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

Launched by EMORY UNIVERSITY · Oct 8, 2024

Keywords

ClinConnect Summary

The LAPP Trial is a research study looking at how well two medications, lovastatin and pembrolizumab, work together to treat patients with certain types of head and neck cancer that have either returned after initial treatment or spread to other parts of the body. Lovastatin is commonly used to lower cholesterol but may also help kill cancer cells and make them more responsive to treatment. Pembrolizumab is an immunotherapy that helps the body's immune system recognize and attack cancer cells. The goal is to see if combining these two drugs can be more effective for patients with recurrent or metastatic head and neck cancer.

To be eligible for this trial, participants must be adults aged 18 or older with specific types of head and neck cancer that test positive for a virus called HPV. They should also have measurable disease and not be candidates for further surgery. Participants can expect to receive both medications during the study, and they will be monitored closely for side effects and effectiveness. It's important to note that anyone currently taking a statin, pregnant, or with certain health issues may not qualify for this study.

Gender

ALL

Eligibility criteria

• 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