Lexington

Researchers are evaluating whether taking tirzepatide before bariatric surgery can improve outcomes for adults with obesity and related health conditions. This Phase 4 study focuses on patients scheduled for sleeve gastrectomy or gastric bypass surgery. The goal is to see if preoperative tirzepatide reduces inflammation and improves weight loss, metabolic health, and surgical recovery compared to patients not using the drug. Participants will be assigned to either a group that receives tirzepatide injections once weekly for three months before surgery or a standard care group that receives dietary and lifestyle education. Those taking tirzepatide will start with a 2.5 mg subcutaneous injection once a week and may have their dose increased following package instructions during monthly clinic visits. All participants will continue with their planned bariatric surgery and follow-up care as usual. Throughout the study, participants will visit the endocrine clinic monthly for drug prescriptions and side effect monitoring. They will keep diaries to track drug use and any side effects. Researchers will measure changes in inflammatory markers such as CRP, IL-6, TNF, leptin, adiponectin, and RAAS from baseline to three months after starting the drug, and RNA sequencing will be performed at surgery. The study will also assess weight loss, metabolic and inflammatory improvements, comorbidity resolution, and 30-day postoperative complications.

Researchers are investigating the targets of disease-reactive T cells in patients with various autoimmune diseases, including inflammatory bowel diseases, celiac disease, ankylosing spondylitis, multiple sclerosis, scleroderma, systemic sclerosis with lung involvement, and others. The study focuses on identifying the natural peptide targets recognized by T cell receptors (TCRs) in inflamed tissues, which may help develop new treatments that specifically target these immune responses. This approach uses high-throughput technology developed by TScan to discover these targets from active disease tissues. Participants will provide tissue samples during clinically indicated procedures or research biopsies, along with companion blood samples collected around the same time. The study involves isolating T cells from diseased tissues and matched blood or normal tissues, then identifying T cell clones expanded in the affected organs. These clones' TCR targets will be determined using TScan's genome-wide technology. No specific drug treatments are administered by the study; instead, it collects biospecimens for analysis. During the study, researchers will collect and analyze tissue and blood samples to identify disease-associated TCRs and their peptide targets over a 3-year period. Participants must be willing and able to consent and undergo the procedures. The study tracks T cell targets as the primary outcome, aiming to discover new therapeutic targets. Safety considerations include excluding those with conditions that increase biopsy risks. Total participation duration depends on the timing of tissue collection and subsequent analyses.

Researchers are investigating the relationship between amylin, a hormone increased in people with Type-2 diabetes, and the severity of peripheral neuropathy symptoms in affected individuals. This study aims to see if amylin deposits found in the blood vessels of patients with Type-2 diabetes correlate with nerve damage and sensory loss in the upper limbs. The study focuses on adults diagnosed with Type-2 diabetes who have mild to severe peripheral neuropathy, as measured by nerve conduction velocity tests. Participants will have blood and skin biopsy samples taken from the forearm to measure amylin levels in red blood cells and blood vessels. These samples will be collected immediately after nerve conduction studies are performed. Researchers will also assess participants' sensation and pain responses to heat, cold, and pressure in their upper extremities. The study will collect serum HbA1c levels to explore links with blood sugar control. During the study, participants will undergo clinical sensory examinations and nerve conduction tests. Blood and skin samples will be analyzed for amylin deposition to evaluate its role in microvascular disease related to diabetes. The study measures include the amount of amylin in red blood cells and skin vessel walls compared to the severity of peripheral neuropathy. This pilot research may lead to larger trials investigating amylin as a biomarker and potential target for therapies to reduce diabetic vascular complications.

Researchers are evaluating new treatment options for adults with locally advanced or metastatic colorectal cancer that cannot be removed by surgery and has a specific KRAS G12C gene mutation. This study compares the safety and effectiveness of adding calderasib and cetuximab, both targeted therapies, to a standard chemotherapy regimen called mFOLFOX6. The goal is to see if this combination can help patients live longer without their cancer growing or spreading compared to current treatments that may include mFOLFOX6 with or without bevacizumab. The study has two parts. It involves treatment with calderasib taken as an oral tablet, cetuximab given according to standard procedures, and mFOLFOX6 chemotherapy combining oxaliplatin, leucovorin/levofolinate calcium, and 5-fluorouracil. Some participants may receive bevacizumab or a bevacizumab biosimilar as part of the comparison. The treatments are given following approved dosing schedules. This design allows researchers to assess the safety and tolerability of these drug combinations in treating this type of colorectal cancer with the KRAS G12C mutation. Participants will be monitored for side effects, treatment tolerability, and cancer progression over a period that may last up to about 44 months. Researchers will track outcomes such as how many participants experience dose-limiting toxicities or adverse events, how many stop treatment due to side effects, and progression-free survival time. Assessments include health evaluations, laboratory tests, and imaging to observe cancer status. This long-term follow-up aims to understand both safety and effectiveness of the treatment combinations.

Researchers are evaluating a new treatment called ifinatamab deruxtecan (I-DXd) for men with metastatic castration-resistant prostate cancer (mCRPC). This study compares I-DXd to chemotherapy to see if it helps people live longer overall and live longer without their cancer worsening. It is a Phase 3, open-label trial focused on patients who have progressed on prior therapies and have evidence of metastatic disease. Participants receive either I-DXd through an intravenous infusion every 3 weeks or docetaxel chemotherapy administered every 3 weeks. Prednisone tablets are also given daily as part of the treatment plan. Before each I-DXd dose, premedication is provided to help prevent nausea and vomiting using a combination of drugs such as corticosteroids and anti-nausea medicines. Treatment continues until disease progression, unacceptable side effects, or other reasons to stop. During the study, researchers monitor overall survival and how long patients live without their cancer progressing, for up to about 36 months. Participants undergo tumor tissue collection, scans, and assessments to track disease status and side effects. Safety is closely watched throughout treatment. The study includes men aged 18 and older with confirmed prostate cancer and metastatic disease who have previously received certain hormone therapies but no prior taxane chemotherapy for mCRPC.

