Garner

Researchers are evaluating the safety and effectiveness of licaminlimab eye drops compared to a placebo in people with Dry Eye Disease who have a specific TNFR1 gene type. This study is a combined Phase 2b/3 clinical trial that focuses on how well the treatment reduces eye discomfort over a 29-day period. Participants first use artificial tear eye drops three times daily for about 14 days as a run-in period. After that, they are randomly assigned to receive either licaminlimab eye drops or a placebo solution, both administered three times daily for 29 days. The study is conducted in a double-masked way, meaning neither the participants nor the researchers know who receives the active drug or placebo. During the trial, researchers monitor changes in the severity of eye discomfort from the start until Day 29. Participants will be assessed regularly to track their symptoms and safety while using the eye drops. The study includes genetic testing to confirm the specific gene type required for participation, ensuring accurate evaluation of treatment effects.

This research investigates dry eye disease by evaluating the safety and effectiveness of a fixed-dose combination of lifitegrast and perfluorohexyloctane given twice daily. The study is a 4-week, randomized, double-masked, parallel-group, active-controlled, multicenter trial focusing on improving signs and symptoms of dry eye disease. Participants must have a history of dry eye disease in both eyes for at least six months and meet specific symptom and sign criteria at screening and baseline. Participants will be assigned to one of several groups receiving topical eye drops for four weeks: the fixed-dose combination of lifitegrast and perfluorohexyloctane, lifitegrast alone, perfluorohexyloctane alone, or a vehicle drop without active ingredients. Each treatment is administered as an eye drop twice daily. The study compares these treatments to assess their impact on dry eye disease. Throughout the study, participants will undergo assessments including corneal fluorescein staining to measure changes from baseline at day 29. They will be monitored for adherence and safety, with evaluations of visual acuity and ocular health. The total participation time is approximately four weeks, during which researchers will track changes in dry eye disease signs and symptoms to evaluate treatment effects.

Researchers are investigating the addition of an immunotherapy drug called durvalumab to standard chemotherapy treatment in patients with MammaPrint High 2 Risk (MP2) stage II-III hormone receptor positive, HER2 negative breast cancer. This phase III trial aims to compare the effectiveness of usual chemotherapy alone versus chemotherapy combined with durvalumab. Immunotherapy with durvalumab may help the immune system attack cancer cells and prevent tumor growth and spread, while chemotherapy drugs like paclitaxel, doxorubicin, and cyclophosphamide work to stop cancer cells from growing or dividing. Previous studies suggest patients with an MP2 result might respond better to this combined treatment approach. Participants first undergo MammaPrint testing to confirm MP2 status before randomization into two groups. One group receives paclitaxel intravenously on days 1 and 8 every 14 days for 6 cycles, followed by doxorubicin and cyclophosphamide intravenously on day 1 every 14 days for 4 cycles. The other group receives the same chemotherapy schedule plus durvalumab intravenously over 60 minutes on specified cycles during both chemotherapy phases. Mammography is performed during screening, and optional tissue and blood samples are collected for future studies. Throughout the study, participants are monitored through various assessments including imaging, physical exams, laboratory tests, and quality of life questionnaires focusing on fatigue and physical and mental health. Researchers track breast cancer event-free survival and other outcomes such as treatment side effects and response rates. After completing treatment, patients are followed for up to 10 years or until death to evaluate long-term outcomes and safety.

Researchers are collecting blood and tissue samples from people with and without cancer to study and evaluate tests that could help detect cancer early. The goal is to create a blinded reference set of samples to validate blood-based tests for early detection of multiple types of cancer, including leukemia, lymphoma, breast, lung, and others. The study also aims to assess how well these tests perform at the time of initial cancer diagnosis, considering different tumor types and cancer stages. Participants complete a baseline questionnaire and provide blood samples at registration and again 12 months later. Those diagnosed with cancer may also provide tissue samples at these times. The study includes patients aged 40 to 75 years, with cancer diagnoses at various stages or individuals without cancer. Special procedures are in place for patients with high suspicion of certain cancers before confirmation. During the study, researchers collect detailed information through questionnaires, blood draws, and tissue sampling to analyze test accuracy. Participants are monitored for up to one year after registration to follow outcomes. The primary measure is providing this blinded set of blood samples to help validate future cancer detection tests, supporting research that could improve early diagnosis and treatment.

Researchers are evaluating how to best recommend chemotherapy for patients with colon cancer after surgery by using the presence or absence of circulating tumor DNA (ctDNA) in the blood. This approach aims to identify microscopic residual tumor cells and may provide better risk prediction for cancer recurrence compared to traditional methods. The trial focuses on patients with Stage IIB, IIC, or III colon cancer who have undergone complete tumor removal. Participants will have their tumor tissue and blood tested centrally using the Signatera assay to determine ctDNA status. Patients without detectable ctDNA may avoid chemotherapy, while those with detectable ctDNA are considered at higher risk and will be randomly assigned to receive different chemotherapy regimens, including mFOLFOX6, CAPOX, or mFOLFIRINOX, given intravenously or orally over periods ranging from 3 to 6 months. The study includes initial screening, treatment, and possible second randomization for patients whose ctDNA status changes during monitoring. During the study, participants will undergo various assessments including blood tests, imaging scans, and performance evaluations to monitor their health and response to therapy. Researchers will track the time to ctDNA positivity and disease-free survival for up to 3 and 5 years, respectively. Safety and treatment effects will be closely observed throughout the study duration, ensuring thorough follow-up and monitoring for all participants.

