia Guerrieri
Bladder Urothelial Carcinoma, Muscle-invasive Bladder Cancer
Bladder-Sparing Treatment With Disitamab Vedotin and Toripalimab With or Without Pelvic Lymph Node Dissection in Bladder Cancer
This is a prospective, multicenter, randomized controlled superiority study designed to evaluate whether the addition of pelvic lymph node dissection improves bladder-intact event-free survival in patients with cT2-3N0M0 bladder…
- Conditions
- Bladder Urothelial Carcinoma, Muscle-invasive Bladder Cancer, Bladder Cancer
- Trial name
- NCT07756008
- Testing
- Disitamab Vedotin (RC48), Toripalimab, Transurethral Resection of Bladder Tumor
- Where
- China
- Volunteers
- 114 people
- Sponsor
- Tianjin Medical University Second Hospital
Non-Muscle Invasive Bladder Urothelial Carcinoma, Recurrent Non-Muscle Invasive Bladder Urothelial Carcinoma
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
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.
- Conditions
- Non-Muscle Invasive Bladder Urothelial Carcinoma, Recurrent Non-Muscle Invasive Bladder Urothelial Carcinoma, Stage I Bladder Cancer AJCC v8
- Trial name
- NCT06770582
- Testing
- Biospecimen Collection, Cisplatin, Computed Tomography
- Where
- 147 sites in United States, Canada
- Volunteers
- 160 people
- Sponsor
- National Cancer Institute (NCI)
Urothelial Carcinoma (UC)
Neoadjuvant Enfortumab Vedotin Plus Pembrolizumab in Muscle-Invasive Bladder Cancer and Upper Tract Urothelial Carcinoma
Radical cystectomy remains the standard curative-intent treatment for most patients with muscle-invasive bladder cancer, but it is associated with significant morbidity and long-term quality-of-life implications.
- Trial name
- NCT07643519
- Testing
- enfortumab vedotin and pembrolizumab (EV/P)
- Volunteers
- 39 people
- Sponsor
- University of Florida
Bladder (Urothelial, Transitional Cell) Cancer
Chemoablation for Low-Grade Bladder Cancer
The goal of this single arm, prospective, open-label, investigator-initiated Phase 2 clinical trial is to evaluate the efficacy of intravesical chemoablation in patients with low grade bladder cancer.
- Trial name
- COBRA (NCT07019220)
- Testing
- Gemcitabine
- Where
- Austria
- Volunteers
- 47 people
- Sponsor
- Ekaterina Laukhtina
Bladder (Urothelial, Transitional Cell) Cancer, NMIBC
A Phase 1 Dose-escalation Study of UGN-501 Administered Intravesically in Adult Participants With Recurrent NMIBC
This study is being conducted to evaluate the safety and tolerability of UGN-501 administered intravesically in adult participants with recurrent non-muscle invasive bladder cancer (NMIBC) and to determine the recommended Phase 2…
- Conditions
- Bladder (Urothelial, Transitional Cell) Cancer, NMIBC, Urothelial Carcinoma Bladder, Urothelial Carcinoma in Situ
- Trial name
- NCT07725796
- Testing
- UGN-501
- Where
- 15 sites in United States
- Volunteers
- 30 people
- Sponsor
- UroGen Pharma, Inc., a subsidiary of UroGen Pharma Ltd.
Urinary Bladder Cancer
An Epidemiologic Study on PD-L1 Expression Combined With Clinical Observation in the Chinese MIUBC Patients.
The Primary Objective of this observational study is to investigate the prevalence of high PD-L1 expression in Chinese MIUBC patients.
- Trial name
- POLARIS (NCT03433924)
- Where
- 17 sites in China
- Volunteers
- 248 people
- Sponsor
- AstraZeneca
Muscle Invasive Bladder Urothelial Carcinoma, Muscle-Invasive Bladder Carcinoma
Surveillance of the Genetic Signature in Circulating Tumor DNA for Guiding Adjuvant Chemotherapy in Urothelial Carcinoma
Urothelial carcinomas are one of the most commonly diagnosed cancers worldwide. Postoperative patients carry a poor prognosis with an estimated five-year disease-specific survival rate of 50%.
- Trial name
- NCT06257017
- Testing
- gemcitabine, Cisplatin
- Where
- Hong Kong
- Volunteers
- 15 people
- Sponsor
- Yung NA