Gjovik

Researchers are evaluating a new treatment called ifinatamab deruxtecan (I-DXd) for men with metastatic castration-resistant prostate cancer (mCRPC). This study compares I-DXd to chemotherapy to see if it helps people live longer overall and live longer without their cancer worsening. It is a Phase 3, open-label trial focused on patients who have progressed on prior therapies and have evidence of metastatic disease. Participants receive either I-DXd through an intravenous infusion every 3 weeks or docetaxel chemotherapy administered every 3 weeks. Prednisone tablets are also given daily as part of the treatment plan. Before each I-DXd dose, premedication is provided to help prevent nausea and vomiting using a combination of drugs such as corticosteroids and anti-nausea medicines. Treatment continues until disease progression, unacceptable side effects, or other reasons to stop. During the study, researchers monitor overall survival and how long patients live without their cancer progressing, for up to about 36 months. Participants undergo tumor tissue collection, scans, and assessments to track disease status and side effects. Safety is closely watched throughout treatment. The study includes men aged 18 and older with confirmed prostate cancer and metastatic disease who have previously received certain hormone therapies but no prior taxane chemotherapy for mCRPC.

Researchers are evaluating the safety and effectiveness of combining durvalumab and domvanalimab compared to durvalumab plus placebo in adults with locally advanced (Stage III), unresectable non-small cell lung cancer (NSCLC) whose disease has not worsened after definitive platinum-based concurrent chemoradiation therapy. This Phase III, randomized, double-blind, placebo-controlled, international study involves multiple centers. Participants receive intravenous infusions of durvalumab and domvanalimab or durvalumab and placebo. The treatments are given after patients have completed concurrent platinum-based chemotherapy and radiation therapy with a total radiation dose of approximately 60 Gy. The study monitors patients over time to assess treatment effects and safety. During the study, participants undergo evaluations including tumor tissue analysis for PD-L1 status, performance status assessments, and monitoring of organ and marrow function. The main outcome measured is progression-free survival up to 8 years after randomization. Researchers also monitor for any adverse effects and disease progression throughout the study period.

Researchers are evaluating the effectiveness of adding LY3537982 (olomorasib) to standard anti-cancer drugs compared to standard treatment alone in participants with untreated advanced non-small cell lung cancer (NSCLC) that has a specific KRAS G12C gene mutation. This pivotal Phase 3 trial includes participants with locally advanced or metastatic NSCLC and considers their programmed death-ligand 1 (PD-L1) expression levels. The study includes multiple parts: Dose Optimization, Part A, and Part B are randomized, while Safety Lead-In for Part B and Part C are non-randomized. Treatments being assessed include LY3537982 taken orally, pembrolizumab administered intravenously, and standard chemotherapy drugs such as cisplatin, carboplatin, and pemetrexed given intravenously. Participants receive these treatments according to their assigned groups based on their PD-L1 expression and tumor histology. Participants will be monitored with regular assessments including measuring disease progression, safety evaluations, and treatment emergent adverse events for up to approximately one year, with overall study participation potentially lasting up to three years depending on individual response and health status. Outcome measures focus on progression-free survival and safety, capturing any adverse events from the start of treatment until disease progression or death.

Researchers are evaluating whether adding sacituzumab tirumotecan to pembrolizumab after surgery improves treatment outcomes for adults with resectable non-small cell lung cancer (NSCLC) who have not achieved a complete response after initial therapy. This Phase 3 study compares the combination of sacituzumab tirumotecan and pembrolizumab to pembrolizumab alone, focusing on disease-free survival as measured by a blinded independent central review. Participants receive neoadjuvant treatments including pembrolizumab with platinum-based doublet chemotherapy (such as cisplatin, pemetrexed, gemcitabine, carboplatin, or paclitaxel) before surgery. After surgery, those without a complete pathological response are randomized to receive either sacituzumab tirumotecan every two weeks for up to 24 weeks plus pembrolizumab every six weeks for up to 42 weeks, or pembrolizumab alone. Rescue medications may be given to prevent infusion reactions and oral side effects. During the study, participants undergo regular radiological assessments and provide tumor tissue samples to evaluate markers like PD-L1 and TROP2. Researchers monitor disease-free survival for up to approximately 93 months. Safety assessments, recovery from previous therapies, and control of infections such as HIV or hepatitis are also part of participant evaluations throughout the study period.

Researchers are evaluating a complex intervention aimed at implementing advance care planning (ACP) for severely ill elderly patients who live at home and are acutely admitted to hospital. The study uses a cluster randomized design involving twelve Norwegian hospital units specializing in geriatric care. It seeks to understand current ACP implementation, identify barriers and facilitators at multiple levels, explore ethical dilemmas, and assess the benefits and challenges experienced by patients, relatives, and healthcare staff. The project also aims to measure the impact of an implementation support program on communication quality, decision-making, and healthcare outcomes, as well as its cost-effectiveness. The intervention includes a comprehensive implementation support program featuring leadership commitment, responsive evaluation, a whole ward approach, and a train-the-trainer model to ensure sustainability. This program provides an implementation team and ACP coordinators, along with training, supervision, network conferences, and shared resources such as guidelines and teaching materials. The clinical intervention involves routine information and invitation to ACP for eligible patients, written materials for patients and relatives, and documentation with collaboration across healthcare levels. Half of the hospital units receive this support immediately, while the others receive it after the intervention period. Participants are involved through questionnaires to staff, clinicians, patients, and relatives, as well as patient record reviews and qualitative interviews. The study measures fidelity to the ACP model at multiple time points and evaluates patient-reported, relative-reported, and clinician outcomes during the intervention period, which spans 10 to 18 months after starting the support. Researchers also assess barriers and facilitators in wider healthcare contexts and perform economic analyses. The total involvement includes baseline and follow-up assessments up to 18 months.

