Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2025-12-26 @ 2:32 AM
Study NCT ID:
NCT04645602
Status:
RECRUITING
Last Update Posted:
2025-11-13
First Post:
2020-11-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Merck IIT: RRP Pembro and Lenvatinib
Sponsor:
Yale University
Organization:
Study Overview
Official Title:
A Pilot Study of Lenvatinib in Combination With Pembrolizumab in HPV-associated Recurrent Respiratory Papillomatosis Patients
Status:
RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: