Alexandria

Researchers are evaluating the effects of TEV-56286, an oral medication, for treating adults with Multiple System Atrophy (MSA). This phase 2 study aims to assess how well TEV-56286 works, measure specific treatment responses, and monitor its safety and tolerability. The trial is sponsored by Teva Branded Pharmaceutical Products R&D LLC and will take place across several countries including the US, Israel, and Japan. Participants will take TEV-56286 or a placebo once daily as capsules during a 48-week double-blind treatment period. Before this, there is a screening period of up to 4 weeks to determine eligibility. After completing the treatment, participants will attend a follow-up visit about 4 weeks later. The total time per participant is approximately 56 weeks, with the overall study lasting around 27 months. During the study, researchers will assess participant health using measures like the Unified Multiple System Atrophy Rating Scale (UMSARS), MRI scans to measure brain volumes, walking tests, and quality of life questionnaires. Safety will be monitored through adverse event tracking, laboratory tests, and vital signs. The primary outcome focuses on changes in MSA symptoms from baseline to week 48, with additional measures evaluating physical function and disease progression.

Fatigue is a common side effect for women undergoing pelvic radiation therapy for endometrial cancer, often making daily activities more difficult. While exercise has been recommended to help with fatigue in cancer patients, there is limited research on its role during pelvic radiation therapy. This trial aims to evaluate whether an activity coaching program can improve treatment-related fatigue in women receiving this therapy. Participants will take part in an exercise coaching program involving ten weekly check-ins with a certified exercise coach. They will set weekly activity goals based on what is easy and enjoyable for them, with check-ins available in person or virtually. Participants will be randomly assigned to start the program either immediately during radiation therapy or after radiation therapy has ended, with the study lasting about six months. All participants will receive a Fitbit to monitor activity, heart rate, and steps. Throughout the study, participants will complete four surveys and perform a 6-minute walk test four times to assess heart and lung response to exercise. At the end of the trial, an interview will be conducted to gather feedback on the program. Researchers will monitor adherence to coaching sessions as the primary outcome, along with changes in fatigue, bowel and urinary symptoms, quality of life, cognitive function, sexual function, self-efficacy, and walking distance. The study aims to follow participants for up to 24 months.

Researchers are evaluating the effects of combining two drugs, cabozantinib and nivolumab, in treating patients with advanced melanoma or squamous cell head and neck cancer that has spread to nearby tissues, lymph nodes, or distant parts of the body. This phase II study aims to understand how well patients can be grouped based on tumor biomarkers, specifically tumor mutational burden and tumor inflammation signature, and to see if these markers influence how the cancer responds to treatment. Participants receive nivolumab through an intravenous infusion on the first day of each 28-day cycle, while cabozantinib is taken orally every day. Treatment cycles continue for up to two years unless the cancer worsens or side effects become unacceptable. During the study, patients undergo CT or MRI scans and blood sample collections. Tumor biopsies are done at screening and optionally during follow-up. After treatment ends, patients are followed every 12 weeks for one year, then every six months for up to three years. Throughout the trial, researchers monitor tumor response, including shrinkage or stabilization, and assess safety and side effects. They measure how quickly biomarker results can be obtained, overall response rates, disease control, progression-free survival, and overall survival. Additional analyses aim to identify biomarkers that predict response and side effects. Participants are regularly evaluated through scans, blood tests, and biopsies to track their health and treatment effects over time.

Researchers are evaluating the effectiveness of computerized cognitive training methods to help breast cancer survivors who experience cognitive difficulties related to cancer and its treatments. This trial focuses on breast cancer survivors with non-metastatic disease who report cognitive problems after their cancer therapy, aiming to address the long-lasting challenges that affect their work and health. The study is a Phase III, double-blind, randomized controlled trial comparing two types of cognitive training methods. Participants will be assigned to one of two groups. The first group will use global stimulation games featuring non-speeded, strategy-based exercises like solitaire, sudoku, and word search that do not adapt to the player's skill. The second group will use neuroplasticity games designed to improve cognitive functions such as attention, working memory, processing speed, and executive function, with exercises that adapt to the user's performance. The training involves eight exercises tailored to address cognitive concerns common among breast cancer survivors. During the study, participants will be monitored over 12 weeks post-randomization for self-reported cognitive impairment, with further assessments extending to 36 weeks. Researchers will collect data through cognitive tests, questionnaires, and behavioral tracking within the programs to measure changes in cognitive performance. The trial will also evaluate the safety and adherence to the training programs, with the total participation period lasting up to 36 weeks from randomization.

Researchers are evaluating how well proton beam radiation therapy compares to intensity modulated photon radiotherapy in treating patients with stage I-IVA esophageal cancer. This phase III trial aims to determine whether proton beam therapy improves overall survival and reduces serious heart and lung side effects compared to photon radiotherapy. The study also examines symptom burden, quality of life, treatment costs, and disease control outcomes. Participants are randomly assigned to one of two treatment groups. One group receives proton beam therapy over 28 sessions in 5.5 weeks alongside chemotherapy with drugs like carboplatin, paclitaxel, or fluorouracil-based regimens. The other group receives intensity modulated photon radiotherapy on the same schedule with similar chemotherapy options. Both groups undergo blood sample collection and imaging scans such as PET/CT or CT during treatment. Surgery to remove the esophagus is considered within 4 to 8 weeks after therapy if feasible. Throughout the study, participants will have follow-up visits every 3 to 6 months for three years, then annually afterward. Researchers will monitor survival, heart and lung toxicities, immune cell counts, symptom changes, hospital stays, and cancer progression. Patient-reported outcomes and quality-of-life measures are collected, along with biospecimens for future biomarker analysis. This comprehensive monitoring will help assess the benefits and risks of each radiation approach over time.

