Clinical trials: Muscle-invasive Urothelial Cancer of the Bladder, open to volunteers
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, Bladder (Urothelial, Transitional Cell) Cancer Superficial (Non-Invasive)
A Study of NDV-01 (Sustained-release Gemcitabine-docetaxel) in Participants With Non-muscle Invasive Bladder Cancer
Study REL-NDV01-303 is a Phase 3, open-label, multi-center study to determine the safety and efficacy of NDV-01 in adult participants with NMIBC.
- Conditions
- Bladder (Urothelial, Transitional Cell) Cancer, Bladder (Urothelial, Transitional Cell) Cancer Superficial (Non-Invasive), Urothelial Carcinoma Bladder, Urothelial Carcinoma Recurrent
- Trial name
- RESCUE (NCT07464145)
- Testing
- NDV-01 (sustained-release gemcitabine-docetaxel)
- Volunteers
- 393 people
- Sponsor
- Relmada Therapeutics, Inc.
Bladder (Urothelial, Transitional Cell) Cancer
A Clinical Study Evaluating the Efficacy and Safety of Disitamab Vedotin Combined With PD-1 Inhibitor and Radiotherapy as Bladder-preserving Therapy in Patients With Localized HER2-high Expressing Muscle-invasive Bladder Urothelial Carcinoma Following Maximal Transurethral Resection
This is a prospective, open label, multicenter clinical study of vediximab combined with PD-1 and radiation therapy for bladder preservation in MIBC patients with HER-2 high expression (IHC 2+or 3+), conducted in accordance with…
- Trial name
- DECIDING (NCT07142200)
- Testing
- Disitamab Vedotin, PD-1 inhibitor, radiotherapy
- Where
- China
- Volunteers
- 45 people
- Sponsor
- RenJi Hospital
Muscle Invasive Bladder Urothelial Carcinoma, Stage II Bladder Cancer AJCC v8
Tumor-informed ctDNA in Muscle-invasive Bladder Cancer for Evaluation of Residual/Recurrent Disease - the TiMBER Trial
This study investigates the feasibility of the Labcorp Plasma Detect, which is an assay (test) that looks for circulating tumor DNA (ctDNA) in patients who have muscle-invasive (MI) urothelial carcinoma (also known as MI bladder…
- Conditions
- Muscle Invasive Bladder Urothelial Carcinoma, Stage II Bladder Cancer AJCC v8, Stage IIIA Bladder Cancer AJCC v8
- Trial name
- NCT07726602
- Testing
- Non-Interventional Study
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- OHSU Knight Cancer Institute
Muscle-Invasive Bladder Carcinoma, Muscle Invasive Bladder Urothelial Carcinoma
Study on the Quality of Life and Pathological State in Patients Who Underwent Radical Cystectomy
Observational study on the quality of life and pathological state of patients underwent radical cystectomy.
- Conditions
- Muscle-Invasive Bladder Carcinoma, Muscle Invasive Bladder Urothelial Carcinoma, Bladder Cancer TNM Staging, Bladder Cancer Stage IIa
- Trial name
- NCT06170177
- Testing
- Radical Cystectomy
- Where
- Italy
- Volunteers
- 4,000 people
- Sponsor
- IRCCS San Raffaele
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
Localized Muscle Invasive Bladder Urothelial Carcinoma, Muscle-Invasive Bladder Carcinoma
Adaptive RADiation Therapy With Concurrent Sacituzumab Govitecan (SG) for Muscle Invasive Bladder Cancer
The purpose of this study is to examine the safety and tolerability of treatment with concurrent Sacituzumab Govitecan (SG) and adaptive radiation therapy.
- Trial name
- NCT05833867
- Testing
- Sacituzumab govitecan, Adaptive Radiotherapy
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Shilpa Gupta, MD
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
Muscle Invasive Bladder Cancer (MIBC)
RESTORE-BLADDER (REgistry on STrategies for Organ pREservation in Muscle-invasive BLADDER Cancer)
Removal of the urinary bladder (radical cystectomy) is a major surgical procedure that can have a permanent impact on a patient's quality of life.
- Trial name
- NCT07744958
- Testing
- None. Registry.
- Volunteers
- 100 people
- Sponsor
- Heinrich-Heine University, Duesseldorf
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
Non-muscle Invasive Bladder Cancer, Non-Muscle Invasive Bladder Urothelial Carcinoma
A Trial of Durvalumab (MEDI4736) Plus Monalizumab in Non-Muscle-Invasive Bladder Cancer
This is a phase 2 open-label two cohort study of durvalumab plus monalizumab in patients with BCG-unresponsive or BCG-exposed CIS NMIBC.
- Trial name
- ENHANCE (NCT06503614)
- Testing
- Durvalumab, Monalizumab
- Where
- 5 sites in United States
- Volunteers
- 60 people
- Sponsor
- John Sfakianos
Urinary Bladder Neoplasms, Neoplasm Metastasis
FORAGER-1: A Study of Vepugratinib (LY3866288; LOXO-435) in Participants With Cancer With a Change in a Gene Called FGFR3
The main purpose of this study is to learn more about the safety, side effects, and effectiveness of Vepugratinib by itself or when it is combined with other medicines that treat cancer.
