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NCT02859454 · ClinicalTrials.gov registry record · Phase 2
Avelumab for People With Recurrent Respiratory Papillomatosis
A Phase 2 study of Human Papilloma Virus and Recurrent Respiratory Papillomatosis, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 13
- Enrollment target
- 1
- Study location
NCT02859454 is a Phase 2 study of Human Papilloma Virus and Recurrent Respiratory Papillomatosis that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 13 participants, below the 624-participant average among 26 other Human Papilloma Virus trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02859454, a Phase 2 study of Human Papilloma Virus and Recurrent Respiratory Papillomatosis, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 13 participants
- Enrollment target
- 1
- Study location
Study 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. Programmed death-ligand 1 (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 Computed tomography (CT) scans Apheresis: An intravenous (IV) is inserted into an arm vein. White blood cells are separated from the rest of the blood and stored for research. The rest of the blood is returned through the same IV or one in the other arm. Participants will get the study drug by IV every 2 weeks for up to 12 weeks. Participants will repeat the previous tests throughout the study. If they respond to treatment, participants will be evaluated every 6 weeks (3 times), then every 12 weeks (3 times), then every 26 weeks (2 times) until their disease progresses. Participants will be evaluated 30 days after their last infusion. They will then be contacted annually.
Conditions Studied
Interventions
- DRUG Avelumab
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2016-08-06 |
| Est. Completion | 2021-09-15 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02859454
The ClinicalTrials.gov registry entry for NCT02859454 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 624-participant average among 26 other Human Papilloma Virus trials with a reported enrollment target (98% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 5 conditions, with Human Papilloma Virus appearing as the primary indexed condition, and to 1 intervention - of which Avelumab is the first listed.
NCT02859454 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT02859454 about?
NCT02859454 is a clinical study titled "Avelumab for People With Recurrent Respiratory Papillomatosis". Background: Recurrent respiratory papillomatosis (RRP) is a rare disease caused by human papillomavirus. It can cause voice changes, airway compromise, pulmonary lesions, and cancers. Programmed death-ligand 1 (PD-L1) is a protein on cells. It may be able to stop or decrease the immune system s res...
What is the current status of trial NCT02859454?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 13 participants. The study started on 2016-08-06. Estimated completion is 2021-09-15.
What conditions does trial NCT02859454 study?
This clinical trial studies the following conditions: Human Papilloma Virus, Recurrent Respiratory Papillomatosis, Juvenile Laryngeal Papilloma, Laryngeal Papilloma, Recurrent, Respiratory Papillomatosis.
What interventions are being tested in trial NCT02859454?
The interventions under investigation include: Avelumab (DRUG).
Who is sponsoring clinical trial NCT02859454?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02859454 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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