NCT06636734 · Emory University
Lovastatin and Pembrolizumab for the Treatment of Patients With Recurrent or Metastatic Head and Neck Cancer, LAPP Trial
What this study is about
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.
View original scientific description
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.
Interventions
PROCEDURE
Biospecimen Collection
Undergo blood sample collection
PROCEDURE
Computed Tomography
Undergo CT or PET/CT
DRUG
Lovastatin
Given PO
PROCEDURE
Magnetic Resonance Imaging
Undergo MRI
BIOLOGICAL
Pembrolizumab
Given IV
PROCEDURE
Positron Emission Tomography
Undergo PET/CT
Primary outcome measures
Objective response rate (ORR)
Time frame: Up to 1 year
ORR will be defined as the proportion of subjects with partial response or complete response. ORR will be evaluated using Response Evaluation Criteria in Solid Tumors version (RECIST) (v)1.1 response criteria. ORR will be calculated with 95% confidence interval by binomial distribution.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Atlanta, Georgia
Collaborators
National Cancer Institute (NCI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 11, 2026 · Source of record for eligibility and locations