Clinical trials: Non-Muscle Invasive Bladder Urothelial Carcinoma
- Condition Non-Muscle Invasive Bladder Urothelial Carcinoma
- Funder type Industry (pharma, biotech, devices)
Non-Muscle Invasive Bladder Cancer, Urothelial Carcinoma
An Expanded Access Program of Cretostimogene Grenadenorepvec for Treatment of NMIBC for Patients Unresponsive to BCG
This is an open-label, expanded access trial designed to provide access to cretostimogene in patients with NMIBC (specifically CIS with or without HG Ta/T1) unresponsive to BCG.
- Conditions
- Non-Muscle Invasive Bladder Cancer, Urothelial Carcinoma, Urologic Cancer, Bladder Cancer
- Trial name
- NCT06443944
- Testing
- Cretostimogene Grenadenorepvec, n-dodecyl-B-D-maltoside
- Where
- 27 sites in United States
- Sponsor
- CG Oncology, Inc.
Bladder Cancer, Urothelial Carcinoma
Feasibility of Home Instillation of UGN-102 for Treatment of Low-Grade (LG) Non-Muscle Invasive Bladder Cancer (NMIBC)
This study aims to demonstrate that home instillation of UGN-102 is a feasible alternative to instillation in a clinical setting, which might mitigate patient challenges (logistical, expense, and comfort) when receiving treatment…
- Conditions
- Bladder Cancer, Urothelial Carcinoma, Urothelial Carcinoma Bladder
- Trial name
- NCT05136898
- Testing
- UGN-102
- Where
- 5 sites in United States
- Volunteers
- 8 people
- Sponsor
- UroGen Pharma Ltd.
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
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, 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.
Non-muscle Invasive Bladder Cancer
A Study of Intravesical BCG in Combination With ALT-803 in Patients With Non-Muscle Invasive Bladder Cancer
This is a Phase Ib/IIb, randomized, two-cohort, open-label, multicenter study of intravesical N-803 plus BCG versus BCG alone, in BCG naïve patients with high-grade NMIBC.
- Trial name
- NCT02138734
- Testing
- BCG (50mg/instillation) + N-803 (400 μg/instillation), BCG (50mg/instillation)
- Where
- 108 sites in United States, India and 1 more
- Volunteers
- 369 people
- Sponsor
- ImmunityBio, Inc.
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.
Non-Muscle Invasive Bladder Cancer (NMIBC) Refractory to BCG
Intravesical Photodynamic Therapy (PDT) in BCG Refractory High-Risk Non-muscle Invasive Bladder Cancer (NMIBC) Patients
This is a phase Ib, open-label, single-arm, single-center study conducted in Canada. Subjects with NMIBC (Ta, T1, and/or Tis) who are not candidates for or have refused radical cystectomy will be eligible for participation in the…
- Trial name
- NCT03053635
- Testing
- TLD1433 infusion and photodynamic therapy (PDT) treatment
- Where
- Canada
- Volunteers
- 6 people
- Sponsor
- Theralase® Technologies Inc.
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
Carcinoma, Transitional Cell, Bladder Neoplasms
Dose-Escalation Study of CG0070 for Bladder Cancer After BCG (Bacillus Calmette-Guerin) Failure
The main purpose of this research study is to evaluate the safety and dosing of CG0070.
- Trial name
- NCT00109655
- Testing
- Oncolytic adenovirus (serotype 5) - CG0070
- Where
- 10 sites in United States, Canada
- Volunteers
- 75 people
- Sponsor
- Cell Genesys
Bladder Neoplasm, Neoplasm Recurrence, Local
Efficacy and Safety Evaluation of EN3348 (Mycobacterial Cell Wall-DNA Complex [MCC]) as Compared With Mitomycin C in the Intravesical Treatment of Subjects With BCG Recurrent/Refractory Non-muscle Invasive Bladder Cancer
This is a phase 3 randomized, active-controlled, open-label, multicenter study that will be conducted in approximately 120 investigational sites worldwide.
- Conditions
- Bladder Neoplasm, Neoplasm Recurrence, Local, Transitional Cell, Carcinoma, Carcinoma in Situ
- Trial name
- EMBARC-RF (NCT01200992)
- Testing
- EN3348, Mitomycin C
- Where
- 72 sites in United States, Canada and 4 more
- Volunteers
- 84 people
- Sponsor
- Bioniche Life Sciences Inc.
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.
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
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.
Advanced or Metastatic Solid Tumors, Non-Small Cell Lung Cancer
A Study in Advanced/Metastatic Solid Tumors With the Study Medicine (PF-07329640) When Given Alone or In Combination
The purpose of this study is to learn about the safety (the impact of the study drug on the participant's body), effects of the study drug alone or in combination with bevacizumab or sasanlimab, and to find the best dose.
- Conditions
- Advanced or Metastatic Solid Tumors, Non-Small Cell Lung Cancer, Colorectal Cancer, Urothelial Cancer
- Trial name
- LTbR (NCT06448364)
- Testing
- PF-07329640, sasanlimab, bevacizumab
- Where
- 7 sites in United States, Puerto Rico
- Volunteers
- 4 people
- Sponsor
- Pfizer
Non-muscle Invasive Bladder Cancer
A Study of ALT-801 in Patients With Bacillus Calmette-Guerin (BCG) Failure Non-Muscle Invasive Bladder Cancer
This is a Phase Ib/II, open-label, multi-center and competitive enrollment study of ALT-801 combined with gemcitabine for patients who have BCG failure (defined as refractory, relapsing or intolerant), non-muscle invasive bladder…
- Trial name
- NCT01625260
- Testing
- ALT-801, Gemcitabine
- Where
- 5 sites in United States
- Volunteers
- 12 people
- Sponsor
- Altor BioScience
Non-muscle Invasive Bladder Cancer (NMIBC)
LCS103 Herbal Formula for Secondary Prevention of Non-Muscle Invasive Urothelial Carcinoma of the Bladder
This study is a phase IIA, single-site, randomized, controlled, open-label clinical trial evaluating the safety and efficacy of the LCS103 oral herbal formula for the secondary prevention of NMIBC.
- Trial name
- LCS103 (NCT07728474)
- Testing
- LCS103
- Where
- Israel
- Volunteers
- 60 people
- Sponsor
- LifeBiotic Medical Research Ltd.
Locally Advanced Urothelial Carcinoma, Metastatic Urothelial Carcinoma
Safety and Preliminary Anti-Tumor Activity of TYRA-300 in Advanced Urothelial Carcinoma and Other Solid Tumors With FGFR3 Gene Alterations
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of TYRA-300 in cancers with FGFR3 activating gene alterations, including locally advanced/metastatic…
- Conditions
- Locally Advanced Urothelial Carcinoma, Metastatic Urothelial Carcinoma, Solid Tumor, Urothelial Carcinoma
- Trial name
- SURF301 (NCT05544552)
- Testing
- TYRA-300
- Where
- 19 sites in United States, Australia and 2 more
- Volunteers
- 310 people
- Sponsor
- Tyra Biosciences, Inc
Bladder Cancer
PF-07225570 Alone or in Combination With an Anti-PD-1 Antibody in Recurrent Non-muscle Invasive Bladder Cancer (NMIBC)
The primary objective of this study is to evaluate the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of PF-07225570 alone or in combination with an anti-PD-1 antibody in participants with recurrent…
- Trial name
- NCT05259397
- Testing
- PF-07225570, sasanlimab
- Where
- 4 sites in United States, Poland
- Sponsor
- Pfizer