Clinical trials: Muscle Invasive Bladder Urothelial Carcinoma, active
Muscle Invasive Bladder Urothelial Carcinoma
Enfortumab Vedotin Plus Pembrolizumab With Selective Bladder Sparing for Treatment of Muscle-invasive Bladder Cancer
Patients with MIBC will receive 3 cycles (C1-C3) of induction enfortumab vedotin plus pembrolizumab followed by restaging including MRI of the bladder, urine cytology, and cystoscopy with TURBT of any visible tumor and/or…
- Trial name
- NCT06809140
- Testing
- Enfortumab vedotin, Pembrolizumab
- Where
- 5 sites in United States
- Volunteers
- 75 people
- Sponsor
- Matthew Galsky
Bladder Cancer, Bladder (Urothelial, Transitional Cell) Cancer Resectable (Pre-Cystectomy)
Feasibility of HISA During TURBT for NMIBC
The goal of this prospective pilot study is to evaluate the safety and feasibility of using heated saline during bladder tumor surgery in patients with non-muscle invasive bladder cancer.
- Conditions
- Bladder Cancer, Bladder (Urothelial, Transitional Cell) Cancer Resectable (Pre-Cystectomy), Non-muscle Invasive Bladder Cancer (NMIBC), Non-Muscle Invasive Bladder Neoplasms
- Trial name
- NCT07817173
- Testing
- HISA
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- CAMC Health System
Muscle-Invasive Bladder Cancer (MIBC)
EV + Toripalimab vs GC as Neoadjuvant Therapy in Locally Advanced/High-Risk MIBC
The purpose of this Phase II, open-label, multicenter, randomized controlled study is to evaluate the efficacy and safety of Enfortumab Vedotin in combination with Toripalimab compared to Gemcitabine plus Cisplatin.
- Trial name
- NCT07647289
- Testing
- enfortumab vedotin (EV), Toripalimab, Gemcitabine (Chemotherapy)
- Where
- China
- Volunteers
- 58 people
- Sponsor
- Peking University Third Hospital
Urothelial Carcinoma Bladder, Bladder Cancer
Intravesical Gemcitabine and Docetaxel for BCG naïve Non-muscle Invasive Bladder Cancer
A single-arm, two-stage, open-label, phase 2 study investigating the safety and efficacy of intravesical gemcitabine/docetaxel for bacillus Calmette-Guerin (BCG)-naïve patients with non-muscle invasive bladder cancer (NMIBC).
- Trial name
- GEMDOCE (NCT04386746)
- Testing
- Gemcitabine, Docetaxel
- Where
- United States
- Volunteers
- 27 people
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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.
Localized Non-Muscle Invasive Bladder Urothelial Carcinoma, Stage 0a Bladder Cancer AJCC v8
Home-Based Physical Activity Program With Digital App Versus Health Education Group for Improving Physical Activity Among Patients With Non-muscle Invasive Bladder Cancer, The EMPOWER Trial
This clinical trial compares how well a home-based personalized physical activity program (PAP) that is delivered by a digital application (app) (the ExerciseRx app) works compared to health education in improving physical…
- Conditions
- Localized Non-Muscle Invasive Bladder Urothelial Carcinoma, Stage 0a Bladder Cancer AJCC v8, Stage 0is Bladder Cancer AJCC v8, Stage I Bladder Cancer AJCC v8
- Trial name
- EMPOWER (NCT07302230)
- Testing
- Internet-Based Intervention, Best Practice, Exercise Intervention
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- University of Washington
Muscle-Invasive Bladder Carcinoma, Metastatic Urothelial Carcinoma
Modular Trial of sEphB4-HSA in EphrinB2-High Solid Tumors
Patients with solid tumors that have high expression levels of EphrinB2 are treated with regimens that include EphrinB2 inhibitor, sEphB4-HSA.
