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Researchers are evaluating whether combining pasritamig with docetaxel can extend the time before prostate cancer worsens in men with metastatic castration-resistant prostate cancer mCRPC, a type of prostate cancer that continues to grow despite low hormone levels. This Phase 3 study compares pasritamig plus docetaxel against docetaxel alone to see if the combination improves radiographic progression-free survival rPFS, which is the time until disease progression or death as seen on scans. Participants are randomly assigned to receive either pasritamig together with docetaxel or docetaxel plus prednisoneprednisolone as background medication. Treatment continues until disease progression is confirmed by scans or other criteria are met. The study is open-label, meaning both participants and researchers know which treatment is given. During the trial, participants will have regular scans such as CT, MRI, or bone scans to monitor disease progression, assessed by independent review. Researchers will also evaluate overall survival, symptom progression, response rates, prostate-specific antigen PSA levels, quality of life measures, and safety by tracking adverse events and lab results. The study may last up to approximately 4 years and 5 months, with frequent assessments throughout.

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.

The registry focuses on patients with venous thromboembolism VTE, including those often excluded from typical clinical trials such as pregnant women, elderly patients, and those with serious health conditions. It aims to improve medical knowledge and patient care by collecting detailed data on these patients clinical status and treatment outcomes. The project also seeks to develop predictive scores to identify patients at higher risk of complications from thromboembolic disease. This observational registry collects extensive information on patients diagnosed with VTE, including details on coexisting conditions, antithrombotic treatment type, dose, and duration, as well as outcomes during the first three months of therapy. It captures data on VTE recurrences, bleeding complications, and deaths, providing insights into real-world treatment and patient management. Participants provide informed consent and are followed for at least three months to monitor clinical outcomes. The registry supports physicians by giving access to data on patients with similar profiles to help manage complex cases. The main outcomes measured include VTE events and complications over a three-year period, supporting ongoing improvements in patient care and risk assessment.

Researchers are developing and validating a language model called eCREAMLM designed to interpret emergency department electronic health records EHRs from adult patients treated between 2021 and 2023. This observational, retrospective study aims to see if the language model can accurately extract relevant information from free-text medical notes for research and clinical analysis across six languages. The study involves multiple centers across several European countries and addresses challenges in emergency medicine research due to high patient volume and limited staff for data collection. The eCREAMLM model will be created by training and fine-tuning existing open-source language models on billions of medical texts and millions of free-text notes from hospital records. Expert physicians will annotate thousands of clinical notes to guide the fine-tuning process. Once developed, the models accuracy will be validated by comparing its data extraction against physician annotations in 1,000 clinical notes. Data will be anonymized and pooled by language to protect patient privacy. Participants contribute by having their anonymized emergency department medical notes included in the study database. The researchers will analyze how well the language model fills out a virtual case report form compared to experts, using statistical measures of agreement. This process requires no active participation from patients. The study is expected to run until September 2027, with outcomes measured at one month after validation starts.

The trial investigates the efficacy and safety of TYRA-300 in adults with FGFR3 altered low-grade, intermediate-risk non-muscle invasive bladder cancer NMIBC. This Phase 2, multicenter, open-label study focuses on participants with specific tumor characteristics confirmed by diagnostic biopsy and who meet intermediate risk criteria according to updated guidelines. The study is designed to evaluate a new oral treatment option for this condition, providing important insights into its potential role in managing this cancer type. Participants receive TYRA-300 as a self-administered oral tablet daily in one of several dose groups 60 mg, 50 mg, or a dose to be determined. The study is randomized and open-label, with participants assigned to different dose cohorts to assess treatment effects. The treatment period and dose details are structured to monitor safety and response over time, allowing evaluation of how well the drug works in this patient group. Throughout the study, participants are monitored for efficacy and safety outcomes, including disease response at 3 months, duration and timing of any recurrence, recurrence-free survival at 12 and 24 months, and progression-free survival. Safety is assessed through adverse event monitoring up to 2 years. Participants undergo various clinical evaluations, including tumor assessments and laboratory tests, to track treatment effects and health status. The total study duration extends to September 2028, with ongoing follow-up to capture long-term outcomes and tolerability.

Researchers are evaluating the time to clinical liver decompensation, quality of life, effectiveness, and safety of the combination of tremelimumab plus durvalumab, known as STRIDE, in patients with advanced or unresectable hepatocellular carcinoma HCC who have not received any prior systemic treatment. This observational Italian multicenter study focuses on real-world patients with advanced or unresectable HCC to better understand the impact of STRIDE in routine clinical practice. Participants in this study receive a single dose of tremelimumab 300 mg combined with durvalumab 1500 mg on the first day of treatment cycle, followed by durvalumab alone every 4 weeks. The treatment is given according to routine clinical care in Italy, and patients are observed over time to collect data on outcomes and safety. During the study, participants will be monitored up to 30 months for various outcomes including time to first hepatic decompensation, time to disease worsening, overall survival, progression-free survival, tumor response rates, disease control, and safety. Assessments include clinical evaluations and data collection at baseline and regular intervals during treatment. The study aims to provide detailed information on how patients respond and tolerate STRIDE in everyday clinical settings.

Researchers are conducting a multicenter, observational study in Italy to collect detailed information on patients with bone metastases. The study aims to establish a national database to better understand clinical and biological factors related to primary tumors and their bone metastases. This research will also evaluate the impact of treatments and care pathways on skeletal events over a period of up to 15 years. Patients with bone metastases from solid tumors will be enrolled in this study and registered in a specialized online database. Each participant will be followed from enrollment until death or until they stop follow-up for other reasons. The study does not involve any experimental treatments but collects comprehensive data on patients conditions and care. Participants will provide informed consent and their medical data will be regularly recorded and analyzed. The study monitors clinical outcomes, skeletal-related events, and the efficiency of treatment pathways. Data collection will continue for up to 15 years, providing long-term insights into bone metastases and patient management.

Researchers are evaluating whether valproic acid can improve the effectiveness of anti-EGFR treatments and help prevent or reverse resistance in patients with advanced or metastatic colorectal cancer who have RASBRAF wild-type tumors. This randomized phase 2 study includes patients eligible for a rechallenge treatment setting, aiming to better understand tumor responses and identify biomarkers through tissue and blood sample analysis. Participants will be randomly assigned to receive either standard treatment with irinotecan and panitumumab or the same treatment combined with valproic acid VPA. Irinotecan and panitumumab are given every two weeks, while VPA is taken orally daily with dose adjustments to reach target blood levels. The study includes a safety phase for the VPA combination, and treatment continues until disease progression, unacceptable side effects, or other reasons for stopping. Throughout the study, patients will undergo tumor assessments by CT or MRI scans every 8 weeks, blood tests, and quality of life questionnaires. Toxicities will be monitored during treatment and up to 4 weeks after. Blood and tissue samples will be collected to study biomarkers related to treatment response and side effects. Follow-up will continue until death, recording subsequent treatments, with the primary outcome measuring progression-free survival at 16 weeks.