Clinical trials: Carcinoma of Urinary Bladder, Invasive
Non Muscle Invasive Bladder Cancer, High-grade Ta/ T1 Papillary Disease Bladder Cancer
Study of Cretostimogene Given in Patients With Non-Muscle Invasive Bladder Cancer ,Unresponsive to Bacillus-Calmette-Guerin
This study aims to evaluate the efficacy and safety of Cretostimogene in patients with BCG-unresponsive high-risk non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without Ta/T1 papillary tumors.
- Trial name
- NCT07283835
- Testing
- Cretostimogene Grenadenorepvec, n-dodecyl-B-D-maltoside
- Where
- 14 sites in China
- Volunteers
- 16 people
- Sponsor
- Lepu Biopharma Co., Ltd.
Non-muscle Invasive Bladder Cancer (NMIBC)
Codex: Study of Inodiftagene Vixteplasmid (BC-819) in Unresponsive NMIBC
This study, BC-819-18-204, is a Phase 2, open-label, monotherapy, single-arm, multicenter clinical trial of BC-819 (inodiftagene vixteplasmid) in patients with NMIBC adequately treated with Bacillus Calmette-Guerin (BCG) whose…
- Trial name
- NCT03719300
- Testing
- inodiftagene vixteplasmid
- Where
- 48 sites in United States
- Volunteers
- 32 people
- Sponsor
- Anchiano Therapeutics Israel Ltd.
Bladder Cancer, Bladder Tumor
A Study of Nivolumab Plus Bempegaldesleukin (Bempeg/NKTR-214) vs Nivolumab Alone vs Standard of Care in Participants With Bladder Cancer That May Have Invaded The Muscle Wall of the Bladder and Who Cannot Get Cisplatin, A Type of Medicine Given To Treat Bladder Cancer
The purpose of the study is to see if treatment with nivolumab plus bempegaldesleukin or nivolumab alone, before and after surgery to remove the bladder, is more effective than surgery alone in participants with high-risk…
- Conditions
- Bladder Cancer, Bladder Tumor, Muscle-Invasive Bladder Cancer
- Trial name
- NCT04209114
- Testing
- Nivolumab, Radical cystectomy (RC), Bempegaldesleukin
- Where
- 116 sites in United States, Argentina and 18 more
- Volunteers
- 114 people
- Sponsor
- Bristol-Myers Squibb
Bladder Cancer
Single Immediate Instillation of EO9 After TURBT in Patients With Non-muscle-invasive Bladder Cancer (NMIBC)
The purpose of this study is to evaluate the efficacy and safety in patients with non-muscle invasive bladder cancer histologically diagnosed to be stage Ta and G1 or G2 and who were randomized into either an EO9 or placebo group…
- Trial name
- NCT01475266
- Testing
- EO9 (Apaziquone)
- Where
- 20 sites in Japan, South Korea
- Volunteers
- 51 people
- Sponsor
- Nippon Kayaku Co., Ltd.
Urothelial Carcinoma
An Umbrella Study to Determine the Safety and Efficacy of Various Monotherapy or Combination Therapies in Neoadjuvant Urothelial Carcinoma
This is a multicenter, open-label, randomized, Phase 2 umbrella study of various neoadjuvant treatment combinations in participants who have muscle-invasive urothelial carcinoma of the bladder and are cisplatin-ineligible or…
- Trial name
- Optimus (NCT04586244)
- Testing
- retifanlimab, epacadostat, INCAGN02385
- Where
- 12 sites in United States, France and 1 more
- Volunteers
- 30 people
- Sponsor
- Incyte Corporation
Various Advanced Cancer
An Investigational Immuno-therapy Study of Nivolumab, Compared to Placebo, in Patients With Bladder or Upper Urinary Tract Cancer, Following Surgery to Remove the Cancer
The purpose of this study is to determine the effectiveness and safety of Nivolumab compared to placebo in participants who have undergone radical surgery for invasive urothelial cancer.
- Trial name
- CheckMate 274 (NCT02632409)
- Testing
- Nivolumab
- Where
- 188 sites in United States, Argentina and 28 more
- Volunteers
- 709 people
- Sponsor
- Bristol-Myers Squibb
Urinary Bladder Neoplasms, Non-muscle Invasive Bladder Cancer (NMIBC)
A Study to Investigate the Efficacy and Safety of Alpha1H as a Neoadjuvant Therapy in Participants With Low- to Intermediate-Risk/Low-Grade Papillary Non-Muscle Invasive Bladder Cancer
The goal of this clinical trial is to learn if the drug Alpha1H works to treat low-to-intermediate risk non-muscle-invasive bladder cancer in adults. It will also learn about the safety of drug Alpha1H.
- Trial name
- NCT07804056
- Testing
- Alpha1H, Transurethral Resection of Bladder Tumor (TURBT), Intravesical Chemotherapy
- Where
- Czechia
- Volunteers
- 194 people
- Sponsor
- Hamlet Pharma AB
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
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.
Urothelial Cancer, Urinary Bladder Neoplasms
Enfortumab Vedotin in Combination With Pembrolizumab vs. Concurrent Chemoradiotherapy (cCRT) in People With Muscle Invasive Bladder Cancer (EV-309)
This study is being done to see how well two drugs (enfortumab vedotin and pembrolizumab) work together as a bladder preservation approach to treat patients with muscle invasive bladder cancer.
- Trial name
- NCT07566156
- Testing
- Enfortumab vedotin, Conventional Radiotherapy, Hypofractionated Radiotherapy
- Where
- 29 sites in United States, Canada and 2 more
- Volunteers
- 390 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Urinary Bladder Cancer
An Epidemiologic Study on PD-L1 Expression Combined With Clinical Observation in the Chinese MIUBC Patients.
