Lisle

Researchers are evaluating the safety and effectiveness of the FloStent, a medical device designed to treat men experiencing symptoms of Benign Prostatic Hyperplasia (BPH). This clinical study compares the FloStent to a sham procedure, which involves flexible cystoscopy without deploying the device. The purpose is to assess how well the FloStent improves urinary symptoms in men with BPH. Participants will undergo a flexible cystoscopy. Those assigned to the treatment group will have the FloStent deployed during the procedure, while those in the control group will have the cystoscopy without device deployment. The study is designed as a prospective, multicenter, double-blind, randomized trial ensuring unbiased results. During the 12-month study period, researchers will monitor changes in participants' International Prostate Symptom Score (IPSS) to measure symptom improvement. Participants must complete all study visits and protocols as part of their involvement. Safety and effectiveness outcomes will be carefully tracked throughout the trial.

Researchers are investigating whether treating children with amblyopia using spectacles and patching at the same time leads to similar vision improvement compared to treating first with spectacles alone and then adding patching if needed. This randomized Phase 3 trial focuses on children aged 3 to under 13 years who have not been treated for amblyopia before. The study looks at amblyopia caused by differences in eye focusing (anisometropia), eye misalignment (strabismus), or both. At the start, children's vision will be tested with trial glasses based on a recent eye exam. Eligible children will receive new glasses and return for a baseline visit after wearing them for at least 10 minutes to confirm eligibility. Then they will be randomly assigned to either the sequential group (glasses first, patching added if needed) or the simultaneous group (glasses and patching together). Follow-up visits will happen every 8 weeks for up to 56 weeks, with vision tested each time to track improvement or stability. Patching will be monitored using an occlusion dose monitor (ODM). Throughout the study, vision in the amblyopic eye will be regularly measured to assess changes. Participants will be categorized as improving or stable/worsening at each visit. Those with stable or worsening vision and remaining amblyopia in the sequential group will begin patching and continue follow-up visits. Treatment adjustments will be made based on investigator judgment. The main outcome is the average change in distance visual acuity in the amblyopic eye after 56 weeks of treatment. The study ends after the final 56-week visit.

Researchers are evaluating whether combining pasritamig with docetaxel can extend the time before prostate cancer worsens, compared to docetaxel alone. This study focuses on participants with metastatic castration-resistant prostate cancer, a form of prostate cancer that continues to grow despite low male hormone levels. The trial is a Phase 3, randomized, open-label study assessing radiographic progression-free survival as the main outcome. Participants in this study receive pasritamig, a T-cell-redirecting agent targeting human kallikrein 2, along with docetaxel, a chemotherapy drug. Prednisone is also administered as part of the treatment. The study compares this combination therapy against docetaxel alone to determine if the addition of pasritamig can improve outcomes. During the study, participants undergo regular scans to monitor cancer progression and other assessments to evaluate their health status. Researchers track how long participants live without the cancer worsening based on imaging results. The study includes ongoing monitoring of treatment effects and safety, lasting up to nearly two years to observe radiographic progression-free survival.

Researchers are evaluating the safety, tolerability, and effectiveness of SYNC-T Therapy SV-102 in men with metastatic castration-resistant prostate cancer. This phase 2a study aims to find the highest dose patients can safely tolerate and the best dose to use in future studies. The therapy targets advanced prostate cancer that has progressed after previous treatments, including second-generation androgen-receptor inhibitors and possibly taxane therapy, for patients with few or no remaining standard treatment options. The study involves two main interventions: partial tumor destruction through cryolysis and direct injection of SV-102 into the tumor. Eligible tumors must be accessible for biopsy and treatment either within the prostate or in metastatic sites. Participants will receive treatment after passing cardiac clearance and anesthesia readiness checks. The study includes a dose-escalation phase to determine the maximum tolerated dose and an optimization phase to select the recommended dose for further trials. Participants will be followed for up to two years to monitor side effects, immune reactions, and tumor responses. Assessments include tumor biopsies, imaging scans, blood tests, and safety evaluations. Researchers will track adverse events and measure the objective response rate to evaluate how well the cancer responds to treatment. The study also monitors participants' overall health and treatment tolerability throughout the study period.

Researchers are evaluating the effectiveness and safety of adding Tersolisib (LY4064809/STX-478) to other anti-cancer drugs as the first treatment for adults with advanced hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer. This phase 3 study focuses on participants whose cancer has a specific genetic change called a PIK3CA mutation and who have not received prior treatment for advanced breast cancer. The study aims to understand how well this treatment combination works and its safety over time. Participants will receive Tersolisib or a placebo, combined with a CDK4/6 inhibitor (Ribociclib, Palbociclib, or Abemaciclib) and endocrine therapy (Anastrozole, Letrozole, Exemestane, or Fulvestrant). All drugs are given orally except for Fulvestrant, which is given by injection into the muscle. The study includes two parts: Part 1 allows participants who have had up to two prior treatments for advanced breast cancer, including chemotherapy; Part 2 includes those with no prior treatment for advanced disease and classifies them as endocrine sensitive or resistant based on their cancer history. During the study, participants will be regularly assessed for cancer response, progression-free survival, and side effects. Researchers will monitor measurable disease or bone involvement and track overall response rates, including complete or partial tumor shrinkage. The study will continue as long as the treatment is helping without causing unbearable side effects. Follow-up may last up to five years to observe long-term outcomes and safety.

