Combining lovastatin and pembrolizumab for advanced head and neck cancer treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II trial evaluates the effectiveness of lovastatin and pembrolizumab in treating patients with recurrent or metastatic head and neck cancer. Lovastatin, a cholesterol-lowering drug, may enhance the sensitivity of tumor cells to immunotherapy, while pembrolizumab is an immunotherapy that helps the immune system target cancer cells. Patients will receive lovastatin orally and pembrolizumab intravenously in cycles lasting up to 12 months, with assessments of tumor response and immune cell activity throughout the study. The trial aims to determine the combination's impact on tumor response rates, progression-free survival, and overall survival.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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
* Measurable disease by RECIST 1.1 criteria
* Life expectancy of more than 3 months, as determined by the investigator
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Recovery to baseline or ≤ grade 1 Common Terminology Criteria for Adverse Events (CTCAE) version (v.)5.0 from toxicities related to any prior treatments, unless adverse events are clinically non-significant and/or stable on supportive therapy
* For men or women of reproductive potential: use of highly effective contraception for at least 1 month prior to enrollment and agreement to use such a method during study participation and for an additional 8 weeks after the end of lovastatin/pembrolizumab administration
* Absolute neutrophil count (ANC) ≥ 1000/mm\^3 without colony stimulating factor support
* Platelets ≥ 100,000/mm\^3
* Hemoglobin ≥ 9 g/dL
* Bilirubin ≤ 1.5 x the upper limit of normal (ULN). For subjects with known Gilbert's disease, bilirubin ≤ 3.0 mg/dL
* Serum albumin ≥ 2.8 g/dl
* Serum creatinine ≤ 1.5 x ULN or creatinine clearance (CrCl) ≥ 40 mL/min. For creatinine clearance estimation, the Cockcroft and Gault equation should be used
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.0 x ULN
* Serum phosphorus, calcium, magnesium and potassium ≥ lower limit of normal (LLN)

Exclusion Criteria:

* 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
* Prior treatment with immune checkpoint blocking therapy
* Current use of drugs that interact with lovastatin (cimetidine, spironolactone, ketoconazole, and others)
* Pregnancy, lactation, or plan to become pregnant
* Inability to swallow lovastatin tablets
* Known allergy or prior adverse reaction to lovastatin, other statin drugs, or pembrolizumab

Where it's running

• Emory University Hospital Midtown
  Atlanta, Georgia, United States Recruiting
• Emory University Hospital/Winship Cancer Institute
  Atlanta, Georgia, United States Recruiting

Study contacts

• Principal investigator: Nicole C Schmitt, D, FACS — Emory University Hospital/Winship Cancer Institute
• Study coordinator: Nicole C. Schmitt, MD, FACS
• Email: nicole.cherie.schmitt@emory.edu
• Phone: 404-778-0278

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.