Researchers are evaluating treatments for breast cancer that is hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-), specifically in cases where the cancer is either locally advanced and cannot be removed by surgery or has spread to other parts of the body (metastatic). The study aims to determine if patritumab deruxtecan (also called HER3-DXd or MK-1022) helps patients live longer overall or without the cancer growing compared to chemotherapy or trastuzumab deruxtecan. This is a Phase 3 clinical trial focusing on this particular type of breast cancer. Participants receive one of several treatments: patritumab deruxtecan through intravenous infusion, chemotherapy options like paclitaxel or nab-paclitaxel via IV, oral capecitabine tablets, liposomal doxorubicin via IV, or trastuzumab deruxtecan via IV infusion. The study compares the effects of patritumab deruxtecan alone to the treatment chosen by the physician. Treatments are administered according to standard dosing schedules during the trial. During the study, participants are monitored for how long they live without the cancer progressing (up to about 45 months) and overall survival (up to about 85 months). Researchers assess disease status through imaging and other evaluations. Participants have regular check-ups to monitor health, treatment effects, and any side effects. The study tracks treatment response and safety over the extended follow-up period to understand the benefits and risks of the therapies.

Researchers are looking for ways to treat germinal center B-cell-like diffuse large B-cell lymphoma (GCB DLBCL). DLBCL is a fast-growing blood cancer that affects B-cells. GCB is a type of DLBCL that affects young B-cells that are still maturing. The goal of this study is to learn if more people who receive zilovertamab vedotin (MK-2140) and R-CHP have the cancer respond (go away) than those who receive polatuzumab vedotin and R-CHP.

Researchers are evaluating a culturally-tailored, home-based physical activity program designed to improve physical fitness in Hispanic or Latino/Latina adolescent and young adult childhood cancer survivors. These survivors may face long-term effects such as weight gain, fatigue, and reduced fitness after cancer treatment, with Hispanic or Latino/Latina individuals potentially at higher risk. The study aims to increase moderate to vigorous physical activity (MVPA) through a mobile health and social media intervention. The study has two stages. Stage 1 involves developing the intervention using feedback from 20 Latinx survivors who speak either English or Spanish. Stage 2 is a randomized controlled trial comparing the intervention group with a control group that only uses a Fitbit tracker. The intervention group receives Fitbit trackers, weekly reminders, goal-setting sessions, social media peer support 2-3 times a week, badges, monthly Zoom meetings, and may choose a physical activity partner who also receives support. After 12 weeks, a 4-week maintenance phase continues these supports with less structure. The control group wears a Fitbit daily for 12 weeks without additional support. Participants wear Fitbit trackers daily, attend weekly sessions, post on social media, and complete interviews and questionnaires. Researchers measure changes in physical activity levels, sedentary time, quality of life, and cardiometabolic health indicators. Data is collected using Fitbit devices, interviews, and surveys, with follow-up over 12 weeks plus maintenance. Safety and acceptability of the intervention are also assessed throughout the study.

Researchers are evaluating the efficacy and safety of rilvegostomig compared to pembrolizumab as first-line treatments for patients with metastatic non-small cell lung cancer (mNSCLC) whose tumors have high PD-L1 expression. This Phase III, randomized, double-blind, and global study focuses on participants with stage IV mNSCLC who do not have certain genetic mutations or rearrangements and are eligible for systemic therapy. Participants receive either rilvegostomig or pembrolizumab intravenously on Day 1 of each 21-day cycle. The study compares these two biological treatments given as monotherapy. Both groups will be monitored over time to assess treatment impact and safety. Throughout the study, participants undergo evaluations including tumor measurements by CT or MRI, performance status assessments, and organ function tests. Researchers will measure overall survival and progression-free survival for up to approximately five years. Tumor samples are collected before treatment for central testing, and participants’ health and treatment responses are closely followed during the trial period.

Researchers are evaluating the safety and effectiveness of rilvegostomig compared to pembrolizumab, both combined with platinum-based doublet chemotherapy, as initial treatments for patients with metastatic non-squamous non-small cell lung cancer (mNSCLC) whose tumors express PD-L1. This Phase III, randomized, double-blind, global study focuses on patients whose tumors meet the PD-L1 expression threshold of 1% or higher and do not have certain genetic mutations or rearrangements that would require other targeted therapies. Participants receive either rilvegostomig or pembrolizumab intravenously on the first day of each 21-day treatment cycle. Both groups also receive platinum-based chemotherapy drugs such as carboplatin or cisplatin, administered intravenously up to four cycles, along with pemetrexed given intravenously on Day 1 of each cycle. The study monitors these treatments as first-line therapy for metastatic non-squamous NSCLC. During the study, participants undergo regular assessments including imaging scans to measure tumor size and response, as well as evaluations of organ and bone marrow function. Researchers track overall survival and progression-free survival for up to approximately five years. Safety is closely monitored throughout, and patients are followed long-term to assess outcomes related to treatment effectiveness and tolerability.