Watertown

Researchers are evaluating treatments for adults with early-stage stage II-IIIB non-small cell lung cancer who are scheduled for surgery. The study compares an investigational treatment combining the immunotherapy drug cemiplimab, chemotherapy, and a third drug, REGN7075, against cemiplimab plus chemotherapy without the additional drug. The study also investigates side effects, effects on surgery type, drug levels in blood, and the bodys antibody response to the drugs. Participants are randomly assigned to one of two study groups one group receives cemiplimab plus chemotherapy, and the other group receives cemiplimab plus chemotherapy plus REGN7075. All drugs are given by intravenous infusion. The study focuses on the period leading up to surgery and includes up to 12 weeks for assessing major pathologic response and other tumor-related outcomes. During the study, participants will undergo medical evaluations including tumor measurements using pathology review, blood tests to monitor drug levels and antibodies, and assessments of side effects. Researchers will track event-free and overall survival outcomes for up to 5 years and monitor adverse events for up to 76 weeks. The total study duration may extend to several years for long-term monitoring of treatment effects and safety.

Researchers are evaluating the safety and effectiveness of DPX-Survivac combined with pembrolizumab, with and without low-dose cyclophosphamide CPA, in adults with relapsed or refractory diffuse large B-cell lymphoma DLBCL. This Phase 2b, randomized, open-label study aims to better understand how these treatments work in this group of patients who have had previous therapies. The study is sponsored by ImmunoVaccine Technologies, Inc. IMV Inc.. Participants will be randomly assigned to one of two groups one group receives DPX-Survivac, pembrolizumab, and intermittent low-dose CPA, while the other group receives DPX-Survivac and pembrolizumab without CPA. DPX-Survivac is given as two 0.5 mL doses three weeks apart on days 7 and 28, followed by up to twelve 0.1 mL doses every eight weeks. Pembrolizumab is administered intravenously at 200 mg on day 7 and then every three weeks. In the CPA group, subjects take 50 mg of oral CPA twice daily for 7 days followed by 7 days off, repeating this cycle throughout the treatment period. During the study, participants will undergo assessments to monitor tumor response and safety for about 24 months, with some measures extending up to 48 months. Researchers will evaluate objective response rates, adverse events, duration and time to response, progression-free survival, and disease control rates. Patient-reported outcomes will be collected using specific questionnaires. The study involves regular visits for treatment administration, tumor biopsies, and laboratory tests to track the participants health and treatment effects over time.

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.