Clinical trials: High-Risk Non-Muscle-Invasive Bladder Cancer
- Condition High-Risk Non-Muscle-Invasive Bladder Cancer
- Funder type Industry (pharma, biotech, devices)
Non-Muscle Invasive Bladder Cancer
Clinical Trial for Evaluating the Efficacy and Safety of BCG for Therapeutic Use in the Prevention of Postoperative Recurrence of Medium/High-risk Non-muscle Invasive Bladder Cancer (NMIBC)
A phase III multi-center randomized, double-blind and positive-controlled clinical trial for evaluating the efficacy and safety of BCG for Therapeutic Use（BCG） in the prevention of postoperative recurrence of medium/high-risk…
- Trial name
- NCT06241755
- Testing
- BCG for Therapeutic Use
- Where
- China
- Volunteers
- 412 people
- Sponsor
- Chengdu CoenBiotech Co., Ltd
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
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
Bladder Cancer
A Study of Toca 511 & Toca FC in Patients With Recurrent High Grade Non-Muscle Invasive Bladder Cancer (Toca 8)
This is a Phase 1, multicenter, open-label study of intravesical Toca 511 followed by oral Toca FC in patients with high grade (HG) non-muscle invasive bladder cancer (NMIBC), with cohort expansion at the recommended Phase 2…
- Trial name
- NCT04089163
- Testing
- Toca 511, Toca FC (extended-release formulation of flucytosine)
- Sponsor
- Tocagen Inc.
NMIBC
ANKTIVA Plus BCG Versus BCG Monotherapy In Participants With BCG-Naïve/BCG-Exposed High-Grade Non-Muscle Invasive Papillary Bladder Cancer
This is an open-label, randomized, phase 3 study of intravesical BCG plus ANKTIVA (experimental arm) versus BCG alone (control arm) in participants who have histologically confirmed, BCG-naïve/BCG-exposed high-grade Ta/T1…
- Trial name
- NCT07551544
- Testing
- BCG (50 mg) plus ANKTIVA (400 µg), BCG (50 mg)
- Sponsor
- ImmunityBio, Inc.
Bladder Cancer
Safety and Efficacy of FE 999326 Administered Intravesically to Japanese Subjects With High-grade, BCG Unresponsive, Non-muscle Invasive Bladder Cancer (NMIBC)
To evaluate the safety and efficacy of FE 999326 in Japanese subjects with high-grade, BCG unresponsive NMIBC.
- Trial name
- NCT05704244
- Testing
- FE 999326
- Where
- 24 sites in Japan
- Volunteers
- 25 people
- Sponsor
- Ferring Pharmaceuticals
Non-Muscle Invasive Bladder Cancer, NMIBC
Sample Collection for Ongoing Research and Product Evaluation Study - Non-muscle Invasive Bladder Cancer (SCORE-NMIBC)
The SCORE-NMIBC study is a prospective, multi-center, study designed to collect data and biological samples from participants diagnosed with non-muscle Invasive Bladder Cancer (NMIBC).
- Conditions
- Non-Muscle Invasive Bladder Cancer, NMIBC, High-risk Non-Muscle Invasive Bladder Cancer
- Trial name
- SCORE-NMIBC (NCT07763197)
- Where
- United States
- Volunteers
- 400 people
- Sponsor
- Natera, Inc.
Non-Muscle Invasive Bladder Neoplasms
A Study to Evaluate TAR-210 Versus Intravesical Chemotherapy Treatment in Participants With High Risk Non-Muscle-Invasive Bladder Cancer
The main purpose of this study is to compare the disease-free survival (the length of time after randomization that a participant survives without any signs or symptoms of the cancer returning, or progressing) between Bacillus…
- Trial name
- MoonRISe-3 (NCT06919965)
- Testing
- TAR-210, Mitomycin C, Gemcitabine
- Where
- 114 sites in United States, Argentina and 13 more
- Volunteers
- 220 people
- Sponsor
- Janssen Research & Development, LLC
Non-muscle Invasive Bladder Cancer
Safety and Efficacy Study of Intravesical Instillation of TARA-002 in Adults With High-grade Non-muscle Invasive Bladder Cancer
TARA-002-101-Ph2 is an open-label study to investigate the safety and efficacy of intravesical instillation of TARA-002 in adults 18 years of age or older with high-grade CIS NMIBC (± Ta/T1).
- Trial name
- ADVANCED-2 (NCT05951179)
- Testing
- TARA-002
- Where
- 78 sites in United States, Argentina and 5 more
- Volunteers
- 131 people
- Sponsor
- Protara Therapeutics
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.
High Risk Non-muscle Invasive Bladder Cancer
A Phase I/II Study of JL19001 Injection Alone or in Combination With BCG in Subjects With High Risk Non-Muscle Invasive Bladder Cancer.
Phase Ia, an open-label, sequential, dose escalation study to evaluate the tolerability and safety of JL19001 Injection alone in subjects with high risk NMIBC.
- Trial name
- JL19001-NMIBC (NCT07483970)
- Testing
- JL19001 Injection
- Where
- China
- Volunteers
- 18 people
- Sponsor
- Jecho Biopharmaceuticals Co., Ltd.
