Bodelwyddan

Researchers are evaluating the cannabinoid Nabiximols Sativex added to the standard chemotherapy temozolomide TMZ in patients with recurrent MGMT methylated glioblastoma GBM. This phase II, multi-center, double-blind, placebo-controlled, randomized trial aims to compare Nabiximols with a matched placebo alongside TMZ treatment. The study is linked with the Tessa Jowell BRAIN MATRIX program to streamline patient entry and data sharing while providing additional oversight. Participants will be randomly assigned in a 21 ratio to receive either Nabiximols or placebo, both combined with temozolomide. Temozolomide is given orally once daily on days 1-5 of each 28-day cycle, starting at 150mgm2 in cycle 1 and increasing to 200mgm2 in subsequent cycles, for up to six cycles. Nabiximols or placebo sprays are self-titrated up to 12 sprays per day over the first 14 days of cycle 1, continuing for up to six cycles. Patients will attend 4-weekly follow-up visits for at least 52 weeks or until death. MRI scans are scheduled at screening, weeks 10, 22, 30, and then every three months after starting treatment. Researchers will monitor overall survival, progression-free survival, health-related quality of life, and adverse events. The initial 40 patients will be evaluated for safety, compliance, and recruitment feasibility before continuing the trial. Total participation may last up to a year or more depending on individual outcomes.

Researchers are evaluating the effect of muvalaplin in lowering cardiovascular risks among adults with elevated lipoproteina who either have atherosclerotic cardiovascular disease or are at risk of a first heart attack or stroke. This phase 3, randomized, double-blind study aims to investigate whether muvalaplin can reduce major adverse cardiovascular events compared to placebo in this high-risk population. Participants are randomly assigned to receive either muvalaplin or a placebo, both given orally. The study is designed with parallel groups and will last about 5.25 years, during which the occurrence of cardiovascular events and changes in lipoproteina levels will be closely monitored. Throughout the study, participants will undergo regular assessments including measurement of lipoproteina levels, monitoring of cardiovascular events such as heart attacks or strokes, and evaluation of healthcare resource use. The primary outcome is the time to first major adverse cardiac event, tracked from baseline until the study ends. Safety and pharmacokinetics of muvalaplin will also be evaluated during the trial period.

This trial investigates treatment options for adults aged 16 to 69 with early-stage classical Hodgkin lymphoma, specifically stage I or II supradiaphragmatic disease without mediastinal bulk or B symptoms. The study compares two chemotherapy regimens ABVD and A2VD, using a PET response-adapted design to adjust therapy based on treatment response. It is a phase III, randomized, open-label trial conducted internationally and sponsored by University College London and Canadian Cancer Trials Group. Participants will be randomly assigned to receive either ABVD chemotherapy doxorubicin, bleomycin, vinblastine, and dacarbazine or A2VD chemotherapy doxorubicin, brentuximab vedotin, vinblastine, and dacarbazine with growth factor support. After two 28-day cycles, a PET-CT scan will assess response using the Deauville score to guide further treatment. Patients with scores 1-3 receive one more cycle those with score 4 receive two more cycles followed by involved site radiotherapy patients with score 5 discontinue trial treatment and receive alternative therapy as determined by their clinician. Throughout the study, participants undergo PET-CT scans and clinical assessments to monitor treatment response and safety. They will be followed for at least five years post-treatment to evaluate progression-free survival and other outcomes such as event-free survival, overall survival, and incidence of second cancers or cardiovascular disease. Safety and toxicity are monitored from treatment start until 30 days after completion. The overall study period extends until 2032.

