Actively Recruiting
Lovastatin and Pembrolizumab for Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma: A Phase II Trial
Led by Emory University · Updated on 2026-02-11
28
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
Sponsors
E
Emory University
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating how well lovastatin combined with pembrolizumab works to treat patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). This phase II trial focuses on patients whose cancer has returned or spread, and it aims to measure the treatment's effects on tumor response and survival. Lovastatin may help kill tumor cells and increase their sensitivity to immunotherapy, while pembrolizumab is an immunotherapy drug that helps the immune system attack cancer cells. Participants in the trial receive lovastatin orally once daily and pembrolizumab through an intravenous infusion on the first day of each 21-day cycle. Treatment may continue for up to 12 months unless the cancer worsens or unacceptable side effects occur. During the study, patients will also undergo blood sample collections and imaging scans such as CT, MRI, or PET/CT to monitor the disease and treatment effects. Throughout the study, researchers will assess tumor response using standardized criteria and track progression-free and overall survival for up to one year. They will also monitor adverse events for safety up to 30 days after the last dose. Following treatment, participants will be followed for up to two years to observe long-term outcomes and effects on immune cells. The study is sponsored by Emory University and involves regular clinical visits and evaluations.
CONDITIONS
Brief Title
Lovastatin and Pembrolizumab for the Treatment of Patients With Recurrent or Metastatic Head and Neck Cancer, LAPP Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients aged 18 years or older who can provide informed consent
- Pathologically confirmed recurrent or metastatic head and neck squamous cell carcinoma involving oral cavity, oropharynx, larynx, hypopharynx, nasopharynx, paranasal sinuses, or HPV-positive unknown primary involving cervical lymph nodes
- PD-L1 combined positive score (CPS) of 1 or higher
- Not under consideration for salvage surgery
- Measurable disease by RECIST 1.1 criteria
- Life expectancy longer than 3 months
- ECOG performance status of 0 or 1
- Recovery to baseline or grade 1 or less from prior treatment toxicities
- Use of highly effective contraception for men or women of reproductive potential during and after study treatment
- Adequate blood counts and organ function as specified in the criteria
You will not qualify if you...
- Current use of any statin drug
- Liver problems preventing statin use
- Radiation therapy to head, neck, or other sites within 4 weeks before enrollment
- Cytotoxic chemotherapy or investigational therapy within 4 weeks prior to treatment
- Prior treatment with immune checkpoint inhibitors
- Current use of drugs that interact with lovastatin (e.g., cimetidine, spironolactone, ketoconazole)
- Pregnancy, breastfeeding, or planning pregnancy
- Inability to swallow lovastatin tablets
- Known allergy or prior adverse reaction to lovastatin, other statins, or pembrolizumab
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months in the absence of disease progression or unacceptable toxicity
Participants receive lovastatin orally once daily and pembrolizumab intravenously on day 1 of each 21-day cycle. Blood samples are collected and imaging scans such as CT, MRI, or PET/CT are performed throughout the treatment period to monitor response.
Visits every 3 weeks for treatment and monitoring
Duration - Up to 2 years
Participants are followed for safety and survival outcomes after completing treatment for up to 2 years.
Visits scheduled as needed during follow-up
Trial Site Locations
Total: 2 locations
1
Emory University Hospital Midtown
Atlanta, Georgia, United States, 30308
Actively Recruiting
2
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Actively Recruiting
Research Team
N
Nicole C. Schmitt, MD, FACS
N
Nabil F Saba, MD, FACP
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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