Gjovik

Researchers are studying metastatic castration-resistant prostate cancer mCRPC to find new treatment options. This trial evaluates if the study medicine ifinatamab deruxtecan I-DXd or MK-2400 helps people live longer overall and experience slower cancer growth or spread compared to chemotherapy. The study is a Phase 3 trial comparing I-DXd with standard chemotherapy for mCRPC patients. Participants are randomly assigned to receive either I-DXd at 12 mgkg every 3 weeks through intravenous infusion or docetaxel chemotherapy at 75 mgm2 every 3 weeks combined with daily prednisone pills. Treatment continues until the disease progresses, unacceptable side effects occur, or treatment is stopped for other reasons. Premedication is given before each dose of I-DXd to help prevent nausea and vomiting. During the study, participants will have regular visits for treatment and monitoring. Researchers will assess overall survival and radiographic progression-free survival for up to about 36 months. Additional measures include response rates, time to pain progression, PSA progression, and adverse events. The study tracks safety, treatment effects, and quality of life over a long follow-up period to better understand the potential benefits and risks of I-DXd compared to chemotherapy.

Researchers are evaluating the efficacy and safety 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 progressed after definitive platinum-based concurrent chemoradiotherapy cCRT. This Phase III, randomized, double-blind, placebo-controlled, international study aims to provide new insights into treatment options for this patient population. Participants will receive either durvalumab and domvanalimab or durvalumab plus placebo as intravenous infusions every four weeks, beginning on Day 1 and continuing for up to 12 months. The study includes two groups one receiving the combination of durvalumab and domvanalimab, and the other receiving durvalumab with a placebo. Both treatments are given through infusion to assess their effects on disease progression and safety. During the trial, participants will undergo regular assessments including monitoring progression-free survival for up to 8 years after randomization. Other measures include overall survival, response rates, duration of response, and various time-to-event outcomes related to disease progression and symptom deterioration. Researchers will also evaluate drug concentrations and immune responses approximately 12 weeks after the last dose. Participants can expect scheduled visits for infusions and evaluations as part of this long-term study.

Researchers are evaluating if adding LY3537982 olomorasib to standard anti-cancer drugs improves treatment for participants with untreated advanced non-small cell lung cancer NSCLC that has a specific KRAS G12C gene change. This Phase 3 treatment study includes participants with locally advanced or metastatic NSCLC and aims to compare this combination against standard care. The study is sponsored by Eli Lilly and Company and could last up to 3 years depending on individual response and disease progression. Participants receive LY3537982 orally combined with pembrolizumab given intravenously in 21-day cycles. Some groups also receive chemotherapy drugs pemetrexed and platinum cisplatin or carboplatin intravenously. There are different dose levels and combinations being tested, including placebo groups for comparison. Treatment continues until specific discontinuation criteria are met. Parts of the study are randomized and double-blinded, with some parts non-randomized for safety lead-in. During the study, participants have regular assessments including imaging scans to measure tumor response, blood tests, and questionnaires about symptoms and quality of life. Researchers monitor side effects and survival outcomes. The main measures include progression-free survival and treatment-emergent adverse events over about one year, with overall survival followed for up to three years. Participants are closely followed throughout treatment and after to evaluate the effects and safety of the study medications.

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 do not achieve a complete response after initial therapy. This Phase 3 trial compares the combination of sacituzumab tirumotecan plus pembrolizumab against pembrolizumab alone, focusing on disease-free survival assessed by a blinded independent central review. The study is sponsored by Merck Sharp & Dohme LLC and targets participants with specific stages of NSCLC who have undergone neoadjuvant therapy and surgery but still have residual disease. Participants first receive neoadjuvant therapy consisting of pembrolizumab combined with double-platinum chemotherapy tailored to the tumor type for up to 12 weeks before surgery. After surgery, those not achieving pathological complete response are assigned to either receive sacituzumab tirumotecan infusions every two weeks for up to 24 weeks alongside pembrolizumab monotherapy every six weeks for approximately 42 weeks, or pembrolizumab monotherapy alone on the same schedule. Rescue medications to manage infusion reactions may be given as needed during the study. Throughout the trial, participants undergo assessments including radiological scans, tumor tissue analysis for markers like PD-L1 and TROP2, and monitoring for adverse events and quality of life changes. Key outcomes include disease-free survival, overall survival, distant metastasis-free survival, and lung cancer-specific survival, with evaluations continuing for up to nearly 10 years. Safety and tolerability are closely monitored, and questionnaires assess physical functioning, symptoms like cough and chest pain, and overall health status during and after treatment.

Researchers are evaluating a complex intervention to improve advance care planning ACP for severely ill elderly people living at home who are acutely admitted to hospital. This cluster randomized study involves twelve Norwegian geriatric hospital units and aims to enhance patient and family involvement in treatment decisions, improve quality of life, and support ethical and legal care planning. The project also explores barriers and facilitators to implementing ACP at clinical, health service, and governmental levels, including economic analyses. The intervention group receives a comprehensive support program that includes leadership commitment, training for staff, implementation teams, ACP coordinators, and practical tools such as guidelines and documentation templates. The control group receives no implementation support during the trial but will be offered the program afterward. The study period includes baseline, 9-month, and 18-month assessments for the intervention group and baseline and 18-month assessments for the control group. Participants will undergo questionnaires and interviews with patients, relatives, clinicians, and staff at multiple time points before, during, and after the implementation. Data from patient records and national health registers will be collected to assess the fidelity of ACP implementation, clinical outcomes, communication quality, and cost-effectiveness. The trial runs until December 2026 and includes various measures to evaluate the impact of the support program on ACP delivery and related outcomes.

