Clinical trials: Non-muscle Invasive Bladder Cancer (NMIBC)
Urinary Bladder Neoplasms
A Study of Stimulator of Interferon Genes (STING) Agonist E7766 in Non-muscle Invasive Bladder Cancer (NMIBC) Including Participants Unresponsive to Bacillus Calmette-Guerin (BCG) Therapy, INPUT-102
This is an open label, multicenter, phase 1/1b study to assess safety/tolerability and preliminary clinical activity of E7766 as a single agent administered intravesically in participants with NMIBC.
- Trial name
- NCT04109092
- Testing
- E7766
- Where
- 9 sites in United States
- Sponsor
- Eisai Inc.
Bladder Cancer, Recurrent Bladder Cancer
A Study of Oral Erdafitinib in People With Recurrent Non-Invasive Bladder Cancer
The purpose of this study is to assess the effectiveness of erdafitinib in people with non-muscle invasive bladder cancer (NMIBC) that has come back after standard treatment, such as Bacillus Calmette-Guerin (BCG) or chemotherapy…
- Conditions
- Bladder Cancer, Recurrent Bladder Cancer, FGFR3 Gene Mutation
- Trial name
- NCT04917809
- Testing
- Erdafitinib
- Where
- 7 sites in United States
- Volunteers
- 20 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
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.
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
Safety and Efficacy of APL-1202 in Combination With Epirubicin Hydrochloride Versus Epirubicin Hydrochloride Alone in Intermediate and High-risk Chemo-refractory Non-muscle Invasive Bladder Cancer (NMIBC) Patients
To evaluate the clinical efficacy (median event-free survival) of APL-1202 in combination with Epirubicin hydrochloride versus Epirubicin hydrochloride alone in intermediate and high-risk chemo-refractory non-muscle invasive…
- Trial name
- ACCRUE (NCT04490993)
- Testing
- APL-1202 in combination with Epirubicin
- Where
- China
- Volunteers
- 359 people
- Sponsor
- Jiangsu Yahong Meditech Co., Ltd aka Asieris
Non-muscle Invasive Bladder Cancer
"En Bloc" Resection of NMIBC: a Prospective， Single Centre，Randomized Study
The traditional method of choice for intravesical resection of bladder tumors is conventional transurethral resection of bladder tumor (cTURBT).
- Trial name
- NCT03221062
- Testing
- Laser en Bloc Resection
- Volunteers
- 180 people
- Sponsor
- Tongji Hospital
Bladder Cancer
Study of Pembrolizumab (MK-3475) and Pembrolizumab With Other Investigational Agents in Participants With High Risk Non-muscle Invasive Bladder Cancer (MK-3475-057/KEYNOTE-057)
In this study, participants with high risk non-muscle-invasive bladder cancer (NMIBC) unresponsive to Bacillus Calmette Guerin (BCG) therapy and who are considered ineligible for or have refused to undergo radical cystectomy…
- Trial name
- NCT02625961
- Testing
- Pembrolizumab, Pembrolizumab/vibostolimab coformulation, Favezelimab/pembrolizumab coformulation
- Volunteers
- 296 people
- Sponsor
- Merck Sharp & Dohme LLC
Non-Muscle Invasive Bladder Neoplasms
Study of Erdafitinib Intravesical Delivery System for Localized Bladder Cancer
The purpose of the study in Part 1 (dose escalation) and in Part 2 (dose expansion) is to determine the recommended Phase 2 dose(s) (RP2D[s]) and evaluate preliminary clinical efficacy.
- Trial name
- NCT05316155
- Testing
- Erdafitinib Intravesical Delivery System
- Where
- 59 sites in United States, Canada and 6 more
- Volunteers
- 235 people
- Sponsor
- Janssen Research & Development, LLC
Low-grade NMIBC, FGFR Gene Amplification
Efficacy and Safety of TYRA-300 in Participants With FGFR3 Altered Low Grade, Intermediate Risk Non-Muscle Invasive Bladder Cancer
Phase 2 Study of TYRA-300 in FGFR3 Altered Low Grade, Intermediate Risk NMIBC
- Conditions
- Low-grade NMIBC, FGFR Gene Amplification, FGFR Gene Alterations, FGFR3 Gene Alteration
- Trial name
- SURF302 (NCT06995677)
- Testing
- TYRA-300 60mg, TYRA-300 50mg, TYRA-300 Dose 70 mg
- Where
- 48 sites in United States, Australia and 2 more
- Volunteers
- 90 people
- Sponsor
- Tyra Biosciences, Inc
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.
Non-Muscle-Invasive Bladder Cancer (NMIBC)
Disitamab Vedotin Plus Intravesical Mitomycin C in HER2-Expressing Intermediate- to High-Risk Non-Muscle-Invasive Bladder Cancer
This study aims to evaluate the efficacy and safety of intravenous administration of vedacitinib combined with intravesical instillation of mitomycin in treating patients with high-risk NMIBC with HER2 expression.
- Trial name
- NCT07646145
- Testing
- Disitamab Vedotin, Mitomycin C (MMC)
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Shanxi Province Cancer Hospital
Bladder Cancer, Urothelial Carcinoma
Evaluation of NanoDoce® in Participants With Urothelial Carcinoma
This is a clinical trial studying the administration of NanoDoce as a direct injection to the bladder wall immediately after tumor resection and as an intravesical instillation.
