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Pembrolizumab + Lenvatinib + Chemo for Esophageal Cancer
Study Summary
This trial is meant to compare the effects of two different cancer treatments on patients with metastatic esophageal cancer. The first treatment is pembrolizumab plus lenvatinib plus chemotherapy, and the second treatment is pembrolizumab plus chemotherapy. The study will measure overall survival and progression-free survival to see which treatment is more effective.
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.Side effects data
From 2012 Phase 3 trial • 256 Patients • NCT01005680Trial Design
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Who is running the clinical trial?
Media Library
- My organs are functioning well.I have received treatment for advanced esophageal cancer that cannot be surgically removed.I have cancer that has spread to my brain or spinal cord.I have had serious heart problems in the last year.My blood pressure is 150/90 or lower, and my medication hasn't changed in the last week.I am not pregnant, breastfeeding, and if able to have children, I use effective birth control or practice abstinence.I haven't had serious coughing up of blood or tumor bleeding in the last 3 weeks.I am a male willing to use contraception or abstain from sex as required.My cancer, which started in the esophagus, has spread to other parts of my body.I have trouble swallowing or an obstruction in my digestive tract.I have not had major surgery or significant injury in the last 3 weeks.I have a history of Hepatitis B or an active Hepatitis C infection.I frequently need treatment for fluid buildup in my chest or abdomen.I have lost more than 20% of my weight in the last 3 months.I have another cancer that is getting worse or was treated in the last 3 years.My cancer has spread to nearby organs like the aorta or windpipe.I have frequent and uncontrollable diarrhea.My scans show my tumor is surrounding a major blood vessel or has holes.I am at risk for or have had significant GI bleeding.I have an immune system disorder, am on long-term steroids, or have had an organ transplant.I have had lung inflammation not caused by infection, treated with steroids.My cancer is in the esophagus and has not spread far.I have not had radiotherapy in the last 2 weeks or suffered from radiation pneumonitis.I have not received a live vaccine within the last 30 days.I have moderate to severe numbness, tingling, or pain in my hands or feet.My esophageal cancer is confirmed to be squamous cell and has spread.I have an autoimmune disease but haven't needed strong medication for it in the last 2 years.
- Group 1: Pembrolizumab + Lenvatinib + Chemotherapy
- Group 2: Pembrolizumab + Chemotherapy
- 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
Are there harmful side effects associated with Cisplatin?
"There is both prior clinical data and multiple rounds of supportive data, so Cisplatin received a score of 3 for safety."
For what medical condition is Cisplatin most often prescribed?
"Cisplatin is commonly used to treat aggressive cancers. However, it has also been shown to be effective against microsatellite instability high and rectal carcinoma."
Is there still room for new volunteers in this research project?
"Yes, the trial is ongoing and you can find more information about it on clinicaltrials.gov. This particular research project was posted on July 28th 2021 and updated November 17th of this year. They are looking for 862 participants total from 9 different locations."
How many people can join this study at most?
"Yes, you're right. The trial was originally posted on 7/28/2021 and is still recruiting patients, as indicated by an update on 11/17/2022. They are looking for 862 individuals total from 9 different locations."
Does Cisplatin have a history of being tested in other medical studies?
"At present, there are a total of 2144 Cisplatin studies underway. 527 of those trials are currently in Phase 3. While the majority of Cisplatin trials are based in Guangzhou, Guangdong, there are 90871 locations running these sorts of studies."
At how many facilities can people participate in this clinical trial?
"Across 9 different locations, this trial is currently underway. If you're interested in enrolling and would like to minimize travel, it may be helpful for you to choose a site near Louisville, New york or Seattle."
What are the goals of this clinical trial?
"The primary outcome for this trial is the number of participants with dose-limiting toxicities (DLTs) over a period of up to 21 days. Secondary outcomes include the duration of response (DOR) in participants with PD-L1 CPS ≥10, time to deterioration (TTD) in HRQoL score using EORTC QLQ-C30, and overall survival (OS) in participants with PD-L1 CPS ≥10."
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