Clinical trials: Non-Muscle-Invasive Bladder Cancer
Urinary Bladder Tumour, MRI
Tumor Staging T of Bladder Tumours: Correlation of MRI and Anatomopathologic Analysis
Urinary bladder tumors with a frequency of 13000 new cases a year, have a heterogeneity in terms of survival according to the stage of local flooding. This is an aggressive tumor because of the potential muscular infiltration.
- Conditions
- Urinary Bladder Tumour, MRI, Invasion, Diagnosis
- Trial name
- IRMAA (NCT05464576)
- Testing
- MRI
- Where
- France
- Volunteers
- 150 people
- Sponsor
- University Hospital, Clermont-Ferrand
Non-muscle-invasive Bladder Cancer
Replacing Invasive Cystoscopy With Urine Testing for Non-muscle Invasive Bladder Cancer Surveillance
The purpose of this research is to determine whether bladder cancer monitoring can be improved by replacing some cystoscopy procedures with urine testing.
- Trial name
- ReplaceCysto (NCT05796375)
- Testing
- Cystoscopy, Bladder EpiCheck urine test, Xpert Bladder Cancer Monitor urine test
- Where
- 10 sites in United States
- Volunteers
- 240 people
- Sponsor
- White River Junction Veterans Affairs Medical Center
Non-muscle-invasive Bladder Cancer
Intravesical BCG vs GEMDOCE in NMIBC
The study hypothesis is that BCG naïve non-muscle invasive bladder cancer (NMIBC) patients treated with intravesical Gemcitabine + Docetaxel (GEMDOCE) will result in a non-inferior event-free survival (EFS) compared to standard…
- Trial name
- BRIDGE (NCT05538663)
- Testing
- Gemcitabine, Docetaxel, Bacillus Calmette Guerin
- Where
- 229 sites in United States
- Volunteers
- 870 people
- Sponsor
- ECOG-ACRIN Cancer Research Group
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.
Urinary Bladder Neoplasms, Carcinoma in Situ
A Study of Intravesical Enfortumab Vedotin For Treatment of Patients With Non-muscle Invasive Bladder Cancer (NMIBC)
This study will test a drug called enfortumab vedotin in participants with a type of bladder cancer called non-muscle invasive bladder cancer (NMIBC).
- Conditions
- Urinary Bladder Neoplasms, Carcinoma in Situ, Carcinoma Transitional Cell, Non-muscle Invasive Bladder Cancer
- Trial name
- NCT05014139
- Testing
- Enfortumab vedotin
- Where
- 32 sites in United States, Canada and 4 more
- Volunteers
- 37 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Bladder Cancer, Bladder (Urothelial, Transitional Cell) Cancer Resectable (Pre-Cystectomy)
Feasibility of HISA During TURBT for NMIBC
The goal of this prospective pilot study is to evaluate the safety and feasibility of using heated saline during bladder tumor surgery in patients with non-muscle invasive bladder cancer.
- Conditions
- Bladder Cancer, Bladder (Urothelial, Transitional Cell) Cancer Resectable (Pre-Cystectomy), Non-muscle Invasive Bladder Cancer (NMIBC), Non-Muscle Invasive Bladder Neoplasms
- Trial name
- NCT07817173
- Testing
- HISA
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- CAMC Health System
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.
Non-Muscle Invasive Bladder Cancer
Radiotherapy for BCG-unresponsive Non-muscle-invasive Carcinoma in Situ (CIS) Bladder Cancer: an Open-label, Single-arm, Multicentre, Phase 2 Study
Standard treatment for patients with high-risk NMIBC (high-grade Ta, CIS, or any T1) consists of intravesical Bacillus Calmette-Guerin (BCG) immunotherapy.
- Trial name
- BRACE (NCT06990061)
- Testing
- Radiation therapy
- Where
- 3 sites in Belgium
- Volunteers
- 50 people
- Sponsor
- European Organisation for Research and Treatment of Cancer - EORTC
Urinary Bladder Neoplasms, Carcinoma, Transitional Cell
Toripalimab ± Sequential Intravesical Gemcitabine-Mitomycin C for BCG-Unresponsive/-Intolerant High-Risk NMIBC: Open-Label Randomized Phase 2 Study
This open-label, randomised, multicentre, phase 2 study (OHAI-NMIBC-01) compares toripalimab plus sequential intravesical gemcitabine followed by mitomycin C (GEM→MMC) with toripalimab alone in adults with BCG-unresponsive or…
- Conditions
- Urinary Bladder Neoplasms, Carcinoma, Transitional Cell, Carcinoma in Situ of Bladder, Non-Muscle-Invasive Bladder Cancer
- Trial name
- OHAI-NMIBC-01 (NCT07189793)
- Testing
- Toripalimab, Gemcitabine (GEM), Mitomycin C (MMC)
- Where
- China
- Volunteers
- 106 people
- Sponsor
- First Affiliated Hospital of Wenzhou Medical University
Papillary-Only Non-muscle-invasive Bladder Cancer
A Study of SHR-1501 Combination With BCG Versus Placebo Combined With BCG in Subjects With Papillary-Only NMIBC
This is a multicenter, randomized, Double-blind phase III study to determine the efficacy and safety of intravesical SHR-1501 combined with Bacillus Calmette Guerin (BCG) versus Placebo Combined with BCG in patients with…
- Trial name
- NiBladder 2 (NCT07726992)
- Testing
- SHR-1501+BCG
- Where
- 2 sites in China
- Volunteers
- 750 people
- Sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Non Muscle Invasive Bladder Cancer
Toripalimab Combined With Intravesical Gemcitabine as Adjuvant Therapy for High-Risk Non-Muscle-Invasive Bladder Cancer After TURBT
This is a prospective, open-label, single-center, single-arm phase II clinical study to evaluate the efficacy and safety of toripalimab combined with intravesical gemcitabine as adjuvant therapy in patients with high-risk…
- Trial name
- NCT07808216
- Testing
- Toripalimab (JS001 ), Gemcitabine (GEM)
- Volunteers
- 54 people
- Sponsor
- Tianjin First Central Hospital
Bladder Cancer, Non-muscle Invasive Bladder Cancer
Exploration of Novel AI-enabled Blue Light Enhanced Cystoscopy
Blue light cystoscopy (BLC) is a diagnostic procedure in bladder cancer where the inside of the bladder is observed with a camera to detect bladder lesions.
