Clinical trials: Non-muscle-invasive Bladder Cancer
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
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
Superficial Bladder Cancer
ADSTILADRIN (=INSTILADRIN) in Patients With High-Grade, Bacillus Calmette-Guerin (BCG) Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC)
Previous multi-dose Phase I and Phase II clinical studies have demonstrated that ADSTILADRIN is a safe and effective treatment for BCG-refractory and recurrent NMIBC.
- Trial name
- NCT02773849
- Testing
- ADSTILADRIN
- Where
- 34 sites in United States
- Volunteers
- 157 people
- Sponsor
- Ferring Pharmaceuticals
Carcinoma in Situ, Non Muscle Invasive Bladder Cancer
Study With TMX-101 in Patients With Carcinoma In Situ (CIS) Bladder Cancer
This is a Phase II pilot study to explore the effect of intravesical TMX-101 in patients with CIS bladder cancer, as assessed by histology and cytology after TMX-101 treatment.
- Trial name
- NCT01731652
- Testing
- TMX-101
- Where
- 4 sites in United States
- Volunteers
- 12 people
- Sponsor
- Telormedix SA
NMIBC
ResQ132EX-NMIBC: Expanded Access Use of Recombinant Bacillus Calmette-Guérin in Nonmuscle Invasive Bladder Cancer
This expanded access protocol is designed to provide Recombinant Mycobacterium BCG (rMBCG) to patients with Non-muscle invasive bladder cancer (NMIBC) who are eligible to receive TICE® BCG, may benefit from its use, and who are…
- Trial name
- NCT06810141
- Testing
- rMBCG
- Where
- 66 sites in United States
- Sponsor
- ImmunityBio, Inc.
Urinary Bladder Neoplasms
A Study to Characterize High-Risk Non-Muscle-Invasive Bladder Cancer Participants in Portugal
The purpose of this study is to understand how the participants with high-risk non-muscle invasive bladder cancer are diagnosed, treated, and cared for in regular clinical practice in Portugal.
- Trial name
- BRITE (NCT07784387)
- Where
- Portugal
- Volunteers
- 250 people
- Sponsor
- Janssen-Cilag Farmaceutica Ltda.
NMIBC
Feasibility of Automatic, Laser-based Distance Control in Persons With Superficial Bladder Tumors
The goal of this clinical investigation is to test the sensing and guiding part of the ATLAS system in the human bladder of people with Ta low grade bladder tumors.
- Trial name
- LUMINA I (NCT07860398)
- Testing
- ATLAS system
- Where
- Denmark
- Volunteers
- 25 people
- Sponsor
- Optheras AS
Superficial Bladder Cancer
Maximum Tolerable Concentration of abnobaVISCUM Fraxini Intravesically in Patients With Superficial Bladder Cancer
The aim of this phase Ib/IIa study is to investigate the maximum tolerable concentration of abnobaVISCUM® Fraxini for intravesical instillation in patients with superficial bladder cancer.
- Trial name
- NCT02007005
- Testing
- abnobaVISCUM Fraxini
- Where
- 2 sites in Egypt, Germany
- Volunteers
- 37 people
- Sponsor
- Abnoba Gmbh
Bladder Cancer, Urothelial Carcinoma
A Phase 3 Single-Arm Study of UGN-102 for Treatment of Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer
This Phase 3, multinational, single-arm study was designed to evaluate the efficacy and safety of UGN-102 as primary chemoablative therapy in patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer…
- Conditions
- Bladder Cancer, Urothelial Carcinoma, Urothelial Carcinoma Bladder
- Trial name
- ENVISION (NCT05243550)
- Testing
- UGN-102
- Where
- 65 sites in United States, Austria and 8 more
- Volunteers
- 240 people
- Sponsor
- UroGen Pharma Ltd.
Urothelial Carcinoma, Non Muscle Invasive Bladder Cancer
Brazilian Reality of Urinary Bladder Cancers - BRA-BLADDER
A national, multicenter, non-randomized, retrospective, observational study (Real-World Evidence-RWE) aimed at analyzing clinical presentation profiles and demographic characteristics of patients with early urothelial bladder…
- Conditions
- Urothelial Carcinoma, Non Muscle Invasive Bladder Cancer, Muscle-invasive Bladder Cancer
- Trial name
- NCT05945108
- Where
- 5 sites in Brazil
- Volunteers
- 400 people
- Sponsor
- AstraZeneca
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.
