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
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, 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
Mitomycin C Versus Bacillus Calmette-Guerin in the Intravesical Treatment of Non-Muscle-Invasive Bladder Cancer Patients
The purpose of this study is to compare the bladder cancer treatments, Mitomycin C (MMC) and Bacillus Calmette Guerin (BCG), to find out which is better.
- Trial name
- NCT00974818
- Testing
- Mitomycin C (MMC), Bacillus Calmette-Guerin (BCG)
- Where
- 2 sites in United States
- Volunteers
- 50 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
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
Bladder Cancer TNM Staging Primary Tumor (T) Ta, Bladder Cancer TNM Staging Primary Tumor (T) T1
Intravesical Adjuvant Electromotive Mitomycin-C
In laboratory and clinical studies, intravesical electromotive drug administration increased mitomycin bladder uptake, improving clinical efficacy in high-risk non-muscle invasive urothelial bladder cancer.
- Conditions
- Bladder Cancer TNM Staging Primary Tumor (T) Ta, Bladder Cancer TNM Staging Primary Tumor (T) T1, Bladder Cancer Transitional Cell Grade
- Trial name
- EMDA/MMC (NCT01920269)
- Testing
- Trans-urethral resection, intravesical passive diffusion mitomycin, intravesical electromotive mitomycin
- Where
- Italy
- Volunteers
- 331 people
- Sponsor
- University of Rome Tor Vergata
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
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.
Bladder Cancer
Evaluation of PD-L1 Expression and Immune Infiltration in High-risk Non Muscle Invasive Bladder Cancer
Non-muscle-invasive bladder cancer (NMIBC) has a high rate of recurrence (60 to 70%) and progression (20 to 30%) to muscle-invasive bladder cancer (MIBC).
- Trial name
- IMMUN VESSIE (NCT04726735)
- Testing
- Samples of bladder tissue
- Where
- France
- Volunteers
- 100 people
- Sponsor
- University Hospital, Bordeaux
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.