Patchogue

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 a drug called sigvotatug vedotin SGN-B6A alone and in combination with pembrolizumab, with or without chemotherapy, to assess its safety and effects in people with advanced solid tumors. This Phase 1 study aims to determine the side effects and whether sigvotatug vedotin works to treat various solid tumors including lung, head and neck, breast, esophageal, skin, pancreatic, bladder, cervical, gastric, and ovarian cancers. The study is divided into four parts to explore dosage, safety, and combination treatments. Participants may receive sigvotatug vedotin alone or combined with pembrolizumab, sometimes alongside chemotherapy drugs carboplatin or cisplatin, depending on the study part. Part A focuses on finding the right dose of sigvotatug vedotin. Part B uses this dose to further test safety and effectiveness. Parts C and D study the drug combined with pembrolizumab and possibly chemotherapy in different tumor types and treatment settings, including people who have not previously received treatment. Treatments are given intravenously, with pembrolizumab administered every 3 or 6 weeks and chemotherapy every 3 weeks. During the study, participants undergo tumor biopsies, clinical evaluations, and monitoring for side effects, including blood tests and safety assessments. Researchers track adverse events, lab abnormalities, and dose-limiting toxicities up to 30-37 days after treatment, with some follow-up extending up to 3 years. They also measure tumor response using standard criteria and monitor survival and drug levels in the body. Participants will have regular visits for treatment and assessments throughout the study duration, which may last several years.

Researchers are evaluating the safety and effectiveness of GDC-4198 alone and combined with giredestrant compared to abemaciclib combined with giredestrant in participants who have locally advanced or metastatic estrogen receptor-positive ER, HER2-negative breast cancer. This Phase IbII study focuses on participants who have previously experienced progression during or after treatment with a CDK46 inhibitor. The study aims to assess the safety, pharmacokinetics, and activity of these treatments in this population. Participants receive GDC-4198 orally, either alone or in combination with giredestrant at 30 mg daily, following a pre-defined dosing schedule during 28-day cycles until unacceptable side effects, disease progression, or loss of clinical benefit occurs. The study includes a Phase Ib dose-finding stage assessing safety and pharmacokinetics, followed by a Phase II stage that compares the activity and safety of GDC-4198 plus giredestrant against abemaciclib plus giredestrant, which is given orally at 150 mg twice daily with giredestrant 30 mg daily. During the study, participants undergo regular monitoring for adverse events, dose-limiting toxicities, and progression-free survival, with assessments lasting up to 36 months. Researchers measure response rates, clinical benefits, duration of response, overall survival, and plasma concentration of GDC-4198. Safety and activity data are collected throughout treatment cycles, with ongoing evaluations for up to three years to understand the long-term effects and recommended dosing.

Researchers are evaluating the use of a cellular, acellular, matrix-like product called Amnio-Maxx4 Dual Layer Amnion Patch alongside the Standard of Care SOC compared to SOC alone for closing nonhealing diabetic foot ulcers DFUs. This Phase 4 randomized controlled trial focuses on adult patients with chronic DFUs to better understand how Amnio-Maxx may affect healing rates. Participants will receive either the Standard of Care, which includes cleansing, debridement, wound documentation, and off-loading, or the Standard of Care plus the application of the Amnio-Maxx Dual Layer Amnion Patch. The study uses random assignment without masking. Treatments are applied during study visits, and the ulcer is carefully monitored for closure and healing progress. During the 12-week trial, participants will undergo assessments including ulcer measurements to evaluate complete closure and percentage area reduction. Pain related to the ulcer will be tracked using the Numeric Pain Rating Scale. Researchers will also monitor adverse events throughout the study. Participants must follow treatment protocols and attend regular visits to support accurate evaluation of outcomes related to healing diabetic foot ulcers.

Researchers are evaluating the safety and effectiveness of nipocalimab compared to a placebo in adults with chronic inflammatory demyelinating polyneuropathy CIDP who initially respond to nipocalimab. The study includes both Phase 2 and Phase 3 stages and aims to delay relapse in patients with CIDP who have shown clinical improvement from the treatment. Participants first receive an open-label loading dose of nipocalimab by intravenous infusion on Day 1, followed by infusions every two weeks from Week 2 to Week 12 Stage A. Those who respond and show clinical improvement move to Stage B, where they are randomly assigned to receive either nipocalimab or placebo infusions every two weeks for up to 52 weeks. After Stage B or if relapse occurs, participants may join an open-label extension phase receiving nipocalimab infusions every two weeks for up to two years or until commercial availability. During the study, participants undergo regular assessments including clinical evaluations, muscle strength tests, disability scales, and monitoring for adverse events. Researchers track time to relapse, changes in disability scores, muscle strength, grip strength, and laboratory values over the study periods. Safety is closely monitored through vital signs, laboratory tests, and adverse event reporting. The total participation can extend through the treatment phases and the long-term open-label extension as applicable.

