Fribourg

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 effectiveness of zanubrutinib combined with anti-CD20 antibodies compared to lenalidomide plus rituximab (R2) in adults with relapsed or refractory follicular lymphoma (FL) or marginal zone lymphoma (MZL). The study aims to measure progression-free survival using independent review committees and established lymphoma response criteria based on PET/CT and CT imaging. Participants will receive zanubrutinib orally either as 160 mg twice daily or 320 mg once daily in continuous 28-day cycles. In the zanubrutinib plus rituximab group, rituximab is given intravenously at 375 mg/m2 on Days 1, 8, 15, and 22 of Cycle 1 and Day 1 of Cycles 2 to 5, each cycle lasting 28 days. The comparator group receives lenalidomide orally at 20 mg daily on Days 1 to 21 of each 28-day cycle for 12 cycles, plus obinutuzumab intravenously at 1000 mg on Cycle 1 Days 1, 8, 15 and Cycles 2 to 6 Day 1. During the study, participants will undergo imaging assessments such as PET/CT and CT scans to evaluate disease progression. Researchers will monitor treatment response and safety over approximately 78 months. Progression-free survival is the primary outcome, measured by a blinded independent review committee. Participants are expected to have measurable disease and adequate organ function at enrollment, with ongoing assessments to track treatment effects and adverse events.

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 the benefit of adding adjuvant durvalumab after neoadjuvant chemotherapy combined with durvalumab and surgery in patients with early-stage, operable non-small cell lung cancer (NSCLC), specifically stages IIB to IIIB (N2). This international, multicenter, open-label phase III trial aims to see if additional durvalumab treatment after surgery improves disease-free survival in patients who do not achieve complete pathological response after initial therapy. The study includes patients with resectable tumors who meet specific staging and health criteria.

Researchers are investigating better treatments for people with advanced non-small cell lung cancer (NSCLC) that has specific genetic changes called HER2 mutations. Advanced NSCLC refers to lung cancers that have spread or are unlikely to be controlled with current treatments. HER2 is a protein that helps cells grow, and mutations cause abnormal HER2 leading to cancer growth. This Phase 3 study aims to compare the safety and effectiveness of a new drug, sevabertinib, against standard treatment in patients with this type of lung cancer. Participants will be randomly assigned to receive either sevabertinib tablets twice daily by mouth or standard treatment consisting of cycles of intravenous infusions including drugs like pembrolizumab, cisplatin, carboplatin, and pemetrexed every 21 days. Treatments continue as long as participants benefit without severe side effects or until they or their doctors decide to stop. Participants on standard treatment whose disease worsens may switch to sevabertinib and continue until progression, intolerable side effects, or decision to stop. During the study, participants will undergo imaging scans such as CT, PET, MRI, and X-rays to monitor cancer spread. Health checks include blood and urine tests, heart monitoring with ECG, and pregnancy tests for women. Researchers will ask about participants’ well-being and record any medical problems or side effects experienced. The main outcome measured is progression-free survival over up to about two years.

Researchers are evaluating whether antibiotic treatment is necessary for children aged 3 to 17 years with community-acquired pneumonia caused by Mycoplasma pneumoniae, a common bacterial cause of pneumonia in children. This study compares the effect of a placebo to a commonly used antibiotic, macrolides (specifically azithromycin), in treating this infection. The study is a randomized, double-blind, placebo-controlled trial conducted across 13 pediatric centers in Switzerland, aiming to address concerns about antibiotic effectiveness and growing resistance. Participants diagnosed with community-acquired pneumonia and confirmed to have Mycoplasma pneumoniae infection through an IgM test will be randomly assigned to receive either azithromycin or a placebo for five days. Azithromycin dosing starts at 10 mg/kg on the first day and continues at 5 mg/kg on days two through five. The study includes both ambulatory and hospitalized children and uses a blinded design to ensure unbiased comparison between the antibiotic and placebo treatments. During the study, participants will be monitored closely for changes in symptoms and vital signs until recovery. Researchers will measure the number of days until vital signs return to normal and track changes in patient care status related to pneumonia for up to 28 days. Data collection includes symptom tracking, clinical assessments, and follow-up visits to evaluate the effectiveness and safety of treatment, with a focus on whether antibiotics provide additional benefits over placebo.

