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NCT02730546 · ClinicalTrials.gov registry record · Phase 1

Pembrolizumab, Combination Chemotherapy, and Radiation Therapy Before Surgery in Treating Adult Patients With Locally Advanced Gastroesophageal Junction or Gastric Cardia Cancer That Can Be Removed by Surgery

A Phase 1 study, sponsored by Mayo Clinic.

Completed
Registry status
Phase 1
Development phase
31
Enrollment target

NCT02730546: Completed Phase 1 study, sponsored by Mayo Clinic.

NCT02730546 is a Phase 1 study that has completed, run by Mayo Clinic. The registered enrollment target is 31 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02730546, a Phase 1 study, has completed, sponsored by Mayo Clinic.

COMPLETED
Registry status
Phase 1
Development phase
31 participants
Enrollment target

Study Summary

This phase Ib/II trial studies the side effects and best way to give pembrolizumab with combination chemotherapy and radiation therapy before surgery and to see how well it works in treating adult patients with gastroesophageal junction or gastric cardia cancer that has spread from where it started to nearby tissue and can be removed by surgery. Monoclonal antibodies, such as pembrolizumab, may block tumor growth in different ways by targeting certain cells. Drugs used in chemotherapy 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, combination chemotherapy, and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

Primary Outcome

Defined as number of patients with pathologic complete responses (pCR) divided by total evaluable patients. pCR is defined as no recognized cancer and margins free of tumor as found by the pathologist following resection of the esophageal specimen and accompanying lymph nodes.

Interventions

  • DRUG Carboplatin
  • PROCEDURE Computed Tomography
  • DRUG Fluorouracil
  • OTHER Laboratory Biomarker Analysis
  • DRUG Leucovorin Calcium

Trial Details

FieldValue
Enrollment Target 31 participants
Start Date 2016-06-24
Est. Completion 2023-10-31
Phase Phase 1
Mayo Clinic

2,844 total trials

What the finished NCT02730546 record still lists

NCT02730546 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower).

The record links to 0 conditions, and to 5 interventions - of which Carboplatin is the first listed.

NCT02730546 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02730546 about?

NCT02730546 is a clinical study titled "Pembrolizumab, Combination Chemotherapy, and Radiation Therapy Before Surgery in Treating Adult Patients With Locally Advanced Gastroesophageal Junction or Gastric Cardia Cancer That Can Be Removed by Surgery". This phase Ib/II trial studies the side effects and best way to give pembrolizumab with combination chemotherapy and radiation therapy before surgery and to see how well it works in treating adult patients with gastroesophageal junction or gastric cardia cancer that has spread from where it started ...

What is the current status of trial NCT02730546?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2016-06-24. Estimated completion is 2023-10-31.

What interventions are being tested in trial NCT02730546?

The interventions under investigation include: Carboplatin (DRUG), Computed Tomography (PROCEDURE), Fluorouracil (DRUG), Laboratory Biomarker Analysis (OTHER), Leucovorin Calcium (DRUG).

Who is sponsoring clinical trial NCT02730546?

This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02730546's enrollment target sits among peer trials

31 1322nd of 2000 higher than 669 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02730546, the US trial registry maintained by the National Library of Medicine. NCT02730546 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.