Clinical trials: Non-muscle Invasive Bladder Cancer (NMIBC)
Bladder Cancer
Investigating Bladder Chemotherapy Instead of Surgery for Low Risk Bladder Cancer
Patients diagnosed with low risk non-muscle invasive bladder cancer (NMIBC) are at risk of frequent low grade recurrence, which usually necessitates surgical intervention under general anaesthetic.
- Trial name
- CALIBER (NCT02070120)
- Testing
- Mitomycin C, Surgical Management
- Where
- 38 sites in United Kingdom
- Volunteers
- 82 people
- Sponsor
- Institute of Cancer Research, United Kingdom
Bladder Cancer, Bladder Neoplasm
Mitomycin C Intravesical Chemotherapy in Conjunction With Synergo® Radiofrequency-Induced Hyperthermia for Treatment of Carcinoma in Situ Non-Muscle Invasive Bladder Cancer Patients Unresponsive to Bacillus Calmette-Guérin, With or Without Papillary Tumors.
This study will determine whether Synergo® RITE + MMC treatment is efficacious as second-line therapy for CIS NMIBC BCG-unresponsive patients with or without papillary NMIBC, through examination of the complete response rate…
- Conditions
- Bladder Cancer, Bladder Neoplasm, Bladder Tumors, Cancer of Bladder
- Trial name
- RITE-USA (NCT03335059)
- Testing
- Synergo® RITE + MMC
- Where
- 4 sites in United States
- Volunteers
- 5 people
- Sponsor
- Medical Enterprises Ltd.
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
Non-muscle Invasive Bladder Cancer, NMIBC
A Phase 1 Dose-escalation Study of UGN-301 in Patients With Recurrent Non-muscle Invasive Bladder Cancer (NMIBC)
This study is being conducted to evaluate the safety and determine the recommended Phase 2 dose (RP2D) of UGN-301 (zalifrelimab) administered intravesically as monotherapy and in combination with other agents in patients with…
- Conditions
- Non-muscle Invasive Bladder Cancer, NMIBC, Carcinoma in Situ of Bladder, Bladder Cancer
- Trial name
- NCT05375903
- Testing
- UGN-301, UGN-201, Gemcitabine
- Where
- 13 sites in United States, Italy and 1 more
- Volunteers
- 51 people
- Sponsor
- UroGen Pharma Ltd.
Non-muscle Invasive Bladder Cancer (NMIBC)
Hyaluronic Acid Sodium Salt and Hydeal-D in the Management of LUTS After TURBT for NMIBC.
This will be an open-label, prospective, single-centre, randomised, controlled, parallel-group medical device investigation. The investigational plan will include four visits in total at the investigational site.
- Trial name
- NCT06069453
- Testing
- Hyaluronic Acid (HA) sodium salt and Hydeal-D
- Where
- Italy
- Volunteers
- 54 people
- Sponsor
- Fidia Farmaceutici s.p.a.
Bladder Cancer
Toripalimab Combined With BCG Perfusion for the Treatment of HR-NMIBC After TURBT Surgery Exploration
This is a single-center, prospective, open-label, non-randomized clinical study initiated and conducted by the Department of Urology, Shanghai Changhai Hospital.
- Trial name
- MARINE-01 (NCT07307456)
- Testing
- Treatment with toripalimab combined with BCG perfusion following transurethral resection of bladder tumor (TURBT)
- Where
- China
- Volunteers
- 31 people
- Sponsor
- Changhai Hospital
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.
Bladder Cancer, Urothelial Carcinoma
Evaluation of NanoDoce® in Participants With Urothelial Carcinoma
This is a clinical trial studying the administration of NanoDoce as a direct injection to the bladder wall immediately after tumor resection and as an intravesical instillation.
- Conditions
- Bladder Cancer, Urothelial Carcinoma, Urinary Bladder Neoplasm, Urinary Bladder Cancer
- Trial name
- NCT03636256
- Testing
- NanoDoce (direct injection), NanoDoce (intravesical instillation) - Visit 2 Instillation, Institutional Standard of Care
- Where
- 5 sites in United States
- Volunteers
- 36 people
- Sponsor
- NanOlogy, LLC
Non Muscle Invasive Bladder Cancer
Study to Evaluate the Efficacy and Safety Of Intravesical Nanoxel®M In BCG Refractory NMIBC
The purpose of this study is to determine whether Nanoxel®M is effective in the treatment of patients with recurrent Ta and T1 who experienced treatment failure with at least one prior BCG intravesical treatment.
