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Can a common cholesterol drug boost immunotherapy against head and neck cancer?

NCT ID NCT06636734

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase II trial tests whether adding lovastatin, a common cholesterol-lowering drug, to the immunotherapy pembrolizumab can help shrink tumors in people with head and neck cancer that has returned or spread. The study will enroll 28 adults whose tumors express PD-L1. Researchers will measure how many patients respond and how long the benefit lasts.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
lovastatin and pembrolizumab
What this could lead to
If it works, this could point toward a more effective treatment for recurrent or metastatic head and neck cancer by combining a common cholesterol drug with immunotherapy.
What could go wrong
This is a small, early-phase trial with only 28 participants, so results may not apply to everyone. The combination may not work better than pembrolizumab alone, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 28 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2024

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Emory University Hospital Midtown

    RECRUITING

    Atlanta, Georgia, 30308, United States

  • Emory University Hospital/Winship Cancer Institute

    RECRUITING

    Atlanta, Georgia, 30322, United States

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