Clinical trials: NMIBC
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
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
Non-muscle Invasive Bladder Cancer
Safety and Toxicity Study of Intravesical Instillation of TARA-002 in Adults with High-grade Non-muscle Invasive Bladder Cancer (Phase 1a)
This study is an open-label dose escalation study (Phase 1a) to investigate the safety and toxicity of intravesical treatment of high-grade NMIBC (HGTa or CIS, including CIS with concomitant Ta) after transurethral resection of…
- Trial name
- ADVANCED-1 (NCT05085977)
- Testing
- TARA-002
- Where
- 14 sites in United States, Moldova and 2 more
- Volunteers
- 12 people
- Sponsor
- Protara Therapeutics
Non-muscular Invasive Bladder Cancer
Clinical Study to Investigate the Safety and Tolerance of Therapeutic BCG in Postoperative Adjuvant Therapy in Subjects With Moderate to High-risk Non-muscular Invasive Bladder Cancer (NMIBC)
Phase I clinical study to investigate the safety and tolerance of therapeutic BCG in postoperative adjuvant therapy in subjects with moderate to high-risk non-muscular invasive bladder cancer (NMIBC)
- Trial name
- NCT06350838
- Testing
- BCG for Therapeutic Use
- Where
- China
- Volunteers
- 10 people
- Sponsor
- Chengdu CoenBiotech Co., Ltd
Papillary-Only Non-muscle-invasive Bladder Cancer
A Study of SHR-1501 Combination With BCG Versus Placebo Combined With BCG in Subjects With Papillary-Only NMIBC
This is a multicenter, randomized, Double-blind phase III study to determine the efficacy and safety of intravesical SHR-1501 combined with Bacillus Calmette Guerin (BCG) versus Placebo Combined with BCG in patients with…
- Trial name
- NiBladder 2 (NCT07726992)
- Testing
- SHR-1501+BCG
- Where
- 2 sites in China
- Volunteers
- 750 people
- Sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Urinary Bladder Neoplasms
A Study Comparing the Efficacy and Safety of Nivolumab in Combination With Bacillus Calmette-Guerin (BCG) Versus BCG Alone in Participants With High-Risk Non-Muscle Invasive Bladder Cancer (HR NMIBC)
A study comparing nivolumab and bacterial drugs given to help the body's immune system in the bladder versus bacterial drugs alone in high risk bladder cancer participants.
- Trial name
- CheckMate 7G8 (NCT04149574)
- Testing
- nivolumab, Bacillus Calmette-Guérin (BCG)
- Where
- 63 sites in United States, Argentina and 14 more
- Volunteers
- 13 people
- Sponsor
- Bristol-Myers Squibb
Urinary Bladder Neoplasms
A Study of Radical Cystectomy in Participants With Non-Muscle Invasive Bladder Cancer (NMIBC) and Muscle Invasive Bladder Cancer (MIBC) in Korea
The purpose of this study is to assess participant's overall well-being and the extent to which medical services are used by participants with non-muscle invasive bladder cancer (NMIBC) and muscle invasive bladder cancer (MIBC)…
- Trial name
- BC RC DB (NCT07735793)
- Volunteers
- 1 people
- Sponsor
- Janssen Korea, Ltd., Korea
Bladder Cancer, Urothelial Carcinoma
A Phase 3 Study of UGN-103 for Treatment of Patients With Low-grade Intermediate-risk Non-muscle Invasive Bladder Cancer
This Phase 3, single-arm, multicenter study was designed to evaluate the efficacy and safety of UGN-103, a novel formulation of UGN-102, instilled in the urinary bladder of patients with recurrent low-grade intermediate-risk…
- Conditions
- Bladder Cancer, Urothelial Carcinoma, Urothelial Carcinoma Bladder
- Trial name
- UTOPIA (NCT06331299)
- Testing
- UGN-103
- Where
- 48 sites in United States, Bulgaria and 5 more
- Volunteers
- 99 people
- Sponsor
- UroGen Pharma Ltd.
Urinary Bladder Neoplasms, Non-muscle Invasive Bladder Cancer (NMIBC)
A Study to Investigate the Efficacy and Safety of Alpha1H as a Neoadjuvant Therapy in Participants With Low- to Intermediate-Risk/Low-Grade Papillary Non-Muscle Invasive Bladder Cancer
The goal of this clinical trial is to learn if the drug Alpha1H works to treat low-to-intermediate risk non-muscle-invasive bladder cancer in adults. It will also learn about the safety of drug Alpha1H.
- Trial name
- NCT07804056
- Testing
- Alpha1H, Transurethral Resection of Bladder Tumor (TURBT), Intravesical Chemotherapy
- Where
- Czechia
- Volunteers
- 194 people
- Sponsor
- Hamlet Pharma AB
Bladder Cancer, Urothelial Carcinoma
A Phase 3 Single-Arm Study of UGN-102 for Treatment of Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer
This Phase 3, multinational, single-arm study was designed to evaluate the efficacy and safety of UGN-102 as primary chemoablative therapy in patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer…
- Conditions
- Bladder Cancer, Urothelial Carcinoma, Urothelial Carcinoma Bladder
- Trial name
- ENVISION (NCT05243550)
- Testing
- UGN-102
- Where
- 65 sites in United States, Austria and 8 more
- Volunteers
- 240 people
- Sponsor
- UroGen Pharma Ltd.
