Fribourg

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 Dostarlimab compared to a placebo in adults with locally advanced unresected Head and Neck Squamous Cell Carcinoma HNSCC. This phase 3 trial aims to assess the safety and effectiveness of Dostarlimab as a sequential therapy following chemoradiation treatment in participants with this type of cancer. Participants are randomly assigned to receive either Dostarlimab or a placebo, both given as intravenous infusions. The study is double-blind, meaning neither the participants nor the researchers know which treatment is being given. The treatments follow completion of chemoradiation with cisplatin and radiotherapy intended to cure the cancer. During the study, participants will be monitored for up to approximately 5 years. Researchers will evaluate event-free survival and overall survival, with safety assessments including treatment-emergent adverse events and laboratory tests. Blood samples will be taken to measure drug levels and immune responses. This long-term follow-up will help understand the effects and safety of Dostarlimab after chemoradiation therapy.

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 conducting an international, multicenter, open-label phase III trial to evaluate the addition of adjuvant durvalumab after neoadjuvant chemotherapy combined with durvalumab and surgery in patients with early-stage, operable non-small cell lung cancer NSCLC stages IIB to IIIB. The main goal is to see if giving durvalumab after surgery improves disease-free survival in patients who do not achieve complete pathological response after initial treatment. The treatment plan involves 3 to 4 cycles of neoadjuvant durvalumab combined with platinum-based doublet chemotherapy, followed by surgery to remove the tumor. After surgery, patients with complete R0 or microscopic residual R1 resection are randomly assigned to either receive adjuvant durvalumab given intravenously at 1500 mg every 4 weeks for up to 12 cycles or to be observed without additional treatment. Participants will be monitored regularly for about 60 months after randomization to assess disease-free survival and other outcomes such as overall survival, time to recurrence, and treatment toxicity. Assessments include imaging scans to check for metastatic disease, pathological review after surgery, and ongoing safety evaluations. Participants must attend scheduled visits and follow study procedures throughout the treatment and follow-up periods.

Researchers are evaluating treatments for people with advanced non-small cell lung cancer NSCLC that have specific genetic changes called HER2 mutations. This lung cancer has spread or cannot be controlled with current treatments. The study aims to compare how well a drug called sevabertinib works and how safe it is compared to standard treatment for this type of cancer. Participants will receive either sevabertinib tablets twice daily or standard treatment consisting of pembrolizumab combined with platinum-based chemotherapy given every 21 days by infusion. Those on standard treatment who experience disease progression may switch to sevabertinib. Treatment continues as long as participants benefit and do not have severe side effects or until they or their doctor decide to stop. During the study, participants will have imaging scans like CT, PET, MRI, and X-rays to monitor cancer spread. Doctors will also perform health checks including blood and urine tests, heart monitoring with ECG, pregnancy tests for women, and ask about symptoms or side effects. The main measure is progression-free survival assessed up to about 2 years, with additional outcomes related to survival, response rates, side effects, and quality of life followed up to 4 years.

Researchers are evaluating whether antibiotic treatment is necessary for children with community-acquired pneumonia caused by the bacterium Mycoplasma pneumoniae. This trial compares the effects of a commonly used antibiotic, azithromycin, with a placebo in children aged 3 to 17 years. The study addresses concerns about increasing antibiotic resistance and aims to improve treatment decisions for this common cause of pneumonia in children. Participants are randomly assigned to receive either azithromycin or a placebo for five days. The azithromycin group takes a daily dose of 10mgkg on the first day followed by 5mgkg on days 2 through 5. This randomized, double-blind, placebo-controlled trial takes place across multiple pediatric centers and includes both ambulatory and hospitalized children. The study involves initial screening to confirm Mycoplasma pneumoniae infection using a specific antibody test before starting the assigned treatment. During the study, researchers will monitor symptom duration, vital signs, and changes in patient care status for up to 28 days. They will also assess overall clinical outcomes, symptom resolution, quality of life impacts on the family, time to return to normal daily activities, and the development of any complications related to the infection. Follow-up includes clinical examinations and parent reports to track progress and safety throughout the study period.

