Clinical trials: Non-Muscle Invasive Bladder Cancer (NMIBC)
Non-Muscle-Invasive Bladder Cancer (NMIBC)
A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SIM0237 Alone or in Combination with BCG in NMIBC
This is an open-label, multicenter phase 1 study to evaluate the safety, efficacy, and pharmacokinetics (PK) characteristics of SIM0237 alone or in combination with bacillus Calmette-Guerin (BCG) in participants with…
- Trial name
- NCT06186414
- Testing
- SIM0237, SIM0237 and BCG
- Where
- 14 sites in China
- Volunteers
- 152 people
- Sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
Bladder Cancer, Liquid Biopsy
The Guiding Value of Liquid Biopsy Based on Urinary Tumor DNA/RNA in the Second Transurethral Resection of High-risk Non-muscle Invasive Bladder Cancer
High-risk non-muscle-invasive bladder cancer (NMIBC) carries a substantial risk of residual disease after initial transurethral resection of bladder tumor (TURBT).
- Trial name
- NCT07130578
- Testing
- urine tumor DNA/RNA testing
- Where
- 2 sites in China
- Volunteers
- 60 people
- Sponsor
- Tianjin Medical University Second Hospital
Non-muscle-invasive Bladder Cancer
External Validation of Uromonitor as a Biomarker for Optimization of NMIBC Management by the CUETO Group
Independent validation of Uromonitor as a non-invasive biomarker of recurrence of Non Muscle Invasive Bladder Cancer
- Trial name
- EVALUATION (NCT05864599)
- Where
- Spain
- Volunteers
- 600 people
- Sponsor
- Pharmalink
HER2-expressing High-risk or Very High-risk NMIBC Without Visible Foci of Disease After TURBT
RC48 in Combination With Radiotherapy for HER2-Expressing NMIBC Patients
This study is an open, single-arm, single-center exploratory clinical study to explore the efficacy and safety of Disitamab Vedotin (RC-48) in combination with radiotherapy for the treatment of patients with HER2-expressing…
- Trial name
- NCT07100184
- Testing
- Disitamab Vedotin combined with Radiotherapy
- Volunteers
- 30 people
- Sponsor
- Peking University First Hospital
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 (Urothelial, Transitional Cell) Cancer, NMIBC
DV+BCG in HER2-Expressing, BCG-Naïve High-Risk NMIBC
The purpose of this study is to learn about the safety and effects of the study medicine (Disitamab Vedotin) in people with non-muscle invasive bladder cancer.
- Trial name
- HERO (NCT07207824)
- Testing
- Active Comparator: BCG induction and maintenance, DV + BCG induction and maintenance
- Where
- China
- Volunteers
- 182 people
- Sponsor
- Fudan University
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
Evaluation of ATO-101™ in Patients With Non-Muscle-Invasive Bladder Cancer (PERSEVERANCE EU)
Non-Muscle-Invasive Bladder cancer (NMIBC) tumours often recur despite TransUrethral Resection of Bladder (TURB) and Bacillus Calmette-Guerin (BCG) intravesical instillations, and have no effective conservative treatment options.
- Trial name
- PERSEVERANCE (NCT07260162)
- Testing
- ATO-101™
- Where
- France
- Volunteers
- 24 people
- Sponsor
- Institut Cancerologie de l'Ouest
Urinary Bladder Neoplasms, Carcinoma, Transitional Cell
Toripalimab ± Sequential Intravesical Gemcitabine-Mitomycin C for BCG-Unresponsive/-Intolerant High-Risk NMIBC: Open-Label Randomized Phase 2 Study
This open-label, randomised, multicentre, phase 2 study (OHAI-NMIBC-01) compares toripalimab plus sequential intravesical gemcitabine followed by mitomycin C (GEM→MMC) with toripalimab alone in adults with BCG-unresponsive or…
- Conditions
- Urinary Bladder Neoplasms, Carcinoma, Transitional Cell, Carcinoma in Situ of Bladder, Non-Muscle-Invasive Bladder Cancer
- Trial name
- OHAI-NMIBC-01 (NCT07189793)
- Testing
- Toripalimab, Gemcitabine (GEM), Mitomycin C (MMC)
- Where
- China
- Volunteers
- 106 people
- Sponsor
- First Affiliated Hospital of Wenzhou Medical University
Non-muscle-invasive Bladder Cancer
Blue Laser -5ala Photodynamic Therapy (PDT) in High-Risk Non-muscle Invasive Bladder Cancer (NMIBC) Patients
This project will conduct a large-sample, multi-center prospective clinical trial to further establish the safety and efficacy of BL-5ALA-PDT in preventing Non-Muscle Invasive Bladder Cancer (NMIBC) recurrence when compared to…
- Trial name
- BL-PDT-RCT (NCT05547516)
- Testing
- Standard infusion chemotherapy, BL - 5 ala PDT
- Where
- China
- Volunteers
- 140 people
- Sponsor
- First Affiliated Hospital Xi'an Jiaotong University
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.
