Clinical trials: High-risk Non-muscle Invasive Bladder Cancer
Bladder Carcinoma
Sequential Intravesical Bacillus Calmette-Guérin and Electromotive Mitomycin-C After Transuretheral Resection
The primary objective of the study is to assess the bladder cancer recurrence free rate, according to a phase II pilot study, of intravesical instillation of sequential BCG and EMDA/MMC after TUR.
- Trial name
- NCT02202044
- Testing
- Intravesical BCG and EMDA/MMC
- Where
- 2 sites in United States
- Volunteers
- 13 people
- Sponsor
- University of Colorado, Denver
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
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
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.
Carcinoma of Urinary Bladder, Superficial
Combined Use of BCG and Interferon Alpha in Bladder Cancer
To compare the toxicity and efficacy of the combination of BCG and interferon alpha to standard dose and low dose BCG alone in high risk superficial bladder cancer
- Trial name
- NCT00330707
- Testing
- Bacillus Calmette Guerin and interferon alpha
- Where
- Singapore
- Volunteers
- 140 people
- Sponsor
- National University Hospital, Singapore
Bladder Cancer Stage 0, Bladder Cancer Stage I
Efficacy and Safety of Obturator Nerve Block During Transurethral Resection on Non-muscle Invasive Intermediate and High Risk Lateral Wall Bladder Tumours
In this prospective randomized controlled study, the effects of obturator nerve block (ONB) on obturator reflex, incomplete resection, perforation, tumor recurrence and progression, presence of muscle tissue in the specimen, need…
- Trial name
- NCT04885309
- Testing
- Nerve Stimulator-guided Obturator Nerve Block
- Where
- Turkey (Türkiye)
- Volunteers
- 104 people
- Sponsor
- Ankara Training and Research Hospital
Bladder Cancer
Sequential Bacillus Calmette-Guérin (BCG) and Electromotive Mitomycin-C Versus Bacillus Calmette-Guérin (BCG) Alone for High Risk Superficial Bladder Cancer
Intravesical treatment for superficial bladder cancer has been used for the past 4-5 decades. Intravesical chemotherapy is beneficial in terms of recurrence and time to recurrence in grade 1-2 stage Ta tumours, usually…
- Trial name
- BCG/EMDA-MMC (NCT01442519)
- Testing
- bacillus Calmette-Guerin, electromotive mitomycin
- Where
- Italy
- Volunteers
- 212 people
- Sponsor
- University of Rome Tor Vergata
Transitional Cell Carcinoma, Transurethral Resection
BCG + MMC: Adding Mitomycin C to BCG in High-risk, Non-muscle-invasive Bladder Cancer
Instillation of Bacillus of Calmette-Guerin (BCG) into the urinary bladder (intravesical administration) improves rates of disease recurrence and progression after transurethral resection (TUR) of high risk, non-muscle-invasive…
- Trial name
- NCT06462001
- Testing
- Bacillus Calmette-Guerin Vaccine Intravesical, Mitomycin
- Where
- United Kingdom
- Volunteers
- 500 people
- Sponsor
- Nottingham University Hospitals NHS Trust
Bladder Cancer
Intravesical Electromotive Mitomycin After Bacillus Calmette-Guérin Failure
Patients with urothelial high risk non-muscle invasive bladder cancer patients will be treated with intravesical electromotive drug administration/mitomycin (EMDA/MMC) after bacillus Calmette-Guerin (BCG) failure.
- Trial name
- NCT04311580
- Testing
- intravesical electromotive administration of mitomycin
- Volunteers
- 52 people
- Sponsor
- University of Rome Tor Vergata
Her2 Overexpressing High-Risk Non-Muscle Invasive Bladder Urothelial Carcinoma
Disitamab Vedotin Combined With Tislelizumab for Her2 Overexpressing High-Risk Non-Muscle-Invasive Urothelial Bladder Carcinoma Which is Not Completely Resectable
This is a phase II study to determine the safety and efficacy of Disitamab Vedotin when given in combination with Tislelizumab as treatment for patients with Her2 overexpressing high-risk non-muscle-invasive bladder cancer (HR…
- Trial name
- NCT05495724
- Testing
- Disitamab Vedotin Tislelizumab, Disitamab Vedotin
- Where
- China
- Volunteers
- 176 people
- Sponsor
- Tianjin Medical University Second Hospital
Bladder (Urothelial, Transitional Cell) Cancer, Antibody-drug Conjugates
Antibody-Drug Conjugate Plus Immunotherapy Versus Immunotherapy Plus Chemotherapy for Extensive Transurethrally Unresectable Very-High-Risk Non-Muscle-Invasive Bladder Cancer
This randomized controlled trial aims to evaluate the efficacy and safety of antibody-drug conjugate (ADC) plus immunotherapy compared with immunotherapy plus chemotherapy in patients with extensive transurethrally unresectable…
- Conditions
- Bladder (Urothelial, Transitional Cell) Cancer, Antibody-drug Conjugates, Immunotherapy, Chemotherapy
- Trial name
- NCT07879469
- Testing
- Disitamab Vedotin and Toripalimab, Toripalimab and Nab-Paclitaxel
- Where
- 2 sites in China
- Volunteers
- 150 people
- Sponsor
- Tianjin Medical University Second Hospital
NMIBC, High Risk NMIBC
A Phase 1/1b Study of ZH9 Treatment in Patients With Non-Muscle Invasive Bladder Cancer
This is a first-in-human, multicenter, Phase 1/1b, 3-part, double-blind study of ZH9 in patients with recurrent NMIBC who are eligible for intravesical therapy.
