Watertown

Researchers are evaluating treatments for adults with early-stage (stage II to IIIB) non-small cell lung cancer who are scheduled for surgery. The study aims to compare an investigational treatment combining the immunotherapy drug cemiplimab, chemotherapy, and a third drug against cemiplimab plus chemotherapy alone. The trial also explores side effects of these treatments, effects on the type of surgery performed, drug levels in the blood, and whether the body produces antibodies that might affect the treatment's effectiveness or cause side effects. Participants receive treatments through intravenous infusions. One group receives cemiplimab plus chemotherapy, while the other group receives cemiplimab, chemotherapy, and an additional drug called REGN7075. The treatments are given before surgery with the goal of shrinking tumors. The study is a randomized Phase 2 platform trial designed to assess these combined therapies in a perioperative setting. During the study, participants undergo evaluations including pathology reviews up to 12 weeks after treatment to determine tumor response. Researchers monitor major pathological responses and collect tumor samples. Safety and side effects are closely followed. Overall, the study involves treatment, surgery, and follow-up assessments to understand how well the treatments work and their safety profiles.

Researchers are evaluating the effectiveness of zanubrutinib combined with anti-CD20 antibodies compared to lenalidomide plus rituximab (R2) in adults with relapsed or refractory follicular lymphoma (FL) or marginal zone lymphoma (MZL). The study aims to measure progression-free survival using independent review committees and established lymphoma response criteria based on PET/CT and CT imaging. Participants will receive zanubrutinib orally either as 160 mg twice daily or 320 mg once daily in continuous 28-day cycles. In the zanubrutinib plus rituximab group, rituximab is given intravenously at 375 mg/m2 on Days 1, 8, 15, and 22 of Cycle 1 and Day 1 of Cycles 2 to 5, each cycle lasting 28 days. The comparator group receives lenalidomide orally at 20 mg daily on Days 1 to 21 of each 28-day cycle for 12 cycles, plus obinutuzumab intravenously at 1000 mg on Cycle 1 Days 1, 8, 15 and Cycles 2 to 6 Day 1. During the study, participants will undergo imaging assessments such as PET/CT and CT scans to evaluate disease progression. Researchers will monitor treatment response and safety over approximately 78 months. Progression-free survival is the primary outcome, measured by a blinded independent review committee. Participants are expected to have measurable disease and adequate organ function at enrollment, with ongoing assessments to track treatment effects and adverse events.

Researchers are evaluating the safety and effectiveness of DPX-Survivac combined with pembrolizumab, with or 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 compare these treatments in patients who have previously received at least two lines of systemic therapy but whose disease has progressed. Participants will be randomly assigned to one of two groups: one group will receive DPX-Survivac, pembrolizumab, and intermittent low-dose CPA; the other group will receive DPX-Survivac and pembrolizumab without CPA. DPX-Survivac is given as two subcutaneous injections three weeks apart followed by up to twelve smaller doses every eight weeks. Pembrolizumab is administered by intravenous infusion every three weeks. For those in the CPA group, oral CPA is taken twice daily in a cycle of seven days on and seven days off, continuing throughout treatment. During the study, participants will be monitored for treatment response over approximately 24 months, focusing on the objective response rate in each group. Evaluations include tumor biopsies before and during treatment, laboratory tests, and disease assessments. Safety will be closely observed, and participants must have a life expectancy greater than three months to join. The study plans to enroll up to 102 subjects, with regular follow-up to track treatment effects and side effects.

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.