Teaneck

Researchers are evaluating molnupiravir, an oral medicine designed to stop the COVID-19 virus from multiplying, to see if it can prevent severe illness from COVID-19 in people at high risk of disease progression. The study focuses on adults with confirmed COVID-19 infection who are at increased risk due to age, medical conditions, or other factors. This is a Phase 3 randomized, placebo-controlled, double-blind clinical trial led by Merck Sharp & Dohme LLC. Participants will be randomly assigned to receive either molnupiravir or a matching placebo. Those in the molnupiravir group will take 800 mg orally every 12 hours for 5 days, totaling 10 doses. The same dosing schedule applies to the placebo group. Some participants may also receive remdesivir as part of standard care if clinically appropriate. During the study, participants will be monitored for up to 29 days to assess outcomes such as hospitalization, death, or medically attended visits related to COVID-19. Safety will be evaluated by tracking adverse events and discontinuation due to side effects. Researchers will also measure symptom relief, viral RNA levels, and other health indicators. The study is expected to continue until January 2031.

Researchers are evaluating a new care strategy for people at increased risk of atherosclerotic cardiovascular disease ASCVD but without symptoms. The study compares a Cleerly Coronary Artery Disease CAD Staging System-based care approach against the usual risk factor-based care to see if it better reduces cardiovascular events. This pragmatic, randomized trial addresses the need for improved methods to identify and personalize treatment for asymptomatic individuals at risk due to age, diabetes, prediabetes, or metabolic syndrome. Participants are randomly assigned to one of two groups. The risk factor-based care group receives usual care managed by their providers, while a cardiology team monitors and supports guideline-based treatment without revealing certain imaging results during the study. The Cleerly stage-based care group gets personalized management from a remote cardiologist-led team using the Cleerly CAD Staging System, which includes imaging to assess coronary atherosclerosis and guides pharmacotherapy and education. Treatment intensity may increase if plaque worsens after 24 months. During the study, participants will have assessments to monitor heart health and treatment adherence over an average of 3.5 years. Researchers will measure cardiovascular events and other related health outcomes to compare the two care strategies. The study involves ongoing medication monitoring, lab tests, and feedback to optimize prevention, with the goal of improving personalized care for cardiovascular risk management.

Researchers are evaluating the real-world use and safety of BRIUMVI4 ublituximab-xiiy in adults with relapsing multiple sclerosis RMS. The study aims to understand the safety, effectiveness, and treatment experience of participants prescribed this medication outside of controlled clinical trials. This observational study is sponsored by TG Therapeutics, Inc. and focuses on patients receiving routine care with BRIUMVI4. Participants in this study will receive BRIUMVI4 through intravenous infusion as prescribed for RMS treatment. The study includes participants who have been prescribed BRIUMVI4 but have not yet received their first infusion at the start of the study. No placebo or other interventions are involved, and the study observes the treatment as it is given in real-world medical settings. During the study, participants will be monitored for up to 96 weeks to assess their annualized relapse rate ARR. Researchers will also track adverse events, serious adverse events, and infusion-related reactions at each infusion. Participant safety and treatment experience will be observed through regular clinical assessments and data collection, with the study lasting until April 2032.

Researchers are evaluating the experimental drugs pozelimab and cemdisiran for treating Geographic Atrophy GA, a late stage of Age-related Macular Degeneration AMD that affects central vision. The study aims to compare the progression rate of GA in patients receiving cemdisiran alone, the combination of pozelimab and cemdisiran, or a placebo. Additional goals include monitoring side effects, drug levels in the blood over time, and the bodys antibody response to these drugs. Participants will receive subcutaneous injections of either pozelimab combined with cemdisiran, cemdisiran alone, or a placebo. The study is randomized and double-masked with three groups receiving different treatments. Treatment and monitoring will continue through specified time points up to 104 weeks, with follow-up on safety and antibody responses extending even further. During the study, participants will attend regular clinic visits for eye exams, imaging using Fundus Autofluorescence to measure GA lesion growth, vision tests including visual acuity and contrast sensitivity, and blood tests to assess drug levels and antibody formation. Researchers will track treatment-emergent adverse events and evaluate changes in vision and GA progression over time. Participation lasts until the study completion date in April 2033, with primary outcomes assessed at 52 weeks and further evaluations up to 296 weeks.

Researchers are evaluating the effectiveness of amivantamab combined with either lazertinib or platinum-based chemotherapy in treating participants who have epidermal growth factor receptor mutated EGFRm non-small cell lung cancer NSCLC. This study focuses on advanced or metastatic NSCLC cases where standard curative treatments are not suitable. It aims to assess the antitumor activity of these treatment combinations in this patient population. Participants receive either amivantamab with oral lazertinib in 28-day cycles or amivantamab with intravenous chemotherapy consisting of carboplatin and pemetrexed in 21-day cycles. Treatment continues until disease progression, participant withdrawal, death, or investigator decision to stop treatment. The study is designed with two separate groups receiving these distinct treatment combinations. Throughout the study, participants will undergo assessments to monitor treatment effects and safety. Researchers will measure progression-free survival as the primary outcome up to 4 years and 6 months, along with secondary outcomes including dose adjustments, adverse events, overall survival, response rates, and duration of response. Participants are followed regularly during treatment to track these outcomes and manage any side effects until the studys completion.

