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Pembrolizumab + Lenvatinib for Endometrial Cancer (LEAP-001 Trial)
LEAP-001 Trial Summary
This trial will compare the effectiveness of a new immunotherapy drug combination to chemotherapy for women with advanced endometrial cancer. The hypothesis is that the immunotherapy combo will be better than chemo in terms of progression-free survival and overall survival.
LEAP-001 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowLEAP-001 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-001 Trial Design
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Who is running the clinical trial?
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- I have a severe fistula.I have provided a sample of my tumor for MMR status testing.My scans show cancer has spread to major blood vessels.I am fully active or restricted in physically strenuous activity but can do light work.I had treatment for brain metastasis and stopped steroids over 4 weeks ago.I have received an organ or tissue transplant from another person.I am currently on medication for an infection.I have a condition that affects how my body absorbs medication.I have an autoimmune disease but haven't needed strong medication for it in the last 2 years, except for psoriasis.I had radiotherapy over 4 weeks ago and have recovered from side effects.I have a history of hepatitis B or active hepatitis C.I have been treated with drugs targeting cancer blood vessel growth or specific immune checkpoints.I haven't had serious heart problems in the last year.I am still recovering from major surgery complications.I have another cancer besides endometrial carcinoma that has been treated or progressed in the last 3 years.I have advanced or recurrent endometrial cancer that can be seen on scans.I am not pregnant or breastfeeding and, if able to have children, I agree to use birth control during and after the study.I have not coughed up significant blood or had tumor bleeding recently.I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.I have had chemotherapy for endometrial cancer before.I have a specific type of uterine cancer.My blood pressure has been stable for the last week.I have received hormonal therapy for endometrial cancer within the last week.My organs are functioning well, as tested within the last week.I have or had lung inflammation treated with steroids.I have not received a live vaccine in the last 30 days.
- Group 1: Lenvatinib + Pembrolizumab
- Group 2: Paclitaxel + Carboplatin
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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
Does Pembrolizumab have any long-term effects?
"Pembrolizumab has undergone multiple rounds of testing and there is some efficacy data, so it scores a 3 on our team's safety scale."
How many people will be included in the final data analysis of this experiment?
"As of July 14th, 2022, this clinical trial is no longer enrolling patients. It was initially posted on April 11th, 2019. If you are interested in other studies, there are 291 trials related to endometrial neoplasms and 2150 for Pembrolizumab recruiting patients right now."
Could you please list other scientific research that has been published on Pembrolizumab?
"City of Hope Comprehensive Cancer Center first studied pembrolizumab in 1997 and, since then, there have been 1806 completed trials. Right now, there are 2150 active clinical trials, with many of these taking place in Hackensack, New jersey."
Are there any available vacancies in this clinical trial for new patients?
"This research is not seeking new participants at the moment, as per clinicaltrials.gov. The listing was created on April 11th, 2019 and last updated on July 14th, 2022. Although this particular trial isn't looking for new patients, there are 2441 other studies that are."
In how many different hospitals is this study being run today?
"Presently, this trial is looking for participants from a total of 41 sites. If you are considering enrolling, it may be prudent to choose a location nearest to you to reduce travel. The 41 sites are situated in Hackensack, The Woodlands, New Haven, and other cities."
What are the standard conditions that Pembrolizumab is used to combat?
"Pembrolizumab is most frequently used to target malignant neoplasms; however, it can also be used to ameliorate conditions such as unresectable melanoma and high risk of recurrence."
What are the proposed benefits of participating in this medical study?
"The sponsor of this clinical trial, Merck Sharp & Dohme Corp., is measuring the primary outcome of Progression-free survival (PFS) based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR). This will be done over a Up to approximately 45 months time frame. Additionally, this trial will assess secondary outcomes including Mean change from baseline in the global health status/quality of life score of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core-30 ("
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