- Conditions
- NMIBC, High Risk NMIBC, Non Muscle Invasive Bladder Cancer
- Trial name
- PARADIGM-1 (NCT06181266)
- Testing
- ZH9
- Where
- 4 sites in United States
- Volunteers
- 22 people
- Sponsor
- Prokarium Ltd
Bladder Cancer, Liquid Biopsy
Urinary Tumor DNA-Guided Systemic Immunotherapy for Unresectable Very-High-Risk Non-Muscle-Invasive Bladder Cancer
This study evaluates whether urinary tumor DNA (utDNA) testing, together with clinical, pathologic, and radiographic assessment, can help guide treatment discontinuation and active surveillance in patients with unresectable…
- Conditions
- Bladder Cancer, Liquid Biopsy, Immunotherapy
- Trial name
- NCT07475403
- Testing
- Systemic immunotherapy
- Where
- 3 sites in China
- Volunteers
- 53 people
- Sponsor
- Tianjin Medical University Second Hospital
Non-muscle Invasive Bladder Cancer
Safety and Toxicity Study of Intravesical Instillation of TARA-002 in Adults with High-grade Non-muscle Invasive Bladder Cancer (Phase 1b)
This study is open-label dose expansion study to investigate the safety and toxicity of intravesical treatment of high-grade NMIBC (HGTa or CIS, including CIS with concomitant Ta) after transurethral resection of bladder tumor…
- Trial name
- ADVANCED-1 (NCT05085990)
- Testing
- TARA-002
- Where
- 10 sites in United States
- Volunteers
- 10 people
- Sponsor
- Protara Therapeutics
High Risk Non-Muscle Invasive Bladder Urothelial Carcinoma, Stage 0a Bladder Cancer AJCC v8
IDO and PD-L1 Peptide Based Immune-Modulatory Therapeutic (IO102-IO103) in Combination With Pembrolizumab for BCG-Unresponsive or Intolerant, Non-Muscle Invasive Bladder Cancer
This phase I trial tests the safety and side effects of a PD-L1/IDO peptide vaccine (IO102-IO103) in combination with pembrolizumab in treating patients with non-muscle invasive bladder cancer.
- Conditions
- High Risk Non-Muscle Invasive Bladder Urothelial Carcinoma, Stage 0a Bladder Cancer AJCC v8, Stage 0is Bladder Cancer AJCC v8, Stage I Bladder Cancer AJCC v8
- Trial name
- NCT05843448
- Testing
- PD-L1/IDO Peptide Vaccine, Pembrolizumab
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- University of California, Davis
Recurrent Non-Muscle Invasive Bladder Carcinoma, Stage 0a Bladder Cancer AJCC v8
Testing the Addition of an Anti-Cancer Drug, Gemcitabine, to Usual Treatment (BCG Alone) in People Whose Non-Muscle Invasive Bladder Cancer (NMIBC) Came Back After Prior BCG Therapy
This phase III trial compares the effect of adding gemcitabine to intravesical Bacillus Calmette Guerin (BCG) versus intravesical BCG alone in patients with non-muscle invasive bladder cancer that has come back after a period of…
- Conditions
- Recurrent Non-Muscle Invasive Bladder Carcinoma, Stage 0a Bladder Cancer AJCC v8, Stage I Bladder Cancer AJCC v8
- Trial name
- GAIN-BCG (NCT07000084)
- Testing
- BCG Solution, Biopsy of Bladder, Cystoscopy
- Where
- 60 sites in United States
- Volunteers
- 330 people
- Sponsor
- Alliance for Clinical Trials in Oncology
Bladder Cancer
QUILT-3.032: A Multicenter Clinical Trial of Intravesical Bacillus Calmette-Guerin (BCG) in Combination With ALT-803 (N-803) in Patients With BCG Unresponsive High Grade Non-Muscle Invasive Bladder Cancer
This is a Phase II/III, open-label, single-arm, multicenter study of intravesical BCG plus N-803 or N-803 only in patients with BCG unresponsive high grade non-muscle invasive bladder cancer (NMIBC).
- Trial name
- NCT03022825
- Testing
- N-803 and BCG, N-803
- Where
- 28 sites in United States
- Volunteers
- 190 people
- Sponsor
- ImmunityBio, Inc.
Bladder Cancer
Clinical Study of T3011 Intravesical Instillation for Treatment of NMIBC Patients
This is a prospective, open-label, single-arm investigator-initiated clinical study. It is used to evaluate the safety and efficacy of T3011 intravesical instillation in patients with BCG-failure high-risk non-muscle invasive…
- Trial name
- NCT06427291
- Testing
- Herpes virus T3011 injection
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Fudan University
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
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.