Lenvatinib + Pembrolizumab for Respiratory Papillomatosis

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Sara I Pai, MD, PHD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Yale University

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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

Research Team

Sara I Pai, MD, PHD

Principal Investigator

Yale University

Eligibility Criteria

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.

Inclusion Criteria

I can provide a recent biopsy sample.

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

I agree to use contraception while on this trial.

Exclusion Criteria

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

You had severe allergic reactions to drugs similar to pembrolizumab or lenvatinib in the past.

Your heart's electrical activity stays prolonged for too long.

Treatment Details

Interventions

• Lenvatinib (Tyrosine Kinase Inhibitor)
• Pembrolizumab (Monoclonal Antibodies)

Trial Overview 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.

Participant Groups

Group I: Lenvatinib + Pembrolizumab Experimental Treatment 2 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.

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

Nancy J. Brown

Yale University

Chief Medical Officer since 2020

MD from Yale School of Medicine

Peter Salovey

Yale University

Chief Executive Officer since 2013

PhD in Psychology from Yale University

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Dr. William Curry

Massachusetts General Hospital

Chief Medical Officer

MD from Harvard Medical School

Dr. Anne Klibanski

Massachusetts General Hospital

Chief Executive Officer since 2019

MD from Harvard Medical School

Eisai Inc.

Industry Sponsor

Trials

524

Recruited

161,000+

Founded

Eisai Inc. was established in 1995 as the U.S. subsidiary of Eisai Co., Ltd.

Headquarters

Woodcliff Lake, NJ, USA

Known For

Neurology and Oncology

Top Products

Aricept (donepezil), Lenvima (lenvatinib), Leqembi (lecanemab), Halaven (eribulin)

Lynn Kramer

Eisai Inc.

Chief Medical Officer since 2019

MD

Tatsuyuki Yasuno

Eisai Inc.

Chief Executive Officer since 2023

MBA from Kellogg School of Management, Northwestern University; Bachelor of Political Science from Waseda University

Merck Sharp & Dohme LLC

Industry Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University