Clinical trials: Non-Muscle Invasive Bladder Cancer (NMIBC)
Urinary Bladder Diseases, Urinary Bladder Neoplasms
Hyperthermia Treatment in Conjunction With Mitomycin C Versus Bacillus Calmette-Guérin Immunotherapy (BCG) for Superficial Bladder Cancer
The study is designed to compare the efficacy and safety of 2 treatment types for the prevention of tumor recurrence of superficial bladder cancer: 1. A combination of bladder wall heating and local chemotherapy (Synergo) 2.
- Conditions
- Urinary Bladder Diseases, Urinary Bladder Neoplasms, Urinary Bladder Cancer, Malignant Tumor of Urinary Bladder
- Trial name
- NCT00384891
- Testing
- Synergo + MMC, Bacillus Calmette-Guérin
- Where
- 8 sites in Austria, Israel and 2 more
- Volunteers
- 190 people
- Sponsor
- Medical Enterprises Europe B.V.
NMIBC
The Study is to Evaluate the Safety and Tolerability of SPGL008 Alone or in Combination With BCG in the Patients With NMIBC, and to Determine the RP2D of SPGL008 Alone or in Combination With BCG.To Evaluate the Preliminary Efficacy of SPGL008 Alone or in Combination With BCG.
The goal of clinical trial is to Evaluate the Safety and Tolerability of SPGL008 Alone or in Combination With BCG in the Patients With on-Muscle-Invasive Bladder Cancer. The main questions it aims to answer are: 1.
- Trial name
- NCT07445308
- Testing
- SPGL008
- Volunteers
- 120 people
- Sponsor
- Shenyang Sunshine Pharmaceutical Co., LTD.
Bladder Cancer, Non-muscle Invasive Bladder Cancer
Precise Chemoresection in Low-grade NMIBC Using Drug Screens in Patient-derived Organoids
Based on the unmet clinical need to reduce invasiveness of treatment of low grade NMIBC, the investigators conduct this prospective, open label, single arm and single center phase II trial.
- Conditions
- Bladder Cancer, Non-muscle Invasive Bladder Cancer, Low Grade
- Trial name
- POLO (NCT06227065)
- Testing
- Epirubicin, Mitomycin, Gemcitabine
- Where
- 2 sites in Switzerland
- Volunteers
- 28 people
- Sponsor
- Hospital Centre Biel/Bienne
NMIBC
A Clinical Trial Evaluating the Efficacy and Safety of Disitamab Vedotin Plus Tislelizumab Combined with Re-TURBT in the Treatment of HER-2-high Expression(2+-3+) Non-muscle Invasive Bladder Cancer At High-risk and Very High-risk.
This prospective, multicenter, single-arm phase II trial aims to evaluate the clinical efficacy and safety of the combination therapy of Disitamab Vedotin with Tislelizumab and a second transurethral resection for the treatment…
- Trial name
- NCT06630871
- Testing
- Distitamab Vedotin in combination with Tislelizumab
- Where
- China
- Volunteers
- 40 people
- Sponsor
- Fujian Medical University Union Hospital
High-risk NMIBC
A Study of SHR-1501 Alone or in Combination With BCG or SHR-1316 in Subjects With NMIBC
The study is to evaluate the safety and tolerability of SHR-1501 alone or in combination with BCG or SHR-1316 in the patients with NMIBC, and to determine the RP2D of SHR-1501 in combination with BCG or SHR-1316.
- Trial name
- NCT05410730
- Testing
- SHR-1501
- Where
- China
- Volunteers
- 150 people
- Sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.
Bladder Cancer, Urothelial Carcinoma
A Phase 3 Study of UGN-102 for Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer
This global, randomized, controlled, open-label Phase 3 study was designed to assess the long-term efficacy and safety of UGN-102 (mitomycin) for intravesical solution with or without (±) transurethral resection of bladder tumors…
- Conditions
- Bladder Cancer, Urothelial Carcinoma, Urothelial Carcinoma Bladder
- Trial name
- ATLAS (NCT04688931)
- Testing
- UGN-102, TURBT
- Where
- 139 sites in United States, Bulgaria and 8 more
- Volunteers
- 282 people
- Sponsor
- UroGen Pharma Ltd.
NMIBC
Feasibility of Automatic, Laser-based Distance Control in Persons With Superficial Bladder Tumors
The goal of this clinical investigation is to test the sensing and guiding part of the ATLAS system in the human bladder of people with Ta low grade bladder tumors.
