Basel

Researchers are investigating the drug bezuclastinib in an open-label, two-part Phase 2 study for patients with Advanced Systemic Mastocytosis (AdvSM), including Aggressive Systemic Mastocytosis (ASM), Systemic Mastocytosis with an Associated Hematologic Neoplasm (SM-AHN), and Mast Cell Leukemia (MCL). The study aims to evaluate the safety, effectiveness, and how the drug behaves in the body for these serious conditions. Bezuclastinib is given orally as tablets taken continuously in 28-day cycles. The study has two parts: Part I focuses on identifying safe and tolerable doses of bezuclastinib over 18 months, while Part II evaluates its effectiveness by measuring the objective response rate and confirming the relationship between drug exposure and response during another 18-month period. Participants will undergo assessments including clinical evaluations, laboratory tests, and monitoring of their disease status to determine treatment effects and safety. Researchers will track the drug's impact on the disease and patient health throughout the study, which involves continuous treatment and follow-up over the specified time frames.

Researchers are evaluating the safety and effectiveness of elenestinib (BLU-263) combined with symptom-directed therapy (SDT) compared to placebo plus SDT in people with indolent systemic mastocytosis (ISM) whose symptoms are not well controlled by SDT alone. This Phase 2/3 randomized, double-blind, placebo-controlled study includes participants with ISM and smoldering systemic mastocytosis, and also involves groups for pharmacokinetic studies and participants who previously received a selective KIT inhibitor. The study is divided into multiple parts. Parts 1 and 2 enroll participants with ISM who will receive either elenestinib oral tablets or placebo alongside their symptom-directed therapy. Participants from Part 2 may continue into Part 3, which is an open-label extension where all receive elenestinib. Part K enrolls participants with ISM who have prior experience with selective KIT inhibitors. The study tracks treatment effects and safety over time. Participants will be monitored for up to 5 years, with assessments including the number of treatment-emergent adverse events, changes in symptom scores measured by the ISM-Symptom in Assessment Form, and overall safety monitoring. Evaluations occur at baseline, 13 weeks, 49 weeks, and throughout the long-term follow-up. The study also includes detailed tracking of symptom control and adverse events to evaluate the impact of treatment on participants' health and quality of life.

This research aims to compare postoperative pain levels in patients who receive a small-bore (16F) chest drain versus those who receive the standard large-bore (24F) chest drain after minimally invasive lung surgeries such as lobectomy and segmentectomy for non-small cell lung cancer (NSCLC). Minimally invasive techniques like video-assisted and robotic-assisted thoracoscopic surgery are increasingly used and linked to better recovery and less pain than traditional surgery. Since chest drains are commonly used after lung resections to remove air and fluid, this study investigates whether smaller drains and earlier removal can reduce patient discomfort without risking safety. Participants will receive either a 16F or 24F chest drain after their lung surgery. The study also compares early drain removal, defined as removal 2 to 6 hours after surgery, with the standard removal which occurs one day postoperatively. Both devices and removal timings are carefully monitored. The aim is to see if smaller drains and earlier removal lead to less pain and faster recovery. During the study, participants will be assessed for postoperative chest pain at multiple time points including 4 and 6 hours after surgery, twice daily until day 3 or until the drain is removed, at discharge, and during follow-ups at 30 and 180 days. Researchers will also evaluate pain relief during coughing at these times. These measurements will help determine the best chest drain size and removal timing to improve patient comfort after minimally invasive lung surgery.

