Clinical Trials Logo
  1. Home
  2. Human Papilloma Virus
  3. NCT04645602

Lenvatinib and Pembrolizumab Combination Therapy In HPV-associated Recurrent Respiratory Papilloma Patients With Laryngeal, Tracheal, and/or Pulmonary Involvement

Human Papilloma Virus Clinical Trial

Official title:
A Phase II Study of Lenvatinib in Combination With Pembrolizumab in HPV-associated Recurrent Respiratory Papilloma Patients

Clinical Trial Summary

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

Clinical Trial Description

This is a non-randomized phase II trial in adult male and female subjects diagnosed with human papillomavirus (HPV)-associated Recurrent Respiratory Papilloma to test the safety and efficacy of the drug combination Lenvatinib and Pembrolizumab. The U.S. Food and Drug Administration (FDA) has not approved Pembrolizumab or Lenvatinib for HPV-associated Recurrent Respiratory Papilloma but they have been approved for other uses. Lenvatinib works by blocking certain proteins that are associated with tumor growth. Lenvatinib also blocks the growth of blood vessels feeding tumors to cause tumor cell death. Pembrolizumab helps the body's immune system destroy cancer cells. This study is investigating whether the combination of Lenvatinib and Pembrolizumab may eliminate HPV-associated RRPs. The research study procedures include screening for eligibility, study treatment and evaluations and follow up visits. Participants will receive study treatment for up to 2 years and will be followed for 1 year. It is expected that about 21 people will take part in this research study. Merck is supporting this research study by providing Pembrolizumab and supporting the research study procedures. Eisai is supporting this research study by providing Lenvatinib. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04645602
Study type Interventional
Source Massachusetts General Hospital
Contact Sara I Pai, MD, PHD
Phone 617-726-5251
Email sara.pai@mgh.harvard.edu
Status Not yet recruiting
Phase Phase 2
Start date July 2024
Completion date December 1, 2027
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05329961 - Immunogenicity of the 9vHPV Vaccination 2-dose Regimen Among Children 4 to 8 Years Old, An Exploratory Immunogenicity Study Early Phase 1
Completed NCT05862844 - Promise Women Project N/A
Active, not recruiting NCT04199078 - Clinical Trial to Explore Papilocare Gel Efficacy to Repair of the Cervico-vaginal Mucosa With HPV High Risk Lesions. N/A
Recruiting NCT05566106 - Anal Follow-up of Patients With a Gynecological History of High-grade Lesion and More Induced HPV
Not yet recruiting NCT06436274 - Efficacy of Human Papillomavirus (HPV) Vaccination to Prevent Infection Among Women Living With HIV. Phase 4
Not yet recruiting NCT06229353 - Developing and Evaluating a Novel Approach to Improve HPV Vaccination Coverage Among High-risk, Under-immunized Adults Via the Emergency Department
Completed NCT01757392 - Candin Safety & Efficacy Study for the Treatment of Warts Phase 2
Active, not recruiting NCT04716127 - A Proximity-incentive Strategy for Cervical Cancer Screening N/A
Recruiting NCT05210348 - Clinical Evaluation of Detection of High Risk HPV in Urine
Recruiting NCT05835947 - Anal Cancer Risk In Women
Not yet recruiting NCT03947775 - HPV-SAVE_Merck_Sub-Study for Preventing Recurrence of HSIL Phase 2
Terminated NCT03404310 - Zinc Sulfate for Human Papillomavirus (HPV) N/A
Recruiting NCT03302858 - A Safety and Efficacy Trial of Circumferential Anal Canal Radiofrequency Ablation for High-Grade Anal Intraepithelial Neoplasia Using the BARRX™ Anorectal Wand Phase 2
Completed NCT03082950 - HPV Infections, Cancer of the Vulva and Therapeutical Success
Active, not recruiting NCT04950101 - Prevalence of Anal High-risk Human Papilloma Virus Infection and Abnormal Anal Cytology in Men Who Have Sex With Men Using Pre Exposure Prophylaxis N/A
Recruiting NCT05146895 - A Cohort Study of Hyperthermia and Imiquimod for the Treatment of Flat Warts N/A
Completed NCT04002154 - Clinical Trial to Explore the Papilocare Gel Efficacy to Repair the Cervico-vaginal Mucosa With Lesions Caused by HPV N/A
Recruiting NCT04232917 - Study of 2LPAPI® on the Clearance of Genital HR-HPV Infections. Phase 4
Active, not recruiting NCT03729518 - TORS De-Intensification Protocol Version 2.0: Dose and Volume Reduction in the Neck N/A
Recruiting NCT05640700 - Vaginal Microbiome and HPV Pre-malignant and Cervical Dysplasia