Clinical trials: Non-Muscle Invasive Bladder Neoplasms, open to volunteers
Non-muscle Invasive Bladder Cancer
Study of 2141-V11 in People With Non-muscle Invasive Bladder Cancer That Did Not Respond to Standard Treatment
The purpose of this study is to test the safety of the study drug 2141-V11 in people whose NMIBC did not respond to standard treatment, and who will not have the standard surgical procedure to remove the bladder.
- Trial name
- NCT05126472
- Testing
- anti-CD40 antibody 2141-V11, Intravesical Gemcitabine, Intravesical Gemcitabine with anti-CD40 antibody 2141-V11
- Where
- 7 sites in United States
- Volunteers
- 115 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
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, Non Muscle Invasive
Safety, Tolerability, and Preliminary Efficacy of BH011 in Subjects With Non-Muscle-Invasive Bladder Cancer
The purpose of this study is to determine the safety and tolerability of intravesical BH011 in patients with high-risk non-muscle invasive bladder cancer（NMIBC） after Bacillus Calmette-Guerin（BCG） failure and to assess the…
- Trial name
- NCT06732531
- Testing
- BH011
- Where
- 6 sites in China
- Volunteers
- 48 people
- Sponsor
- Zhuhai Beihai Biotech 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
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
- 81 sites in United States, Canada and 6 more
- Volunteers
- 250 people
- Sponsor
- Ferring Pharmaceuticals
Bladder Cancer
DURvalumab in Combination With S-488210/S-488211 vAccine in Non-muscle Invasive Bladder CancEr
DURANCE is a two part, phase Ib/II, multi-centre study to assess the safety and activity of S-488210/S-488211 in combination with durvalumab, in patients with non-muscle invasive bladder cancer (NMIBC).
- Trial name
- DURANCE (NCT04106115)
- Testing
- Durvalumab, S-488210/S-488211
- Where
- 7 sites in United Kingdom
- Volunteers
- 52 people
- Sponsor
- University College, London
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.
Urinary Bladder Neoplasms, Non-Muscle Invasive Bladder Neoplasms
A Clinical Study of Intismeran Autogene (V940) and BCG in People With Bladder Cancer (V940-011/INTerpath-011)
Researchers are looking for new ways to treat people with high-risk non-muscle invasive bladder cancer (HR NMIBC). NMIBC is cancer in the tissue that lines the inside of the bladder but has not spread to the bladder muscle or…
- Conditions
- Urinary Bladder Neoplasms, Non-Muscle Invasive Bladder Neoplasms, Carcinoma in Situ
- Trial name
- NCT06833073
- Testing
- Intismeran autogene, BCG
- Where
- 89 sites in United States, Argentina and 17 more
- Volunteers
- 308 people
- Sponsor
- Merck Sharp & Dohme LLC
Non-Muscle Invasive Bladder Cancer
Radiotherapy for BCG-unresponsive Non-muscle-invasive Carcinoma in Situ (CIS) Bladder Cancer: an Open-label, Single-arm, Multicentre, Phase 2 Study
Standard treatment for patients with high-risk NMIBC (high-grade Ta, CIS, or any T1) consists of intravesical Bacillus Calmette-Guerin (BCG) immunotherapy.
- Trial name
- BRACE (NCT06990061)
- Testing
- Radiation therapy
- Where
- 3 sites in Belgium
- Volunteers
- 50 people
- Sponsor
- European Organisation for Research and Treatment of Cancer - EORTC
NMIBC
Trop2-Targeted Near-Infrared Fluorescence Imaging-Guided Precise Resection of Non-Muscle Invasive Bladder Cancer
Research Objective Taking Trop2, a specific target of bladder urothelial carcinoma, as the research basis, this study adopts a Trop2-targeted near-infrared (NIR) fluorescent probe combined with an intravesical rapid incubation…
- Trial name
- NCT07800507
- Testing
- TTP-ICG NIR fluorescent diagnostic agent
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Yunnan Cancer Hospital
Muscle-Invasive Bladder Carcinoma, Gastroesophageal Adenocarcinoma
Personalized Cancer Vaccine (PCV) Strategy in Patients With Solid Tumors and Molecular Residual Disease
This is a phase 1 clinical trial to evaluate the safety, feasibility and immunogenicity of a personalized cancer vaccine strategy in patients with solid tumors and molecular residual disease.
- Conditions
- Muscle-Invasive Bladder Carcinoma, Gastroesophageal Adenocarcinoma, Melanoma, Non-small Cell Lung Cancer
- Trial name
- NCT06529822
- Testing
- Synthetic long peptide personalized cancer vaccine, Poly ICLC, Signatera or Altera testing
- Where
- 3 sites in United States
- Volunteers
- 64 people
- Sponsor
- Washington University School of Medicine
Non-Muscle Invasive Bladder Cancer
A Phase II Trial of Bicalutamide in Patients Receiving Intravesical BCG for Non-muscle Invasive Bladder Cancer
This is a phase II randomized controlled clinical trial comparing standard induction BCG versus bicalutamide and standard induction BCG among patients with non-muscle invasive bladder cancer.
