Clinical trials: Non-muscular Invasive Bladder Cancer
Non-muscle-invasive Bladder Cancer
OH2 Oncolytic Viral Therapy in Non-Muscle-Invasive Bladder Cancer
This phase Ⅰb/Ⅱ study evaluates the safety and efficacy of OH2 for adjuvant therapy in non-muscle-invasive bladder cancer after first-line prophylactic intravesical instillation therapy.
- Trial name
- NCT05232136
- Testing
- OH2 injection
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Binhui Biopharmaceutical Co., Ltd.
Urothelial Carcinoma of the Urinary Bladder
A Phase 1 Study of Intravesical VAX014 for Instillation in Subjects With Non-Muscle Invasive Bladder Cancer
The purpose of this research study is to evaluate the safety, tolerability and activity of VAX014 for Instillation (VAX014) in patients with low-grade Non-Muscle Invasive Bladder Cancer (NMIBC).
- Trial name
- NCT03854721
- Testing
- VAX014
- Where
- 5 sites in United States
- Volunteers
- 6 people
- Sponsor
- Vaxiion Therapeutics
Non-muscle Invasive Bladder Cancer
CAVATAK (CVA21) in Non-muscle Invasive Bladder Cancer (VLA-012 CANON)
The study consisted of 2 sequential parts. Part A assessed the safety and tolerability of CAVATAK administered via intravesical instillation in patients with non-muscle invasive bladder cancer scheduled to undergo TUR.
- Trial name
- CANON (NCT02316171)
- Testing
- CVA21, Mitomycin C
- Where
- United Kingdom
- Volunteers
- 16 people
- Sponsor
- Viralytics
Bladder Cancer
Safety Study of Recombinant Human Hyaluronidase (Chemophase) in Combination With Mitomycin in Participants With Superficial Bladder Cancer
The purpose of this study is to explore a treatment that potentially enhances the delivery of chemotherapy to tumors in participants with superficial bladder cancer.
- Trial name
- NCT00318643
- Testing
- Mitomycin C, Chemophase
- Where
- 5 sites in United States
- Volunteers
- 27 people
- Sponsor
- Halozyme Therapeutics
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.
Bladder Neoplasms
Mycobacterial Cell Wall-DNA Complex in Treatment of BCG-refractory Patients With Non-muscle Invasive Bladder Cancer
The purpose of this study is to determine the efficacy and safety of intravesical Mycobacterial Cell Wall-DNA Complex (MCC) in patients with non-muscle invasive transitional cell carcinoma (papillary tumors and/or carcinoma in…
- Trial name
- NCT00406068
- Testing
- Mycobacterial cell wall-DNA complex
- Where
- 31 sites in United States, Canada
- Volunteers
- 129 people
- Sponsor
- Bioniche Life Sciences Inc.
Non-Muscle- Invasive Bladder Cancer
BCG in Combination With Durvalumab in Adult BCG-naïve, High-risk NMIBC Participants
The purpose of this study is to assess the safety, tolerability, and efficacy profile of durvalumab + BCG (induction and maintenance) combination therapy in adult United States participants with a histologically confirmed…
- Trial name
- PATAPSCO (NCT05943106)
- Testing
- Durvalumab, BCG
- Where
- 19 sites in United States
- Volunteers
- 100 people
- Sponsor
- AstraZeneca
High-Risk Non-Muscle-Invasive Bladder Cancer
Immunological Response to Intravesical BCG Therapy of Superficial Bladder Cancer by Prior Administration of RUTI®
The RUTIVAC-1 study is a Phase I Clinical Trial designed to evaluate the systemic and mucosal immunological response and provide safety information after the use of RUTI® administration to individuals with NMIBC.
- Trial name
- RUTIVAC-1 (NCT03191578)
- Testing
- RUTI®
- Where
- Spain
- Volunteers
- 44 people
- Sponsor
- Archivel Farma S.L.
Bladder Cancer
A Study of IAP0971 in Combination With Bacillus Calmette Guerin in High Risk Non-muscular Invasive Bladder Cancer
The efficacy and safety of IAP0971 single drug or combined with BCG intravesical instillation in the treatment of high-risk non muscle invasive bladder cancer with BCG treatment failure.