Researchers are evaluating two different monitoring approaches for pancreatic cysts and associated biomarkers to improve risk detection of progression to pancreatic cancer. This observational study aims to compare more frequent versus less frequent monitoring schedules and identify biomarkers from blood tests and imaging that may better predict the development of concerning features or high-risk signs. The study also assesses patient quality of life, financial distress, anxiety, and healthcare costs related to these surveillance programs. Participants undergo magnetic resonance imaging (MRI), computed tomography (CT), or endoscopic ultrasound (EUS) scans, as well as blood sample collections throughout the trial. The study originally randomized patients into two surveillance arms: a low-intensity group with less frequent imaging and a high-intensity group with more frequent imaging based on cyst size. Patients may also undergo biopsies, fine needle aspiration, and surgery as clinically needed. The study is closed to new accrual but continues follow-up. Participants are followed every 6 to 12 months for up to 5 years after enrollment. Researchers collect imaging results, blood samples, and clinical data to track the development of worrisome cyst features or high-risk stigmata. They also evaluate patient-reported outcomes including quality of life, anxiety, and financial distress. Safety and treatment pathways are documented, and the primary outcome focuses on the time to detecting concerning cyst features on imaging over the 5-year period.

Researchers are evaluating the safety and effectiveness of AZD2373 in adults aged 18 to 65 years who have APOL1-Mediated Kidney Disease (AMKD) and carry high-risk APOL1 genotypes (G1 and G2). This Phase 2b study aims to see if AZD2373 can reduce the Urine Albumin-Creatinine Ratio (UACR) compared to placebo, with the main focus on the relative change in UACR at 30 weeks. Participants with certain kidney function levels and albuminuria will be included, while those on dialysis or with other organ transplants will be excluded. Participants will be randomly assigned to one of three groups receiving different doses of AZD2373 or a placebo, all given as subcutaneous injections. The study is blinded, meaning neither participants nor study staff know who receives which treatment. Treatment will last for at least 30 weeks, with about 96 participants total, divided evenly among the three groups. During the study, participants will undergo regular urine tests to measure albumin and protein levels, kidney function assessments, and monitoring for any adverse events. Blood samples will be collected to check drug levels and immune responses. These evaluations will continue until the last participant completes the 30-week treatment period, ensuring thorough assessment of AZD2373's impact and safety.

Researchers are evaluating the effectiveness of two digital mindfulness-based interventions for younger breast cancer survivors who experience elevated depressive symptoms. This phase III clinical trial focuses on women diagnosed with breast cancer at age 50 or younger who have completed their primary cancer treatments at least six months prior. The study aims to identify which digital mindfulness approach best improves mental health and well-being, while exploring factors that influence intervention benefits and cost-effectiveness. The study includes three groups: one attends live, instructor-led mindfulness sessions via Zoom once a week for six weeks; another uses a self-paced mindfulness app with structured lessons and exercises over six weeks; and a control group accesses guided audio mindfulness meditations. Participants without digital devices or internet access will be provided with tablets and hotspots. Both English and Spanish speakers are included in live and audio meditation groups, while the app group includes English speakers only. All groups have access to the mindfulness app for up to six months. Participants will attend sessions or use digital tools over six weeks, with daily home practice encouraged. Researchers will assess depressive symptoms shortly after the intervention and up to six months later, along with fatigue symptoms. Use of mindfulness materials and session attendance will be tracked to measure engagement. The study also collects information on emotion regulation, demographic factors, and social determinants of health to understand how these influence outcomes. Participation lasts approximately six months, with ongoing access to mindfulness resources during follow-up.

Researchers are studying high-risk locally advanced cervical cancer that has spread to nearby tissue or lymph nodes. This trial compares adding induction chemotherapy with carboplatin, paclitaxel, and pembrolizumab before standard treatment, versus standard chemoradiation with pembrolizumab followed by pembrolizumab maintenance. The goal is to see if adding induction therapy improves progression-free survival and overall survival, while also assessing treatment side effects and biomarkers related to outcomes. Participants are randomly assigned to one of two groups. One group receives standard chemoradiation with cisplatin and pembrolizumab alongside radiation therapy, followed by pembrolizumab maintenance. The other group receives induction chemotherapy with carboplatin, paclitaxel, and pembrolizumab for two cycles before starting chemoradiation plus pembrolizumab and then pembrolizumab maintenance. Radiation is given daily for several weeks followed by brachytherapy treatments. The study includes blood tests, PET, CT, chest x-rays, and MRI scans throughout. Participants will be monitored with scans and blood samples during treatment and followed every three months for two years, then every six months for three more years. Researchers measure progression-free survival as the main outcome, along with overall survival, treatment side effects, treatment completion times, and biomarker changes. Safety and response to therapy are closely tracked for up to seven years after randomization.

This research aims to evaluate the long-term safety and tolerability of pelacarsen (TQJ230) given once a month at 80 mg in patients with elevated Lipoprotein(a) (Lp(a)) and established atherosclerotic cardiovascular disease (ASCVD). It is a Phase 3, open-label extension study that includes participants who have successfully completed prior double-blind parent studies. The goal is to monitor ongoing effects and provide continued access to the study drug for these patients. Participants will receive pelacarsen 80 mg monthly by subcutaneous injection during the open-label extension period. This rollover extension program allows all consenting participants from the parent studies who meet eligibility criteria to continue treatment with pelacarsen. The study will last up to 48 months, with regular dosing and follow-up visits scheduled throughout this time. Throughout the study, participants will be monitored for adverse events and serious adverse events to assess safety. Researchers will also measure changes in Lp(a) levels compared to baselines from both the parent studies and the extension study at multiple time points up to 48 months. Participants can expect regular clinical evaluations and laboratory testing to track these outcomes and ensure ongoing safety during the study period.