Campo Grande

This trial investigates the safety and effectiveness of rilvegostomig combined with fluoropyrimidine and trastuzumab deruxtecan (T-DXd) compared to trastuzumab, chemotherapy, and pembrolizumab in adults with HER2-positive locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 with a combined positive score of 1 or higher. Additionally, rilvegostomig combined with trastuzumab and chemotherapy is studied separately to understand each component's contribution. This Phase 2, randomized, open-label, global study is conducted at 200-250 sites in about 25 countries. Participants are randomly assigned to one of three arms: Arm A receives rilvegostomig, fluoropyrimidine, and T-DXd; Arm B receives trastuzumab, chemotherapy, and pembrolizumab; Arm C receives rilvegostomig, trastuzumab, and chemotherapy. Treatments are administered mostly by intravenous infusion every three weeks, with capecitabine given orally twice daily. The study compares these treatment regimens to evaluate their effects on the cancer. Throughout the study, participants undergo assessments including tumor measurements, organ function tests, and heart function evaluation to ensure safety and monitor disease progression. The main outcomes measured are progression-free survival and overall survival for up to approximately six years. Researchers will also monitor adverse events and overall health status during and after treatment.

Researchers are studying whether baricitinib can help preserve beta-cell function in children and adults newly diagnosed with type 1 diabetes. This Phase 3 trial focuses on participants aged 1 to less than 36 years who have recently been diagnosed with this condition. The goal is to understand if baricitinib, compared to a placebo, can maintain insulin-producing cell activity. Participants will be randomly assigned to receive either baricitinib or a placebo, both given orally. The study is double-blind, meaning neither participants nor researchers know who receives the active drug or placebo. Treatment and observation will continue for about 60 weeks. During the study, participants will undergo evaluations including measuring C-peptide levels to assess beta-cell function at the start and after 52 weeks. Researchers will monitor health status, collect laboratory tests, and track any side effects or changes in diabetes-related markers to determine the effects of baricitinib over the study period.

Researchers are evaluating the effects of the drug orforglipron compared with a placebo on cardiovascular outcomes in adults who have atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease (CKD). This is a Phase 3, randomized, double-blind, placebo-controlled study designed to investigate major adverse cardiovascular events over a long period. Participants will receive either orforglipron or a placebo orally. The study is event-driven and will continue until the occurrence of major cardiovascular events or up to about 5 years. The treatments are administered without revealing to participants which group they are in to ensure unbiased results. During the study, participants will be monitored for the time to the first occurrence of a major cardiovascular event. Researchers will collect data from baseline through the end of the study, which lasts approximately 5 years. Regular assessments will help evaluate the safety and effects of the treatments on cardiovascular health in this population.

Researchers are investigating the use of biperiden to prevent post traumatic epilepsy (PTE), a common neurological complication following moderate to severe traumatic brain injury (TBI). PTE accounts for 5% of all epilepsy cases and often develops within two years after injury. Currently, no effective treatment exists to reduce the risk of PTE. Previous animal studies suggest biperiden may lower both the occurrence and severity of epileptic seizures and delay their onset, making it a promising candidate for preventing PTE. Participants will be randomly assigned to receive either 5 mg of biperiden diluted in saline or a placebo infusion every 6 hours for 10 consecutive days starting within 18 hours after their brain injury. The treatment is given intravenously. The study will follow patients for two years, with periodic visits to monitor the development of epileptic seizures and assess other factors such as brain activity abnormalities, genetic markers, and cognitive function. The study also aims to evaluate any side effects of biperiden at these doses and its cost-effectiveness in the healthcare system. Throughout the study, patients will undergo brain scans, clinical evaluations, and neuropsychological assessments. Researchers will track the incidence of PTE and record any severe adverse events over 24 months. Monitoring will include evaluating treatment safety and effectiveness, alongside measuring quality of life and other health outcomes. The total participation time for each patient is two years, allowing for comprehensive observation of long-term effects and epilepsy prevention.

Researchers are evaluating maridebart cafraglutide, a drug given as an addition to standard care, to see if it reduces heart-related problems and deaths better than a placebo in people with atherosclerotic cardiovascular disease who are overweight or obese. This phase 3 study focuses on cardiovascular events such as heart attacks, strokes, and deaths related to heart conditions, aiming to improve outcomes in this high-risk population. Participants will receive either maridebart cafraglutide or a placebo, both administered by injection under the skin. The study compares these two groups over a period of up to approximately 35 months, monitoring heart-related health events to assess the drug's impact. The placebo group will receive injections that look identical but contain no active drug, ensuring a double-blind study design. During the study, participants will be regularly evaluated for major cardiovascular events, including heart attack, stroke, heart failure, and death. Researchers will track the time until these events occur to measure the drug's effectiveness. Safety and health will be closely monitored throughout the study period, and participants will be followed for up to nearly three years to gather comprehensive data on cardiovascular outcomes and overall survival.

