Clinical trials: High-Risk Non-Muscle-Invasive Bladder Cancer
Non Muscle Invasive Bladder Cancer
The Role of Definitive Radiotherapy in Non Muscle Invasive Bladder Cancer
Bladder cancer is one of the most common malignancies worldwide and represents a major global health burden. According to the GLOBOCAN 2022 estimates, approximately 614,298 new cases and 220,596 deaths from bladder cancer were…
- Trial name
- NCT07873333
- Testing
- Definitive radiotherapy, BCG, Concurrent chemotherapy
- Volunteers
- 70 people
- Sponsor
- Assiut University
Pharmacokinetics
PK Sub-Study of QUILT-3.032 (CA ALT-803-01-16) and of QUILT-2.005 (CA ALT-803-01-14)
Non-interventional PK sub-study of QUILT-3.032 (CA-ALT-803-01-16) and QUILT-2.005 (CA-ALT-803-01-14)
- Trial name
- NCT04142359
- Testing
- BCG in Combination with N-803, N-803 alone
- Where
- 6 sites in United States
- Volunteers
- 1 people
- Sponsor
- Altor BioScience
Urinary Bladder Neoplasms
A Study of TAR-200 in Combination With Cetrelimab, TAR-200 Alone, or Cetrelimab Alone in Participants With Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Intravesical Bacillus Calmette-Guérin Who Are Ineligible for or Elected Not to Undergo Radical Cystectomy
The purpose of this study is to evaluate the overall complete response (CR) rate in participants treated with TAR-200 in combination with cetrelimab (Cohort 1), or TAR-200 alone (Cohort 2), or cetrelimab alone (Cohort 3) with…
- Trial name
- SunRISe-1 (NCT04640623)
- Testing
- TAR-200, Cetrelimab
- Where
- 144 sites in United States, Australia and 14 more
- Volunteers
- 220 people
- Sponsor
- Janssen Research & Development, LLC
Non-Muscle-Invasive Bladder Cancer (NMIBC)
Investigating the Efficacy and Safety of Neoadjuvant Intravesical Instillation of Mitomycin C in Treating High-risk NMIBC Patients
The goal of this clinical trial is to learn if neoadjuvant intravesical instillation of mitomycin C combined with en-bloc surgery works to treat high-risk non-muscle-invasive bladder cancer (NMIBC) patients.
- Trial name
- NCT06696794
- Testing
- Mitomycin C (MMC)
- Where
- 3 sites in China
- Volunteers
- 180 people
- Sponsor
- Shaogang Wang
Bladder Cancer
The Performance of Cancer Risk Genes in the Necessity of Secondary TURBT
Investigators performed the Genetron Uro V1 test on the urine of patients before secondary TURBT and compared it with the final pathological results.
- Trial name
- RE-TURBT (NCT05112523)
- Where
- China
- Volunteers
- 200 people
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
Non-Muscle Invasive Bladder Urothelial Carcinoma, Recurrent Non-Muscle Invasive Bladder Urothelial Carcinoma
Testing the Addition of the Immunotherapy Drug, Pembrolizumab, to Radiation Therapy Compared to the Usual Chemotherapy Treatment During Radiation Therapy for Bladder Cancer, PARRC Trial
This phase II trial compares the use of pembrolizumab and radiation therapy to chemotherapy with cisplatin, gemcitabine, 5-fluorouracil or mitomycin-C and radiation therapy for the treatment of non-muscle invasive bladder cancer.
- Conditions
- Non-Muscle Invasive Bladder Urothelial Carcinoma, Recurrent Non-Muscle Invasive Bladder Urothelial Carcinoma, Stage I Bladder Cancer AJCC v8
- Trial name
- NCT06770582
- Testing
- Biospecimen Collection, Cisplatin, Computed Tomography
- Where
- 147 sites in United States, Canada
- Volunteers
- 160 people
- Sponsor
- National Cancer Institute (NCI)
Non-muscle-invasive Bladder Cancer
Intravesical BCG vs GEMDOCE in NMIBC
The study hypothesis is that BCG naïve non-muscle invasive bladder cancer (NMIBC) patients treated with intravesical Gemcitabine + Docetaxel (GEMDOCE) will result in a non-inferior event-free survival (EFS) compared to standard…
- Trial name
- BRIDGE (NCT05538663)
- Testing
- Gemcitabine, Docetaxel, Bacillus Calmette Guerin
- Where
- 229 sites in United States
- Volunteers
- 870 people
- Sponsor
- ECOG-ACRIN Cancer Research Group
Bladder Cancer
Evaluation of PD-L1 Expression and Immune Infiltration in High-risk Non Muscle Invasive Bladder Cancer
Non-muscle-invasive bladder cancer (NMIBC) has a high rate of recurrence (60 to 70%) and progression (20 to 30%) to muscle-invasive bladder cancer (MIBC).
- Trial name
- IMMUN VESSIE (NCT04726735)
- Testing
- Samples of bladder tissue
- Where
- France
- Volunteers
- 100 people
- Sponsor
- University Hospital, Bordeaux
Bladder Cancer
Treatment of High-risk Non-muscle Invasive Bladder Cancer With IMUNO BGC Moreau RJ as Prophylaxis
Bladder cancer is the fourth reason of neoplasia in our environment, there are 25 new cases diagnosed per 100,000 inhabitants each year.
