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

Exploring Lovastatin and Pembrolizumab for head and neck cancer treatment.

Recruiting
18 years and older
All
Phase 2

Study Overview: This study is testing two drugs, lovastatin and pembrolizumab, for people with head and neck cancer that has come back or spread to other body parts. Lovastatin, often used to lower cholesterol, might help kill cancer cells and make them more sensitive to pembrolizumab, a medicine that helps the immune system attack cancer cells.

Treatment Plan: Participants take lovastatin by mouth daily and receive pembrolizumab through an IV every 21 days, continuing for up to 12 months. The study includes regular scans and blood tests to check progress, and participants will be followed up for two years after treatment.

  • Study Duration: Up to 12 months on treatment, plus 2 years follow-up.
  • Eligibility: Adults aged 18+ with specific types of head and neck cancer.
  • Requirements: Participants must not use certain other drugs and must agree to use birth control.

Important Considerations: Make sure you are not currently taking statins, have not had recent chemotherapy or radiation, and can swallow pills. Discuss any allergies or medications with your doctor to ensure this study is a good fit for you.

Study details
    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

NCT06636734

Emory University

25 January 2025

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