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Pembrolizumab + Chemotherapy for Stomach Cancer
Study Summary
This trial will study whether the use of pembrolizumab can help treat patients with gastric or GEJ adenocarcinoma.
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 had pneumonitis treated with steroids or have it now.I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.I have a history of Hepatitis B or active Hepatitis C.I agree to give tumor tissue samples before and during surgery.I am fully active or restricted in physically strenuous activity but can do light work.I agree to use birth control during and for 6 months after the study.I am currently being treated for an infection.I have not received a live vaccine in the last 30 days.I plan to have surgery after chemotherapy, as recommended by my doctors.I have been treated with specific immune system targeting drugs or participated in a Merck pembrolizumab trial.I have received treatment, including experimental drugs, for my current cancer.I have not had active treatment for another cancer, except for certain skin cancers or in situ cancers, in the last 5 years.I have an active case of tuberculosis.I am not pregnant, breastfeeding, nor planning to become pregnant during the study and for up to 6 months after.I have received an organ or tissue transplant from another person.My stomach cancer has not spread but is advanced.My organs are functioning well.I am a man who plans to have children during or within 6 months after the study.I agree to use birth control during and up to 6 months after the study.
- Group 1: Pembrolizumab+Chemotherapy
- Group 2: Placebo+Chemotherapy
- Group 3: Pembrolizumab+FLOT Cohort
- Group 4: Placebo+FLOT Cohort
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- 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 are the Pembrolizumab safety trials looking like?
"Pembrolizumab has undergone multiple rounds of testing, with some data supporting efficacy, which gives it a safety rating of 3."
What are the maladies that Pembrolizumab has been shown to ameliorate?
"Pembrolizumab is the standard treatment for esophageal neoplasms malignant. Additionally, pembrolizumab can also help patients with actinic keratosis, disease, and hodgkin disease."
Out of how many people apply, how many are typically accepted into this type of program?
"This particular study is no longer looking for patients to participate. However, there are 1139 other trials for patients with malignant neoplasms and 2442 trials for Pembrolizumab that are ongoing."
Why was this clinical trial designed in this way?
"According to the sponsor of the trial, Merck Sharp & Dohme Corp., the primary outcome will be Percentage of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE) - Pembrolizumab+FLOT and Placebo+FLOT Cohorts, and it will be measured over a Up to approximately 2 years time span. Additionally, this study will measure secondary outcomes including Disease-free Survival (DFS) Per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) - Pembrolizumab+Chemotherapy and Placebo+Chemotherapy"
What other testing has been done with Pembrolizumab in the past?
"Pembrolizumab was first evaluated in 1997 at City of Hope Comprehensive Cancer Center. So far, 21054 clinical trials have been completed. There are currently 2442 ongoing studies, with a significant number of these trials based in Edmonton, Alberta."
In how many different hospitals is this clinical study being offered?
"There are 22 different hospitals conducting this trial at the moment. Some of the locations include Edmonton, Fairfax and Greenfield Park. If you are considering participating, it would be most convenient for you to select a hospital close to your home to limit travel."
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