Clinical trials: Non-muscular Invasive Bladder Cancer
Bladder Cancer
Study of Pembrolizumab (MK-3475) and Pembrolizumab With Other Investigational Agents in Participants With High Risk Non-muscle Invasive Bladder Cancer (MK-3475-057/KEYNOTE-057)
In this study, participants with high risk non-muscle-invasive bladder cancer (NMIBC) unresponsive to Bacillus Calmette Guerin (BCG) therapy and who are considered ineligible for or have refused to undergo radical cystectomy…
- Trial name
- NCT02625961
- Testing
- Pembrolizumab, Pembrolizumab/vibostolimab coformulation, Favezelimab/pembrolizumab coformulation
- Volunteers
- 296 people
- Sponsor
- Merck Sharp & Dohme LLC
Urinary Bladder Neoplasms, Urologic Neoplasms
Pilot Study to Evaluate the Clinical Response to Mitomycin-C in Hydrogel (TC-3) Administered Intravesically in NMIBC Patients
The purpose of this study is to evaluate the clinical response of the tumors within the bladder of recurrent NMIBC patients to Mitomycin-C embedded in UroGen Pharma's (known at that time as TheraCoat Ltd.) TC-3 Sterile Hydrogel…
- Conditions
- Urinary Bladder Neoplasms, Urologic Neoplasms, Neoplasms, Urinary Bladder Diseases
- Trial name
- NCT02891460
- Testing
- 40 mg MMC in 40 mL TC-3., 80 mg MMC in 40 mL TC-3.
- Where
- India
- Volunteers
- 18 people
- Sponsor
- UroGen Pharma Ltd.
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, Non-Muscle Invasive Bladder Urothelial Carcinoma
Analytical Specificity of Bladder EpiCheck Test in Healthy Population and Urology Patients Without Prior History or Evidence of Bladder Cancer
This is a prospective study to establish the analytical specificity of Bladder EpiCheck test in urine samples from healthy population and urology patients without prior history or evidence of bladder cancer.
- Trial name
- NCT06020807
- Testing
- Bladder EpiCheck
- Where
- United States
- Volunteers
- 168 people, healthy volunteers welcome
- Sponsor
- Nucleix Ltd.
Carcinoma in Situ of Bladder
Retrospective Chart Review of Valstar
This is an observational study involving a retrospective review of medical records of adult patients who have been treated with intravesical valrubicin for bladder carcinoma in situ (CIS) since October 2009.
- Trial name
- NCT01304173
- Where
- United States
- Volunteers
- 113 people
- Sponsor
- Endo USA Inc., a Keenova Therapeutics Company
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
A Study of Intravesical Qapzola (Apaziquone) as a Surgical Adjuvant in Participants Undergoing Transurethral Resection of Bladder Tumor (TURBT)
This is a randomized, multicenter, two-arm, double-blind, placebo-controlled study of Qapzola in participants with low- to intermediate-risk non-muscle invasive bladder cancer (NMIBC), assessed according to the 2016 American…
- Trial name
- NCT03224182
- Testing
- Qapzola
- Where
- United States
- Volunteers
- 118 people
- Sponsor
- Spectrum Pharmaceuticals, Inc
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
Superficial Bladder Cancer
Maximum Tolerable Concentration of abnobaVISCUM Fraxini Intravesically in Patients With Superficial Bladder Cancer
The aim of this phase Ib/IIa study is to investigate the maximum tolerable concentration of abnobaVISCUM® Fraxini for intravesical instillation in patients with superficial bladder cancer.
- Trial name
- NCT02007005
- Testing
- abnobaVISCUM Fraxini
- Where
- 2 sites in Egypt, Germany
- Volunteers
- 37 people
- Sponsor
- Abnoba Gmbh
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 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
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.
Urothelial Carcinoma, Non Muscle Invasive Bladder Cancer
Brazilian Reality of Urinary Bladder Cancers - BRA-BLADDER
A national, multicenter, non-randomized, retrospective, observational study (Real-World Evidence-RWE) aimed at analyzing clinical presentation profiles and demographic characteristics of patients with early urothelial bladder…
- Conditions
- Urothelial Carcinoma, Non Muscle Invasive Bladder Cancer, Muscle-invasive Bladder Cancer
- Trial name
- NCT05945108
- Where
- 5 sites in Brazil
- Volunteers
- 400 people
- Sponsor
- AstraZeneca
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
Cis-urocanic Acid (Cis-UCA) in Patients With Primary or Recurrent Non-muscle Invasive Bladder Cancer
The purpose of this study is to evaluate safety, tolerability and pharmacokinetics of intravesical cis-urocanic acid in patients with primary or recurrent non-muscle invasive bladder cancer.
- Trial name
- NCT01458847
- Testing
- cis-UCA solution
- Where
- 2 sites in Finland
- Volunteers
- 12 people
- Sponsor
- BioCis Pharma Ltd
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
Bladder Cancer
A Performance Evaluation Study of Arquer's MCM5 Elisa Test (ADXBLADDER) to Aid in the Monitoring of Recurrence in Non-Muscle Invasive Bladder Cancer
The objective of this prospective, multi-centre study is to evaluate the performance of ADXBLADDER, a urine MCM5 ELISA test, as an aid in the detection of bladder cancer recurrence.
- Trial name
- NCT05508568
- Testing
- ADXBLADDER
- Where
- 13 sites in United States
- Volunteers
- 650 people
- Sponsor
- Arquer Diagnostics Ltd
Urinary Bladder Neoplasms, Carcinoma in Situ
A Study of Intravesical Enfortumab Vedotin For Treatment of Patients With Non-muscle Invasive Bladder Cancer (NMIBC)
This study will test a drug called enfortumab vedotin in participants with a type of bladder cancer called non-muscle invasive bladder cancer (NMIBC).
- Conditions
- Urinary Bladder Neoplasms, Carcinoma in Situ, Carcinoma Transitional Cell, Non-muscle Invasive Bladder Cancer
- Trial name
- NCT05014139
- Testing
- Enfortumab vedotin
- Where
- 32 sites in United States, Canada and 4 more
- Volunteers
- 37 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Bladder Cancer
Vicinium Treatment for Subjects With Non-muscle Invasive Bladder Cancer Previously Treated With BCG
Because of the high risk for development of muscle invasive disease, cystectomy is recommended for CIS, high-grade Ta and T1 patients who experience disease recurrence following intravesical therapy.
- Trial name
- VISTA (NCT02449239)
- Testing
- Vicinium
- Where
- 70 sites in United States, Canada
- Volunteers
- 133 people
- Sponsor
- Sesen Bio, Inc.
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.