Avelumab for People With Recurrent Respiratory Papillomatosis
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|ClinicalTrials.gov Identifier: NCT02859454|
Recruitment Status : Recruiting
First Posted : August 9, 2016
Last Update Posted : March 12, 2018
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.
To see if Avelumab works in treating RRP and is safe.
People ages 18 and older with aggressive RRP that has not responded to available treatments
Participants will be screened with:
Previously collected tumor tissue
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
Apheresis: An 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.
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Respiratory Papillomatosis Juvenile Laryngeal Papilloma Laryngeal Papilloma, Recurrent Respiratory Papillomatosis Human Papilloma Virus||Drug: Avelumab||Phase 2|
- Recurrent respiratory papillomatosis (RRP) is a rare papillomatous disease of the aerodigestive tract that is caused by the Human Papilloma Virus (HPV).
- RRP can progress to cause airway compromise, fatal pulmonary lesions, and invasive cancers.
- There is no effective systemic therapy for RRP. Patients require repeated interventional procedures for disease control.
- Study of a small number of RRP samples has shown PD-L1 expression by inflammatory mononuclear cells and by papilloma epithelial cells.
- This clinical trial will evaluate the activity of a PD-L1-targeted drug, avelumab, in the treatment of RRP. This drug was selected for its demonstrated activity in a variety of cancers and for its acceptable safety profile.
-Determine the complete response rate for avelumab in the treatment of patients with RRP.
- Histologically confirmed diagnosis of RRP.
One of the following:
- A Derkay anatomic score of 10 or greater and a history of two or more endoscopic interventions in the last 12 months for control of RRP.
- Pulmonary RRP with pulmonary disease that is measurable by computed tomography scan.
- Tracheal involvement with RRP that has required either two or more endoscopic interventions in the last 12 months or a tracheostomy.
- Age 18 years or greater.
- Eastern Oncology Cooperative Group Performance Score of 0 or 1.
- Phase II clinical trial
- Simon optimal two-stage design with initial enrollment of 12 patients and expansion to 37 patients if one or more complete response(s) is/are observed in the initial patients.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Avelumab in Subjects With Recurrent Respiratory Papillomatosis|
|Study Start Date :||August 6, 2016|
|Estimated Primary Completion Date :||June 30, 2018|
|Estimated Study Completion Date :||June 30, 2023|
Avelumab 10 mg/kg IV every 2 weeks for up to 6 doses.
Avelumab 10 mg/kg IV every 2 weeks for up to 6 doses.
- Complete response rate [ Time Frame: End of treatment ]
- Effect of treatment with avelumab on Derkay and Voice Handicap Index-10 scores [ Time Frame: End of treatment ]
- Partial response rate for avelumab [ Time Frame: End of treatment ]
- Duration of clinical responses to avelumab [ Time Frame: Time to progression ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02859454
|Contact: Erin W Ferraro, R.N.||(833) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office 888-624-1937|
|Principal Investigator:||Christian S Hinrichs, M.D.||National Cancer Institute (NCI)|