Researchers are evaluating tarlatamab in patients with extensive-stage small cell lung cancer ES-SCLC who have already received one line of platinum-etoposide chemotherapy combined with immune-checkpoint inhibition and have an ECOG Performance Status of 2. This phase II international trial aims to assess the clinical effectiveness of tarlatamab by measuring the overall survival rate at 12 months in this population whose disease has progressed. Participants receive tarlatamab through an intravenous infusion starting with 1 mg on day 1, followed by 10 mg on days 8 and 15, and then 10 mg every two weeks thereafter. This treatment continues until disease progression, unacceptable side effects, or the participant decides to stop. The study includes only one treatment arm with tarlatamab. During the trial, participants are monitored for overall survival up to about 41 months, along with other outcomes such as response to treatment, disease control, progression-free survival, and adverse events. The study involves regular assessments to track these outcomes while ensuring patient safety. The total study duration extends until October 2029.

Researchers are studying hereditary breast and ovarian cancer HBOC and Lynch syndrome LS, which together account for about 30% of new cancer cases in Switzerland. The study focuses on genetic testing for these hereditary cancers to identify mutation carriers and improve prevention through early detection and management. Despite available genetic services, many mutation carriers and their family members do not use these services due to care coordination and communication challenges. The study uses a family-based cohort approach called CASCADE genetic screening, involving mutation carriers, their blood relatives who test negative, and untested relatives. It aims to survey index patients with HBOC or LS and their family members to understand their cancer status, genetic testing use, care coordination needs, communication patterns, and quality of life. The study will also explore the acceptability of a family-based communication and decision support intervention. Participants will be involved in surveys assessing their cancer and genetic mutation status, surveillance practices, psychosocial needs, communication with providers and family, and willingness to engage in genetic services. The primary outcome is establishing the CASCADE cohort within 12 months, with secondary outcomes including cancer surveillance practices. The study is observational and ongoing, with participants living in Switzerland and able to communicate in German, French, Italian, or English.

Researchers are investigating the best approach to treat low-risk patients with isolated subsegmental pulmonary embolism SSPE, a type of blood clot in small lung arteries. The study aims to determine whether monitoring patients without anticoagulation is as safe and effective as giving anticoagulant medication. This is important because many patients currently receive anticoagulants that carry a risk of bleeding, but it is unclear if all patients with isolated SSPE need this treatment. Patients in the trial are randomly assigned to one of two groups. One group receives the anticoagulant drug rivaroxaban, starting with 15 mg twice daily for 21 days, then 20 mg once daily for a total of 90 days. The other group receives a placebo matching the same schedule. The trial compares clinical surveillance without anticoagulation to anticoagulation treatment to assess safety and effectiveness. Participants will be followed for 90 days after randomization to monitor for recurrent venous thromboembolism, significant bleeding events, and overall survival. Researchers will track these outcomes through clinical assessments and safety monitoring. This study is designed to evaluate if careful monitoring alone is a safe alternative to anticoagulation in selected patients with isolated SSPE, potentially reducing bleeding risks from treatment.

Researchers are investigating the use of Trastuzumab deruxtecan T-DXd in adults with unresectable or metastatic HER2-low and HER2-ultralow breast cancer. This includes patients who have previously received chemotherapy for metastatic breast cancer or have hormone receptor-positive disease treated with endocrine therapy but are unsuitable for further endocrine treatment. The study aims to understand treatment effectiveness, patient characteristics, and experiences in a real-world setting through a non-interventional approach. Participants will be observed while receiving either T-DXd or conventional chemotherapy as part of their routine care, without any drug administration by the study itself. The study includes two groups one with patients having HER2-low breast cancer treated with T-DXd after prior chemotherapy, and another with hormone receptor-positive, HER2-low or HER2-ultralow breast cancer patients treated with either T-DXd or conventional chemotherapy but not prior chemotherapy for metastatic disease. Data will be collected on treatments, side effects, and management of adverse drug reactions. During the study, participants demographic and clinical data, treatment patterns, tolerability, and quality of life will be monitored over approximately 37 months. Assessments include the time to next treatment, treatment discontinuation, physician-reported safety events, patient-reported tolerability, quality of life questionnaires, and symptom diaries. This long-term observation will help evaluate real-world outcomes and patient experiences with T-DXd and conventional chemotherapy in this population.