Pembrolizumab for HPV-associated Recurrent Respiratory Papilloma Patients With Laryngeal, Tracheal and/or Pulmonary Involvement
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02632344|
Recruitment Status : Active, not recruiting
First Posted : December 16, 2015
Last Update Posted : December 10, 2019
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Respiratory Papillomatosis||Drug: Pembrolizumab||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pembrolizumab for HPV-associated Recurrent Respiratory Papilloma Patients With Laryngeal, Tracheal and/or Pulmonary Involvement|
|Study Start Date :||April 2016|
|Estimated Primary Completion Date :||October 2020|
|Estimated Study Completion Date :||June 2023|
Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks. Treatment will be administered on Day 1 of each cycle after all procedures/assessments have been completed
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.
- Overall Response Rate Via Clinical Assessment and/or RECIST [ Time Frame: Up to 2 years ]
- Assess Quality of Life Via Self-Report Questionnaires [ Time Frame: Pre-treatment and every 3 weeks up to 2 years ]
- Number of Participants with Adverse Events Through CTCAE [ Time Frame: Up to 3 years after enrollment of the last the patient ]
- Assess Change in Immune Biomarkers [ Time Frame: Pre-treatment and Weeks 12, 24, 36, 48, 60, 72, 84, and 96 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02632344
|United States, Illinois|
|NorthShore University HealthSystem|
|Evanston, Illinois, United States, 60208|
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Sara Pai, MD PhD||Massachusetts General Hospital|