Tarragona

Researchers are evaluating the recurrence-free survival of women with advanced HRD-positive high-grade ovarian cancer, fallopian tube cancer, primary peritoneal cancer, and clear cell carcinoma of the ovary after complete tumor removal. This phase II, randomized, open-label study compares two treatment strategies involving chemotherapy and maintenance therapy with niraparib. The study focuses on patients with no residual tumor mass following primary tumor debulking and aims to determine if fewer cycles of chemotherapy followed by niraparib maintenance are as effective as the standard number of chemotherapy cycles plus niraparib. Participants are randomly assigned to one of two groups: one receiving 3 cycles of carboplatin plus paclitaxel chemotherapy followed by niraparib maintenance, and the other receiving 6 cycles of carboplatin plus paclitaxel followed by niraparib maintenance. Randomization is based on genetic analysis and disease stage. Tumor assessments using CT or MRI scans will be done at defined intervals after treatment starts and during maintenance. Blood markers and safety monitoring will be conducted regularly throughout the treatment period. During the study, patients will have clinical visits every 3 weeks during chemotherapy and monthly during the first 11 months of maintenance, then quarterly thereafter. Safety is monitored continuously through adverse event reporting. The study plans to enroll 640 patients across about 60 sites in six European countries over 36 months. The primary outcome measured is recurrence-free survival over 8 years.

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study to see if it can reduce the risk of major adverse cardiovascular events (MACE-PLUS) in adults with established atherosclerotic cardiovascular disease (ASCVD) or those at high risk for a first ASCVD event. The study compares AZD0780 to a placebo and monitors participants from randomization until the primary analysis censoring date, followed by a final study closure visit. Participants will be randomly assigned to receive either oral AZD0780 or an oral placebo once daily. The treatment period lasts until the primary analysis censoring date, after which a study closure visit will occur. The study is event-driven and designed to assess the time to the first major cardiovascular event during treatment. During the study, participants will be closely monitored with various assessments to evaluate cardiovascular outcomes and safety over approximately 54 months. Researchers will track the time to first event of any component of MACE-PLUS and collect data to assess the effect of AZD0780 compared to placebo. The study includes regular visits and evaluations to ensure participant safety and adherence to treatment.

Researchers are investigating treatments for patients with hormone receptor-positive (HR-positive), HER2-negative early-stage breast cancer who are at higher risk of relapse after surgery within the last five years. This phase II, open-label study uses a biomarker-driven approach to monitor minimal residual disease (MRD) by analyzing circulating tumor DNA (ctDNA) in blood samples. The study includes a pre-screening phase, a molecular follow-up phase with ctDNA surveillance, and an interventional treatment phase, aiming to identify patients at molecular relapse and evaluate whether early treatment can improve outcomes. Participants first enter a ctDNA surveillance phase where tumor tissue and blood samples are collected to create individualized mutation panels. Blood is tested every three months during the first year and every six months thereafter. If ctDNA is detected, patients may enter one of four treatment arms: standard treatment followed by change, giredestrant alone, giredestrant combined with abemaciclib, or giredestrant combined with inavolisib. LHRH agonists are given as appropriate for men and premenopausal women. Treatment dosing and schedules are defined, including special dosing for certain kidney function levels. The study allows arm expansions based on ctDNA response criteria. Throughout the study, patients undergo regular ctDNA assessments to monitor treatment response. Safety and disease progression are tracked with scans and clinical evaluations. After treatment, a follow-up period collects survival and new therapy information every three months until study end. The primary outcome is measuring a decrease or clearance of baseline ctDNA three months after starting treatment. Total enrollment includes 976 patients for surveillance, with 40 allocated to treatment arms initially, and potential expansion based on results.

Researchers are evaluating ALE.P03 as a monotherapy in adult patients with selected advanced or metastatic Claudin-1 positive (CLDN1+) solid tumors, including cervical squamous cell carcinoma, squamous non-small-cell lung cancer, colorectal cancer, intrahepatic cholangiocarcinoma, and urothelial carcinoma. The study aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, preliminary anti-tumor activity, and to determine the recommended Phase II dose (RP2D) of ALE.P03. This is a Phase I/II, open-label, multicenter trial focusing on patients with documented disease progression and prior systemic treatments. The study includes a Phase I dose escalation to find the recommended dose for expansion (RDE) and a Phase II treatment phase using ALE.P03 administered by intravenous infusion according to assigned arms. Participants in the Phase I dose escalation must have received and be refractory or intolerant to available systemic standard-of-care regimens. In Phase I RDE and Phase II, patients should have received 1-2 systemic standard-of-care regimens and be refractory or intolerant to treatment. Those with actionable oncogenic drivers should have received feasible targeted therapy. Patients receive ALE.P03 monotherapy intravenously on the assigned schedule during the study periods. Participants will undergo various assessments including imaging to measure disease status by RECIST 1.1 criteria, evaluations of performance status, and laboratory tests to monitor bone marrow and organ function. Researchers will track adverse events, dose limiting toxicities, overall response rate, and duration of response from treatment initiation up to four years. Safety follow-up occurs about 30 days after the last dose, and long-term monitoring extends for up to four years to evaluate treatment effects and patient outcomes.

Researchers are evaluating whether the medicine tenecteplase helps adults recover from an acute ischemic stroke when given more than 4.5 hours after they were last seen well. This study focuses on people who had a stroke caused by a clot blocking blood flow in the brain and who have imaging showing brain tissue that can still be saved. Participants should not be planning to receive a procedure to remove the clot and must have a pre-stroke disability level of 0 or 1 on the modified Rankin Scale. Participants are randomly placed into two groups. One group receives a single injection of tenecteplase into a vein, while the other group receives standard medical care. The study includes adults aged 18 and over who had an acute stroke or woke up with stroke symptoms more than 4.5 hours ago. Imaging with MRI or CT is used to confirm eligibility. The study lasts about three months, starting with a hospital stay of about one week. During the study, participants have seven clinical examinations or visits to monitor their recovery and health. The last two visits may be done from home to allow remote assessments. Researchers use the modified Rankin Scale to measure disability or dependence in daily activities at 90 days after treatment. They also monitor for any side effects or health changes to compare the effects of tenecteplase against standard care.

Researchers are investigating whether using artificial intelligence (AI) to guide monitoring and timing of ovulation triggering in women undergoing ovarian stimulation for in vitro fertilization (IVF) can achieve clinical outcomes similar to those from traditional physician-led decisions. This study focuses on improving the number of mature eggs retrieved while managing clinic workload, especially by reducing weekend procedures, without compromising treatment success. AI is being explored as a tool to personalize treatment and optimize timing based on patient-specific responses, which can vary between cycles. The study compares two approaches: one where the physician makes ovulation trigger decisions based solely on clinical judgment and another where the physician uses recommendations from an AI software called STIMAI®. STIMAI® predicts the number of mature oocytes for different trigger days to assist the physician in deciding the best day for ovulation triggering. The physician retains final decision-making authority. Trigger timing is based on follicle size detected by ultrasound scans, with decisions made when 2-3 follicles reach 17 mm. Participants will be closely monitored with ultrasound scans at the study centers during their controlled ovarian stimulation cycles for IVF or fertility preservation. The primary outcome measured is the number of mature (MII) oocytes retrieved approximately 34-36 hours after ovulation trigger. The trial aims to assess if AI assistance can improve efficiency and outcomes without increasing clinical workload or compromising patient care. The study includes women aged 18 to 42 years undergoing ovarian stimulation with their own or donated eggs.

