Clinical trials: Non-Muscle Invasive Bladder Cancer (NMIBC)
Urinary Bladder Neoplasms
A Study of Erdafitinib Versus Investigator Choice of Intravesical Chemotherapy in Participants Who Received Bacillus Calmette-Guérin (BCG) and Recurred With High Risk Non-Muscle-Invasive Bladder Cancer (NMIBC)
The purpose of this study is to evaluate recurrence-free survival (RFS) in participants treated with erdafitinib vs Investigator's Choice, for participants with high-risk non-muscle-invasive bladder cancer (NMIBC) who harbor…
- Trial name
- NCT04172675
- Testing
- Erdafitinib, Investigator Choice (Gemcitabine), Investigator Choice (Mitomycin C)
- Where
- 150 sites in United States, Argentina and 15 more
- Volunteers
- 107 people
- Sponsor
- Janssen Research & Development, LLC
Non-muscle Invasive Bladder Cancer
Safety and Efficacy Study of Intravesical Instillation of TARA-002 in Adults With High-grade Non-muscle Invasive Bladder Cancer
TARA-002-101-Ph2 is an open-label study to investigate the safety and efficacy of intravesical instillation of TARA-002 in adults 18 years of age or older with high-grade CIS NMIBC (± Ta/T1).
- Trial name
- ADVANCED-2 (NCT05951179)
- Testing
- TARA-002
- Where
- 78 sites in United States, Argentina and 5 more
- Volunteers
- 131 people
- Sponsor
- Protara Therapeutics
Non Muscle Invasive Bladder Cancer
Intravesical Chemotherapy in Combination With Systemic Pembrolizumab in NMIBC Unresponsive or Exposed to BCG Therapy
interventional study of intravesical chemotherapy and sistemic immunotherapy in NMIBC
- Trial name
- NCT06972615
- Testing
- intravesical Chemotherapy docetaxel/gemcitabine
- Where
- Argentina
- Volunteers
- 37 people
- Sponsor
- BLATAM
Bladder Cancer, Urothelial Carcinoma
A Phase 3 Study of UGN-103 for Treatment of Patients With Low-grade Intermediate-risk Non-muscle Invasive Bladder Cancer
This Phase 3, single-arm, multicenter study was designed to evaluate the efficacy and safety of UGN-103, a novel formulation of UGN-102, instilled in the urinary bladder of patients with recurrent low-grade intermediate-risk…
- Conditions
- Bladder Cancer, Urothelial Carcinoma, Urothelial Carcinoma Bladder
- Trial name
- UTOPIA (NCT06331299)
- Testing
- UGN-103
- Where
- 48 sites in United States, Bulgaria and 5 more
- Volunteers
- 99 people
- Sponsor
- UroGen Pharma Ltd.
Bladder Cancer
Radiotherapy for BCG-unresponsive Non-muscle-invasive Carcinoma in Situ (CIS) Bladder Cancer
The investigators aim to investigate a possible role for radiotherapy in good prognosis bladder cancer patients has been identified as a possible alternative to cystectomy, especially for patients non-eligible for surgery but has…
- Trial name
- NCT06310369
- Testing
- radiation therapy
- Volunteers
- 50 people
- Sponsor
- European Organisation for Research and Treatment of Cancer - EORTC
Urinary Bladder Neoplasm, Transitional Cell Carcinoma
CTC Quantification During TURBT and PKVBT of Transitional Cell Carcinoma in Purging Fluid and Blood
Transurethral resection of bladder tumor (TURBT) is usually performed in a piecemeal technique. Tumor fragmentation and cell spilling could be responsible for high recurrence rates.
