M7824 in People With Recurrent Respiratory Papillomatosis
Status:
Active, not recruiting
Trial end date:
2022-07-06
Target enrollment:
Participant gender:
Summary
Background:
Programmed cell death protein 1 (PD-L1) is a protein on the surface of cells. It regulates if
a cell can be killed by immune system cells. It is thought to be able to affect the immune
system response to diseased cells like those infected with a virus. The molecule M7824
interferes with the activity of PD-L1. It could help the immune system kill cells infected
with a virus . Since recurrent respiratory papillomatosis is caused by a virus infection,
this molecule could help.
Objective:
To see if M7824 works in treating recurrent respiratory papillomatosis.
Eligibility:
Adults ages 18 years or older with recurrent respiratory papillomatosis
Design:
Participants will be screened with:
Medical history
Physical exam
Blood and pregnancy tests
Endoscopy procedure in clinic. A small tube with a camera will look at the inside of the
nose, throat, larynx, and upper windpipe.
Some participants will also be screened with a chest scan.
At the start of the study, participants will:
Have a sedated endoscopy procedure where biopsies will be taken.
Have blood tests.
Have apheresis. Blood will be collected by a tube in an arm vein. A machine will remove white
blood cells. The rest of the blood will be returned into an arm vein.
Fill out a voice questionnaire.
Participants will get the study molecule into a vein over about 1 hour. They will get it
every other week for up to 12 weeks.
Participants will repeat screening and starting procedures throughout the study. They will
also review side effects and any medicine they are taking.
When they are done with the study treatment, participants will be evaluated by repeating the
study procedures. They may be evaluated periodically until their disease progresses.