- Trial name
- NCT03982797
- Testing
- Instillation of IMUNO BCG Moreau RJ
- Where
- 15 sites in Spain
- Volunteers
- 306 people
- Sponsor
- Biofabri, S.L
Bladder Cancer
Efficacy and Safety of Pseudomonas Aeruginosa for Intermediate and High-risk Non-muscle Invasive Bladder Cancer
This is a multicenter, single-arm study to evaluate the efficacy and safety of Pseudomonas aeruginosa the treatment of patients with intermediate and high risk non-muscle invasive bladder cancer.
- Trial name
- NCT05975151
- Testing
- Pseudomonas aeruginosa
- Where
- China
- Volunteers
- 63 people
- Sponsor
- Qilu Hospital of Shandong University
Bladder Cancer
Prognostic Effect of Whether Doing PLND During RC for High-risk NMIBC
There is no consensus on the need for lymph node dissection in radical cystectomy (RC) for high-risk non-muscular invasive bladder cancer (NMIBC).
- Trial name
- PLND-Less (NCT05123625)
- Testing
- Reduce surgical procedures
- Where
- China
- Volunteers
- 200 people
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
Urinary Bladder Neoplasms, Non-Muscle Invasive Bladder Neoplasms
A Clinical Study of Intismeran Autogene (V940) and BCG in People With Bladder Cancer (V940-011/INTerpath-011)
Researchers are looking for new ways to treat people with high-risk non-muscle invasive bladder cancer (HR NMIBC). NMIBC is cancer in the tissue that lines the inside of the bladder but has not spread to the bladder muscle or…
- Conditions
- Urinary Bladder Neoplasms, Non-Muscle Invasive Bladder Neoplasms, Carcinoma in Situ
- Trial name
- NCT06833073
- Testing
- Intismeran autogene, BCG
- Where
- 89 sites in United States, Argentina and 17 more
- Volunteers
- 308 people
- Sponsor
- Merck Sharp & Dohme LLC
High-Risk Non-Muscle Invasive Bladder Urothelial Carcinoma
Tilelizumab Combined With Nab-Paclitaxel for High-Risk Non-Muscle-Invasive Urothelial Bladder Carcinoma Which is Not Completely Resectable: a Multi-center Study
This is a phase II study to determine the safety and efficacy of tislelizumab when given in combination with nab-paclitaxel as treatment for patients with high-risk non-muscle-invasive bladder cancer (HR NMIBC) which is not…
- Trial name
- NCT05418309
- Testing
- Tislelizumab Nab paclitaxel
- Where
- China
- Volunteers
- 63 people
- Sponsor
- Tianjin Medical University Second Hospital
Invasive Bladder Cancer
Atezolizumab and BCG in High Risk BCG naïve Non-muscle Invasive Bladder Cancer (NMIBC) Patients (BladderGATE)
Patients with high-risk non-muscle invasive bladder cancer (NMIBC) are usually managed by transurethral resection of their bladder tumor (TURBT) alone plus additional intravesical therapy to deliver high local concentrations of a…
- Trial name
- BladderGATE (NCT04134000)
- Testing
- Atezolizumab, BCG
- Where
- Spain
- Volunteers
- 40 people
- Sponsor
- Fundacion Oncosur
Non Muscle Invasive Bladder Cancer
A Study Comparing the Necessity of a Second Transurethral Resection in High-Risk Non-Muscle-Invasive Bladder Cancer Patients With Negative Results From Post-Initial Resection Urine Genome-Wide Low-Depth Sequencing
This study is a prospective, randomized, multicenter clinical trial aiming to enroll 428 patients with non-muscle-invasive bladder cancer (NMIBC) from the Department of Urology at Jiangsu Provincial People's Hospital and its…
- Trial name
- NCT07036731
- Testing
- Urine biomarker -Guided without reTURBT
- Where
- China
- Volunteers
- 428 people
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
High-Risk, Non-Muscle Invasive Bladder Urothelial Carcinoma
Tilelizumab Combined With Nab-Paclitaxel for High-Risk Non-Muscle-Invasive Urothelial Bladder Carcinoma Which is Not Completely Resectable
This is a phase II study to determine the safety and efficacy of tislelizumab when given in combination with nab-paclitaxel as treatment for patients with high-risk non-muscle-invasive bladder cancer (HR NMIBC) which is not…
- Trial name
- NCT04730232
- Testing
- Tislelizumab, Nab-paclitaxel
- Where
- China
- Volunteers
- 63 people
- Sponsor
- Tianjin Medical University Second Hospital
Bladder Cancer
First Line Comparative Study of EN3348 (MCC) vs BCG in NMIBC
The purpose of this study is to compare the safety and efficacy of EN3348 (MCC) versus BCG as first line treatment in patients with non-muscle invasive bladder cancer that are at high risk for recurrence or progression.
- Trial name
- NCT01284205
- Testing
- Mycobacterial Cell-Wall DNA Complex, Bacillus Calmette-Guerin
- Where
- 14 sites in United States
- Sponsor
- Bioniche Life Sciences Inc.
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
NMIBC
RC48-ADC in Combination With Gemcitabine in High Risk NMIBC Subjects
In this study, participants with high risk non-muscle-invasive bladder cancer (NMIBC) who are BCG Naïve or BCG Unresponsive and are considered ineligible for or have refused to undergo radical cystectomy, will receive RC48-ADC in…
- Trial name
- NCT05943379
- Testing
- RC48-ADC in Combination with gemcitabine
- Where
- China
- Volunteers
- 85 people
- Sponsor
- RemeGen Co., Ltd.
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.