Clinical trials: Muscle-Invasive Bladder Cancer (MIBC)
Carcinoma, Transitional Cell, Urinary Bladder Neoplasms
A Study of Enfortumab Vedotin Alone or With Other Therapies for Treatment of Urothelial Cancer
This study will test an experimental drug (enfortumab vedotin) alone and with different combinations of anticancer therapies. Pembrolizumab is an immune checkpoint inhibitor (CPI) that is used to treat patients with cancer of the…
- Conditions
- Carcinoma, Transitional Cell, Urinary Bladder Neoplasms, Urologic Neoplasms, Renal Pelvis Neoplasms
- Trial name
- EV-103 (NCT03288545)
- Testing
- enfortumab vedotin (EV), pembrolizumab, cisplatin
- Where
- 106 sites in United States, Canada and 4 more
- Volunteers
- 348 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Muscle-invasive Bladder Cancer
Remodeling of MHC-related Immune Microenvironment in MIBC After Neoadjuvant Therapy
In this study, the relevant biomarkers for predicting the efficacy of neoadjuvant therapy in patients with MIBC were further explored.
- Trial name
- NCT07440901
- Testing
- Immunotherapy plus chemotherapy
- Volunteers
- 30 people
- Sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Muscle-Invasive Bladder Cancer (MIBC)
Trastuzumab Rezetecan and Adebrelimab as Neoadjuvant Therapy for HER2-Positive Muscle-Invasive Bladder Cancer
This study aims to evaluate the efficacy and safety of neoadjuvant trastuzumab rezetecan combined with adebrelimab for the treatment of HER2-positive muscle-invasive bladder cancer.
- Trial name
- NCT07624201
- Testing
- Trastuzumab Rezetecan Combined with Adebelizumab
- Where
- China
- Volunteers
- 58 people
- Sponsor
- Harbin Medical University
Non-Muscle Invasive Bladder Neoplasms
Study of Erdafitinib Intravesical Delivery System for Localized Bladder Cancer
The purpose of the study in Part 1 (dose escalation) and in Part 2 (dose expansion) is to determine the recommended Phase 2 dose(s) (RP2D[s]) and evaluate preliminary clinical efficacy.
- Trial name
- NCT05316155
- Testing
- Erdafitinib Intravesical Delivery System
- Where
- 59 sites in United States, Canada and 6 more
- Volunteers
- 235 people
- Sponsor
- Janssen Research & Development, LLC
Bladder Cancer
Radiation and Durvalumab Immunotherapy As Neoadjuvant Treatment for MIBC
This study assesses the effect of sequential radiation and durvalumab immunotherapy given as treatment prior to surgery with radical cystectomy for bladder cancer.
- Trial name
- RADIANT (NCT04543110)
- Testing
- Durvalumab, Immune Modulating Radiation
- Where
- 4 sites in Canada
- Volunteers
- 16 people
- Sponsor
- Ottawa Hospital Research Institute
Bladder Cancer
Perioperative Pembrolizumab (MK-3475) Plus Neoadjuvant Chemotherapy Versus Perioperative Placebo Plus Neoadjuvant Chemotherapy for Cisplatin-eligible Muscle-invasive Bladder Cancer (MIBC) (MK-3475-866/KEYNOTE-866)
A global study to evaluate peri-operative pembrolizumab with chemotherapy versus placebo to pembrolizumab plus chemotherapy in cisplatin eligible patients.
- Trial name
- KEYNOTE-866 (NCT03924856)
- Testing
- Pembrolizumab, Gemcitabine, Cisplatin
- Where
- 175 sites in United States, Australia and 20 more
- Volunteers
- 907 people
- Sponsor
- Merck Sharp & Dohme LLC
Bladder Cancer, Urothelial Carcinoma
Evaluation of NanoDoce® in Participants With Urothelial Carcinoma
This is a clinical trial studying the administration of NanoDoce as a direct injection to the bladder wall immediately after tumor resection and as an intravesical instillation.