This research aims to evaluate the rate and severity of eye-related side effects caused by mirvetuximab soravtansine MIRV in women with recurrent ovarian cancer that expresses high levels of folate receptor alpha. The study compares two strategies to prevent these eye side effects by randomly assigning participants to receive either steroid eye drops or vasoconstricting eye drops as primary prophylaxis. Participants include those with platinum-sensitive or platinum-resistant ovarian cancer who have undergone prior therapies and meet specific safety and recovery criteria. Participants will be randomly placed into one of two groups. One group will use prednisolone acetate steroid eye drops six times daily initially, then four times daily, along with lubricating eye drops throughout each 21-day treatment cycle. The other group will use brimonidine tartrate vasoconstricting eye drops three times daily plus lubricating drops on the same schedule. All participants receive MIRV intravenously at a dose of 6 mg per kilogram of adjusted ideal body weight on the first day of each 21-day cycle. The study treatment continues for up to 18 weeks or through five cycles, followed by a 30-day follow-up. Throughout the study, participants undergo regular eye examinations to monitor for treatment-emergent adverse events and complete questionnaires measuring visual function. Blood samples are collected to analyze MIRV drug levels. The main outcome is the number of participants experiencing moderate or worse corneal side effects during treatment. Secondary outcomes include other eye-related symptoms and drug concentration measures. Safety and adherence to the eye drop schedules are carefully tracked during the trial period.

Researchers are evaluating the safety and effectiveness of Raludotatug Deruxtecan R-DXd in adults with platinum-resistant, high-grade ovarian, primary peritoneal, or fallopian tube cancer. This study includes a Phase 2 dose-optimization part to find the best dose based on safety and effectiveness, followed by a Phase 3 part comparing R-DXd to chemotherapy chosen by the investigator. The study targets tumors that overexpress CDH6, a protein that R-DXd specifically binds to. Participants are randomly assigned to receive intravenous R-DXd at various doses every three weeks or an investigators choice of chemotherapy drugs including paclitaxel, pegylated liposomal doxorubicin, or topotecan. The Phase 2 portion focuses on determining the optimal dose, while the Phase 3 portion compares the recommended dose with standard chemotherapy. Treatments are given through IV infusions according to the assigned group. During the study, participants undergo scheduled visits for drug administration, safety monitoring, and evaluations including imaging scans to assess tumor response. Researchers measure outcomes such as objective response rate, progression-free survival, overall survival, duration of response, symptom changes, and pharmacokinetics over periods up to 40 months. Safety is closely monitored through adverse event tracking and laboratory tests, with participants followed until the studys completion in 2030.

Non-small cell lung cancer NSCLC is a condition where cancer cells grow uncontrollably in the lung tissues. This study evaluates the safety of an investigational drug called telisotuzumab vedotin in adults with previously treated NSCLC that overexpresses c-Met. The trial also monitors changes in disease activity and side effects over time. Participants will be randomly assigned to receive one of three different doses of telisotuzumab vedotin through intravenous IV infusion. Each dose group receives treatment as part of a study lasting up to three years. The study involves approximately 150 adults with c-Met positive NSCLC across many sites worldwide. Throughout the study, participants will attend regular hospital or clinic visits where they undergo medical assessments, blood tests, and complete questionnaires to evaluate how the drug affects their disease and any side effects experienced. The study measures treatment-related adverse events, disease response, and survival outcomes over the three-year period.

This research aims to evaluate the safety and effectiveness of neoadjuvant carboplatin combined with mirvetuximab soravtansine in women with advanced-stage serous epithelial ovarian, fallopian tube, or primary peritoneal cancer that expresses folate receptor alpha FR. Mirvetuximab soravtansine is an investigational antibody drug designed to selectively target and kill cancer cells carrying FR. The study enrolls about 140 adult female participants with stage III or IV disease across approximately 80 sites in the United States. Participants receive intravenous infusions of mirvetuximab soravtansine together with carboplatin on the first day of each 21-day cycle, for up to 6 to 9 cycles. Bevacizumab may also be given at the investigators discretion. This single-group study includes regular treatment cycles over a period lasting approximately three years. During the study, participants will have frequent visits to hospitals or clinics for medical assessments, blood tests, and scans to monitor their health and response to treatment. Researchers will measure outcomes including tumor response based on independent central review, adverse events, disease control, progression-free survival, and symptom changes. Safety and treatment effects will be tracked throughout the study duration of about three years.

Researchers are studying gynecologic cancers, including ovarian, fallopian tube, and primary peritoneal cancers, to evaluate the safety and tolerability of IMGN151 given alone or with other anti-cancer therapies. This Phase 1b trial involves adult female participants and aims to understand how IMGN151 works in combination with treatments like carboplatin, olaparib, and bevacizumab, or by itself. Approximately 377 participants will take part worldwide. Participants are divided into one of six groups, each receiving different treatments. Some groups receive IMGN151 combined with carboplatin, olaparib, or bevacizumab, while others receive IMGN151 alone. Treatments are given as intravenous infusions on Day 1 of each 21-day cycle, with olaparib taken orally twice a day in one group. The study lasts about three years. During the study, participants attend regular hospital or clinic visits for medical check-ups, blood tests, and scans to monitor health and treatment effects. Researchers will track side effects and dose-related toxicities, along with responses to treatment and disease progression over the study period. The goal is to gather detailed information about how participants tolerate these treatments and how their cancers respond.