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Lovastatin and Pembrolizumab for Recurrent or Metastatic Head and Neck Cancer

This study is testing if combining lovastatin (a cholesterol-lowering drug that may also fight cancer) with pembrolizumab (an immunotherapy that helps your immune system attack cancer) can help patients with head and neck cancer that has returned or spread. Researchers will look at how many patients respond to this treatment. You might be eligible if you are an adult with recurrent or metastatic head and neck squamous cell carcinoma. The study aims to enroll 28 participants and is currently unclear regarding its status.

Study design
This is an interventional study with a planned enrollment of 28 participants. It is testing the combination of two drugs.
What's involved
You would receive lovastatin by mouth daily and pembrolizumab intravenously every 21 days for up to 12 months. You would also undergo blood draws, CT scans, MRI scans, or PET/CT scans.
Compensation
Not stated in the trial record.
Follow-up
After completing treatment, you will be followed for up to 2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06636734

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Emory University
~28 participants
Updated 2026-02-11 on ClinicalTrials.gov
What's tested:Biospecimen CollectionComputed TomographyLovastatinMagnetic Resonance ImagingPembrolizumabPositron Emission Tomography

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Objective response rate (ORR)
Measured over Up to 1 year

Conditions

Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
Human Papillomavirus-Related Neck Squamous Cell Carcinoma of Unknown Primary
Metastatic Head and Neck Squamous Cell Carcinoma
Metastatic Hypopharyngeal Squamous Cell Carcinoma
Metastatic Laryngeal Squamous Cell Carcinoma
Metastatic Nasopharyngeal Squamous Cell Carcinoma
Metastatic Oral Cavity Squamous Cell Carcinoma
Metastatic Oropharyngeal Squamous Cell Carcinoma
Metastatic Paranasal Sinus Squamous Cell Carcinoma
Recurrent Head and Neck Squamous Cell Carcinoma
Recurrent Hypopharyngeal Squamous Cell Carcinoma
Recurrent Laryngeal Squamous Cell Carcinoma
Recurrent Nasopharyngeal Squamous Cell Carcinoma
Recurrent Oral Cavity Squamous Cell Carcinoma
Recurrent Oropharyngeal Squamous Cell Carcinoma
Recurrent Paranasal Sinus Squamous Cell Carcinoma
Stage IV Hypopharyngeal Carcinoma AJCC v8
Stage IV Laryngeal Cancer AJCC v8
Stage IV Lip and Oral Cavity Cancer AJCC v8
Stage IV Nasopharyngeal Carcinoma AJCC v8
Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC v8
Stage IV Sinonasal Cancer AJCC v8

Explore related trials

Head and Neck Squamous Cell CarcinomaProgrammed Cell Death 1 Ligand 1

Where it's being run

2 sites across 1 states
Georgia2

Study leadership

  • Nicole C Schmitt, D, FACS · PRINCIPAL_INVESTIGATOR · Emory University Hospital/Winship Cancer Institute

Who to contact

Nicole C. Schmitt, MD, FACS
[email protected]
404-778-0278
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Objective response rate (ORR)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.