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Monoclonal Antibodies
Pembrolizumab + Radiation Therapy for Metastatic Stomach Cancer
Phase 2
Waitlist Available
Led By Joseph Chao
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 36 months
Awards & highlights
Study Summary
This trial is testing the effectiveness of pembrolizumab and palliative radiation therapy in treating patients with cancer that has spread from the esophagus, stomach, or gastroesophageal junction to other parts of the body.
Who is the study for?
This trial is for adults with metastatic esophageal, stomach, or gastroesophageal junction cancer needing symptom relief from pain or bleeding. They should have measurable disease outside the radiation target and adequate organ function. Participants must not have had certain prior treatments, be willing to use birth control if applicable, and have a life expectancy of at least 3 months.Check my eligibility
What is being tested?
The study tests pembrolizumab (a monoclonal antibody) combined with palliative external beam radiation therapy. The goal is to see if this combination better manages symptoms and controls cancer growth in patients whose cancer has spread beyond the original site.See study design
What are the potential side effects?
Pembrolizumab may cause immune-related side effects such as inflammation in organs like lungs or intestines, skin reactions, hormone gland problems (like thyroid), liver issues, and infusion-related reactions. Radiation therapy might cause skin irritation at the treatment site, fatigue, and mild digestive troubles.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 36 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Changes in Combined Positive Scoring (CPS) in Non-irradiated Sites Assessed by Flow Cytometry
Body Weight Changes
Changes in Tumor Proportion Scores (TPS) in Non-irradiated Sites Assessed by Flow Cytometry
Secondary outcome measures
Incidence of Treatment Related Adverse Events of Pembrolizumab
Overall Response Rate (ORR)
Overall Survival (OS)
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (pembrolizumab, RT)Experimental Treatment3 Interventions
INITIAL TREATMENT: Patients undergo palliative external beam RT daily. On day 1, patients undergo the first RT fraction and then receive pembrolizumab intravenously (IV) over 30 minutes. Cycles repeat every 3 weeks for up to 35 cycles in the absence of disease progression or unacceptable toxicity.
SECOND PHASE: Patients who achieve a complete response, stop study treatment, and then experience radiographic disease progression may be eligible for the second phase at the discretion of the investigator if no cancer treatment was administered since the last dose of pembrolizumab and trial eligibility safety parameters are met. Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks for up to 17 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
External Beam Radiation Therapy
2006
Completed Phase 3
~3070
Find a Location
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
567 Previous Clinical Trials
1,922,646 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,667 Previous Clinical Trials
40,926,152 Total Patients Enrolled
Joseph ChaoPrincipal InvestigatorCity of Hope Medical Center
5 Previous Clinical Trials
51 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have another type of cancer that is getting worse or needs ongoing treatment.You have used an experimental device within the last 4 weeks before starting treatment.You are allergic to pembrolizumab or any of the ingredients in it.You have a history or current signs of a lung condition called non-infectious pneumonitis.You have received a type of cancer treatment called monoclonal antibody within the past 4 weeks. Or, if you had any side effects from previous treatments more than 4 weeks ago, you have not fully recovered from them.You have tumors that have spread to your brain or the lining around your brain.You are expected to live for at least 3 more months.You are currently taking a medication that is still being tested and not approved for regular use.You are about to receive radiation therapy to treat a symptom-causing tumor in your brain or spinal cord.You have had treatment for certain types of skin cancer or in situ cervical cancer.You may need to get a blood transfusion during the study.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (pembrolizumab, RT)
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.
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