Clinical trials: Non-Muscle Invasive Bladder Cancer (NMIBC)
Low-grade NMIBC, FGFR Gene Amplification
Efficacy and Safety of TYRA-300 in Participants With FGFR3 Altered Low Grade, Intermediate Risk Non-Muscle Invasive Bladder Cancer
Phase 2 Study of TYRA-300 in FGFR3 Altered Low Grade, Intermediate Risk NMIBC
- Conditions
- Low-grade NMIBC, FGFR Gene Amplification, FGFR Gene Alterations, FGFR3 Gene Alteration
- Trial name
- SURF302 (NCT06995677)
- Testing
- TYRA-300 60mg, TYRA-300 50mg, TYRA-300 Dose 70 mg
- Where
- 48 sites in United States, Australia and 2 more
- Volunteers
- 90 people
- Sponsor
- Tyra Biosciences, Inc
Non Muscle Invasive Bladder Cancer
Follow up of Intravesical N-803 Plus BCG in BCG-Naive Non-Muscle Invasive Bladder Cancer (NMIBC)
The purpose of this clinical trial is to obtain long-term follow-up information and status of bladder cancer for patients who received study treatment in the QUILT-2.005 study.
- Trial name
- NCT05981131
- Testing
- N803 plus Bacillus Calmette-Guerin (BCG)
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- ImmunityBio, Inc.
Non-Muscle Invasive Bladder Neoplasms
A Study to Assess Real-World Use and Outcomes of TAR-200 for Participants With Non-Muscle Invasive Bladder Cancer (NMIBC) in the United States
The purpose of this study is to assess how well TAR-200 works in real-word by measuring the time taken from the first TAR-200 insertion to worsening of cancer or until the signs and symptoms of cancer occur again (disease-free…
- Trial name
- Nova-sTAR (NCT07309445)
- Where
- 23 sites in United States
- Volunteers
- 150 people
- Sponsor
- Janssen Research & Development, LLC
Bladder Cancer
A Study of TAR-200 in Combination With Cetrelimab or TAR-200 Alone Versus Intravesical Bacillus Calmette-Guérin (BCG) in Participants With BCG-naïve High-risk Non-muscle Invasive Bladder Cancer (HR-NMIBC)
The purpose of this study is to compare event-free survival (EFS) in participants with Bacillus Calmette-Guerin (BCG)-naive high-risk non-muscle invasive bladder cancer (HR-NMIBC), including high-grade papillary Ta, any T1, or…
- Trial name
- SunRISe-3 (NCT05714202)
- Testing
- TAR-200, Cetrelimab, BCG Vesiculture
- Where
- 240 sites in United States, Argentina and 19 more
- Volunteers
- 1,135 people
- Sponsor
- Janssen Research & Development, LLC
Bladder Cancer
A Study of Blue Light Flexible Cystoscopy With Cysview in the Detection of Bladder Cancer in the Surveillance Setting
The purpose of this study is to investigate if blue light cystoscopy with Cysview improves detection of tumors in patients with bladder cancer during surveillance cystoscopy, using the KARL STORZ D-Light C PDD Flexible Videoscope…
- Trial name
- NCT02560584
- Testing
- Hexaminolevulinate hydrochloride, KARL STORZ D-Light C PDD Flexible Videoscope System
- Where
- 17 sites in United States
- Volunteers
- 304 people
- Sponsor
- Photocure
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
Bladder Cancer
Efficacy and Safety of Multi-Instillations of Apaziquone in Patients With Non-Muscle Invasive Bladder Cancer
This is an international, multicenter, double-blind, placebo-controlled, randomized study. All eligible patients entering the open label phase of the study will receive a single immediate instillation of apaziquone (4 mg in 40 mL…
- Trial name
- NCT01410565
- Testing
- Apaziquone
- Where
- 47 sites in United States, Canada
- Volunteers
- 66 people
- Sponsor
- Spectrum Pharmaceuticals, Inc
Urinary Bladder Neoplasms
A Study of Radical Cystectomy in Participants With Non-Muscle Invasive Bladder Cancer (NMIBC) and Muscle Invasive Bladder Cancer (MIBC) in Korea
The purpose of this study is to assess participant's overall well-being and the extent to which medical services are used by participants with non-muscle invasive bladder cancer (NMIBC) and muscle invasive bladder cancer (MIBC)…
- Trial name
- BC RC DB (NCT07735793)
- Volunteers
- 1 people
- Sponsor
- Janssen Korea, Ltd., Korea
Bladder Cancer
Study of Pembrolizumab (MK-3475) and Pembrolizumab With Other Investigational Agents in Participants With High Risk Non-muscle Invasive Bladder Cancer (MK-3475-057/KEYNOTE-057)
In this study, participants with high risk non-muscle-invasive bladder cancer (NMIBC) unresponsive to Bacillus Calmette Guerin (BCG) therapy and who are considered ineligible for or have refused to undergo radical cystectomy…
- Trial name
- NCT02625961
- Testing
- Pembrolizumab, Pembrolizumab/vibostolimab coformulation, Favezelimab/pembrolizumab coformulation
- Volunteers
- 296 people
- Sponsor
- Merck Sharp & Dohme LLC
