NCT02632344

Pembrolizumab for HPV-associated Recurrent Respiratory Papilloma Patients

Pembrolizumab for HPV-associated Recurrent Respiratory Papilloma Patients With Laryngeal, Tracheal and/or Pulmonary Involvement

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

This research study is evaluating an immune modulatory agent as a possible treatment for patients with Recurrent Respiratory Papillomatosis (RRP) with significant disease involving the larynx, trachea, and/or lungs. The investigators will be using Pembrolizumab as the treating agent.

Detailed description

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease. The FDA (the U.S. Food and Drug Administration) has not approved Pembrolizumab for your specific disease but it has been approved for other uses. Pembrolizumab is a humanized monoclonal antibody. Pembrolizumab is being studied in several other clinical trials to see if it has an effect in helping the immune system to recognize and eliminate abnormal cells in the body. The antibody blocks a receptor expressed on immune cells, called T cells, and by blocking this receptor it has the potential to activate the T cells to kill abnormal cells, such as virally infected cells. In this research study, the investigators are looking at whether Pembrolizumab can restore the natural ability of the immune system to recognize and eliminate Human papillomavirus (HPV)-infected cells from the body.

Conditions

• Recurrent Respiratory Papillomatosis

Interventions

Type	Name	Description
DRUG	Pembrolizumab	200 mg will be administered as a 30 minute IV infusion every 3 weeks on day 1 of each cycle after all procedures/assessments have been completed.

Timeline

• Start date: 2016-04-01
• Primary completion: 2022-02-01
• Completion: 2025-12-01
• First posted: 2015-12-16
• Last updated: 2025-08-29
• Results posted: 2023-07-03

Locations

2 sites across 1 country: United States