- Conditions
- Bladder Cancer, Urothelial Carcinoma, Urinary Bladder Neoplasm, Urinary Bladder Cancer
- Trial name
- NCT03636256
- Testing
- NanoDoce (direct injection), NanoDoce (intravesical instillation) - Visit 2 Instillation, Institutional Standard of Care
- Where
- 5 sites in United States
- Volunteers
- 36 people
- Sponsor
- NanOlogy, LLC
Urinary Bladder Neoplasms
Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Chemoradiotherapy (CRT) Versus CRT Alone in Muscle-invasive Bladder Cancer (MIBC) (MK-3475-992/KEYNOTE-992)
Researchers are looking for new ways to treat muscle-invasive bladder cancer (MIBC). MIBC is a type of cancer that has not spread from the muscles in the bladder to other parts of the body.
- Trial name
- NCT04241185
- Testing
- Pembrolizumab, Conventional Radiotherapy (Bladder only), Conventional Radiotherapy (Bladder and pelvic nodes)
- Where
- 134 sites in United States, Australia and 23 more
- Volunteers
- 520 people
- Sponsor
- Merck Sharp & Dohme LLC
Radical Cystectomy, Muscle-Invasive Bladder Carcinoma
Clinical Utility of VI-RADS in Diagnosis of MIBC
Bladder Cancer (BCa) is the 9th most common cancer worldwide. In general, BCa is presented as a non-muscle invasive bladder cancer (NMIBC) in 70% of patients and treated with transurethral resection of bladder tumor (TUR-BT).
- Conditions
- Radical Cystectomy, Muscle-Invasive Bladder Carcinoma, Multiparametric MRI, Vesical Imaging Report and Data System
- Trial name
- NCT05097404
- Where
- South Korea
- Volunteers
- 73 people
- Sponsor
- Samsung Medical Center
Localized Muscle Invasive Bladder Urothelial Carcinoma, Muscle-Invasive Bladder Carcinoma
Adaptive RADiation Therapy With Concurrent Sacituzumab Govitecan (SG) for Muscle Invasive Bladder Cancer
The purpose of this study is to examine the safety and tolerability of treatment with concurrent Sacituzumab Govitecan (SG) and adaptive radiation therapy.
- Trial name
- NCT05833867
- Testing
- Sacituzumab govitecan, Adaptive Radiotherapy
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Shilpa Gupta, MD
Bladder Cancer
Improving Clinical Staging for Muscle Invasive Bladder Cancer Through Molecular Profiling and Improved Imaging
The goal of this research study is to improve detection of cancer outside of the bladder through genetic testing and improved imaging.
- Trial name
- NCT02203136
- Testing
- Tissue Biopsy, Magnetic Resonance Imaging (MRI)
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- M.D. Anderson Cancer Center
Bladder (Urothelial, Transitional Cell) Cancer, Bladder Cancer Requiring Cystectomy
Treatment Expedition With MRI Processing and Optimization for Muscle Invasive Bladder Cancer
The TEMPO-MIBC trial is a phase III, single-center, two-arm, randomized, controlled trial. Its primary objective is to evaluate the efficacy of a simplified diagnostic and treatment pathway for muscle-invasive bladder cancer…
- Conditions
- Bladder (Urothelial, Transitional Cell) Cancer, Bladder Cancer Requiring Cystectomy, Bladder Carcinoma, Bladder Neoplasm
- Trial name
- TEMPO-MIBC (NCT07067749)
- Testing
- multiparametric magnetic resonance imaging (mpMRI) of the bladder, Transurethral resection of bladder tumour (TURBt), Circulating tumour DNA levels assessment
- Where
- Italy
- Volunteers
- 92 people
- Sponsor
- University of Rome Tor Vergata
NMIBC, MIBC
Outcomes for IR and High Risk (HR) Non-muscle Invasive Bladder Cancer (NMIBC) and ctDNA-based Biomarkers for Response and Recurrence in Muscle Invasive Bladder Cancer (MIBC)
This study aims to better understand how treatment choices impact outcomes for patients with intermediate- and high-risk non-muscle-invasive bladder cancer (NMIBC), as well as the factors that influence treatment decisions made…
- Conditions
- NMIBC, MIBC, Muscle Invasive Bladder Cancer (MIBC), Non Muscle Invasive Bladder Cancer
- Trial name
- BLAST (NCT07893509)
- Testing
- This is a non-interventional, observational, prospective study.