Researchers are evaluating a preventive intervention called Condensed Internet-delivered Prolonged Exposure CIPE for people experiencing symptoms of post-traumatic stress disorder PTSD about one month after a traumatic event. The goal is to test the effectiveness and cost-effectiveness of CIPE when added to usual treatment provided by psychosocial crisis teams in Norwegian municipalities. This study addresses the lack of evidence-based preventive interventions available for victims after crises and disasters in Norway. Participants are randomly assigned to receive either treatment-as-usual TAU alone or TAU plus the CIPE intervention. CIPE is a therapist-supported, internet-based program consisting of four modules delivered over six weeks. Participants are encouraged to engage daily with their therapist through a secure platform and may have phone sessions. The total therapist contact is generally under 60 minutes, while participants work on intervention tasks about six hours weekly. TAU involves proactive support from interdisciplinary crisis teams following national guidelines. Throughout the one-year study period after trauma, participants undergo assessments including the PTSD Checklist for DSM-5 at 10 to 13 weeks, 6 months, and 12 months post-trauma. Other measures include depression, insomnia, grief symptoms, treatment satisfaction, and quality of life. Researchers will monitor use of specialized mental health services and cost-effectiveness. The study aims to understand how CIPE plus usual care compares to usual care alone in reducing PTSD symptoms and improving overall outcomes.

Researchers are investigating palliative radiotherapy for patients with symptomatic pelvic soft tissue tumors from gastrointestinal, urological, or gynecological cancers. This national, randomized, open-label phase III trial aims to determine if a short-course radiotherapy schedule 1-2 fractions of 8 Gy provides symptom relief that is not worse than a longer schedule 5 fractions of 5 Gy. The study also evaluates health-related quality of life, toxicities, survival, and biomarkers related to tumor hypoxia as secondary and exploratory goals. Participants will receive either a short-course radiotherapy treatment of 8 Gy in 1-2 sessions or a longer course of 5 Gy in 5 sessions. Both schedules are delivered as palliative care to relieve symptoms such as pain, bleeding, or dysfunction in bowel, urinary, or vaginal areas. Patients will choose a main symptom to track during the study. The trial specifically excludes curative treatments and focuses on symptom control with radiation therapy. During the study, patients are monitored through patient-reported symptom intensity assessments, physician-reported toxicities up to 52 weeks, and survival evaluations over two years. Researchers will also collect quality of life data and explore biomarkers to better understand treatment effects. Participation involves regular symptom reporting and clinical follow-up, with the primary outcome measured 12 weeks after treatment.

Researchers are evaluating whether olomorasib combined with pembrolizumab or durvalumab is more effective than these immunotherapies alone in participants with KRAS G12C-mutant non-small cell lung cancer NSCLC. The study focuses on two groups those with resected NSCLC and those with unresectable NSCLC. This Phase 3 trial aims to assess disease-free survival and progression-free survival among these participants over an estimated period of up to 3 years. Participants will receive either olomorasib or a placebo orally along with pembrolizumab or durvalumab administered intravenously for up to one year. After this combination phase, participants continue with olomorasib or placebo alone for up to a total of three years of treatment. The study includes randomized, double-blind groups to compare these combinations in both resected and unresectable NSCLC. During the study, participants undergo regular assessments to monitor disease progression, overall survival, and quality of life using questionnaires and imaging. Researchers measure outcomes such as disease-free survival, progression-free survival, response rates, and symptom changes related to NSCLC. The study also tracks safety and health impacts over the treatment period, which may last up to three years for each participant.

Ankle fractures are common injuries occurring in about 1 in 800 people each year. This research evaluates whether repairing the deltoid ligament in unstable ankle fractures improves joint stability, functional outcomes, and may help prevent long-term osteoarthritis. The study focuses on patients with severe ankle fractures, as these injuries can significantly reduce daily function and affect the ability to work, potentially increasing community healthcare costs. Participants will be randomly assigned to one of two groups one receiving standard treatment involving plate and screw fixation of the lateral malleolus only, and the other receiving the same standard treatment plus an additional surgical repair suture of the deep deltoid ligament. The ligament repair involves a specific surgical technique where the ligament is reattached to an anchor in the talus. This multicenter randomized controlled study aims to compare these approaches in unstable Weber B ankle fractures. During the study, participants will be evaluated through patient-reported functional outcomes and radiological stability measurements at 1 and 2 years after injury, with functional outcome data also collected at 5 years. Additional assessments include general health, pain levels, ankle arthritis development, and foot and ankle function scores collected at various intervals up to 5 years. Researchers will monitor the long-term effects of ligament repair on ankle stability and function, with follow-up visits planned to assess recovery and outcomes.

Researchers are conducting an observational study to understand how new immunotherapies are used in treating multiple myeloma and related conditions in Norway. The study aims to fill knowledge gaps, provide evidence for future trials, and help develop guidelines for monitoring and managing side effects to improve patient survival and quality of life. This research focuses on patients with multiple myeloma, primary plasma cell leukemia, and AL amyloidosis. Participants are observed while receiving immunotherapies including Teclistamab, Elranatamab, Talquetamab, Idecabtagene vicleucel, and Ciltacabtagene Autoleucel as part of their routine care outside of clinical trials. The study monitors how these treatments are used in real-world settings, including dosing and administration. There is no assigned treatment group or placebo instead, the study collects data on treatments given during regular healthcare. Throughout the study, participants response to treatment, progression-free survival, time to next treatment, overall survival, and adverse events are tracked for up to ten years. Researchers collect data on infections, antibiotic resistance, airway viruses, and use of antimicrobial prophylaxis during therapy. This long-term monitoring aims to provide comprehensive safety and effectiveness information to guide future care and research.