Plant City

Researchers are evaluating the effectiveness and safety of subcutaneous anifrolumab compared with a placebo in adults with moderate to severe Idiopathic Inflammatory Myopathies IIM, including polymyositis PM and dermatomyositis DM. This phase III, multicenter, randomized, placebo-controlled, and double-blind study aims to assess how adding anifrolumab to standard care affects overall disease activity in these patients. Participants will receive either anifrolumab or a matching placebo as a subcutaneous injection once a week for 52 weeks, alongside their standard of care treatments. After this initial period, all participants will be offered open-label anifrolumab once weekly for an additional 52 weeks, allowing further evaluation of long-term treatment effects. During the study, participants will be monitored through various assessments including muscle strength tests, disease activity scores, corticosteroid usage, and skin severity indexes over 52 weeks. The main outcome measure is the Total Improvement Score response at 52 weeks. Safety and disease activity will be carefully tracked throughout the treatment and follow-up periods, with study participation potentially lasting up to two years.

Researchers are studying adults newly diagnosed with breast, colorectal, melanoma, non-Hodgkin lymphoma, or non-small cell lung cancer who are planning to receive systemic cancer therapies such as chemotherapy and immune checkpoint inhibitors ICIs. The study aims to understand how cannabis and cannabinoid use relates to cancer-related symptoms over one year. This observational research includes patients treated in community oncology clinics and is sponsored by Wake Forest University Health Sciences. Participants complete surveys and allow medical record reviews throughout the study. The study tracks cannabis and cannabinoid use as well as perceived benefits, harms, and adverse effects monthly for 12 months following enrollment. An optional sub-study is available at select sites for patients with non-small cell lung cancer receiving specific chemotherapy with ICIs. During the study, participants fill out monthly surveys about their symptoms and cannabis use. Researchers also review medical records to assess cancer-related symptoms and treatment progress. The main measure is cancer-related symptoms assessed monthly for up to one year. Secondary measures include cannabis use patterns and adverse effects. Participation involves ongoing survey completion and record review, with the total study duration lasting 12 months post-enrollment.

Researchers are collecting blood and tissue samples from people with and without cancer to help evaluate new tests that could detect cancer early. This study aims to create a set of blinded blood samples from both cancer and non-cancer patients to validate these tests, focusing on multiple cancer types and stages. The goal is to improve early cancer detection through laboratory research. Participants complete a questionnaire at the start and provide blood samples at registration and again 12 months later. Those diagnosed with cancer may also have tissue samples collected at these times. The study includes patients with various cancer types and stages, as well as individuals without cancer, with some allowing enrollment before full cancer confirmation under specific conditions. During the study, researchers review the collected samples and questionnaire data to assess test performance by tumor type and clinical stage at diagnosis. Participants are followed for one year after completing the study. Key measurements include the provision of a blinded reference set of cancer versus non-cancer blood samples to support future clinical trials focused on blood-based multi-cancer early detection.

Researchers are evaluating treatments for patients with psoriatic arthritis PsA who have not responded well to tumor necrosis factor inhibitors TNFi. The trial aims to find out if switching to guselkumab, a selective interleukin 23 inhibitor IL23i, is more effective than switching to a second TNFi, golimumab. This is the first study to compare these treatment switches in PsA patients and will focus on those who have an inadequate response to TNFi in a real-world clinical setting. Participants will be randomly assigned to one of three treatment groups guselkumab 100mg every 4 weeks, guselkumab 100mg every 8 weeks, or golimumab 50mg every 4 weeks. Both medications are given as subcutaneous injections. The study is open-label, meaning both patients and researchers know which treatment is given. The trial will continue for 12 months to assess treatment effectiveness. Throughout the study, participants will be monitored for disease activity using measures like cDAPSA low disease activity and Investigator Global Assessment of Psoriasis. Additional assessments include minimal disease activity, quality of life questionnaires, fatigue, and resolution of symptoms such as dactylitis and enthesitis. Safety and treatment response will be evaluated regularly, with the main outcomes measured at 6 and 12 months.

Researchers are studying how certain factors like age, gender, other medical conditions, and the type of immunotherapy affect whether patients with malignant solid tumors develop mild or serious side effects from immune checkpoint inhibitor treatments. This observational study aims to develop and validate a model that predicts severe immune-related side effects during the first year of immunotherapy, while also assessing quality of life and adverse events over 12 months. The study is sponsored by the SWOG Cancer Research Network and includes translational medicine goals such as evaluating cytokine levels as predictors and establishing a tissue and blood sample repository. Participants will provide a tissue sample at the start of their routine cancer treatment and complete questionnaires at multiple time points at treatment start, and weeks 4, 12, 24, and 52. They may also provide optional blood samples during the study. This design allows researchers to monitor immune-related side effects and patient-reported outcomes over time. During the study, participants will complete various questionnaires to report their quality of life, cognitive function, and side effects. Blood and tissue samples will be analyzed to explore predictive markers of toxicity. Researchers will track the occurrence of severe immune-related side effects over 52 weeks and assess changes in patient-reported outcomes. The study includes ongoing monitoring and data collection, with participation lasting approximately one year from treatment start.

