Lund

Researchers are evaluating the combination of CGT9486 and sunitinib compared to sunitinib alone in patients with locally advanced, unresectable, or metastatic Gastrointestinal Stromal Tumors GIST. This Phase 3, open-label international trial involves multiple parts, including dose confirmation, drug interaction assessments, and efficacy comparisons. The study also includes substudies focusing on drug-drug interaction potential and first-line treatment in patients with specific genetic mutations KIT exon 9. Approximately 482 patients will participate across these parts.

Researchers are evaluating whether 18F-choline positron-emission-tomography computed tomography 18F-ch-PET-CT is better than conventional imaging methods like ultrasonography and sestamibi scintigraphy at locating diseased parathyroid glands in adults with primary hyperparathyroidism pHPT. The study aims to improve surgical precision, increase cure rates, reduce complications, and shorten operation times. Primary hyperparathyroidism causes problems like kidney stones and bone weakness because of enlarged parathyroid glands producing too much hormone. This open, randomized clinical trial compares two imaging approaches before surgery. One group receives 18F-ch-PET-CT imaging, while the other undergoes standard ultrasonography and sestamibi scintigraphy. Patients are randomly assigned to one of these groups. The study will measure how long the surgery takes and look at cure rates, complication rates, and the accuracy of each imaging method. The trial is conducted at a single center and does not involve blinding. Participants will have their imaging results and surgery details recorded. Researchers will monitor operation times from start to finish and evaluate cure by checking calcium levels one month after surgery. They will also track complications like nerve damage or persistent disease. Data are collected securely in a national registry. The study aims to include 100 participants and expects to complete analyses within a few years. Safety monitoring includes assessment of potential side effects from the imaging agents used.

Researchers are investigating new treatments for metastatic cervical cancer, which is cancer that has spread beyond the cervix, the lower part of the uterus. This study evaluates the safety and effectiveness of the antibody drug conjugate sacituzumab tirumotecan sac-TMT combined with pembrolizumab and bevacizumab. The goal is to find out if these treatments, given together or with some variations, help patients live longer or delay cancer progression compared to standard care. The study has two parts. In Part 1, participants receive sac-TMT, pembrolizumab, and bevacizumab together to assess safety. In Part 2, all participants first get standard induction treatment with pembrolizumab, paclitaxel, and cisplatin or carboplatin, possibly with bevacizumab. Those whose cancer does not worsen then enter maintenance treatment, where they are randomly assigned to receive either pembrolizumab alone or sac-TMT plus pembrolizumab, with optional bevacizumab. Participants are involved for up to about 20 months during maintenance treatment after up to 4 months of induction. The study monitors safety by tracking side effects and treatment discontinuations. Effectiveness is measured by progression-free survival and overall survival up to several years. Quality of life and physical functioning are also assessed through questionnaires. Treatments and evaluations occur through regular intravenous infusions and periodic monitoring visits.

Researchers are evaluating the effectiveness and safety of an investigational drug called BNT323 also known as DB-1303 compared with standard chemotherapy in women with recurrent endometrial cancer. The study includes two groups based on the level of HER2 protein in the tumor Cohort 1 with HER2 levels 1 or 2 who have been previously treated with immune checkpoint inhibitors, and Cohort 2 with HER2 level 3. The study aims to understand how well BNT323 or chemotherapy controls cancer progression and how the drug affects patients immune response and quality of life. Participants in Cohort 1 will be randomly assigned to receive either BNT323 or chemotherapy drugs such as doxorubicin, paclitaxel, or docetaxel. In Cohort 2, participants will receive BNT323 alone. Treatments are given intravenously and continue until the cancer progresses, unacceptable side effects occur, or consent is withdrawn. The study includes screening, treatment, safety follow-up, efficacy follow-up, and a long-term survival follow-up lasting up to about 53 months. During the study, participants will undergo regular assessments including tumor evaluations, safety monitoring, and quality of life questionnaires. Researchers will measure progression-free survival in Cohort 1 and tumor response rate in Cohort 2. Safety is monitored by tracking adverse effects and drug levels in the body. Participants can expect to be followed for up to 53 months after treatment to assess long-term outcomes and survival.

Researchers are evaluating the safety, tolerability, and therapeutic effects of BNT113 combined with pembrolizumab compared to pembrolizumab alone as a first-line treatment for patients with unresectable recurrent or metastatic head and neck squamous cell carcinoma HNSCC positive for human papilloma virus 16 HPV16 and expressing the protein PD-L1 with a combined positive score of 1 or higher. This is an open-label, multi-site, Phase IIIII clinical trial consisting of two parts an initial safety run-in phase and a randomized phase. In the safety run-in phase Part A, patients receive BNT113 in combination with pembrolizumab to confirm safety and tolerability at selected dose levels. The randomized phase Part B compares BNT113 combined with pembrolizumab against pembrolizumab monotherapy. Treatments are given by intravenous injection or infusion and continue for up to 24 months. An optional pre-screening phase allows tumor samples to be tested for HPV16 DNA and PD-L1 expression before the main trial screening. Participants will be closely monitored throughout the study. Assessments include safety evaluations, tumor response, and survival outcomes such as overall survival and progression-free survival. Tumor tissue samples must be provided for testing. Researchers will measure treatment-emergent adverse events, response rates, duration of response, and disease control. The study may last up to 48 months, with ongoing safety and efficacy monitoring during and after treatment.

