Brescia

Researchers are evaluating the combination of CGT9486 and sunitinib compared to sunitinib alone in patients with locally advanced, unresectable, or metastatic Gastrointestinal Stromal Tumors GIST. This Phase 3, open-label international trial involves multiple parts, including dose confirmation, drug interaction assessments, and efficacy comparisons. The study also includes substudies focusing on drug-drug interaction potential and first-line treatment in patients with specific genetic mutations KIT exon 9. Approximately 482 patients will participate across these parts.

This observational study aims to create a national registry in Italy for multiple myeloma to monitor routine clinical practice and describe the standard care used for diagnosis and treatment. Multiple myeloma accounts for a small percentage of tumor diagnoses in Italy, with incidence rates of 9.5 per 100,000 males and 8.1 per 100,000 females. The registry will help analyze current treatment patterns and patient demographics to address future changes in care. The study involves a non-interventional, multicenter registry collecting both retrospective and prospective data from patients diagnosed with multiple myeloma since January 1, 2019. Data will be gathered using an electronic platform, and patients will be enrolled consecutively during their regular appointments after providing informed consent. Patients participating in other studies can also be included, with baseline and survival data collected for those in interventional trials. Participants will have hospital visits every six months, where clinical data and patient-reported outcomes will be recorded. Researchers will assess overall survival and time to next treatment over three years, along with patient-reported outcomes and costs incurred by patients. The study provides long-term monitoring without altering patients usual care, and participation duration may vary depending on individual follow-up.

This research investigates treatments for metastatic castration-resistant prostate cancer mCRPC focusing on a drug called ifinatamab deruxtecan I-DXd. The study aims to assess the safety, how well participants tolerate the treatments, and appropriate dosing levels of I-DXd alone or combined with other therapies. Researchers will also monitor participants prostate specific antigen PSA levels during treatment to understand its effects. Participants are assigned to one of several treatment groups. One group receives docetaxel every three weeks for up to 10 cycles. Other groups receive I-DXd alone or combined with either opevesostat or androgen receptor pathway inhibitors such as abiraterone acetate or enzalutamide. I-DXd is given every three weeks until unacceptable side effects, disease progression, death, or withdrawal, while the other drugs continue until specific discontinuation criteria are met. Premedication is required before each I-DXd dose to prevent nausea and vomiting. Throughout the study, participants undergo various assessments including monitoring of dose-limiting toxicities, adverse events, and PSA response rates. Researchers also track objective response rates, progression-free survival, overall survival, and other clinical outcomes over up to approximately 54 months. The study involves regular evaluations to assess safety and treatment effects until study completion.

Researchers are investigating new treatments for metastatic cervical cancer, which is cancer that has spread beyond the cervix, the lower part of the uterus. This study evaluates the safety and effectiveness of the antibody drug conjugate sacituzumab tirumotecan sac-TMT combined with pembrolizumab and bevacizumab. The goal is to find out if these treatments, given together or with some variations, help patients live longer or delay cancer progression compared to standard care. The study has two parts. In Part 1, participants receive sac-TMT, pembrolizumab, and bevacizumab together to assess safety. In Part 2, all participants first get standard induction treatment with pembrolizumab, paclitaxel, and cisplatin or carboplatin, possibly with bevacizumab. Those whose cancer does not worsen then enter maintenance treatment, where they are randomly assigned to receive either pembrolizumab alone or sac-TMT plus pembrolizumab, with optional bevacizumab. Participants are involved for up to about 20 months during maintenance treatment after up to 4 months of induction. The study monitors safety by tracking side effects and treatment discontinuations. Effectiveness is measured by progression-free survival and overall survival up to several years. Quality of life and physical functioning are also assessed through questionnaires. Treatments and evaluations occur through regular intravenous infusions and periodic monitoring visits.

Researchers are evaluating the safety, tolerability, and therapeutic effects of BNT113 combined with pembrolizumab compared to pembrolizumab alone as a first-line treatment for patients with unresectable recurrent or metastatic head and neck squamous cell carcinoma HNSCC positive for human papilloma virus 16 HPV16 and expressing the protein PD-L1 with a combined positive score of 1 or higher. This is an open-label, multi-site, Phase IIIII clinical trial consisting of two parts an initial safety run-in phase and a randomized phase. In the safety run-in phase Part A, patients receive BNT113 in combination with pembrolizumab to confirm safety and tolerability at selected dose levels. The randomized phase Part B compares BNT113 combined with pembrolizumab against pembrolizumab monotherapy. Treatments are given by intravenous injection or infusion and continue for up to 24 months. An optional pre-screening phase allows tumor samples to be tested for HPV16 DNA and PD-L1 expression before the main trial screening. Participants will be closely monitored throughout the study. Assessments include safety evaluations, tumor response, and survival outcomes such as overall survival and progression-free survival. Tumor tissue samples must be provided for testing. Researchers will measure treatment-emergent adverse events, response rates, duration of response, and disease control. The study may last up to 48 months, with ongoing safety and efficacy monitoring during and after treatment.

