CompletedPhase 2

M7824 in People With Recurrent Respiratory Papillomatosis

United States9 participantsStarted 2018-12-19

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

* INCLUSION CRITERIA: Recurrent Respiratory Papillomatosis (RRP) criteria: * Histological diagnosis of RRP confirmed by pathology report from a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory. * 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 and evaluated by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria. * Tracheal involvement with RRP that has required either two or more endoscopic interventions in the last 12 months or a tracheostomy. * Greater than or equal to 18 years of age. * Able to understand and sign the Informed Consent Document. * Clinical performance status of Eastern Cooperative Oncology Group (ECOG) 0 or 1. * Willing to undergo endoscopic evaluation with biopsies in compliance with this protocol. * No systemic therapy for RRP for at least 3 half-lives of the prior drug(s). * Screening laboratory values must meet the following criteria and should be obtained within 14 days prior to first dose: * White Blood Count (WBC) \> 2000/ microliter * Neutrophils \> 1000/ microliter * Platelets \> 75 x10(3)/ microliter * Hemoglobin \> 9.0 g/dL * Serum Creatinine \< 1.5 x upper limits of normal (ULN) OR estimated glomerular filtration rate (eGFR) \> 30 mL/min (measured or calculated using the Modification of Diet in Ren…

What they're measuring

Proportion of Participants With a Complete Response

Timeframe: Response was assessed by flexible endoscopy with or without imaging studies before treatment and 6 and 12 weeks after starting treatment.

Trial details

NCT IDNCT03707587

SponsorNational Cancer Institute (NCI)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2019-10-29

Results submitted2020-08-13