- Where
- United States
- Volunteers
- 1,400 people
- Sponsor
- Bladder Cancer Advocacy Network
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
Predicting Response to Neoadjuvant Chemotherapy in Muscle-invasive Bladder Cancer
Bladder cancer (BC) is the 10th most commonly diagnosed cancer worldwide and the second most common cancer among Egyptian males.
- Trial name
- NCT06325423
- Testing
- neoadjuvant chemotherapy
- Volunteers
- 50 people
- Sponsor
- Assiut University
Urinary Bladder Neoplasms
HOPE-07-MIBC: Disitamab Vedotin Plus Immunotherapy vs Chemoimmunotherapy in Resectable HER2-Expressing MIBC
This is a multicenter, randomized controlled clinical trial (HOPE-07) designed to evaluate the efficacy and safety of perioperative treatment with disitamab vedotin (RC48) combined with toripalimab compared with toripalimab…
- Trial name
- HOPE-07-MIBC (NCT07608224)
- Testing
- Disitamab Vedotin (RC48), Gemcitabine + Cisplatin（GC）+Toripalimab, Toripalimab (JS001 )
- Volunteers
- 240 people
- Sponsor
- West China Hospital
Bladder Cancer, Metastatic Bladder Cancer
A Window of Opportunity Trial: Avelumab in Non-metastatic Muscle Invasive Bladder Cancer
This is a pilot study of avelumab in patients with non-metastatic, muscle invasive bladder cancer who are eligible for radical cystectomy (RC), but are ineligible for cisplatin based neoadjuvant therapy.
- Conditions
- Bladder Cancer, Metastatic Bladder Cancer, Invasive Bladder Cancer
- Trial name
- NCT03498196
- Testing
- Avelumab
- Where
- 3 sites in United States
- Volunteers
- 1 people
- Sponsor
- Baylor College of Medicine
Urothelial Carcinoma of the Bladder, Muscle Invasive Bladder Cancer (MIBC)
Perioperative Systemic Therapies in Muscle-Invasive Bladder Cancer (GUARDIANS)
This is a multicenter, non-interventional, prospective and retrospective observational patient registry study of adults with muscle-invasive bladder cancer receiving perioperative systemic therapy as part of routine clinical…
- Trial name
- GUARDIANS (NCT07855926)
- Testing
- Perioperative Systemic Therapy Registry
- Where
- Germany
- Volunteers
- 500 people
- Sponsor
- LMU Klinikum
Muscle-Invasive Bladder Cancer (MIBC)
Response-Guided Bladder Preservation With Trastuzumab Rezetecan, Adebrelimab, and Concurrent Bladder Radiotherapy in HER2-Expressing Muscle-Invasive Bladder Cancer
This prospective, multicenter, open-label phase II study will evaluate a response-guided bladder-preservation strategy in patients with HER2-expressing muscle-invasive bladder cancer.
- Trial name
- RG-BP-MIBC (NCT07865611)
- Testing
- Trastuzumab Rezetecan, Adebrelimab, Concurrent Bladder Radiotherapy
- Where
- China
- Volunteers
- 70 people
- Sponsor
- Tongji Hospital
Bladder Cancer
Perioperative Enfortumab Vedotin (EV) Plus Pembrolizumab (MK-3475) Versus Neoadjuvant Chemotherapy for Cisplatin-Eligible Muscle Invasive Bladder Cancer (MIBC) (MK-3475-B15/ KEYNOTE-B15 / EV-304)
The purpose of this study is to assess the antitumor efficacy and safety of perioperative enfortumab vedotin (EV) plus pembrolizumab and radical cystectomy (RC) + pelvic lymph node dissection (PLND) compared with the current…
- Trial name
- KEYNOTE-B15 (NCT04700124)
- Testing
- Pembrolizumab, Enfortumab vedotin (EV), RC + PLND
- Where
- 188 sites in United States, Argentina and 27 more
- Volunteers
- 808 people
- Sponsor
- Merck Sharp & Dohme LLC