Clinical trials: Muscle Invasive Bladder Urothelial Carcinoma
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.
Carcinoma in Situ, Transitional Cell Carcinoma
Multi-center Study to Evaluate the Efficacy and Safety of Maintenance Therapy With Valrubicin Versus no Maintenance, in Subjects Treated With Valrubicin Induction for Carcinoma in Situ (CIS) of the Bladder
This is a Phase 3b open-label, randomized, parallel-arm, multicenter study to evaluate the efficacy and safety of 10 monthly intravesical administrations of maintenance therapy with valrubicin following induction with valrubicin…
- Conditions
- Carcinoma in Situ, Transitional Cell Carcinoma, Non-muscle Invasive Bladder Cancer
- Trial name
- NCT01310803
- Testing
- VALSTAR - Maintenance Therapy, No Maintenance treatment ( Standard of Care)
- Where
- 6 sites in United States
- Volunteers
- 1 people
- Sponsor
- Endo USA Inc., a Keenova Therapeutics Company
Muscle-invasive Bladder Cancer
Impact of Positron Emission Tomography (PET) Imaging in Muscle-invasive Urothelial Carcinoma of the Bladder Staging
Bladder cancer is the fifth most common cancer in Canada and there has been relatively little progress in altering its clinical course over the last three decades.
- Trial name
- PET MUSE (NCT02462239)
- Testing
- Whole-body FDG PET-CT
- Where
- 6 sites in Canada
- Volunteers
- 292 people
- Sponsor
- Ontario Clinical Oncology Group (OCOG)
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 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
Lung Cancer (NSCLC)
Snakehead Fish Extract and Curcumin Co-Supplementation in Advanced Lung Cancer on Inflammation, Nutritional Status, and Quality of Life
Background: Patients with advanced lung cancer receiving systemic therapy often experience nutritional decline, systemic inflammation, and impaired quality of life.
- Trial name
- BMI (NCT07906626)
- Testing
- Snakehead Fish Extract and Curcumin
- Where
- Indonesia
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Universitas Sumatera Utara
Muscle Invasive Bladder Cancer (MIBC)
RESTORE-BLADDER (REgistry on STrategies for Organ pREservation in Muscle-invasive BLADDER Cancer)
Removal of the urinary bladder (radical cystectomy) is a major surgical procedure that can have a permanent impact on a patient's quality of life.
- Trial name
- NCT07744958
- Testing
- None. Registry.
- Volunteers
- 100 people
- Sponsor
- Heinrich-Heine University, Duesseldorf
Muscle-Invasive Bladder Carcinoma, Tumor
Bladder Preservation for Patients With Muscle Invasive Bladder Cancer (MIBC) With Variant Histology
This is a Phase II, single cohort study designed to evaluate outcomes in patients with muscle invasive bladder cancer (MIBC) with variant histology who receive neoadjuvant chemotherapy (NAC) with or without immunotherapy (IO)…
- Trial name
- NCT06417190
- Testing
- Trimodal therapy (TMT) within 45 days of neoadjuvant chemotherapy (NAC)
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Leslie Ballas
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
Urothelial Carcinoma Bladder, Sperm Count, Low
Effect of Intravesical B.C.G and Gemcitabine on Semen Analysis and Testicular Volume in NMIBC
To evaluate the effects of local intravesical B.C.G and gemcitabine on semen quality and testicular volume.
- Conditions
- Urothelial Carcinoma Bladder, Sperm Count, Low, Testis; Fibrosis, Non Muscle Invasive Bladder Cancer
- Trial name
- NCT05701332
- Testing
- Bacillus Calmette Guerin, Gemcitabine HCL (Gemzar)
- Where
- Egypt
- Volunteers
- 86 people
- Sponsor
- Assiut University
Superficial Bladder Cancer
Intravesical Administration of rAd-IFN/Syn3 in Patients With BCG-Refractory or Relapsed Bladder Cancer
This Phase 2 study is designed to assess the efficacy and safety of INSTILADRIN (rAd-IFN with Syn3) when given intravesically to patients with high grade non-muscle invasive bladder cancer who are refractory to or have relapsed…
- Trial name
- NCT01687244
- Testing
- INSTILADRIN
- Volunteers
- 40 people
- Sponsor
- FKD Therapies Oy
Bladder Cancer
Prognostic Biomarkers in Patients With Urothelial Carcinoma
Bladder cancer (BC) is a heterogeneous malignancy with dismal outcome.Despite treatment, the 5-year overall survival rates for MIBC are <50%, with many patients unresponsive or inapt, necessitating biomarkers to select those most…
- Trial name
- NCT04872036
- Volunteers
- 66 people
- Sponsor
- Hellenic Cooperative Oncology Group
Urinary Bladder Neoplasms, Carcinoma in Situ
A Study of Intravesical Enfortumab Vedotin For Treatment of Patients With Non-muscle Invasive Bladder Cancer (NMIBC)
This study will test a drug called enfortumab vedotin in participants with a type of bladder cancer called non-muscle invasive bladder cancer (NMIBC).