- Trial name
- ENAiBLE (NCT07144319)
- Where
- 8 sites in United States, Belgium and 3 more
- Volunteers
- 500 people
- Sponsor
- Photocure
Non-muscle Invasive Bladder Cancer
The Role of Universal Cancer Only Marker SIX6 in Diagnosing Non-Muscle Invasive Bladder Cancer
Transurethral resection of bladder tumor (TURBT) is the standard therapeutic approach for patients with non-muscle-invasive bladder cancer (NMIBC).
- Trial name
- NMIBC (NCT07252297)
- Testing
- SIX6 Gene Methylation Assay
- Where
- China
- Volunteers
- 177 people
- Sponsor
- Xijing Hospital
High-risk Non-muscle-invasive Bladder Cancer
A Study of HS-10566 in Patients With High-risk Non-muscle-invasive Bladder Cancer Who Are Ineligible for or Refuse Radical Cystectomy
This is a multicenter, open-label, Phase I/II clinical study evaluating the safety, efficacy, tolerability, and pharmacokinetic/pharmacodynamic (PK/PD) profiles of HS-10566 in patients with high-risk non-muscle-invasive bladder…
- Trial name
- NCT07468851
- Testing
- HS-10566
- Where
- 2 sites in China
- Volunteers
- 180 people
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
High-Risk Non-Muscle-Invasive Bladder Cancer
Phase 2 Study to Evaluate Safety and Efficacy of Cretostimogene Grenadenorepvec in High-Risk NMIBC
This is a Phase 2, Multi-Arm, Multi-Cohort, Open-Label Study to Evaluate the Safety and Efficacy of Cretostimogene Grenadenorepvec in Participants with High-Risk Non-Muscle-Invasive Bladder Cancer.
- Trial name
- NCT06567743
- Testing
- Cretostimogene Grenadenorepvec
- Where
- 80 sites in United States, Canada
- Volunteers
- 325 people
- Sponsor
- CG Oncology, Inc.
Non Muscle-invasive Bladder Cancer
Evaluation of Immediate Preoperative Instillation (IPOI) of Mitomycin C Compared to Early Postoperative Instillation (IPOP) in Non-muscle Invasive Bladder Cancer
This study seeks to optimize the management of TVNIM (reduction of the risk of reccurence of the disease) by comparing in terms of efficacy and tolerance the immediate preoperative administration of mitomycin C (IPOI) to an early…
- Trial name
- NCT02075060
- Testing
- IPOI, IPOP
- Where
- 3 sites in France
- Volunteers
- 60 people
- Sponsor
- Poitiers University Hospital
Bladder Cancer, Non-Muscle-Invasive Urothelial Carcinoma
BGJ398 in Non-Muscle-Invasive Urothelial Carcinoma of the Bladder
The purpose of this study is to study the activity and effects of BGJ398 on bladder cancer tumors that are confined to the lining of the bladder.
- Trial name
- NCT02657486
- Testing
- BGJ398
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Bladder Cancer, Recurrent Bladder Cancer
A Study of Oral Erdafitinib in People With Recurrent Non-Invasive Bladder Cancer
The purpose of this study is to assess the effectiveness of erdafitinib in people with non-muscle invasive bladder cancer (NMIBC) that has come back after standard treatment, such as Bacillus Calmette-Guerin (BCG) or chemotherapy…
- Conditions
- Bladder Cancer, Recurrent Bladder Cancer, FGFR3 Gene Mutation
- Trial name
- NCT04917809
- Testing
- Erdafitinib
- Where
- 7 sites in United States
- Volunteers
- 20 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Non Muscle Invasive Bladder Cancer
A Study to Evaluate the Safety and Efficacy of NDV-01 in Participants With NMIBC
This is a prospective, single-arm study evaluating the safety and efficacy of NDV01 KIT, a fixed-dose combination of gemcitabine HCl and docetaxel, administered via intravesical instillation in patients with high-grade Non-Muscle…
- Trial name
- NMIBC (NCT06663137)
- Testing
- NDV01 intravesical controlled release formulation of gemcitabine and docetaxel
- Where
- Israel
- Volunteers
- 70 people
- Sponsor
- Relmada Therapeutics, Inc.
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.