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

PHASE2RecruitingINTERVENTIONAL
Enrollment

28

Participants

Timeline

Start Date

December 9, 2024

Primary Completion Date

December 31, 2027

Study Completion Date

December 31, 2028

Conditions
Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC V8Human Papillomavirus-Related Neck Squamous Cell Carcinoma of Unknown PrimaryMetastatic Head and Neck Squamous Cell CarcinomaMetastatic Hypopharyngeal Squamous Cell CarcinomaMetastatic Laryngeal Squamous Cell CarcinomaMetastatic Nasopharyngeal Squamous Cell CarcinomaMetastatic Oral Cavity Squamous Cell CarcinomaMetastatic Oropharyngeal Squamous Cell CarcinomaMetastatic Paranasal Sinus Squamous Cell CarcinomaRecurrent Head and Neck Squamous Cell CarcinomaRecurrent Hypopharyngeal Squamous Cell CarcinomaRecurrent Laryngeal Squamous Cell CarcinomaRecurrent Nasopharyngeal Squamous Cell CarcinomaRecurrent Oral Cavity Squamous Cell CarcinomaRecurrent Oropharyngeal Squamous Cell CarcinomaRecurrent Paranasal Sinus Squamous Cell CarcinomaStage IV Hypopharyngeal Carcinoma AJCC V8Stage IV Laryngeal Cancer AJCC V8Stage IV Lip and Oral Cavity Cancer AJCC V8Stage IV Nasopharyngeal Carcinoma AJCC V8Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC V8Stage IV Sinonasal Cancer AJCC V8
Interventions
PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Computed Tomography

Undergo CT or PET/CT

DRUG

Lovastatin

Given PO

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

BIOLOGICAL

Pembrolizumab

Given IV

PROCEDURE

Positron Emission Tomography

Undergo PET/CT

Trial Locations (1)

30322

RECRUITING

Emory University Hospital/Winship Cancer Institute, Atlanta

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Emory University

OTHER