Bridgeton

Researchers are evaluating rilvegostomig compared with pembrolizumab monotherapy as a first-line treatment for people with metastatic non-small cell lung cancer (mNSCLC) whose tumors have high PD-L1 expression. This Phase III, global, randomized, and double-blind study aims to assess the efficacy and safety of these treatments in this patient population. The trial is sponsored by AstraZeneca and focuses on patients with specific tumor characteristics and no certain genetic mutations. Participants will receive either rilvegostomig or pembrolizumab intravenously on Day 1 of each 21-day cycle. The study has two treatment arms: one for the investigational drug rilvegostomig and one for the active comparator pembrolizumab. Both treatments are given as monotherapy to understand their effects as initial therapy in this cancer setting. During the study, participants will be monitored for overall survival and progression-free survival for up to approximately 5 years. Additional assessments include tumor response, duration of response, time to second progression or death, drug pharmacokinetics, immunogenicity, and patient-reported outcomes related to physical function, quality of life, and lung cancer symptoms. The study involves regular evaluations to track treatment effects and safety over an extended period.

Researchers are evaluating the effectiveness and safety of two treatments, rilvegostomig and pembrolizumab, each combined with platinum-based doublet chemotherapy, as first-line therapy for patients with metastatic non-squamous non-small cell lung cancer (mNSCLC) whose tumors express PD-L1. The study is a Phase III, randomized, double-blind trial conducted globally at multiple centers. It focuses on patients with tumors expressing PD-L1 at 1% or higher and aims to compare these treatment combinations in this specific lung cancer population. Participants will be randomly assigned to one of two groups. One group receives rilvegostomig intravenously on Day 1 of each 21-day cycle, combined with platinum-based chemotherapy (carboplatin or cisplatin) and pemetrexed, followed by maintenance rilvegostomig plus pemetrexed monotherapy. The other group receives pembrolizumab intravenously on the same schedule with the same chemotherapy drugs, followed by pembrolizumab plus pemetrexed maintenance. Chemotherapy is given for up to four cycles. During the study, participants will be monitored for overall survival and progression-free survival for up to approximately five years. Researchers will also assess response rates, duration of response, pharmacokinetics, immunogenicity, and patient-reported physical function and quality of life. Safety will be carefully tracked throughout the study. The trial began in late 2024 and is expected to conclude around March 2030.

Researchers are evaluating the efficacy and safety of rilvegostomig combined with platinum-based chemotherapy compared to pembrolizumab combined with the same chemotherapy for first-line treatment of patients with metastatic squamous non-small cell lung cancer (mNSCLC) whose tumors express programmed death-ligand 1 (PD-L1) at 1% or higher. This Phase III, randomized, double-blind, global study focuses on patients with squamous mNSCLC without actionable genomic mutations and assesses these treatments over approximately five years. Participants receive either rilvegostomig or pembrolizumab intravenously on Day 1 of each 21-day cycle, combined with carboplatin and paclitaxel or nab-paclitaxel chemotherapy. Chemotherapy is given up to 4 cycles, with nab-paclitaxel administered on Days 1, 8, and 15 of each cycle. After chemotherapy, patients continue with the assigned immunotherapy drug. The study compares these two treatment regimens as first-line therapy. During the study, participants undergo regular assessments including imaging to measure tumor response, survival, and disease progression up to about five years. Researchers also monitor physical functioning, quality of life, lung cancer symptoms, and drug pharmacokinetics and immunogenicity. Safety is closely followed, and overall survival and progression-free survival are the primary outcomes measured to evaluate the treatments' impact.

Researchers are evaluating the effectiveness and safety of three different dose regimens of MORF-057 in adults with moderately to severely active Crohn's disease. This Phase 2, randomized, double-blind, placebo-controlled, multicenter study aims to compare these doses against a matching placebo during a 14-week induction period. Crohn's disease activity is assessed using clinical and endoscopic scores to understand the impact of the treatment. During the 14-week induction phase, participants receive blinded MORF-057 in one of two dosing regimens or a matching placebo. Following this, all participants enter a 38-week maintenance period where they receive open-label MORF-057. Those completing the full 52-week treatment period may continue in a 52-week long-term extension to further evaluate treatment effects and safety. Participants will undergo evaluations including endoscopic assessments using the Simple Endoscopic Score for Crohn's Disease (SES-CD) and clinical responses measured by the Crohn's Disease Activity Index (CDAI). Researchers will monitor endoscopic response at week 14 as the primary measure and assess clinical response and remission as secondary outcomes. Safety and adherence will be closely observed throughout the study and extension periods, spanning up to 104 weeks in total.

Researchers are evaluating multiple investigational therapies in adult participants with moderately to severely active Crohn's Disease or Ulcerative Colitis, which are types of Inflammatory Bowel Disease (IBD). This Phase 2 platform study aims to assess the safety, effectiveness, how the body processes the drugs, and their effects on the disease. The study is sponsored by Mirador Therapeutics, Inc. and is designed to explore several oral or intravenous experimental treatments. Participants will be assigned to receive one of several treatments including MT-501 tablets or multiple intravenous doses of MT-201 combined with standard care. Different groups will receive these therapies to compare their effects. The treatment period lasts up to 13 weeks, during which participants will be closely monitored for responses and side effects. During the study, participants will undergo assessments including endoscopy and clinical evaluations to measure disease activity and response. Laboratory tests will monitor safety, and pharmacokinetics will track how the drugs are absorbed and processed. Researchers will observe treatment side effects and disease improvement using specific clinical and endoscopic measures over 12 to 13 weeks. The total participation duration corresponds to the treatment and monitoring period outlined.

