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Lenvatinib + Pembrolizumab for Respiratory Papillomatosis
Study 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).
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- 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.I have not received a live vaccine in the last 30 days.I have an autoimmune disease treated with medication in the last 2 years.I can provide a recent biopsy sample.I have a bleeding or clotting disorder, or I'm at high risk for severe bleeding.I have had 3 or more surgeries in a year to remove larynx lesions.I agree to use contraception while on this trial.I have a serious heart condition.My blood pressure is under control, with or without medication.I have a history of colitis.I have an active tuberculosis infection.I had radiotherapy less than 2 weeks before starting the study treatment.My cancer can be measured by scans or endoscopy.I am 18 years old or older.I have a heart condition and have been assessed using the NYHA classification.I am using two birth control methods or am not able to have children, and will continue for 120 days after my last dose.I have confirmed respiratory papillomas in my trachea, lungs, or larynx.Your urine test shows high levels of protein, unless a 24-hour urine test shows that the amount of protein is low.My lesions are confirmed to be HPV-related.I am a woman who can have children and I have a negative pregnancy test taken within the last 28 days.I have another cancer that is getting worse or was treated in the last 3 years.I can carry out all my daily activities without help.I haven't had any cancer treatment or experimental drugs in the last 4 weeks.Your blood pressure is not well controlled (systolic BP >150 mmHg or diastolic BP >90 mmHg).I have had or currently have lung inflammation treated with steroids.I have been diagnosed with HIV.I am currently being treated for an infection.I have not taken steroids or immunosuppressants in the last 7 days.I have a history of PRES.I don't have any health issues that could affect the study's results.My organs and bone marrow are functioning well.I have a condition that significantly affects my body's ability to absorb nutrients.
- Group 1: Lenvatinib + Pembrolizumab
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
How many individuals are participating in this clinical research study?
"Unfortunately, this specific study is not currently looking for new participants. The 12/1/2022 posting was updated on 12/10/2021. That said, there are 1280 and 1076 studies respectively which are still active in recruiting patients with papillomavirus infections and Pembrolizumab."
Has Pembrolizumab been verified by the FDA?
"Pembrolizumab has received a score of 2 for safety. While there is some evidence supporting its safety, none of the clinical data collected thus far points to Pembrolizumab's efficacy."
What is the standard use of Pembrolizumab?
"Pembrolizumab is a medication that can be used to treat various cancers, as well as other diseases like microsatellite instability high and conditions where chemotherapy has failed."
Could you please provide some context for this new Pembrolizumab clinical trial?
"Pembrolizumab is being researched in 1076 clinical trials, with 134 of those currently ongoing and in Phase 3. The largest concentration of these studies is located in Sacramento, California; however, there are research sites in 37366 locations across the globe."
Are there any openings for patients who wish to enroll in this research?
"The clinical trial mentioned is not looking for patients at the moment, as noted on clinicaltrials.gov. The study was created on December 1st, 2020 and updated most recently on December 10th, 2021. There are 2356 other trials that are actively recruiting patients right now."
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