Clinical trials: Muscle-Invasive Bladder Carcinoma
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
Urinary Bladder Cancer, Muscle-invasive
Perioperative Pembrolizumab (MK-3475) Plus Cystectomy or Perioperative Pembrolizumab Plus Enfortumab Vedotin Plus Cystectomy Versus Cystectomy Alone in Participants Who Are Cisplatin-ineligible or Decline Cisplatin With Muscle-invasive Bladder Cancer (MK-3475-905/KEYNOTE-905/EV-303)
This is a study of perioperative pembrolizumab or enfortumab vedotin in combination with pembrolizumab in participants who are cisplatin-ineligible or decline cisplatin with muscle-invasive bladder cancer (MIBC).
- Trial name
- NCT03924895
- Testing
- Pembrolizumab, Surgery (radical cystectomy (RC) plus Pelvic Lymph Node Dissection [PLND]), Enfortumab Vedotin
- Where
- 242 sites in United States, Argentina and 26 more
- Volunteers
- 595 people
- Sponsor
- Merck Sharp & Dohme LLC
Bladder (Urothelial, Transitional Cell) Cancer, Non-Muscle Invasive Bladder Carcinoma
Efficacy and Safety of Intravesical TARA-002 Compared With Investigator's Choice of Intravesical Chemotherapy in Participants With BCG-naïve High-grade Non-muscle Invasive Bladder Cancer
The goal of this clinical trial is to learn if TARA-002 can treat high-grade non-muscle invasive bladder cancer (NMIBC) in BCG-naïve adults 18 years of age or older.
- Conditions
- Bladder (Urothelial, Transitional Cell) Cancer, Non-Muscle Invasive Bladder Carcinoma, Non-muscle Invasive Bladder Cancer With Carcinoma in Situ
- Trial name
- ADVANCED-3 (NCT07480356)
- Testing
- TARA-002, Investigator's Choice of Intravesical Chemotherapy
- Where
- 11 sites in United States, Ukraine
- Volunteers
- 284 people
- Sponsor
- Protara Therapeutics
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, 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
Non Muscle Invasive Bladder Cancer
A Study to Evaluate the Safety and Efficacy of NDV-01 in Participants With NMIBC
This is a prospective, single-arm study evaluating the safety and efficacy of NDV01 KIT, a fixed-dose combination of gemcitabine HCl and docetaxel, administered via intravesical instillation in patients with high-grade Non-Muscle…
- Trial name
- NMIBC (NCT06663137)
- Testing
- NDV01 intravesical controlled release formulation of gemcitabine and docetaxel
- Where
- Israel
- Volunteers
- 70 people
- Sponsor
- Relmada Therapeutics, Inc.
Urinary Bladder Neoplasms, Urologic Neoplasms
A Study of Vepugratinib (LY3866288) in Adults With Non-Muscle Invasive Bladder Cancer and Upper Tract Urothelial Cancer
The main purpose of this study is to see how well vepugratinib works in adults with low grade, intermediate risk, non-muscle invasive bladder cancer (LG IR NMIBC) or low-grade upper tract urothelial carcinoma (LG UTUC).
- Conditions
- Urinary Bladder Neoplasms, Urologic Neoplasms, Receptor, Fibroblast Growth Factor, Type 3
- Trial name
- FORAY (NCT07827612)
- Testing
- Vepugratinib
- Where
- United States
- Volunteers
- 161 people
- Sponsor
- Eli Lilly and Company
Bladder Cancer, Non-muscle Invasive Bladder Cancer
Exploration of Novel AI-enabled Blue Light Enhanced Cystoscopy
Blue light cystoscopy (BLC) is a diagnostic procedure in bladder cancer where the inside of the bladder is observed with a camera to detect bladder lesions.
- Trial name
- ENAiBLE (NCT07144319)
- Where
- 8 sites in United States, Belgium and 3 more
- Volunteers
- 500 people
- Sponsor
- Photocure
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
Non-muscle Invasive Bladder Cancer (NMIBC)
Phase 1/2 Study of ABI-009 in Nonmuscle Invasive Bladder Cancer
Purpose of this study is to determine appropriate dosing of ABI-009 and evaluate the safety and anti-tumor activity of ABI-009 in treatment of non-muscle invasive bladder cancer
- Trial name
- NCT02009332
- Testing
- ABI-009, Gemcitabine
- Where
- 2 sites in United States
- Volunteers
- 21 people
- Sponsor
- Aadi Bioscience, Inc.
High-risk Muscle Invasive Urothelial Carcinoma
An Open-label Study to Investigate the Efficacy and Safety of Dato-DXd + Rilvegostomig vs SoC in Adult Participants With High-risk MIUC
Purpose: to assess efficacy and safety of Dato-DXd + rilvegostomig as adjuvant therapy versus SoC in MIUC participants with high-risk residual disease after radical resection.
