Gavle

Cardiovascular disease CVD is a leading cause of death worldwide and unhealthy lifestyle behaviors are well-known risk factors. This study evaluates whether a digital lifestyle intervention developed within Swedish primary healthcare can improve important cardiovascular health outcomes and promote healthier lifestyle behaviors in patients aged 40 to 60 years. Participants are recruited from multiple centers in Sweden and randomized to either the intervention or control group with standard care. Participants in the intervention group receive support through a digital lifestyle program that includes lectures, home assignments, and group meetings, along with personalized digital feedback from healthcare providers. Both groups receive standard care, which is one structured health dialogue focused on lifestyle habits. The study measures outcomes at 6 months post-randomization, including LDL-cholesterol as the primary outcome, and several secondary outcomes related to cholesterol levels, blood glucose, blood pressure, weight, lifestyle behaviors, and quality of life. Throughout the study, participants undergo assessments of blood lipids, glucose, blood pressure, body measurements, and lifestyle factors such as diet, physical activity, sleep, stress, alcohol, and tobacco use. Researchers also evaluate cardiovascular risk scores and collect participant feedback on using the digital intervention. The total study duration is 6 months post-randomization with data collected to assess the impact of the digital program compared to standard care.

Researchers are investigating ways to personalize treatment for patients with head and neck squamous cell carcinoma HNSCC, especially those with advanced disease who face a higher risk of treatment failure. This phase III study compares two radiotherapy approaches for patients intended for curative treatment the standard radiotherapy and a hyperfractionated radiotherapy HFX-RT with a higher total radiation dose. The study also aims to improve prognostic and predictive methods by including exploratory analyses such as MRI to evaluate tumor hypoxia, gene profiling, immune profiling, and imaging texture analyses during treatment and follow-up. Participants will be randomly assigned to either standard radiotherapy, which delivers 68.0 Gy in daily fractions of 2.0 Gy, or to hyperfractionated radiotherapy, which delivers 83.0 Gy in smaller doses twice daily 1.22 Gy per fraction over five days per week. The doses vary depending on the tumor volume and lymph node involvement. Patients with lower-risk tumors not eligible for randomization may still participate in the translational research parts of the study. During the study, participants will be closely monitored with regular follow-up visits every three months for two years, then every six months up to five years, focusing on local tumor control. Researchers will collect imaging data, conduct gene and protein analyses, and assess tumor response. The study evaluates treatment effects and tumor behavior over time to better understand and improve outcomes for head and neck cancer patients.

Researchers are evaluating an intermittent dosing approach of ibrutinib, a drug used to treat advanced-phase chronic lymphocytic leukemia CLL and small lymphocytic lymphoma SLL. The study explores whether stopping and restarting ibrutinib based on disease progression can maintain disease control while potentially reducing drug costs and side effects. This pilot study focuses on patients who have already received at least six months of ibrutinib and achieved a stable partial remission. Participants will follow an ON-OFF dosing schedule where ibrutinib is stopped after stable partial response and restarted upon clinical progression. The drug is given at the standard daily oral dose of 420 mg during ON periods, and cycles of treatment and off-therapy periods may be repeated until resistance, intolerance, or the need for continuous dosing arises. This approach is being tested to assess the feasibility of intermittent therapy. Throughout the study, participants will be monitored for safety by tracking adverse events over 1 to 24 months. Researchers will also evaluate response rates, time to partial remission, duration off therapy before restarting ibrutinib, cumulative dose, survival, risk of early disease rebound, and time until alternative treatments are needed. Participants will have regular visits for clinical assessments, laboratory tests, and adherence to the study schedule.

Researchers are investigating whether regular radiological assessments during follow-up after surgery for high-risk malignant melanoma improve patient survival. The study addresses concerns about the resource demands, potential radiation exposure, and anxiety caused by such imaging, especially given the recent introduction of effective medical treatments for melanoma. There is currently no clear evidence supporting routine imaging in this context. Participants are randomly assigned to one of two groups. One group follows national guidelines with regular doctor appointments for 3 years, while the other group receives the same follow-up plus additional whole-body CT or PET scans and blood tests at baseline, 6, 12, 24, and 36 months. An interim analysis will be done after 1,000 patients enroll. During the study, researchers will monitor overall survival at 5 years as the primary outcome. They will also assess quality of life through questionnaires over the 3-year follow-up. Participants will attend scheduled visits for clinical evaluations, imaging, and blood tests, with the study aiming to provide clear evidence about the role of imaging in post-surgical melanoma care.

Researchers are comparing two treatment combinations for adults with advanced nonsquamous non-small cell lung cancer NSCLC that have a specific KRAS p.G12C mutation and are negative for PD-L1 expression. The study aims to evaluate progression-free survival and overall survival between participants receiving sotorasib with platinum doublet chemotherapy and those receiving pembrolizumab with platinum doublet chemotherapy. This phase 3, randomized, open-label trial is led by Amgen and includes participants with stage IV or advanced stage IIIBC NSCLC. Participants will be randomly assigned to receive either sotorasib orally combined with carboplatin and pemetrexed, or pembrolizumab intravenously combined with the same chemotherapy drugs. These treatments are given as front-line therapy. The study includes a treatment period with these drug combinations and monitoring for outcomes such as response rates and quality of life over several years. During the study, participants will be regularly assessed through various measures including survival status, tumor response, and quality-of-life questionnaires focusing on lung cancer symptoms. Researchers will monitor safety by tracking adverse events, vital signs, and laboratory tests. Treatment concentrations of sotorasib will also be measured up to 64 days after starting. The total study duration includes follow-up for up to approximately 5.5 years to fully evaluate treatment effects and outcomes.

