Clinical trials: Non-muscle-invasive Bladder Cancer
Non-muscle Invasive Bladder Cancer
Validation of a Urine-based Assay With Genomic Markers for Predicting Recurrence for Non-muscle Invasive Bladder Cancer
A study to validate, in a prospective manner, the ability of the predefined Genomic Health bladder cancer assay to detect recurrence in patients undergoing surveillance for non-muscle invasive bladder cancer.
- Trial name
- NCT02969109
- Where
- United States
- Volunteers
- 417 people
- Sponsor
- Genomic Health®, Inc.
Superficial Bladder Cancer
ADSTILADRIN (=INSTILADRIN) in Patients With High-Grade, Bacillus Calmette-Guerin (BCG) Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC)
Previous multi-dose Phase I and Phase II clinical studies have demonstrated that ADSTILADRIN is a safe and effective treatment for BCG-refractory and recurrent NMIBC.
- Trial name
- NCT02773849
- Testing
- ADSTILADRIN
- Where
- 34 sites in United States
- Volunteers
- 157 people
- Sponsor
- Ferring Pharmaceuticals
Solid Tumor, Bladder Cancer
LUMINOS-103: A Basket Trial of Safety & Efficacy of Lerapolturev With or Without Checkpoint Inhibitors
This is a Phase 1/2, open-label, multi-center, single arm basket study evaluating the administration of lerapolturev ± anti programmed cell death protein 1 (PD 1)/programmed death-ligand 1 (PD L1) monoclonal antibody (mAb) (which…
- Conditions
- Solid Tumor, Bladder Cancer, Non-muscle-invasive Bladder Cancer
- Trial name
- NCT04690699
- Testing
- Lerapolturev, 5% DDM
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Istari Oncology, Inc.
Non-Muscle Invasive Bladder Cancer (NMIBC)
Study of APL-1202 in Non-Muscle Invasive Bladder Cancer Patients Who Are Resistant to One Induction Course of BCG Treatment
A Phase Ib, open label, non randomized study to measure the safety and PK characteristics of APL-1202 at steady-state in adult male and female BCG resistant NMIBC patients when it is administered alone and concurrently with BCG.
- Trial name
- NMIBC (NCT03672240)
- Testing
- APL-1202
- Where
- 2 sites in United States
- Volunteers
- 6 people
- Sponsor
- Asieris Pharmaceutical Technologies Co., Ltd.
Non-Muscle Invasive Bladder Neoplasms
Pre-Approval Expanded Access Study for TAR-200 Treating Physician Use
The purpose of this pre-approval access program is to provide access to TAR-200 prior to its marketing authorization for the treatment of participant(s) with high-risk non-muscle invasive bladder cancer (HR-NMIBC).
- Trial name
- NCT06877676
- Testing
- TAR-200
- Sponsor
- Janssen Research & Development, LLC
Carcinoma, Transitional Cell, Bladder Neoplasms
Dose-Escalation Study of CG0070 for Bladder Cancer After BCG (Bacillus Calmette-Guerin) Failure
The main purpose of this research study is to evaluate the safety and dosing of CG0070.
- Trial name
- NCT00109655
- Testing
- Oncolytic adenovirus (serotype 5) - CG0070
- Where
- 10 sites in United States, Canada
- Volunteers
- 75 people
- Sponsor
- Cell Genesys
Bladder Cancer
Safety and Pharmacology Study of Atezolizumab Alone and in Combination With Bacille Calmette-Guérin (BCG) in High-Risk Non-Muscle-Invasive Bladder Cancer (NMIBC) Participants
This Phase Ib/II study is designed to assess the safety, tolerability, pharmacokinetics, immunogenicity, patient reported outcomes (PROs), and preliminary anti-tumor activity of atezolizumab administered by intravenous (IV)…
- Trial name
- NCT02792192
- Testing
- Atezolizumab, Bacille Calmette-Guérin
- Where
- 8 sites in United States
- Volunteers
- 24 people
- Sponsor
- Hoffmann-La Roche
NMIBC
ResQ132EX-NMIBC: Expanded Access Use of Recombinant Bacillus Calmette-Guérin in Nonmuscle Invasive Bladder Cancer
This expanded access protocol is designed to provide Recombinant Mycobacterium BCG (rMBCG) to patients with Non-muscle invasive bladder cancer (NMIBC) who are eligible to receive TICE® BCG, may benefit from its use, and who are…
- Trial name
- NCT06810141
- Testing
- rMBCG
- Where
- 66 sites in United States
- Sponsor
- ImmunityBio, Inc.
Bladder Cancer Cell Transitional, Non-Muscle Invasive Bladder Cancer
Proliposomal Intravesical Paclitaxel for Treatment of Low-Grade, Stage Ta, Non Muscle Invasive Bladder Cancer
This is a single-arm, phase 1/2a study of formulated paclitaxel in subjects with low-grade, noninvasive papillary carcinoma (stage Ta) of the bladder.
