Clinical trials: NMIBC, active
High-risk Non-muscle Invasive Bladder Cancer
To Evaluate the Safety, Efficacy, and Pharmacokinetics of Intravesical Instiliations of Disitamab Vedotin in Patients With High-risk Non-muscular Invasive Bladder Cancer (NMIBC) That Express HER2
The purpose of this study is to evaluate the safety, efficacy, and pharmacokinetics of intravesical instiliations of Disitamab Vedotin in patients with high-risk non-muscular invasive bladder cancer (NMIBC) that express HER2
- Trial name
- NCT06378242
- Testing
- Disitamab Vedotin for injection
- Where
- 6 sites in China
- Volunteers
- 24 people
- Sponsor
- RemeGen Co., Ltd.
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
Urothelial Carcinoma Bladder, Bladder Cancer
Intravesical Gemcitabine and Docetaxel for BCG naïve Non-muscle Invasive Bladder Cancer
A single-arm, two-stage, open-label, phase 2 study investigating the safety and efficacy of intravesical gemcitabine/docetaxel for bacillus Calmette-Guerin (BCG)-naïve patients with non-muscle invasive bladder cancer (NMIBC).
- Trial name
- GEMDOCE (NCT04386746)
- Testing
- Gemcitabine, Docetaxel
- Where
- United States
- Volunteers
- 27 people
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Non-muscle Invasive Bladder Cancer (NMIBC)
Using Urine Tumor DNA to De-Intensify Surveillance in Non-Muscle Invasive Bladder Cancer
The goal of this clinical trial is to use urine tumor DNA (utDNA) as an indicator for non-muscle invasive bladder cancer to identify patients suitable for less frequent cystoscopy surveillance.
- Trial name
- NCT07187063
- Testing
- UroAmp Test (Convergent Genomics, Inc.)
- Where
- United States
- Volunteers
- 56 people
- Sponsor
- Lahey Clinic
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.
Non-Muscle Invasive Bladder Neoplasms
A Study of TAR-200 Versus Intravesical Chemotherapy in Participants With Recurrent High-Risk Non-Muscle-Invasive Bladder Cancer (HR-NMIBC) After Bacillus Calmette-Guérin (BCG)
The purpose of this study is to compare disease free survival (DFS) in participants with recurrence of papillary-only high-risk non-muscle-invasive bladder cancer (HR-NMIBC) within 1 year of last dose of Bacillus Calmette-Guérin…
- Trial name
- SunRISe-5 (NCT06211764)
- Testing
- TAR-200, Mitomycin C, Gemcitabine
- Where
- 123 sites in United States, Argentina and 12 more
- Volunteers
- 272 people
- Sponsor
- Janssen Research & Development, LLC
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
A Study to Learn About the Study Medicine PF-08052667 in People With Bladder Cancer
The purpose of this study is to learn how a new medicine called PF-08052667 works when used by itself or together with another medicine called Bacillus Calmette Guerin (BCG), and/or a medicine called sasanlimab.
