Lenvatinib and Pembrolizumab Combination Therapy In HPV-associated Recurrent Respiratory Papillomatosis Patients With Laryngeal, Tracheal, and/or Pulmonary Involvement

Description

This is a non-randomized phase II trial in adult male and female subjects diagnosed with human papillomavirus (HPV)-associated Recurrent Respiratory Papillomatosis to test the safety and efficacy of the drug combination Lenvatinib and Pembrolizumab.

The U.S. Food and Drug Administration (FDA) has not approved Pembrolizumab or Lenvatinib for HPV-associated Recurrent Respiratory Papilloma but they have been approved for other uses.

Lenvatinib works by blocking certain proteins that are associated with tumor growth. Lenvatinib also blocks the growth of blood vessels feeding tumors to cause tumor cell death. Pembrolizumab helps the body’s immune system destroy cancer cells.

This study is investigating whether the combination of Lenvatinib and Pembrolizumab may eradicate HPV-associated RRP.

The research study procedures include screening for eligibility, study treatment and evaluations and follow up visits.

Participants will receive study treatment for up to 2 years and will be followed for 1 year.

It is expected that about 10 people will take part in this research study.

Merck is supporting this research study by providing Pembrolizumab and supporting the research study procedures. Eisai is supporting this research study by providing Lenvatinib.