Viterbo

This research evaluates whether adding axitinib to nivolumab maintenance treatment after initial therapy with nivolumab plus ipilimumab can improve response rates in patients with metastatic renal cell carcinoma mRCC who have not achieved a complete response or experienced disease progression. The study is a phase II, open-label trial that aims to increase partial response rates based on prior trial results. Participants are randomly assigned to one of two groups one group receives axitinib 5 mg twice daily orally in addition to nivolumab 480 mg intravenously every four weeks, while the other group continues with nivolumab alone at the same dose and schedule. Treatment continues until disease progression, unacceptable side effects, patient withdrawal, or physician decision. The trial plans to enroll 118 patients to detect meaningful differences between groups. Throughout the study, participants will be closely monitored with tumor assessments and health evaluations to measure outcomes such as progression-free survival, overall survival, depth and duration of response, and treatment-related adverse events. Follow-up includes tracking health status and life status from enrollment through treatment and up to 100 days after the last dose. The study is sponsored by Consorzio Oncotech and started in April 2023, with an estimated end date in April 2027.

Researchers are studying patients with Philadelphia chromosome-negative Myeloproliferative Neoplasms MPN Ph negative to observe inflammatory biomarkers and track their changes over the course of the disease. The study aims to find links between these biomarkers and important disease outcomes such as blood clots, bleeding events, and progression to more severe disease stages like accelerated or blast phases. This observational study is designed to improve risk assessment for patients with these blood disorders. This study is observational and does not involve experimental treatments. It gathers data on inflammatory markers and clinical events in patients diagnosed with types of MPN including polycythemia vera, essential thrombocythemia, primary myelofibrosis, and post-PV or post-ET myelofibrosis. The study collects information retrospectively and prospectively from medical records and laboratory tests over a period of up to 60 months 5 years. Participants will be monitored through routine blood counts with white cell formulas to calculate inflammatory ratios, along with tracking arterial and venous thrombotic events. The study also measures conventional and new inflammatory biomarkers, time to thrombo-hemorrhagic events, survival status, and disease progression to fibrotic, accelerated, or leukemic phases. The total observation period is planned for 60 months, and participants provide informed consent to share their data for this research.

Researchers are studying patients with early breast cancer, focusing on those with HER2-positive and Triple Negative tumors who have received neoadjuvant treatment in the past five years. The study aims to understand the percentage of such patients among all who underwent neoadjuvant treatment, along with analyzing treatment choices, tumor characteristics, responses to therapy, surgical procedures, and survival outcomes based on molecular subtypes and initial cancer staging. This observational study reviews clinical data collected from multiple oncology centers in Italy. It examines neoadjuvant treatments given before surgery, the radiological responses assessed by breast MRI, ultrasound, or mammography, and the surgical methods used on the breast and axilla. The study also looks at adjuvant therapies after surgery and tracks changes in eligibility criteria for neoadjuvant treatments over the last five years. Participants medical records will be evaluated to capture information on tumor pathology, treatment responses, and survival rates including disease-free and overall survival. The primary measurement is the percentage of HER2-positive and Triple Negative patients treated neoadjuvantly during the defined period. Secondary analyses include treatment patterns, pathological and radiological responses, surgical details, and correlations between complete pathological response and survival outcomes. The study spans five years of retrospective data and is led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.

The trial investigates treatment options for adults aged 18 to 70 with newly diagnosed higher-risk myelodysplastic syndromes HR-MDS, focusing on the feasibility of allogeneic stem cell transplantation HSCT. It compares upfront HSCT with pre-treatment using azacitidine or conventional chemotherapy based on the patients bone marrow blast counts. This phase III, open-label, randomized multicenter study aims to determine whether pre-transplant treatments affect the ability to proceed with HSCT. Participants are assigned to groups depending on their bone marrow blast levels. Those with 10% or more blasts receive either conventional chemotherapy following a 37 protocol or azacitidine given subcutaneously at 75 mgm2 daily for 7 days every 28 days for at least 4 cycles before HSCT if a suitable donor is available. Patients with less than 10% blasts may receive upfront HSCT or azacitidine prior to HSCT under similar dosing schedules. The study evaluates these different sequences of therapy to assess HSCT feasibility. During the study, participants undergo regular assessments over four years to monitor whether they proceed to HSCT. Researchers track treatment outcomes, safety, and overall feasibility by measuring the proportion of randomized patients who receive the transplantation. The trial includes follow-up for at least four years to collect data on these outcomes and ensure participant safety and treatment adherence throughout the process.

Researchers are evaluating the addition of Atezolizumab to a chemotherapy regimen called FOLFOXIRI plus Bevacizumab as the first treatment for patients with metastatic colorectal cancer that has proficient mismatch repair pMMR and high Immunoscore IC. This phase III, open-label, randomized trial aims to compare how well this combination works in delaying cancer progression, known as Progression Free Survival PFS. Participants will be randomly assigned to one of two groups. One group receives FOLFOXIRI plus Bevacizumab treatment every two weeks for up to 8 cycles, followed by maintenance therapy with 5-FULV plus Bevacizumab until cancer progresses or side effects become unacceptable. The other group receives the same treatment plus Atezolizumab, with a similar schedule and maintenance phase including Atezolizumab. Treatments involve intravenous infusions of multiple drugs, and dosing times vary from 30 minutes to several hours depending on the drug and cycle number. During the study, participants will undergo regular assessments including tumor measurements, quality of life questionnaires, and monitoring for side effects. Researchers will track outcomes such as cancer response rates, toxicity, overall survival, and quality of life over periods up to 48 months. The study includes safety monitoring and follow-up until disease progression, unacceptable toxicity, or patient choice to stop treatment.

Researchers are evaluating the use of HIV pre-exposure prophylaxis PrEP in Italy to prevent new HIV infections. The study aims to understand how effective and tolerable PrEP is, how well people stick with it, and what barriers exist to its long-term use. It is an observational study coordinated by Fondazione ICONA, including about 5,000 HIV-negative adults who are either starting or continuing PrEP. Participants are followed in 49 hospital and university infectious disease clinics and 4 community-based checkpoints across Italy. They attend routine clinical visits every 3 to 5 months, where they undergo HIV and STI testing, safety laboratory tests, and complete electronic questionnaires via a mobile app. The study collects data on demographics, clinical status, behavior, and quality of life to monitor HIV seroconversion rates and other outcomes. During the study, participants will be monitored for new HIV infections, side effects related to PrEP, adherence to treatment, and behavioral factors affecting persistence in care. Data are securely collected and managed in an electronic case report form. The study will run for at least 10 years, with regular follow-up visits to ensure ongoing assessment of PrEPs real-world use and impact.

This research aims to understand how clinical and laboratory features of myelofibrosis affect patients long-term survival when treated with ruxolitinib. It focuses on adults diagnosed with primary myelofibrosis or secondary myelofibrosis related to essential thrombocythemia or polycythemia vera. The study is observational, involving multiple centers, and includes both retrospective and prospective patient groups. Participants are those who have started ruxolitinib treatment as part of their usual care, without influence from the study itself. The study collects data from laboratory tests, histological, cytogenetic, molecular, and radiologic exams done during routine care. Information on symptoms and spleen enlargement is gathered at diagnosis and during regular disease assessments. Each patient is observed for a minimum of three months, with the overall study lasting up to ten years. During the study, researchers collect and review medical records, test results, and imaging done in normal clinical practice to analyze outcomes such as long-term survival. They also evaluate factors like peripheral blood blasts, specific genetic mutations, and adverse events related to treatment. The study aims to validate prognostic tools and monitor safety over a long period, ensuring participants receive their standard medical care throughout.