Researchers are evaluating two treatments for breast cancer patients who have a positive sentinel lymph node after receiving neoadjuvant systemic therapy. The study focuses on comparing axillary radiotherapy (ART) without lymphadenectomy to axillary lymph node dissection (ALND) to see which approach lowers the risk of lymphedema while monitoring cancer recurrence and overall survival. The trial includes patients treated with either neoadjuvant chemotherapy or hormone therapy and aims to assess quality of life alongside clinical outcomes. This is a prospective, randomized, open-label, multicenter study involving about 820 patients divided evenly between chemotherapy and hormone therapy groups. Participants will receive either ART targeting axillary levels I and II plus level III, supraclavicular, and possibly the internal mammary chain, or undergo ALND followed by radiotherapy to level III, supraclavicular, and possibly the internal mammary chain. A pilot phase with the first 200 patients has been completed, and an interim analysis will be conducted on this group. During the study, researchers will track disease-free survival over up to five years from diagnosis, noting any recurrence or death. Patients will undergo imaging assessments such as ultrasound or MRI to evaluate axillary response after treatment. Quality of life and side effects like lymphedema will also be measured. Follow-up will include monitoring overall survival and recurrence, ensuring comprehensive evaluation of both treatment safety and effectiveness.

Researchers are evaluating the use, benefits, and safety of cemiplimab-based treatment regimens for adults with advanced non-small cell lung cancer (NSCLC). This observational study focuses on patients prescribed cemiplimab as part of routine care in Europe. The study aims to gather real-world information on how cemiplimab is used and how it affects patient outcomes. Participants receive cemiplimab, given by intravenous infusion, often combined with platinum-based chemotherapy, also administered intravenously. Data collection occurs during regular clinical visits approximately every three months while patients are on cemiplimab treatment. After treatment ends, follow-up visits occur about every six months for up to two years. The recruitment phase will last 48 months. Participants will be followed from the start of cemiplimab treatment until death, loss to follow-up, withdrawal, or up to 72 months after the study begins. During the study, researchers will collect information from routine visits and questionnaires. The primary outcome measured is overall survival up to 72 months. Safety and effectiveness of the treatment regimen will be monitored throughout the study period.

Researchers are evaluating whether ziltivekimab can help people who were hospitalized due to a heart attack by potentially reducing the development of heart disease and preventing new heart attacks or strokes. This Phase 3 study compares ziltivekimab with a placebo, which is a dummy medicine that has no effect on the body. Both treatments are given by chance, with equal likelihood for participants to receive either ziltivekimab or placebo. Participants will inject the study medicine once a month under the skin in the stomach, thigh, or upper arm. Ziltivekimab is given as an initial loading dose followed by monthly maintenance doses. The placebo group receives a matching injection schedule. The study duration is about two years. During the study, researchers will monitor participants for the time until the first serious heart-related event, including cardiovascular death, non-fatal heart attack, or non-fatal stroke. Participants will be closely observed from the start of randomization up to 25 months. The study includes regular follow-ups to assess safety and effectiveness of the treatments throughout this period.

Researchers are investigating sovateltide, a new drug that targets ETB receptors, for treating acute cerebral ischemic stroke (ACIS), a condition caused by a blocked blood vessel in the brain leading to brain tissue damage. ACIS is the most common type of stroke and a serious emergency with limited treatment options. Current standard treatment with tissue plasminogen activator (t-PA) has a narrow time window and limited success in fully resolving stroke effects. Sovateltide has shown promise in animal studies and early human trials by promoting brain repair and improving neurological outcomes. The study compares sovateltide treatment alongside standard care to a placebo (normal saline) in patients who recently experienced ACIS. Participants will receive the study drug within 24 hours of stroke symptom onset. This phase III trial is randomized, double-blind, and placebo-controlled, conducted across multiple centers in the United States, Canada, the United Kingdom, and Europe. The trial builds on positive results from earlier phase II and III studies conducted in India. Participants will be followed for 90 days after treatment to assess recovery using scales that measure disability and neurological function. Researchers will monitor safety and effectiveness by evaluating participants' abilities and stroke outcomes, including the modified Rankin Scale score. The trial aims to provide further evidence on whether sovateltide can improve recovery and function after acute ischemic stroke when added to standard treatment.