Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: A Phase II Study of Avelumab in Subjects With Recurrent Respiratory Papillomatosis
Brief Summary:
Background:
Recurrent respiratory papillomatosis (RRP) is a rare disease caused by human papillomavirus. It can cause voice changes, airway compromise, pulmonary lesions, and cancers. PD-L1 is a protein on cells. It may be able to stop or decrease the immune system s response to viruses such as human papillomavirus. The drug Avelumab interferes with the activity of PD-L1. Researchers want to see if Avelumab treats RRP and study its side effects.
Objective:
To see if Avelumab works in treating RRP and is safe.
Eligibility:
People ages 18 and older with aggressive RRP that has not responded to available treatments
Design:
Participants will be screened with:
Medical history
Previously collected tumor tissue
Physical exam
Blood, urine, and heart tests
Endoscopy procedure: A small tube with a camera is used to look in the nose, throat, larynx,
and upper windpipe.
Before starting treatment, participants will have:
Endoscopy under anesthesia. A sample of papilloma will be taken.
Voice handicap questionnaire
CT scans
Apheresis: An IV is inserted