Clinical trials: Muscle-Invasive Bladder Cancer (MIBC)
Muscle Invasive Bladder Carcinoma
FL- 101 Study in Non-Metastatic MIBC
A pilot window of opportunity study of FL-101 in patients with non-metastatic MIBC who are eligible for radical cystectomy (RC) but are ineligible for, or decline, cisplatin-based neoadjuvant therapy.
- Trial name
- NCT05395260
- Testing
- FL-101
- Sponsor
- Flame Biosciences
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
Muscle-invasive Bladder Cancer
A Study of Atezolizumab Versus Placebo as Adjuvant Therapy in Participants With High-risk Muscle-invasive Bladder Cancer (MIBC) Who Are ctDNA Positive Following Cystectomy
This is a global Phase III, randomized, placebo-controlled, double-blind study designed to evaluate the efficacy and safety of adjuvant treatment with atezolizumab compared with placebo in participants with MIBC who are…
- Trial name
- IMvigor011 (NCT04660344)
- Testing
- Atezolizumab, Signatera
- Where
- 141 sites in United States, Argentina and 21 more
- Volunteers
- 761 people
- Sponsor
- Hoffmann-La Roche
Muscle Invasive Bladder Cancer (MIBC)
MRI-Guided Bladder Preservation Program For Patients With Muscle Invasive Bladder Cancer
The goal of this clinical trial is to learn if the use of MRI-guided irradiation increases the rates of bladder preservation as well as to decrease complications in patients with muscle invasive bladder cancer who wish to retain…
- Trial name
- NCT07026864
- Testing
- MR-guided Radiation Therapy
- Volunteers
- 31 people
- Sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
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
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
Bladder Cancer, Muscle Invasive Bladder Cancer (MIBC)
Home Intravenous Fluid Infusion After Undergoing Radical Cystectomy
Radical cystectomy is the standard of care for muscle invasive bladder cancer, however despite advances, it is still associated with high morbidity.
- Conditions
- Bladder Cancer, Muscle Invasive Bladder Cancer (MIBC), Muscle Invasive Bladder Cancer Urothelial Carcinoma, Cystectomy
- Trial name
- NCT07225205
- Testing
- Intravenous fluids, ERAS
- Where
- 2 sites in United States
- Volunteers
- 130 people
- Sponsor
- Johns Hopkins University
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
Bladder Cancer, Muscle-invasive Bladder Cancer
Disitamab Vedotin Combined With Ivonescimab in Cisplatin-Ineligible Muscle-Invasive Bladder Cancer
This is a single-arm, open-label, Phase Ib/II clinical trial designed to evaluate the efficacy and safety of Disitamab Vedotin combined with Ivonescimab in the perioperative treatment of cisplatin-ineligible patients with…
- Trial name
- DIVON (NCT06957561)
- Testing
- Disitamab Vedotin Injection, Ivonescimab（AK112，a PD-1/VEGF bispecific antibody）, Radical Cystectomy with Pelvic Lymph Node Dissection
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Sun Yat-sen University
Urothelial Bladder Carcinoma, Bladder Carcinoma
Tumor Budding and T1 Substaging in Urothelial Bladder Cancer
Bladder cancer is a significant global and local health concern, and predicting how aggressive a patient's tumor will behave is critical for guiding treatment.
- Conditions
- Urothelial Bladder Carcinoma, Bladder Carcinoma, Non-Muscle-Invasive Bladder Cancer (NMIBC), Muscle-Invasive Bladder Cancer (MIBC)
- Trial name
- NCT07529639
- Volunteers
- 100 people
- Sponsor
- Assiut University
Bladder Cancer
Window of Opportunity Study of Pembrolizumab Alone and in Combinations in Bladder Cancer
This is an open-label, window of opportunity platform study for subjects with muscle-invasive bladder cancer (MIBC) who are deemed ineligible or refuse cisplatin-based neoadjuvant chemotherapy and are scheduled to undergo…
- Trial name
- NCT03978624
- Testing
- Pembrolizumab, Entinostat, Procedure/Surgery
- Where
- 2 sites in United States
- Volunteers
- 20 people
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
Bladder Cancer, Bladder Cancer, Metastatic
Treatment Of Metastatic Bladder Cancer at the Time Of Biochemical reLApse Following Radical Cystectomy
Immunotherapy (checkpoint inhibitors) is approved as first and second line treatment to patients with metastatic bladder cancer.
