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

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT06636734
Phase
PHASE2
Status
Recruiting
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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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Computed Tomography — PROCEDURE
    Undergo CT or PET/CT
  • Lovastatin — DRUG
    Given PO
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Pembrolizumab — BIOLOGICAL
    Given IV
  • Positron Emission Tomography — PROCEDURE
    Undergo PET/CT

Study Details

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.

Key Dates

Start date
Dec 9, 2024
Status verified
Feb 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
28 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (lovastatin, pembrolizumab)
    Patients receive lovastatin PO QD and pembrolizumab IV over 60 minutes on day 1 of each cycle. Cycles repeat every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection, and CT, MRI or PET/CT throughout the study.

Primary Outcome Measure

Objective response rate (ORR) [ Time Frame: Up to 1 year ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Emory University Hospital MidtownAtlantaGeorgia30308
Ardith Deshay
[email protected]
404-686-1858
Nicole C. Schmitt, MD, FACS (PRINCIPAL_INVESTIGATOR)
Emory University Hospital/Winship Cancer InstituteAtlantaGeorgia30322
Ardith C. Deshay
[email protected]
404-686-1858
Nicole C. Schmitt, MD, FACS (PRINCIPAL_INVESTIGATOR)

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By research site
Emory University Hospital Midtown· Atlanta, GAEmory University Hospital/Winship Cancer Institute· Atlanta, GA

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