Clinical trials: Non-muscular Invasive Bladder Cancer
Non-Muscle Invasive Bladder Cancer ("NMIBC") Unresponsive/Intolerant to BCG
Intravesical Photodynamic Therapy ("PDT") in BCG-Unresponsive/Intolerant Non-Muscle Invasive Bladder Cancer ("NMIBC") Patients
This is a phase II, open-label, single-arm, multi-center Study conducted in Canada and the United States. Patients with Non-Muscle Invasive Bladder Cancer ("NMIBC") Carcinoma In-Situ ("CIS") (with or without resected papillary…
- Trial name
- NCT03945162
- Testing
- Ruvidar® (TLD-1433) bladder infusion and PDT
- Where
- 16 sites in United States, Canada
- Volunteers
- 90 people
- Sponsor
- Theralase® Technologies Inc.
Bladder Cancer, Urothelial Carcinoma
A Phase 2b Study of UGN-102 for Low Grade Intermediate Risk Non-Muscle-Invasive Bladder Cancer
This Phase 2b, single-arm, multicenter study evaluated the efficacy and safety of UGN-102 as primary chemoablative therapy in patients with low grade intermediate risk non-muscle-invasive bladder cancer (LG IR NMIBC).
- Conditions
- Bladder Cancer, Urothelial Carcinoma, Urothelial Carcinoma Bladder
- Trial name
- OPTIMA II (NCT03558503)
- Testing
- UGN-102
- Where
- 19 sites in United States, Israel
- Volunteers
- 63 people
- Sponsor
- UroGen Pharma Ltd.
Bladder Cancer, Urinary Bladder Neoplasms
A Clinical Study of MK-3120 in People With Bladder Cancer (MK-3120-003)
Researchers are looking for new ways to treat high-risk non-muscle invasive bladder cancer (HR NMIBC). NMIBC is cancer in the tissue that lines the inside of the bladder and has not spread to the bladder muscle or outside of the…
- Trial name
- NCT07222488
- Testing
- MK-3120
- Where
- 17 sites in United States, Austria and 10 more
- Volunteers
- 45 people
- Sponsor
- Merck Sharp & Dohme LLC
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
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 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
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
Clinical Evaluation of BCDx for Monitoring of Recurrence in Non-Muscle Invasive Bladder Cancer
BCDx is a urine-based multi-omic assay for early cancer recurrence detection in patients with a history of bladder cancer. This prospective, blinded study evaluates its efficacy in detecting recurrent NMIBC, offering a…
- Trial name
- NCT05982561
- Where
- 3 sites in United States
- Volunteers
- 500 people
- Sponsor
- Early is Good Inc.
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
High-risk NMIBC
A Study of SHR-1501 Alone or in Combination With BCG or SHR-1316 in Subjects With NMIBC
The study is to evaluate the safety and tolerability of SHR-1501 alone or in combination with BCG or SHR-1316 in the patients with NMIBC, and to determine the RP2D of SHR-1501 in combination with BCG or SHR-1316.
- Trial name
- NCT05410730
- Testing
- SHR-1501
- Where
- China
- Volunteers
- 150 people
- Sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.
Carcinoma of Urinary Bladder, Invasive
Safety and Tolerability Study Which Evaluate Intravesical Instillation With Mitomycin C Mixed With TC-3 Drug Retaining Hydrogel Device In Patients With Muscle Invasive Bladder Cancer
The purpose of this study is to evaluate the safety of intravesical instillation of TC-3 Hydrogel disposable device for retention of mitomycin C chemotherapeutic drug in the urinary bladder.
- Trial name
- NCT01648010
- Testing
- TC-3 gel, TC-3 gel mixed with Mitomycin C (MMC)
- Where
- 3 sites in Israel
- Volunteers
- 7 people
- Sponsor
- UroGen Pharma Ltd.
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
RITE-EUROPE (Radiofrequency-Induced Thermochemotherapy Effect-EUROPE)
This multicenter, prospective, single-arm, phase 3 study will assess the proportion of disease-free patients, starting from administration of the first study treatment to at least 12-months after the first treatment, and up to 2…
- Trial name
- NCT02471495
- Testing
- Synergo® RITE + MMC
- Sponsor
- Medical Enterprises Europe B.V.