- Conditions
- Urinary Bladder Neoplasm, Transitional Cell Carcinoma, Urogenital Neoplasms, Circulating Tumor Cell
- Trial name
- NCT04811846
- Testing
- Bipolar transurethral resection of bladder tumor (TURBT), Bipolar transurethral plasma kinetic vaporization of bladder tumor (PKVBT)
- Where
- 2 sites in Austria
- Volunteers
- 40 people
- Sponsor
- University Teaching Hospital Hall in Tirol
Bladder (Urothelial, Transitional Cell) Cancer Superficial (Non-Invasive), Bladder (Urothelial, Transitional Cell) Cancer
A Study of Adjuvant NDV-01 (Sustained-release Gemcitabine-docetaxel) for the Treatment of Intermediate Risk NMIBC Following TURBT
This is a Phase 3, open-label, randomized trial designed to evaluate the DFS of TURBT followed by NDV-1 (sustained-release gemcitabine-docetaxel) versus TURBT followed by surveillance for the treatment of participants with…
- Conditions
- Bladder (Urothelial, Transitional Cell) Cancer Superficial (Non-Invasive), Bladder (Urothelial, Transitional Cell) Cancer, Urothelial Carcinoma Bladder, Urologic Cancer
- Trial name
- BOOST (NCT07313891)
- Testing
- NDV-01 (sustained-release gemcitabine-docetaxel)
- Sponsor
- Relmada Therapeutics, Inc.
Non Muscle-invasive Bladder Cancer
Evaluation of Immediate Preoperative Instillation (IPOI) of Mitomycin C Compared to Early Postoperative Instillation (IPOP) in Non-muscle Invasive Bladder Cancer
This study seeks to optimize the management of TVNIM (reduction of the risk of reccurence of the disease) by comparing in terms of efficacy and tolerance the immediate preoperative administration of mitomycin C (IPOI) to an early…
- Trial name
- NCT02075060
- Testing
- IPOI, IPOP
- Where
- 3 sites in France
- Volunteers
- 60 people
- Sponsor
- Poitiers University Hospital
Bladder Cancer, Bladder Neoplasm
Mitomycin C Intravesical Chemotherapy in Conjunction With Synergo® Radiofrequency-Induced Hyperthermia for Treatment of Carcinoma in Situ Non-Muscle Invasive Bladder Cancer Patients Unresponsive to Bacillus Calmette-Guérin, With or Without Papillary Tumors.
This study will determine whether Synergo® RITE + MMC treatment is efficacious as second-line therapy for CIS NMIBC BCG-unresponsive patients with or without papillary NMIBC, through examination of the complete response rate…
- Conditions
- Bladder Cancer, Bladder Neoplasm, Bladder Tumors, Cancer of Bladder
- Trial name
- RITE-USA (NCT03335059)
- Testing
- Synergo® RITE + MMC
- Where
- 4 sites in United States
- Volunteers
- 5 people
- Sponsor
- Medical Enterprises Ltd.
Bladder Cancer
Safety and Efficacy of 9MW2821 in the Treatment of High-risk Non-muscle-invasive Bladder Cancer (NMIBC)
Assess the safety and efficacy of 9MW2821 in patients with high-risk non-muscle-invasive bladder cancer (NMIBC) who have previously failed to intravesical therapy.
- Trial name
- NCT06551233
- Testing
- 9MW2821
- Where
- China
- Volunteers
- 30 people
- Sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Urinary Bladder Neoplasms
A Study of Nivolumab or Nivolumab Plus Experimental Medication BMS-986205 With or Without Bacillus Calumette-Guerin (BCG) in BCG Unresponsive Bladder Cancer That Has Not Invaded Into the Muscle Wall of the Bladder
A study to evaluate the safety and tolerability of nivolumab or nivolumab Plus BMS-986205 with or without BCG in BCG-Unresponsive non-muscle invasive Bladder Cancer.
- Trial name
- CheckMate 9UT (NCT03519256)
- Testing
- Nivolumab, BCG, BMS-986205
- Where
- 88 sites in United States, Argentina and 13 more
- Volunteers
- 142 people
- Sponsor
- Bristol-Myers Squibb
Non-muscle Invasive Bladder Cancer (NMIBC)
A Study to Evaluate the Efficacy and Safety of RAG-01 as Monotherapy and in Combination With Chemotherapy in Patients With Non-muscle Invasive Bladder Cancer (NMIBC).
