Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2025-12-25 @ 3:45 AM
NCT ID:
NCT04645602
Brief Summary:
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
Detailed Description:
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 weeks +/- 3 days) in the clinic with a video-recorded flexible laryngoscopy examination to assess clinical response for those with laryngeal involvement. In addition, CT scans of the chest will be obtained every 4 cycles (+/- 7 days) to assess response per RECIST 1.1 criteria. In addition, subjects will complete quality of life questionnaires to assess preference of pembrolizumab and lenvatinib as compared to standard of care treatment for this patient population.
Study:
NCT04645602
Study Brief:
Protocol Section:
NCT04645602