Germantown

Researchers are evaluating the safety and effects of the study medicine PF-07248144 combined with fulvestrant for treating hormone receptor-positive, HER2-negative advanced or metastatic breast cancer. This study focuses on participants whose breast cancer has worsened after prior treatment with CDK46 inhibitor-based therapy. The trial compares PF-07248144 plus fulvestrant to the current standard treatment involving everolimus and endocrine therapy. Participants will be randomly assigned to one of two groups. One group will take PF-07248144 tablets daily at home in 28-day cycles along with fulvestrant injections administered at the clinic. The other group will receive everolimus tablets daily plus either exemestane tablets or fulvestrant injections, based on the study doctors choice. Treatments will continue according to the schedule for each participant. During the study, participants will undergo regular evaluations including scans to measure tumor response, lab tests, electrocardiograms, and monitoring of side effects. Researchers will track progression-free survival up to about two years, as well as overall survival and response duration up to about five years. Safety and drug levels will also be monitored throughout and after treatment. The total duration of participation may span several years depending on individual outcomes.

Researchers are evaluating the study medicine PF-08046054 compared to the standard treatment docetaxel in adults with non-small cell lung cancer NSCLC that has PD-L1 expression of 1% or higher. These participants have cancer that has spread or cannot be treated with surgery or definitive radiation and have shown disease progression during or after previous treatments including PD-L1 or PD-1 inhibitors, platinum-based chemotherapy, and targeted therapies for known genomic alterations. The study is a randomized phase 3 trial assessing treatment options for advanced NSCLC. Participants are randomly assigned to one of two groups one receives PF-08046054 as an intravenous IV infusion twice during each 21-day cycle, and the other receives docetaxel as an IV infusion once every 21 days. The study treatment may continue for up to 5 years if the participants cancer responds to therapy. Both treatments are given in cycles, and participants receive the medicine through infusions during clinic visits. During the study, participants will have regular clinic visits to monitor their health and how well the treatment is working. Assessments include measuring overall survival, progression-free survival, tumor response rates, and quality of life through questionnaires. Safety is monitored for adverse events up to 90 days after treatment ends. Blood samples are also taken to study the medicines levels and immune response. The total study duration can be up to 5 years depending on individual responses and outcomes.

Researchers are studying Alzheimers disease AD and mild cognitive impairment MCI to better understand molecular and genetic differences among patient subtypes and how these differences relate to disease progression. This observational study also includes cognitively normal participants as controls. The goal is to gather detailed molecular and clinical information that could inform future therapies and clinical strategies. Participants will provide samples such as olfactory neuron cells and blood at several visits over the study period. They will also complete cognitive and clinical assessments both in person and virtually. The study tracks changes over time, aiming to capture molecular signatures that distinguish different participant groups. During the study, participants will attend baseline and follow-up visits for up to 18 months. Assessments include cognitive tests like the Clinical Dementia Rating Sum of Boxes CDR-SB, Mini-Mental State Examination MMSE, and Rey Auditory Verbal Learning Test RAVLT. Researchers will analyze changes in molecular profiles from olfactory neurons and blood, monitor progression of cognitive symptoms, and collect detailed medical histories. Participants will be observed for safety and adherence throughout the study.

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 studying a new medicine called PF-08634404 combined with chemotherapy in people 18 years and older who have locally advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma. This study aims to understand how well this combination works and how safe it is compared to another approved treatment, nivolumab plus chemotherapy, in those who have not yet received treatment for advanced disease. Participants will receive intravenous PF-08634404 combined with chemotherapy in repeated treatment cycles. The study has two parts the first part focuses on safety and response to the new treatment, and the second part compares the new treatment plus chemotherapy against nivolumab plus chemotherapy. Treatments are given intravenously, and the study lasts approximately four years to monitor effects and outcomes. During the study, participants will be regularly monitored with medical tests to assess tumor response, side effects, survival, and quality of life. Researchers will collect data on tumor shrinkage using RECIST 1.1 criteria, adverse events, laboratory results, and serum levels of the study drug. Follow-up includes assessments up to 90 days after treatment ends. The total participation duration spans about four years, covering both treatment and observation periods.

Researchers are evaluating whether a new medicine called PF-08634404, given with chemotherapy, works better than the current standard treatment of pembrolizumab combined with chemotherapy for adults with a type of lung cancer known as non-small cell lung cancer NSCLC. This study focuses on participants with locally advanced or metastatic NSCLC who are not candidates for surgery or curative chemoradiotherapy and have no known actionable genomic alterations. The study is a Phase 3 randomized trial with double-blind masking to compare these treatments. Participants are assigned to one of two parts based on their tumor type those with squamous NSCLC are in Part 1, and those with non-squamous NSCLC are in Part 2. Each participant is randomly placed into one of two treatment groups the experimental group receives PF-08634404 plus chemotherapy, while the control group receives pembrolizumab plus chemotherapy. Treatments are given through intravenous infusions in cycles, followed by maintenance therapy with either PF-08634404 or pembrolizumab, depending on the part of the study. Participants continue treatment as long as it helps and side effects are manageable. During the study, participants attend regular visits for treatment and health assessments. Cancer response is checked every 6 weeks for the first 48 weeks and then every 12 weeks after that. Researchers monitor overall survival, progression-free survival, objective response rates, duration of response, adverse events, lab abnormalities, and quality of life measures. The study includes detailed tracking of drug levels and immune responses. Participation may last up to approximately 39 months, with continuous safety and effectiveness monitoring.