Bridgeton

Researchers are evaluating the efficacy and safety of rilvegostomig compared to pembrolizumab monotherapy as the first-line treatment for patients with metastatic non-small cell lung cancer mNSCLC whose tumors express high levels of PD-L1. This Phase III, randomized, double-blind, multicenter global study focuses on patients with mNSCLC without certain genetic mutations who are suitable for this treatment approach. Participants are randomly assigned to receive either rilvegostomig or pembrolizumab intravenously on Day 1 of each 21-day cycle. The study compares these two drugs over repeated treatment cycles as first-line therapy. Both treatments are biological agents given by infusion, and the study is designed to monitor their effects over up to approximately five years. During the trial, participants will undergo regular assessments including physical exams, imaging scans such as CT or MRI to measure tumor lesions, and laboratory tests to evaluate organ function. Researchers will closely monitor overall survival, progression-free survival, treatment response, duration of response, and patient-reported outcomes on physical functioning and quality of life. Safety and immunogenicity of rilvegostomig will also be evaluated. Participants are followed and assessed for up to five years to gather comprehensive data on treatment effects and long-term outcomes.

Researchers are evaluating the efficacy and safety of rilvegostomig compared to pembrolizumab, both combined with platinum-based doublet chemotherapy, as a first-line treatment for patients with locally advanced or metastatic non-squamous non-small cell lung cancer NSCLC whose tumors express PD-L1 at levels of 1% or higher. This Phase III, randomized, double-blind, global study aims to compare these treatments to improve outcomes for this patient group. Participants will receive either rilvegostomig or pembrolizumab, each given intravenously on Day 1 of every 21-day cycle, combined with platinum-based doublet chemotherapy either carboplatin or cisplatin also given on Day 1 of each cycle for up to four cycles. After chemotherapy cycles, patients continue with rilvegostomig or pembrolizumab monotherapy combined with pemetrexed maintenance. The study follows patients for up to approximately six years to monitor treatment effects and safety. During the study, participants undergo assessments including imaging scans to measure tumor size, blood tests to evaluate organ function, and questionnaires about symptoms and quality of life. Researchers monitor overall survival and progression-free survival as primary outcomes, alongside other measures such as response duration and physical functioning. Safety is closely observed throughout, with study visits scheduled regularly during treatment and follow-up periods, lasting up to six years in total.

Researchers are evaluating the safety and effectiveness of rilvegostomig combined with platinum-based chemotherapy compared to pembrolizumab combined with platinum-based chemotherapy as a first treatment for patients with locally advanced or metastatic squamous non-small cell lung cancer mNSCLC whose tumors express programmed death-ligand 1 PD-L1. This Phase III global study focuses on patients with PD-L1 tumor cell expression of 1% or higher and aims to determine which treatment provides better overall and progression-free survival. Participants will be randomly assigned to one of two study groups one group will receive rilvegostomig plus carboplatin and either paclitaxel or nab-paclitaxel chemotherapy, while the other group will receive pembrolizumab plus the same chemotherapy options. Rilvegostomig and pembrolizumab are both given intravenously on Day 1 of each 21-day cycle, with chemotherapy given up to 4 cycles. Nab-paclitaxel may be administered on Days 1, 8, and 15 of each cycle. Treatment continues with rilvegostomig or pembrolizumab until disease progression or other criteria are met. During the study, participants will undergo regular assessments including imaging scans to measure tumor response, laboratory tests to monitor organ function, and patient questionnaires about physical function and quality of life. Researchers will track overall survival, progression-free survival, response rates, and duration of response for up to approximately 6 years. Safety and immune response to rilvegostomig will also be evaluated. Participants will be closely monitored throughout the treatment and follow-up periods.

Researchers are evaluating the safety and effectiveness of three different dose regimens of MORF-057, a small molecule drug, in adults with moderately to severely active Crohns disease CD. This Phase 2, randomized, double-blind, placebo-controlled, multicenter study aims to compare these doses with a matching placebo during an induction treatment period. The study includes adult participants who have active symptoms of CD and have not adequately responded to other treatments. Participants will first undergo a 14-week induction period where they receive either one of the three blinded MORF-057 dose regimens or a matching placebo, all taken orally. Following this, all participants enter a 38-week maintenance period receiving open-label MORF-057. Those who complete this 52-week treatment phase may have the chance to continue treatment for an additional 52 weeks during a long-term extension. MORF-057 is designed to selectively inhibit integrin 47. During the study, participants will have their disease activity monitored using endoscopic assessments and clinical symptom scores, such as the Simple Endoscopic Score for Crohns Disease SES-CD and the Crohns Disease Activity Index CDAI. Researchers will assess the proportion of participants showing endoscopic response and clinical remission at Week 14. Safety and adherence will be closely followed throughout the treatment and extension phases. The entire study spans up to 6 years, allowing for long-term evaluation.

