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Pembrolizumab + Trastuzumab + Chemotherapy for Gastric Cancer
Study Summary
This trial will compare the efficacy of two different treatments for HER2-positive gastric cancer. The first treatment is pembrolizumab in combination with standard chemotherapy, and the second is trastuzumab in combination with standard chemotherapy. The hypothesis of the study is that pembrolizumab is superior to trastuzumab in terms of progression free survival and overall survival.
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 2024 Phase 2 trial • 57 Patients • NCT03004183Trial Design
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- I have received treatment for advanced stomach cancer that cannot be surgically removed.I have another cancer that has gotten worse or needed treatment in the last 5 years.I have had fluid buildup needing drainage or water pills in the last 2 weeks.I agree to use contraception as required.I frequently have severe diarrhea that is hard to control.My cancer is advanced stomach or GEJ cancer that has not been treated and is HER2 positive.I am fully active or restricted in physically strenuous activity but can do light work.I am currently being treated for an infection.I am a woman of childbearing potential and my recent pregnancy test was negative.I have a history of Hepatitis B or active Hepatitis C.I am not pregnant or breastfeeding and will use birth control if capable of becoming pregnant.I have a heart condition that affects my daily life.I have mild to severe nerve damage.I have been diagnosed with HIV.I have been treated for an autoimmune disease in the last 2 years.I have an active tuberculosis infection.I have received an organ or tissue transplant from another person.My organs are functioning well.I have been treated with specific immune therapy for cancer.My cancer is HER2-positive, confirmed by specific tests on my tumor.I have had pneumonitis treated with steroids or have it now.I have an immune system disorder or am on long-term steroids.I have undergone radiotherapy in the last 14 days.I haven't had major surgery or serious injury in the last 28 days and don't expect to need major surgery while on the study treatment.I have cancer that has spread to my brain or spinal cord.
- Group 1: Pembrolizumab +Trastuzumab + Chemotherapy
- Group 2: Placebo +Trastuzumab + Chemotherapy
- 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 benefits are researchers hoping to achieve through this clinical trial?
"Progression-Free Survival (PFS) will be the primary outcome measure of this trial, which is set to last for 5 years. PFS refers to how long patients live without their cancer progressing, as assessed by Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 and Blinded Independent Central Review (BICR). Additionally, the study will monitor Objective Response Rate (ORR), defined as the percentage of participants who have either a Complete Response (CR, disappearance of all evidence of disease) or Partial Response (PR, regression of measurable disease with no new sites). ORR will be determined for each"
What are Pembrolizumab's most common applications?
"Pembrolizumab is an immunotherapy medication that can be used to effectively treat refractory, relapsed mediastinal large b-cell lymphoma, inflammatory breast cancer (ibc), and advanced testicular cancer."
What other scientific research has been conducted on Pembrolizumab?
"Pembrolizumab was first researched in 1997 at City of Hope Comprehensive Cancer Center. Since then, there have been a total of 20578 completed clinical trials worldwide. Right now, there are 2284 active studies taking place, with a large concentration in Harrison, New york."
Can new patients still sign up for this clinical trial?
"This particular trial, which was first announced on October 5th 2018, is not recruiting patients at this time according to the clinicaltrials.gov website. The most recent update to the posting was on July 21st 2022. Despite this study being closed to participants, there are still over 3000 other trials that are currently looking for volunteers."
Has Pembrolizumab been given the green light by the FDA?
"Since this is a Phase 3 clinical trial, there is some data supporting Pembrolizumab's efficacy and multiple rounds of safety data. Therefore, our team rates the safety as a 3."
What is the total amount of people that are able to enroll in this clinical test?
"This specific clinical trial is not currently recruiting patients. Although, there are 1379 other trials for cancer of the esophagus and 2284 studies involving Pembrolizumab that are accepting participants."
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