Sanatorio San Luigi

Researchers are evaluating the disease-free survival in participants with high-risk non-muscle-invasive bladder cancer HR-NMIBC who have previously received Bacillus Calmette-Gurin BCG treatment. This Phase 3 trial compares a new treatment called TAR-210 with the investigators choice of intravesical chemotherapy. The study focuses on participants with specific fibroblast growth factor receptor FGFR alterations and aims to find out which treatment better prevents cancer recurrence or progression after BCG therapy. Participants are randomly assigned to one of two groups. Group A will have TAR-210 inserted into the bladder starting on Day 1 and continuing for about 2 years. Group B will receive either mitomycin C or gemcitabine chemotherapy, chosen by the investigator, given once weekly for 4 to 6 weeks induction, followed by monthly maintenance doses for up to 1 year, with a possible second year of maintenance at the investigators discretion. All treatments are delivered directly into the bladder intravesically. During the study, participants will be monitored for up to 5 years to track disease-free survival and other outcomes such as recurrence-free survival, time to next intervention, disease worsening, progression, and overall survival. Researchers will also assess side effects, laboratory and vital sign changes, and quality of life using specific questionnaires. The study includes regular evaluations and safety monitoring throughout the participation period, which may last several years.

Researchers are evaluating the effectiveness of two drugs, zanzalintinib and everolimus, in participants with previously treated, unresectable, locally advanced, or metastatic neuroendocrine tumors. This study includes participants with pancreatic or extra-pancreatic neuroendocrine tumors that have shown disease progression after prior treatments. The trial is a Phase 23, randomized, open-label study aiming to compare these treatments to better understand their impact on this condition. Participants will be randomly assigned to receive either everolimus or zanzalintinib as oral tablets taken once daily. The study follows a sequential model where participants receive one of the two study drugs, and treatment continues as per protocol. There is no placebo group, and the study is designed to monitor and compare the treatments over an extended period. During the study, participants will be regularly assessed through imaging tests like CT or MRI scans to measure tumor progression using RECIST 1.1 criteria. Researchers will monitor progression-free survival, overall survival, response rates, duration of response, and disease control rates up to 48-60 months. Participant-reported quality of life and symptoms will also be evaluated using specific questionnaires. Safety will be monitored by tracking adverse events throughout the study duration.