- Trial name
- NCT07206225
- Testing
- PF-08052667, Sasanlimab, BCG
- Where
- 69 sites in United States, France and 4 more
- Volunteers
- 294 people
- Sponsor
- Pfizer
Bladder Cancer
Pembrolizumab (MK-3475) and Bacillus Calmette-Guérin (BCG) as First-Line Treatment for High-Risk T1 Non-Muscle-Invasive Bladder Cancer (NMIBC) and High-Grade Non-Muscle-Invasive Upper Tract Urothelial Carcinoma (NMI-UTUC)]
The purpose of this study is to find out the effectiveness of pembrolizumab in combination with BCG as a first line therapy for participants with high grade T1 bladder cancer who are at "high risk" for BCG alone to be ineffective…
- Trial name
- NCT03504163
- Testing
- Pembrolizumab (MK-3475), Bacillus Calmette-Guérin (BCG)
- Where
- 7 sites in United States
- Volunteers
- 45 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Bladder Cancer
The Impact of PDD During TURB for NMIBC
The goal of this clinical trial is to learn if photodynamic diagnosis (PDD) performed using violet light after intra-vesical instillation of hexaminolaevulinic acid (Hexvix 85mg/50ml) is more sensitive than the standard white…
- Trial name
- TUR_BLUE (NCT06548438)
- Testing
- Transurethral resection of the bladder performed with PDD tecnique and Hexvix
- Volunteers
- 300 people
- Sponsor
- A.O.U. Città della Salute e della Scienza
Non Muscle Invasive Bladder Cancer
Intravesical Chemotherapy in Combination With Systemic Pembrolizumab in NMIBC Unresponsive or Exposed to BCG Therapy
interventional study of intravesical chemotherapy and sistemic immunotherapy in NMIBC
- Trial name
- NCT06972615
- Testing
- intravesical Chemotherapy docetaxel/gemcitabine
- Where
- Argentina
- Volunteers
- 37 people
- Sponsor
- BLATAM
Urothelial Carcinoma, Non-Invasive Bladder Urothelial Carcinoma
Intravesical Adoptive Cell Therapy w/ TIL for BCG Exposed High Grade NMIBC
The purpose of the study is to evaluate the feasibility, safety and tolerability of intravesical adoptive cell therapy using TIL (tumor infiltrating lymphocytes) in participants with urothelial cell carcinoma (UCC) non-muscle…
- Trial name
- NCT05768347
- Testing
- Adoptive Cell Therapy with Tumor-infiltrating Lymphocytes (TIL)
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
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.
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 (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
- 50 people
- Sponsor
- Shanxi Province Cancer Hospital
Bladder Cancer
The Role of ERBT Plus Adjuvant Intravesical Induction and Maintenance Chemotherapy for Intermediate-Risk NMIBC
This is a prospective, multi-centre randomised trial comparing between ERBT plus 1-year of Ad-MMC, versus ERBT alone, in treating intermediate-risk NMIBC.
- Trial name
- NCT07907575
- Testing
- ERBT and Adjuvant MMC Therapy, ERBT
- Where
- 2 sites in Hong Kong
- Volunteers
- 440 people
- Sponsor
- Chinese University of Hong Kong
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 (NMIBC)
Clinical Trial of Ablation Therapy in Participants With Intermediate-Risk Non-Muscle Invasive Papillary Bladder Cancer
This is an open-label, phase 2, randomized study of intravesical N-803 plus BCG (experimental arm A) and intravesical N-803 plus gemcitabine (experimental arm B) in participants who have intermediate-risk Ta/T1 papillary disease.
- Trial name
- NCT06829823
- Testing
- N-803 and BCG, N-803 and Gemcitabine
- Volunteers
- 20 people
- Sponsor
- ImmunityBio, Inc.
Urinary Bladder Neoplasm, Transitional Cell Carcinoma
CTC Quantification During TURBT and PKVBT of Transitional Cell Carcinoma in Purging Fluid and Blood
Transurethral resection of bladder tumor (TURBT) is usually performed in a piecemeal technique. Tumor fragmentation and cell spilling could be responsible for high recurrence rates.
- Conditions
- Urinary Bladder Neoplasm, Transitional Cell Carcinoma, Urogenital Neoplasms, Circulating Tumor Cell
- Trial name
- NCT04811846
- Testing
- Bipolar transurethral resection of bladder tumor (TURBT), Bipolar transurethral plasma kinetic vaporization of bladder tumor (PKVBT)
- Where
- 2 sites in Austria
- Volunteers
- 40 people
- Sponsor
- University Teaching Hospital Hall in Tirol
Bladder Cancer
Blue Light Cystoscopy With Cysview® Registry
Registry study to gather more information on the current use of Blue Light Cystoscopy with Cysview (BLCC) in urologists' practices.
- Trial name
- BLCCR (NCT02660645)
- Testing
- Hexaminolevulinate hydrochloride (HCL), Karl Storz D-Light C Photodynamic Diagnostic (PDD) system
- Where
- 23 sites in United States
- Volunteers
- 4,400 people
- Sponsor
- Photocure