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.
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
Urinary Bladder Neoplasms, Immunotherapy
Safety and Efficacy of Camrelizumab for High-risk NMIBC Failing BCG Treatment
This study will evaluate the safety and efficacy of bladder intravesical Camrelizumab in patients with high-risk non-muscle-invasive bladder cancer who failed BCG therapy.
- Trial name
- NCT04706598
- Testing
- Camrelizumab
- Where
- 4 sites in China
- Volunteers
- 25 people
- Sponsor
- Fudan University
Superficial Bladder Cancer, Non-muscle Invasive Bladder Cancer With Carcinoma in Situ
LEGEND Study: EG-70 in NMIBC Patients BCG-Unresponsive and High-Risk NMIBC Incompletely Treated With BCG or BCG-Naïve
This study will evaluate the safety and efficacy of intravesical administration of detalimogene (EG-70) in the bladder and its effect on bladder tumors in patients with NMIBC.
- Conditions
- Superficial Bladder Cancer, Non-muscle Invasive Bladder Cancer With Carcinoma in Situ, Non-muscle Invasive Bladder Cancer
- Trial name
- NCT04752722
- Testing
- EG-70 (phase 1), EG-70 (phase 2) Master Protocol, Surfactant Bladder Pre-Rinse and EG-70 (Substudy)
- Where
- 102 sites in United States, Australia and 8 more
- Volunteers
- 350 people
- Sponsor
- enGene, Inc.
Carcinoma in Situ of Bladder
Retrospective Chart Review of Valstar
This is an observational study involving a retrospective review of medical records of adult patients who have been treated with intravesical valrubicin for bladder carcinoma in situ (CIS) since October 2009.
- Trial name
- NCT01304173
- Where
- United States
- Volunteers
- 113 people
- Sponsor
- Endo USA Inc., a Keenova Therapeutics Company
Non-muscle-invasive Bladder Cancer, NMIBC
A Phase 1, Open-label Trial of Belzupacap Sarotalocan (AU-011) in Bladder Cancer
The main objectives of this study are to determine the feasibility and safety of Belzupacap Sarotalocan (AU-011, bel-sar) treatment of bladder cancer utilizing focal injections with or without laser application.
- Conditions
- Non-muscle-invasive Bladder Cancer, NMIBC, Non-Muscle Invasive Bladder Carcinoma, Non-Muscle Invasive Bladder Neoplasms
- Trial name
- NCT05483868
- Testing
- AU-011, AU-011 in Combination with Medical Laser Adminstration, AU-011 in Combination with Medical Laser Administration
- Where
- 19 sites in United States, Australia
- Volunteers
- 55 people
- Sponsor
- Aura Biosciences
Bladder Cancer
Efficacy and Safety Study of Apaziquone vs. Placebo in Patients With Non-Muscle Invasive Bladder Cancer (NMIBC)
This is an international, multicenter, double-blind, placebo-controlled, randomized study. All eligible patients entering the open label phase of the study will receive a single immediate instillation of apaziquone (4 mg in 40 mL…
- Trial name
- NCT01469221
- Testing
- Apaziquone
- Where
- 29 sites in United States, Czechia and 2 more
- Volunteers
- 47 people
- Sponsor
- Spectrum Pharmaceuticals, Inc
Superficial Bladder Cancer
ADSTILADRIN (=INSTILADRIN) in Patients With High-Grade, Bacillus Calmette-Guerin (BCG) Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC)
Previous multi-dose Phase I and Phase II clinical studies have demonstrated that ADSTILADRIN is a safe and effective treatment for BCG-refractory and recurrent NMIBC.
- Trial name
- NCT02773849
- Testing
- ADSTILADRIN
- Where
- 34 sites in United States
- Volunteers
- 157 people
- Sponsor
- Ferring Pharmaceuticals
Non-Muscle Invasive Bladder Cancer, NMIBC
Sample Collection for Ongoing Research and Product Evaluation Study - Non-muscle Invasive Bladder Cancer (SCORE-NMIBC)
The SCORE-NMIBC study is a prospective, multi-center, study designed to collect data and biological samples from participants diagnosed with non-muscle Invasive Bladder Cancer (NMIBC).
- Conditions
- Non-Muscle Invasive Bladder Cancer, NMIBC, High-risk Non-Muscle Invasive Bladder Cancer
- Trial name
- SCORE-NMIBC (NCT07763197)
- Where
- United States
- Volunteers
- 400 people
- Sponsor
- Natera, Inc.