- Trial name
- BicaBCa (NCT05327647)
- Testing
- Bicalutamide, Control Arm
- Where
- 7 sites in Canada
- Volunteers
- 160 people
- Sponsor
- CHU de Quebec-Universite Laval
Bladder Cancer
The Role of ERBT Plus Adjuvant Intravesical Induction and Maintenance Chemotherapy for Intermediate-Risk NMIBC
This is a prospective, multi-centre randomised trial comparing between ERBT plus 1-year of Ad-MMC, versus ERBT alone, in treating intermediate-risk NMIBC.
- Trial name
- NCT07907575
- Testing
- ERBT and Adjuvant MMC Therapy, ERBT
- Where
- 2 sites in Hong Kong
- Volunteers
- 440 people
- Sponsor
- Chinese University of Hong Kong
Asymptomatic Bacteriuria in Subjects Not Requiring Assisted Bladder Emptying, Asymptomatic Bacteriuria in Subjects Relying on Some Type of Catheter
Effects of Microbiological and Immunological Factors on the Lower Urinary Tract
Millions of patients of all ages suffer worldwide from diverse urinary pathologies, such as lower urinary tract (LUT) dysfunction, bladder pain syndrome, urinary tract infections (UTIs), or bladder cancer.
- Conditions
- Asymptomatic Bacteriuria in Subjects Not Requiring Assisted Bladder Emptying, Asymptomatic Bacteriuria in Subjects Relying on Some Type of Catheter, Recurrent Non-catheter Associated UTIs, Acute Catheter-associated UTI (CAUTI)
- Trial name
- MiLUT (NCT07494864)
- Where
- Switzerland
- Volunteers
- 800 people, healthy volunteers welcome
- Sponsor
- University of Zurich
Low-grade NMIBC, FGFR Gene Amplification
Efficacy and Safety of TYRA-300 in Participants With FGFR3 Altered Low Grade, Intermediate Risk Non-Muscle Invasive Bladder Cancer
Phase 2 Study of TYRA-300 in FGFR3 Altered Low Grade, Intermediate Risk NMIBC
- Conditions
- Low-grade NMIBC, FGFR Gene Amplification, FGFR Gene Alterations, FGFR3 Gene Alteration
- Trial name
- SURF302 (NCT06995677)
- Testing
- TYRA-300 60mg, TYRA-300 50mg, TYRA-300 Dose 70 mg
- Where
- 48 sites in United States, Australia and 2 more
- Volunteers
- 90 people
- Sponsor
- Tyra Biosciences, Inc
NMIBC
Immediate Chemotherapy Following Resection for High-Risk Non-Muscle-Invasive Bladder Cancer
Residual tumors after transurethral resection of bladder tumors (TURBT) range from 17-70%, and floating tumor cells from traditional segmental resection may lead to recurrence if they re-implant in the bladder wall.
- Trial name
- HIGCrecur (NCT06889623)
- Testing
- Immediate postoperative chemotherapy
- Where
- China
- Volunteers
- 72 people
- Sponsor
- Changhai Hospital
NMIBC
SHR-1501 Combined With SHR-2005 for High-Risk Non-Muscle Invasive Bladder Cancer Which is Not Completely Resectable by TURBt
This is a single-center, single-arm, phase Ib/II study, aimed at assessing the safety and efficacy of SHR-1501 in combination with SHR-2005 as treatment for patients with high-risk non-muscle invasive bladder cancer (HR NMIBC)…
- Trial name
- NCT06588179
- Testing
- SHR-1501+SHR-2005
- Where
- China
- Volunteers
- 58 people
- Sponsor
- Fudan University
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
NMIBC, TURBT
Anesthesia Modality and Oncologic Outcomes in High-Risk NMIBC: A Randomized Trial
To demonstrate the superior efficacy of spinal anesthesia (SA) versus general anesthesia (GA) according to the delay of time to recurrence in high-risk NMIBC patients up to Week 104 after TURBT.
- Conditions
- NMIBC, TURBT, Bladder (Urothelial, Transitional Cell) Cancer, Bladder Cancer Recurrence
- Trial name
- NCT06982690
- Testing
- Spinal Anesthesia, General Anesthesia
- Where
- Taiwan
- Volunteers
- 370 people
- Sponsor
- National Taiwan University Hospital
Non-Muscle Invasive Bladder Cancer
Chemoablation Or Bladder Resection With Adjuvant Chemotherapy in Recurrent Non-Muscle Invasive Bladder Cancer
The investigartors will conduct a randomized, multinational study with the aim to assess if the efficacy of a dose dense chemoablation with Mitomycin C (MMC) with adjuvant BCG in non-responding patients is superior regarding long…
- Trial name
- COBRA-NMIBC (NCT06781879)
- Testing
- Mitomycin c
- Where
- 8 sites in Denmark, Iceland and 2 more
- Volunteers
- 272 people
- Sponsor
- Jakob Kristian Jakobsen