Gavle

Unhealthy lifestyle habits are major risk factors for cardiovascular disease (CVD), which is the leading cause of death worldwide and in Sweden. This research evaluates a digital lifestyle program developed within Swedish primary healthcare to see if it can improve important heart health outcomes and encourage healthier habits in adults aged 40 to 60. The study is a multi-center randomized trial comparing standard care alone to standard care plus the digital intervention. The main goal is to measure LDL-cholesterol levels six months after starting the study, along with other health and lifestyle factors. Participants receive standard care consisting of one structured health dialogue focused on lifestyle habits. Those in the intervention group also get access to the digital lifestyle program, which includes digital lectures, home assignments, and group meetings online. Healthcare providers can offer personalized digital support and feedback to help patients improve diet, physical activity, alcohol use, tobacco use, sleep, and stress management. The intervention is delivered entirely through digital means alongside regular primary care. During the study, participants will be monitored for changes in cholesterol levels, blood sugar, blood pressure, weight, body measurements, cardiovascular risk scores, diet, physical activity, sleep, stress, alcohol and tobacco use, and quality of life. These assessments happen six months after randomization to evaluate the effects of the intervention. The study uses these measures to understand how well the digital program supports healthier lifestyle changes and reduces cardiovascular risk.

Researchers are studying head and neck squamous cell carcinoma (HNSCC) patients with factors that increase the risk of treatment failure. The goal is to personalize treatment and improve outcomes for those receiving curative radiotherapy. This phase III trial compares the standard radiation dose to a higher dose given more frequently (hyperfractionated radiotherapy) to see if intensifying treatment benefits patients with advanced disease. The study also explores advanced imaging and genetic tests to better predict treatment response and cancer behavior. Participants will be randomly assigned to receive either the standard radiotherapy dose of 68.0 Gy in 34 fractions once daily or a higher hyperfractionated dose of 83.0 Gy in 68 fractions given twice daily over five days a week. Different radiation doses are targeted to the primary tumor and affected lymph nodes based on risk areas. The trial includes translational research using MRI, CT, and PET scans, as well as gene and protein analyses, to understand tumor characteristics and treatment effects. Patients with lower-risk tumors not eligible for randomization can still join the research parts that do not involve altered radiation schedules. During the study, participants will undergo regular monitoring including imaging and clinical assessments every three months for two years, then every six months up to five years to check local tumor control. Researchers will collect data from these visits along with tissue and blood samples for genetic and immune profiling. Safety, treatment adherence, and long-term outcomes will be closely followed to evaluate the impact of the different radiotherapy approaches and the predictive value of the biological tests.

Researchers are studying an intermittent dosing strategy of ibrutinib, a drug approved for chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). Ibrutinib is usually given daily at a continuous dose of 420 mg until the disease progresses. Due to increasing drug costs and some patients maintaining disease control even after stopping ibrutinib because of side effects, this pilot study explores whether cycling ibrutinib on and off could be effective and reduce costs and side effects. The study also looks at long-term effects on mutations related to the drug's target, Brutonb4s tyrosine kinase (BTK).

Researchers are investigating whether adding regular radiological scans during follow-up after surgery for high-risk malignant melanoma improves patient survival. This study focuses on patients who have undergone radical surgery for stage IIb-c and III cutaneous malignant melanoma. Since radiological exams can be costly, cause anxiety, and expose patients to radiation, the study aims to determine their value especially given the availability of effective medical treatments for melanoma. Participants are randomly assigned to one of two groups for a 3-year follow-up period. One group receives routine follow-up with regular doctor visits according to national guidelines. The other group receives the same follow-up plus whole body CT or PET scans and blood tests at baseline, 6, 12, 24, and 36 months. An interim analysis will be done after 1000 patients have enrolled. Throughout the study, researchers will monitor overall survival over a 5-year period. Participants will have scheduled assessments including scans and blood tests if assigned to the imaging group. The study also tracks adherence to follow-up visits and any health changes. This approach aims to provide clear evidence on the benefit and impact of imaging during follow-up after melanoma surgery.

Researchers are conducting a Phase 3 study to compare two front-line treatments for adults with nonsquamous non-small cell lung cancer (NSCLC) that is stage IV or advanced stage IIIB/C. The study focuses on patients whose tumors have a KRAS p.G12C mutation and are negative for PD-L1 expression. The main goal is to evaluate how each treatment affects progression-free survival and overall survival over about 2.5 years. Participants will be randomly assigned to receive either sotorasib combined with platinum doublet chemotherapy or pembrolizumab combined with platinum doublet chemotherapy. Sotorasib is given orally, while pembrolizumab is given intravenously. Both groups will receive the combination therapies as their initial treatment for advanced NSCLC. During the study, participants will be monitored regularly to assess treatment effects and safety. Researchers will track how long patients live without the cancer worsening and overall survival over approximately 2.5 years. The study includes evaluations to determine eligibility and ongoing assessments to monitor health and treatment response throughout the trial period.

