Study on Lovastatin and Pembrolizumab for Treating Recurrent or Metastatic Head and Neck Cancer (LAPP Trial)

Sponsor: Emory University

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06636734

Provider View

This clinical trial is exploring the effectiveness of combining lovastatin, a cholesterol-lowering drug, with pembrolizumab, an immunotherapy, to treat head and neck cancer that has returned or spread to other parts of the body.

Patient Parameters

Program Overview

The purpose of this study is to see if using lovastatin together with pembrolizumab can help kill more cancer cells in patients with head and neck cancer that has come back or spread. Lovastatin is known for lowering cholesterol but may also help make cancer cells more sensitive to immunotherapy. Pembrolizumab is an immunotherapy that helps the immune system attack cancer cells. By combining these two treatments, researchers hope to improve outcomes for patients with recurrent or metastatic head and neck cancer.

Description

The main goal of this study is to evaluate how well the combination of pembrolizumab and lovastatin works in shrinking tumors in patients with head and neck cancer. Researchers will measure the response rate of tumors to this treatment using specific criteria.

Secondary goals include assessing how long patients live without the cancer getting worse and their overall survival.

Additional exploratory goals are to study how the combination affects immune cells in the blood and to find any links between treatment effectiveness and immune cell activity.

Patients in the study will take lovastatin by mouth once a day and receive pembrolizumab through an IV every 21 days for up to a year, as long as the cancer does not progress or side effects are manageable. Throughout the study, patients will have blood tests and imaging scans like CT, MRI, or PET/CT to monitor their condition.

After finishing the treatment, patients will be followed for up to two years to track their health and any long-term effects.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 or older who can provide informed consent.
  • Diagnosed with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) in specific areas like the oral cavity or throat, or with unknown primary HNSCC in the neck if HPV-positive.
  • Must have a PD-L1 score of 1 or higher, making them eligible for pembrolizumab treatment.
  • Not eligible for surgery to remove the cancer.
  • Have measurable cancer according to specific criteria.
  • Expected to live more than 3 months.
  • In good general health with a performance status of 0 or 1.
  • Have recovered from any side effects of previous treatments to a manageable level.
  • Agree to use effective birth control during the study and for 8 weeks after treatment ends.
  • Meet specific blood count and organ function requirements, including:
    • Neutrophil count of at least 1000/mm³.
    • Platelet count of at least 100,000/mm³.
    • Hemoglobin level of at least 9 g/dL.
    • Bilirubin, albumin, creatinine, ALT, and AST levels within specified limits.
    • Normal levels of phosphorus, calcium, magnesium, and potassium.

Exclusion Criteria

  • Currently taking a statin drug.
  • Have liver problems that prevent the use of statins.
  • Received radiation to the head, neck, or other areas within 4 weeks before joining the study.
  • Had chemotherapy or experimental treatments within 4 weeks before starting the study treatment.
  • Previously treated with immune checkpoint therapy.
  • Taking medications that interact with lovastatin, such as cimetidine or ketoconazole.
  • Pregnant, breastfeeding, or planning to become pregnant.
  • Unable to swallow lovastatin tablets.
  • Allergic or had a bad reaction to lovastatin, other statins, or pembrolizumab.

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