Researchers are evaluating Pumitamig compared to Durvalumab in adults with unresectable stage III Non-small Cell Lung Cancer NSCLC who have completed concurrent chemoradiation therapy. This phase 3 study aims to assess which treatment better controls cancer progression and improves survival outcomes in this patient population. Participants are randomly assigned to receive either Pumitamig or Durvalumab at specified doses on designated days. Both treatments are administered following at least two cycles of platinum-based concurrent chemoradiotherapy with a radiation dose of at least 54 Gy. The study focuses on patients who have no progressive disease after this initial treatment and have good performance status. Throughout the trial, participants will be monitored for progression-free survival and other outcomes such as overall survival, objective response, disease control rate, and duration of response over several years. Assessments include imaging reviewed by independent central reviewers and investigators according to standardized criteria. The study involves regular evaluations to track cancer status and safety, with follow-up extending up to approximately nine years to understand long-term effects.

Researchers are evaluating the effectiveness of Pumitamig compared to Pembrolizumab in adults with previously untreated advanced Non-Small Cell Lung Cancer NSCLC who have a PD-L1 expression level of 50% or higher. This Phase 3 randomized, double-blind study focuses on patients with locally advanced or metastatic NSCLC to better understand first-line treatment options. Participants receive either Pumitamig or Pembrolizumab as the study drug, given at specified doses on certain days. The study uses a parallel design with two treatment groups to compare these therapies as first-line options. The study is planned to continue until October 2031, with treatment and follow-up periods extending up to approximately 5 years for overall survival assessments. During the study, participants will have regular assessments to monitor disease progression and response to treatment using criteria like RECIST v1.1. Researchers will evaluate progression-free survival, overall survival, objective response rates, duration of response, disease control rate, and symptom changes related to lung cancer over time. Safety and treatment effects will be closely monitored throughout the study duration.

Researchers are evaluating the study medicine PF-08046054 compared to the standard treatment docetaxel in adults with non-small cell lung cancer NSCLC that has PD-L1 expression of 1% or higher. These participants have cancer that has spread or cannot be treated with surgery or definitive radiation and have shown disease progression during or after previous treatments including PD-L1 or PD-1 inhibitors, platinum-based chemotherapy, and targeted therapies for known genomic alterations. The study is a randomized phase 3 trial assessing treatment options for advanced NSCLC. Participants are randomly assigned to one of two groups one receives PF-08046054 as an intravenous IV infusion twice during each 21-day cycle, and the other receives docetaxel as an IV infusion once every 21 days. The study treatment may continue for up to 5 years if the participants cancer responds to therapy. Both treatments are given in cycles, and participants receive the medicine through infusions during clinic visits. During the study, participants will have regular clinic visits to monitor their health and how well the treatment is working. Assessments include measuring overall survival, progression-free survival, tumor response rates, and quality of life through questionnaires. Safety is monitored for adverse events up to 90 days after treatment ends. Blood samples are also taken to study the medicines levels and immune response. The total study duration can be up to 5 years depending on individual responses and outcomes.

Researchers are investigating the use of adjuvant CDK46 inhibitors combined with endocrine therapy in older breast cancer patients aged 70 years and above. This study focuses on the specific challenges faced by this population, including comorbidities that may increase the risk of treatment-related toxicities and affect quality of life. Due to limited representation of older patients in previous trials, this study aims to better understand the benefits and risks of such treatment in this age group and the role of geriatric assessments to guide therapy. Participants will undergo geriatric screening using tools such as the Geriatric 8 G8 and Vulnerable Elders Survey-13 VES-13 to assess frailty before starting adjuvant CDK46 inhibitor therapy alongside endocrine treatment. The study will examine multiple outcomes including treatment side effects, dose intensity, treatment discontinuation, quality of life, hospitalization, cancer recurrence, and survival. These measures will be collected over several years with follow-ups at various intervals, up to 10 years for some outcomes. Throughout the study, participants will complete questionnaires assessing frailty and quality of life at baseline and at multiple points after starting treatment. Adverse events, hospitalizations, dose adjustments, and treatment discontinuation will be monitored regularly up to six months after ending CDK46 inhibitor therapy. Long-term outcomes such as breast cancer recurrence and survival will be tracked at 3, 5, and 10 years. This approach aims to provide a thorough evaluation of how geriatric screening relates to treatment effects and long-term health in this patient group.

Researchers are evaluating whether a shorter period of immunotherapy after radical surgery is as effective as the standard longer treatment for patients with high-risk malignant skin melanoma. This study focuses on people aged 18 and older who have undergone surgery for stage IIb-c, III, or IV melanoma. The goal is to see if six months of immunotherapy can prevent cancer recurrence as well as the current 12-month treatment, potentially reducing side effects, hospital visits, and healthcare costs. The study is a randomized phase 3 trial conducted internationally with patients followed for up to five years. Participants will receive immunotherapy drugs, currently nivolumab or pembrolizumab, given intravenously. They are randomly assigned to either six months experimental group or 12 months standard group of treatment. Patients who had immunotherapy before surgery neoadjuvant treatment can also join, with their pre-surgery treatment time added to the post-surgery treatment. Medical exams and imaging scans CT or PET-CT are done at the start, six months, and 36 months, along with regular check-ups over three years. If cancer returns, additional tests and treatments are planned based on medical team decisions. During the study, participants will have scheduled visits for physical exams, blood tests, and scans to monitor their health and detect any recurrence. Researchers will measure relapse-free survival and distant metastatic-free survival at two years as primary outcomes, with overall survival and health economic effects also assessed over five years. Safety monitoring includes standard care practices and follow-up for up to five years. The study aims to confirm if shorter immunotherapy duration maintains the same outcomes while benefiting patients and healthcare systems.