Non-muscle Invasive Bladder Cancer
A Study to Evaluate Eciskafusp Alfa in Combination With Bacillus Calmette-guerin (BCG) in Participants With BCG-unresponsive High-risk Non-muscle Invasive Bladder Cancer (NMIBC)
The study aims to establish the safety, tolerability, pharmacokinetics (PK), relevant biomarkers, pharmacodynamics (PD) and preliminary anti-tumor activity of the intravesical administration of eciskafusp alfa in combination with…
- Trial name
- NCT06816017
- Testing
- Eciskafusp Alfa, BCG Medac Strain
- Where
- 9 sites in Australia, Italy and 4 more
- Sponsor
- Hoffmann-La Roche
Bladder Cancer, Urothelial Carcinoma
A Phase 3 Study of UGN-102 for Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer
This global, randomized, controlled, open-label Phase 3 study was designed to assess the long-term efficacy and safety of UGN-102 (mitomycin) for intravesical solution with or without (±) transurethral resection of bladder tumors…
- Conditions
- Bladder Cancer, Urothelial Carcinoma, Urothelial Carcinoma Bladder
- Trial name
- ATLAS (NCT04688931)
- Testing
- UGN-102, TURBT
- Where
- 139 sites in United States, Bulgaria and 8 more
- Volunteers
- 282 people
- Sponsor
- UroGen Pharma Ltd.
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
Superficial Bladder Cancer
A Randomized Study Comparing Single Agent Gemcitabine Intravesical Therapy Versus Mitomycin C in Patients With Intermediate Risk Superficial Bladder Cancer
Gemcitabine has been shown to be highly effective and well tolerated in the first and second line therapy, as a single agent or in combination therapy for treatment of metastatic transitional cell carcinoma.
- Trial name
- NCT00192049
- Testing
- Gemcitabine, mitomycin C
- Where
- 5 sites in Israel
- Volunteers
- 90 people
- Sponsor
- Eli Lilly and Company
BCG
BCG for Therapeutic Use Phase Ⅲ Clinical Trial
Research topic: A randomized, double-blind, active-controlled, multicenter phase III clinical trial evaluating the efficacy and safety of therapeutic BCG for the prevention of postoperative recurrence of non-muscle-invasive…
- Trial name
- NCT06747455
- Testing
- BCG for Therapeutic Use, BCG for Therapeutic Use ( BI SAI JI )
- Where
- China
- Volunteers
- 439 people
- Sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
Bladder Cancer
A Phase 1/2 Study of HS-410 in Patients With Non-Muscle Invasive Bladder Cancer After TURBT
Phase I/II study: Phase 1 is an open-label, safety study, patients who previously received 3-6 instillations of weekly intravesical Bacillus Calmette-Guerin (BCG) induction therapy (as standard of care) followed by low dose…
- Trial name
- NCT02010203
- Testing
- HS-410, BCG
- Where
- 19 sites in United States
- Volunteers
- 104 people
- Sponsor
- Heat Biologics
High-risk Non-muscle-invasive Bladder Cancer
A Study of HS-10566 in Patients With High-risk Non-muscle-invasive Bladder Cancer Who Are Ineligible for or Refuse Radical Cystectomy
This is a multicenter, open-label, Phase I/II clinical study evaluating the safety, efficacy, tolerability, and pharmacokinetic/pharmacodynamic (PK/PD) profiles of HS-10566 in patients with high-risk non-muscle-invasive bladder…
- Trial name
- NCT07468851
- Testing
- HS-10566
- Where
- 2 sites in China
- Volunteers
- 180 people
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
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 Toca 511 & Toca FC in Patients With Recurrent High Grade Non-Muscle Invasive Bladder Cancer (Toca 8)
This is a Phase 1, multicenter, open-label study of intravesical Toca 511 followed by oral Toca FC in patients with high grade (HG) non-muscle invasive bladder cancer (NMIBC), with cohort expansion at the recommended Phase 2…
- Trial name
- NCT04089163
- Testing
- Toca 511, Toca FC (extended-release formulation of flucytosine)
- Sponsor
- Tocagen Inc.