Pikeville

Researchers are evaluating the safety and effectiveness of combining valemetostat tosylate with pembrolizumab compared to pembrolizumab alone in adults with advanced or metastatic non-small cell lung cancer (NSCLC) that has no actionable genomic alterations and whose tumors show high PD-L1 expression (50% or greater). This trial includes participants who have not previously received systemic therapy for their advanced or metastatic NSCLC. The study is conducted in two phases: a dose escalation phase to find the recommended phase 2 dose, followed by a dose expansion phase to further assess treatment effects. Participants receive valemetostat tosylate orally once daily until the recommended dose is established. Pembrolizumab is given as an intravenous infusion on the first day of each 21-day cycle, for up to 35 cycles. The trial compares this combination treatment to pembrolizumab alone, administered on the same schedule. The study design is open-label and randomized, allowing comparison of both treatment approaches in this patient population. During the study, participants undergo regular assessments including imaging scans to measure disease progression and safety monitoring for side effects. Researchers track dose-limiting toxicities, treatment-related adverse events, and progression-free survival over approximately 31 months. Tumor tissue samples and biomarker analyses are collected to support evaluation. Participant physical status and eligibility are carefully assessed before and during the study. Follow-up includes monitoring for safety up to 30 days after the last dose and long-term evaluation of treatment impact.

Researchers are evaluating surgical and minimally invasive treatments for lumbar spinal stenosis (LSS) by comparing Medicare patients who received the MILD procedure against those who had interspinous process decompression (IPD). The study focuses on outcomes such as the rate of harms related to the initial procedure and the frequency of additional surgical or minimally invasive interventions within 24 months after treatment. Enrollment includes patients treated from January 1, 2017, onward, with continuation until the sponsor decides to stop. The MILD procedure involves percutaneous image-guided lumbar decompression, performed under fluoroscopy through a dorsal approach to partially remove tissue and bone at the affected spinal level. The control group receives the IPD procedure for LSS. Both groups are monitored for a 24-month period post-index procedure using Medicare claims data to track reoperations and any harms. Participants contribute data through Medicare claims without needing prior enrollment or consent, as the study is exempt from IRB oversight. Researchers collect and analyze information on procedure-related harms and subsequent interventions over two years. This approach allows evaluation of long-term safety and effectiveness outcomes for patients treated with either MILD or IPD.

Researchers are evaluating treatment options for adults with metastatic colorectal cancer that has a specific KRAS p.G12C mutation. The study compares progression-free survival in patients who have not received prior treatment. The trial is a Phase 3, multicenter, randomized, open-label study focusing on this particular mutation to improve outcomes in this patient group. Participants will receive one of two treatment combinations. One group will receive sotorasib (an oral drug), panitumumab (given via intravenous infusion every two weeks), and the FOLFIRI regimen—a combination of irinotecan, leucovorin, and 5-fluorouracil administered intravenously every two weeks. The other group will receive FOLFIRI with or without bevacizumab-awwb, which is also given intravenously every two weeks. Treatments continue according to the study schedule to assess effectiveness. Throughout the study, participants will be monitored for progression-free survival using standard criteria (RECIST v1.1) for up to about three years. Researchers will assess tumor response and disease progression to evaluate treatment effects. Participants will undergo regular evaluations to monitor organ function and overall health status during the study period.