- Trial name
- NCT06255964
- Testing
- IAP0971, IAP0971＋BCG
- Volunteers
- 236 people
- Sponsor
- SUNHO（China）BioPharmaceutical CO., Ltd.
Carcinoma in Situ, Transitional Cell Carcinoma
Multi-center Study to Evaluate the Efficacy and Safety of Maintenance Therapy With Valrubicin Versus no Maintenance, in Subjects Treated With Valrubicin Induction for Carcinoma in Situ (CIS) of the Bladder
This is a Phase 3b open-label, randomized, parallel-arm, multicenter study to evaluate the efficacy and safety of 10 monthly intravesical administrations of maintenance therapy with valrubicin following induction with valrubicin…
- Conditions
- Carcinoma in Situ, Transitional Cell Carcinoma, Non-muscle Invasive Bladder Cancer
- Trial name
- NCT01310803
- Testing
- VALSTAR - Maintenance Therapy, No Maintenance treatment ( Standard of Care)
- Where
- 6 sites in United States
- Volunteers
- 1 people
- Sponsor
- Endo USA Inc., a Keenova Therapeutics Company
High-risk Non-muscle Invasive Bladder Cancer
To Evaluate the Safety, Efficacy, and Pharmacokinetics of Intravesical Instiliations of Disitamab Vedotin in Patients With High-risk Non-muscular Invasive Bladder Cancer (NMIBC) That Express HER2
The purpose of this study is to evaluate the safety, efficacy, and pharmacokinetics of intravesical instiliations of Disitamab Vedotin in patients with high-risk non-muscular invasive bladder cancer (NMIBC) that express HER2
- Trial name
- NCT06378242
- Testing
- Disitamab Vedotin for injection
- Where
- 6 sites in China
- Volunteers
- 24 people
- Sponsor
- RemeGen Co., Ltd.
Bladder (Urothelial, Transitional Cell) Cancer, Bladder (Urothelial, Transitional Cell) Cancer Superficial (Non-Invasive)
A Study of NDV-01 as an Intravesical Administration to Patients With BCG-Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC), Refractory to First-line Therapy
This is a Phase 3, open-label single-arm trial designed to evaluate the safety and efficacy of NDV-01 (sustained-release gemcitabine-docetaxel) in adult participants with NMIBC with CIS who have failed BCG therapy and who have…
- Conditions
- Bladder (Urothelial, Transitional Cell) Cancer, Bladder (Urothelial, Transitional Cell) Cancer Superficial (Non-Invasive), Urothelial Carcinoma Bladder, Urothelial Carcinoma Recurrent
- Trial name
- RESCUE (NCT07342517)
- Testing
- NDV-01 (sustained-release gemcitabine-docetaxel)
- Volunteers
- healthy volunteers welcome
- Sponsor
- Relmada Therapeutics, Inc.
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.
Solid Tumor, Bladder Cancer
LUMINOS-103: A Basket Trial of Safety & Efficacy of Lerapolturev With or Without Checkpoint Inhibitors
This is a Phase 1/2, open-label, multi-center, single arm basket study evaluating the administration of lerapolturev ± anti programmed cell death protein 1 (PD 1)/programmed death-ligand 1 (PD L1) monoclonal antibody (mAb) (which…
- Conditions
- Solid Tumor, Bladder Cancer, Non-muscle-invasive Bladder Cancer
- Trial name
- NCT04690699
- Testing
- Lerapolturev, 5% DDM
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Istari Oncology, Inc.
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
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.
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.
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.
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
Superficial Bladder Cancer
Intravesical Gemcitabine Instillation Followed by Transurethral Resection for the Treatment of Patients With Superficial Bladder Cancer at Low Risk.
The purpose of this study is to determine whether neoadjuvant intravesical Gemcitabine is enough active in patients with a solitary, low risk superficial bladder cancer.After diagnostic urethrocystoscopy or bladder sonography…
- Trial name
- NCT00191711
- Testing
- Gemcitabine
- Where
- Italy
- Volunteers
- 43 people
- Sponsor
- Eli Lilly and Company