Yale University
This research study is studying Lenvatinib in combination with Pembrolizumab in people with human papillomavirus (HPV)-associated recurrent respiratory papillomatosis (RRP). The names of the study drugs involved in this study are: * Pembrolizumab * Lenvatinib
This is a non-randomized pilot trial in adult male and female subjects diagnosed with recurrent respiratory papillomatosis (RRP) with pulmonary involvement. Twenty subjects who start protocol treatment are planned to be enrolled in this trial to examine the safety and efficacy in this subject population who would be administered the combination of pembrolizumab 200 mg every 3 weeks and lenvatinib 20 mg daily. Subjects will be evaluated each cycle (+/- 3 days) in the clinic and every 4 cycles (+/- 14 days) in the operating room with a video-recorded examination to assess clinical response. In a…
Inclusion Criteria: \- Participants must have histologically or cytologically confirmed respiratory papillomas with radiologic evidence of lung involvement. Subjects can have measurable or non-measurable\* pulmonary disease based on RECIST 1.1. Non-measurable disease based on RECIST 1.1 is defined as lesions with a short axis less than 10 mm * For those patients with non-measurable pulmonary disease, participants must have disease at other sites such as the larynx and trachea and must have undergone \> 3 surgical procedures over a 12-month period. * Be required to provide tissue from a newly…
Pill taken by mouth, once daily.
Intravenous injection through a vein (IV).
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