Elyria

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 evaluating how well proton beam radiation therapy compares with intensity modulated photon radiotherapy in treating patients with stage I to IVA esophageal cancer. This phase III trial aims to determine if proton beam therapy can improve overall survival and reduce serious heart and lung side effects compared to photon therapy. The study also looks at symptom impact, quality of life, treatment costs, response rates, and hospitalization length between the two treatments. Participants are randomly assigned to receive either proton beam therapy or intensity modulated photon therapy, both given in 28 sessions over 5.5 weeks alongside chemotherapy. Chemotherapy options include carboplatin/paclitaxel, FOLFOX/CAPOX, or docetaxel/fluorouracil regimens, selected by the patient and physician. After completing chemoradiation, patients may have surgery to remove the tumor if it is safe and feasible. During the study, blood samples and imaging scans such as PET/CT or CT are collected to monitor progress. Patients are followed every 3 to 6 months for three years and then yearly to track survival, side effects, and disease status. Researchers also assess patient-reported symptoms and quality of life. The main outcomes measured are overall survival and the occurrence of serious heart and lung side effects related to treatment over up to eight years. Additional assessments include immune cell levels, disease recurrence, and treatment toxicity.

Researchers are evaluating how well radiation therapy works compared to observation in patients with newly diagnosed grade II meningioma that has been completely removed by surgery. This phase III trial aims to determine the clinical benefit of adding radiotherapy after gross total resection of the tumor, while also assessing overall survival, disease-specific survival, side effects, cognitive function, patient-reported outcomes, and biomarker validation. Participants are randomly placed into one of two groups: the first group undergoes observation with regular MRI scans and blood collections, while the second group receives intensity-modulated radiation therapy or proton beam radiation therapy five days a week for about 6.5 to 7 weeks. Treatment continues up to a total of 33 radiation sessions unless the disease progresses or unacceptable side effects occur. Both groups are monitored with imaging and blood samples throughout the study. After treatment, participants are followed up at 3, 6, and 12 months, then every six months for the second and third years, and yearly up to 10 years. Researchers measure progression-free survival from randomization until disease progression or death. The study also collects tissue and specimen samples for future research and monitors patients for side effects and quality of life over the long term.

Researchers are evaluating the effectiveness of radiation therapy with or without the chemotherapy drug cisplatin in patients with stage III-IVA squamous cell carcinoma of the head and neck who have had surgery to remove their tumors. This phase II trial aims to understand if adding cisplatin to radiation therapy improves disease-free survival, especially considering the role of p53 mutations in the cancer cells. The study also investigates toxicities and potential genomic factors that might influence treatment outcomes. Patients are randomly assigned to one of two treatment groups. One group receives intensity-modulated radiation therapy (IMRT) alone once daily, five days a week for six weeks. The other group receives the same radiation treatment combined with weekly intravenous cisplatin over one to two hours, also for six weeks. Treatment continues as long as there is no disease progression or unacceptable side effects. During the study, participants undergo regular follow-ups every six months for three years and then yearly for seven more years to monitor for cancer recurrence or new tumors. Researchers assess disease-free survival, tracking the time from randomization until cancer returns, a second tumor develops, or death. Additional laboratory tests and biomarker analyses are performed to understand genetic changes and treatment effects. Safety and toxicities are closely monitored throughout the study period.

This research aims to compare the effects of usual care including regional radiation therapy with no regional radiation therapy in women with low-risk breast cancer. It focuses on patients with node positive breast cancer or T3N0 disease who typically receive endocrine therapy and possibly chemotherapy to prevent cancer recurrence. The study examines whether skipping regional radiotherapy still effectively prevents breast cancer from returning, potentially reducing unnecessary treatment and side effects. Participants will be divided into two groups: one receiving radiotherapy to the breast/chest area and surrounding lymph nodes, and the other receiving no regional radiotherapy. The study evaluates standard treatments, ensuring radiation therapy starts within specific time frames after surgery or chemotherapy. Treatments include breast-conserving surgery or mastectomy, along with endocrine therapy planned for at least five years. During the study, researchers will monitor breast cancer recurrence-free intervals over approximately 9.5 years. Participants will undergo regular assessments to track cancer status, side effects, and overall health. The study includes quality of life questionnaires for some patients and requires ongoing follow-up to document treatment effects, adverse events, and long-term outcomes.

Researchers are studying patients with metastatic HER-2-positive breast cancer who are receiving trastuzumab-based treatments to understand the risk of heart problems related to their cancer therapy. The study includes two groups: one large observational group of patients already taking beta blockers, ACE inhibitors, or ARBs alongside their cancer treatment, and a smaller randomized group comparing patients who receive carvedilol, a heart medication, to those who do not. The trial aims to assess how often heart issues occur and whether carvedilol can help prevent heart damage from chemotherapy. It also investigates biomarkers and heart function measures as predictors of cardiac risk. In the randomized part, patients not already on beta blockers, ACE inhibitors, or ARBs are assigned to receive carvedilol twice daily or no additional treatment for up to 108 weeks, with treatment cycles repeated every 12 weeks if there is no disease progression or unacceptable side effects. Patients already taking these heart medications join the observational cohort and are monitored for up to 108 weeks without any change in their therapy. The study collects blood samples and performs regular heart imaging to evaluate heart function and strain. Participants will have regular echocardiograms every 12 weeks to monitor heart function, with both local and central readings compared. Blood samples are collected for biomarker analysis, and patient health status is assessed throughout the study. The main outcome measured is the time until any heart dysfunction is first detected, followed for up to 108 weeks. The study also tracks interruptions in cancer therapy due to heart problems and explores genetic and plasma markers that might predict heart risk. Participants are followed closely for safety and treatment effects during the entire study period.

Researchers are evaluating the effectiveness of radiation therapy combined with chemotherapy and immunotherapy in patients with high-risk stage III-IV squamous cell carcinoma of the head and neck that is HPV-negative. The study aims to compare the usual treatment of radiation therapy with cisplatin chemotherapy against two experimental approaches: radiation with docetaxel and cetuximab chemotherapy, and the usual treatment plus the immunotherapy drug atezolizumab. This phase II/III trial focuses on improving disease-free and overall survival in this patient population. Participants are randomly assigned to one of three treatment groups. One group receives intensity-modulated radiation therapy (IMRT) with weekly cisplatin for 6 weeks. Another group receives IMRT with weekly docetaxel and cetuximab. The third group receives IMRT with weekly cisplatin plus atezolizumab administered intravenously every 3 weeks starting one week before radiation, for up to eight doses. Treatments are given in the absence of disease progression or unacceptable side effects. Throughout the study, patients undergo blood sample collection and may have CT scans, MRI, and biopsies as needed. Follow-up visits occur at 1 and 3 months post-treatment, then every 3 months for 2 years, every 6 months for 3 years, and annually thereafter. Researchers measure disease-free survival up to 7 years, overall survival up to 7 years, symptom burden, quality of life, and treatment-related toxicities. Blood and tissue specimens are collected for future research.