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Lenvatinib + Pembrolizumab + Chemotherapy for Gastroesophageal Cancer (LEAP-015 Trial)
LEAP-015 Trial Summary
This trial is testing whether adding lenvatinib and pembrolizumab to chemotherapy can help people with gastroesophageal cancer live longer and have less cancer growth compared to chemotherapy alone.
LEAP-015 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowLEAP-015 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-015 Trial Design
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Who is running the clinical trial?
Media Library
- I needed treatment for fluid buildup in my chest or abdomen recently.I have a history of hepatitis B or active hepatitis C.I am at risk for or have had significant GI bleeding.I have an autoimmune disease treated with medication in the last 2 years.I have undergone radiotherapy in the last 14 days.My cancer can be measured on scans.My cancer is a type that started in the stomach or esophagus and has spread.I am fully active or restricted in physically strenuous activity but can do light work.I have trouble eating or taking pills by mouth.My organs are functioning well.I have not had a live vaccine in the last 30 days.I am not pregnant, breastfeeding, and if able to have children, I use or will use effective birth control or practice abstinence.I have been treated with medication targeting blood vessel growth in cancer.I have another cancer that has gotten worse or needed treatment in the last 5 years.My cancer has spread to my brain or its coverings.My scans show my tumor is affecting major blood vessels or has hollow areas.I have lost more than 20% of my weight in the last 3 months.My stomach cancer is not HER2 positive.My cancer is a type that started in the stomach or esophagus and has spread.I am fully active or restricted in physically strenuous activity but can do light work.I have moderate to severe numbness, tingling, or pain in my hands or feet.I am not expected to need surgery to remove a tumor during my treatment.I am not pregnant, breastfeeding, and if able to have children, I use or will use effective birth control or practice abstinence.I agree to not donate sperm and to either not have sex or use birth control during and up to 90 days after treatment.I am highly allergic to certain cancer drugs or their ingredients.My heart isn't working well.My stomach cancer is not HER2 positive.I have been diagnosed with HIV.I have had treatment for advanced stomach or esophagus cancer.I have not had major surgery in the last 4 weeks.I am not expected to need surgery to remove my tumor during treatment.I frequently have severe diarrhea that is hard to control.My blood pressure is under control, with or without medication.I have received a transplant from another person.I have been treated with specific immune therapy for cancer.I have or had lung inflammation that needed steroids.
- Group 1: Lenvatinib + Pembrolizumab + Chemotherapy
- Group 2: Chemotherapy
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
What other research has Pembrolizumab been used in?
"Pembrolizumab is being trialed in 1726 different medical studies that are still ongoing. Phase 3 trials, which are the most advanced, make up 352 of these investigations. The epicentre for Pembrolizumab clinical trials is Guangzhou, Guangdong; however, the drug is being tested in 62511 different hospitals and research centres."
Pembrolizumab is most commonly used for which type of patient?
"Pembrolizumab is indicated for the treatment of malignant neoplasms. Additionally, it has shown efficacy in treating unresectable melanoma, microsatellite instability high, and patients with a high risk of recurrence."
What are the researchers working to find out through this clinical trial?
"The primary outcome of this study, which will be assessed over a Up to ~34 months time frame is to Part 2: Overall Survival in All Participants. Secondary outcomes include Part 2: Number of Participants with Adverse Events which is defined as An Adverse Event is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants in Part 2 with Adverse Events will be reported by treatment arm., Part 2: Number of Participants who Discontinued Study Treatment Due to an Adverse Event which is defined as An Adverse Event is"
Are patients being actively enrolled in this experiment at this time?
"Yes, this trial is still looking for volunteers according to the information on clinicaltrials.gov. The listing for the trial was first posted on December 30th 2020 and was last edited on November 7th 2022."
What is the Pembrolizumab patient safety profile?
"Pembrolizumab has undergone multiple rounds of testing and has been found to be effective in prior clinical trials. As a result, it has been given a safety score of 3."
How many sites are currently conducting this clinical trial?
"12 hospitals are running this trial, which are Memorial Sloan Kettering Cancer Center ( Site 0032) in New york, Hamilton Health Sciences - Juravinski Site ( Site 0106) in Hamilton, and CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0103) in Sherbrooke. There are 9 other locations running this trial."
Who else is applying?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
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