Researchers are evaluating the effect of AZD0780, an oral PCSK9 inhibitor, compared with a placebo in reducing the risk of major adverse cardiovascular events plus (MACE-PLUS) in adults with established atherosclerotic cardiovascular disease (ASCVD) or at high risk for a first ASCVD event. This phase 3, randomized, placebo-controlled, and double-blind study aims to assess the time to first MACE-PLUS event over up to approximately 54 months from randomization until the primary analysis censoring date. Participants will be randomly assigned to receive either oral AZD0780 once daily or an oral placebo once daily. The study includes a parallel-group design with two arms: the experimental AZD0780 group and the placebo comparator group. After the primary analysis censoring date, a study closure visit will be scheduled as the final visit for each participant. During the study, participants will be monitored for the occurrence of cardiovascular events including myocardial infarction, stroke, urgent coronary revascularization, cardiovascular death, major adverse limb events, and all-cause mortality. Researchers will assess these events through regular follow-up visits up to approximately 54 months. The study includes detailed safety monitoring and outcome evaluations to understand the effects of AZD0780 compared to placebo in this population at risk for cardiovascular events.

Researchers are studying adults with moderate to severely active Ulcerative Colitis (UC) or Crohn's Disease (CD), which are long-term gut conditions causing symptoms like diarrhea, inflammation, bleeding, and belly pain. The study aims to evaluate how many participants achieve remission, meaning their signs and symptoms disappear, after 14 weeks of treatment with Vedolizumab. This is a Phase 4 trial sponsored by Takeda, focused on treatment in a community setting. Participants will receive Vedolizumab initially as an intravenous infusion at weeks 0 and 2. Around week 6, participants may switch to subcutaneous injections every two weeks until week 50. Some participants might receive an additional intravenous dose at week 6 before switching. Those whose treatment does not seem effective by week 14 may stop and switch to other therapies. Additional visits occur at weeks 26 and 52, with a final check 18 weeks after the last Vedolizumab dose. Throughout the study, participants will visit their clinic multiple times for assessments. Researchers will measure remission rates using patient-reported outcomes at various points, including weeks 6, 14, and 52. Other evaluations include clinical responses, endoscopic improvements, and changes in inflammation markers like C-reactive protein and fecal calprotectin. Safety is monitored by tracking infections and adverse events up to 72 weeks, ensuring comprehensive follow-up over approximately one year.

This research aims to evaluate whether adding zilovertamab vedotin to standard treatment helps people with previously untreated diffuse large B-cell lymphoma (DLBCL) live longer without their cancer growing or spreading. The study compares this combination to a standard treatment regimen, focusing on how well each approach controls the disease over time. Participants are randomly assigned to receive either zilovertamab vedotin combined with rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CHP) or the standard treatment of rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP). Treatments are given by intravenous infusion on Day 1 of each 21-day cycle for up to six cycles (around four months), with prednisone or similar steroids taken orally on Days 1 to 5 of each cycle. Participants at high risk may receive two additional cycles of rituximab or its biosimilar. Throughout the study, participants undergo regular assessments including scans, heart function tests, and evaluations of side effects and quality of life. Researchers measure progression-free survival over about 50 months, along with other outcomes such as overall survival and response to treatment. Safety monitoring and health-related quality of life questionnaires are part of the follow-up, which can last up to several years after treatment ends.

Researchers are evaluating the levels of drug exposure in adults with locally advanced, unresectable, or metastatic gastric or gastroesophageal junction adenocarcinoma. This phase 3 study compares tislelizumab administered by subcutaneous injection versus intravenous infusion, both given as first-line therapy alongside chemotherapy. The study includes about 351 participants and aims to understand how these two methods of delivering tislelizumab differ in terms of drug concentration and patient outcomes. Participants are randomly assigned to one of two groups: one group receives tislelizumab 300 mg by subcutaneous injection on the first day of each 21-day cycle, followed by chemotherapy tailored to the patient; the other group receives tislelizumab 200 mg by intravenous infusion on the same schedule, also followed by individualized chemotherapy. The chemotherapy regimens may include drugs such as cisplatin, leucovorin, 5-fluorouracil, oxaliplatin, or capecitabine. The study consists of screening, treatment, and follow-up periods. During the study, participants will have tumor tissue collected for biomarker testing and regular assessments of tumor response, survival, and adverse events for up to two years. Researchers will measure drug levels in the blood at specific times, including trough concentrations and area under the curve, to compare the two administration methods. Safety and overall health will be monitored throughout the study and follow-up periods, which continue until April 2028.

Researchers are investigating sovateltide, a drug that targets ETB receptors, as a potential treatment for acute cerebral ischemic stroke, a serious condition caused by a blocked blood vessel in the brain. This type of stroke leads to brain tissue damage due to lack of oxygen and is more common than hemorrhagic stroke. Previous studies in animals and early human trials have shown sovateltide may help protect and repair brain cells, encouraging further research in a phase III clinical trial across multiple countries. The study compares sovateltide with a placebo (normal saline) alongside standard care for stroke patients. Participants receive three intravenous bolus doses of sovateltide or placebo over one minute each, spaced every 3 hours on day 1, with repeated dosing on days 3 and 6. The treatment starts within 24 hours after stroke symptoms begin. This randomized, double-blind trial aims to assess safety and how well sovateltide improves recovery compared to placebo. Participants will be closely monitored over 90 days, with evaluations including neurological function using scales like the modified Rankin Scale, National Institute of Health Stroke Scale, and Barthel Index. Quality of life and cognitive function will also be assessed at multiple points. Researchers will track any adverse events, recurrent strokes, and mortality. The study requires patients to be available for full treatment and follow-up to measure sovateltide's effects comprehensively.