Researchers are investigating treatments for people with small, unnoticed brain injuries called Covert Brain Infarcts CBIs, which are often found by chance during MRI scans. CBIs do not cause symptoms initially but are linked to higher risks of stroke and death. The study aims to see if medications that prevent stroke, like blood thinners and cholesterol-lowering drugs, can help reduce these risks and whether CBIs increase the chance of dementia. Participants will be randomly assigned to one of four groups one receiving a platelet inhibitor either Aspirin or Clopidogrel without statins, one receiving statin therapy Atorvastatin or Rosuvastatin without platelet inhibitors, one receiving both treatments, and one receiving neither treatment following current prevention guidelines. All groups will receive advice on lifestyle improvements and blood pressure management. Medication doses are carefully adjusted for tolerance, and the study follows a pragmatic, multicenter design. During the study, participants will be monitored for major cardiovascular and brain-related events, bleeding risks, dementia development, cognitive decline, and quality of life over 12 and 36 months. Assessments include MRI scans, physical activity levels, and various scales measuring daily living abilities, frailty, and neurological function. Researchers will also track serious adverse events and subtype characteristics of CBIs. The study duration spans at least three years with regular follow-ups to evaluate treatment effects and safety.

This research aims to gather long-term safety and effectiveness information for people treated with ibrutinib, a medicine taken by mouth that blocks a specific enzyme called brutons tyrosine kinase. The study focuses on participants who previously took part in ibrutinib studies that have finished and are still receiving ibrutinib treatment, continuing to benefit from it. It is an open-label study, meaning both participants and researchers know the treatment being given. Participants will continue taking ibrutinib capsules daily at the dose they were given in their prior study until the doctor decides the treatment is no longer helpful due to disease progression or side effects, the participant chooses to stop, other treatment options become available, or the study ends. Safety will be monitored throughout, and effectiveness data may be combined with previous study results. No formal testing of hypotheses is planned in this extension. During the study, participants will be regularly monitored for safety and disease status. The main outcome is the number of participants experiencing side effects within 30 days after the last ibrutinib dose or before starting another cancer therapy. Participants may continue treatment until alternative access to ibrutinib is arranged or the study ends, which is planned for December 2029. Researchers will collect ongoing data to understand the long-term effects of ibrutinib treatment.

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 a behavioural intervention called Light, activity and sleep in my daily life LAS aimed at improving quality of life for community-dwelling older adults aged 70 and over. The study focuses on addressing challenges related to circadian rhythm sleep disorders, poor sleep, reduced physical activity, and time spent indoors, which affect wellbeing in this population. The intervention targets light-related behaviour, outdoor walking, and sleep routines to promote active ageing and independence. The LAS intervention is delivered as a 9-week web-based course with nine modules covering electric lighting, daylight, outdoor physical activity, and sleep. Participants also receive a test kit with items like light bulbs, a sleep mask, and a sleep diary to support engagement and experimentation. The course includes one introductory physical meeting and three additional meetings held at a senior citizen meeting point. All participants receive the same noninvasive behavioural education and support. Participants complete questionnaires, interviews, and wear accelerometers to track activity and rest patterns before and after the course, with follow-ups at 3, 6, and 10 months after baseline. Outcomes measured include usability of the intervention, mood, sleep quality, behavioural skills, quality of life, physical activity, sedentary behaviour, and step counts. The study also explores factors that help or hinder daytime outdoor walking. Results will guide improvements for future delivery within municipal health promotion services.

Researchers are evaluating the efficacy, safety, and tolerability of a topical gel called TCP-25 in patients diagnosed with two types of Epidermolysis Bullosa, specifically Dystrophic and Junctional forms. This Phase 2, double-blind, randomized, vehicle-controlled study uses a design where matching wounds on the same patient are treated with either TCP-25 gel or a placebo gel to compare effects directly. Participants will undergo a Treatment Period lasting 56 days, during which they will apply either TCP-25 gel or placebo gel locally on designated wounds. Study visits occur every two weeks at baseline Day 1, and on Days 14, 28, 42, and 56. After treatment, a Safety Follow-up via telephone or video call is conducted approximately two weeks post last dose. Wound assessments include 3D digital photography and software measurements taken at all scheduled visits. During the study, participants will have evaluations for wound healing, safety, tolerability, and pharmacokinetics. Clinicians capture detailed images of wounds to measure open wound area and monitor changes. Pain levels, treatment-related local reactions, vital signs, and adverse events are regularly assessed. The total participation time includes screening, 56 days of treatment with five clinic visits, and a follow-up call about two weeks after treatment ends.