Terni

Researchers are creating a national registry in Italy for multiple myeloma, a type of blood cancer that makes up about 1.3% of all tumor diagnoses in men and 1.2% in women. This registry aims to track current clinical practices and describe how patients with multiple myeloma are diagnosed and treated across various hematology centers in Italy. The study also includes a patient-powered registry to encourage patient involvement and better understand treatment patterns and outcomes. The study is observational, meaning it will not involve any experimental treatments but will collect data on routine care and outcomes for patients diagnosed with active or symptomatic multiple myeloma since January 1, 2019. Both physicians and patients will contribute information to the registry, which will help monitor standard care practices nationwide. Participants will be followed to measure important outcomes such as overall survival and the time until the next treatment over a three-year period. The registry will collect data to analyze treatment approaches, patient characteristics, and survival, helping to identify changes and differences in care across Italy. Patients aged 18 years and older who can provide informed consent are eligible to participate, and there are no exclusion criteria.

Researchers are evaluating a new treatment called ifinatamab deruxtecan (I-DXd) for men with metastatic castration-resistant prostate cancer (mCRPC). This study compares I-DXd to chemotherapy to see if it helps people live longer overall and live longer without their cancer worsening. It is a Phase 3, open-label trial focused on patients who have progressed on prior therapies and have evidence of metastatic disease. Participants receive either I-DXd through an intravenous infusion every 3 weeks or docetaxel chemotherapy administered every 3 weeks. Prednisone tablets are also given daily as part of the treatment plan. Before each I-DXd dose, premedication is provided to help prevent nausea and vomiting using a combination of drugs such as corticosteroids and anti-nausea medicines. Treatment continues until disease progression, unacceptable side effects, or other reasons to stop. During the study, researchers monitor overall survival and how long patients live without their cancer progressing, for up to about 36 months. Participants undergo tumor tissue collection, scans, and assessments to track disease status and side effects. Safety is closely watched throughout treatment. The study includes men aged 18 and older with confirmed prostate cancer and metastatic disease who have previously received certain hormone therapies but no prior taxane chemotherapy for mCRPC.

Researchers are conducting a large prospective, observational cohort study to assess the clinical impact of new monoclonal antibodies (MAB) in treating B-cell Non-Hodgkin Lymphoma (NHL) within Italian clinical practice. The study focuses on patients needing treatment for B-cell NHL, including those receiving first-line or relapsed/refractory therapy. The novel MAB being studied have received approval from the European Medicines Agency (EMA) since 2020 and are prescribed according to authorized marketing indications in Italy. Participants will receive novel MAB treatments either alone or in combination, prescribed based on EMA-approved indications since 2020. Patients will be grouped into cohorts according to the treatment indication, antibody type, and lymphoma subtype, with additional sub-cohorts created if necessary. This design allows analysis by indication, antibody type, subtype, and overall evaluation of the entire patient cohort. Throughout the study, researchers will collect clinical information to evaluate the use, feasibility, efficacy, and toxicity of these novel antibodies. Key outcomes measured over at least five years include overall response rate, complete response rate, progression-free survival, overall survival, event-free survival, time to next treatment, non-relapse mortality, duration of response, and incidence of early and late adverse events. Participants will be closely monitored for both short- and long-term effects of the treatments.

Researchers are evaluating the effectiveness and safety of combining inavolisib with a cyclin-dependent kinase 4 and 6 inhibitor (CDK4/6i) and letrozole compared to placebo plus CDK4/6i and letrozole. This study focuses on participants with endocrine-sensitive PIK3CA-mutated hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer. It aims to assess treatment outcomes in the first-line setting for this specific breast cancer type. Participants will be assigned to receive either oral inavolisib once daily or a matching oral placebo once daily. All participants will also receive a CDK4/6 inhibitor on either Days 1-21 or Days 1-28 of each 28-day cycle, along with daily oral letrozole. This randomized, double-blind study will compare these two treatment combinations to monitor differences in disease progression and safety. Throughout the study, researchers will evaluate progression-free survival from the time of randomization until disease progression or death, up to 7 years. Participants will undergo assessments including tumor measurements by RECIST criteria, performance status evaluations, and monitoring of blood and organ function before treatment begins. Safety and efficacy will be closely observed during treatment, aiming to provide detailed long-term data on the study therapies.

Researchers are evaluating the drug disitamab vedotin, alone or combined with pembrolizumab, to treat urothelial cancer that expresses HER2. This cancer is locally advanced, cannot be removed by surgery, or has spread to other parts of the body. The study aims to see how well the drug works and how safe it is for participants by monitoring side effects and treatment responses. Participants will receive disitamab vedotin through an intravenous (IV) infusion every two weeks. Pembrolizumab, when given, is administered by IV on the first day of each six-week cycle. The study includes several groups, called cohorts, each with different treatment histories and eligibility criteria. Treatment and evaluation may continue for about two years. During the study, participants will have regular tests including scans to measure tumor response, lab tests, heart function checks, and monitoring for adverse events. Researchers will also track drug levels in the blood and any changes in heart function. The study will assess confirmed tumor responses and safety outcomes over approximately two years, with close monitoring to understand how participants respond to the treatments and any side effects experienced.

