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Pembrolizumab +/− Lenvatinib for Head and Neck Cancer (LEAP-10 Trial)
LEAP-10 Trial Summary
This trial is studying whether giving pembrolizumab with or without lenvatinib to people with cancer of the head and neck who have PD-L1 selection is better than giving pembrolizumab with placebo.
LEAP-10 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowLEAP-10 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2024 Phase 2 trial • 57 Patients • NCT03004183LEAP-10 Trial Design
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Who is running the clinical trial?
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- I have not had cancer treatment or been in a drug trial in the last 4 weeks.I am currently being treated for an active infection.I haven't had major heart problems or strokes in the last year.I have been treated with specific immune therapy drugs before.I am not pregnant, breastfeeding, and if able to bear children, I agree to use contraception as required.I have not received a live vaccine within the last 30 days.I received my last cancer treatment less than 6 months ago.My head or neck cancer worsened within 6 months after treatment meant to cure it.I have cancer that has spread to my brain or spinal cord.My cancer can be measured and has grown in previously treated areas.My oropharyngeal cancer has been tested for HPV.I am fully active or restricted in physically strenuous activity but can do light work.I have received an organ or tissue transplant from another person.I have not had major surgery in the last 3 weeks.I have had or currently have lung inflammation treated with steroids.My head or neck cancer is newly diagnosed and at stage IV.My cancer is in my throat, mouth, or voice box.I agree to use contraception or avoid sex for 7 days after my last dose.You have a previous stomach or intestine problem that could make it difficult for your body to absorb the medicine taken by mouth.I have an autoimmune disease treated in the last 2 years, but hormone replacements are okay.I have a history of hepatitis B or active hepatitis C.I am not allergic or severely sensitive to pembrolizumab or lenvatinib.My blood pressure is under control, with or without medication.I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.I had radiotherapy less than 2 weeks before starting the study treatment.I have been treated with lenvatinib or pembrolizumab before.My head or neck cancer cannot be cured with surgery or radiation.I have trouble swallowing pills or taking liquid medicine.My condition can be treated with the goal of curing it.I have a severe fistula.My organs are functioning well.I have another cancer that is getting worse or was treated in the last 3 years.
- Group 1: Pembrolizumab with Lenvatinib
- Group 2: Pembrolizumab with Placebo
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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 people are being given the chance to participate in this test?
"Unfortunately, this particular clinical trial is not enrolling patients at the moment. The study was first posted on February 5th, 2020 and received its most recent update on August 1st, 2022. However, there are 2758 other trials for carcinoma, squamous cell and 1076 studies involving Pembrolizumab that are currently looking for test subjects."
What is the short and long term safety profile of Pembrolizumab?
"Pembrolizumab has received a score of 3 for safety from our team at Power. This is because Pembrolizumab is in Phase 3 trials, meaning that there is both some data supporting efficacy and multiple rounds of data supporting safety."
What other Pembrolizumab research is available?
"There are presently 1076 clinical trials underway that involve Pembrolizumab with 134 of those in Phase 3. However, many people don't realize that there are 37362 total locations where these trials are taking place--not just Sacramento, California."
Are new participants being sought for this experiment?
"This study has stopped recruiting patients. The trial was first posted on February 5th, 2020 and the latest update was on August 1st, 2022. If you are looking for other trials, there are currently 2758 studies actively searching for participants with carcinoma, squamous cell and 1076 studies for Pembrolizumab that need patients."
For which type of cancer is Pembrolizumab most commonly prescribed?
"Pembrolizumab is most frequently given to patients with malignant neoplasms, but it can also be used to treat other conditions such as unresectable melanoma and microsatellite instability high."
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