Clinical trials: Non-muscle Invasive Bladder Cancer (NMIBC)
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.
Bladder Cancer
An International Randomized Study to Compare SPIES Versus WLI
This study is a multicenter randomized controlled trial in which the efficacy between SPIES assisted and WLI assisted TURB are compared.
- Trial name
- NCT02252549
- Testing
- SPIES+WLI assisted TURB, WLI assisted TURB
- Volunteers
- 700 people
- Sponsor
- Clinical Research Office of the Endourological Society
Urinary Bladder Neoplasms, Urologic Neoplasms
Safety and Efficacy Study of Tislelizumab in Combination With BCG in HR-NMIBC Patients (TACBIN-01)
This study is a single-arm, open-label, single-center study to assess the safety of tislelizumab with BCG, and to obtain the preliminary efficacy results in subjects who have been diagnosed with high-risk NMIBC without prior BCG…
- Conditions
- Urinary Bladder Neoplasms, Urologic Neoplasms, Urogenital Neoplasms, Antineoplastic Agents
- Trial name
- TACBIN-01 (NCT04922047)
- Testing
- tislelizumab and BCG
- Where
- China
- Volunteers
- 6 people
- Sponsor
- RenJi Hospital
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
Bladder Cancer, Non-Muscle Invasive Bladder Cancer (NMIBC)
Intravesical GEM/DOCE for HR BCG-Unresponsive NMIBC
The goal of this clinical trial is to learn whether a combination of two chemotherapy drugs, Gemcitabine and Docetaxel, can treat high-grade non-muscle-invasive bladder cancer (HG-NMIBC) in adults whose cancer failed conventional…
- Conditions
- Bladder Cancer, Non-Muscle Invasive Bladder Cancer (NMIBC), Urothelial Carcinoma, Carcinoma in Situ (CIS)
- Trial name
- NCT07322263
- Testing
- Intravesical Gemcitabine and Docetaxel
- Where
- United States
- Volunteers
- 174 people
- Sponsor
- Michael A. O'Donnell
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 Carcinoma
Home-Based Outpatient Model for BCG Delivery to Reduce Undue Burden on Patients Undergoing Treatment for Non-Muscle Invasive Bladder Carcinoma
This phase I/II trial tests the feasibility of home based BCG delivery to reduce undue burden on patients undergoing treatment for non-muscle invasive bladder carcinoma.
- Trial name
- NCT07874347
- Testing
- BCG Solution, Best Practice, Cystoscopy
- Where
- United States
- Volunteers
- 49 people
- Sponsor
- Ohio State University Comprehensive Cancer Center
Non-Muscle Invasive Bladder Cancer, Urothelial Carcinoma
An Expanded Access Program of Cretostimogene Grenadenorepvec for Treatment of NMIBC for Patients Unresponsive to BCG
This is an open-label, expanded access trial designed to provide access to cretostimogene in patients with NMIBC (specifically CIS with or without HG Ta/T1) unresponsive to BCG.
- Conditions
- Non-Muscle Invasive Bladder Cancer, Urothelial Carcinoma, Urologic Cancer, Bladder Cancer
- Trial name
- NCT06443944
- Testing
- Cretostimogene Grenadenorepvec, n-dodecyl-B-D-maltoside
- Where
- 27 sites in United States
- Sponsor
- CG Oncology, 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
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.
Non-muscle Invasive Bladder Cancer (NMIBC)
Clinical Trial of Ablation Therapy in Participants With Intermediate-Risk Non-Muscle Invasive Papillary Bladder Cancer
This is an open-label, phase 2, randomized study of intravesical N-803 plus BCG (experimental arm A) and intravesical N-803 plus gemcitabine (experimental arm B) in participants who have intermediate-risk Ta/T1 papillary disease.
- Trial name
- NCT06829823
- Testing
- N-803 and BCG, N-803 and Gemcitabine
- Volunteers
- 20 people
- Sponsor
- ImmunityBio, Inc.
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.
Urinary Bladder Diseases, Urinary Bladder Neoplasms
Hyperthermia Treatment in Conjunction With Mitomycin C Versus Bacillus Calmette-Guérin Immunotherapy (BCG) for Superficial Bladder Cancer
The study is designed to compare the efficacy and safety of 2 treatment types for the prevention of tumor recurrence of superficial bladder cancer: 1. A combination of bladder wall heating and local chemotherapy (Synergo) 2.
- Conditions
- Urinary Bladder Diseases, Urinary Bladder Neoplasms, Urinary Bladder Cancer, Malignant Tumor of Urinary Bladder
- Trial name
- NCT00384891
- Testing
- Synergo + MMC, Bacillus Calmette-Guérin
- Where
- 8 sites in Austria, Israel and 2 more
- Volunteers
- 190 people
- Sponsor
- Medical Enterprises Europe B.V.
Non Muscle Invasive Bladder Cancer
The Necessity of a Second Transurethral Resection in High-risk Non-muscle-invasive Bladder Cancer Patients With Negative Urine Biomarker After Initial Transurethral Resection
The goal of this clinical trial is to evaluate the efficacy of using a urine biomarker test to guide the decision-making process regarding the necessity of reTURBT in NMIBC patients.
- Trial name
- NCT06287541
- Testing
- Urine biomarker -Guided without reTURBT
- Where
- China
- Volunteers
- 428 people
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
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
Bladder Cancer
Assessement of the Concordance of Genomic Alterations Between Urine and Tissue in High-Risk NMIBC Patients
The analysis of cell-free tumor DNA (cfDNA) in plasma has emerged as a clinically relevant predictive and prognostic biomarker in several metastatic solid malignancies, and even now represents standard-of-care for prescription of…
- Trial name
- ALU (NCT04412070)
- Where
- France
- Volunteers
- 20 people
- Sponsor
- Hopital Foch
Bladder Cancer, Non-Muscle-Invasive Bladder Cancer (NMIBC)
Active Surveillance Versus Adjuvant Intravesical Chemotherapy in Liquid Biopsy-Defined Low-Shedding Intermediate-Risk NMIBC
This study will evaluate whether adjuvant intravesical chemotherapy can be safely omitted under active surveillance after complete transurethral resection in selected patients with EAU intermediate-risk non-muscle-invasive…
- Trial name
- NCT07749924
- Testing
- Active Surveillance, Adjuvant Intravesical Chemotherapy
- Where
- 5 sites in China
- Volunteers
- 670 people
- Sponsor
- Tianjin Medical University Second Hospital
Bladder (Urothelial, Transitional Cell) Cancer, NMIBC
DV+BCG in HER2-Expressing, BCG-Naïve High-Risk NMIBC
The purpose of this study is to learn about the safety and effects of the study medicine (Disitamab Vedotin) in people with non-muscle invasive bladder cancer.
- Trial name
- HERO (NCT07207824)
- Testing
- Active Comparator: BCG induction and maintenance, DV + BCG induction and maintenance
- Where
- China
- Volunteers
- 182 people
- Sponsor
- Fudan University
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
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.