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

Human Papilloma Virus Clinical Trial

Official title:
A Phase II Study of Lenvatinib in Combination With Pembrolizumab in HPV-associated Recurrent Respiratory Papilloma Patients

Clinical Trial Summary

This research study is studying Lenvatinib in combination with Pembrolizumab in people with human papillomavirus (HPV)-associated recurrent respiratory papillomatosis (RRP). The names of the study drugs involved in this study are: - Pembrolizumab - Lenvatinib

Clinical Trial Description

This is a non-randomized phase II trial in adult male and female subjects diagnosed with human papillomavirus (HPV)-associated Recurrent Respiratory Papilloma 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 eliminate HPV-associated RRPs. 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 21 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04645602
Study type Interventional
Source Massachusetts General Hospital
Contact Sara I Pai, MD, PHD
Phone 617-726-5251
Email sara.pai@mgh.harvard.edu
Status Not yet recruiting
Phase Phase 2
Start date July 2024
Completion date December 1, 2027
View Details
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