- Conditions
- Urinary Bladder Neoplasms, Neoplasm Metastasis, Ureteral Neoplasms
- Trial name
- FORAGER-1 (NCT05614739)
- Testing
- Vepugratinib, Pembrolizumab, enfortumab vedotin
- Where
- 82 sites in United States, Australia and 12 more
- Volunteers
- 677 people
- Sponsor
- Eli Lilly and Company
Urothelial Carcinoma of the Bladder, Muscle Invasive Bladder Cancer (MIBC)
Perioperative Systemic Therapies in Muscle-Invasive Bladder Cancer (GUARDIANS)
This is a multicenter, non-interventional, prospective and retrospective observational patient registry study of adults with muscle-invasive bladder cancer receiving perioperative systemic therapy as part of routine clinical…
- Trial name
- GUARDIANS (NCT07855926)
- Testing
- Perioperative Systemic Therapy Registry
- Where
- Germany
- Volunteers
- 500 people
- Sponsor
- LMU Klinikum
Bladder Cancer
Prospective Collection of Samples for Urothelial Cancer of Bladder
ProCSUCaB (Prospective Collection of Samples for Urothelial Cancer of Bladder) is a monocentric, non-interventional, prospective registry that will recruit newly diagnosed intermediate- and high-risk NMIBC patients in a tertiary…
- Trial name
- ProCSUCaB (NCT04167332)
- Volunteers
- 630 people
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
Non-Muscle Invasive Bladder Urothelial Carcinoma, Recurrent Non-Muscle Invasive Bladder Urothelial Carcinoma
A Randomized Trial of Bicalutamide in Non-Muscle Invasive Bladder Cancer
This phase I trial evaluates the effects of bicalutamide, compared to no study drug (NSD), on epidermal growth factor receptor (EGFR) protein expression in patients with non-muscle invasive bladder cancer.
- Trial name
- NCT05521698
- Testing
- Bicalutamide, Biopsy Procedure, Biospecimen Collection
- Where
- 6 sites in United States
- Volunteers
- 80 people
- Sponsor
- University of Wisconsin, Madison
Muscle Invasive Bladder Urothelial Carcinoma
Enfortumab Vedotin Plus Pembrolizumab With Selective Bladder Sparing for Treatment of Muscle-invasive Bladder Cancer
Patients with MIBC will receive 3 cycles (C1-C3) of induction enfortumab vedotin plus pembrolizumab followed by restaging including MRI of the bladder, urine cytology, and cystoscopy with TURBT of any visible tumor and/or…
- Trial name
- NCT06809140
- Testing
- Enfortumab vedotin, Pembrolizumab
- Where
- 5 sites in United States
- Volunteers
- 75 people
- Sponsor
- Matthew Galsky
Bladder (Urothelial, Transitional Cell) Cancer, Non Muscle Invasive Bladder Cancer
Is Prolonged Systemic Immunotherapy Necessary After Achieving Tumor-free Status in Patients With Extensive Transurethrally Unresectable Very-high-risk NMIBC?
Patients with extensive transurethrally unresectable very-high-risk non-muscle-invasive bladder cancer (NMIBC) may achieve a tumor-free status after systemic immunotherapy-based bladder-sparing treatment combined with…
- Trial name
- NCT07625527
- Testing
- Active Surveillance, PD-1/PD-L1 Inhibitor-Based Systemic Immunotherapy
- Where
- 4 sites in China
- Volunteers
- 120 people
- Sponsor
- Tianjin Medical University Second Hospital
Bladder Urothelial Carcinoma, Bladder Cancer
Sun Yat-Sen Treatment Strategy for Enhancing Response in Muscle-invasive Bladder Cancer
This is a multicenter, prospective, open-label, Phase II, four-arm parallel study evaluating the efficacy and safety of different sensitization strategies combined with disitamab vedotin and toripalimab in patients with…
- Trial name
- SYSTEM (NCT07717242)
- Testing
- Disitamab vedotin, Toripalimab, Sitagliptin
- Where
- China
- Volunteers
- 80 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Muscle-invasive Bladder Cancer
Erdafitinib Monotherapy or in Combination With Cetrelimab in Muscle-invasive Bladder Cancer Patients With Fibroblast Growth Factor Receptor (FGFR ) Gene Alterations
Erdafitinib (ERDA) alone or in combination with cetrelimab (CET) as neoadjuvant treatment (prior to surgery) in subjects with muscle-invasive bladder cancer (MIBC) whose tumours express Fibroblast Growth Factor Receptor (FGFR…
- Trial name
- SOGUG-NEOWIN (NCT06511648)
- Testing
- Erdafitinib monotherapy, Cetrelimab and Erdafitinib combination
- Where
- 23 sites in France, Italy and 2 more
- Volunteers
- 90 people
- Sponsor
- Spanish Oncology Genito-Urinary Group
Muscle-Invasive Bladder Carcinoma, Metastatic Urothelial Carcinoma
Modular Trial of sEphB4-HSA in EphrinB2-High Solid Tumors
Patients with solid tumors that have high expression levels of EphrinB2 are treated with regimens that include EphrinB2 inhibitor, sEphB4-HSA.
- Trial name
- NCT06493552
- Testing
- SEphB4-HSA, Pembrolizumab, Gemcitabine
- Where
- United States
- Volunteers
- 700 people
- Sponsor
- Vasgene Therapeutics, Inc