Researchers are evaluating multiple investigational therapies in adult participants with moderately to severely active Crohns 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 AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study. This trial focuses on patients with established atherosclerotic cardiovascular disease ASCVD or those at high risk for a first ASCVD event. The study aims to assess how AZD0780 compares to placebo in reducing the risk of major adverse cardiovascular events, also known as MACE-PLUS, over the course of the trial. Participants are randomly assigned to receive either oral AZD0780 once daily or a matching placebo once daily. The study continues until a primary analysis censoring date, which may be up to approximately 54 months from randomization. After this, a study closure visit will be conducted as the final visit for each participant. During the study, participants will be regularly monitored for cardiovascular events including heart attacks, strokes, urgent coronary revascularizations, and other related outcomes. Researchers will track the time to first occurrence of these events as the primary outcome. Safety and other secondary outcomes like all-cause mortality will also be assessed. The total participation time can last up to about 54 months, with ongoing evaluations throughout this period.

Researchers are evaluating the use of Vedolizumab in adults with moderate to severely active Ulcerative Colitis UC or Crohns Disease CD, which are chronic gut conditions causing symptoms such as diarrhea, inflammation, bleeding, and abdominal pain. The study aims to measure how many participants achieve remission, meaning their symptoms disappear, after 14 weeks of treatment. This is a Phase 4 treatment study sponsored by Takeda, focusing on the effectiveness of Vedolizumab administered in a community setting. Participants with either UC or CD will receive Vedolizumab intravenously IV during the first 6 weeks, with doses given at Weeks 0 and 2, and possibly an additional IV dose at Week 6. After this initial period, participants may switch to subcutaneous under the skin injections of Vedolizumab every two weeks from Week 6 until Week 50. If the treatment does not appear effective by Week 14, participants may stop Vedolizumab and switch to another therapy. Additional required visits occur at 26 weeks and 52 weeks, with a final check 18 weeks after the last Vedolizumab dose. Throughout the study, participants will visit the clinic multiple times for treatment and monitoring. Assessments include patient-reported symptom measures at Weeks 6, 14, and 52, clinical response evaluations, and endoscopic examinations to observe mucosal healing. Blood and stool tests will measure inflammation markers like C-reactive protein and fecal calprotectin. Safety monitoring will track serious infections up to 72 weeks. Overall, participants are involved for about one year of treatment plus follow-up to evaluate the long-term effects of Vedolizumab.

This research aims to evaluate the efficacy and safety of belantamab mafodotin given with standard cancer treatments in adults with relapsed or refractory multiple myeloma, a type of blood cancer that has returned or is not responding to prior treatments. The study focuses on whether giving belantamab mafodotin less frequently can still control the cancer while reducing side effects, especially those affecting the eyes. It is a phase 2, open-label study sponsored by GlaxoSmithKline. Participants will receive belantamab mafodotin combined with one of three standard treatment regimens pomalidomide and dexamethasone bortezomib and dexamethasone or carfilzomib and dexamethasone. The study uses an extended dosing schedule to assess if less frequent dosing maintains effectiveness. The treatment continues as per the assigned combination, with no randomization, in multiple centers. During the study, participants will be regularly assessed for response to treatment, including overall response rate and complete response rate, up to about 52 months. Safety will be monitored by recording side effects and eye health through ophthalmic exams. Participants will undergo laboratory tests and clinical evaluations throughout the study. The research will also track how well patient-reported eye symptoms match clinical findings, with the total study duration extending up to approximately four years.

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 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 given by subcutaneous injection versus intravenous infusion as first-line therapy combined with chemotherapy. The study involves approximately 351 participants and aims to understand the treatments effects in this patient group. Participants will be randomly assigned to receive either tislelizumab 300 mg by subcutaneous injection or 200 mg by intravenous infusion on Day 1 of each 21-day cycle. Both groups will also receive chemotherapy tailored to each patient. The study includes a screening period, a treatment period with repeated cycles, and a follow-up period to assess long-term outcomes. During the study, participants will be monitored through various assessments, including tumor evaluations and biomarker tests. Researchers will measure drug concentration levels, response rates, progression-free survival, overall survival, and adverse events for up to two years. Safety and treatment effectiveness will be closely followed throughout the study duration, which ends in April 2028.