Bladder Cancer
First Line Comparative Study of EN3348 (MCC) vs BCG in NMIBC
The purpose of this study is to compare the safety and efficacy of EN3348 (MCC) versus BCG as first line treatment in patients with non-muscle invasive bladder cancer that are at high risk for recurrence or progression.
- Trial name
- NCT01284205
- Testing
- Mycobacterial Cell-Wall DNA Complex, Bacillus Calmette-Guerin
- Where
- 14 sites in United States
- Sponsor
- Bioniche Life Sciences Inc.
Urinary Bladder Neoplasms, Urologic Neoplasms
SHTC - EUROPE-1 Synergo Hyperthermia-Chemotherapy by European Urologists' Research Operation Preserving Evolution Study I
A multi-institutional, prospective, randomised, open-label, superiority, comparative, active-controlled, phase 3 study. The study will compare Synergo RF-induced hyperthermia-chemotherapy (SHTC) plus mitomycin C (MMC) to standard…
- Conditions
- Urinary Bladder Neoplasms, Urologic Neoplasms, Urogenital Neoplasms, Neoplasms
- Trial name
- SHTC-EUROPE-1 (NCT02254915)
- Testing
- Synergo + MMC, Bacillus Calmette-Guérin
- Sponsor
- Medical Enterprises Europe B.V.
NMIBC
ResQ133A-NMIBC: Intravesical Recombinant Mycobacterium (rMBCG) in Participants With NMIBC Eligible to Receive Intravesical Tice BCG
This is a phase 1/2, open-label, multicenter study of intravesical Recombinant Mycobacterium Bacillus Calmette-Guérin (BCG) in participants with Non-muscle invasive bladder cancer (NMIBC) who have not received Bacillus…
- Trial name
- NCT06800963
- Testing
- Intravesical Recombinant Mycobacterium (rMBCG)
- Where
- 9 sites in United States
- Volunteers
- 40 people
- Sponsor
- ImmunityBio, Inc.
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 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.
Non-muscle Invasive Bladder Cancer (NMIBC)
Phase 1/2 Study of ABI-009 in Nonmuscle Invasive Bladder Cancer
Purpose of this study is to determine appropriate dosing of ABI-009 and evaluate the safety and anti-tumor activity of ABI-009 in treatment of non-muscle invasive bladder cancer
- Trial name
- NCT02009332
- Testing
- ABI-009, Gemcitabine
- Where
- 2 sites in United States
- Volunteers
- 21 people
- Sponsor
- Aadi Bioscience, Inc.
Bladder Cancer
Efficacy and Safety of Multi-Instillations of Apaziquone in Patients With Non-Muscle Invasive Bladder Cancer
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
- NCT01410565
- Testing
- Apaziquone
- Where
- 47 sites in United States, Canada
- Volunteers
- 66 people
- Sponsor
- Spectrum Pharmaceuticals, Inc
High-risk Non-muscle Invasive Bladder Cancer
To Evaluate the Safety, Efficacy, and Pharmacokinetics of Intravesical Instiliations of Disitamab Vedotin in Patients With High-risk Non-muscular Invasive Bladder Cancer (NMIBC) That Express HER2
The purpose of this study is to evaluate the safety, efficacy, and pharmacokinetics of intravesical instiliations of Disitamab Vedotin in patients with high-risk non-muscular invasive bladder cancer (NMIBC) that express HER2
- Trial name
- NCT06378242
- Testing
- Disitamab Vedotin for injection
- Where
- 6 sites in China
- Volunteers
- 24 people
- Sponsor
- RemeGen Co., Ltd.
Bladder (Urothelial, Transitional Cell) Cancer, Bladder (Urothelial, Transitional Cell) Cancer Superficial (Non-Invasive)
A Study of NDV-01 as an Intravesical Administration to Patients With BCG-Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC), Refractory to First-line Therapy
This is a Phase 3, open-label single-arm trial designed to evaluate the safety and efficacy of NDV-01 (sustained-release gemcitabine-docetaxel) in adult participants with NMIBC with CIS who have failed BCG therapy and who have…
- Conditions
- Bladder (Urothelial, Transitional Cell) Cancer, Bladder (Urothelial, Transitional Cell) Cancer Superficial (Non-Invasive), Urothelial Carcinoma Bladder, Urothelial Carcinoma Recurrent
- Trial name
- RESCUE (NCT07342517)
- Testing
- NDV-01 (sustained-release gemcitabine-docetaxel)
- Volunteers
- healthy volunteers welcome
- Sponsor
- Relmada Therapeutics, Inc.
Non-Muscle Invasive Bladder Neoplasms
Study of Erdafitinib Intravesical Delivery System for Localized Bladder Cancer
The purpose of the study in Part 1 (dose escalation) and in Part 2 (dose expansion) is to determine the recommended Phase 2 dose(s) (RP2D[s]) and evaluate preliminary clinical efficacy.
- Trial name
- NCT05316155
- Testing
- Erdafitinib Intravesical Delivery System
- Where
- 59 sites in United States, Canada and 6 more
- Volunteers
- 235 people
- Sponsor
- Janssen Research & Development, LLC