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A Phase II Trial of Lovastatin and Pembrolizumab in Patients with RM HNSCC (LAPP)
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.
Eligibility Criteria
Inclusion Criteria
- 1Adult patients, male or female, aged ≥ 18, able to provide informed consent
- 2Subjects 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
- 3PD-L1 combined positive score (CPS) ≥ 1 (i.e., must be a candidate for treatment with pembrolizumab alone)
- 4Patients must not be under consideration for salvage surgery
- 5Measurable disease by RECIST 1.1 criteria
- 6Life expectancy of more than 3 months, as determined by the investigator
- 7Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- 8Recovery 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
- 9For 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
- 10Absolute neutrophil count (ANC) ≥ 1000/mm\^3 without colony stimulating factor support
- 11Platelets ≥ 100,000/mm\^3
- 12Hemoglobin ≥ 9 g/dL
- 13Bilirubin ≤ 1.5 x the upper limit of normal (ULN). For subjects with known Gilbert's disease, bilirubin ≤ 3.0 mg/dL
- 14Serum albumin ≥ 2.8 g/dl
- 15Serum creatinine ≤ 1.5 x ULN or creatinine clearance (CrCl) ≥ 40 mL/min. For creatinine clearance estimation, the Cockcroft and Gault equation should be used
- 16Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.0 x ULN
- 17Serum phosphorus, calcium, magnesium and potassium ≥ lower limit of normal (LLN)
Exclusion Criteria
- 1Patients already taking a statin drug
- 2Liver dysfunction precluding the use of statins
- 3Radiation to the head and neck or other sites within 4 weeks prior to enrollment
- 4Cytotoxic chemotherapy or any form of investigational therapy within 4 weeks prior to study treatment
- 5Prior treatment with immune checkpoint blocking therapy
- 6Current use of drugs that interact with lovastatin (cimetidine, spironolactone, ketoconazole, and others)
- 7Pregnancy, lactation, or plan to become pregnant
- 8Inability to swallow lovastatin tablets
- 9Known allergy or prior adverse reaction to lovastatin, other statin drugs, or pembrolizumab
Locations
1 site participating in this study
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia 30322
Ardith C. Deshay