Clinical trials: Non-muscle Invasive Bladder Cancer (NMIBC)
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
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
Safety and Toxicity Study of Intravesical Instillation of TARA-002 in Adults with High-grade Non-muscle Invasive Bladder Cancer (Phase 1a)
This study is an open-label dose escalation study (Phase 1a) to investigate the safety and toxicity of intravesical treatment of high-grade NMIBC (HGTa or CIS, including CIS with concomitant Ta) after transurethral resection of…
- Trial name
- ADVANCED-1 (NCT05085977)
- Testing
- TARA-002
- Where
- 14 sites in United States, Moldova and 2 more
- Volunteers
- 12 people
- Sponsor
- Protara Therapeutics
NMIBC, High Risk NMIBC
A Phase 1/1b Study of ZH9 Treatment in Patients With Non-Muscle Invasive Bladder Cancer
This is a first-in-human, multicenter, Phase 1/1b, 3-part, double-blind study of ZH9 in patients with recurrent NMIBC who are eligible for intravesical therapy.
- Conditions
- NMIBC, High Risk NMIBC, Non Muscle Invasive Bladder Cancer
- Trial name
- PARADIGM-1 (NCT06181266)
- Testing
- ZH9
- Where
- 4 sites in United States
- Volunteers
- 22 people
- Sponsor
- Prokarium Ltd
Bladder Cancer
Efficacy and Safety of Multi-Instillations of Apaziquone in Patients With Non-Muscle Invasive Bladder Cancer
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
- NCT01410565
- Testing
- Apaziquone
- Where
- 47 sites in United States, Canada
- Volunteers
- 66 people
- Sponsor
- Spectrum Pharmaceuticals, Inc
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
Bladder Cancer, Bladder Cancer Recurrence
Predictive Value of E-cadherin, β-catenin and SOX4 in Recurrence and/or Progression of Non-muscle Invasive Urinary Bladder Transitional Cell Carcinoma. A Retrospective Study
Bladder cancer is common tumor in which recurrence and/or progression in patients undergoing TUR has been reported to range between 30% and 80% in patients with NMIBC TCC.
- Trial name
- NCT07657299
- Where
- Egypt
- Volunteers
- 30 people
- Sponsor
- Ain Shams University
Non-muscle Invasive Bladder Cancer (NMIBC)
Phase 1/2 Study of ABI-009 in Nonmuscle Invasive Bladder Cancer
Purpose of this study is to determine appropriate dosing of ABI-009 and evaluate the safety and anti-tumor activity of ABI-009 in treatment of non-muscle invasive bladder cancer
- Trial name
- NCT02009332
- Testing
- ABI-009, Gemcitabine
- Where
- 2 sites in United States
- Volunteers
- 21 people
- Sponsor
- Aadi Bioscience, Inc.
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
Bladder Cancer
Assessment of Safety, Tolerability, Radiation Dosimetry, Imaging Properties of 89Zr-girentuximab in Patients With NMIBC
The purpose of this study is to evaluate the use of 89Zr-labeled girentuximab (89Zr-TLX250) as a novel, carbonic anhydrase IX (CAIX) targeted PET/CT radiopharmaceutical for the imaging of Non-muscle-invasive bladder cancer…
- Trial name
- PERTINENCE (NCT04897763)
- Testing
- 89Zr-TLX250
- Where
- France
- Volunteers
- 6 people
- Sponsor
- Institut Cancerologie de l'Ouest
Non-Muscle-Invasive Bladder Cancer (NMIBC)
A Study of RAG-01 in Patients With Non-muscle-invasive Bladder Cancer (NMIBC) Who Have Failed Bacillus Calmette Guérin (BCG) Therapy
This is an open label, multi-center study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of RAG-01 in patients with NMIBC who have failed BCG therapy.
- Trial name
- NCT06351904
- Testing
- RAG-01
- Where
- 3 sites in Australia
- Volunteers
- 72 people
- Sponsor
- Ractigen Therapeutics.
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
Bladder Cancer
Toripalimab Combined With BCG Perfusion for the Treatment of HR-NMIBC After TURBT Surgery Exploration
This is a single-center, prospective, open-label, non-randomized clinical study initiated and conducted by the Department of Urology, Shanghai Changhai Hospital.
- Trial name
- MARINE-01 (NCT07307456)
- Testing
- Treatment with toripalimab combined with BCG perfusion following transurethral resection of bladder tumor (TURBT)
- Where
- China
- Volunteers
- 31 people
- Sponsor
- Changhai Hospital
Non-muscle Invasive Bladder Cancer
Study of Continuous APL-1202 Treatment in Subjects With High-Risk Non-Muscle-Invasive Bladder Cancer (NMIBC) Relapsed From Intravesical Chemo/BCG Therapy
To determine the efficacy of oral APL-1202 administered consecutively for 12 weeks in subjects with high-risk NMIBC relapsed from intravesical chemo/BCG therapy based on the recurrence-free rate (RFR) at 12 months after APL-1202…
- Trial name
- NCT04498702
- Testing
- APL-1202 treatment
- Volunteers
- 41 people
- Sponsor
- Jiangsu Yahong Meditech Co., Ltd aka Asieris
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.
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
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
BCG Modulation of the recMAGE-A3 + AS15 ASCI Response in the Treatment of Non Muscle Invasive Bladder Cancer (NMIBC) Patients
In this study, the investigators would like to assess how intravesical BCG schedules after immunization of non muscle invasive bladder patients with the recMAGE-A3 protein, together with adjuvant AS15 (recMAGE-A3 + AS15 ASCI)…
- Trial name
- NCT01498172
- Testing
- MAGE-A3 ASCI, BCG
- Where
- Switzerland
- Volunteers
- 23 people
- Sponsor
- Patrice Jichlinski
Non-muscle Invasive Bladder Cancer (NMIBC)
Evaluating the Safety and Performance of the Eight Medical Hyperthermia System IV 1.0 for HIVEC in NMIBC.
The goal of this clinical trial is to evaluate the safety and performance of the Eight Medical Hyperthermia System IV 1.0 when used to deliver recirculating hyperthermic intravesical chemotherapy (HIVEC) with mitomycin C (MMC) in…
- Trial name
- NCT07758881
- Testing
- Hyperthermic intravesical chemotherapy (HIVEC)
- Where
- 2 sites in Belgium
- Volunteers
- 30 people
- Sponsor
- Eight Medical International BV
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.