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.
Non Muscle Invasive Bladder Cancer
Comparison of BCG RIVM and Russian Strains for Treating Non-Muscle-Invasive Bladder Cancer (NMIBC)
The goal of this clinical trial is to compare the efficacy and safety of two Bacillus Calmette-Guérin (BCG) substrains (RIVM and Russian) in the treatment of intermediate- and high-risk non-muscle-invasive bladder cancer (NMIBC)…
- Trial name
- NCT06767982
- Testing
- Bacillus Calmette-Guerin (BCG)
- Where
- Turkey (Türkiye)
- Volunteers
- 160 people
- Sponsor
- Ankara University
Non-muscle Invasive Bladder Cancer (NMIBC)
LCS103 Herbal Formula for Secondary Prevention of Non-Muscle Invasive Urothelial Carcinoma of the Bladder
This study is a phase IIA, single-site, randomized, controlled, open-label clinical trial evaluating the safety and efficacy of the LCS103 oral herbal formula for the secondary prevention of NMIBC.
- Trial name
- LCS103 (NCT07728474)
- Testing
- LCS103
- Where
- Israel
- Volunteers
- 60 people
- Sponsor
- LifeBiotic Medical Research Ltd.
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.
Bladder Cancer
Safety and Efficacy of CG0070 Oncolytic Virus Regimen for High Grade NMIBC After BCG Failure
To study the safety and efficacy of CG0070, an oncolytic virus expression GM-CSF in high grade non muscle invasive bladder cancer patients who failed BCG therapy and refused cystectomy.
- Trial name
- BOND2 (NCT02365818)
- Testing
- CG0070
- Where
- 17 sites in United States
- Volunteers
- 66 people
- Sponsor
- CG Oncology, Inc.
Bladder Cancer
Investigating Bladder Chemotherapy Instead of Surgery for Low Risk Bladder Cancer
Patients diagnosed with low risk non-muscle invasive bladder cancer (NMIBC) are at risk of frequent low grade recurrence, which usually necessitates surgical intervention under general anaesthetic.
- Trial name
- CALIBER (NCT02070120)
- Testing
- Mitomycin C, Surgical Management
- Where
- 38 sites in United Kingdom
- Volunteers
- 82 people
- Sponsor
- Institute of Cancer Research, United Kingdom
Non-muscle-invasive Bladder Cancer
Assessment of Efficacy and Safety of Durvalumab Plus BCG Compared to the Standard Therapy With BCG in Non-muscle Invasive Bladder Cancer
This is a randomized, open-label, multi-center, global, phase III study to determine the efficacy and safety of Durvalumab + BCG combination therapy in the treatment of patients with non-muscle-invasive bladder cancer
- Trial name
- POTOMAC (NCT03528694)
- Testing
- Durvalumab (MEDI4736), Bacillus Calmette-Guerin (BCG)
- Where
- 120 sites in Australia, Austria and 10 more
- Volunteers
- 1,018 people
- Sponsor
- AstraZeneca
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
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.
Non-muscle Invasive Bladder Cancer With Carcinoma in Situ
A Trial to Evaluate Intravesical Nadofaragene Firadenovec Alone or in Combination With Chemotherapy or Immunotherapy in Participants With High-grade BCG Unresponsive Non-muscle Invasive Bladder Cancer
The pivotal phase 3 trial (rAd-IFN-CS 003) evaluating the efficacy of nadofaragene firadenovec showed that 55 (53.4%) of 103 subjects with CIS ± high-grade Ta/T1 achieved a complete response (CR) at 3 months.
- Trial name
- ABLE-22 (NCT06545955)
- Testing
- Nadofaragene Firadenovec, Gemcitabine, Docetaxel
- Where
- 80 sites in United States, Canada and 6 more
- Volunteers
- 250 people
- Sponsor
- Ferring Pharmaceuticals
Non-Muscle Invasive Bladder Cancer, Urothelial Carcinoma
An Expanded Access Program of Cretostimogene Grenadenorepvec for Treatment of NMIBC for Patients Unresponsive to BCG
This is an open-label, expanded access trial designed to provide access to cretostimogene in patients with NMIBC (specifically CIS with or without HG Ta/T1) unresponsive to BCG.
