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Lovastatin + Pembrolizumab for Head and Neck Cancer

Phase 2

Waitlist Available

Led By Nicole C Schmitt, D, FACS

Research Sponsored by Emory University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

No Placebo-Only Group

Summary

"This trial is testing a combination of lovastatin, a drug that lowers cholesterol and may cause tumor cell death, and pembrolizumab, an immunotherapy drug, to treat patients with head

Who is the study for?

This trial is for patients with head and neck cancer that has either returned after getting better or spread to other body parts. Participants should have a type of cancer listed in the trial conditions, such as nasopharyngeal carcinoma or laryngeal squamous cell carcinoma.

What is being tested?

The LAPP Trial is testing lovastatin combined with pembrolizumab on recurrent or metastatic head and neck cancers. Lovastatin lowers cholesterol but may also make tumor cells more sensitive to immunotherapy, while pembrolizumab boosts the immune system's ability to fight cancer.

What are the potential side effects?

Possible side effects include those common to statins like lovastatin (muscle pain, liver issues) and immunotherapies like pembrolizumab (immune reactions affecting organs, fatigue, skin problems). The exact side effects will vary by individual.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Objective response rate (ORR)

Secondary study objectives

Incidence of adverse events (AEs) and serious adverse events (SAEs)

Overall survival (OS)

Progression free survival (PFS)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (lovastatin, pembrolizumab)Experimental Treatment6 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biospecimen Collection

2004

Completed Phase 3

~2020

Positron Emission Tomography

2011

Completed Phase 2

~2200