Mons

Researchers aim to improve understanding and treatment of brain metastases from solid tumors, which currently have limited systemic treatment options. This study focuses on patients with newly diagnosed non-CNS metastatic solid tumors who are at high risk of developing central nervous system CNS metastases. By gathering detailed clinical and biological information, including analyses of circulating tumor DNA ctDNA from cerebrospinal fluid CSF samples, the study seeks to identify new therapeutic targets and develop innovative treatment strategies. The study is organized into three time periods before the first CNS event Part A, at the first CNS diagnosis Part B, and after the first CNS event Part C. Participants will undergo scheduled collections of plasma, serum, CSF samples, and non-CNS metastatic tumor tissue as applicable, along with brain MRI scans at specific intervals depending on their part in the study. Sample collections and imaging are scheduled annually, every few months, or as clinically indicated, aligned with the participants cancer type and study period. Participants will have regular assessments including imaging and biological sample collections to monitor disease progression and tumor biology. Researchers will analyze the epidemiology and biology of CNS metastases over approximately eight years. Study procedures include lumbar punctures for CSF collection, brain MRIs, and collection of tumor tissue when possible. Participants safety and life expectancy are considered, and follow-up will continue throughout the study duration to support data collection and understanding of CNS metastases.

Researchers are evaluating the efficacy and safety of the combination of divarasib and pembrolizumab compared with pembrolizumab combined with pemetrexed and either carboplatin or cisplatin. This study focuses on adults with previously untreated, advanced or metastatic non-squamous non-small cell lung cancer NSCLC that has a KRAS G12C mutation. The goal is to assess these treatments as first-line options in this specific lung cancer population. Participants will be randomly assigned to one of two groups. One group will take divarasib orally once daily and receive pembrolizumab through an intravenous infusion every three weeks. The other group will receive pembrolizumab, pemetrexed, and either carboplatin or cisplatin via intravenous infusions every three weeks. Treatment continues with these schedules, following the study protocol for up to approximately five years of follow-up. During the study, participants will have regular assessments to monitor their health and response to treatment. These include imaging and clinical evaluations to measure progression-free survival and overall survival for up to five years. Researchers will also track quality of life, symptom changes, treatment side effects, and adverse events using questionnaires and patient-reported outcomes. Safety monitoring and detailed evaluations will help understand the effects of the treatments over the study duration.

Researchers are evaluating the effectiveness of two chemotherapy combinations, 5-FU with nanoliposomal irinotecan NALIRI and 5-FU with nanoliposomal irinotecan plus oxaliplatin NALIRINOX, in patients with metastatic pancreatic ductal adenocarcinoma PDAC who have progressed after treatment with Gemcitabine-Abraxane or Gemcitabine alone. This phase 2 randomized study aims to assess the progression-free survival rate and safety of these treatments in fit patients with good performance status. Participants receive treatment in 14-day cycles. In the NALIRI group, patients are given leucovorin, nanoliposomal irinotecan at 70 mgm, and 5-FU through intravenous infusion. The NALIRINOX group receives oxaliplatin, leucovorin, nanoliposomal irinotecan at 50 mgm, and 5-FU. The study monitors dosing adjustments based on individual tolerance, especially for patients with specific genetic markers. Treatments are administered mostly via intravenous infusions over several hours and continuous infusions over two days. During the study, participants undergo regular imaging scans, tumor marker tests, and safety assessments to evaluate treatment response and side effects. Researchers track progression-free survival at day 85 post-randomization and continue monitoring survival and disease control for up to five years. Safety is closely followed through laboratory tests, physical exams, and adverse event reporting until two weeks after treatment ends. The total participation time varies depending on individual treatment response and follow-up duration.

Researchers are studying the use of bempedoic acid combined with ezetimibe and either rosuvastatin or atorvastatin, known as triple therapy, in adults with primary hypercholesterolemia or mixed dyslipidemia. The study aims to evaluate the effectiveness and safety of this combination in real-world clinical practice, focusing on lowering LDL cholesterol LDL-C levels. This is an observational study, meaning no drugs are administered by the study team instead, existing treatments are monitored. Participants are adults who have started triple therapy within the past four weeks and are followed for up to one year. The study looks at LDL-C changes after 8 weeks and 1 year of treatment, adherence to the therapy, side effects, and cardiovascular events such as heart attacks and strokes. No new treatments are given instead, researchers collect information on the participants ongoing treatments involving bempedoic acid, ezetimibe, and either rosuvastatin or atorvastatin. During the study, participants LDL-C levels, laboratory values, and treatment adherence are regularly reviewed. Researchers will also record any adverse events and track major cardiovascular events over the year. The primary measurement is the change in LDL-C from before treatment to 8 weeks after starting triple therapy. Participants health is followed through routine clinical assessments, and the study lasts for up to one year after beginning triple therapy.

This research aims to observe the real-life effectiveness, safety, and patient-reported outcomes of standard antimyeloma treatments in adults with previously treated relapsed andor refractory multiple myeloma over a 24-month period. The study focuses on participants receiving routine care for this condition as part of their regular medical treatment. Participants with relapsed or refractory multiple myeloma undergoing standard antimyeloma treatments in routine clinical practice will be observed. There is no investigational treatment administered by the study instead, medical records will be the primary data source to track treatments and outcomes during the study. During the study, participants medical records will be reviewed to assess response rates, survival, disease progression, quality of life, and adverse events over up to 52 months. Patient health and well-being will be monitored using standardized questionnaires, and safety will be evaluated through reported side effects. The overall involvement includes observation and data collection without changing the participants treatment plans.