- Trial name
- NCT06493552
- Testing
- SEphB4-HSA, Pembrolizumab, Gemcitabine
- Where
- United States
- Volunteers
- 700 people
- Sponsor
- Vasgene Therapeutics, Inc
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
Clear Cell Renal Cell Cancer (ccRCC), Pancreatic Ductal Adenocarcinoma (PDAC)
A Study to Assess Safety, Tolerability and Imaging Characteristics of [68Ga]Ga-DPI-4452 and to Assess Safety, Tolerability, and Efficacy of [177Lu]Lu-DPI-4452 in Participants With Unresectable Locally Advanced or Metastatic Solid Tumors
The main purpose of Part A of the study is to evaluate safety, tolerability and tracer uptake after a single intravenous (IV) administration of [68Ga]Ga-DPI-4452 for each tumor type such as clear cell renal cell cancer (ccRCC)…
- Conditions
- Clear Cell Renal Cell Cancer (ccRCC), Pancreatic Ductal Adenocarcinoma (PDAC), Colorectal Cancer (CRC), Urothelial Carcinoma (UC)
- Trial name
- NCT05706129
- Testing
- [68Ga]Ga-DPI-4452, [177Lu]Lu-DPI-4452
- Where
- 10 sites in Australia, France
- Volunteers
- 270 people
- Sponsor
- Lumara Bio Oncologics GmbH
Bladder Cancer
Pembrolizumab (MK-3475) and Bacillus Calmette-Guérin (BCG) as First-Line Treatment for High-Risk T1 Non-Muscle-Invasive Bladder Cancer (NMIBC) and High-Grade Non-Muscle-Invasive Upper Tract Urothelial Carcinoma (NMI-UTUC)]
The purpose of this study is to find out the effectiveness of pembrolizumab in combination with BCG as a first line therapy for participants with high grade T1 bladder cancer who are at "high risk" for BCG alone to be ineffective…
- Trial name
- NCT03504163
- Testing
- Pembrolizumab (MK-3475), Bacillus Calmette-Guérin (BCG)
- Where
- 7 sites in United States
- Volunteers
- 45 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Urothelial Carcinoma, Non-Invasive Bladder Urothelial Carcinoma
Intravesical Adoptive Cell Therapy w/ TIL for BCG Exposed High Grade NMIBC
The purpose of the study is to evaluate the feasibility, safety and tolerability of intravesical adoptive cell therapy using TIL (tumor infiltrating lymphocytes) in participants with urothelial cell carcinoma (UCC) non-muscle…
- Trial name
- NCT05768347
- Testing
- Adoptive Cell Therapy with Tumor-infiltrating Lymphocytes (TIL)
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
Non-Muscle Invasive Bladder Urothelial Carcinoma, Recurrent Non-Muscle Invasive Bladder Urothelial Carcinoma
Testing the Addition of the Immunotherapy Drug, Pembrolizumab, to Radiation Therapy Compared to the Usual Chemotherapy Treatment During Radiation Therapy for Bladder Cancer, PARRC Trial
This phase II trial compares the use of pembrolizumab and radiation therapy to chemotherapy with cisplatin, gemcitabine, 5-fluorouracil or mitomycin-C and radiation therapy for the treatment of non-muscle invasive bladder cancer.
- Conditions
- Non-Muscle Invasive Bladder Urothelial Carcinoma, Recurrent Non-Muscle Invasive Bladder Urothelial Carcinoma, Stage I Bladder Cancer AJCC v8
- Trial name
- NCT06770582
- Testing
- Biospecimen Collection, Cisplatin, Computed Tomography
- Where
- 147 sites in United States, Canada
- Volunteers
- 160 people
- Sponsor
- National Cancer Institute (NCI)
Transitional Cell Carcinoma, Transurethral Resection
BCG + MMC: Adding Mitomycin C to BCG in High-risk, Non-muscle-invasive Bladder Cancer
Instillation of Bacillus of Calmette-Guerin (BCG) into the urinary bladder (intravesical administration) improves rates of disease recurrence and progression after transurethral resection (TUR) of high risk, non-muscle-invasive…
- Trial name
- NCT06462001
- Testing
- Bacillus Calmette-Guerin Vaccine Intravesical, Mitomycin
- Where
- United Kingdom
- Volunteers
- 500 people
- Sponsor
- Nottingham University Hospitals NHS Trust
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
This phase II/III trial examines whether patients who have undergone surgical removal of bladder, kidney, ureter or urethra, but require an additional treatment called immunotherapy to help prevent their urinary tract…
- Conditions
- Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma, Muscle Invasive Ureter Urothelial Carcinoma, Muscle Invasive Urethral Urothelial Carcinoma
- Trial name
- NCT05987241
- Testing
- Biospecimen Collection, cfDNA or ctDNA Measurement, Computed Tomography
- Where
- 505 sites in United States, Canada
- Volunteers
- 992 people
- Sponsor
- National Cancer Institute (NCI)
Bladder Flat Urothelial Carcinoma In Situ, Non-Muscle Invasive Bladder Urothelial Carcinoma
Testing the Addition of an Anti-cancer Drug, Pembrolizumab, to the Usual Intravesical Chemotherapy Treatment (Gemcitabine) for the Treatment of BCG-Unresponsive Non-muscle Invasive Bladder Cancer
This phase II trial studies the effect of adding pembrolizumab to gemcitabine in treating patients with non-muscle invasive bladder cancer whose cancer does not respond to Bacillus Calmette-Guerin (BCG) treatment.
- Conditions
- Bladder Flat Urothelial Carcinoma In Situ, Non-Muscle Invasive Bladder Urothelial Carcinoma, Stage 0a Bladder Cancer AJCC v8, Stage 0is Bladder Cancer AJCC v8
- Trial name
- NCT04164082
- Testing
- Biopsy Procedure, Biospecimen Collection, Computed Tomography
- Where
- 390 sites in United States, Guam and 1 more
- Volunteers
- 161 people
- Sponsor
- National Cancer Institute (NCI)
Urinary Bladder Neoplasm, Transitional Cell Carcinoma
CTC Quantification During TURBT and PKVBT of Transitional Cell Carcinoma in Purging Fluid and Blood
Transurethral resection of bladder tumor (TURBT) is usually performed in a piecemeal technique. Tumor fragmentation and cell spilling could be responsible for high recurrence rates.
- Conditions
- Urinary Bladder Neoplasm, Transitional Cell Carcinoma, Urogenital Neoplasms, Circulating Tumor Cell
- Trial name
- NCT04811846
- Testing
- Bipolar transurethral resection of bladder tumor (TURBT), Bipolar transurethral plasma kinetic vaporization of bladder tumor (PKVBT)
- Where
- 2 sites in Austria
- Volunteers
- 40 people
- Sponsor
- University Teaching Hospital Hall in Tirol
Bladder Cancer, Urothelial Carcinoma
Risk-Enabled Therapy After Initiating EV/Pembro for Bladder Cancer
RETAIN-3 is a phase II study in patients with cT2-T3N0M0 muscle-invasive urothelial carcinoma of the bladder. Participants will receive neoadjuvant enfortumab vedotin and pembrolizumab followed by clinical and biomarker-based…
- Conditions
- Bladder Cancer, Urothelial Carcinoma, Muscle-Invasive Bladder Carcinoma, Muscle-invasive Bladder Urothelial Carcinoma
- Trial name
- RETAIN-3 (NCT07908979)
- Testing
- Enfortumab vedotin, Pembrolizumab, Cisplatin
- Where
- United States
- Volunteers
- 70 people
- Sponsor
- Fox Chase Cancer Center
Muscle-invasive Bladder Urothelial Carcinoma
A Phase II Study of Toripalimab Plus RC48-ADC With Radiotherapy for Bladder Preservation in HER2-Positive Muscle-Invasive Bladder Cancer
This is a prospective, open-label, single-center, single-arm clinical study. Plans to enroll 45 MIBC patients with clinical stage T2-T4aN0M0 and HER2-positive (IHC 1+/2+/3+) status.
- Trial name
- NCT07279597
- Testing
- RC48-ADC + Toripalimab
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Tongji Hospital
Muscle Invasive Bladder Carcinoma, Localized Cancer
Pembrolizumab in Muscle-invasive Bladder Cancer
Subjects with cT2-T3N0M0 urothelial cancer of the bladder will be enrolled. After completing two cycles of pembrolizumab, subjects will undergo a restaging MRI of the abdomen and pelvis with a standard acquisition protocol (as…
- Conditions
- Muscle Invasive Bladder Carcinoma, Localized Cancer, Urothelial Carcinoma
- Trial name
- NCT05406713
- Testing
- Pembrolizumab
- Where
- 4 sites in United States
- Volunteers
- 46 people
- Sponsor
- Matthew Galsky
Bladder Urothelial Carcinoma, Muscle-invasive Bladder Cancer
Bladder-Sparing Treatment With Disitamab Vedotin and Toripalimab With or Without Pelvic Lymph Node Dissection in Bladder Cancer
This is a prospective, multicenter, randomized controlled superiority study designed to evaluate whether the addition of pelvic lymph node dissection improves bladder-intact event-free survival in patients with cT2-3N0M0 bladder…
- Conditions
- Bladder Urothelial Carcinoma, Muscle-invasive Bladder Cancer, Bladder Cancer
- Trial name
- NCT07756008
- Testing
- Disitamab Vedotin (RC48), Toripalimab, Transurethral Resection of Bladder Tumor
- Where
- China
- Volunteers
- 114 people
- Sponsor
- Tianjin Medical University Second Hospital