- Trial name
- NCT02982395
- Testing
- Nanoxel®M, Mitomycin-C
- Where
- South Korea
- Volunteers
- 36 people
- Sponsor
- Samyang Biopharmaceuticals Corporation
NMIBC
A Study of Intravesical SHR-1501 Combination With BCG Versus Investigator-selected Chemotherapy in Subjects With BCG-unresponsive NMIBC
This is a multicenter, randomized, open-label phase III study to determine the efficacy and safety of intravesical SHR-1501 combined with Bacillus Calmette Guerin (BCG) versus investigator-selected chemotherapy in patients with…
- Trial name
- NCT07424287
- Testing
- SHR-1501 for Injection, BCG for Injection, Epirubicin Hydrochloride for Injection
- Where
- 2 sites in China
- Volunteers
- 236 people
- Sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
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
Bladder Cancer, Non-Muscle Invasive Bladder Cancer (NMIBC)
Intravesical GEM/DOCE for HR BCG-Unresponsive NMIBC
The goal of this clinical trial is to learn whether a combination of two chemotherapy drugs, Gemcitabine and Docetaxel, can treat high-grade non-muscle-invasive bladder cancer (HG-NMIBC) in adults whose cancer failed conventional…
- Conditions
- Bladder Cancer, Non-Muscle Invasive Bladder Cancer (NMIBC), Urothelial Carcinoma, Carcinoma in Situ (CIS)
- Trial name
- NCT07322263
- Testing
- Intravesical Gemcitabine and Docetaxel
- Where
- United States
- Volunteers
- 174 people
- Sponsor
- Michael A. O'Donnell
Bladder Cancer
Assessment of Safety, Tolerability, Radiation Dosimetry, Imaging Properties of 89Zr-girentuximab in Patients With NMIBC
The purpose of this study is to evaluate the use of 89Zr-labeled girentuximab (89Zr-TLX250) as a novel, carbonic anhydrase IX (CAIX) targeted PET/CT radiopharmaceutical for the imaging of Non-muscle-invasive bladder cancer…
- Trial name
- PERTINENCE (NCT04897763)
- Testing
- 89Zr-TLX250
- Where
- France
- Volunteers
- 6 people
- Sponsor
- Institut Cancerologie de l'Ouest
Bladder Cancer, Urothelial Carcinoma
A Phase 3 Study of UGN-103 for Treatment of Patients With Low-grade Intermediate-risk Non-muscle Invasive Bladder Cancer
This Phase 3, single-arm, multicenter study was designed to evaluate the efficacy and safety of UGN-103, a novel formulation of UGN-102, instilled in the urinary bladder of patients with recurrent low-grade intermediate-risk…
- Conditions
- Bladder Cancer, Urothelial Carcinoma, Urothelial Carcinoma Bladder
- Trial name
- UTOPIA (NCT06331299)
- Testing
- UGN-103
- Where
- 48 sites in United States, Bulgaria and 5 more
- Volunteers
- 99 people
- Sponsor
- UroGen Pharma Ltd.
Non-muscle Invasive Bladder Cancer
Study of Continuous APL-1202 Treatment in Subjects With High-Risk Non-Muscle-Invasive Bladder Cancer (NMIBC) Relapsed From Intravesical Chemo/BCG Therapy
To determine the efficacy of oral APL-1202 administered consecutively for 12 weeks in subjects with high-risk NMIBC relapsed from intravesical chemo/BCG therapy based on the recurrence-free rate (RFR) at 12 months after APL-1202…
- Trial name
- NCT04498702
- Testing
- APL-1202 treatment
- Volunteers
- 41 people
- Sponsor
- Jiangsu Yahong Meditech Co., Ltd aka Asieris
Bladder Cancer
Neoadjuvant Chemotherapy in Non Muscle Invasive T1b Bladder Cancer
The aim of our study is to evaluate the benefit of NAC in T1b NMIBC .
- Trial name
- NCT04245618
- Testing
- neoadjuvant chemotherapy ( cisplatin - gemcitabine)
- Volunteers
- 50 people
- Sponsor
- Assiut University
Non-muscle Invasive Bladder Cancer (NMIBC)
Evaluating the Safety and Performance of the Eight Medical Hyperthermia System IV 1.0 for HIVEC in NMIBC.
The goal of this clinical trial is to evaluate the safety and performance of the Eight Medical Hyperthermia System IV 1.0 when used to deliver recirculating hyperthermic intravesical chemotherapy (HIVEC) with mitomycin C (MMC) in…
- Trial name
- NCT07758881
- Testing
- Hyperthermic intravesical chemotherapy (HIVEC)
- Where
- 2 sites in Belgium
- Volunteers
- 30 people
- Sponsor
- Eight Medical International BV
Recurrence Free Survival, Bladder Cancer Recurrence
CRUCIAL-R Study : Cruciferous Vegetables Dietary Regimen in NMIBC
Emerging evidence highlights the importance of nutrition in modulating cancer-related pathways, suggesting that specific dietary patterns and food choices may influence cancer risk.
- Trial name
- CRUCIAL-R (NCT07391137)
- Testing
- Cruciferae intake diet, Habituary dietary regimen
- Where
- Italy
- Volunteers
- 250 people, healthy volunteers welcome
- Sponsor
- S. Andrea Hospital
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
Non-Muscle-Invasive Bladder Cancer (NMIBC)
A Study of RAG-01 in Patients With Non-muscle-invasive Bladder Cancer (NMIBC) Who Have Failed Bacillus Calmette Guérin (BCG) Therapy
This is an open label, multi-center study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of RAG-01 in patients with NMIBC who have failed BCG therapy.
- Trial name
- NCT06351904
- Testing
- RAG-01
- Where
- 3 sites in Australia
- Volunteers
- 72 people
- Sponsor
- Ractigen Therapeutics.