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Anti-metabolites
Pembrolizumab + Capecitabine + Radiation for Gastric Cancer
Phase 2
Recruiting
Led By Salma Jabbour
Research Sponsored by Rutgers, The State University of New Jersey
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Mismatch repair deficiency as identified by immunohistochemistry or Epstein-Barr virus positivity
Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
Study Summary
This trial is testing pembrolizumab with capecitabine and radiation therapy to treat gastric cancer.
Who is the study for?
This trial is for adults with operable gastric cancer that's mismatch repair deficient or Epstein-Barr virus positive. They must have certain blood and organ function levels, not be pregnant or breastfeeding, agree to use contraception, and have no history of specific treatments or conditions that could affect the trial.Check my eligibility
What is being tested?
The study tests pembrolizumab (a monoclonal antibody) combined with capecitabine (chemotherapy) and radiation therapy. It aims to see if this combination is more effective in stopping the growth of tumor cells compared to current standard treatments.See study design
What are the potential side effects?
Potential side effects include immune system reactions, fatigue, nausea from chemotherapy, skin irritation from radiation, as well as possible liver and kidney function changes. The severity can vary among patients.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is mismatch repair deficient or EBV positive.
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I am willing to undergo a biopsy to provide a tissue sample.
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My stomach cancer is at a stage that can be operated on.
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I am fully active or restricted in physically strenuous activity but can do light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Recurrence-free survival (RFS) rate
Side effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (pembrolizumab, capecitabine, radiation therapy)Experimental Treatment4 Interventions
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 2 courses in the absence of disease progression or unacceptable toxicity. Within 2-6 weeks, patients undergo surgery. Beginning up to 56 days after surgery, patients receive pembrolizumab IV over 30 minutes on day 1 and capecitabine PO BID on days 1-14. Treatment repeats every 21 days for up to 5 courses in the absence of disease progression or unacceptable toxicity. Within 2-6 weeks of resting, patients continue to receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 11 courses in the absence of disease progression or unacceptable toxicity. Beginning course 4, patients undergo radiation therapy over 15-30 minutes on days 1-5 for up to 5 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Capecitabine
2013
Completed Phase 3
~3420
Pembrolizumab
2017
Completed Phase 2
~2010
Radiation Therapy
2017
Completed Phase 3
~7250
Find a Location
Who is running the clinical trial?
Rutgers, The State University of New JerseyLead Sponsor
429 Previous Clinical Trials
64,192 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,663 Previous Clinical Trials
40,925,865 Total Patients Enrolled
Salma Jabbour4.413 ReviewsPrincipal Investigator - Rutgers Cancer Institute of New Jersey
Rutgers Cancer Institute of New Jersey
2 Previous Clinical Trials
46 Total Patients Enrolled
5Patient Review
Dr. Jabbour is an attentive, considerate, and comprehensive physician who always puts her patients first. She is always available and provides top-notch care.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a man who can father a child and agree to use birth control.I have not taken steroids or immunosuppressants in the last week.I have had pneumonitis treated with steroids or have it now.I haven't had any cancer antibody treatments in the last 4 weeks.I have been treated with drugs targeting PD-1, PD-L1, or PD-L2.I have not received a live vaccine in the last 30 days.I've had recent scans and tests to check my cancer's stage.My cancer is mismatch repair deficient or EBV positive.My cancer has spread to other parts of my body.I am not pregnant and agree to use birth control.I have received treatments like chemotherapy or radiotherapy for stomach cancer before.I haven't had chemotherapy, targeted therapy, or radiation in the last 2 weeks.I have been diagnosed with active tuberculosis.I have a history of HIV or active hepatitis B or C.I am willing to undergo a biopsy to provide a tissue sample.My stomach cancer is at a stage that can be operated on.I am fully active or restricted in physically strenuous activity but can do light work.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (pembrolizumab, capecitabine, radiation therapy)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this research currently need any volunteers?
"This medical study is open to enrollment and the most recent update was posted on November 2nd 2022. On September 29th 2017, this study was initially announced on clinicaltrials.gov."
Answered by AI
Has Pembrolizumab been explored in other clinical trials?
"The initial study of pembrolizumab was conducted in 2005 at Withington Hospital. Since then, 1436 studies have been completed and 1270 are still ongoing; many of these trials have their base in Atlanta, Georgia."
Answered by AI
To what medical conditions is Pembrolizumab commonly administered?
"Pembrolizumab is a highly effective remedy for malignant neoplasms, as well as unresectable melanoma, microsatellite instability high conditions and those at an elevated risk of recurrence."
Answered by AI
How many subjects have been included in this medical experiment?
"This medical study necessitates the enrolment of 40 participants who meet its designated criteria. People can become involved with this trial from multiple locations, for example Emory University located in Atlanta ga and Rutgers Cancer Institute situated in New Brunswick NJ."
Answered by AI
What has been the track record of Pembrolizumab with regards to patient safety?
"There is some evidence of safety in regard to Pembrolizumab, so its score was 2. However, no clinical trial data has been collected that proves efficacy yet."
Answered by AI
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