Clinical trials: Non-muscle-invasive Bladder Cancer
Non-muscle Invasive Bladder Cancer
A Phase 3 Study to Evaluate the Safety and Efficacy of APL-1202 as a Single-agent Oral Treatment Versus Intravesical Instillation of Epirubicin Hydrochloride in naïve Intermediate-risk NMIBC Patients
A multi-center, randomized, open-label, parallel-controlled Phase Ⅲ clinical trial to evaluate the clinical safety and efficacy of APL-1202 as a single-agent oral treatment versus intravesical instillation of Epirubicin…
- Trial name
- ASCERTAIN (NCT04736394)
- Testing
- APL-1202, Epirubicin Hydrochloride
- Where
- China
- Volunteers
- 800 people
- Sponsor
- Jiangsu Yahong Meditech Co., Ltd aka Asieris
Non-muscle-invasive Bladder Cancer
A Study of STM-416 Administered to Patients Undergoing TURBT for Recurrent Bladder Cancer
This is a first-in-human (FIH), Phase 1/2a, multi center, open-label, single treatment, dose escalation and expansion study designed to determine the safety and tolerability of STM-416 in patients with bladder cancer.
- Trial name
- NCT05710848
- Testing
- STM-416
- Where
- 20 sites in United States
- Volunteers
- 75 people
- Sponsor
- SURGE Therapeutics
High Risk Non-muscle Invasive Bladder Cancer
A Phase I/II Study of JL19001 Injection Alone or in Combination With BCG in Subjects With High Risk Non-Muscle Invasive Bladder Cancer.
Phase Ia, an open-label, sequential, dose escalation study to evaluate the tolerability and safety of JL19001 Injection alone in subjects with high risk NMIBC.
- Trial name
- JL19001-NMIBC (NCT07483970)
- Testing
- JL19001 Injection
- Where
- China
- Volunteers
- 18 people
- Sponsor
- Jecho Biopharmaceuticals Co., Ltd.
Bladder Neoplasms
Phase II Trial of EOquin in High-risk Superficial Bladder Cancer
A non-randomized, open-label phase II study to explore the feasibility, time to recurrence, duration of response and safety of the adjuvant intravesical instillation of EOquin (apaziquone) in patients with high-risk superficial…
- Trial name
- NCT00141531
- Testing
- Apaziquone
- Where
- Netherlands
- Volunteers
- 53 people
- Sponsor
- Spectrum Pharmaceuticals, Inc
Urinary Bladder Cancer
Safety and Tolerability of TAR-200 mg in Subjects With Non-Muscle-Invasive Bladder Cancer
The purpose of this study is to determine if TAR-200, an investigational drug-delivery system is safe and tolerable in patients with recurrent low or intermediate risk non-muscle-invasive bladder cancer (NMIBC) between diagnosis…
- Trial name
- NCT02720367
- Testing
- Gemcitabine-Releasing Intravesical System (GemRIS)/TAR-200
- Where
- 2 sites in Netherlands
- Volunteers
- 12 people
- Sponsor
- Taris Biomedical LLC
Bladder (Urothelial, Transitional Cell) Cancer, Bladder (Urothelial, Transitional Cell) Cancer Superficial (Non-Invasive)
A Study of NDV-01 (Sustained-release Gemcitabine-docetaxel) in Participants With Non-muscle Invasive Bladder Cancer
Study REL-NDV01-303 is a Phase 3, open-label, multi-center study to determine the safety and efficacy of NDV-01 in adult participants with NMIBC.
- Conditions
- Bladder (Urothelial, Transitional Cell) Cancer, Bladder (Urothelial, Transitional Cell) Cancer Superficial (Non-Invasive), Urothelial Carcinoma Bladder, Urothelial Carcinoma Recurrent
- Trial name
- RESCUE (NCT07464145)
- Testing
- NDV-01 (sustained-release gemcitabine-docetaxel)
- Volunteers
- 393 people
- Sponsor
- Relmada Therapeutics, Inc.
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
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.
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
Non-Muscle Invasive Bladder Cancer
Clinical Trial for Evaluating the Efficacy and Safety of BCG for Therapeutic Use in the Prevention of Postoperative Recurrence of Medium/High-risk Non-muscle Invasive Bladder Cancer (NMIBC)
A phase III multi-center randomized, double-blind and positive-controlled clinical trial for evaluating the efficacy and safety of BCG for Therapeutic Use（BCG） in the prevention of postoperative recurrence of medium/high-risk…
- Trial name
- NCT06241755
- Testing
- BCG for Therapeutic Use
- Where
- China
- Volunteers
- 412 people
- Sponsor
- Chengdu CoenBiotech Co., Ltd
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
Bladder Cancer, Non Muscle Invasive
Safety, Tolerability, and Preliminary Efficacy of BH011 in Subjects With Non-Muscle-Invasive Bladder Cancer
The purpose of this study is to determine the safety and tolerability of intravesical BH011 in patients with high-risk non-muscle invasive bladder cancer（NMIBC） after Bacillus Calmette-Guerin（BCG） failure and to assess the…
- Trial name
- NCT06732531
- Testing
- BH011
- Where
- 6 sites in China
- Volunteers
- 48 people
- Sponsor
- Zhuhai Beihai Biotech Co., Ltd
Urinary Bladder Neoplasms
Investigation of Safety and Tolerability of Catumaxomab in Patients With NMIBC
The purpose of the study is to investigate the safety, tolerability, and preliminary efficacy of the monoclonal bispecific trifunctional antibody Catumaxomab in patients with non-muscle invasive bladder cancer (NMIBC).
