Clinical trials: Non-muscle Invasive Bladder Cancer, 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
Urinary Bladder Neoplasms, BCG-Induced Cystitis
Early vs Delayed Intravesical Blad-Care During BCG Therapy
Intravesical Bacillus Calmette-Guérin (BCG) therapy is the standard adjuvant treatment for patients with intermediate- and high-risk non-muscle-invasive bladder cancer (NMIBC).
- Trial name
- PRO-GAG (NCT07495072)
- Testing
- Hyaluronic Acid and Chondroitin Sulfate (Blad-Care™)
- Where
- South Korea
- Volunteers
- 56 people
- Sponsor
- BLAD-HYA Group
Bladder Cancer, Urothelial Carcinoma (UC)
Specimen Collection for Validation of UroAmp: A Next Generation Sequencing Platform for Detection and Surveillance of Bladder Cancer
This is a prospective, multicenter observational study designed to collect urine and tumor biospecimens and associated clinical data from patients undergoing evaluation, treatment, or surveillance for urothelial carcinoma.
- Conditions
- Bladder Cancer, Urothelial Carcinoma (UC), Hematuria, Upper Tract Urothelial Cancer
- Trial name
- INSITE (NCT07673016)
- Where
- 23 sites in United States, Puerto Rico
- Volunteers
- 2,500 people
- Sponsor
- Convergent Genomics, Inc.
Non-muscle Invasive Bladder Cancer (NMIBC)
A Study of Intravesical FL115 Alone or in Combination With BCG in Non-Muscle Invasive Bladder Cancer
The study is to evaluate the safety and tolerability of intravesical FL115 alone or in combination with BCG in the patients with NMIBC, and to determine the RP2D of FL115 in combination with BCG.
- Trial name
- NCT07122414
- Testing
- FL115, FL115+BCG
- Where
- 12 sites in China
- Volunteers
- 80 people
- Sponsor
- Suzhou Forlong Biotechnology Co., Ltd
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 (NMIBC)
Investigating the Efficacy and Safety of Neoadjuvant Intravesical Instillation of Mitomycin C in Treating High-risk NMIBC Patients
The goal of this clinical trial is to learn if neoadjuvant intravesical instillation of mitomycin C combined with en-bloc surgery works to treat high-risk non-muscle-invasive bladder cancer (NMIBC) patients.
- Trial name
- NCT06696794
- Testing
- Mitomycin C (MMC)
- Where
- 3 sites in China
- Volunteers
- 180 people
- Sponsor
- Shaogang Wang
Bladder Cancer Cell Transitional
Sarcopenia and NMIBC Prognosis Study
The goal of this observational study is to evaluate whether body composition abnormalities (sarcopenia, myosteatosis, and obesity) and nutritional status influence the risk of recurrence and progression in adult patients with…
- Trial name
- SARC-NMIBC (NCT07285408)
- Volunteers
- 150 people
- Sponsor
- General Hospital Sveti Duh
NMIBC
The Study is to Evaluate the Safety and Tolerability of SPGL008 Alone or in Combination With BCG in the Patients With NMIBC, and to Determine the RP2D of SPGL008 Alone or in Combination With BCG.To Evaluate the Preliminary Efficacy of SPGL008 Alone or in Combination With BCG.
The goal of clinical trial is to Evaluate the Safety and Tolerability of SPGL008 Alone or in Combination With BCG in the Patients With on-Muscle-Invasive Bladder Cancer. The main questions it aims to answer are: 1.
- Trial name
- NCT07445308
- Testing
- SPGL008
- Volunteers
- 120 people
- Sponsor
- Shenyang Sunshine Pharmaceutical Co., LTD.
HER2-expressing High-risk or Very High-risk NMIBC Without Visible Foci of Disease After TURBT
RC48 in Combination With Radiotherapy for HER2-Expressing NMIBC Patients
This study is an open, single-arm, single-center exploratory clinical study to explore the efficacy and safety of Disitamab Vedotin (RC-48) in combination with radiotherapy for the treatment of patients with HER2-expressing…
- Trial name
- NCT07100184
- Testing
- Disitamab Vedotin combined with Radiotherapy
- Volunteers
- 30 people
- Sponsor
- Peking University First Hospital
Non Muscle Invasive Bladder Cancer
The Necessity of a Second Transurethral Resection in High-risk Non-muscle-invasive Bladder Cancer Patients With Negative Urine Biomarker After Initial Transurethral Resection
The goal of this clinical trial is to evaluate the efficacy of using a urine biomarker test to guide the decision-making process regarding the necessity of reTURBT in NMIBC patients.