Researchers are evaluating the effectiveness and safety of opevesostat combined with hormone replacement therapy compared to alternative treatments with abiraterone acetate or enzalutamide in people with metastatic castration-resistant prostate cancer (mCRPC) who have already been treated with one next-generation hormonal agent. This Phase 3 study aims to determine whether opevesostat improves radiographic progression-free survival, assessed by independent central review, in participants with or without androgen receptor ligand binding domain mutations. Participants will receive either oral opevesostat along with hormone replacement therapy drugs such as dexamethasone and fludrocortisone acetate, or they will receive alternative oral treatments including abiraterone acetate with prednisone acetate or enzalutamide. Hydrocortisone can be used as a rescue drug if needed. The study is open-label and randomized, comparing these treatment strategies in participants who have progressed after prior hormonal therapy. During the study, participants will undergo assessments including imaging scans to monitor disease progression. Researchers will measure radiographic progression-free survival up to approximately 52 months. Safety and overall survival are also monitored as secondary outcomes. Participants must attend scheduled visits for evaluations, provide tumor tissue samples, and have ongoing monitoring of organ function, hormone levels, and other relevant health parameters throughout the study period.

This research aims to evaluate the long-term safety of pirtobrutinib in adults who have previously been treated for chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). It focuses on participants who completed a prior study (J2N-MC-JZNN/LOXO-BTK-20020) and offers them continued access to the study drug or follow-up visits. The study is in Phase 4 and targets assessing safety outcomes over an extended period. Participants will receive pirtobrutinib orally every four weeks. The study includes treatment administration and ongoing follow-up for about five years, allowing researchers to monitor the long-term effects of the drug. Idelalisib is also listed as an intervention but the study primarily assesses pirtobrutinib. Throughout the study, researchers will monitor participants for any treatment-emergent adverse events of grade 3 or higher from the first dose until 30 days after the last dose or start of new anticancer therapy, whichever occurs first. Participants will be regularly assessed during their visits to ensure safety and collect necessary data over the duration of the study.

Researchers are investigating the use of raludotatug deruxtecan (R-DXd) monotherapy for patients with locally advanced or metastatic solid tumors that show various levels of cadherin-6 (CDH6) expression. This includes several gynecological cancers such as endometrial cancer, cervical cancer, and non-high-grade serous ovarian cancer, as well as genitourinary cancers like urothelial cancer and clear cell renal cell carcinoma (ccRCC). The study is a phase 2, multi-center, open-label trial focusing on evaluating the treatment's effectiveness and safety. Participants will receive raludotatug deruxtecan administered intravenously every three weeks. The trial includes different cohorts based on tumor type: for most cohorts except ccRCC, the main measure is the objective response rate evaluated by investigators using RECIST 1.1 criteria. For the ccRCC group, the primary measure is disease control rate. The study also monitors safety and tolerability across all groups. Treatment and assessments will continue up to 32 months from baseline. During the study, participants will undergo regular evaluations including imaging to measure tumor response, safety monitoring for any adverse events, and collection of biopsy samples before treatment begins. Researchers will track treatment-emergent adverse events, serious adverse events, and any adverse events of special interest. The study involves close follow-up and assessments to understand both the benefit and side effects of the treatment over an extended period, with total participation lasting up to 32 months.

Researchers are evaluating repotrectinib in adults and adolescents with advanced or metastatic solid tumors that have specific gene rearrangements (ALK, ROS1, NTRK1, NTRK2, or NTRK3). The study includes a Phase 1 dose escalation to determine safe dosage levels and side effects, and a Phase 2 expansion to assess the drug's overall response rate in different patient groups. The trial also investigates the drug's effect on liver enzymes in a substudy and measures outcomes like duration of response and survival. The treatment involves oral repotrectinib capsules given to participants. Phase 1 focuses on finding the maximum tolerated dose and recommended dose for Phase 2 by monitoring toxicities within 28 days of dosing. Phase 2 enrolls subjects into six groups based on prior treatments and tumor gene status, including those who are new to ROS1 or TRK targeted therapies and those who have received previous therapies. Each group receives repotrectinib to evaluate its effects in their specific conditions. Participants will undergo assessments including tumor measurements by imaging reviewed independently, laboratory tests, and monitoring for side effects. Researchers will track dose-limiting toxicities, response rates over two to three years, and survival outcomes. Safety and tolerability are closely observed during treatment. The study requires ongoing follow-up, including confirmation of tumor gene status and evaluation of response and progression over time.

Researchers are evaluating the effectiveness and safety of the drug BMS-986365 compared to the investigator's choice of therapy in men with metastatic castration-resistant prostate cancer. This Phase 3 study aims to measure the length of time participants live without radiographic disease progression, using established criteria for bone and soft tissue cancer progression. The study focuses on patients who have already been treated with androgen receptor pathway inhibitors and have metastatic prostate cancer confirmed by imaging. Participants will be randomly assigned to receive either one of two dose levels of BMS-986365 or the investigator's choice of treatment, which may include Docetaxel plus Prednisone/Prednisolone, Abiraterone plus Prednisone/Prednisolone, or Enzalutamide. The study has two parts: initially, participants are assigned to one of three groups including two BMS-986365 doses or comparator therapy, followed by a second part where they are randomized to either the selected BMS-986365 dose or the comparator treatment. During the study, participants will be monitored for disease progression through scans and evaluations using Response Evaluation Criteria in Solid Tumors and Prostate Cancer Clinical Trials Working Group criteria, with follow-up lasting up to four years. Safety and treatment effects will be assessed regularly, and participants' symptoms and quality of life will be closely observed. This long-term follow-up helps researchers understand the treatment's impact on cancer progression and patient well-being.