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
Locations
2Sponsors and collaborators
Emory University
Lead sponsor
National Cancer Institute (NCI)
Collaborator