- Trial name
- NCT04819399
- Testing
- Catumaxomab
- Where
- Germany
- Volunteers
- 34 people
- Sponsor
- Lindis Biotech GmbH
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
Non-Muscle- Invasive Bladder Cancer
BCG in Combination With Durvalumab in Adult BCG-naïve, High-risk NMIBC Participants
The purpose of this study is to assess the safety, tolerability, and efficacy profile of durvalumab + BCG (induction and maintenance) combination therapy in adult United States participants with a histologically confirmed…
- Trial name
- PATAPSCO (NCT05943106)
- Testing
- Durvalumab, BCG
- Where
- 19 sites in United States
- Volunteers
- 100 people
- Sponsor
- AstraZeneca
Solid Tumor, Bladder Cancer
LUMINOS-103: A Basket Trial of Safety & Efficacy of Lerapolturev With or Without Checkpoint Inhibitors
This is a Phase 1/2, open-label, multi-center, single arm basket study evaluating the administration of lerapolturev ± anti programmed cell death protein 1 (PD 1)/programmed death-ligand 1 (PD L1) monoclonal antibody (mAb) (which…
- Conditions
- Solid Tumor, Bladder Cancer, Non-muscle-invasive Bladder Cancer
- Trial name
- NCT04690699
- Testing
- Lerapolturev, 5% DDM
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Istari Oncology, Inc.
Carcinoma of Urinary Bladder, Superficial
Pre-TURBT TC-3 Gel Intravesical Instillation in NMIBC
In the proposed study the investigators aim to evaluate the effect of the standard of care dose (40mg) of MMC mixed with TC-3 gel (with sustained release mechanism on the drug) on low risk recurrent NMIBC lesions and to compare…
- Trial name
- OPTIMA (NCT01803295)
- Testing
- 40 mg MMC gel, Standard of care MMC mixed with water, 80 mg MMC gel
- Where
- 13 sites in Israel, Italy and 2 more
- Volunteers
- 80 people
- Sponsor
- UroGen Pharma Ltd.
Urinary Bladder Neoplasms, Neoplasm Metastasis
FORAGER-1: A Study of Vepugratinib (LY3866288; LOXO-435) in Participants With Cancer With a Change in a Gene Called FGFR3
The main purpose of this study is to learn more about the safety, side effects, and effectiveness of Vepugratinib by itself or when it is combined with other medicines that treat cancer.
- Conditions
- Urinary Bladder Neoplasms, Neoplasm Metastasis, Ureteral Neoplasms
- Trial name
- FORAGER-1 (NCT05614739)
- Testing
- Vepugratinib, Pembrolizumab, enfortumab vedotin
- Where
- 82 sites in United States, Australia and 12 more
- Volunteers
- 677 people
- Sponsor
- Eli Lilly and Company
NMIBC
RC48-ADC in Combination With Gemcitabine in High Risk NMIBC Subjects
In this study, participants with high risk non-muscle-invasive bladder cancer (NMIBC) who are BCG Naïve or BCG Unresponsive and are considered ineligible for or have refused to undergo radical cystectomy, will receive RC48-ADC in…
- Trial name
- NCT05943379
- Testing
- RC48-ADC in Combination with gemcitabine
- Where
- China
- Volunteers
- 85 people
- Sponsor
- RemeGen Co., Ltd.
Bladder Cancer Cell Transitional, Non-Muscle Invasive Bladder Cancer
Proliposomal Intravesical Paclitaxel for Treatment of Low-Grade, Stage Ta, Non Muscle Invasive Bladder Cancer
This is a single-arm, phase 1/2a study of formulated paclitaxel in subjects with low-grade, noninvasive papillary carcinoma (stage Ta) of the bladder.
- Conditions
- Bladder Cancer Cell Transitional, Non-Muscle Invasive Bladder Cancer, Bladder Cancer, Urinary Bladder
- Trial name
- NCT03081858
- Testing
- TSD-001
- Where
- 5 sites in United States
- Volunteers
- 15 people
- Sponsor
- Lipac Oncology LLC