Researchers are evaluating new treatments for advanced ovarian cancer in women who have completed initial surgery and chemotherapy. The study focuses on non-HRD positive ovarian cancer, comparing a targeted therapy called sacituzumab tirumotecan sac-TMT given alone or with bevacizumab, against standard care options such as bevacizumab maintenance or observation. The goal is to see if sac-TMT with or without bevacizumab can help patients live longer without their cancer worsening. Participants in the experimental group will receive sac-TMT through intravenous infusion on days 1, 15, and 29 of every 6-week cycle until the cancer progresses, side effects become prohibitive, or other reasons for stopping arise. They may optionally receive bevacizumab on days 1 and 22 of each cycle. The comparator group will either receive bevacizumab alone every 3 weeks for up to 22 courses or be monitored without active treatment. Supportive medications like steroid mouthwash and other rescue drugs are recommended before sac-TMT infusions. Throughout the study, participants will be regularly monitored for how long they live without their disease progressing, overall survival, side effects, and quality of life using specialized questionnaires. These assessments will continue for up to approximately 78 months. The study is randomized, with single masking, and led by Merck Sharp & Dohme LLC. Participants can expect regular visits for treatment and monitoring during this period.

This research aims to assess the effectiveness of a combination of rituximab and golcadomide as a chemotherapy-free treatment for older, frail patients newly diagnosed with Diffuse Large B Cell Non-Hodgkin Lymphoma DLBCL. The study focuses on patients considered frail based on a simplified geriatric assessment sGA and who are not suitable candidates for standard anthracycline-based chemotherapy treatments like R-CHOP. It is a prospective, multicenter, phase II trial designed to explore this targeted approach in a vulnerable population. Participants will undergo an induction phase receiving rituximab, golcadomide, and dexamethasone during the first cycle, with a total of up to six 28-day cycles. Response evaluations occur after the fourth and sixth cycles to determine treatment continuation or discontinuation. Patients achieving at least a partial response proceed to a consolidation phase involving golcadomide alone for up to six additional cycles, possibly alongside involved site radiotherapy on PET-positive areas. Those with stable or progressive disease at interim assessments will stop the protocol treatment and receive alternative therapies. Throughout the study, participants are closely monitored with imaging scans such as PETCT or CT for disease and sarcopenia assessment, and quality of life evaluations at multiple points including baseline, six months, and twelve months. Follow-up continues for 24 months with regular visits to track progression-free survival and overall health. Treatment failures are followed for survival until study completion. The study also records treatment discontinuation rates and quality of life changes to comprehensively understand the treatment impact.

This research is an international multicenter retrospective observational study focusing on patients with Essential Thrombocythemia ET who are positive for the JAK2V617F mutation. It aims to understand the progression from ET to Polycythemia Vera PV and compare clinical outcomes between those who progressed and those who did not, using criteria defined by the International consensus classification of myeloid neoplasms and acute leukemias from 2022. The study consists of two parts a nested case-control study and a comparative retrospective cohort study. The first part compares ET patients who progressed to PV with matched ET patients who did not progress, based on diagnosis year, age at diagnosis, and disease duration. The second part compares patients diagnosed with de novo PV without prior ET to the ET-to-PV cases, again matched by diagnosis year, age, and disease duration. All patients included in the study were diagnosed by the end of 2020 to allow at least 5 years of follow-up. Participants will have their medical histories reviewed retrospectively to analyze clinical data up to the baseline and at the time of progression. Researchers will assess phenotypic changes and clinical outcomes between groups, with no new treatments or interventions administered. The study is observational and aims to gather information from existing records to better understand disease evolution over time.

Researchers are studying people with idiopathic pulmonary fibrosis IPF or progressive pulmonary fibrosis PPF who have previously taken nerandomilast in another study. The aim is to assess how well patients tolerate long-term treatment with nerandomilast and to evaluate whether it improves lung function and delays worsening symptoms, hospital visits, or death. This open-label extension trial is sponsored by Boehringer Ingelheim and focuses on treatment over an extended period. Participants take nerandomilast tablets for up to 1 year and 10 months while continuing their usual pulmonary fibrosis treatments. The study involves a single treatment group receiving the drug, and no placebo or comparison groups. Regular visits with doctors help monitor health and collect data during this extended treatment phase. Throughout the study, participants undergo regular lung function tests and health assessments to track any adverse events and changes in lung capacity. The main outcome measured is the occurrence of any adverse events for up to about 99 weeks. Secondary outcomes include changes in forced vital capacity and time to worsening of disease symptoms or hospitalization. The study includes ongoing safety monitoring with a total participation time of up to nearly two years.

This research aims to better understand mitral and tricuspid valve leakage regurgitation in patients diagnosed with transthyretin amyloid cardiomyopathy ATTR-CM. It focuses on measuring how common these valve problems are, their severity, and how they affect patient outcomes. The study also seeks to create new standards for grading this leakage that fit the unique heart function changes seen in ATTR-CM, improving on current methods that do not account for this specific condition. As an observational study, it will gather detailed heart ultrasound echocardiographic data from patients with ATTR-CM, focusing on quantitative and semi-quantitative measures of mitral and tricuspid regurgitation. There are no experimental treatments instead, the study collects information to better define and predict the impact of valve leakage in this condition. The research is conducted internationally across multiple centers, starting in 2025. Participants will undergo comprehensive baseline heart ultrasound assessments within about six months of diagnosis and then be followed for up to 60 months. Researchers will track outcomes including all-cause death, cardiovascular death, and hospitalizations due to heart failure. The study involves regular clinical follow-up and data collection to analyze the relationship between valve leakage measures and patient prognosis under typical care conditions.