Non Muscle Invasive Bladder Cancer
A Prospective Open Label Comparative Dose Ranging Study Evaluating the Effect of Pre-TURBT Intravesical Instillation of Mitomycin C (MMC) Mixed With TC-3 Gel in Patients With Non Muscle Invasive Bladder Cancer (NMIBC)
This study is a prospective randomized open labeled dose ranging comparative study. Twenty four (24) patients with NMIBC who meet the inclusion/exclusion criteria will be recruited for the study following the initial diagnostic…
- Trial name
- NMIBC TURBT HG (NCT01799499)
- Testing
- TC-3 hydrogel
- Where
- Israel
- Sponsor
- UroGen Pharma Ltd.
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
Non-muscle Invasive Bladder Cancer
A Study of Sasanlimab in People With Non-muscle Invasive Bladder Cancer
The purpose of this study is to learn about the safety and effects of the study medicine (sasanlimab) in people with non-muscle invasive bladder cancer.
- Trial name
- CREST (NCT04165317)
- Testing
- PF-06801591, Bacillus Calmette-Guerin
- Where
- 196 sites in United States, Australia and 12 more
- Volunteers
- 1,068 people
- Sponsor
- Pfizer
Non Muscle Invasive Bladder Cancer, Urologic Cancer
A Study of Adjuvant Cretostimogene Grenadenorepvec for Treatment of Intermediate Risk NMIBC Following TURBT
This is a Phase 3, open-label, randomized trial designed to evaluate the RFS of TURBT followed by cretostimogene grenadenorepvec versus TURBT followed by surveillance for the treatment of participants with IR-NMIBC.
- Conditions
- Non Muscle Invasive Bladder Cancer, Urologic Cancer, Bladder Cancer, Urothelial Carcinoma
- Trial name
- NCT06111235
- Testing
- Cretostimogene Grenadenorepvec, n-dodecyl-B-D-maltoside
- Where
- 95 sites in United States, Canada
- Volunteers
- 367 people
- Sponsor
- CG Oncology, Inc.
Bladder (Urothelial, Transitional Cell) Cancer, NMIBC
A Phase 1 Dose-escalation Study of UGN-501 Administered Intravesically in Adult Participants With Recurrent NMIBC
This study is being conducted to evaluate the safety and tolerability of UGN-501 administered intravesically in adult participants with recurrent non-muscle invasive bladder cancer (NMIBC) and to determine the recommended Phase 2…
- Conditions
- Bladder (Urothelial, Transitional Cell) Cancer, NMIBC, Urothelial Carcinoma Bladder, Urothelial Carcinoma in Situ
- Trial name
- NCT07725796
- Testing
- UGN-501
- Where
- 15 sites in United States
- Volunteers
- 30 people
- Sponsor
- UroGen Pharma, Inc., a subsidiary of UroGen Pharma Ltd.
Bladder Cancer
Safety and Efficacy of CG0070 Oncolytic Virus Regimen for High Grade NMIBC After BCG Failure
To study the safety and efficacy of CG0070, an oncolytic virus expression GM-CSF in high grade non muscle invasive bladder cancer patients who failed BCG therapy and refused cystectomy.
- Trial name
- BOND2 (NCT02365818)
- Testing
- CG0070
- Where
- 17 sites in United States
- Volunteers
- 66 people
- Sponsor
- CG Oncology, Inc.
Non-Muscle Invasive Bladder Cancer
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Patients With Bladder Cancer (MK-2870-027)
The goal of the study is to learn about the safety of Sacituzumab Tirumotecan and if people can tolerate it when given in the bladder and find the highest dose that people can take without having certain problems.
- Trial name
- TroFuse-027 (NCT06637423)
- Testing
- Sacituzumab tirumotecan, Rescue medication, Supportive care measures
- Where
- 13 sites in United States, Canada and 4 more
- Volunteers
- 35 people
- Sponsor
- Merck Sharp & Dohme LLC