This is a randomized, controlled, multicenter clinical study to evaluate the efficacy and safety of RAG-01 monotherapy and in combination with chemotherapy in patients with NMIBC.
- Trial name
- NCT07777848
- Testing
- RAG-01, Chemotherapy agent
- Where
- China
- Volunteers
- 114 people
- Sponsor
- Ractigen Therapeutics.
High-Risk Non-Muscle-Invasive Bladder Cancer
Immunological Response to Intravesical BCG Therapy of Superficial Bladder Cancer by Prior Administration of RUTI®
The RUTIVAC-1 study is a Phase I Clinical Trial designed to evaluate the systemic and mucosal immunological response and provide safety information after the use of RUTI® administration to individuals with NMIBC.
- Trial name
- RUTIVAC-1 (NCT03191578)
- Testing
- RUTI®
- Where
- Spain
- Volunteers
- 44 people
- Sponsor
- Archivel Farma S.L.
Urothelial Bladder Carcinoma, Bladder Carcinoma
Tumor Budding and T1 Substaging in Urothelial Bladder Cancer
Bladder cancer is a significant global and local health concern, and predicting how aggressive a patient's tumor will behave is critical for guiding treatment.
- Conditions
- Urothelial Bladder Carcinoma, Bladder Carcinoma, Non-Muscle-Invasive Bladder Cancer (NMIBC), Muscle-Invasive Bladder Cancer (MIBC)
- Trial name
- NCT07529639
- Volunteers
- 100 people
- Sponsor
- Assiut University
High-Risk Non-Muscle-Invasive Bladder Cancer
Phase 2 Study to Evaluate Safety and Efficacy of Cretostimogene Grenadenorepvec in High-Risk NMIBC
This is a Phase 2, Multi-Arm, Multi-Cohort, Open-Label Study to Evaluate the Safety and Efficacy of Cretostimogene Grenadenorepvec in Participants with High-Risk Non-Muscle-Invasive Bladder Cancer.
- Trial name
- NCT06567743
- Testing
- Cretostimogene Grenadenorepvec
- Where
- 80 sites in United States, Canada
- Volunteers
- 325 people
- Sponsor
- CG Oncology, Inc.
Non-muscle Invasive Bladder Cancer (NMIBC)
Pembrolizumab in Intermediate Risk Recurrent Non-muscle Invasive Bladder Cancer (NMIBC)
A parallel group, open label, multi-centre, phase I/II marker-lesion study of intravesical or intravenous pembrolizumab in recurrent intermediate risk NMIBC.
- Trial name
- PemBla (NCT03167151)
- Testing
- Pembrolizumab
- Where
- 3 sites in United Kingdom
- Volunteers
- 6 people
- Sponsor
- University of Oxford
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)
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
NMIBC, Non-Muscle Invasive Bladder Urothelial Carcinoma
A Tumor Immune Biomarker Guided Approach for Improving Response to BCG in Patients With High-risk NMIBC.
This study is being conducted to establish a novel tumor tissue- and blood-based biomarker test to assess early systemic and local response to immunomodulation by BCG immunotherapy in patients with high-risk non-muscle invasive…
- Conditions
- NMIBC, Non-Muscle Invasive Bladder Urothelial Carcinoma, Bladder (Urothelial, Transitional Cell) Cancer, Urothelial Carcinoma Bladder
- Trial name
- BCG-TIME (NCT07064863)
- Testing
- Gemcitabine + BCG, BCG (TICE strain)
- Where
- Canada
- Volunteers
- 31 people
- Sponsor
- Queen's University
Bladder Cancer
Safety and Efficacy of FE 999326 Administered Intravesically to Japanese Subjects With High-grade, BCG Unresponsive, Non-muscle Invasive Bladder Cancer (NMIBC)
To evaluate the safety and efficacy of FE 999326 in Japanese subjects with high-grade, BCG unresponsive NMIBC.
- Trial name
- NCT05704244
- Testing
- FE 999326
- Where
- 24 sites in Japan
- Volunteers
- 25 people
- Sponsor
- Ferring Pharmaceuticals