Pembrolizumab for Malignant neoplasm of stomach

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Malignant neoplasm of stomach+13 More
Pembrolizumab - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing pembrolizumab with capecitabine and radiation therapy to treat gastric cancer.

Eligible Conditions
  • Malignant neoplasm of stomach
  • Mismatch Repair Protein Deficiency
  • Stage IIB Gastric Cancer AJCC v7
  • Stage III Gastric Cancer AJCC v7
  • Stage IB Gastric Cancer AJCC v7
  • Stage IIIC Gastric Cancer AJCC v7
  • Adenocarcinoma
  • Receptors, Complement 3d
  • Stage II Gastric Cancer AJCC v7
  • Stage IIA Gastric Cancer AJCC v7

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: 3 years

3 years
Recurrence-free survival (RFS) rate

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Pembrolizumab Second Course
100%Urinary tract infection
100%Parkinsonism
100%Inappropriate antidiuretic hormone secretion
This histogram enumerates side effects from a completed 2021 Phase 3 trial (NCT03066778) in the Pembrolizumab Second Course ARM group. Side effects include: Urinary tract infection with 100%, Parkinsonism with 100%, Inappropriate antidiuretic hormone secretion with 100%.

Trial Design

1 Treatment Group

Treatment (pembrolizumab, capecitabine, radiation therapy)
1 of 1
Experimental Treatment

40 Total Participants · 1 Treatment Group

Primary Treatment: Pembrolizumab · No Placebo Group · Phase 2

Treatment (pembrolizumab, capecitabine, radiation therapy)Experimental Group · 4 Interventions: Pembrolizumab, Radiation Therapy, Laboratory Biomarker Analysis, Capecitabine · Intervention Types: Biological, Radiation, Other, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved
Radiation Therapy
2005
Completed Phase 3
~7080
Capecitabine
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 3 years

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
12,990 Previous Clinical Trials
41,298,848 Total Patients Enrolled
Rutgers, The State University of New JerseyLead Sponsor
369 Previous Clinical Trials
60,661 Total Patients Enrolled
Salma Jabbour4.413 ReviewsPrincipal Investigator - Rutgers Cancer Institute of New Jersey
Rutgers Cancer Institute of New Jersey
2 Previous Clinical Trials
45 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.

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a mismatch repair deficiency as identified by immunohistochemistry or other institutional standard, or you have Epstein-Barr virus positivity as determined by in situ hybridization or other institutional standard.
You have a platelet count of at least 100,000 / microliter.
You are willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion; newly-obtained is defined as a specimen obtained up to 10 weeks (70 days) prior to initiation of treatment on day 1; subjects for whom newly-obtained samples cannot be provided (e.g

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 16th, 2021

Last Reviewed: October 24th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.