View clinical trials related to Urinary Bladder Neoplasms.
Filter by:Research Hypothesis Approximately 75% of patients with bladder cancer (BC) present with a disease confined to the mucosa (stage Ta, CIS) or submucosa (stage T1) (non-muscle invasive BC [NMIBC]). For high grade NMIBC, i.e. TaG3, T1G3 and CIS, intravesical bacillus Calmette-Guérin (BCG) immunotherapy is the treatment of choice, given that it prevents recurrence and reduces the odds of progression to MIBC. However, since initial BCG therapy fails in approximately 40% of patients over a 2-year period, new treatment options for these patients are of utmost importance. In that field of research durvalumab, a human monoclonal antibody that binds programmed cell death ligand-1 (PD-L1), demonstrated meaningful clinical activity as well as manageable safety profile in PD-L1-positive patients with BC, many of whom were heavily pretreated. Certain studies using systemic administration of anti-PD1 agents for BCG refractory NMIBC are ongoing. Nevertheless, intravesical administration may be advantageous, since selective bladder tumor uptake of monoclonal antibodies following intravesical administration, while this method results in negligible absorption in the circulation and, therefore, minimal risk of systemic toxicity. This notion is supported by the findings of a recent study of intravesical administration of recombinant adenovirus-mediated interferon-α2b gene therapy (rAd-IFNα), No rAd-IFNα DNA was detected in the blood. Furthermore, no systemic toxicity was reported in a phase II study using the same agent. The investigators, therefore, propose a phase II study of intravesical administration of durvalumab in patients with BCG refractory NMIBC. Since no safety or efficacy data specifically on intravesical administration of durvalumab exist, a run-in part will precede the main phase II, in order to confirm safety of the procedure and to reject a futility hypothesis, as described in the following sections of the protocol. Correlative studies of potential biomarkers in tumor tissue before and after durvalumab instillation are also proposed.
This phase III trial studies how well nutrition therapy works in improving immune system in patients with bladder cancer that can be removed by surgery. Improving nutrition before and after surgery may reduce the infections and other problems that sometimes occur after surgery.
A Global Study to Determine the Efficacy and Safety of Durvalumab in Combination with Gemcitabine+Cisplatin for Neoadjuvant Treatment and Durvalumab Alone for Adjuvant Treatment in Patients with Muscle-Invasive Bladder Cancer
Combined-modality treatment of localized muscle invasive bladder cancer including transurethral resection (TUR), radiotherapy and dual checkpoint inhibition immunotherapy could achieve pathological complete response in some patients. These patients could avoid to undergone radical surgery with radical cystectomy and preserve their bladder, without the side-effects associated with chemotherapy and surgery. This study has been design to determine the efficacy of durvalumab plus tremelimumab with concurrent radiotherapy in terms of pathological response rate in patients with localized muscle invasive bladder cancer treated with bladder preservation intent.
Patients older than ≥18 years, with muscle-invasive bladder cancer unfit for radical cystectomy because of age, comorbidities, and/or patient's refusal. This study is designed as a multicentre, single-arm phase II study.
Open-label, interventional, multi-centre, randomized phase II study. Cancer studied is non-metastatic muscle invasive bladder cancer (MIBC). Avelumab administered every 2 weeks is used as neoadjuvant therapy in subjects with urothelial muscle invasive bladder cancers in combination with standard chemotherapy or alone.
The purpose of this study is to compare nivolumab plus neoadjuvant gemcitabine/cisplatin (GC) chemotherapy, followed by post-surgery continuation of immuno-oncology (IO) therapy, with neoadjuvant GC chemotherapy alone in adult participants with previously untreated muscle-invasive bladder cancer (MIBC).
This phase II trial studies the side effects and how well radiation therapy and durvalumab with or without tremelimumab work in treating participants with bladder cancer that cannot be removed by surgery, has spread to nearby tissue or lymph nodes, or that has spread to other parts of the body. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Monoclonal antibodies, such as durvalumab and tremelimumab, may interfere with the ability of tumor cells to grow and spread. It is not yet known whether giving radiation therapy and durvalumab with or without tremelimumab will work better in treating participants with bladder cancer.
A prospective, single arm, multicenter, Phase II-Trial to assess safety and efficacy of preoperative Radiation therapy before radical CystEctomy combined with ImmunoTherapy in locally advanced urothelial carcinoma of the bladder
This is a randomized, open-label, multi-center, global, phase III study to determine the efficacy and safety of Durvalumab + BCG combination therapy in the treatment of patients with non-muscle-invasive bladder cancer