Researchers are evaluating tarlatamab, an intravenous drug, in patients with extensive-stage small cell lung cancer (ES-SCLC) who have an ECOG performance status of 2 and have already received one line of platinum-etoposide chemotherapy with immune checkpoint inhibition. This international, multicenter, single-arm phase II trial aims to assess the effectiveness of tarlatamab by measuring the overall survival rate at 12 months after enrollment, with follow-up for up to approximately 41 months. Participants receive tarlatamab as an intravenous infusion starting with 1 mg on day 1, followed by 10 mg on days 8 and 15 of the first cycle. After that, 10 mg infusions are given every two weeks until the disease progresses, unacceptable side effects occur, or the patient decides to stop treatment. The treatment follows disease progression criteria defined by RECIST v1.1 and continues under close monitoring. Throughout the study, patients are monitored for survival and treatment safety. Researchers assess overall survival from enrollment until death from any cause. The study involves regular clinical evaluations to track disease progression, side effects, and patient well-being. Participation duration varies depending on treatment response and disease status, with safety and effectiveness observed for up to 41 months after enrollment.

Breast, colorectal, ovarian, and endometrial cancers account for about 30% of new cancer cases in Switzerland, affecting over 12,000 people each year. Many of these patients may carry genetic mutations linked to Hereditary Breast and Ovarian Cancer (HBOC) or Lynch Syndrome (LS). Genetic testing can help prevent cancer deaths by identifying those at risk early and providing management options like surveillance, prevention, or surgery. However, many mutation carriers and their families do not use genetic services due to poor care coordination or lack of communication within families. This research is studying a family-based approach called CASCADE genetic screening. It involves enrolling mutation carriers, their blood relatives who test negative, and untested relatives into a cohort. The goal is to understand cancer status, surveillance habits, care coordination needs, communication patterns, and quality of life among these groups. The study also explores how patient-provider communication affects family communication and tests the acceptability of interventions focused on family-based communication and decision support. Participants will complete surveys about their cancer and mutation status, surveillance practices, psychosocial needs, and communication experiences. Researchers will assess willingness to serve as advocates for genetic services and to participate in related studies. The study monitors outcomes over 12 months to establish the CASCADE cohort. Eligibility includes adults living in Switzerland who carry mutations linked to HBOC or LS and have living blood relatives. The study emphasizes understanding and improving the use of genetic testing and care among families at risk.

This research investigates the best approach for treating low-risk patients with isolated subsegmental pulmonary embolism (SSPE), a condition where small blood clots block tiny arteries in the lungs. The study aims to clarify whether SSPE truly requires anticoagulant treatment or if careful monitoring without medication is a safe option. Currently, many patients receive anticoagulants, which can increase bleeding risk, but some evidence suggests that avoiding these drugs might be safe in selected patients without other complications. Participants are randomly assigned to receive either the anticoagulant drug rivaroxaban or a placebo, allowing comparison between clinical surveillance without anticoagulation and standard anticoagulation treatment. This phase 4, multicenter trial evaluates outcomes over a 90-day period following randomization. During the study, researchers monitor participants for recurrent venous thromboembolism and assess safety outcomes related to bleeding. Participants provide informed consent and are followed closely to observe any clots returning or adverse events. The total follow-up is at least 90 days to determine the efficacy and safety of withholding anticoagulation in this specific patient group.

Researchers are evaluating Trastuzumab deruxtecan (T-DXd) in adult patients with unresectable or metastatic HER2-low expressing breast cancer. This non-interventional study aims to assess the effectiveness of T-DXd, patients' demographic and clinical characteristics, treatment patterns, tolerability, management of adverse drug reactions, and patient experience. The study also collects data on conventional chemotherapy treatments in a disease registry to better understand treatment outcomes in this population. Participants will receive treatment with Trastuzumab deruxtecan or conventional chemotherapy drugs such as capecitabine, eribulin, gemcitabine, paclitaxel, or nab-paclitaxel according to the Summary of Product Characteristics and routine clinical practice. No study drug will be administered by the researchers, as treatments follow physicians' standard care decisions. This approach allows observation of real-world treatment use and outcomes. During the study, patients' treatment timelines and responses will be followed, focusing on the time to next treatment up to 31 months. Researchers will monitor tolerability, adverse drug reactions, and patient-reported experiences. Data collection includes clinical and demographic information, treatment patterns, and outcomes to provide a comprehensive understanding of T-DXd and conventional chemotherapy use in this patient group.