Researchers are investigating breast and prostate cancer in patients treated through the Brazilian Unified Health System. The study focuses on understanding molecular changes in tumors, including genetic mutations that arise during cancer development, which can influence treatment responses and disease outcomes. It also aims to identify hereditary genetic syndromes to improve cancer follow-up and risk prediction. This effort supports the Brazilian Ministry of Health's National Precision Genomics and Health Program, Genomas Brasil, while collecting data on the population's ancestry. The project involves detailed genetic testing using whole exome and whole genome sequencing. For prostate and HER2-positive breast cancer, both somatic and germline whole exome sequencing will be conducted. For triple-negative breast cancer, somatic whole exome and germline whole genome sequencing will be analyzed. These tests are performed on tumor tissue and blood samples to map genetic variations linked to these cancers. Participants will provide tumor tissue and blood samples for genetic analysis. The study will characterize the complete somatic and germline exomes and genomes over a 12-month period. Researchers will collect clinical and genomic data to better understand cancer genetics and ancestry. Consent is required before inclusion, and the study monitors the genetic profiles of breast and prostate cancer patients to support precision medicine efforts in Brazil.

Researchers are evaluating whether intravenous Tenecteplase (TNK) is better than placebo for patients who have a non-large vessel occlusion ischemic stroke occurring between 4.5 and 12 hours from when they were last seen well. This phase III, multi-center, randomized, double-blind trial focuses on patients showing a clinical-radiological mismatch or evidence of salvageable brain tissue on perfusion imaging, aiming to improve functional outcomes measured at 90 days after treatment. Participants will be randomly assigned in a 1:1 ratio to receive either intravenous TNK at a dose of 0.25 mg/kg (maximum 25 mg) given as a bolus over 5 seconds, or a matching placebo. Randomization accounts for age, stroke severity, therapeutic window, and clinical site. The trial plans to enroll a total of 466 participants, with interim analyses to monitor efficacy and safety. During the study, participants will be followed for 90 days after randomization. Researchers will assess functional outcomes using the modified Rankin Scale adjusted for baseline stroke severity and neurological status. Imaging such as CT or MRI scans and clinical evaluations will be used to confirm eligibility and monitor progress. Safety and efficacy data will be collected throughout the study period.

Researchers are evaluating the effectiveness of perioperative dostarlimab compared to the standard of care in adults with untreated T4N0 or Stage III resectable colon cancer that shows defective mismatch repair or high microsatellite instability. This is a Phase 3, open-label, randomized study aiming to improve treatment outcomes for this specific type of colon cancer. Participants will receive either dostarlimab alone or standard chemotherapy regimens such as CAPEOX or FOLFOX. The treatments are given around the time of surgery (perioperative) to address the cancer before and after surgical removal. The study compares the new treatment approach with the current standard therapies to see which is more effective and safe. During the study, participants will be monitored for up to approximately 5 years to assess event-free survival, meaning the length of time they remain free from cancer recurrence or other related events. Researchers will perform regular evaluations, including imaging and clinical assessments, to track the participant’s progress and treatment response. Safety and side effects will also be closely observed throughout the study duration.

Researchers are conducting a prospective, observational, multicenter cohort study to evaluate patients with severe and very severe Chronic Obstructive Pulmonary Disease (COPD) in Brazil. The study focuses on patients classified by the GOLD 2024 guidelines, aiming to understand the relationship between COPD severity, exacerbation rates, disease progression, complications, and mortality. This research addresses the lack of national data on this specific subgroup of COPD patients in Brazil, considering regional differences in risk factors, population, and genetics. The study will include multiple medical centers across all five regions of Brazil, representing diverse environments with varying exposure to tobacco smoke, biomass burning, and pollution. Patients will be enrolled consecutively and followed over 12 months. Visits will occur on-site at the start, 6 months, and 12 months, with additional tele-consults at 3 and 9 months to collect clinical data, especially regarding exacerbations. Data collection will be managed locally at each site and reviewed by the ARO Team. Participants will undergo clinical assessments during on-site and remote visits, including spirometry and symptom evaluations with tests like the COPD Assessment Test (CAT) or Chronic Airway Assessment Test (CAAT). The study will monitor the incidence of hospitalizations, exacerbations, and mortality throughout the follow-up period. This comprehensive monitoring will help characterize the disease course and outcomes among severe COPD patients in different Brazilian regions over approximately one year.

Researchers are evaluating the effect of abelacimab compared to a placebo in patients with atrial fibrillation (AF) who are considered unsuitable for oral anticoagulation therapy. This study focuses on people at high risk for ischemic stroke or systemic embolism and aims to assess the safety and effectiveness of abelacimab in preventing these events. The study is a Phase 3, multicenter, randomized, double-blind, placebo-controlled trial involving patients with AF who have specific risk factors and treatment challenges. Participants will receive either abelacimab, provided as a liquid in vials at 150 mg/mL, or a matching placebo liquid. The study design includes parallel groups with blinded treatment assignment. The trial does not describe additional treatment phases or extensions but focuses on the comparison of abelacimab and placebo over the study duration. During the study, participants will be monitored for up to 30 months to measure the time until the first occurrence of ischemic stroke or systemic embolism, as well as the time until the first occurrence of serious bleeding as defined by the Bleeding Academic Research Consortium (BARC) type 3c/5 bleeding. Safety and efficacy will be closely evaluated, with ongoing assessments to track these outcomes throughout the follow-up period.