Clinical trials: Non Muscle Invasive Bladder Cancer, active
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
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 (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
Bladder Cancer
QUILT-3.032: A Multicenter Clinical Trial of Intravesical Bacillus Calmette-Guerin (BCG) in Combination With ALT-803 (N-803) in Patients With BCG Unresponsive High Grade Non-Muscle Invasive Bladder Cancer
This is a Phase II/III, open-label, single-arm, multicenter study of intravesical BCG plus N-803 or N-803 only in patients with BCG unresponsive high grade non-muscle invasive bladder cancer (NMIBC).
- Trial name
- NCT03022825
- Testing
- N-803 and BCG, N-803
- Where
- 28 sites in United States
- Volunteers
- 190 people
- Sponsor
- ImmunityBio, Inc.
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.
Stage 0 Bladder Urothelial Carcinoma, Stage 0is Bladder Urothelial Carcinoma
S1602: Different Strains of BCG With or Without Vaccine in High Grade Non- Muscle Invasive Bladder Cancer
This randomized phase III trial studies Tokyo-172 strain bacillus Calmette-Guerin (BCG) solution with or without a vaccination using Tokyo-172 strain BCG to see how well it works compared with TICE BCG solution in treating…
- Conditions
- Stage 0 Bladder Urothelial Carcinoma, Stage 0is Bladder Urothelial Carcinoma, Stage I Bladder Urothelial Carcinoma
- Trial name
- NCT03091660
- Testing
- BCG Solution, BCG Tokyo-172 Strain Solution, BCG Tokyo-172 Strain Vaccine
- Where
- 174 sites in United States
- Volunteers
- 1,000 people
- Sponsor
- SWOG Cancer Research Network
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
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
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
Bladder Cancer, Cancer of the Bladder, Recurrent
CISTO: Comparison of Intravesical Therapy and Surgery as Treatment Options for Bladder Cancer
Bladder cancer is the most common urinary tract cancer and the 5th most common cancer in the US (1). Yet bladder cancer research is underfunded relative to other common cancers.
- Conditions
- Bladder Cancer, Cancer of the Bladder, Recurrent, Non-muscle Invasive Bladder Cancer
- Trial name
- CISTO (NCT03933826)
- Where
- 36 sites in United States
- Volunteers
- 570 people
- Sponsor
- University of Washington
Non Muscle Invasive Bladder Cancer, High-grade Ta/ T1 Papillary Disease Bladder Cancer
Study of Cretostimogene Given in Patients With Non-Muscle Invasive Bladder Cancer ,Unresponsive to Bacillus-Calmette-Guerin
This is a Phase 3, open-label, single arm trial designed to evaluate Cretostimogene patients with NMIBC who have failed prior BCG therapy.
- Trial name
- BOND-003 (NCT04452591)
- Testing
- Cretostimogene Grenadenorepvec, n-dodecyl-B-D-maltoside
- Where
- 86 sites in United States, Australia and 4 more
- Volunteers
- 190 people
- Sponsor
- CG Oncology, Inc.
High Risk Non-Muscle Invasive Bladder Urothelial Carcinoma, Stage 0a Bladder Cancer AJCC v8
IDO and PD-L1 Peptide Based Immune-Modulatory Therapeutic (IO102-IO103) in Combination With Pembrolizumab for BCG-Unresponsive or Intolerant, Non-Muscle Invasive Bladder Cancer
This phase I trial tests the safety and side effects of a PD-L1/IDO peptide vaccine (IO102-IO103) in combination with pembrolizumab in treating patients with non-muscle invasive bladder cancer.
- Conditions
- High Risk Non-Muscle Invasive Bladder Urothelial Carcinoma, Stage 0a Bladder Cancer AJCC v8, Stage 0is Bladder Cancer AJCC v8, Stage I Bladder Cancer AJCC v8
- Trial name
- NCT05843448
- Testing
- PD-L1/IDO Peptide Vaccine, Pembrolizumab
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- University of California, Davis
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