The Primary Objective of this observational study is to investigate the prevalence of high PD-L1 expression in Chinese MIUBC patients.
- Trial name
- POLARIS (NCT03433924)
- Where
- 17 sites in China
- Volunteers
- 248 people
- Sponsor
- AstraZeneca
Urinary Bladder Neoplasms
A Study of Erdafitinib Versus Investigator Choice of Intravesical Chemotherapy in Participants Who Received Bacillus Calmette-Guérin (BCG) and Recurred With High Risk Non-Muscle-Invasive Bladder Cancer (NMIBC)
The purpose of this study is to evaluate recurrence-free survival (RFS) in participants treated with erdafitinib vs Investigator's Choice, for participants with high-risk non-muscle-invasive bladder cancer (NMIBC) who harbor…
- Trial name
- NCT04172675
- Testing
- Erdafitinib, Investigator Choice (Gemcitabine), Investigator Choice (Mitomycin C)
- Where
- 150 sites in United States, Argentina and 15 more
- Volunteers
- 107 people
- Sponsor
- Janssen Research & Development, LLC
Urinary Bladder Neoplasms
A Study to Evaluate Treatment Preferences for Japanese Participants With Muscle-invasive Urothelial Carcinoma of the Bladder
The main purpose of this study is to identify important treatment attributes for post-radical cystectomy (RC) treatment for participants with MIBC (Muscle-Invasive Bladder Cancer) and assess the relative importance of treatment…
- Trial name
- SNUGGLE (NCT05742867)
- Where
- United States
- Volunteers
- 115 people
- Sponsor
- Bristol-Myers Squibb
Non-muscle Invasive Bladder Cancer
Safety and Efficacy Study of Intravesical Instillation of TARA-002 in Adults With High-grade Non-muscle Invasive Bladder Cancer
TARA-002-101-Ph2 is an open-label study to investigate the safety and efficacy of intravesical instillation of TARA-002 in adults 18 years of age or older with high-grade CIS NMIBC (± Ta/T1).
- Trial name
- ADVANCED-2 (NCT05951179)
- Testing
- TARA-002
- Where
- 78 sites in United States, Argentina and 5 more
- Volunteers
- 131 people
- Sponsor
- Protara Therapeutics
Muscle Invasive Bladder Carcinoma
FL- 101 Study in Non-Metastatic MIBC
A pilot window of opportunity study of FL-101 in patients with non-metastatic MIBC who are eligible for radical cystectomy (RC) but are ineligible for, or decline, cisplatin-based neoadjuvant therapy.
- Trial name
- NCT05395260
- Testing
- FL-101
- Sponsor
- Flame Biosciences
Bladder Cancer, Urothelial Carcinoma
A Phase 3 Study of UGN-103 for Treatment of Patients With Low-grade Intermediate-risk Non-muscle Invasive Bladder Cancer
This Phase 3, single-arm, multicenter study was designed to evaluate the efficacy and safety of UGN-103, a novel formulation of UGN-102, instilled in the urinary bladder of patients with recurrent low-grade intermediate-risk…
- Conditions
- Bladder Cancer, Urothelial Carcinoma, Urothelial Carcinoma Bladder
- Trial name
- UTOPIA (NCT06331299)
- Testing
- UGN-103
- Where
- 48 sites in United States, Bulgaria and 5 more
- Volunteers
- 99 people
- Sponsor
- UroGen Pharma 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
Bladder Cancer
Treatment of High-risk Non-muscle Invasive Bladder Cancer With IMUNO BGC Moreau RJ as Prophylaxis
Bladder cancer is the fourth reason of neoplasia in our environment, there are 25 new cases diagnosed per 100,000 inhabitants each year.
- Trial name
- NCT03982797
- Testing
- Instillation of IMUNO BCG Moreau RJ
- Where
- 15 sites in Spain
- Volunteers
- 306 people
- Sponsor
- Biofabri, S.L
Bladder Cancer
A Study of Intravesical Qapzola (Apaziquone) as a Surgical Adjuvant in Participants Undergoing Transurethral Resection of Bladder Tumor (TURBT)
This is a randomized, multicenter, two-arm, double-blind, placebo-controlled study of Qapzola in participants with low- to intermediate-risk non-muscle invasive bladder cancer (NMIBC), assessed according to the 2016 American…
- Trial name
- NCT03224182
- Testing
- Qapzola
- Where
- United States
- Volunteers
- 118 people
- Sponsor
- Spectrum Pharmaceuticals, Inc
Bladder (Urothelial, Transitional Cell) Cancer Superficial (Non-Invasive), Bladder (Urothelial, Transitional Cell) Cancer
A Study of Adjuvant NDV-01 (Sustained-release Gemcitabine-docetaxel) for the Treatment of Intermediate Risk NMIBC Following TURBT
This is a Phase 3, open-label, randomized trial designed to evaluate the DFS of TURBT followed by NDV-1 (sustained-release gemcitabine-docetaxel) versus TURBT followed by surveillance for the treatment of participants with…
- Conditions
- Bladder (Urothelial, Transitional Cell) Cancer Superficial (Non-Invasive), Bladder (Urothelial, Transitional Cell) Cancer, Urothelial Carcinoma Bladder, Urologic Cancer
- Trial name
- BOOST (NCT07313891)
- Testing
- NDV-01 (sustained-release gemcitabine-docetaxel)
- Sponsor
- Relmada Therapeutics, Inc.