RecruitingPhase 2NCT06636734

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

A Phase II Trial Of Lovastatin And Pembrolizumab In Patients With RM HNSCC (LAPP)

Sponsor

Emory University

Enrollment

28 participants

Start Date

Dec 9, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This phase II trial tests how well lovastatin and pembrolizumab work in treating patients with head and neck cancer that has come back after a period of improvement (recurrent) or that has spread from where it first started (primary site) to other places in the body (metastatic). Lovastatin is a drug used to lower the amount of cholesterol in the blood and may also cause tumor cell death. In addition, studies have shown that lovastatin may make the tumor cells more sensitive to immunotherapy. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving lovastatin and pembrolizumab may kill more tumor cells in patients with recurrent or metastatic head and neck cancer.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (LAPP Trial) tests whether adding lovastatin — a common cholesterol-lowering drug — to pembrolizumab (an immunotherapy drug) helps treat people with recurrent or metastatic head and neck squamous cell cancer. Lab research suggests statins may boost the immune system's ability to fight cancer. **You may be eligible if...** - You are 18 or older with recurrent or metastatic head and neck squamous cell cancer (mouth, throat, voice box, or nearby areas) - Your cancer has a PD-L1 score of 1 or higher (meaning you would normally qualify for pembrolizumab alone) - You have measurable tumors and are not a candidate for salvage surgery - Your blood counts, liver, and kidney function meet the required levels - You have a life expectancy of more than 3 months **You may NOT be eligible if...** - You are already taking a statin drug (like atorvastatin or simvastatin) - You have significant liver disease - You are pregnant or breastfeeding - You have uncontrolled serious illness or active autoimmune disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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