High-risk Non-muscle Invasive Bladder Cancer
Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Bacillus Calmette-Guerin (BCG) in High-Risk Non-Muscle Invasive Bladder Cancer (HR NMIBC) (MK-3475-676/KEYNOTE-676)
Researchers are looking for new ways to treat high-risk non muscle invasive bladder cancer (HR NMIBC). NMIBC is cancer in the tissue that lines the inside of the bladder but has not spread to the bladder muscle or outside of the…
- Trial name
- NCT03711032
- Testing
- Pembrolizumab, BCG
- Where
- 209 sites in United States, Australia and 28 more
- Volunteers
- 1,397 people
- Sponsor
- Merck Sharp & Dohme LLC
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 Cancer
ADSTILADRIN Early Utilization and Outcomes in the Real World Setting
Multi-center, prospective non-interventional study to collect data on the early use of Adstiladrin in the US and Israel. Data will be collected from patients and prescribing physicians in a real-world setting
- Trial name
- ABLE-41 (NCT06026332)
- Testing
- ADSTILADRIN
- Where
- 31 sites in United States
- Volunteers
- 202 people
- Sponsor
- Ferring Pharmaceuticals
Urinary Bladder Neoplasms
A Study of Stimulator of Interferon Genes (STING) Agonist E7766 in Non-muscle Invasive Bladder Cancer (NMIBC) Including Participants Unresponsive to Bacillus Calmette-Guerin (BCG) Therapy, INPUT-102
This is an open label, multicenter, phase 1/1b study to assess safety/tolerability and preliminary clinical activity of E7766 as a single agent administered intravesically in participants with NMIBC.
- Trial name
- NCT04109092
- Testing
- E7766
- Where
- 9 sites in United States
- Sponsor
- Eisai Inc.
Bladder Cancer
First Line Comparative Study of EN3348 (MCC) vs BCG in NMIBC
The purpose of this study is to compare the safety and efficacy of EN3348 (MCC) versus BCG as first line treatment in patients with non-muscle invasive bladder cancer that are at high risk for recurrence or progression.
- Trial name
- NCT01284205
- Testing
- Mycobacterial Cell-Wall DNA Complex, Bacillus Calmette-Guerin
- Where
- 14 sites in United States
- Sponsor
- Bioniche Life Sciences Inc.
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
Bladder Cancer, Urothelial Carcinoma
A Phase 2b Study of UGN-102 for Low Grade Intermediate Risk Non-Muscle-Invasive Bladder Cancer
This Phase 2b, single-arm, multicenter study evaluated the efficacy and safety of UGN-102 as primary chemoablative therapy in patients with low grade intermediate risk non-muscle-invasive bladder cancer (LG IR NMIBC).
- Conditions
- Bladder Cancer, Urothelial Carcinoma, Urothelial Carcinoma Bladder
- Trial name
- OPTIMA II (NCT03558503)
- Testing
- UGN-102
- Where
- 19 sites in United States, Israel
- Volunteers
- 63 people
- Sponsor
- UroGen Pharma Ltd.
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.
Non Muscle Invasive Bladder Cancer
Study of CG0070 Given in Combination With Pembrolizumab, in Non-Muscle Invasive Bladder Cancer, Unresponsive to Bacillus Calmette-Guerin
To evaluate the activity of intravesical administration of CG0070 and intravenous administration of Pembrolizumab in patients with tissue pathology-confirmed non-muscle invasive bladder cancer (NMIBC) who have…
- Trial name
- CORE-001 (NCT04387461)
- Testing
- CG0070, Pembrolizumab Injection, n-dodecyl-B-D-maltoside
- Where
- 19 sites in United States, South Korea
- Volunteers
- 35 people
- Sponsor
- CG Oncology, Inc.
Non-muscle-invasive Bladder Cancer
Assessment of Efficacy and Safety of Durvalumab Plus BCG Compared to the Standard Therapy With BCG in Non-muscle Invasive Bladder Cancer
This is a randomized, open-label, multi-center, global, phase III study to determine the efficacy and safety of Durvalumab + BCG combination therapy in the treatment of patients with non-muscle-invasive bladder cancer
- Trial name
- POTOMAC (NCT03528694)
- Testing
- Durvalumab (MEDI4736), Bacillus Calmette-Guerin (BCG)
- Where
- 120 sites in Australia, Austria and 10 more
- Volunteers
- 1,018 people
- Sponsor
- AstraZeneca
Non-muscular Invasive Bladder Cancer
Clinical Study to Investigate the Safety and Tolerance of Therapeutic BCG in Postoperative Adjuvant Therapy in Subjects With Moderate to High-risk Non-muscular Invasive Bladder Cancer (NMIBC)
Phase I clinical study to investigate the safety and tolerance of therapeutic BCG in postoperative adjuvant therapy in subjects with moderate to high-risk non-muscular invasive bladder cancer (NMIBC)
- Trial name
- NCT06350838
- Testing
- BCG for Therapeutic Use
- Where
- China
- Volunteers
- 10 people
- Sponsor
- Chengdu CoenBiotech Co., Ltd