Trials / Recruiting
RecruitingNCT04645602
Merck IIT: RRP Pembro and Lenvatinib
A Pilot Study of Lenvatinib in Combination With Pembrolizumab in HPV-associated Recurrent Respiratory Papillomatosis Patients
- Status
- Recruiting
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- Sponsor
- Yale University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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 days) in the clinic and every 4 cycles (+/- 14 days) in the operating room with a video-recorded examination to assess clinical response. In addition, low dose CT scans of the chest will be obtained every 4 cycles (+/- 7 days) to assess response per a RRP-specific modified 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Lenvatinib | Pill taken by mouth, once daily. |
| DRUG | Pembrolizumab | Intravenous injection through a vein (IV). |
Timeline
- Start date
- 2025-07-18
- Primary completion
- 2027-12-01
- Completion
- 2027-12-01
- First posted
- 2020-11-27
- Last updated
- 2026-04-16
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04645602. Inclusion in this directory is not an endorsement.