Clinical trials: Non-urothelial Bladder
Non-muscle-invasive Bladder Cancer, Non-Muscle Invasive Bladder Urothelial Carcinoma
Vesical Imaging-Reporting and Data System (VI-RADS) Followed by Photodynamic Trans-urethral Resection of Bladder Tumours (PDD-TURBT) to Avoid Secondary Resections (Re-TURBT) in Non-Muscle Invasive Bladder Cancers (NMIBCs)
Background: In European Association of Urology (EAU) Guidelines, the vast majority of non-muscle-invasive bladder cancers (NMIBCs) undergo a primary transurethral resection of the bladder tumor (TURBT) followed by a repeat TURBT…
- Conditions
- Non-muscle-invasive Bladder Cancer, Non-Muscle Invasive Bladder Urothelial Carcinoma, High Risk Non-Muscle Invasive Bladder Urothelial Carcinoma
- Trial name
- CUT-less (NCT05962541)
- Testing
- PDD-TURBT with hexaminolevulinate (Hexvix®), Power Led Saphira (TM)
- Where
- Italy
- Volunteers
- 327 people
- Sponsor
- University of Roma La Sapienza
Bladder Cancer, Urothelial Carcinoma (UC)
Specimen Collection for Validation of UroAmp: A Next Generation Sequencing Platform for Detection and Surveillance of Bladder Cancer
This is a prospective, multicenter observational study designed to collect urine and tumor biospecimens and associated clinical data from patients undergoing evaluation, treatment, or surveillance for urothelial carcinoma.
- Conditions
- Bladder Cancer, Urothelial Carcinoma (UC), Hematuria, Upper Tract Urothelial Cancer
- Trial name
- INSITE (NCT07673016)
- Where
- 23 sites in United States, Puerto Rico
- Volunteers
- 2,500 people
- Sponsor
- Convergent Genomics, Inc.
Immunotherapy, Cancer
Observational Basket Trial to Collect Tissue to Develop and Train a Live Tumor Diagnostic Platform (ELEPHAS-02)
The primary objective of this study is to develop and train the Elephas live tumor diagnostic platform and determine the ex-vivo accuracy of the Elephas Score using in-vivo RECIST 1.1 as the reference method
- Conditions
- Immunotherapy, Cancer, Bladder Cancer, Urothelial Carcinoma Bladder
- Trial name
- ELEPHAS-02 (NCT05520099)
- Testing
- Core Needle Biopsy, Forceps Biopsy, Punch Biopsy
- Where
- 12 sites in United States
- Volunteers
- 416 people
- Sponsor
- Elephas
Urothelial Cancer
A Study Of Avelumab In Patients With Locally Advanced Or Metastatic Urothelial Cancer (JAVELIN Bladder 100)
The main purpose of this study is to compare maintenance treatment with avelumab plus best supportive care (BSC) with BSC alone, to determine if avelumab has an effect on survival in patients with locally advanced or metastatic…
- Trial name
- NCT02603432
- Testing
- Avelumab, Best Supportive Care, Following the planned interim analysis for this study: Avelumab
- Where
- 382 sites in United States, Argentina and 27 more
- Volunteers
- 700 people
- Sponsor
- Pfizer
Melanoma (Excluding Uveal Melanoma), Cervical Carcinoma
A Study of XmAb®23104 in Subjects With Selected Advanced Solid Tumors (DUET-3)
This is a Phase 1, multiple dose, ascending dose escalation study to define a MTD/RD and regimen of XmAb23104, to describe safety and tolerability, to assess PK and immunogenicity, and to preliminarily assess anti-tumor activity…
- Conditions
- Melanoma (Excluding Uveal Melanoma), Cervical Carcinoma, Pancreatic Carcinoma, Breast Carcinoma That is Estrogen Receptor, Progesterone Receptor, and Her2 Negative
- Trial name
- DUET-3 (NCT03752398)
- Testing
- XmAb®23104, Yervoy® (ipilimumab)
- Where
- 18 sites in United States
- Volunteers
- 198 people
- Sponsor
- Xencor, Inc.
Urinary Bladder Cancer
Safety and Tolerability of TAR-200 mg in Subjects With Non-Muscle-Invasive Bladder Cancer
The purpose of this study is to determine if TAR-200, an investigational drug-delivery system is safe and tolerable in patients with recurrent low or intermediate risk non-muscle-invasive bladder cancer (NMIBC) between diagnosis…
- Trial name
- NCT02720367
- Testing
- Gemcitabine-Releasing Intravesical System (GemRIS)/TAR-200
- Where
- 2 sites in Netherlands
- Volunteers
- 12 people
- Sponsor
- Taris Biomedical LLC
Bladder Carcinoma
hARnessing CAbozantinib and Durvalumab Immuno-oncology Association: ARCADIA Study"
Cabozantinib plus Durvalumab in patients with advanced and chemotherapy-treated bladder carcinoma, of urothelial and non-urothelial histology: an open-label, single-centre, phase 2, single-arm proof-of-concept trial: ARCADIA study
- Trial name
- ARCADIA (NCT03824691)
- Testing
- Cabozantinib, Durvalumab
- Where
- Italy
- Volunteers
- 122 people
- Sponsor
- Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Non-Small Cell Lung Cancer, Urothelial Cancer
DK222 Study at Hopkins
This Phase 1 clinical trial will test a new drug called [18F]DK222 in people with cancer. The goal is to see if the drug is safe, how it spreads through the body, how long it stays in the body, and how much radiation it gives…
- Trial name
- NCT07140315
- Testing
- [18F]DK222 radiotracer
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Urothelial Carcinoma, Renal Cell Carcinoma
Study of Cabozantinib Alone or in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors
This is a multicenter Phase 1b, open-label study to assess safety, tolerability, preliminary efficacy, and pharmacokinetics (PK) of cabozantinib taken in combination with atezolizumab in subjects with multiple tumor types…
- Conditions
- Urothelial Carcinoma, Renal Cell Carcinoma, Non-Small Cell Lung Cancer, Castration-resistant Prostate Cancer
- Trial name
- NCT03170960
- Testing
- cabozantinib, atezolizumab
- Where
- 124 sites in United States, Australia and 7 more
- Volunteers
- 914 people
- Sponsor
- Exelixis
Advanced Solid Tumor, Metastatic Cancer
Study of AU-007, A Monoclonal Antibody That Binds to IL-2 and Inhibits IL-2Rα Binding, in Patients With Unresectable Locally Advanced or Metastatic Cancer
This is a first in human, open-label, multi-center Phase 1 / 2 study to evaluate the safety, tolerability, and initial efficacy of AU-007, also known as imneskibart, in patients with advanced solid tumors.
- Conditions
- Advanced Solid Tumor, Metastatic Cancer, Cutaneous Melanoma, Non-Small Cell Lung Cancer
- Trial name
- NCT05267626
- Testing
- AU-007, Aldesleukin, Avelumab
- Where
- 17 sites in United States, Australia
- Volunteers
- 159 people
- Sponsor
- Aulos Bioscience, Inc.
Bladder (Urothelial, Transitional Cell) Cancer
Chemoablation for Low-Grade Bladder Cancer
The goal of this single arm, prospective, open-label, investigator-initiated Phase 2 clinical trial is to evaluate the efficacy of intravesical chemoablation in patients with low grade bladder cancer.
- Trial name
- COBRA (NCT07019220)
- Testing
- Gemcitabine
- Where
- Austria
- Volunteers
- 47 people
- Sponsor
- Ekaterina Laukhtina
Bladder Cancer, Urothelial Carcinoma (UC)
Comparison of CT and MR (VI-RADS) Imaging for Local Bladder Cancer Staging
This prospective diagnostic accuracy study compares computed tomography (CT) and multiparametric magnetic resonance imaging (MRI) using the Vesical Imaging-Reporting and Data System (VI-RADS) for local staging of newly diagnosed…
- Conditions
- Bladder Cancer, Urothelial Carcinoma (UC), Muscle Invasive Bladder Cancer (MIBC), Non Muscle Invasive Bladder Cancer
- Trial name
- NCT07602010
- Where
- Norway
- Volunteers
- 150 people
- Sponsor
- Oslo University Hospital
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.
Recurrent Bladder Carcinoma, Stage 0a Bladder Urothelial Carcinoma
Pembrolizumab and BCG Solution in Treating Patients With Recurrent Non-Muscle-Invasive Bladder Cancer
The purpose of this study is to evaluate the efficacy (the effect of drug on tumor) and the tolerability (the effect of drug on the body) of pembrolizumab, when given as a single agent in patients with bladder tumors.
- Conditions
- Recurrent Bladder Carcinoma, Stage 0a Bladder Urothelial Carcinoma, Stage 0is Bladder Urothelial Carcinoma, Stage I Bladder Cancer
- Trial name
- NCT02808143
- Testing
- BCG Solution, Laboratory Biomarker Analysis, Pembrolizumab
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Northwestern University
High-Risk, Non-Muscle Invasive Bladder Urothelial Carcinoma, Perfusion; Complications
Hyperthermic Intravesical Perfusion for Muscle-invasive Bladder Urothelial Carcinoma
To evaluate the effect of hyperthermic intravesical perfusion on the risk of intraoperative implantation of muscle-invasive bladder urothelial carcinoma and its safety.
- Conditions
- High-Risk, Non-Muscle Invasive Bladder Urothelial Carcinoma, Perfusion; Complications, Intraoperative Complications
- Trial name
- NCT05276167
- Testing
- hyperthermic intravesical perfusion
- Where
- China
- Volunteers
- 40 people
- Sponsor
- Henan Cancer Hospital
Urothelial Carcinoma Bladder, Triple Negative Breast Cancer (TNBC)
A Study of [225Ac]Ac-AKY-1189 in Patients With Solid Tumors
This is a first-in-human Phase 1b, 2-part, multicenter open-label clinical study to evaluate safety and efficacy of a Nectin-4 radiopharmaceutical ([225Ac]Ac-AKY-1189) in patients with locally advanced or metastatic solid tumors…
- Conditions
- Urothelial Carcinoma Bladder, Triple Negative Breast Cancer (TNBC), Hormone Receptor Positive Breast Adenocarcinoma, Non Small Cell Lung Cancer
- Trial name
- NCT07020117
- Testing
- [225Ac]Ac-AKY-1189 (therapeutic), [64Cu]Cu-AKY-1189 (imaging)
- Where
- 14 sites in United States
- Volunteers
- 150 people
- Sponsor
- Aktis Oncology, Inc.
Non-muscle Invasive Bladder Cancer
A First-in-Human Study of alpha1H in Patients With Non-muscle Invasive Bladder Cancer
This study evaluates the tolerability and preliminary anti-tumour effect of alpha1H in adults with non-muscle invasive bladder cancer, who are awaiting transurethral surgery.
- Trial name
- NCT03560479
- Testing
- alpha1H, 7.4 mg/mL, alpha1H, 37 mg/mL, alpha1H, 74 mg/mL
- Where
- Czechia
- Volunteers
- 52 people
- Sponsor
- Hamlet Pharma AB
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.
Urothelial Cancer, Urinary Bladder Neoplasms
Enfortumab Vedotin in Combination With Pembrolizumab vs. Concurrent Chemoradiotherapy (cCRT) in People With Muscle Invasive Bladder Cancer (EV-309)
This study is being done to see how well two drugs (enfortumab vedotin and pembrolizumab) work together as a bladder preservation approach to treat patients with muscle invasive bladder cancer.
- Trial name
- NCT07566156
- Testing
- Enfortumab vedotin, Conventional Radiotherapy, Hypofractionated Radiotherapy
- Where
- 29 sites in United States, Canada and 2 more
- Volunteers
- 390 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Non Small Cell Lung Cancer, Cervical Cancer
A Phase 1/1b of RNDO-564 Single Agent or in Combination With Pembrolizumab in Bladder Cancer and Other Solid Tumors Associated With Nectin-4
The main goal of this study is to evaluate how safe and tolerable RNDO-564 is and to identify the best dose of RNDO-564 as a single agent and in combination with pembrolizumab.
- Conditions
- Non Small Cell Lung Cancer, Cervical Cancer, Head and Neck Squamous Cell Cancer, Triple Negative Breast Cancer (TNBC)
- Trial name
- NCT07218003
- Testing
- RNDO-564, Pembrolizumab
- Where
- 11 sites in United States
- Volunteers
- 149 people
- Sponsor
- Rondo Therapeutics