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Avelumab for People With Recurrent Respiratory Papillomatosis
NCT02859454 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 2,390 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02859454 reports 1 study location spanning 1 distinct geographic area — top geographies include Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02859454?
The interventions under investigation include: Avelumab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02859454?
This trial is sponsored by National Cancer Institute (NCI), which has 2,390 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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