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NCT03257163 · ClinicalTrials.gov registry record · Phase 2

Pembrolizumab, Capecitabine, and Radiation Therapy in Treating Patients With Mismatch-Repair Deficient and Epstein-Barr Virus Positive Gastric Cancer

A Phase 2 study of Gastric Adenocarcinoma and Stage III Gastric Cancer AJCC v7, sponsored by Rutgers, The State University of New Jersey.

Active
Registry status
Phase 2
Development phase
40
Enrollment target
4
Study locations

NCT03257163 is a Phase 2 study of Gastric Adenocarcinoma and Stage III Gastric Cancer AJCC v7 that is active but no longer recruiting, run by Rutgers, The State University of New Jersey. The registered enrollment target is 40 participants, below the 244-participant average among 47 other Gastric Adenocarcinoma trials with a reported enrollment target (84% lower). The trial reports 4 study locations across 3 states.

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The verdict

NCT03257163, a Phase 2 study of Gastric Adenocarcinoma and Stage III Gastric Cancer AJCC v7, is active but no longer recruiting, sponsored by Rutgers, The State University of New Jersey.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
40 participants
Enrollment target
4
Study locations

Study Summary

This phase II trial studies how well pembrolizumab works with capecitabine and radiation therapy in treating patients with mismatch repair deficient and Epstein-Barr virus positive gastric cancer. Monoclonal antibodies, such as pembrolizumab may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving pembrolizumab, capecitabine and radiation therapy may work better at treating gastric cancer.

Interventions

  • BIOLOGICAL Pembrolizumab
  • DRUG Capecitabine
  • OTHER Laboratory Biomarker Analysis
  • RADIATION Radiation Therapy

Study Locations (4)

New Jersey

  • RWJBarnabas Health - Robert Wood Johnson University Hospital, Hamilton - Hamilton
  • Rutgers Cancer Institute of New Jersey - New Brunswick

Georgia

  • Emory University - Atlanta

New York

  • Montefiore Medical Center - The Bronx

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2017-09-29
Est. Completion 2026-12-31
Phase Phase 2

What the Registry Record Tells You About NCT03257163

The ClinicalTrials.gov registry entry for NCT03257163 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 244-participant average among 47 other Gastric Adenocarcinoma trials with a reported enrollment target (84% lower). The listed sponsor is Rutgers, The State University of New Jersey, which has 413 total studies on file at ClinicalTrials.gov.

The record links to 10 conditions, with Gastric Adenocarcinoma appearing as the primary indexed condition, and to 4 interventions - of which Pembrolizumab is the first listed.

NCT03257163 reports 4 study locations spanning 3 distinct geographic areas - top geographies include New Jersey, Georgia, New York.

Frequently Asked Questions

What is clinical trial NCT03257163 about?

NCT03257163 is a clinical study titled "Pembrolizumab, Capecitabine, and Radiation Therapy in Treating Patients With Mismatch-Repair Deficient and Epstein-Barr Virus Positive Gastric Cancer". This phase II trial studies how well pembrolizumab works with capecitabine and radiation therapy in treating patients with mismatch repair deficient and Epstein-Barr virus positive gastric cancer. Monoclonal antibodies, such as pembrolizumab may interfere with the ability of tumor cells to grow and ...

What is the current status of trial NCT03257163?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2017-09-29. Estimated completion is 2026-12-31.

What conditions does trial NCT03257163 study?

This clinical trial studies the following conditions: Gastric Adenocarcinoma, Stage III Gastric Cancer AJCC v7, Epstein-Barr Virus Positive, Mismatch Repair Protein Deficiency, Stage IB Gastric Cancer AJCC v7.

What interventions are being tested in trial NCT03257163?

The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Capecitabine (DRUG), Laboratory Biomarker Analysis (OTHER), Radiation Therapy (RADIATION).

Who is sponsoring clinical trial NCT03257163?

This trial is sponsored by Rutgers, The State University of New Jersey, which has 413 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03257163 being conducted?

This trial has 4 study locations across Georgia, New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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