OncoMatch/Clinical Trials/NCT06636734
Lovastatin and Pembrolizumab for the Treatment of Patients With Recurrent or Metastatic Head and Neck Cancer, LAPP Trial
Is NCT06636734 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Pembrolizumab and Lovastatin for clinical stage iv hpv-mediated (p16-positive) oropharyngeal carcinoma ajcc v8.
Treatment: Lovastatin · Pembrolizumab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Biomarker criteria
Required: PD-L1 (CD274) cps ≥ 1 (cps ≥ 1)
Disease stage
Metastatic disease required
recurrent or metastatic head and neck squamous cell carcinoma (HNSCC)...Measurable disease by RECIST 1.1 criteria
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: statin
Patients already taking a statin drug
Cannot have received: cytotoxic chemotherapy
Exception: within 4 weeks prior to study treatment
Cytotoxic chemotherapy or any form of investigational therapy within 4 weeks prior to study treatment
Cannot have received: immune checkpoint inhibitor
Prior treatment with immune checkpoint blocking therapy
Cannot have received: investigational therapy
Exception: within 4 weeks prior to study treatment
Cytotoxic chemotherapy or any form of investigational therapy within 4 weeks prior to study treatment
Cannot have received: radiation therapy
Exception: to the head and neck or other sites within 4 weeks prior to enrollment
Radiation to the head and neck or other sites within 4 weeks prior to enrollment
Lab requirements
Blood counts
ANC ≥ 1000/mm^3 without colony stimulating factor support; Platelets ≥ 100,000/mm^3; Hemoglobin ≥ 9 g/dL
Kidney function
Serum creatinine ≤ 1.5 x ULN or creatinine clearance (CrCl) ≥ 40 mL/min (Cockcroft and Gault equation)
Liver function
Bilirubin ≤ 1.5 x ULN (≤ 3.0 mg/dL if Gilbert's disease); ALT and AST ≤ 2.0 x ULN; Serum albumin ≥ 2.8 g/dl
ANC ≥ 1000/mm^3 without colony stimulating factor support; Platelets ≥ 100,000/mm^3; Hemoglobin ≥ 9 g/dL; Bilirubin ≤ 1.5 x ULN (≤ 3.0 mg/dL if Gilbert's disease); Serum albumin ≥ 2.8 g/dl; Serum creatinine ≤ 1.5 x ULN or creatinine clearance (CrCl) ≥ 40 mL/min; ALT and AST ≤ 2.0 x ULN; Serum phosphorus, calcium, magnesium and potassium ≥ LLN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Emory University Hospital Midtown · Atlanta, Georgia
- Emory University Hospital/Winship Cancer Institute · Atlanta, Georgia
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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