Clinical trials: High-risk Non-muscle-invasive Bladder Cancer
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
Stage 0 Bladder Urothelial Carcinoma, Stage 0is Bladder Urothelial Carcinoma
S1602: Different Strains of BCG With or Without Vaccine in High Grade Non- Muscle Invasive Bladder Cancer
This randomized phase III trial studies Tokyo-172 strain bacillus Calmette-Guerin (BCG) solution with or without a vaccination using Tokyo-172 strain BCG to see how well it works compared with TICE BCG solution in treating…
- Conditions
- Stage 0 Bladder Urothelial Carcinoma, Stage 0is Bladder Urothelial Carcinoma, Stage I Bladder Urothelial Carcinoma
- Trial name
- NCT03091660
- Testing
- BCG Solution, BCG Tokyo-172 Strain Solution, BCG Tokyo-172 Strain Vaccine
- Where
- 174 sites in United States
- Volunteers
- 1,000 people
- Sponsor
- SWOG Cancer Research Network
High-Risk, Non-Muscle Invasive Bladder Urothelial Carcinoma
Tilelizumab Combined With Nab-Paclitaxel for 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 tislelizumab when given in combination with nab-paclitaxel as treatment for patients with high-risk non-muscle-invasive bladder cancer (HR NMIBC) which is not…
- Trial name
- NCT04730232
- Testing
- Tislelizumab, Nab-paclitaxel
- Where
- China
- Volunteers
- 63 people
- Sponsor
- Tianjin Medical University Second 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.
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
Non-Muscle Invasive Bladder Cancer, HER2
RC48 Combined With Tislelizumab for Bladder Sparing Treatment in NMIBC With BCG Treatment Failure and HER2 Expression
This is a prospective, open, single-center clinical study of anti-HER2-ADC combined with PD-1 monoclonal antibody for bladder sparing treatment in non-muscular invasive bladder cancer (NMIBC) patients with HER2-expressing.
- Trial name
- NCT05957757
- Testing
- RC48, Tislelizumab
- Where
- China
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- RenJi 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 1a)
This study is an open-label dose escalation study (Phase 1a) 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…
- Trial name
- ADVANCED-1 (NCT05085977)
- Testing
- TARA-002
- Where
- 14 sites in United States, Moldova and 2 more
- Volunteers
- 12 people
- Sponsor
- Protara Therapeutics
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-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
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.
Non Muscle Invasive Bladder Cancer
The Role of Definitive Radiotherapy in Non Muscle Invasive Bladder Cancer
Bladder cancer is one of the most common malignancies worldwide and represents a major global health burden. According to the GLOBOCAN 2022 estimates, approximately 614,298 new cases and 220,596 deaths from bladder cancer were…
- Trial name
- NCT07873333
- Testing
- Definitive radiotherapy, BCG, Concurrent chemotherapy
- Volunteers
- 70 people
- Sponsor
- Assiut University
Superficial Bladder Cancer, Non-muscle Invasive Bladder Cancer With Carcinoma in Situ
LEGEND Study: EG-70 in NMIBC Patients BCG-Unresponsive and High-Risk NMIBC Incompletely Treated With BCG or BCG-Naïve
This study will evaluate the safety and efficacy of intravesical administration of detalimogene (EG-70) in the bladder and its effect on bladder tumors in patients with NMIBC.
- Conditions
- Superficial Bladder Cancer, Non-muscle Invasive Bladder Cancer With Carcinoma in Situ, Non-muscle Invasive Bladder Cancer
- Trial name
- NCT04752722
- Testing
- EG-70 (phase 1), EG-70 (phase 2) Master Protocol, Surfactant Bladder Pre-Rinse and EG-70 (Substudy)
- Where
- 102 sites in United States, Australia and 8 more
- Volunteers
- 350 people
- Sponsor
- enGene, Inc.
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
Safety and Pharmacology Study of Atezolizumab Alone and in Combination With Bacille Calmette-Guérin (BCG) in High-Risk Non-Muscle-Invasive Bladder Cancer (NMIBC) Participants
This Phase Ib/II study is designed to assess the safety, tolerability, pharmacokinetics, immunogenicity, patient reported outcomes (PROs), and preliminary anti-tumor activity of atezolizumab administered by intravenous (IV)…
- Trial name
- NCT02792192
- Testing
- Atezolizumab, Bacille Calmette-Guérin
- Where
- 8 sites in United States
- Volunteers
- 24 people
- Sponsor
- Hoffmann-La Roche
Bladder Cancer, High Grade
Safety and Efficacy of CG0070 Oncolytic Virus Regimen in Patients With High Grade Non-Muscle Invasive Bladder Cancer
This is an expanded access protocol to study the safety and efficacy of CG0070 in Cis and Cis with Ta and/or T1 disease patients who failed both BCG therapy and the BOND protocol (NCT 01438112), or in high grade Ta and T1…
- Conditions
- Bladder Cancer, High Grade, Non Muscle Invasive
- Trial name
- exBOND (NCT02143804)
- Testing
- oncolytic adenovirus expressing GMCSF
- Where
- United States
- Sponsor
- CG Oncology, Inc.
NMIBC, MIBC
Outcomes for IR and High Risk (HR) Non-muscle Invasive Bladder Cancer (NMIBC) and ctDNA-based Biomarkers for Response and Recurrence in Muscle Invasive Bladder Cancer (MIBC)
This study aims to better understand how treatment choices impact outcomes for patients with intermediate- and high-risk non-muscle-invasive bladder cancer (NMIBC), as well as the factors that influence treatment decisions made…
- Conditions
- NMIBC, MIBC, Muscle Invasive Bladder Cancer (MIBC), Non Muscle Invasive Bladder Cancer
- Trial name
- BLAST (NCT07893509)
- Testing
- This is a non-interventional, observational, prospective study.
- Where
- United States
- Volunteers
- 1,400 people
- Sponsor
- Bladder Cancer Advocacy Network
Non-muscle Invasive Bladder Cancer (NMIBC)
A Study to Evaluate the Efficacy and Safety of RAG-01 as Monotherapy and in Combination With Chemotherapy in Patients With Non-muscle Invasive Bladder Cancer (NMIBC).
This is a randomized, controlled, multicenter clinical study to evaluate the efficacy and safety of RAG-01 monotherapy and in combination with chemotherapy in patients with NMIBC.
- Trial name
- NCT07777848
- Testing
- RAG-01, Chemotherapy agent
- Where
- China
- Volunteers
- 114 people
- Sponsor
- Ractigen Therapeutics.
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.
Urinary Bladder Neoplasms, Immunotherapy
Safety and Efficacy of Camrelizumab for High-risk NMIBC Failing BCG Treatment
This study will evaluate the safety and efficacy of bladder intravesical Camrelizumab in patients with high-risk non-muscle-invasive bladder cancer who failed BCG therapy.
- Trial name
- NCT04706598
- Testing
- Camrelizumab
- Where
- 4 sites in China
- Volunteers
- 25 people
- Sponsor
- Fudan University
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