Researchers are evaluating a phase II Lung-MAP treatment trial testing combinations of targeted drugs—capmatinib, osimertinib, and ramucirumab—to treat patients with advanced non-small cell lung cancer (NSCLC) that has spread and shows EGFR and MET gene changes. Capmatinib and osimertinib are kinase inhibitors that block abnormal proteins signaling cancer growth, while ramucirumab is an antibody that may stop new blood vessel growth needed by tumors. Targeting these gene changes may help shrink or control the cancer. Patients are randomized into two groups: one group receives capmatinib and osimertinib orally along with ramucirumab intravenously, while the other group receives capmatinib and osimertinib orally without ramucirumab. Throughout the study, participants undergo CT or MRI scans and provide blood samples. The treatments are given according to the assigned group to compare their effects and safety. During the trial, participants are closely monitored with imaging and blood tests to assess cancer progression and treatment side effects. The main measure is progression-free survival, tracking time until cancer worsens or death, over up to 3 years. Researchers also evaluate response rates, overall survival, toxicity, and collect tissue and blood samples to study tumor DNA. Participants' health status and laboratory values are regularly checked to ensure safety and effectiveness of the treatments.

The goal of this clinical trial is to evaluate the safety and efficacy of the DG1 spectacle lens for myopia progression control in children. * To assess if the DG1 lens will slow the progression of myopia through an adjusted mean difference (e.g., age and baseline SER) of approximately 0.75D in cycloplegic spherical equivalent autorefraction refractive error compared to single-vision (SV) spectacles over the study period. * To assess if DG1 lens will slow the progression of myopia through an adjusted mean difference (e.g., age and baseline SER) of approximately 0.3mm in axial elongation compared to SV over the study period. The clinical trial will compare DG1 spectacle lens to single vision spectacle lens. Participants will wear spectacle lenses and return for visits at regularly scheduled intervals through a 36-month follow up visit. All subjects who complete the 36-month visit will continue in the study for an additional 12 months for the rebound evaluation.

Researchers are evaluating if adding adjuvant chemotherapy (ACT) to ovarian function suppression (OFS) plus endocrine therapy (ET) improves invasive breast cancer-free survival (IBCFS) compared to OFS plus ET alone. This Phase III trial focuses on premenopausal women with early-stage breast cancer that is estrogen receptor (ER)-positive, HER2-negative, and has a 21-gene recurrence score between 16-25 for node-negative patients or 0-25 for patients with 1-3 positive nodes. The study addresses the need for better treatment options for younger women diagnosed with this type of breast cancer, as younger age is linked to worse outcomes despite standard therapies. Participants receive one of two treatments: either OFS combined with an aromatase inhibitor (AI) for five years or adjuvant chemotherapy followed by the same OFS plus AI regimen. The specific AI and GnRH agonist used, along with their dosing schedules, are chosen by the investigator, commonly including goserelin, leuprolide, or triptorelin administered monthly or every three months. Bilateral oophorectomy may be used instead of ovarian suppression if preferred. Endocrine therapy beyond five years is at the investigator's discretion. During the trial, participants will be closely monitored for invasive breast cancer-free survival over an 11-year period from randomization. Assessments include clinical evaluations, hormone receptor testing, tumor staging, and genetic recurrence scoring prior to enrollment. Safety and effectiveness data will be collected throughout the study, with particular attention to treatment side effects and long-term outcomes. The trial involves detailed eligibility screening and ongoing follow-up to ensure accurate measurement of the study's primary outcome.

Researchers are evaluating the safety, tolerability, and effectiveness of GRF312 5% ophthalmic solution in adults with Dry Eye Disease (DED) through a Phase 2, multi-site, double-blind, randomized, vehicle-controlled study. The study focuses on adults who have a history of DED and meet specific clinical criteria for moderate to severe disease. This research aims to compare GRF312 5% to a placebo vehicle to better understand its potential benefits and risks for those affected by DED. Participants will be randomly assigned to receive either the GRF312 5% eye drops or a placebo vehicle. They will self-administer these eye drops according to the study instructions throughout the treatment period. The study includes a screening phase, a run-in period, and a treatment phase lasting up to 84 days. During this time, participants will be closely monitored for any treatment-emergent adverse events, serious adverse events, and any events that may cause them to stop treatment. Throughout the study, participants will attend required visits where their visual acuity, symptom severity, and other eye health measures will be assessed. Researchers will track safety and tolerability, as well as how participants respond to the treatment. The main outcomes include the number and proportion of participants experiencing adverse events up to Day 84. Participants will need to follow the study protocol carefully and attend all scheduled visits for the duration of the trial.

Researchers are evaluating a screening and multi-sub-study randomized phase II/III trial called Lung-MAP, designed for patients with previously treated non-small cell lung cancer. The trial aims to establish a genomic screening method to assign patients to biomarker-driven or non-matched sub-studies. Depending on the cancer biomarker type, participants may receive new targeted cancer therapies or combinations compared to standard care, with the goal of approving new treatments. An optional ancillary study explores patient and physician attitudes about returning genetic findings related to germline mutations. The study involves testing patient specimens to determine eligibility for various sub-studies under the Lung-MAP protocol. Patients undergo screening to analyze tumor tissue and blood samples for biomarkers including PD-L1 and c-MET. Those requiring a fresh biopsy also submit blood for circulating tumor DNA testing. Sub-study assignment depends on the molecular profile results. This screening process includes both patients progressing after prior therapy and those pre-screened before progression on current treatment. Participants provide informed consent and tumor tissue that meets quality standards for testing. Researchers collect clinical data including smoking history and performance status. Outcomes focus on screening success, such as adequate tissue submission and matching to biomarker-driven sub-studies, tracked for up to three years. The study also monitors patient and physician knowledge and preferences regarding genomic findings. Participation duration varies based on screening and sub-study assignment.