Non-muscle Invasive Bladder Cancer
Safety and Efficacy of APL-1202 in Combination With Epirubicin Hydrochloride Versus Epirubicin Hydrochloride Alone in Intermediate and High-risk Chemo-refractory Non-muscle Invasive Bladder Cancer (NMIBC) Patients
To evaluate the clinical efficacy (median event-free survival) of APL-1202 in combination with Epirubicin hydrochloride versus Epirubicin hydrochloride alone in intermediate and high-risk chemo-refractory non-muscle invasive…
- Trial name
- ACCRUE (NCT04490993)
- Testing
- APL-1202 in combination with Epirubicin
- Where
- China
- Volunteers
- 359 people
- Sponsor
- Jiangsu Yahong Meditech Co., Ltd aka Asieris
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.
Urinary Bladder Neoplasms
A Study of Erdafitinib Versus Investigator Choice of Intravesical Chemotherapy in Participants Who Received Bacillus Calmette-Guérin (BCG) and Recurred With High Risk Non-Muscle-Invasive Bladder Cancer (NMIBC)
The purpose of this study is to evaluate recurrence-free survival (RFS) in participants treated with erdafitinib vs Investigator's Choice, for participants with high-risk non-muscle-invasive bladder cancer (NMIBC) who harbor…
- Trial name
- NCT04172675
- Testing
- Erdafitinib, Investigator Choice (Gemcitabine), Investigator Choice (Mitomycin C)
- Where
- 150 sites in United States, Argentina and 15 more
- Volunteers
- 107 people
- Sponsor
- Janssen Research & Development, LLC
Bladder Cancer, Urothelial Carcinoma
Evaluation of NanoDoce® in Participants With Urothelial Carcinoma
This is a clinical trial studying the administration of NanoDoce as a direct injection to the bladder wall immediately after tumor resection and as an intravesical instillation.
- Conditions
- Bladder Cancer, Urothelial Carcinoma, Urinary Bladder Neoplasm, Urinary Bladder Cancer
- Trial name
- NCT03636256
- Testing
- NanoDoce (direct injection), NanoDoce (intravesical instillation) - Visit 2 Instillation, Institutional Standard of Care
- Where
- 5 sites in United States
- Volunteers
- 36 people
- Sponsor
- NanOlogy, LLC
Non-muscle Invasive Bladder Cancer
A Study to Evaluate Eciskafusp Alfa in Combination With Bacillus Calmette-guerin (BCG) in Participants With BCG-unresponsive High-risk Non-muscle Invasive Bladder Cancer (NMIBC)
The study aims to establish the safety, tolerability, pharmacokinetics (PK), relevant biomarkers, pharmacodynamics (PD) and preliminary anti-tumor activity of the intravesical administration of eciskafusp alfa in combination with…
- Trial name
- NCT06816017
- Testing
- Eciskafusp Alfa, BCG Medac Strain
- Where
- 9 sites in Australia, Italy and 4 more
- Sponsor
- Hoffmann-La Roche
Superficial Bladder Cancer, Non-muscle Invasive Bladder Cancer With Carcinoma in Situ
LEGEND Study: EG-70 in NMIBC Patients BCG-Unresponsive and High-Risk NMIBC Incompletely Treated With BCG or BCG-Naïve
This study will evaluate the safety and efficacy of intravesical administration of detalimogene (EG-70) in the bladder and its effect on bladder tumors in patients with NMIBC.
- Conditions
- Superficial Bladder Cancer, Non-muscle Invasive Bladder Cancer With Carcinoma in Situ, Non-muscle Invasive Bladder Cancer
- Trial name
- NCT04752722
- Testing
- EG-70 (phase 1), EG-70 (phase 2) Master Protocol, Surfactant Bladder Pre-Rinse and EG-70 (Substudy)
- Where
- 102 sites in United States, Australia and 8 more
- Volunteers
- 350 people
- Sponsor
- enGene, Inc.
Non-Muscle- Invasive Bladder Cancer
BCG in Combination With Durvalumab in Adult BCG-naïve, High-risk NMIBC Participants
The purpose of this study is to assess the safety, tolerability, and efficacy profile of durvalumab + BCG (induction and maintenance) combination therapy in adult United States participants with a histologically confirmed…
- Trial name
- PATAPSCO (NCT05943106)
- Testing
- Durvalumab, BCG
- Where
- 19 sites in United States
- Volunteers
- 100 people
- Sponsor
- AstraZeneca
Bladder Cancer, High Grade
Safety and Efficacy of CG0070 Oncolytic Virus Regimen in Patients With High Grade Non-Muscle Invasive Bladder Cancer
This is an expanded access protocol to study the safety and efficacy of CG0070 in Cis and Cis with Ta and/or T1 disease patients who failed both BCG therapy and the BOND protocol (NCT 01438112), or in high grade Ta and T1…
- Conditions
- Bladder Cancer, High Grade, Non Muscle Invasive
- Trial name
- exBOND (NCT02143804)
- Testing
- oncolytic adenovirus expressing GMCSF
- Where
- United States
- Sponsor
- CG Oncology, Inc.
Non-Muscle Invasive Bladder Cancer (NMIBC) Refractory to BCG
Intravesical Photodynamic Therapy (PDT) in BCG Refractory High-Risk Non-muscle Invasive Bladder Cancer (NMIBC) Patients
This is a phase Ib, open-label, single-arm, single-center study conducted in Canada. Subjects with NMIBC (Ta, T1, and/or Tis) who are not candidates for or have refused radical cystectomy will be eligible for participation in the…
- Trial name
- NCT03053635
- Testing
- TLD1433 infusion and photodynamic therapy (PDT) treatment
- Where
- Canada
- Volunteers
- 6 people
- Sponsor
- Theralase® Technologies Inc.