Actively Recruiting
A Pilot Study of Lenvatinib in Combination With Pembrolizumab in HPV-associated Recurrent Respiratory Papillomatosis Patients
Led by Yale University · Updated on 2026-04-16
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
Y
Yale University
Lead Sponsor
E
Eisai Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of Lenvatinib and Pembrolizumab in adults diagnosed with recurrent respiratory papillomatosis (RRP) that affects the lungs and is associated with human papillomavirus (HPV). This early phase 1 pilot trial aims to study the safety and effectiveness of these drugs together in 20 adult participants who have pulmonary involvement of RRP. The study is sponsored by Yale University and focuses on this specific population with HPV-related lung disease. Participants will receive Lenvatinib as a daily pill and Pembrolizumab as an intravenous infusion every three weeks. Lenvatinib is taken daily during each 3-week treatment cycle, up to 9 cycles, while Pembrolizumab is given as a 200 mg infusion on day 1 of each cycle, up to 35 cycles. Participants will keep medication and blood pressure diaries and be monitored closely throughout treatment. After completing the treatment cycles, participants will be followed for up to one year to observe longer-term effects. Throughout the study, participants will have clinic visits every cycle to evaluate safety and response, including video-recorded examinations in the operating room every four cycles. Low dose CT chest scans will be performed every four cycles to assess disease status using specialized criteria. Quality of life questionnaires will also be completed to understand participant preferences compared to standard treatment. The main outcomes measured include objective response rate and adverse events over up to two years or until the end of treatment, with secondary measures tracking duration and timing of response.
CONDITIONS
Brief Title
Merck IIT: RRP Pembro and Lenvatinib
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosed with recurrent respiratory papillomas confirmed by tissue biopsy with lung involvement
- Measurable or non-measurable pulmonary disease based on RECIST 1.1 criteria
- For non-measurable lung disease, must have disease in other sites and have had more than 3 surgeries in the past year
- Ability to provide a recent or archived biopsy specimen showing HPV-associated lesions
- ECOG performance status 0 to 1
- Adequate organ and marrow function as specified in the study
- Controlled blood pressure (systolic ≤140 mmHg and diastolic ≤90 mmHg) with or without medication
- Women of childbearing potential must use effective contraception or abstain during and after treatment
- Men must use contraception or remain abstinent during and after treatment
- Ability to complete medication and blood pressure diaries
- Willingness to sign informed consent
You will not qualify if you...
- Prior systemic anti-cancer therapy or investigational agents within 4 weeks before enrollment
- Prior radiotherapy within 2 weeks before treatment
- Major surgery within 3 weeks before treatment or inadequate wound healing
- Received live vaccine within 30 days before treatment
- Participation in another investigational study within 4 weeks before treatment
- Immunodeficiency or recent use of systemic immunosuppressive therapy
- Active or progressing additional malignancy requiring treatment
- History of severe allergic reactions to study drugs
- Active autoimmune disease requiring systemic treatment in past 2 years
- History or current pneumonitis requiring steroids
- Active infection requiring systemic therapy
- Known HIV, active Hepatitis B or C, or active tuberculosis
- Urine protein ≥1 g/24 hours
- Electrolyte abnormalities not corrected
- Significant cardiovascular disease or abnormal heart function
- Prolonged QTc interval above study limits
- Bleeding or thrombotic disorders or high risk of severe hemorrhage
- History of colitis or significant gastrointestinal malabsorption
- Grade 3 or higher fistula or active hemoptysis within 3 weeks
- History of posterior reversible encephalopathy syndrome
- Psychiatric or social conditions limiting study compliance
- Pregnant or breastfeeding women or those planning to conceive during study and follow-up period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 35 cycles of 3 weeks each for pembrolizumab; lenvatinib taken daily during each 3-week cycle up to 9 cycles
Participants receive a combination of pembrolizumab infusions every 3 weeks and daily oral lenvatinib during each 3-week study cycle to treat recurrent respiratory papillomatosis with lung involvement. Participants document their medication and blood pressure regularly and are evaluated each cycle in the clinic and every 4 cycles in the operating room to assess clinical response.
Clinic visits every 3 weeks and operating room visits every 12 weeks (every 4 cycles), with low dose chest CT scans every 12 weeks
Duration - Up to 1 year after treatment completion
Participants are followed for up to one year after completing study treatment to monitor safety and long-term outcomes.
Visits as scheduled during follow-up period
Trial Site Locations
Total: 1 location
1
Yale University
New Haven, Connecticut, United States, 06510
Actively Recruiting
Research Team
S
Sara Pai
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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