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Lenvatinib + Pembrolizumab in HPV-associated Recurrent Respiratory Papillomatosis
NCT04645602Phase 2
Key facts
- Status
- Recruiting
- Start
- Jul 2025
- Primary completion
- Dec 2027
- Countries
- 1
- Sponsor
- Yale University
- Modality
- Immune Checkpoint Inhibitors, Recombinant Proteins and Enzymes, Small Molecules
- Conditions
- recurrent respiratory papillomatosis (RRP)
01
Overview
Phase 2, open-label, single-arm trial of lenvatinib and pembrolizumab in recurrent respiratory papillomatosis (RRP), sponsored by Yale University. Primary endpoints: Objective Response Rate up to 2 years and Adverse Events up to 2 years. Started Jul 2025; status: recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Lenvatinib + Pembrolizumab
Lenvatinib daily + Pembrolizumab every 3 weeks
03
Who it enrols
Adults with HPV-associated recurrent respiratory papillomatosis with pulmonary involvement, adequate organ function, ECOG 0-1, and controlled blood pressure. Excludes patients with active autoimmune disease, immunodeficiency, recent live vaccines, or significant cardiovascular disease.
04
Endpoints
Primary
Objective Response Rate
Adverse Events
Secondary
Objective Response Rate
Change in Time Interval
Duration of Response
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