Aarau

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 conducting a global study to understand the impact of moderate to severe alopecia areata (AA), non-segmental vitiligo (NSV), and hidradenitis suppurativa (HS) on adolescents and adults. This study aims to assess the burden these conditions place on patients' quality of life and daily functioning in a large real-world population. The study involves participants diagnosed by a physician with one of the three conditions: AA, NSV, or HS. There are no interventional treatments or medications being tested in this study, as it is observational in nature. Data collection focuses on patient-reported outcomes and measures that evaluate disease severity and its effects. Participants will complete various questionnaires and assessments related to their condition, such as the Alopecia Areata Symptom Impact Scale (AASIS) for AA, the Severity of Alopecia Tool (SALT) for scalp hair loss in AA, the Facial Vitiligo Area Scoring Index (F-VASI) and Vitiligo Quality of Life Score (VitiQoL) for vitiligo, and the Dermatology Life Quality Index (DLQI) and International Hidradenitis Suppurativa Severity Scoring System (IHS4) for HS. These tools help researchers understand how symptoms affect quality of life and disease severity. The study collects information up to the day of the study visit.

Malignant cerebral infarction can cause dangerous brain swelling that increases pressure inside the skull. The usual treatment involves removing part of the skull (decompressive hemicraniectomy or DCE) to relieve pressure, followed by a second surgery months later to replace the bone flap or use a substitute (cranioplasty or CP). This study is exploring whether a new approach using a specially molded space-expanding shield implanted during the initial surgery can protect the brain and avoid the risks linked to the two-step process, such as brain exposure and bone resorption. Participants will be divided into two groups: one receiving the standard DCE followed by CP about 90 days later, and the other receiving DCE plus implantation of the space-expanding shield in a single surgery. The shield is designed to allow brain swelling while providing protection, potentially eliminating the need for a second operation. The cranioplasty in the control group may use either the patient's original bone flap or a synthetic PMME bone flap. Patients will be monitored through examinations at 1 to 7 days, 6 weeks, 3 months, and 6 months after surgery. The main outcome measured is the modified Ranking Scale score at 6 months, which evaluates patients’ recovery and function. The study aims to assess whether the shield offers a viable alternative to the traditional two-step surgical approach, with follow-up lasting six months for each participant.

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.

Researchers are evaluating how well elacestrant works compared to standard endocrine therapy in adults with node-positive, Estrogen Receptor-positive (ER+), Human Epidermal Growth Factor-2 negative (HER2-) early breast cancer who are at high risk of the cancer returning. This is a Phase 3 global, multicenter, randomized, open-label study focusing on participants who have had early invasive breast cancer removed and meet specific receptor and risk criteria. The study aims to understand which treatment better prevents invasive breast cancer over up to five years. Participants will receive either elacestrant or one of several standard endocrine therapies, including anastrozole, letrozole, exemestane, or tamoxifen, all given as oral tablets. Treatments will be administered according to the study plan, with careful monitoring throughout the trial. The study includes adults who have already received between 24 and 60 months of prior endocrine therapy, with or without certain inhibitors, and who have completed or stopped these treatments as required. During the study, participants will be monitored for invasive breast cancer-free survival for up to five years. Researchers will perform regular assessments to track treatment effects, side effects, and cancer recurrence. The study also includes safety monitoring and may involve additional tests or evaluations as needed to ensure participant well-being throughout the trial.

Researchers are evaluating the effectiveness of iberdomide maintenance therapy compared to lenalidomide maintenance therapy after autologous stem cell transplantation (ASCT) in adults with newly diagnosed multiple myeloma. This phase 3 study aims to determine which maintenance treatment better supports patients following their initial transplant and induction therapies. Participants must have responded to prior treatments and undergone ASCT within specified time frames. Participants will receive either iberdomide or lenalidomide at specified doses on scheduled days as maintenance therapy after their ASCT. The study is randomized, multi-center, and open-label, meaning both participants and researchers know which treatment is given. The treatments will be administered following a standard induction therapy including proteasome inhibitors, immunomodulatory drugs, and possibly monoclonal antibodies, with or without consolidation after transplant. Throughout the study, participants will be monitored for progression-free survival for up to 6 years to assess how well the maintenance therapies prevent disease progression. Researchers will also evaluate safety and treatment response according to established myeloma criteria. Regular assessments will include clinical evaluations and monitoring for any signs of disease relapse or adverse effects over the long term.

