Clinical trials: NMIBC
Bladder Cancer
Investigating Bladder Chemotherapy Instead of Surgery for Low Risk Bladder Cancer
Patients diagnosed with low risk non-muscle invasive bladder cancer (NMIBC) are at risk of frequent low grade recurrence, which usually necessitates surgical intervention under general anaesthetic.
- Trial name
- CALIBER (NCT02070120)
- Testing
- Mitomycin C, Surgical Management
- Where
- 38 sites in United Kingdom
- Volunteers
- 82 people
- Sponsor
- Institute of Cancer Research, United Kingdom
Bladder (Urothelial, Transitional Cell) Cancer
Phase II Prospective Cohort Study of Intravesical Recombinant Human Type 5 Adenovirus Injection for Treatment of High-Risk Non-Muscle Invasive Bladder Cancer: Evaluating Efficacy and Safety
This is a prospective, open label, single center clinical study on the use of recombinant human adenovirus type 5 injection for bladder instillation therapy in high-risk non muscle invasive bladder urothelial carcinoma patients.
- Trial name
- REBIRTH-013 (NCT07356791)
- Testing
- Recombinant Human Adenovirus Type 5 injection
- Volunteers
- 18 people
- Sponsor
- RenJi Hospital
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.
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.
Low-grade NMIBC, FGFR Gene Amplification
Efficacy and Safety of TYRA-300 in Participants With FGFR3 Altered Low Grade, Intermediate Risk Non-Muscle Invasive Bladder Cancer
Phase 2 Study of TYRA-300 in FGFR3 Altered Low Grade, Intermediate Risk NMIBC
- Conditions
- Low-grade NMIBC, FGFR Gene Amplification, FGFR Gene Alterations, FGFR3 Gene Alteration
- Trial name
- SURF302 (NCT06995677)
- Testing
- TYRA-300 60mg, TYRA-300 50mg, TYRA-300 Dose 70 mg
- Where
- 48 sites in United States, Australia and 2 more
- Volunteers
- 90 people
- Sponsor
- Tyra Biosciences, Inc
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.
Non Muscle Invasive Bladder Cancer
Study to Evaluate the Efficacy and Safety Of Intravesical Nanoxel®M In BCG Refractory NMIBC
The purpose of this study is to determine whether Nanoxel®M is effective in the treatment of patients with recurrent Ta and T1 who experienced treatment failure with at least one prior BCG intravesical treatment.
- Trial name
- NCT02982395
- Testing
- Nanoxel®M, Mitomycin-C
- Where
- South Korea
- Volunteers
- 36 people
- Sponsor
- Samyang Biopharmaceuticals Corporation
Non-muscle Invasive Bladder Cancer (NMIBC)
Using Urine Tumor DNA to De-Intensify Surveillance in Non-Muscle Invasive Bladder Cancer
The goal of this clinical trial is to use urine tumor DNA (utDNA) as an indicator for non-muscle invasive bladder cancer to identify patients suitable for less frequent cystoscopy surveillance.
- Trial name
- NCT07187063
- Testing
- UroAmp Test (Convergent Genomics, Inc.)
- Where
- United States
- Volunteers
- 56 people
- Sponsor
- Lahey Clinic
Bladder Cancer, Disease Progression
In the Prediction of Recurrence and Progression of NMIBC; EORTC or CUETO or Both?
Investigators aimed to evaluate the performance of The European Organization for Research and Treatment of Cancer(EORTC) and the Spanish Urology Association for Oncological Treatment(CUETO) risk tables on all non-muscle invasive…
- Conditions
- Bladder Cancer, Disease Progression, Recurrent Bladder Cancer
- Trial name
- NCT03174912
- Testing
- Intravesical BCG instillation
- Volunteers
- 400 people
- Sponsor
- Ankara Training and Research Hospital
Bladder Cancer, CIS
A Prospective Registry to Assess the Effectiveness and Local Tolerability of Intravesical Valrubicin in Subjects With Non-muscle Invasive Bladder Cancer (NMIBC)
The purpose of this study is to observe and describe the effectiveness and local tolerability of intravesical treatment with valrubicin for non-muscle invasive bladder cancer (NMIBC) in a cohort of subjects treated under routine…
- Trial name
- NCT01314664
- Where
- 11 sites in United States
- Volunteers
- 15 people
- Sponsor
- Endo USA Inc., a Keenova Therapeutics Company
Bladder (Urothelial, Transitional Cell) Cancer, NMIBC
A Phase 1 Dose-escalation Study of UGN-501 Administered Intravesically in Adult Participants With Recurrent NMIBC
This study is being conducted to evaluate the safety and tolerability of UGN-501 administered intravesically in adult participants with recurrent non-muscle invasive bladder cancer (NMIBC) and to determine the recommended Phase 2…
- Conditions
- Bladder (Urothelial, Transitional Cell) Cancer, NMIBC, Urothelial Carcinoma Bladder, Urothelial Carcinoma in Situ
- Trial name
- NCT07725796
- Testing
- UGN-501
- Where
- 15 sites in United States
- Volunteers
- 30 people
- Sponsor
- UroGen Pharma, Inc., a subsidiary of UroGen Pharma Ltd.
