Upper Marlboro

The trial investigates the use of volrustomig in participants with unresected locally advanced head and neck squamous cell carcinoma (LA-HNSCC) who have not shown disease progression after receiving definitive concurrent chemoradiotherapy (cCRT). The study aims to evaluate the efficacy and safety of volrustomig compared to observation in this patient population. Participants have tumors that express PD-L1 and the study is conducted as a Phase III, randomized, open-label, multi-center global trial. Participants are assigned to receive either volrustomig as sequential therapy following cCRT or to an observation group. The treatment period involves monitoring participants who have completed definitive cCRT but remain unresected and have no evidence of metastatic disease. The study focuses on participants with Stage III, IVA, or IVB LA-HNSCC according to AJCC criteria, who have not undergone tumor resection before cCRT and have not been treated with radiotherapy alone. During the study, participants are regularly evaluated for progression-free survival, with follow-up lasting up to approximately 8 years to assess long-term outcomes. Researchers will monitor safety and disease progression closely. The overall participation duration includes screening, treatment or observation, and extended follow-up to capture both efficacy and safety data over time.

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 investigating the effectiveness of Saruparib (AZD5305) combined with a physician's choice of new hormonal agents (NHA) compared to a placebo plus NHA in men with metastatic castration-sensitive prostate cancer (mCSPC). This phase III study aims to demonstrate whether Saruparib plus NHA can improve radiographic progression-free survival (rPFS) in two groups of participants: those with homologous recombination repair mutations (HRRm) and those without (non-HRRm). About 1800 adult male participants with mCSPC will be divided into two cohorts based on their HRRm status. Each cohort will be randomized equally to receive either Saruparib orally with their chosen NHA or a placebo orally with the chosen NHA. The new hormonal agents may include abiraterone acetate, darolutamide, or enzalutamide. Participants will continue their assigned treatment and undergo regular tumor evaluation scans until their disease progresses or treatment is stopped for other reasons. Throughout the study, participants will have tumor tissue and blood samples collected to confirm HRRm status and monitor disease. They will be followed for survival until the study ends. An independent data monitoring committee will review safety and tolerability of Saruparib plus NHA. The main outcome measured is radiographic progression-free survival, tracked for up to approximately 50 months, to evaluate how well the treatments control cancer progression.