Actively Recruiting
Merck IIT: RRP Pembro and Lenvatinib
Led by Yale University · Updated on 2026-04-16
20
Participants Needed
1
Research Sites
123 weeks
Total Duration
On this page
Sponsors
Y
Yale University
Lead Sponsor
E
Eisai Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Merck IIT: RRP Pembro and Lenvatinib
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed respiratory papillomas with lung involvement
- Measurable or non-measurable pulmonary disease based on RECIST 1.1
- For non-measurable lung disease, lesions must also be present in larynx or trachea with more than 3 surgeries in past 12 months
- Provide tissue from a new biopsy within 6 weeks before first study drug dose or an archived specimen if new biopsy not possible
- Confirmed HPV-associated lesions by in-situ hybridization or PCR testing
- Age 18 years or older
- ECOG performance status of 0 or 1
- Adequate organ and marrow function based on specified blood counts and lab values
- Cardiac function classified as New York Heart Association class 2B or better
- Controlled blood pressure (systolic 140 mmHg and diastolic 90 mmHg) with stable medications
- Female participants of childbearing potential must have negative pregnancy test within 28 days before first dose
- Women of childbearing potential must agree to use 2 birth control methods or abstain from heterosexual activity during treatment and for 120 days after last pembrolizumab dose or 30 days after last lenvatinib dose
- Male participants must agree to use contraception or abstain from heterosexual intercourse during treatment and for 7 days after last lenvatinib dose
- Ability to complete medication and blood pressure diaries
- Willingness and ability 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 study treatment
- Major surgery within 3 weeks before first study dose or inadequate wound healing
- Live vaccine within 30 days before first study dose
- Participation in another investigational study within 4 weeks before first study dose
- Immunodeficiency or chronic systemic steroid/immunosuppressive therapy within 7 days before first dose
- Active progressing malignancy requiring treatment in past 3 years, except certain indolent cancers
- History of severe allergic reactions to pembrolizumab, lenvatinib, or their components
- Active autoimmune disease requiring systemic treatment in past 2 years
- History or current pneumonitis requiring steroids
- Active infection requiring systemic therapy
- Known HIV infection
- Known active Hepatitis B or C infection
- Active tuberculosis
- Urine protein 1 g/24 hours or significant proteinuria
- Uncorrected electrolyte abnormalities
- Significant cardiovascular disease within 12 months including heart failure NYHA class >2B, recent heart attack or stroke
- Reduced left ventricular ejection fraction below normal
- Prolonged QTcF interval >480 msec
- Bleeding or clotting disorders or risk for severe bleeding
- History of colitis
- Gastrointestinal malabsorption affecting lenvatinib absorption
- Grade 3 or higher gastrointestinal or non-gastrointestinal fistula
- Active hemoptysis within 3 weeks before first study dose
- History of posterior reversible encephalopathy syndrome
- Conditions or situations that may interfere with study participation or results
- Psychiatric or social issues limiting compliance
- Pregnant or breastfeeding, or planning pregnancy during study and 120 days after last dose
AI-Screening
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Trial Site Locations
Total: 1 location
1
Yale University
New Haven, Connecticut, United States, 06510
Actively Recruiting
Research Team
S
Sara Pai
CONTACT
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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