Researchers are evaluating durvalumab, an immunotherapy drug, compared to standard patient observation after surgery in patients with early-stage non-small cell lung cancer who have no remaining cancer cells. This phase III trial aims to determine if durvalumab can improve outcomes such as disease-free survival and overall survival compared to the usual approach of monitoring without additional treatment. The study also assesses quality of life, side effects, and patient-reported symptoms. Participants are randomly assigned to one of two groups. One group receives durvalumab intravenously once every 28 days for up to 12 cycles unless the disease progresses or side effects become unacceptable. The other group undergoes active surveillance with regular monitoring. Both groups have computed tomography scans and blood samples collected throughout the 12-month study period. After treatment or observation, patients are followed annually for up to 10 years. Participants will complete questionnaires about their quality of life and symptoms. Researchers will monitor disease recurrence, new lung cancers, and overall survival for up to 10 years. Blood tests and imaging scans will be used to track health status and side effects. Safety and adverse events are evaluated during and after treatment, with long-term follow-up to assess the durability of outcomes.

Researchers are evaluating olpasiran, compared to a placebo, to see how it affects the risk of coronary heart disease death, heart attacks, or urgent coronary revascularization in people at risk for their first major cardiovascular event who have high levels of lipoproteina. This Phase 3 study focuses on participants aged 50 to 105 years with multiple cardiovascular risk factors or evidence of atherosclerosis. Participants will be randomly assigned to receive either olpasiran or a placebo through subcutaneous injections. The study is double-blind, so neither participants nor researchers know who receives the active drug or placebo. Treatments and evaluations will continue for up to approximately 6.2 years. Throughout the study, participants will be monitored for heart-related events such as heart attacks, cardiovascular death, strokes, and coronary revascularizations. Researchers will also measure changes in lipoproteina levels at baseline and at Week 48, along with tracking adverse events. The total participation duration can extend up to about 6.2 years, with ongoing assessments to evaluate the treatments effect over time.

Researchers are evaluating a phase III trial comparing shorter chemotherapy-immunotherapy without anthracycline drugs to the usual chemo-immunotherapy for treating early-stage triple negative breast cancer TNBC. This study aims to see if the shorter treatment works as well as the usual anthracycline-containing treatment. The trial also assesses patient-reported outcomes like fatigue and physical function, as well as safety and survival measures. It involves participants with specific stages of TNBC and includes detailed evaluations of tumor response and immune markers. Participants are randomly assigned to one of two treatment groups. One group receives paclitaxel, carboplatin, and pembrolizumab followed by doxorubicin, cyclophosphamide, and pembrolizumab, then surgery, with possible pembrolizumab after surgery. The other group receives docetaxel, carboplatin, and pembrolizumab prior to surgery, with possible pembrolizumab after surgery. Blood samples may be collected throughout the trial for research purposes. During the study, participants undergo surgery after chemotherapy-immunotherapy. They are followed every six months for two years, then annually up to five years. Assessments include breast cancer event-free survival, pathological response, distant relapse-free survival, overall survival, adverse events, and patient-reported fatigue and physical function. Quality of life and other patient-reported symptoms are also evaluated. Specimens are banked for future research. The total participation may last up to five years from registration.

This trial evaluates whether a shorter duration of HER2-targeted therapy is as effective as the standard length for treating early-stage HER2-positive breast cancer in patients who had a complete response after preoperative chemotherapy with trastuzumab. The study focuses on comparing 6 months versus 12 months of combined neoadjuvant and adjuvant HER2 blockade and also assesses quality of life and safety outcomes. The trial aims to determine if shorter treatment can maintain similar recurrence-free survival and reduce side effects. Participants are randomly assigned to receive trastuzumab and possibly pertuzumab either intravenously or subcutaneously every 21 days. One group receives treatment for up to 17 cycles about 12 months, while the other group receives treatment for up to 9 cycles about 6 months, as long as no disease progression or unacceptable toxicity occurs. Throughout the trial, patients undergo heart function tests echocardiography or MUGA and breast imaging mammography, ultrasound, or MRI. Optional blood and tissue samples may be collected for additional studies. Participants are followed for recurrence and survival for up to 10 years after treatment begins, with check-ins every 6 months for the first 5 years and then yearly afterward. The study measures recurrence-free survival, overall survival, local and distant cancer recurrence, and patient-reported quality of life using specific questionnaires. It also monitors serious side effects and symptoms like diarrhea, fatigue, and rash. This comprehensive follow-up helps evaluate long-term outcomes and treatment impact.