Phase 2 Head and Neck Cancer Trial, Recruiting NCT06636734 Sponsor: Emory University Condition: Head and Neck Cancer
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Phase 2 Head and Neck Cancer Trial, Recruiting

NCT06636734
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Adults aged 18 or older who are able to give informed consent to participate
  • People who have been diagnosed through laboratory testing with head and neck squamous cell cancer (a type of cancer affecting the mouth, throat, voice box, nasal passages, or sinuses) that has come back or spread; people with cancer of unknown origin in the neck lymph nodes may also be considered if their cancer tests positive for HPV
  • People whose cancer has a protein marker called PD-L1 with a combined positive score of 1 or higher, meaning a doctor has determined them to be a candidate for treatment with pembrolizumab alone
  • People who are not being considered for surgery to remove the cancer
  • People whose cancer can be measured on scans according to a standard set of measurement rules (RECIST 1.1)
  • People expected by the investigator to live for more than 3 months
  • People with a general health and activity level rated as 0 or 1 on a standard medical scale (meaning fully active or able to carry out light activity)
  • People who have recovered from most side effects of any previous cancer treatments
  • People of reproductive potential who have used reliable contraception for at least 1 month before joining, and who agree to continue using it throughout the study and for 8 weeks after the last dose of study treatment
  • People whose blood test results meet specific minimum levels for white blood cells, platelets, haemoglobin, liver function, kidney function, and certain minerals (confirm exact values with the trial site)

Who may not be able to join:

  • People who are already taking a statin medication (a type of cholesterol-lowering drug)
  • People with liver problems that would make taking a statin unsafe
  • People who have had radiation therapy to the head and neck or other areas within the 4 weeks before joining
  • People who have received chemotherapy or another experimental treatment within the 4 weeks before joining
  • People who have previously been treated with immune checkpoint therapy (a type of cancer immunotherapy)
  • People currently taking certain medications that are known to interact with lovastatin, such as cimetidine, spironolactone, or ketoconazole (confirm the full list with the trial site)
  • People who are pregnant, breastfeeding, or planning to become pregnant
  • People who are unable to swallow tablets
  • People with a known allergy or previous serious reaction to lovastatin, other statin drugs, or pembrolizumab

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 20 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Nicole C Schmitt, D, FACS, Emory University Hospital/Winship Cancer Institute

Phone: 404-778-0278

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
9 December 2024
Est. completion
31 December 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Objective response rate (ORR)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 20 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov