Actively Recruiting
Lovastatin and Pembrolizumab for the Treatment of Patients With Recurrent or Metastatic Head and Neck Cancer, LAPP Trial
Led by Emory University · Updated on 2026-02-11
28
Participants Needed
2
Research Sites
211 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
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.
CONDITIONS
Official 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...
- Adults aged 18 years or older able to provide informed consent
- Pathologically confirmed recurrent or metastatic head and neck squamous cell carcinoma involving specified sites or HPV-positive unknown primary HNSCC
- PD-L1 combined positive score (CPS) of 1 or higher
- Not considered for salvage surgery
- Measurable disease by RECIST 1.1 criteria
- Life expectancy greater than 3 months
- ECOG performance status of 0 or 1
- Recovery to baseline or grade 1 or less toxicity from prior treatments
- For reproductive potential: use of highly effective contraception before and during study and for 8 weeks after treatment
- Absolute neutrophil count (ANC) of at least 1000/mm3
- Platelets of at least 100,000/mm3
- Hemoglobin of at least 9 g/dL
- Bilirubin less than or equal to 1.5 times upper limit of normal (ULN) or 3.0 mg/dL if Gilbert's disease
- Serum albumin of at least 2.8 g/dL
- Serum creatinine less than or equal to 1.5 times ULN or creatinine clearance of at least 40 mL/min
- ALT and AST less than or equal to 2.0 times ULN
- Serum phosphorus, calcium, magnesium, and potassium at or above lower limit of normal
You will not qualify if you...
- Current use of statin drugs
- Liver dysfunction preventing statin use
- Radiation to head and neck or other sites within 4 weeks prior to enrollment
- Cytotoxic chemotherapy or investigational therapy within 4 weeks prior to study treatment
- Prior immune checkpoint blocking therapy
- Use of drugs that interact with lovastatin (e.g., cimetidine, spironolactone, ketoconazole)
- Pregnancy, breastfeeding, or plans to become pregnant
- Inability to swallow lovastatin tablets
- Known allergy or prior adverse reaction to lovastatin, other statins, or pembrolizumab
AI-Screening
AI-Powered Screening
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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
CONTACT
N
Nabil F Saba, MD, FACP
CONTACT
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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