Clinical trials: Carcinoma of Urinary Bladder, Invasive
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
Intermediate and High-risk Non-muscle Invasive Bladder Cancer
A Phase I Clinical Study of SHR-2005 Intravesical Instillation in the Treatment of Intermediate and High-risk Non-muscle Invasive Bladder Cancer (NMIBC)
This study is an open-label, multicenter Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-2005 for Intravesical perfusion in patients with intermediate and high-risk non-muscle…
- Trial name
- NCT06108492
- Testing
- SHR-2005
- Where
- China
- Volunteers
- 170 people
- Sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.
Muscle Invasive Bladder Cancer
A Study to Evaluate the Safety and Efficacy of Oral APL-1202 in Combination With Tislelizumab Compared to Tislelizumab Alone as Neoadjuvant Therapy in Patients With Muscle Invasive Bladder Cancer
This trial is designed to evaluate the safety, efficacy, and biomarker response of APL-1202 in combination with tislelizumab as neoadjuvant therapy for patients with MIBC who are cisplatin ineligible or refuse cisplatin-based…
- Trial name
- ANTICIPATE (NCT04813107)
- Testing
- APL-1202 in combination with tislelizumab, Tislelizumab alone
- Where
- 2 sites in United States, China
- Volunteers
- 79 people
- Sponsor
- Jiangsu Yahong Meditech Co., Ltd aka Asieris
Muscle-Invasive Bladder Carcinoma, Metastatic Urothelial Carcinoma
Modular Trial of sEphB4-HSA in EphrinB2-High Solid Tumors
Patients with solid tumors that have high expression levels of EphrinB2 are treated with regimens that include EphrinB2 inhibitor, sEphB4-HSA.
- Trial name
- NCT06493552
- Testing
- SEphB4-HSA, Pembrolizumab, Gemcitabine
- Where
- United States
- Volunteers
- 700 people
- Sponsor
- Vasgene Therapeutics, Inc
Locally Advanced or Metastatic Urothelial Cell Carcinoma, Urinary Bladder Disease
A Study of B-701 in Combination With Pembrolizumab in Treatment of Locally Advanced or Metastatic Urothelial Cell Carcinoma
This is a Phase 1b/2 multi-center, open-label study to establish the initial safety and to determine a recommended Phase 2 dose of B-701 in combination with pembrolizumab, and to determine safety, tolerability and efficacy of…
- Conditions
- Locally Advanced or Metastatic Urothelial Cell Carcinoma, Urinary Bladder Disease, Urological Diseases
- Trial name
- FIERCE-22 (NCT03123055)
- Testing
- B-701, Pembrolizumab
- Where
- 52 sites in United States, Belgium and 15 more
- Volunteers
- 28 people
- Sponsor
- Rainier Therapeutics
Non-muscle Invasive Bladder Cancer
A Study to Evaluate Eciskafusp Alfa in Combination With Bacillus Calmette-guerin (BCG) in Participants With BCG-unresponsive High-risk Non-muscle Invasive Bladder Cancer (NMIBC)
The study aims to establish the safety, tolerability, pharmacokinetics (PK), relevant biomarkers, pharmacodynamics (PD) and preliminary anti-tumor activity of the intravesical administration of eciskafusp alfa in combination with…
- Trial name
- NCT06816017
- Testing
- Eciskafusp Alfa, BCG Medac Strain
- Where
- 9 sites in Australia, Italy and 4 more
- Sponsor
- Hoffmann-La Roche
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
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 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 (NMIBC)
A Study of Intravesical FL115 Alone or in Combination With BCG in Non-Muscle Invasive Bladder Cancer
The study is to evaluate the safety and tolerability of intravesical FL115 alone or in combination with BCG in the patients with NMIBC, and to determine the RP2D of FL115 in combination with BCG.
- Trial name
- NCT07122414
- Testing
- FL115, FL115+BCG
- Where
- 12 sites in China
- Volunteers
- 80 people
- Sponsor
- Suzhou Forlong Biotechnology Co., Ltd
Superficial Bladder Cancer
A Randomized Study Comparing Single Agent Gemcitabine Intravesical Therapy Versus Mitomycin C in Patients With Intermediate Risk Superficial Bladder Cancer
Gemcitabine has been shown to be highly effective and well tolerated in the first and second line therapy, as a single agent or in combination therapy for treatment of metastatic transitional cell carcinoma.
- Trial name
- NCT00192049
- Testing
- Gemcitabine, mitomycin C
- Where
- 5 sites in Israel
- Volunteers
- 90 people
- Sponsor
- Eli Lilly and Company
BCG
BCG for Therapeutic Use Phase Ⅲ Clinical Trial
Research topic: A randomized, double-blind, active-controlled, multicenter phase III clinical trial evaluating the efficacy and safety of therapeutic BCG for the prevention of postoperative recurrence of non-muscle-invasive…
- Trial name
- NCT06747455
- Testing
- BCG for Therapeutic Use, BCG for Therapeutic Use ( BI SAI JI )
- Where
- China
- Volunteers
- 439 people
- Sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., 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
High-risk Non-muscle-invasive Bladder Cancer
A Study of HS-10566 in Patients With High-risk Non-muscle-invasive Bladder Cancer Who Are Ineligible for or Refuse Radical Cystectomy
This is a multicenter, open-label, Phase I/II clinical study evaluating the safety, efficacy, tolerability, and pharmacokinetic/pharmacodynamic (PK/PD) profiles of HS-10566 in patients with high-risk non-muscle-invasive bladder…
- Trial name
- NCT07468851
- Testing
- HS-10566
- Where
- 2 sites in China
- Volunteers
- 180 people
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
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
A Study of Toca 511 & Toca FC in Patients With Recurrent High Grade Non-Muscle Invasive Bladder Cancer (Toca 8)
This is a Phase 1, multicenter, open-label study of intravesical Toca 511 followed by oral Toca FC in patients with high grade (HG) non-muscle invasive bladder cancer (NMIBC), with cohort expansion at the recommended Phase 2…
- Trial name
- NCT04089163
- Testing
- Toca 511, Toca FC (extended-release formulation of flucytosine)
- Sponsor
- Tocagen Inc.
Papillary-Only Non-muscle-invasive Bladder Cancer
A Study of SHR-1501 Combination With BCG Versus Placebo Combined With BCG in Subjects With Papillary-Only NMIBC
This is a multicenter, randomized, Double-blind phase III study to determine the efficacy and safety of intravesical SHR-1501 combined with Bacillus Calmette Guerin (BCG) versus Placebo Combined with BCG in patients with…
- Trial name
- NiBladder 2 (NCT07726992)
- Testing
- SHR-1501+BCG
- Where
- 2 sites in China
- Volunteers
- 750 people
- Sponsor
- Suzhou Suncadia Biopharmaceuticals Co., 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.
Superficial Bladder Cancer
Phase 2b, Trial of Intravesical DTA-H19/PEI in Patients With Intermediate-Risk Superficial Bladder Cancer
This study is designed to assess the efficacy and safety of DTA-H19/PEI given as six intravesical instillations of 20 mg of plasmid DNA complexed with PEI into the bladder of patients with intermediate risk superficial bladder…
- Trial name
- NCT00595088
- Testing
- BC-819/PEI
- Where
- 6 sites in United States, Israel
- Volunteers
- 47 people
- Sponsor
- Anchiano Therapeutics Israel Ltd.