A study to evaluate Pumitamig versus Durvalumab following concurrent chemoradiation therapy in participants with unresectable stage III Non-small Cell Lung Cancer (NSCLC)

This trial investigates the effectiveness of Pumitamig compared to Pembrolizumab in adults with advanced Non-Small Cell Lung Cancer (NSCLC) who have not received prior treatment and whose tumors express PD-L1 at 50% or higher. The study targets individuals with locally advanced or metastatic NSCLC, focusing on those with measurable disease and good performance status. It is a Phase 3 randomized, double-blind study designed to compare these two treatments as first-line options for this patient group. Participants will receive either Pumitamig or Pembrolizumab at specified doses on scheduled days. The treatments are given as monotherapy, meaning each participant receives only one of these drugs throughout the study. The study does not mention additional treatment phases or extensions, focusing on the direct comparison of these two drugs for initial treatment. Throughout the study, researchers will assess how long participants live without their cancer worsening, using standardized criteria over about three years. Overall survival will also be tracked for up to five years. Participants will be monitored regularly to evaluate their response to treatment and overall health. Safety and effectiveness outcomes will be gathered through medical assessments consistent with clinical trial standards for NSCLC.

Researchers are evaluating the study medicine PF-08046054 compared to the standard chemotherapy drug docetaxel in adults with non-small cell lung cancer (NSCLC) that has spread or cannot be removed with surgery or radiation. Participants must have PD-L1 expression on 1% or more of their tumor cells and have experienced cancer progression during or after treatment with PD-L1 or PD-1 inhibitors, platinum-based chemotherapy, and targeted therapies for those with known genetic mutations. The trial is a Phase 3 randomized study to better understand how well PF-08046054 works alone compared to docetaxel alone. Participants will be randomly assigned to receive either PF-08046054 or docetaxel. Those in the PF-08046054 group will get intravenous (IV) infusions twice every 21-day cycle, while those in the docetaxel group will receive one IV infusion every 21 days. The treatment period may last up to 5 years if their NSCLC responds to the therapy. No other treatments are combined during the study period. Throughout the study, participants will have regular clinic visits for evaluations and monitoring to see how they respond to the treatment. Researchers will collect information on overall survival over approximately 5 years. They will also monitor safety and disease progression during these visits to understand the long-term effects and benefits of the treatments.

Researchers are investigating whether a shorter duration of immunotherapy is as effective as the current standard for patients with high-risk malignant skin melanoma who have undergone radical surgery. This phase 3 international study focuses on patients aged 18 and older with stage IIb-c, III, or IV melanoma. The goal is to compare six months versus twelve months of immunotherapy to determine if the shorter treatment can prevent cancer recurrence as well as the longer one, potentially reducing side effects, hospital visits, and healthcare costs. The study treatment involves immunotherapy using drugs nivolumab or pembrolizumab given intravenously according to routine clinical practice. Patients are randomized to receive either six months (experimental group) or twelve months (standard group) of treatment. For those who received neoadjuvant immunotherapy before surgery, treatment durations are adjusted accordingly to total six or twelve months. Follow-up includes imaging scans at baseline, six months, and thirty-six months, along with medical examinations at multiple time points up to three years. If relapse occurs, further evaluations and treatment decisions are made by a multidisciplinary team. Participants will have regular visits for physical exams, imaging tests, and blood work to monitor their health and treatment response. The main outcomes measured are relapse-free survival and distant metastatic-free survival at two years. Overall survival and health economic effects will also be assessed. Patients are followed for up to five years to track survival and any disease recurrence, ensuring close monitoring of safety and effectiveness throughout the study period.

Researchers are evaluating adults with advanced small cell lung cancer (SCLC) in this study. The main goal is to see if adding a medicine called obrixtamig to the usual treatment, which includes atezolizumab, carboplatin, and etoposide, helps patients live longer compared to the usual treatment alone. Obrixtamig is an antibody-like drug that may support the immune system in fighting cancer. The study also tests a new medical device designed to measure levels of a tumor marker called DLL3. Participants are randomly assigned to one of two groups. One group receives obrixtamig along with the standard treatment, while the other group gets only the standard treatment. All medicines are given through a vein. Those receiving obrixtamig must stay overnight at the study site after their first two treatments with this medicine. Treatment continues as scheduled, following the same general approach for both groups. During up to three years of participation, patients regularly visit the study site for tumor size assessments and health checks. Researchers monitor side effects and compare the results between the two groups to determine treatment effectiveness. The main outcome measured is overall survival over this period.