RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-12-09
Study Completion:2028-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06636734

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adult patients, male or female, aged ≥ 18, able to provide informed consent
  2. * 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
  3. * PD-L1 combined positive score (CPS) ≥ 1 (i.e., must be a candidate for treatment with pembrolizumab alone)
  4. * Patients must not be under consideration for salvage surgery
  5. * Measurable disease by RECIST 1.1 criteria
  6. * Life expectancy of more than 3 months, as determined by the investigator
  7. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  8. * 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
  9. * 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
  10. * Absolute neutrophil count (ANC) ≥ 1000/mm\^3 without colony stimulating factor support
  11. * Platelets ≥ 100,000/mm\^3
  12. * Hemoglobin ≥ 9 g/dL
  13. * Bilirubin ≤ 1.5 x the upper limit of normal (ULN). For subjects with known Gilbert's disease, bilirubin ≤ 3.0 mg/dL
  14. * Serum albumin ≥ 2.8 g/dl
  15. * 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
  16. * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.0 x ULN
  17. * Serum phosphorus, calcium, magnesium and potassium ≥ lower limit of normal (LLN)
  1. * Patients already taking a statin drug
  2. * Liver dysfunction precluding the use of statins
  3. * Radiation to the head and neck or other sites within 4 weeks prior to enrollment
  4. * Cytotoxic chemotherapy or any form of investigational therapy within 4 weeks prior to study treatment
  5. * Prior treatment with immune checkpoint blocking therapy
  6. * Current use of drugs that interact with lovastatin (cimetidine, spironolactone, ketoconazole, and others)
  7. * Pregnancy, lactation, or plan to become pregnant
  8. * Inability to swallow lovastatin tablets
  9. * Known allergy or prior adverse reaction to lovastatin, other statin drugs, or pembrolizumab

Contacts and Locations

Study Contact

Nicole C. Schmitt, MD, FACS
CONTACT
404-778-0278
nicole.cherie.schmitt@emory.edu
Nabil F Saba, MD, FACP
CONTACT
404-778-1900
nfsaba@emory.edu

Principal Investigator

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

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Emory University

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-09
Study Completion Date2028-12-31

Study Record Updates

Study Start Date2024-12-09
Study Completion Date2028-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • 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