- Trial name
- NCT06287541
- Testing
- Urine biomarker -Guided without reTURBT
- Where
- China
- Volunteers
- 428 people
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
Bladder (Urothelial, Transitional Cell) Cancer
Phase II Prospective Cohort Study of Intravesical Recombinant Human Type 5 Adenovirus Injection for Treatment of High-Risk Non-Muscle Invasive Bladder Cancer: Evaluating Efficacy and Safety
This is a prospective, open label, single center clinical study on the use of recombinant human adenovirus type 5 injection for bladder instillation therapy in high-risk non muscle invasive bladder urothelial carcinoma patients.
- Trial name
- REBIRTH-013 (NCT07356791)
- Testing
- Recombinant Human Adenovirus Type 5 injection
- Volunteers
- 18 people
- Sponsor
- RenJi Hospital
Non Muscle Invasive Bladder Cancer, Bladder Cancer
Hyperthermic Intravesical Chemotherapy (HIVEC) in BCG-Non-Responsive High-Grade NMIBC Patients
This is a Phase II, prospective, single-arm, open-label clinical study evaluating hyperthermic intravesical chemotherapy (HIVEC) with Mitomycin C in patients with high-grade, non-muscle-invasive bladder cancer (NMIBC) who are…
- Conditions
- Non Muscle Invasive Bladder Cancer, Bladder Cancer, Carcinoma in Situ of Bladder, Urinary Bladder Neoplasms
- Trial name
- HIVEC (NCT07231809)
- Testing
- Hyperthermic Intravesical Chemotherapy (HIVEC)
- Where
- Italy
- Volunteers
- 50 people
- Sponsor
- AC.TA. S.r.l.
Urinary Bladder Neoplasms, BCG Vaccine
Multicenter Clinical Trial on the Effectiveness and Safety of Instillation of BCG and Alternative BCG Protocols for Intermediate and High-risk Non-muscle Invasive Bladder Cancer
Previous studies have reported the efficacy of Bacillus Calmette-Guérin (BCG) combined with other drugs for the treatment of bladder cancer.
- Conditions
- Urinary Bladder Neoplasms, BCG Vaccine, Immunotherapy, Active, Multicenter Study
- Trial name
- NCT06441110
- Testing
- Tislelizumab in Combination with Bacillus Calmette-Guérin
- Where
- China
- Volunteers
- 76 people
- Sponsor
- Fujian Medical University Union Hospital
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
Non-muscle Invasive Bladder Cancer With Carcinoma in Situ
A Trial to Evaluate Intravesical Nadofaragene Firadenovec Alone or in Combination With Chemotherapy or Immunotherapy in Participants With High-grade BCG Unresponsive Non-muscle Invasive Bladder Cancer
The pivotal phase 3 trial (rAd-IFN-CS 003) evaluating the efficacy of nadofaragene firadenovec showed that 55 (53.4%) of 103 subjects with CIS ± high-grade Ta/T1 achieved a complete response (CR) at 3 months.
- Trial name
- ABLE-22 (NCT06545955)
- Testing
- Nadofaragene Firadenovec, Gemcitabine, Docetaxel
- Where
- 81 sites in United States, Canada and 6 more
- Volunteers
- 250 people
- Sponsor
- Ferring Pharmaceuticals
Bladder Cancer
A Study of IAP0971 in Combination With Bacillus Calmette Guerin in High Risk Non-muscular Invasive Bladder Cancer
The efficacy and safety of IAP0971 single drug or combined with BCG intravesical instillation in the treatment of high-risk non muscle invasive bladder cancer with BCG treatment failure.
- Trial name
- NCT06255964
- Testing
- IAP0971, IAP0971＋BCG
- Volunteers
- 236 people
- Sponsor
- SUNHO（China）BioPharmaceutical CO., Ltd.
Bladder Cancer
Clinical Evaluation of BCDx for Monitoring of Recurrence in Non-Muscle Invasive Bladder Cancer
BCDx is a urine-based multi-omic assay for early cancer recurrence detection in patients with a history of bladder cancer. This prospective, blinded study evaluates its efficacy in detecting recurrent NMIBC, offering a…
- Trial name
- NCT05982561
- Where
- 3 sites in United States
- Volunteers
- 500 people
- Sponsor
- Early is Good Inc.
Bladder Cancer
Role of ERBT Plus Intravesical BCG in Intermediate-Risk or High-Risk NMBC
This is a prospective, multi-centre randomised trial comparing between cTURBT plus 1-year BCG therapy, and ERBT plus 1-year BCG therapy, in patients with intermediate-risk or high-risk NMIBC.
- Trial name
- NCT07724886
- Testing
- Conventional Transurethral Resection of Bladder Tumour, Transurethral En Bloc Resection of Bladder Tumour
- Where
- 2 sites in Hong Kong
- Volunteers
- 732 people
- Sponsor
- Chinese University of Hong Kong
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
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.