Researchers are evaluating a preventive intervention called Condensed Internet-delivered Prolonged Exposure (CIPE) for people who have symptoms of post-traumatic stress disorder (PTSD) about one month after experiencing a traumatic event. The study aims to test the effectiveness and cost-effectiveness of CIPE in Norwegian municipal psychosocial crisis services, comparing it to usual treatment. This research addresses the lack of evidence-based preventive options available for trauma victims in Norway and explores how CIPE may reduce PTSD symptoms, depression, insomnia, prolonged grief, and the need for specialized mental health care. CIPE is a therapist-supported program delivered online through four modules. It includes education about normal trauma reactions, exposure techniques to confront reminders of trauma both in real life and imagination, and a breathing exercise. Participants receive CIPE alongside treatment as usual (TAU), which varies but generally involves psychological first aid, psychoeducation, social support activation, and practical help. The study compares outcomes between those receiving CIPE plus TAU and those receiving only TAU. Participants are involved for at least 6 weeks after starting treatment, with follow-ups at 6 and 12 months post-trauma. Researchers assess symptoms using the PTSD Checklist for DSM-5 (PCL-5) and measure depression, insomnia, prolonged grief, treatment satisfaction, and referrals to specialized care. The study also evaluates quality of life and cost-effectiveness of adding CIPE to usual care. Participants must complete questionnaires and provide informed consent, with language requirements for English or Norwegian speakers aged 16 to 99 years.

Researchers are evaluating whether a shorter course of palliative radiotherapy given in 1-2 treatments is not less effective than a longer course given in five treatments for patients with pelvic soft tissue tumors caused by gastrointestinal, urological, or gynecological cancers. This national, open-label, randomized phase III trial aims to compare how well each schedule relieves symptoms reported by patients. Other outcomes studied include quality of life, side effects, survival, and biomarkers related to prognosis and treatment response, especially tumor hypoxia. The trial compares two radiotherapy schedules: a short-course schedule delivering 8 Gy in 1-2 fractions and a longer schedule delivering 5 Gy in 5 fractions. Patients will identify one main symptom from categories such as pain, bleeding, or dysfunction of bowel, urinary, or vaginal systems to monitor changes in symptom severity. The study will assess toxicities, quality of life, and survival alongside exploring predictive biomarkers. Women of childbearing potential must have a negative pregnancy test and agree to effective contraception or abstinence during the study intervention. Participants will be monitored for at least 12 weeks after treatment to assess symptom changes and side effects through patient-reported outcomes and questionnaires. They must be able to pause systemic cancer treatments around the radiotherapy period. The study requires participants to understand Norwegian or English and be able to provide informed consent. Researchers will also evaluate overall survival and collect data on health-related quality of life throughout the trial.

Researchers are investigating whether olomorasib combined with pembrolizumab is more effective than pembrolizumab plus placebo for participants with resected KRAS G12C-mutant non-small cell lung cancer (NSCLC) in part A. In part B, they are assessing if olomorasib combined with durvalumab is more effective than durvalumab plus placebo for participants with unresectable KRAS G12C-mutant NSCLC. This Phase 3 study may last up to 3 years for each participant.

Ankle fractures are common injuries, occurring in about 1 in 800 people each year. The deep deltoid ligament plays a crucial role in stabilizing the ankle joint and influences treatment decisions. Researchers aim to find out if repairing the deltoid ligament in unstable ankle fractures leads to better function and may help prevent long-term osteoarthritis compared to treating only the lateral malleolus fracture. This study is a multicenter randomized controlled trial focusing on patients with complex ankle fractures requiring surgery. Participants will be randomly assigned to receive either the standard surgical repair of the lateral malleolus alone or with an additional procedure to suture the deep deltoid ligament. The ligament repair involves a curved incision to access and suture the ligament to an anchor in the talus bone. This treatment may also help compensate for related syndesmotic injuries. The study will compare functional outcomes and ankle stability between these treatments over time. Participants will be followed for up to five years after injury, with key assessments at one and two years, including patient-reported function and radiological evaluations of ankle stability. Data on function at five years will also be collected. Researchers will monitor recovery, ankle joint condition, and any signs of arthritis to determine if ligament repair offers long-term benefits. The total participation time involves initial treatment and multiple follow-up visits for evaluations and imaging.

Researchers are studying the effectiveness and potential complications of new immunotherapies used to treat multiple myeloma, plasma cell leukemia, and AL amyloidosis in routine care settings in Norway. The goal is to fill gaps in knowledge, support future clinical trials, and help develop guidelines for monitoring and managing side effects to improve patient survival and quality of life. This observational study focuses on patients receiving these treatments as part of regular medical care. The treatments studied include Teclistamab, Elranatamab, Talquetamab, Idecabtagene vicleucel, and Ciltacabtagene autoleucel. The study tracks how these therapies are used and dosed in real-world settings outside clinical trials. Patients receive these immunotherapies as planned by their healthcare providers, and their treatment details and outcomes are observed over time. Participants will be followed for up to ten years from the start of treatment. Researchers will gather data on overall response rates, progression-free survival, time to next treatment, and overall survival. They will also monitor the frequency and severity of adverse events, infection patterns, antibiotic resistance, and use of antimicrobial prevention methods. Data collection includes real-world clinical outcomes to better understand the long-term effects and safety of these immunotherapies.