About this trial

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 criteria

Qualifiers

Adult patients, male or female, aged ≥ 18, able to provide informed consent

Subjects with pathologically proven, recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) involving the oral cavity, oropharynx, larynx, hypopharynx, nasopharynx, or paranasal sinuses; patients with unknown primary HNSCC involving the cervical lymph nodes can be included if human papillomavirus (HPV)-positive

PD-L1 combined positive score (CPS) ≥ 1 (i.e., must be a candidate for treatment with pembrolizumab alone)

Patients must not be under consideration for salvage surgery

Disqualifiers

Patients already taking a statin drug

Liver dysfunction precluding the use of statins

Radiation to the head and neck or other sites within 4 weeks prior to enrollment

Cytotoxic chemotherapy or any form of investigational therapy within 4 weeks prior to study treatment

Trial design

Treatments tested in this trial

  • Biospecimen Collection
  • Computed Tomography
  • Lovastatin
  • Magnetic Resonance Imaging
  • Pembrolizumab
  • Positron Emission Tomography

Treatment groups

28 Participants
are divided into 1 treatment group

Locations

2
Emory University Hospital Midtown30308, AtlantaGeorgia, United States
Emory University Hospital/Winship Cancer Institute30322, AtlantaGeorgia, United States

Sponsors and collaborators

Emory University

Lead sponsor

National Cancer Institute (NCI)

Collaborator