Phase II Study of Lovastatin and Pembrolizumab for Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

What this Trial Is About

Researchers are evaluating how well lovastatin combined with pembrolizumab works to treat patients with recurrent or metastatic head and neck squamous cell carcinoma HNSCC. This phase II trial focuses on patients whose cancer has returned or spread, and it aims to measure the treatments effects on tumor response and survival. Lovastatin may help kill tumor cells and increase their sensitivity to immunotherapy, while pembrolizumab is an immunotherapy drug that helps the immune system attack cancer cells. Participants in the trial receive lovastatin orally once daily and pembrolizumab through an intravenous infusion on the first day of each 21-day cycle. Treatment may continue for up to 12 months unless the cancer worsens or unacceptable side effects occur. During the study, patients will also undergo blood sample collections and imaging scans such as CT, MRI, or PETCT to monitor the disease and treatment effects. Throughout the study, researchers will assess tumor response using standardized criteria and track progression-free and overall survival for up to one year. They will also monitor adverse events for safety up to 30 days after the last dose. Following treatment, participants will be followed for up to two years to observe long-term outcomes and effects on immune cells. The study is sponsored by Emory University and involves regular clinical visits and evaluations.

Lovastatin and Pembrolizumab for the Treatment of Patients With Recurrent or Metastatic Head and Neck Cancer, LAPP Trial