- Trial name
- LUMINA I (NCT07860398)
- Testing
- ATLAS system
- Where
- Denmark
- Volunteers
- 25 people
- Sponsor
- Optheras AS
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
Non-Muscle Invasive Bladder Neoplasms
A Study to Evaluate TAR-210 Versus Single Agent Intravesical Cancer Treatment in Participants With Bladder Cancer
The main purpose of this study is to compare the disease-free survival between participants receiving treatment with TAR-210 versus investigator's choice of intravesical chemotherapy for treatment of intermediate-risk NMIBC.
- Trial name
- MoonRISe-1 (NCT06319820)
- Testing
- TAR-210, Gemcitabine, MMC
- Where
- 193 sites in United States, Argentina and 18 more
- Volunteers
- 641 people
- Sponsor
- Janssen Research & Development, LLC
Non-muscle-invasive Bladder Cancer
A Phase I Intravesical PPM Therapy for NMIBC
This clinical trial is to determine the safety and effectiveness of an investigational bladder cancer drug named "PLZ4-coated paclitaxel-loaded nanoscale micelle (PPM)." PPM is tiny particles that contain the chemotherapy drug…
- Trial name
- NCT05519241
- Testing
- PLZ4-coated paclitaxel-loaded micelles (PPM)
- Where
- United States
- Volunteers
- 29 people
- Sponsor
- VA Office of Research and Development
Non Muscle Invasive Bladder Cancer
Study to Evaluate the Efficacy and Safety Of Intravesical Nanoxel®M In BCG Refractory NMIBC
The purpose of this study is to determine whether Nanoxel®M is effective in the treatment of patients with recurrent Ta and T1 who experienced treatment failure with at least one prior BCG intravesical treatment.
- Trial name
- NCT02982395
- Testing
- Nanoxel®M, Mitomycin-C
- Where
- South Korea
- Volunteers
- 36 people
- Sponsor
- Samyang Biopharmaceuticals Corporation
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
NMIBC
ANKTIVA Plus BCG Versus BCG Monotherapy In Participants With BCG-Naïve/BCG-Exposed High-Grade Non-Muscle Invasive Papillary Bladder Cancer
This is an open-label, randomized, phase 3 study of intravesical BCG plus ANKTIVA (experimental arm) versus BCG alone (control arm) in participants who have histologically confirmed, BCG-naïve/BCG-exposed high-grade Ta/T1…
- Trial name
- NCT07551544
- Testing
- BCG (50 mg) plus ANKTIVA (400 µg), BCG (50 mg)
- Sponsor
- ImmunityBio, Inc.
Non-muscle Invasive Bladder Cancer (NMIBC)
Using Urine Tumor DNA to De-Intensify Surveillance in Non-Muscle Invasive Bladder Cancer
The goal of this clinical trial is to use urine tumor DNA (utDNA) as an indicator for non-muscle invasive bladder cancer to identify patients suitable for less frequent cystoscopy surveillance.
- Trial name
- NCT07187063
- Testing
- UroAmp Test (Convergent Genomics, Inc.)
- Where
- United States
- Volunteers
- 56 people
- Sponsor
- Lahey Clinic
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
Non-Muscle Invasive Bladder Cancer
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Patients With Bladder Cancer (MK-2870-027)
The goal of the study is to learn about the safety of Sacituzumab Tirumotecan and if people can tolerate it when given in the bladder and find the highest dose that people can take without having certain problems.
- Trial name
- TroFuse-027 (NCT06637423)
- Testing
- Sacituzumab tirumotecan, Rescue medication, Supportive care measures
- Where
- 13 sites in United States, Canada and 4 more
- Volunteers
- 32 people
- Sponsor
- Merck Sharp & Dohme LLC
MRI Contrast Media Adverse Reaction, Bladder Cancer
Can VI-RADS/ADC Accurately Stage Bladder Cancer??
Vesical Imaging-Reporting And Data System (VI-RADS) is proposed for predicting muscle invasive bladder cancer (MIBC) using multi-parametric MRI. However, No validation study on VI-RADS has been reported yet.
- Conditions
- MRI Contrast Media Adverse Reaction, Bladder Cancer, Bladder Disease, Bladder Neoplasm
- Trial name
- NCT04167631
- Testing
- Multi-parametric MRI
- Where
- Egypt
- Volunteers
- 150 people
- Sponsor
- Mansoura University
Non-muscle Invasive Bladder Cancer (NMIBC)
Hyaluronic Acid Sodium Salt and Hydeal-D in the Management of LUTS After TURBT for NMIBC.
This will be an open-label, prospective, single-centre, randomised, controlled, parallel-group medical device investigation. The investigational plan will include four visits in total at the investigational site.
- Trial name
- NCT06069453
- Testing
- Hyaluronic Acid (HA) sodium salt and Hydeal-D
- Where
- Italy
- Volunteers
- 54 people
- Sponsor
- Fidia Farmaceutici s.p.a.
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.
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