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Chemotherapy

Pembrolizumab for Gastric Cancer

Phase 1 & 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
Patients with histologically or cytologically confirmed recurrent or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma progressed or intolerant to >= 2 lines of systemic therapy.
Patients must have recurrent or metastatic gastric/GEJ adenocarcinoma that are not amenable to local therapy with curative intent (surgery or radiation therapy with or without chemotherapy).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study Summary

This trial is testing a combination of drugs to treat gastric or gastroesophageal junction cancer that has come back or spread. The drugs are designed to boost the immune system and kill cancer cells.

Eligible Conditions
  • Gastric Cancer
  • Gastroesophageal Junction Adenocarcinoma

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression-free Survival
Secondary outcome measures
Overall Response
Overall Survival
Other outcome measures
Circulating T cell profiles for each participant with the combination of IRX-2 regimen and pembrolizumab
Difference in tumor tissue Nanostring expression profiling
Hypothesis development for response based on circulating immune cell profiles circulating tumor deoxyribonucleic acid (DNA) from peripheral blood
+1 more

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Kidney Injury and/or Infection
7%
Pneumonia
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Activated partial thromboplastin time prolonged
5%
Intractable pain, back pain, hip pain
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Skin rash
2%
Thrombocytopenia
2%
Respiratory failure
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (pembrolizumab, cyclophosphamide, and IRX-2)Experimental Treatment3 Interventions
Participants receive pembrolizumab IV over 30 minutes on day 1. Participants also receive cyclophosphamide IV on day 1 and IRX-2 SC for 10 days starting on day 4 during cycles 1, 5, 9, 13, 17, 21, 25, 29, and 33. Treatment repeats every 3 weeks for up to 35 cycles in the absence of disease or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cytokine-based Biologic Agent IRX-2
2019
Completed Phase 2
~10
Pembrolizumab
2017
Completed Phase 2
~1950
Cyclophosphamide
1995
Completed Phase 3
~3780

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor
558 Previous Clinical Trials
1,917,443 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,637 Total Patients Enrolled
Joseph ChaoPrincipal InvestigatorCity of Hope Medical Center
5 Previous Clinical Trials
81 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Have there been previously conducted investigations into Pembrolizumab?

"Pembrolizumab's development was kickstarted at the City of Hope Comprehensive Cancer Center in 1997, with 1330 trials now concluded. Currently, 1747 studies are ongoing; many of them taking place in Dallas, Texas."

Answered by AI

To what extent is this medical study engaging participants?

"At this time, recruitment for the trial is closed as it was last updated on May 31st 2022. If you are searching for other studies involving adenocarcinoma and Pembrolizumab, there are a total of 2284 trials actively seeking participants and 1747 clinical studies recruiting patients with the aforementioned drug respectively."

Answered by AI

In what cases is Pembrolizumab commonly prescribed?

"Pembrolizumab is a viable therapy for the treatment of malignant melanoma, recurrent cervical cancer and leukemia."

Answered by AI

Are there any openings in this research initiative for those seeking participation?

"Currently, this medical trial is not actively seeking participants. Last updated on May 31st 2022, the original post was made 19th April 2019. If you are looking for alternative trials to join, there are 2,284 studies recruiting those with adenocarcinoma and 1,747 clinical trials that utilize pembrolizumab in their treatment protocol currently open to enrolment."

Answered by AI
~2 spots leftby Mar 2025