Researchers are evaluating Afimkibart RO7790121 for people with moderately to severely active Crohns disease. This Phase III clinical trial aims to assess the effectiveness and safety of both induction and maintenance therapy using this drug compared to a placebo. The study is designed as a double-blind, placebo-controlled trial across multiple centers. Participants will be randomly assigned to one of three groups receiving either Afimkibart via intravenous infusion followed by subcutaneous injection or matching placebo treatments. The study involves continuous treatment through induction and maintenance phases to compare outcomes at weeks 12 and 52. The trial includes a placebo group to provide a comparison for evaluating Afimkibarts effects. During the study, participants will have regular visits for assessments including clinical remission rates, endoscopic response, symptomatic remission, stool frequency, abdominal pain, and quality of life questionnaires. Researchers will monitor various outcomes over 52 weeks and track adverse events for up to 70 weeks after baseline. This long-term follow-up helps evaluate both the treatments impact and safety throughout the trial period.

Researchers are evaluating whether adding zilovertamab vedotin to a standard treatment regimen can help people with previously untreated diffuse large B-cell lymphoma DLBCL live longer without the cancer growing or spreading. This phase 3 randomized study compares the combination of zilovertamab vedotin with rituximab plus cyclophosphamide, doxorubicin, and prednisone R-CHP against the standard regimen of rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone R-CHOP. The trial is sponsored by Merck Sharp & Dohme LLC and aims to improve treatment outcomes for people with this type of lymphoma. Participants receive treatment in cycles lasting 21 days, for up to 6 cycles approximately 4 months. One group receives zilovertamab vedotin plus rituximab or a rituximab biosimilar, cyclophosphamide, doxorubicin, and prednisone or prednisolone or methylprednisolone, while the comparison group receives rituximab or biosimilar, cyclophosphamide, doxorubicin, vincristine, and prednisone or prednisolone or methylprednisolone. Both groups may receive 2 additional cycles of rituximab or biosimilar if they have high-risk DLBCL. All infusions are given intravenously on Day 1 of each cycle, with prednisone or similar drugs taken orally on Days 1-5 of each cycle. Throughout the study, participants are closely monitored for progression-free survival up to about 50 months, as well as other outcomes such as overall survival, response to treatment, adverse events, and quality of life changes. Assessments include clinical evaluations during treatment and follow-up periods, with safety monitoring continuing for up to 9 months. This comprehensive follow-up helps researchers understand the effects and tolerability of the treatments over time.

Researchers are investigating a new way to treat patients with stage IV non-small cell lung cancer NSCLC by combining chemotherapy and immunotherapy. This approach aims to improve overall survival and progression-free survival, which are important measures of treatment success. The study focuses on delivering cisplatin chemotherapy through a dry powder inhaler, which may reduce the severe side effects seen with traditional chemotherapy and allow for more frequent treatment at home. This inhaled method might provide a safer and potentially effective option alongside standard treatments like pembrolizumab and carboplatin-based chemotherapy. Participants will receive cisplatin administered via a single-use dry powder inhaler device in doses ranging from 2.5 mg to a maximum of 30 mg daily, five days a week with two days off. This inhaled cisplatin will be combined with standard care treatments, including intravenous pembrolizumab alone or with carboplatin-doublet chemotherapy depending on the patients tumor type. The study includes a dose escalation phase to find the maximum tolerated dose, followed by a safety expansion phase to recommend a dose for further study. During the 12-week treatment period, participants will be closely monitored for safety, tolerability, and anti-tumor activity through various tests and assessments. Researchers will measure outcomes such as the maximum tolerated dose, recommended phase II dose, objective response rate, disease control, duration of response, overall survival, and progression-free survival, with some measures followed up to 100 months. Participants will also undergo regular laboratory tests, imaging, and evaluations of lung function and oxygen levels, with an emphasis on safely managing treatment and assessing the potential benefits of inhaled chemotherapy.

Researchers are evaluating ivonescimab as a first-line treatment for patients with metastatic non-small cell lung cancer NSCLC whose tumors show high PD-L1 expression. This phase 3 study compares ivonescimab to pembrolizumab, focusing on overall survival and progression-free survival to understand which treatment may better support patients with this condition. Participants will be randomly assigned to receive either ivonescimab or pembrolizumab through intravenous injection. The study is double-blinded and multiregional, involving continuous treatment and monitoring for up to approximately 36 months. Both groups receive their assigned treatment regularly during this period, with careful observation of treatment responses and side effects. During the trial, participants will undergo evaluations including scans to measure tumor size, laboratory tests, and assessments of adverse events. Researchers will track overall survival, progression-free survival, response rates, disease control, and duration of response. Safety monitoring will continue for up to 24 months after the last dose. The total study period extends until June 2029, allowing long-term data collection on treatment effects and safety.

Researchers are evaluating standard neoadjuvant treatment options for patients aged 70 years or older with high-risk stage II and stage III rectal cancer in a multicentre, open-label, randomized clinical trial called SHAPERS. The study compares conventional neoadjuvant therapy with total neoadjuvant therapy TNT to understand their safety and effectiveness for this older patient group. Participants are randomly assigned to one of two groups. The conventional treatment group receives either short course radiotherapy followed by surgery or watch & wait, with optional adjuvant chemotherapy, or long course chemoradiotherapy followed by surgery or watch & wait, also with optional adjuvant chemotherapy. The TNT group receives one of several treatment regimens decided by the investigator before randomization, including combinations of short course radiotherapy, oxaliplatin-based chemotherapy lasting up to 18 weeks, and chemoradiotherapy, followed by surgery or watch & wait. During the study, participants undergo treatments as assigned and are monitored for outcomes including overall survival, progression-free survival, peripheral sensory neuropathy, and severe toxicities over 3 years after randomization. Researchers will gather information about treatment effects, side effects, and patient survival to compare the two approaches. The study includes follow-up assessments to track these outcomes and participant safety throughout the trial duration.