Researchers are evaluating the safety and sensitivity of a new imaging agent called 61Cu-NODAGA-LM3 compared to the standard 68Ga-DOTATOC for PET/CT scans in patients with well-differentiated bronchopulmonary and gastroenteropancreatic neuroendocrine tumors (NET). These tumors often grow slowly and may be metastatic when diagnosed. The study aims to improve diagnostic accuracy by assessing a novel copper-61 labeled somatostatin receptor antagonist that may offer benefits like longer half-life and better tumor imaging contrast. Participants receive a single intravenous injection of 61Cu-NODAGA-LM3 at doses between 20 and 40 micrograms, followed by up to three PET/CT scans. The comparator group receives a single intravenous injection of 68Ga-DOTATOC with PET/CT scans as part of standard clinical care. The study is open-label, randomized, and conducted at a single center, designed as a Phase I/II trial. During the study, researchers monitor the frequency and severity of adverse events up to 18 hours after injection. They also assess the sensitivity of 61Cu-NODAGA-LM3 PET/CT imaging one hour after injection. Participants undergo PET/CT imaging scans, and safety is closely followed. The total involvement includes baseline assessments, imaging, and safety monitoring to evaluate the new imaging agent's performance compared to the current standard.

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 looking for new medicines to prevent HIV-1 (Human Immunodeficiency Virus Type 1) infection. The goals of this study are to learn: * If taking MK-8527 once a month works to prevent HIV-1 infection as well as or better than a standard (usual) pre-exposure prophylaxis (PrEP) taken once a day * About the safety of MK-8527 and if people tolerate it

Researchers are conducting a phase III randomized trial to evaluate the effectiveness of adjuvant cemiplimab immunotherapy in patients with surgically removed stage II-IIIA non-small cell lung cancer (NSCLC) who have not received prior platinum-based chemotherapy. The study focuses on patients whose tumors express PD-L1 at 1% or higher. The main goal is to measure disease-free survival, tracking the length of time patients remain free from cancer recurrence or death for up to about 59 months. Participants receive cemiplimab intravenously at 350 mg every 3 weeks for four cycles, followed by 700 mg every 6 weeks for six cycles, continuing until cancer relapse or unacceptable side effects occur. The treatment is compared to observation without additional adjuvant therapy. The study involves careful dosing schedules and monitoring to assess the impact of cemiplimab as a post-surgical treatment option. During the study, participants undergo brain imaging for staging, tumor PD-L1 testing, and regular pregnancy tests for women of childbearing potential. Researchers monitor disease recurrence and adverse effects throughout treatment and follow-up. Patients must meet specific health criteria, including recovery from surgery and adequate organ function, and agree to use contraception during treatment and for four months afterward. The total participation period includes treatment cycles and long-term follow-up to evaluate disease-free survival and safety.

Researchers are evaluating the long-term safety and effects of nerandomilast in people with idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF) who have previously completed treatment with nerandomilast in earlier studies. The study aims to understand how well participants tolerate nerandomilast over time, and whether it helps improve lung function, delays symptom worsening, reduces hospital visits, or impacts survival. This is a Phase 3 open-label extension trial. Participants take nerandomilast tablets daily for up to 1 year and 10 months while continuing their usual pulmonary fibrosis treatments. The study follows an open-label design where all participants receive nerandomilast. There are no placebo or comparator groups in this extension phase. Throughout the study, participants regularly visit their doctors for health assessments and lung function tests. Doctors monitor any health problems or side effects experienced during treatment. The main outcome measured is whether participants experience any adverse events up to the final follow-up visit, which occurs at week 99. This close monitoring helps evaluate the long-term safety and potential benefits of nerandomilast in this patient group.

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 whether the drugs retatrutide and tirzepatide can prevent major adverse liver outcomes (MALO) in adults with metabolic dysfunction-associated steatotic liver disease (MASLD) who are at high risk. This Phase 3 trial enrolls about 4,500 adults with MASLD identified by non-invasive tests indicating an increased likelihood of developing serious liver problems. The study aims to understand how these treatments might affect liver health over time compared to a placebo. Participants will be randomly assigned to receive either retatrutide, tirzepatide, or a placebo, all given by subcutaneous injection. The study will last approximately 224 weeks, during which participants may attend 25 to 30 clinic visits for monitoring and assessment. After the main study, eligible participants can join an optional 2-year extension where all will receive either retatrutide or tirzepatide regardless of their original group. Throughout the trial, participants’ liver function and disease progression will be closely monitored through various health assessments. Researchers will track the time to the first major adverse liver event as the main outcome. Safety and health status will be evaluated regularly during clinic visits, ensuring thorough observation over the long study period.