- Conditions
- Bladder Cancer, Urothelial Carcinoma, Urinary Bladder Neoplasm, Urinary Bladder Cancer
- Trial name
- NCT03636256
- Testing
- NanoDoce (direct injection), NanoDoce (intravesical instillation) - Visit 2 Instillation, Institutional Standard of Care
- Where
- 5 sites in United States
- Volunteers
- 36 people
- Sponsor
- NanOlogy, LLC
Bladder Cancer
Assessement of the Concordance of Genomic Alterations Between Urine and Tissue in High-Risk NMIBC Patients
The analysis of cell-free tumor DNA (cfDNA) in plasma has emerged as a clinically relevant predictive and prognostic biomarker in several metastatic solid malignancies, and even now represents standard-of-care for prescription of…
- Trial name
- ALU (NCT04412070)
- Where
- France
- Volunteers
- 20 people
- Sponsor
- Hopital Foch
Bladder Cancer
The Clinical Effectiveness and Safety of Intravesical Mitomycin-C and Gemcitabine Sequential Therapy
The aim of this study is to evaluate the effectiveness and safety of mitomycin-c and gemcitabine sequential instillation in BCG unresponsive high risk non-muscle invasive bladder cancer patients.
- Trial name
- IMGeS (NCT06388720)
- Testing
- Mitomycin-C, gemcitabine
- Where
- South Korea
- Volunteers
- 82 people
- Sponsor
- National Cancer Center, Korea
Non Muscle Invasive Bladder Cancer, Treatment by BCG
Effect on Xpert® Bladder Test of Urines Inflammatory Milieu Induced by BCG Treatment of Patients With NMIBC
Intravesical BCG immunotherapy is used after transurethral resection (TUR) for the prevention of recurrence of NMIBC. BCG treatment is usually started a few weeks after TUR and is given once a week for 6 weeks.
- Trial name
- CEPHEID (NCT02895620)
- Testing
- Xpert bladder Test
- Where
- France
- Volunteers
- 24 people
- Sponsor
- Institut Claudius Regaud
Bladder Cancer
Rogaratinib for BCG Refractory High Risk Non-Muscle Invasive Bladder Cancer With FGFR1/2 Overexpression
This research study is studying the safety, tolerability, and tumor activity of the study drug known as rogaratinib as a possible treatment for bladder cancer.
- Trial name
- NCT04040725
- Testing
- Rogaratinib
- Sponsor
- Dana-Farber Cancer Institute
Urothelial Carcinoma, Non-Invasive Bladder Urothelial Carcinoma
Intravesical Adoptive Cell Therapy w/ TIL for BCG Exposed High Grade NMIBC
The purpose of the study is to evaluate the feasibility, safety and tolerability of intravesical adoptive cell therapy using TIL (tumor infiltrating lymphocytes) in participants with urothelial cell carcinoma (UCC) non-muscle…
- Trial name
- NCT05768347
- Testing
- Adoptive Cell Therapy with Tumor-infiltrating Lymphocytes (TIL)
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
Non Muscle Invasive Bladder Cancer
The Necessity of a Second Transurethral Resection in High-risk Non-muscle-invasive Bladder Cancer Patients With Negative Urine Biomarker After Initial Transurethral Resection
The goal of this clinical trial is to evaluate the efficacy of using a urine biomarker test to guide the decision-making process regarding the necessity of reTURBT in NMIBC patients.
- Trial name
- NCT06287541
- Testing
- Urine biomarker -Guided without reTURBT
- Where
- China
- Volunteers
- 428 people
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
Bladder (Urothelial, Transitional Cell) Cancer, Bladder (Urothelial, Transitional Cell) Cancer Superficial (Non-Invasive)
A Study of NDV-01 (Sustained-release Gemcitabine-docetaxel) in Participants With Non-muscle Invasive Bladder Cancer
Study REL-NDV01-303 is a Phase 3, open-label, multi-center study to determine the safety and efficacy of NDV-01 in adult participants with NMIBC.
- Conditions
- Bladder (Urothelial, Transitional Cell) Cancer, Bladder (Urothelial, Transitional Cell) Cancer Superficial (Non-Invasive), Urothelial Carcinoma Bladder, Urothelial Carcinoma Recurrent
- Trial name
- RESCUE (NCT07464145)
- Testing
- NDV-01 (sustained-release gemcitabine-docetaxel)
- Volunteers
- 393 people
- Sponsor
- Relmada Therapeutics, Inc.
Transitional Cell Carcinoma, Bladder Cancer
Efficacy Study of Recombinant Adenovirus for Non Muscle Invasive Bladder Cancer
The use of a designed viral vector that can destroy cancer cells while leaving normal cells largely unharmed. The virus also stimulates an immunological response by producing a special factor (GM-CSF) to attract and promote the…
- Conditions
- Transitional Cell Carcinoma, Bladder Cancer, Carcinoma in Situ, Carcinoma in Situ Concurrent With Papillary Tumors
- Trial name
- BOND (NCT01438112)
- Testing
- CG0070 Adenovirus Vector, Control Arm: Quadruple Choice
- Where
- 7 sites in United States
- Volunteers
- 22 people
- Sponsor
- CG Oncology, Inc.