- Trial name
- TU-04 (NCT07720284)
- Testing
- Dato-DXd, Rilvegostomig, Durvalumab
- Where
- 160 sites in United States, Australia and 14 more
- Volunteers
- 915 people
- Sponsor
- AstraZeneca
Non-Muscle Invasive Bladder Cancer (NMIBC)
Study of APL-1202 in Non-Muscle Invasive Bladder Cancer Patients Who Are Resistant to One Induction Course of BCG Treatment
A Phase Ib, open label, non randomized study to measure the safety and PK characteristics of APL-1202 at steady-state in adult male and female BCG resistant NMIBC patients when it is administered alone and concurrently with BCG.
- Trial name
- NMIBC (NCT03672240)
- Testing
- APL-1202
- Where
- 2 sites in United States
- Volunteers
- 6 people
- Sponsor
- Asieris Pharmaceutical Technologies Co., Ltd.
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
Bladder Cancer
Phase Ib/II Study Assessing the Neo-adjuvant Combination Therapy of Vinflunine With Cisplatin Followed by Radical Cystectomy in Patients With Muscle-invasive Bladder Cancer (JaNEO)
Phase Ib/II study assessing the neo-adjuvant combination therapy of vinflunine with cisplatin followed by radical cystectomy in patients with muscle-invasive bladder cancer (JaNEO).
- Trial name
- JaNEO (NCT02845050)
- Testing
- Vinflunine, Cisplatin, Radical cystectomy
- Where
- 2 sites in Germany
- Sponsor
- Ligartis GmbH
Bladder Cancer, Urothelial Carcinoma
Rucaparib in Patients With Locally Advanced or Metastatic Urothelial Carcinoma
The purpose of the ATLAS study is to determine how patients with locally advanced unresectable or metastatic urothelial carcinoma respond to treatment with rucaparib.
- Conditions
- Bladder Cancer, Urothelial Carcinoma, Metastatic Urothelial Carcinoma, Renal Pelvis Carcinoma
- Trial name
- ATLAS (NCT03397394)
- Testing
- Rucaparib
- Where
- 64 sites in United States, France and 4 more
- Volunteers
- 97 people
- Sponsor
- pharmaand GmbH
Carcinoma in Situ of Bladder
Retrospective Chart Review of Valstar
This is an observational study involving a retrospective review of medical records of adult patients who have been treated with intravesical valrubicin for bladder carcinoma in situ (CIS) since October 2009.
- Trial name
- NCT01304173
- Where
- United States
- Volunteers
- 113 people
- Sponsor
- Endo USA Inc., a Keenova Therapeutics Company
Non-muscle Invasive Bladder Cancer, NMIBC
A Phase 1 Dose-escalation Study of UGN-301 in Patients With Recurrent Non-muscle Invasive Bladder Cancer (NMIBC)
This study is being conducted to evaluate the safety and determine the recommended Phase 2 dose (RP2D) of UGN-301 (zalifrelimab) administered intravesically as monotherapy and in combination with other agents in patients with…
- Conditions
- Non-muscle Invasive Bladder Cancer, NMIBC, Carcinoma in Situ of Bladder, Bladder Cancer
- Trial name
- NCT05375903
- Testing
- UGN-301, UGN-201, Gemcitabine
- Where
- 13 sites in United States, Italy and 1 more
- Volunteers
- 51 people
- Sponsor
- UroGen Pharma Ltd.
Muscle Invasive Bladder Cancer
Open-Label, Randomised, Multi-Drug, Biomarker-Directed, Phase 1b Study in Pts w/ Muscle Invasive Bladder Cancer
This is an open label, multi-drug, biomarker-directed, multi-centre, multi-arm, Phase 1b study in patients with muscle invasive bladder cancer (MIBC) (urothelial) who have progressed on prior treatment.
- Trial name
- BISCAY (NCT02546661)
- Testing
- AZD4547, MEDI4736, Olaparib
- Where
- 27 sites in United States, Canada and 3 more
- Volunteers
- 117 people
- Sponsor
- AstraZeneca
Urinary Bladder Neoplasms
A Study of TAR-200 in Combination With Cetrelimab Versus Concurrent Chemoradiotherapy in Participants With Muscle-invasive Bladder Cancer (MIBC) of the Bladder
The purpose of study is to compare bladder intact-event free survival (BI-EFS) in participants receiving TAR-200 in combination with intravenous (IV) cetrelimab versus concurrent chemoradiotherapy.
- Trial name
- SunRISe-2 (NCT04658862)
- Testing
- Cetrelimab, TAR-200, Cisplatin
- Where
- 290 sites in United States, Argentina and 23 more
- Volunteers
- 518 people
- Sponsor
- Janssen Research & Development, LLC
Bladder Cancer
Study of Pembrolizumab (MK-3475) and Pembrolizumab With Other Investigational Agents in Participants With High Risk Non-muscle Invasive Bladder Cancer (MK-3475-057/KEYNOTE-057)
In this study, participants with high risk non-muscle-invasive bladder cancer (NMIBC) unresponsive to Bacillus Calmette Guerin (BCG) therapy and who are considered ineligible for or have refused to undergo radical cystectomy…
- Trial name
- NCT02625961
- Testing
- Pembrolizumab, Pembrolizumab/vibostolimab coformulation, Favezelimab/pembrolizumab coformulation
- Volunteers
- 296 people
- Sponsor
- Merck Sharp & Dohme LLC