Lovastatin and Pembrolizumab for the Treatment of Patients with Recurrent or Metastatic Head and Neck Cancer, LAPP Trial

Description

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

Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC V8, Human Papillomavirus-Related Neck Squamous Cell Carcinoma of Unknown Primary, Metastatic Head and Neck Squamous Cell Carcinoma, Metastatic Hypopharyngeal Squamous Cell Carcinoma, Metastatic Laryngeal Squamous Cell Carcinoma, Metastatic Nasopharyngeal Squamous Cell Carcinoma, Metastatic Oral Cavity Squamous Cell Carcinoma, Metastatic Oropharyngeal Squamous Cell Carcinoma, Metastatic Paranasal Sinus Squamous Cell Carcinoma, Recurrent Head and Neck Squamous Cell Carcinoma, Recurrent Hypopharyngeal Squamous Cell Carcinoma, Recurrent Laryngeal Squamous Cell Carcinoma, Recurrent Nasopharyngeal Squamous Cell Carcinoma, Recurrent Oral Cavity Squamous Cell Carcinoma, Recurrent Oropharyngeal Squamous Cell Carcinoma, Recurrent Paranasal Sinus Squamous Cell Carcinoma, Stage IV Hypopharyngeal Carcinoma AJCC V8, Stage IV Laryngeal Cancer AJCC V8, Stage IV Lip and Oral Cavity Cancer AJCC V8, Stage IV Nasopharyngeal Carcinoma AJCC V8, Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC V8, Stage IV Sinonasal Cancer AJCC V8

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Study Overview

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Study Details

Study overview

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.

A Phase II Trial of Lovastatin and Pembrolizumab in Patients with RM HNSCC (LAPP)

Lovastatin and Pembrolizumab for the Treatment of Patients with Recurrent or Metastatic Head and Neck Cancer, LAPP Trial

Condition
Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC V8
Intervention / Treatment

-

Contacts and Locations

Atlanta

Emory University Hospital/Winship Cancer Institute, Atlanta, Georgia, United States, 30322

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Emory University,

Nicole C Schmitt, D, FACS, PRINCIPAL_INVESTIGATOR, Emory University Hospital/Winship Cancer Institute

Study Record Dates

2028-12-31