Researchers are comparing the rates of surgical and minimally invasive interventions, as well as any harms, in Medicare beneficiaries treated with the MILD procedure versus those treated with interspinous process decompression IPD for lumbar spinal stenosis with neurogenic claudication. This observational study uses Medicare claims data to follow patients for 24 months after their initial procedure starting from January 1, 2017. The purpose is to evaluate outcomes between these two types of procedures without requiring prior patient enrollment or consent. The study includes two groups patients who received MILD, which is a percutaneous image-guided lumbar decompression performed under fluoroscopic guidance through a dorsal approach to the spine, and patients who received IPD, a different device-based decompression procedure. Data on reoperations and complications will be collected for both groups over a 24-month follow-up period using Medicare claims. Enrollment continues until the sponsor decides to stop. Participants involvement is passive as the study uses existing Medicare claims data. Researchers will monitor rates of harms related to the initial procedure and subsequent surgical or minimally invasive interventions over two years. No direct patient visits or interventions are conducted, and the study is exempt from institutional review board oversight. The total study duration extends to December 2026, covering cases treated since early 2017.

Researchers are evaluating overall survival in patients with advanced metastatic or locally recurrent breast cancer who have no approved alternative therapies available. This Phase 3, multicenter, randomized, open-label study compares a new combination treatment called the Bria-IMT regimen plus a checkpoint inhibitor Retifanlimab against treatment chosen by patients and their physicians. The study also aims to assess the effectiveness of the Bria-IMT regimen alone compared to its combination with the checkpoint inhibitor. The study includes three initial groups one receiving Bria-IMT plus Retifanlimab, one receiving physicians choice treatment such as eribulin, carboplatin, capecitabine, gemcitabine, vinorelbine, or taxanes, and one receiving Bria-IMT alone. After enrolling 150 patients, the Bria-IMT alone group will be stopped, and those patients may switch to the combination therapy. Treatment cycles for Bria-IMT arms occur every three weeks, with imaging assessments every six weeks twice, then every eight weeks if no disease progression or safety concerns arise. Participants will undergo various assessments throughout the study, including imaging and clinical evaluations, to track overall survival up to 60 months. Secondary outcomes include progression-free survival, clinical benefit rate, overall response rate, quality of life, and central nervous system event-free survival. Safety and treatment effects will be monitored continuously, and participants may be followed for up to five years after starting treatment.

Researchers are evaluating a new medicine called PF-08634404 combined with chemotherapy for adults with colorectal cancer that has spread to other parts of the body. The study aims to understand how well this new combination works compared to an existing treatment using Bevacizumab with chemotherapy. The study is a phase 3, double-blind, randomized trial focusing on treatment effectiveness and safety in participants who have not received prior systemic therapy for metastatic disease. Participants are randomly assigned to one of two groups. One group receives PF-08634404 with chemotherapy, and the other group receives Bevacizumab with chemotherapy. Both treatments are given through intravenous IV infusions in cycles. Treatment continues as long as it helps and side effects are manageable. Treatments are administered at clinical sites by trained staff. Participants will have regular visits for treatment, health evaluations, and various tests. After stopping treatment, there is a follow-up visit about 30 to 37 days later to review health and side effects. Further follow-up occurs every 12 weeks by phone, in person, or via health record review to monitor health status and any new treatments. The study duration for each participant is approximately 33 months. Researchers will measure progression-free survival, overall survival, response rates, quality of life, and monitor safety throughout the study.

Researchers are evaluating the therapeutic cancer vaccine OSE2101 in patients with metastatic non-small cell lung cancer NSCLC who have developed secondary resistance to immune checkpoint inhibitors ICI. This phase 3, multicenter, randomized, open-label study focuses on HLA-A2 positive patients with either squamous or non-squamous NSCLC. The study aims to compare the efficacy and safety of OSE2101 with the standard treatment docetaxel, considering factors like cancer histology and performance status. Participants will be randomized in a 21 ratio to receive either OSE2101 monotherapy or docetaxel monotherapy. OSE2101 is administered as a subcutaneous injection of 5 mg peptides every three weeks for six cycles, then every eight weeks during the first year, and every twelve weeks until the end of the second year. Docetaxel is given as a 75 mgm2 intravenous infusion over one hour every three weeks. Additionally, a companion diagnostic device system is used to assess patient eligibility based on HLA-A2 phenotype. During the study, participants will have regular evaluations including clinical assessments and monitoring of survival time from randomization to death, which is the primary outcome measured over an average of three years. The study involves ongoing monitoring of treatment effects and safety. Participants can expect scheduled visits aligned with treatment cycles and assessments throughout the trial duration, which extends up to nearly five years from start to completion.