- Trial name
- TOMBOLA (NCT04138628)
- Testing
- Atezolizumab
- Where
- 5 sites in Denmark
- Volunteers
- 154 people
- Sponsor
- Jørgen Bjerggaard Jensen
Bladder Cancer
Diagnostic Performance of the Vesical Imaging-Reporting and Data System (VI-RADS) in Detecting Muscle-invasive Bladder Tumour (MIBC) in Clinical Practice: Comparison With Transurethral Resection of Bladder Cancer (TURB) and Evaluation of Diagnostic Accuracy According to Tumour Location
VI-RADS was an observational, prospective, multicenter, no profit study. The aim of the study was to clarify the clinical validity of the Vesical Imaging-Reporting and Data System (VI-RADS) for the assessment of muscle invasion…
- Trial name
- VI-RADS (NCT06337591)
- Testing
- VI-RADS
- Where
- 3 sites in Italy
- Volunteers
- 20 people
- Sponsor
- Istituto Nazionale di Ricovero e Cura per Anziani
Bladder Cancer
Nivolumab Plus Chemoradiotherapy in Patients With Muscle-invasive Bladder Cancer (MIBC) Not Undergoing Cystectomy
The purpose of this study is to investigate the effect synchronous use of nivolumab in addition to chemoradiotherapy in patients withnon-metastatic MIBC who are not candidates for radical cystectomy
- Trial name
- NCT03993249
- Testing
- Nivolumab, chemoradiotherapy
- Where
- Greece
- Volunteers
- 78 people
- Sponsor
- Hellenic GenitoUrinary Cancer Group
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
Urinary Bladder Cancer, Muscle-invasive
Perioperative Pembrolizumab (MK-3475) Plus Cystectomy or Perioperative Pembrolizumab Plus Enfortumab Vedotin Plus Cystectomy Versus Cystectomy Alone in Participants Who Are Cisplatin-ineligible or Decline Cisplatin With Muscle-invasive Bladder Cancer (MK-3475-905/KEYNOTE-905/EV-303)
This is a study of perioperative pembrolizumab or enfortumab vedotin in combination with pembrolizumab in participants who are cisplatin-ineligible or decline cisplatin with muscle-invasive bladder cancer (MIBC).
- Trial name
- NCT03924895
- Testing
- Pembrolizumab, Surgery (radical cystectomy (RC) plus Pelvic Lymph Node Dissection [PLND]), Enfortumab Vedotin
- Where
- 242 sites in United States, Argentina and 26 more
- Volunteers
- 595 people
- Sponsor
- Merck Sharp & Dohme LLC
Muscle-Invasive Bladder Carcinoma, Bladder Cancer
Bladder Preservation or Cystectomy for MIBC
In this research study, investigators will assess whether it is feasible to use information from the genes of a tumor combined with evaluation of the tumor response to systemic therapy to determine if bladder sparing…
- Conditions
- Muscle-Invasive Bladder Carcinoma, Bladder Cancer, Urothelial Carcinoma
- Trial name
- NCT07821177
- Testing
- Gemzar, Cisplatin, Adrucil
- Where
- 2 sites in United States
- Volunteers
- 20 people
- Sponsor
- Dana-Farber Cancer Institute
Urinary Bladder Neoplasms
A Study of Radical Cystectomy in Participants With Non-Muscle Invasive Bladder Cancer (NMIBC) and Muscle Invasive Bladder Cancer (MIBC) in Korea
The purpose of this study is to assess participant's overall well-being and the extent to which medical services are used by participants with non-muscle invasive bladder cancer (NMIBC) and muscle invasive bladder cancer (MIBC)…
- Trial name
- BC RC DB (NCT07735793)
- Volunteers
- 1 people
- Sponsor
- Janssen Korea, Ltd., Korea
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
Muscle Invasive Bladder Cancer
Open-Label, Randomised, Multi-Drug, Biomarker-Directed, Phase 1b Study in Pts w/ Muscle Invasive Bladder Cancer
This is an open label, multi-drug, biomarker-directed, multi-centre, multi-arm, Phase 1b study in patients with muscle invasive bladder cancer (MIBC) (urothelial) who have progressed on prior treatment.
- Trial name
- BISCAY (NCT02546661)
- Testing
- AZD4547, MEDI4736, Olaparib
- Where
- 27 sites in United States, Canada and 3 more
- Volunteers
- 117 people
- Sponsor
- AstraZeneca