- Conditions
- Urinary Bladder Neoplasms, Carcinoma in Situ, Carcinoma Transitional Cell, Non-muscle Invasive Bladder Cancer
- Trial name
- NCT05014139
- Testing
- Enfortumab vedotin
- Where
- 32 sites in United States, Canada and 4 more
- Volunteers
- 37 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Localized Renal Pelvis and Ureter Urothelial Carcinoma, Locally Advanced Bladder Urothelial Carcinoma
Testing MK-3475 (Pembrolizumab) After Surgery for Localized Muscle-Invasive Bladder Cancer and Locally Advanced Urothelial Cancer
This phase III trial studies how well pembrolizumab works in treating patients with bladder cancer that has spread into the deep muscle of the bladder wall (muscle-invasive) or urothelial cancer that has spread from where it…
- Conditions
- Localized Renal Pelvis and Ureter Urothelial Carcinoma, Locally Advanced Bladder Urothelial Carcinoma, Locally Advanced Renal Pelvis and Ureter Urothelial Carcinoma, Locally Advanced Ureter Urothelial Carcinoma
- Trial name
- AMBASSADOR (NCT03244384)
- Testing
- Biospecimen Collection, Clinical Observation, Computed Tomography
- Where
- 914 sites in United States, Guam
- Volunteers
- 739 people
- Sponsor
- National Cancer Institute (NCI)
Muscle-Invasive Bladder Carcinoma, Urothelial Carcinoma (UC)
Immune-Stromal Landscape in Muscle-Invasive Bladder Cancer
Bladder cancer is a significant global health issue. When the cancer spreads into the muscle layer of the bladder (muscle-invasive bladder cancer), a common treatment is the surgical removal of the bladder (radical cystectomy).
- Conditions
- Muscle-Invasive Bladder Carcinoma, Urothelial Carcinoma (UC), Bladder Cancer, Muscle-Invasive Urothelial Bladder Carcinoma
- Trial name
- NCT07525349
- Volunteers
- 100 people
- Sponsor
- Assiut University
Muscle Invasive Bladder Urothelial Carcinoma, Esophageal Cancer
Pan-tumor MRD Study
The purpose of this observational study is to collect clinical information, blood, and tumor tissue samples from participants diagnosed with stage I, stage II, or operable stage III cancer in select solid tumors.
- Conditions
- Muscle Invasive Bladder Urothelial Carcinoma, Esophageal Cancer, Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma, Melanoma (Skin Cancer)
- Trial name
- NCT06605404
- Testing
- blood and tissue samples
- Where
- 47 sites in United States
- Volunteers
- 1,350 people
- Sponsor
- Paradigm Health
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
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
Her2 Overexpressing High-Risk Non-Muscle Invasive Bladder Urothelial Carcinoma
Disitamab Vedotin Combined With Tislelizumab for Her2 Overexpressing High-Risk Non-Muscle-Invasive Urothelial Bladder Carcinoma Which is Not Completely Resectable
This is a phase II study to determine the safety and efficacy of Disitamab Vedotin when given in combination with Tislelizumab as treatment for patients with Her2 overexpressing high-risk non-muscle-invasive bladder cancer (HR…
- Trial name
- NCT05495724
- Testing
- Disitamab Vedotin Tislelizumab, Disitamab Vedotin
- Where
- China
- Volunteers
- 176 people
- Sponsor
- Tianjin Medical University Second Hospital
Muscle-invasive Bladder Cancer
Erdafitinib Monotherapy or in Combination With Cetrelimab in Muscle-invasive Bladder Cancer Patients With Fibroblast Growth Factor Receptor (FGFR ) Gene Alterations
Erdafitinib (ERDA) alone or in combination with cetrelimab (CET) as neoadjuvant treatment (prior to surgery) in subjects with muscle-invasive bladder cancer (MIBC) whose tumours express Fibroblast Growth Factor Receptor (FGFR…
- Trial name
- SOGUG-NEOWIN (NCT06511648)
- Testing
- Erdafitinib monotherapy, Cetrelimab and Erdafitinib combination
- Where
- 23 sites in France, Italy and 2 more
- Volunteers
- 90 people
- Sponsor
- Spanish Oncology Genito-Urinary Group