Researchers are evaluating the effect of a medicine called BI 765423 on lung function in adults aged 40 years and older who have idiopathic pulmonary fibrosis (IPF). Participants must have a forced vital capacity (FVC) of at least 45% of the predicted value and lung fibrosis of 20% or more confirmed by a high-resolution computed tomography (HRCT) scan. The study compares BI 765423 to a placebo to see if it can improve lung capacity after three months of treatment and also examines changes in lung health markers. Participants are randomly assigned to receive either BI 765423 or a placebo. The study drug is given as an intravenous infusion every four weeks. Participants may continue their standard IPF treatments during the study. The study lasts 8 to 10 months and includes several visits for screening, treatment, and follow-up. During the study, doctors regularly measure lung function by testing FVC and take blood samples to assess study outcomes. Researchers monitor participants' health and record any side effects. The main outcome measured is the absolute change in FVC from baseline after 12 weeks of treatment. Results from both groups will be compared to evaluate the treatment's effects.

This trial studies adults aged 18 years and older with lung fibrosis caused by systemic autoimmune rheumatic diseases who have not shown lung function improvement after standard immunosuppressant treatment. It evaluates how the medicine nerandomilast affects lung disease associated with these conditions. The study is a phase 3, double-blind, randomized, placebo-controlled trial designed to test nerandomilast's safety and efficacy over at least 26 weeks. Participants are randomly assigned to receive either nerandomilast tablets or placebo tablets twice daily for a period of at least 26 weeks and up to 1 year. Alongside this, participants continue their ongoing immunosuppressant treatments for their rheumatic disease. The study involves two groups receiving either the active drug or placebo to compare outcomes between them. During the 7.5 to 13 months of participation, individuals visit the study site about 9 to 10 times for lung function tests, chest imaging at select visits, and to complete questionnaires about symptoms and quality of life. Researchers monitor changes in lung disease using high-resolution CT scans and assess safety by recording any side effects. The main outcome is the change in lung fibrosis score after 26 weeks of treatment.

Researchers are evaluating treatment combinations in adults with head and neck squamous cell carcinoma (HNSCC) that has spread or returned and cannot be cured with local therapies. The study aims to determine whether combining the drugs BI 770371, pembrolizumab, and cetuximab can shrink tumors more effectively compared to pembrolizumab alone. This is a Phase Ib open-label randomized trial focused on the first-line treatment of metastatic or recurrent HNSCC. Participants are randomly assigned to one of three groups, each receiving a different combination of the study drugs. All medications are given through vein infusions at the study site. The combinations include BI 770371 with pembrolizumab, with or without cetuximab, or pembrolizumab alone. Participants may continue treatment as long as they benefit from it. Throughout the study, doctors regularly assess tumor size and check for cancer spread using standard criteria. They also monitor participants' overall health and record any side effects. The primary outcome is the objective response of tumors over a period of up to 27 months. Participants provide tissue samples before treatment begins. The study includes ongoing evaluations to ensure safety and measure how well the treatments work.

Glucocorticoids are stress hormones vital for controlling inflammation and regulating the immune system. This research focuses on children treated for lymphoblastic leukemia and lymphoblastic lymphoma, cancers that require glucocorticoid therapy. The study aims to understand how often and for how long natural glucocorticoid production is suppressed in these children after treatment, and to identify those at higher risk for this deficiency. Children with these blood cancers receive glucocorticoids as medication to quickly reduce cancer cells, but this can suppress their body's own hormone production. To study this, doctors will perform regular low-dose ACTH tests during and after treatment to assess hormone levels. These tests are done only when children already have venous access during hospital stays, to avoid extra procedures. Participants will be monitored from the start of their glucocorticoid treatment until three months after their last dose. Researchers will measure the occurrence of adrenal insufficiency, which is when the body does not produce enough glucocorticoids. This monitoring helps improve understanding of hormone deficiency related to cancer treatment and may lead to better detection and care for affected children.