- Conditions
- Non-Muscle Invasive Bladder Cancer, Urothelial Carcinoma, Urologic Cancer, Bladder Cancer
- Trial name
- NCT06443944
- Testing
- Cretostimogene Grenadenorepvec, n-dodecyl-B-D-maltoside
- Where
- 27 sites in United States
- Sponsor
- CG Oncology, Inc.
Urinary Bladder Neoplasms
Investigation of Safety and Tolerability of Catumaxomab in Patients With NMIBC
The purpose of the study is to investigate the safety, tolerability, and preliminary efficacy of the monoclonal bispecific trifunctional antibody Catumaxomab in patients with non-muscle invasive bladder cancer (NMIBC).
- Trial name
- NCT04819399
- Testing
- Catumaxomab
- Where
- Germany
- Volunteers
- 34 people
- Sponsor
- Lindis Biotech GmbH
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 ("NMIBC") Unresponsive/Intolerant to BCG
Intravesical Photodynamic Therapy ("PDT") in BCG-Unresponsive/Intolerant Non-Muscle Invasive Bladder Cancer ("NMIBC") Patients
This is a phase II, open-label, single-arm, multi-center Study conducted in Canada and the United States. Patients with Non-Muscle Invasive Bladder Cancer ("NMIBC") Carcinoma In-Situ ("CIS") (with or without resected papillary…
- Trial name
- NCT03945162
- Testing
- Ruvidar® (TLD-1433) bladder infusion and PDT
- Where
- 16 sites in United States, Canada
- Volunteers
- 90 people
- Sponsor
- Theralase® Technologies Inc.
Urinary Bladder Neoplasms, Urologic Neoplasms
Safety and Efficacy Study of Tislelizumab in Combination With BCG in HR-NMIBC Patients (TACBIN-01)
This study is a single-arm, open-label, single-center study to assess the safety of tislelizumab with BCG, and to obtain the preliminary efficacy results in subjects who have been diagnosed with high-risk NMIBC without prior BCG…
- Conditions
- Urinary Bladder Neoplasms, Urologic Neoplasms, Urogenital Neoplasms, Antineoplastic Agents
- Trial name
- TACBIN-01 (NCT04922047)
- Testing
- tislelizumab and BCG
- Where
- China
- Volunteers
- 6 people
- Sponsor
- RenJi Hospital
Non-Muscle-invasive Bladder Cancer (NMIBC), Bacillus Calmette-Guerin (BCG) Cystitis
Solifenacin, Levofloxacin or Lornoxicam, Which Is Ideal for Management of Intravesical Instillation BCG Side Effects?
Compare the different supposed clinical treatment of side effects associated with intravesical BCG by levofloxacin (quinolones) vs solifenacin (selective anti-muscarinic) vs lornoxicam (NSAID)
- Conditions
- Non-Muscle-invasive Bladder Cancer (NMIBC), Bacillus Calmette-Guerin (BCG) Cystitis, Intra-vesical Instillation
- Trial name
- NCT03038321
- Testing
- sofenacin, Tavanic, Xefo
- Where
- Egypt
- Volunteers
- 150 people
- Sponsor
- Mansoura University
Bladder Cancer
The Impact of Intravesical Gemcitabine and 1/3 Dose Bacillus Calmette-Guerin on the Quality of Life in Superficial Bladder Cancer
To our knowledge, there are no comparative studies on bacillus Calmette-Guerin (BCG) and intravesical chemotherapy addressing quality of life (QoL) issues.
- Trial name
- NCT01697306
- Testing
- Gemcitabine 2 g, BCG Vaccine
- Where
- Italy
- Volunteers
- 120 people
- Sponsor
- A.O.U. Città della Salute e della Scienza