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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 Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Must have at least evaluable disease based on RECIST 1.1 and/or endoscopic parameters

Must not have

Has a known history of Hepatitis B or known active Hepatitis C virus infection

Has active autoimmune disease that has required systemic treatment in the past 2 years

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

No Placebo-Only Group

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.

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.

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 have had 3 or more surgeries in a year to remove larynx lesions.

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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 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 can carry out all my daily activities without help.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of Hepatitis B or active Hepatitis C.

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I have an autoimmune disease treated with medication in the last 2 years.

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I have a bleeding or clotting disorder, or I'm at high risk for severe bleeding.

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I have a serious heart condition.

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I have a history of colitis.

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I have an active tuberculosis infection.

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I have another cancer that is getting worse or was treated in the last 3 years.

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I have had or currently have lung inflammation treated with steroids.

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I have been diagnosed with HIV.

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I am currently being treated for an infection.

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I have not taken steroids or immunosuppressants in the last 7 days.

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I have a history of PRES.

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I have a condition that significantly affects my body's ability to absorb nutrients.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to a post-baseline timepoint up to 2 years and/or end of treatment

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Adverse Events

Overall Response Rate (ORR)

Secondary study objectives

Blood Biomarkers Changes

Quality of Life Assessment

Tissue Biomarkers Changes

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 3

~3150

Lenvatinib

2017

Completed Phase 4

~2070