Intravesical Recombinant BCG Followed by Perioperative Chemo-immunotherapy for Patients With MIBC...
Bladder CancerCurrent treatment of localized muscle-invasive bladder cancer is still associated with high relapse and death rate as well as the need for complete bladder resection or irradiation. The primary objective of this trial is to increase the rate of pathologic complete remission (pCR) at the time of radical cystectomy by the combination of local bladder instillation with Bacillus Calmette Guérin (BCG) in combination with systemic immunotherapy with atezolizumab and standard chemotherapy with cisplatin/gemcitabine. The trial tests the hypothesis whether BCG can enhance systemic and local immune response and thereby increase pCR rate and consequently also event-free survival. Improving pCR rate would be a next step to the ultimate goal of omitting radical surgery or extensive local radiotherapy to the bladder for these patients.
A Study of TAR-200 in Combination With Cetrelimab and Cetrelimab Alone in Participants With Muscle-Invasive...
Urinary Bladder NeoplasmsThe purpose of this study is to evaluate the anti-tumor effects of TAR-200 in combination with intravenous (IV) cetrelimab and IV cetrelimab alone.
LEGEND Study: EG-70 in NMIBC Patients BCG-Unresponsive and High-Risk NMIBC Incompletely Treated...
Superficial Bladder CancerThis study will evaluate the safety and efficacy of intravesical administration of EG-70 and in the bladder and its effect on bladder tumors in patients with NMIBC. This study study consists of two phases; a Phase 1 dose-escalation to establish safety and recommended the phase 2 dose, followed by a Phase 2 study to establish how effective the treatment is. The Study will include patients with NMIBC for whom BCG therapy is unresponsive and are recommended for radical cystectomy, or high-risk NMIBC patients who are BCG-naïve or have received incomplete BCG treatment.
CTC Quantification During TURBT and PKVBT of Transitional Cell Carcinoma in Purging Fluid and Blood...
Urinary Bladder NeoplasmTransitional Cell Carcinoma3 moreTransurethral resection of bladder tumor (TURBT) is usually performed in a piecemeal technique. Tumor fragmentation and cell spilling could be responsible for high recurrence rates. Circulating tumor cells (CTCs) have been shown to be a prognostic predictor in disease progression in transitional cell carcinoma. In the current study the investigators aim to quantify CTCs in purging fluid and blood for recurrent intermediate risk bladder cancer during surgery for two different methods: TURBT and Plasma-kinetic vaporization of bladder tumor (PKVBT). Also correlations for recurrence will be investigated for the two different surgical methods.
Pembrolizumab and Combination Chemotherapy Before Surgery for the Treatment of Muscle-Invasive Bladder...
Stage II Bladder Cancer AJCC v8Stage IIIA Bladder Cancer AJCC v81 moreThis pilot study is evaluating how well pembrolizumab and combination chemotherapy before surgery work for the treatment of specific types of muscle-invasive bladder cancer that have unusual appearance (variants). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as methotrexate, vinblastine, adriamycin, and cisplatin work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving pembrolizumab and combination chemotherapy before surgery may work better in treating patients with these muscle invasive bladder cancer variants compared to chemotherapy alone.
Study of CG0070 Given in Patients With Non-Muscle Invasive Bladder Cancer ,Unresponsive to Bacillus-Calmette-Guerin...
Non Muscular Invasive Bladder CancerTo evaluate the activity of intravesical (IVE) administration of CG0070 in patients with tissue pathology confirmed non-muscular invasive bladder cancer (NMIBC) who have Bacillus-Calmette-Guerin (BCG) unresponsive disease, with either carcinoma in situ with or without Ta/T1 disease
Transurethral Modified En Bloc Resection For Large Bladder Tumours.
Bladder CancerBladder Neoplasm1 moreModified en bloc resection is a hybrid technique involving piecemeal resection of the exophytic part of the bladder tumour, followed by en bloc resection of the tumour base. In this study, we shall investigate the efficacy of modified en bloc resection for patients with bladder tumours of ≥3cm in size.
Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Chemoradiotherapy (CRT) Versus...
Urinary Bladder NeoplasmsThis study is designed to assess the antitumor efficacy and safety of pembrolizumab in combination with chemoradiotherapy (CRT) versus CRT alone in participants with muscle-invasive bladder cancer (MIBC). The primary hypothesis is that pembrolizumab + chemoradiotherapy is superior to placebo + chemoradiotherapy with respect to bladder intact event-free survival.
Comprehensive Geriatric Assessment for Perioperative Optimization in Cystectomy
Bladder CancerPatients with muscle-invasive bladder cancer are often older and multimorbid, thus in an increased risk of perioperative mortality and morbidity in relation to radical cystectomy (RC). The aim of the study is to investigate the effect of perioperative Comprehensive Geriatric Assessment (CGA) and tailored intervention in older, frail patients with bladder cancer undergoing RC.
EffectiveNess of a Multimodal preHAbilitation Program in patieNts With Bladder canCEr Undergoing...
Bladder CarcinomaCurrently, the potential value of a multimodal prehabilitation program in bladder cancer has not been extensively studied. The investigators designed the ENHANCE study to assess the effect of a structured multimodal prehabilitation program in 154 patients with bladder cancer on the number (primary endpoint) and severity of complications within 90 days, length of hospital stay, readmissions, physical fitness, muscle strength, physical functioning, nutritional status, smoking behaviour, anxiety and depression, fatigue, quality of life, physical activity, tumor tissue characteristics, and healthcare costs.