Researchers are conducting a randomized, open-label phase 3 clinical trial to compare the effectiveness and safety of two treatment combinations with docetaxel alone in people with advanced or metastatic non-small cell lung cancer NSCLC who have developed resistance to immune checkpoint inhibitor therapy. The study includes two groups one receiving N-803 plus tislelizumab and docetaxel, and the other receiving N-803 plus a prior failed checkpoint inhibitor and docetaxel. The trial explores how these combinations perform compared to docetaxel by itself in this specific patient population. Participants are divided into two cohorts and randomized to either the experimental treatments or docetaxel monotherapy. Treatments are given in repeated 3-week cycles. In cohort A, N-803, tislelizumab, and docetaxel are given during the first two cycles, followed by N-803 and tislelizumab alone from cycle 3 onward until the study ends. In cohort B, N-803, the prior failed checkpoint inhibitor, and docetaxel are administered in the first two cycles, then N-803 with the prior checkpoint inhibitor continue from cycle 3 onward. The control groups in both cohorts receive docetaxel alone every 3 weeks. Participants will attend regular study visits aligned with the treatment cycles, during which researchers will assess overall survival and monitor safety. The main measurement focuses on comparing survival between the experimental and control arms over approximately 12 months. The study involves follow-up visits and safety monitoring throughout the treatment period. The trial is sponsored by ImmunityBio, Inc. and plans to enroll adults aged 18 to 90 with confirmed stage IV NSCLC who meet specific health and treatment history criteria.

Researchers are conducting a randomized phase III clinical trial to evaluate treatments for patients with unilateral malignant pleural mesothelioma MPM. The study aims to compare progression-free survival and overall survival between two groups. It also assesses safety, tolerability, quality of life, and local disease control. Patients are grouped based on tumor histology, treatment center, tumor location, and time since diagnosis. Participants are randomly assigned to one of two groups. The experimental group receives proton beam therapy PBT to the hemithorax 50 Gy in 25 daily fractions over five weeks, with a boost to 60 Gy for visible tumors. The control group follows standard care with active surveillance and no immediate treatment. Both groups are monitored for two years after randomization, with clinic visits every three months in the first year and every four months in the second year. If disease progresses in the control group, patients may receive immunotherapy or chemotherapy based on doctor recommendation. During the study, patients undergo evaluations including scans, pulmonary function tests, and quality of life questionnaires. Researchers track adverse events related to proton therapy and collect data on healthcare resource use and informal care. Follow-up occurs at local centers for two years after treatment start. The main outcomes measured are time to disease progression and overall survival, assessing the potential benefits and risks of proton beam therapy for MPM.

This research investigates whether personalized medical treatment guided by a special diagnostic procedure during invasive coronary angiography can improve symptoms, wellbeing, cardiovascular risk, and clinical outcomes in patients with angina but no significant blockage in their coronary arteries. It focuses on patients with ischaemic heart disease, particularly those with angina without obstructive coronary artery disease INOCA, a condition affecting the small vessels of the heart. The trial builds on earlier pilot studies that suggested this approach could improve quality of life and symptom control by tailoring diagnosis and treatment more precisely. Participants undergo functional coronary angiography with a guidewire-based interventional diagnostic procedure IDP that measures coronary vascular function to classify patients into specific diagnosis groups, such as microvascular or vasospastic angina. Eligible patients are randomized into two groups one where IDP results are disclosed to clinicians to guide treatment, and another where IDP is performed but results are hidden, with care based on standard angiography and clinical information. Both groups receive medical therapy and lifestyle advice based on their diagnosis. The study also includes a registry for patients with obstructive disease who are not randomized. During the study, participants complete symptom questionnaires like the Seattle Angina Questionnaire to assess their angina symptoms and quality of life over at least 12 months. Researchers monitor health status, clinical outcomes, safety, and health economics, with ongoing follow-up planned for up to 10 years. Both patients and their usual care clinicians are blinded to the group allocation, but informed about the diagnosis to guide treatment. The trial aims to enroll 1500 participants across multiple centers in Europe, assessing the feasibility and impact of this stratified medicine approach.