Researchers are evaluating whether adding sacituzumab tirumotecan to pembrolizumab after surgery improves treatment outcomes for adults with resectable non-small cell lung cancer (NSCLC) who have not achieved a complete response after initial therapy. This Phase 3 study compares the combination of sacituzumab tirumotecan and pembrolizumab to pembrolizumab alone, focusing on disease-free survival as measured by a blinded independent central review. Participants receive neoadjuvant treatments including pembrolizumab with platinum-based doublet chemotherapy (such as cisplatin, pemetrexed, gemcitabine, carboplatin, or paclitaxel) before surgery. After surgery, those without a complete pathological response are randomized to receive either sacituzumab tirumotecan every two weeks for up to 24 weeks plus pembrolizumab every six weeks for up to 42 weeks, or pembrolizumab alone. Rescue medications may be given to prevent infusion reactions and oral side effects. During the study, participants undergo regular radiological assessments and provide tumor tissue samples to evaluate markers like PD-L1 and TROP2. Researchers monitor disease-free survival for up to approximately 93 months. Safety assessments, recovery from previous therapies, and control of infections such as HIV or hepatitis are also part of participant evaluations throughout the study period.

Researchers are evaluating the study medicine PF-08046054 compared to the standard chemotherapy drug docetaxel in adults with non-small cell lung cancer (NSCLC) that has spread or cannot be removed with surgery or radiation. Participants must have PD-L1 expression on 1% or more of their tumor cells and have experienced cancer progression during or after treatment with PD-L1 or PD-1 inhibitors, platinum-based chemotherapy, and targeted therapies for those with known genetic mutations. The trial is a Phase 3 randomized study to better understand how well PF-08046054 works alone compared to docetaxel alone. Participants will be randomly assigned to receive either PF-08046054 or docetaxel. Those in the PF-08046054 group will get intravenous (IV) infusions twice every 21-day cycle, while those in the docetaxel group will receive one IV infusion every 21 days. The treatment period may last up to 5 years if their NSCLC responds to the therapy. No other treatments are combined during the study period. Throughout the study, participants will have regular clinic visits for evaluations and monitoring to see how they respond to the treatment. Researchers will collect information on overall survival over approximately 5 years. They will also monitor safety and disease progression during these visits to understand the long-term effects and benefits of the treatments.

Researchers are evaluating the combination of the investigational drug PF-06821497 (mevrometostat) with enzalutamide compared to enzalutamide alone in men with metastatic castration-resistant prostate cancer (mCRPC) who have not previously received androgen receptor signaling inhibitors (ARSi) or abiraterone. This global, multicenter Phase 3 study focuses on participants whose cancer has progressed despite androgen deprivation therapy (ADT) or first-generation anti-androgens but who have not started other systemic anti-cancer treatments for mCRPC. The study excludes those with prior treatment using enzalutamide, darolutamide, apalutamide, or abiraterone in any setting, though chemotherapy is allowed in the hormone-sensitive setting. The study includes a Screening Phase, followed by randomization where participants are assigned equally to one of two groups: one receiving PF-06821497 plus enzalutamide, and the other receiving placebo plus enzalutamide. All treatments are taken orally on a continuous basis. After the treatment phase, participants enter a Safety Follow-up and a Long-Term Follow-up period to monitor ongoing effects. Participants will undergo assessments during the study to evaluate radiographic progression-free survival over about three years. Researchers will collect imaging data such as bone scans and CT or MRI scans to monitor disease progression. Additional evaluations include performance status, life expectancy assessments, and safety monitoring for adverse events. The study duration spans from screening through treatment and follow-up phases to gather comprehensive data on the combination therapy's impact on mCRPC.

Researchers are evaluating the safety and effectiveness of intravesical nadofaragene firadenovec alone or combined with chemotherapy or immunotherapy in people with high-grade Bacillus Calmette-Guerin (BCG) unresponsive non-muscle invasive bladder cancer (NMIBC) that includes carcinoma in situ (CIS) with or without high-grade Ta/T1 disease. This phase 3 trial builds on earlier findings where over half of participants achieved a complete response after treatment with nadofaragene firadenovec alone at 3 months. The study aims to better understand treatment options for patients who have not responded to BCG therapy. Participants will receive intravesical nadofaragene firadenovec, a gene therapy designed to boost immune response by delivering the human interferon alfa-2b gene directly into the bladder. Some participants may also receive chemotherapy drugs gemcitabine and docetaxel, or the immunotherapy pembrolizumab administered through intravenous infusion. The treatments are given inside the bladder or by IV infusion as appropriate, and the study will assess these approaches alone or in combination. During the study, participants will be closely monitored for response to treatment, particularly looking for complete response up to 6 months after starting therapy. Researchers will regularly evaluate participants’ health status and tumor response, including safety assessments and follow-up visits over the course of the trial. The study requires participants to be available for the entire duration and includes various clinical assessments to track effectiveness and side effects.

This research aims to evaluate the safety and effectiveness of the Edwards SAPIEN X4 Transcatheter Heart Valve (THV) in patients who have a failing aortic bioprosthetic valve and are at high or greater surgical risk. The study focuses on individuals with aortic valve insufficiency or stenosis, assessing the performance of this balloon-expandable valve in a prospective, single-arm, multicenter design. Participants will receive the SAPIEN X4 valve implanted to replace their failing bioprosthetic aortic valve. The study involves a single treatment arm where the device is implanted via a transcatheter procedure, intended for patients whose valve size matches the SAPIEN X4 THV requirements. This procedure is planned for those with moderate or greater valve stenosis or insufficiency. During the study, participants will be closely monitored, with one of the main outcomes measured being a composite of death and stroke assessed over one year. Researchers will evaluate safety and effectiveness through clinical follow-ups, imaging, and other assessments to track valve function and participant health. The total duration includes one year of observation after the valve implantation.