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Tyrosine Kinase Inhibitor

Lenvatinib + Pembrolizumab for Respiratory Papillomatosis

Phase 2
Waitlist Available
Led By Sara I Pai, MD, PHD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must provide tissue from a newly obtained biopsy of a lesion (obtained up to 6 weeks prior to study registration)
If enrolled with laryngeal disease only, must have undergone at least 3 or more surgeries/procedures in any one year to remove the lesions from the larynx
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to a post-baseline timepoint up to 2 years and/or end of treatment
Awards & highlights

Study Summary

This trial is studying how well Lenvatinib in combination with Pembrolizumab works in treating patients with human papillomavirus (HPV)-associated recurrent respiratory papillomatosis (RRP).

Who is the study for?
Adults with HPV-related recurrent respiratory papillomatosis affecting the larynx, trachea, or lungs. Participants must have had multiple surgeries for laryngeal disease and provide recent biopsy samples. They should not be pregnant, agree to contraception use, and have no severe heart issues or uncontrolled blood pressure. Excludes those with certain serious health conditions, recent cancer treatments, or live vaccines.Check my eligibility
What is being tested?
The trial is testing a combination of two drugs: Pembrolizumab and Lenvatinib in patients with HPV-associated respiratory growths that keep coming back. The study aims to see how well these drugs work together to treat this condition.See study design
What are the potential side effects?
Possible side effects include high blood pressure, fatigue, immune system reactions that could affect organs like the lungs (pneumonitis), liver problems, bleeding risks, kidney issues from protein loss in urine and potential harm to an unborn baby.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can provide a recent biopsy sample.
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I have had 3 or more surgeries in a year to remove larynx lesions.
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I agree to use contraception while on this trial.
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My blood pressure is under control, with or without medication.
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My cancer can be measured by scans or endoscopy.
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I am 18 years old or older.
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I have a heart condition and have been assessed using the NYHA classification.
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I am using two birth control methods or am not able to have children, and will continue for 120 days after my last dose.
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I have confirmed respiratory papillomas in my trachea, lungs, or larynx.
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My lesions are confirmed to be HPV-related.
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I am a woman who can have children and I have a negative pregnancy test taken within the last 28 days.
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I can carry out all my daily activities without help.
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My organs and bone marrow are functioning well.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to a post-baseline timepoint up to 2 years and/or end of treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to a post-baseline timepoint up to 2 years and/or end of treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Adverse Events
Overall Response Rate (ORR)
Secondary outcome measures
Blood Biomarkers Changes
Quality of Life Assessment
Tissue Biomarkers Changes

Trial Design

1Treatment groups
Experimental Treatment
Group I: Lenvatinib + PembrolizumabExperimental Treatment2 Interventions
Participants will take: Lenvatinib - At a pre-determined dose, 1x daily during each 3 week study cycle up to 35 cycles/2 years Pembrolizumab - At a pre-determined dose, 1x on Day 1 of each 3 week study cycle up to 35 cycles/2 years Participants will be given a drug diary and asked to document information in the drug diary about the study treatment. Participants will be asked to check their blood pressure 3x every week and document in a supplied diary. Participants will be followed up to one (1) year after study treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~1950
Lenvatinib
2005
Completed Phase 4
~2690

Find a Location

Who is running the clinical trial?

Eisai Inc.Industry Sponsor
515 Previous Clinical Trials
154,078 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,862 Previous Clinical Trials
5,049,688 Total Patients Enrolled
Massachusetts General HospitalLead Sponsor
2,918 Previous Clinical Trials
13,192,947 Total Patients Enrolled

Media Library

Lenvatinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04645602 — Phase 2
Human Papillomavirus Research Study Groups: Lenvatinib + Pembrolizumab
Human Papillomavirus Clinical Trial 2023: Lenvatinib Highlights & Side Effects. Trial Name: NCT04645602 — Phase 2
Lenvatinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04645602 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are participating in this clinical research study?

"Unfortunately, this specific study is not currently looking for new participants. The 12/1/2022 posting was updated on 12/10/2021. That said, there are 1280 and 1076 studies respectively which are still active in recruiting patients with papillomavirus infections and Pembrolizumab."

Answered by AI

Has Pembrolizumab been verified by the FDA?

"Pembrolizumab has received a score of 2 for safety. While there is some evidence supporting its safety, none of the clinical data collected thus far points to Pembrolizumab's efficacy."

Answered by AI

What is the standard use of Pembrolizumab?

"Pembrolizumab is a medication that can be used to treat various cancers, as well as other diseases like microsatellite instability high and conditions where chemotherapy has failed."

Answered by AI

Could you please provide some context for this new Pembrolizumab clinical trial?

"Pembrolizumab is being researched in 1076 clinical trials, with 134 of those currently ongoing and in Phase 3. The largest concentration of these studies is located in Sacramento, California; however, there are research sites in 37366 locations across the globe."

Answered by AI

Are there any openings for patients who wish to enroll in this research?

"The clinical trial mentioned is not looking for patients at the moment, as noted on clinicaltrials.gov. The study was created on December 1st, 2020 and updated most recently on December 10th, 2021. There are 2356 other trials that are actively recruiting patients right now."

Answered by AI
~14 spots leftby Dec 2026