Non-muscle Invasive Bladder Cancer
"En Bloc" Resection of NMIBC: a Prospective， Single Centre，Randomized Study
The traditional method of choice for intravesical resection of bladder tumors is conventional transurethral resection of bladder tumor (cTURBT).
- Trial name
- NCT03221062
- Testing
- Laser en Bloc Resection
- Volunteers
- 180 people
- Sponsor
- Tongji Hospital
Urinary Bladder Cancer
Intravesical Gem/Doce in Patients With NMIBC
Intravesical immunotherapy or chemotherapy for non-muscle invasive bladder cancer (NMIBC) is a well-established treatment for preventing or delaying tumor recurrence after tumor resection.
- Trial name
- NCT05644041
- Testing
- gemcitabine + docetaxel
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- University of Arizona
Bladder Cancer, NMIBC
A Study of Pemigatinib in Non-muscle Invasive Bladder Cancer Patients With Recurrent Low- or Intermediate-Risk Tumors
This phase II trial studies how well Pemigatinib (an orally administered inhibitor of fibroblast growth factor receptors 1, 2, and 3) works in non-muscle invasive bladder cancer (NMIBC) patients with recurrent tumors and a prior…
- Conditions
- Bladder Cancer, NMIBC, Non-Muscle Invasive Bladder Cancer, Urothelial Carcinoma Recurrent
- Trial name
- NCT03914794
- Testing
- Pemigatinib
- Where
- 6 sites in United States
- Volunteers
- 30 people
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
NMIBC, High Risk NMIBC
A Phase 1/1b Study of ZH9 Treatment in Patients With Non-Muscle Invasive Bladder Cancer
This is a first-in-human, multicenter, Phase 1/1b, 3-part, double-blind study of ZH9 in patients with recurrent NMIBC who are eligible for intravesical therapy.
- Conditions
- NMIBC, High Risk NMIBC, Non Muscle Invasive Bladder Cancer
- Trial name
- PARADIGM-1 (NCT06181266)
- Testing
- ZH9
- Where
- 4 sites in United States
- Volunteers
- 22 people
- Sponsor
- Prokarium Ltd
Bladder Cancer, Urothelial Carcinoma
A Phase 3 Study of UGN-102 for Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer
This global, randomized, controlled, open-label Phase 3 study was designed to assess the long-term efficacy and safety of UGN-102 (mitomycin) for intravesical solution with or without (±) transurethral resection of bladder tumors…
- Conditions
- Bladder Cancer, Urothelial Carcinoma, Urothelial Carcinoma Bladder
- Trial name
- ATLAS (NCT04688931)
- Testing
- UGN-102, TURBT
- Where
- 139 sites in United States, Bulgaria and 8 more
- Volunteers
- 282 people
- Sponsor
- UroGen Pharma Ltd.
Non-muscle Invasive Bladder Cancer (NMIBC)
Hyaluronic Acid Sodium Salt and Hydeal-D in the Management of LUTS After TURBT for NMIBC.
This will be an open-label, prospective, single-centre, randomised, controlled, parallel-group medical device investigation. The investigational plan will include four visits in total at the investigational site.
- Trial name
- NCT06069453
- Testing
- Hyaluronic Acid (HA) sodium salt and Hydeal-D
- Where
- Italy
- Volunteers
- 54 people
- Sponsor
- Fidia Farmaceutici s.p.a.
Bladder Cancer, NMIBC
A Bladder-Sparing Treatment Strategies of Large-Volume Non-Muscle-Invasive Bladder Cancer
Bladder cancer is a common malignancy in the urinary system, ranking 11th in cancer incidence in China (3.48/100,000), with male incidence ranking 8th (5.70/100,000).
- Trial name
- NCT06735287
- Testing
- bladder sparing set, RC
- Where
- China
- Volunteers
- 60 people
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
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 1b)
This study is open-label dose expansion study 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 bladder tumor…
- Trial name
- ADVANCED-1 (NCT05085990)
- Testing
- TARA-002
- Where
- 10 sites in United States
- Volunteers
- 10 people
- Sponsor
- Protara Therapeutics
Non Muscle Invasive Bladder Cancer
A Prospective Open Label Comparative Dose Ranging Study Evaluating the Effect of Pre-TURBT Intravesical Instillation of Mitomycin C (MMC) Mixed With TC-3 Gel in Patients With Non Muscle Invasive Bladder Cancer (NMIBC)
This study is a prospective randomized open labeled dose ranging comparative study. Twenty four (24) patients with NMIBC who meet the inclusion/exclusion criteria will be recruited for the study following the initial diagnostic…
- Trial name
- NMIBC TURBT HG (NCT01799499)
- Testing
- TC-3 hydrogel
- Where
- Israel
- Sponsor
- UroGen Pharma Ltd.