- Conditions
- Bladder Cancer Cell Transitional, Non-Muscle Invasive Bladder Cancer, Bladder Cancer, Urinary Bladder
- Trial name
- NCT03081858
- Testing
- TSD-001
- Where
- 5 sites in United States
- Volunteers
- 15 people
- Sponsor
- Lipac Oncology LLC
Locally Advanced Urothelial Carcinoma, Metastatic Urothelial Carcinoma
Safety and Preliminary Anti-Tumor Activity of TYRA-300 in Advanced Urothelial Carcinoma and Other Solid Tumors With FGFR3 Gene Alterations
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of TYRA-300 in cancers with FGFR3 activating gene alterations, including locally advanced/metastatic…
- Conditions
- Locally Advanced Urothelial Carcinoma, Metastatic Urothelial Carcinoma, Solid Tumor, Urothelial Carcinoma
- Trial name
- SURF301 (NCT05544552)
- Testing
- TYRA-300
- Where
- 19 sites in United States, Australia and 2 more
- Volunteers
- 310 people
- Sponsor
- Tyra Biosciences, Inc
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
Non-muscle-invasive Bladder Cancer
OH2 Oncolytic Viral Therapy in Non-Muscle-Invasive Bladder Cancer
This phase Ⅰb/Ⅱ study evaluates the safety and efficacy of OH2 for adjuvant therapy in non-muscle-invasive bladder cancer after first-line prophylactic intravesical instillation therapy.
- Trial name
- NCT05232136
- Testing
- OH2 injection
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Binhui Biopharmaceutical Co., Ltd.
Urothelial Carcinoma of the Urinary Bladder
A Phase 1 Study of Intravesical VAX014 for Instillation in Subjects With Non-Muscle Invasive Bladder Cancer
The purpose of this research study is to evaluate the safety, tolerability and activity of VAX014 for Instillation (VAX014) in patients with low-grade Non-Muscle Invasive Bladder Cancer (NMIBC).
- Trial name
- NCT03854721
- Testing
- VAX014
- Where
- 5 sites in United States
- Volunteers
- 6 people
- Sponsor
- Vaxiion Therapeutics
Non-muscle-invasive Bladder Cancer
A Multi-National Study In Bladder Cancer Patients to Detect Recurrences After TURB (Trans-urethral Resection of the Bladder) Earlier With the Xpert Bladder Cancer Monitor Assay (ANTICIPATE X)
Bladder cancer is the 5th most common cancer in Europe, with more than 151,000 new cases diagnosed in 2012 (4% of the total). Bladder cancer has the highest recurrence rate of any malignancy, often as high as 70% within 5 years…
- Trial name
- ANTICIPATE X (NCT03664258)
- Testing
- Xpert Bladder Cancer Monitor
- Where
- 13 sites in Austria, Czechia and 7 more
- Volunteers
- 852 people
- Sponsor
- Cepheid
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 study aims to evaluate the efficacy and safety of Cretostimogene in patients with BCG-unresponsive high-risk non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without Ta/T1 papillary tumors.
- Trial name
- NCT07283835
- Testing
- Cretostimogene Grenadenorepvec, n-dodecyl-B-D-maltoside
- Where
- 14 sites in China
- Volunteers
- 16 people
- Sponsor
- Lepu Biopharma 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, Bladder Cancer Recurrent
Evaluating Safety and Efficacy of Verity-BCG in BCG-naïve Patients With Intermediate and High-risk Non-muscle Invasive Bladder (NMIBC)
The aim of this study is to evaluate the effect of Verity-BCG in patients with intermediate and high-risk non-muscle-invasive bladder cancer (NMIBC) and to compare our findings to the standard of care BCG formulation, OncoTICE…
- Conditions
- Bladder Cancer, Bladder Cancer Recurrent, Neoplasm Recurrence, Urothelial Carcinoma Bladder
- Trial name
- EVER (NCT05037279)
- Testing
- Bacillus Calmette-Guerin: Strain Russian BCG-I, Bacillus Calmette-Guerin: Strain TICE
- Where
- 6 sites in Canada
- Volunteers
- 540 people
- Sponsor
- Verity Pharmaceuticals Inc.
Bladder Cancer
A Study of IAP0971 in Combination With Bacillus Calmette Guerin in High Risk Non-muscular Invasive Bladder Cancer
The efficacy and safety of IAP0971 single drug or combined with BCG intravesical instillation in the treatment of high-risk non muscle invasive bladder cancer with BCG treatment failure.
- Trial name
- NCT06255964
- Testing
- IAP0971, IAP0971＋BCG
- Volunteers
- 236 people
- Sponsor
- SUNHO（China）BioPharmaceutical CO., Ltd.
Bladder Cancer
Efficacy and Safety Study of Apaziquone vs. Placebo in Patients With Non-Muscle Invasive Bladder Cancer (NMIBC)
This is an international, multicenter, double-blind, placebo-controlled, randomized study. All eligible patients entering the open label phase of the study will receive a single immediate instillation of apaziquone (4 mg in 40 mL…
- Trial name
- NCT01469221
- Testing
- Apaziquone
- Where
- 29 sites in United States, Czechia and 2 more
- Volunteers
- 47 people
- Sponsor
- Spectrum Pharmaceuticals, Inc
Bladder Cancer
Treatment of High-risk Non-muscle Invasive Bladder Cancer With IMUNO BGC Moreau RJ as Prophylaxis
Bladder cancer is the fourth reason of neoplasia in our environment, there are 25 new cases diagnosed per 100,000 inhabitants each year.
- Trial name
- NCT03982797
- Testing
- Instillation of IMUNO BCG Moreau RJ
- Where
- 15 sites in Spain
- Volunteers
- 306 people
- Sponsor
- Biofabri, S.L