Researchers are evaluating a medicine called elranatamab in people with multiple myeloma MM, a type of cancer. This study compares elranatamab to other commonly used combination therapies for MM that has returned or not responded to previous treatments. Participants must be 18 years or older and have received prior treatments, including an anti-CD38 antibody and lenalidomide. The study is a phase 3, randomized trial sponsored by Pfizer. Participants will be randomly assigned to receive either elranatamab alone or one of several combination therapies chosen by the study doctor. Elranatamab is given as a shot under the skin at the study clinic about once a week, with possible adjustments later. The combination therapies include two to three medicines taken by mouth or given by injection or infusion at the clinic. Treatment continues until the multiple myeloma stops responding. During the study, participants attend regular visits to monitor their response and side effects. Follow-up continues after treatment ends through telephone contacts or visits. Researchers will measure outcomes such as progression-free survival, overall survival, response rates, duration of response, and quality of life over approximately five years. Safety monitoring includes tracking adverse events and laboratory results throughout and after treatment.

Researchers are evaluating palazestrant OP-1250 compared to standard endocrine therapies for adults with ER-positive, HER2-negative advanced or metastatic breast cancer that has progressed after endocrine therapy combined with a CDK46 inhibitor. This international phase 3 trial aims to assess the safety and effectiveness of palazestrant versus fulvestrant or aromatase inhibitors such as anastrozole, letrozole, or exemestane. Participants are randomly assigned to receive either palazestrant daily on a 28-day cycle at doses of 90 mg or 120 mg during the dose-selection phase, or the standard-of-care endocrine therapy including fulvestrant administered on specific days or one of the aromatase inhibitors given daily on similar cycles. The trial includes an initial dose-selection period with about 120 participants, followed by a larger randomized phase with approximately 390 participants receiving the selected dose of palazestrant or standard treatment. Throughout the study, participants will be monitored for adverse events, dose adjustments, and drug discontinuations up to 16 weeks. Researchers will measure progression-free survival for up to two years and overall survival for up to four years after randomization. Regular assessments will include clinical evaluations and safety monitoring to observe the effects and tolerability of the treatments during the trial.

This research aims to evaluate the combination of pembrolizumab and olaparib in patients with metastatic pancreatic adenocarcinoma who have a high tumor mutation burden or specific genetic markers like mismatch repair deficiency or microsatellite instability. This phase II, open-label, single-arm trial focuses on patients with advanced disease and looks to assess the effectiveness of this combined therapy. Participants will receive pembrolizumab as a 200 mg intravenous infusion every three weeks, along with oral olaparib at a dose of 300 mg twice daily for 21 days in each cycle. Treatment cycles repeat every three weeks. The study includes only one treatment group receiving this combination, with dosing starting on day one of each cycle. During the study, participants will be monitored regularly through imaging and various assessments including the Objective Response Rate over about two years. Safety and side effects will be tracked, along with measures of response duration, progression-free survival, overall survival, and quality of life using cancer-specific questionnaires every 9 to 12 weeks. The total duration of participation can last up to approximately two years with ongoing evaluations.

Researchers are evaluating treatments for community-acquired pneumonia CAP, especially in patients admitted to intensive care units ICUs. This trial also adapts to study treatments for respiratory pandemics like COVID-19. The goal is to determine which treatment strategies improve outcomes for patients with severe pneumonia, using a flexible, ongoing approach that can test multiple therapies simultaneously and update as new information becomes available. Participants receive different treatment strategies based on random assignment to study groups. Treatments include various antibiotics, steroids, antivirals, immune modulators, anticoagulation methods, and ventilation strategies. Some treatment options have been closed to recruitment, reflecting the trials adaptive nature. The trial includes several domains targeting specific infections such as influenza and COVID-19, with dosing and duration guided by clinical practice and local guidelines. During the study, participants are monitored closely with assessments including survival up to 90 days, days alive without organ support in ICU, ICU and hospital length of stay, ventilator-free days, organ failure-free days, and quality of life up to 6 months. Researchers collect detailed data on patient outcomes, organ support needs, and hospital discharge status. The study runs until February 2028, with ongoing evaluation to improve pneumonia treatment strategies in ICU settings and during respiratory pandemics.