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Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8Phase 2NCT06636734

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

A Phase 2 study testing Biospecimen Collection, Computed Tomography and Lovastatin in people with Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 and Human Papillomavirus-Related Neck Squamous Cell Carcinoma of Unknown Primary, run by Emory University at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Biospecimen Collection, Computed Tomography and Lovastatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
2 sitesUnited States
Study dates
9 Dec 2024to 31 Dec 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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)

Who cannot join

  • 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)
Show all 9Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Nicole C. Schmitt, MD, FACS contact

404-778-0278

nicole.cherie.schmitt@emory.edu

Nabil F Saba, MD, FACP contact

404-778-1900

nfsaba@emory.edu

United States2 sites, 2 recruiting

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308

    Ardith Deshay, 404-686-1858, ardith.deshay.deshay@emory.edu

    Nicole C. Schmitt, MD, FACS

    Recruiting

  • Emory University Hospital/Winship Cancer Institute

    Atlanta, Georgia, 30322

    Ardith C. Deshay, 404-686-1858, ardith.deshay.deshay@emory.edu

    Nicole C. Schmitt, MD, FACS

    Recruiting

Other trials in United States

About this study

Official title: A Phase II Trial Of Lovastatin And Pembrolizumab In Patients With RM HNSCC (LAPP)

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To evaluate anti-tumor activity of the combination of pembrolizumab and lovastatin by assessing the objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST 1.1).

SECONDARY OBJECTIVE:

  1. To evaluate the anti-tumor activity of the combination of by assessing progression-free survival (PFS) and overall survival (OS).

TERTIARY/EXPLORATORY OBJECTIVES:

  1. To assess the effects of the combination of lovastatin + pembrolizumab on immune cells in blood.

II. To assess the association between efficacy measures and expression in tumors.

III. To assess the association between anti-tumor activity and immune cells in the blood.

OUTLINE:

Patients receive lovastatin orally (PO) once daily (QD) and pembrolizumab intravenously (IV) over 60 minutes on day 1 of each cycle. Cycles repeat every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection, and computed tomography (CT), magnetic resonance imaging (MRI) or positron emission tomography (PET)/CT throughout the study.

After completion of study treatment, patients are followed for up to 2 years.

Being tested
Biospecimen Collection, Computed Tomography, Lovastatin, Magnetic Resonance Imaging, Pembrolizumab
Medical subject headings
Oropharyngeal Neoplasms, Squamous Cell Carcinoma of Head and Neck, Hypopharyngeal Neoplasms, Laryngeal Neoplasms, Mouth Neoplasms, Nasopharyngeal Carcinoma, Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo blood sample collection

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo CT or PET/CT

  • LovastatinDrug

    Also called Lovastatin Sodium, Mevacor, Mevinolin, Monacolin K

    Given PO

  • Magnetic Resonance ImagingProcedure or surgery

    Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan

    Undergo MRI

  • PembrolizumabBiological

    Also called BCD-201, GME 751, GME751, Keytruda

    Given IV

  • Positron Emission TomographyProcedure or surgery

    Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)

    Undergo PET/CT

Study groups in NCT06636734
Study groupRoleWhat they receive
Treatment (lovastatin, pembrolizumab)ExperimentalPatients receive lovastatin PO QD and pembrolizumab IV over 60 minutes on day 1 of each cycle. Cycles repeat every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection, and CT, MRI or PET/CT throughout the study.
Receives: Procedure: Biospecimen Collection; Procedure: Computed Tomography; Drug: Lovastatin; Procedure: Magnetic Resonance Imaging; Biological: Pembrolizumab; Procedure: Positron Emission Tomography

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective response rate (ORR)

    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.

    Measured: Up to 1 year

Secondary outcomes (3)

  1. Progression free survival (PFS)

    PFS will be defined as the duration from the date of treatment start to the date of objectively documented progression or death due to any cause, whichever status is recorded first. PFS will be assessed using RECIST v1.1 response criteria. Median PFS will be estimated by Kaplan-Meier method along with 95% confidence interval.

    Measured: From date of treatment start to the date of objectively documented progression or death due to any cause, whichever status is recorded first, assessed up to 1 year

  2. Overall survival (OS)

    To evaluate the anti-tumor activity of the combination of by assessing overall survival (OS).

    Measured: Up to 1 year

  3. Incidence of adverse events (AEs) and serious adverse events (SAEs)

    AEs and SAEs will be assessed and graded according to Common Terminology Criteria for Adverse Events v5.0. Frequency of AEs and SAEs will be summarized accordingly.

    Measured: Up to 30 days after last dose of study treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Oct 2024
  2. Study start9 Dec 2024
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
28 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06636734
Sponsor's protocol ID
STUDY00007740
Other IDs
NCI-2024-06118, STUDY00007740, WINSHIP6229-24, P30CA138292
Status last verified
Feb 2026
First submitted
8 Oct 2024
Last updated
11 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Biospecimen Collection, Computed Tomography and Lovastatin in people with Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 and Human Papillomavirus-Related Neck Squamous Cell Carcinoma of Unknown Primary, run by Emory University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Nicole C. Schmitt, MD, FACS (404-778-0278, nicole.cherie.schmitt@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (ORR) (time frame: Up to 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06636734.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2026.

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