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NCT01585987 · ClinicalTrials.gov registry record · Phase 2

An Efficacy Study in Gastric and Gastroesophageal Junction Cancer Comparing Ipilimumab Versus Standard of Care Immediately Following First Line Chemotherapy

A Phase 2 study of Locally Advanced (Unresectable) or Metastatic Adenocarcinoma of the Gastric and Gastro-esophageal Junction, sponsored by Bristol-Myers Squibb.

Completed
Registry status
Phase 2
Development phase
143
Enrollment target
20
Study locations

NCT01585987: Completed Phase 2 study of Locally Advanced (Unresectable) or Metastatic Adenocarcinoma of the Gastric and Gastro-esophageal Junction, sponsored by Bristol-Myers Squibb.

NCT01585987 is a Phase 2 study of Locally Advanced (Unresectable) or Metastatic Adenocarcinoma of the Gastric and Gastro-esophageal Junction that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 143 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01585987, a Phase 2 study of Locally Advanced (Unresectable) or Metastatic Adenocarcinoma of the Gastric and Gastro-esophageal Junction, has completed, sponsored by Bristol-Myers Squibb.

COMPLETED
Registry status
Phase 2
Development phase
143 participants
Enrollment target
20
Study locations

Study Summary

The purpose of the study is to compare the efficacy of Ipilimumab and standard of care as sequential or maintenance treatment immediately after first-line chemotherapy in the treatment of unresectable or metastatic gastric and gastro-esophageal cancer.

Primary Outcome

irPFS is defined as the time between the randomization date and the time of disease progression per irRC or death, whichever occurs first. irRC criteria=Measurable new lesions: incorporated into the tumor burden (eg, added to the index lesions); do not define progression unless the total measurable tumor burden increases by the required amount (25%). New non-measurable lesions: not considered progression if the total measurable tumor burden is stable or shrinking. irPFS was measured in months.

Conditions Studied

Locally Advanced (Unresectable) or Metastatic Adenocarcinoma of the Gastric and Gastro-esophageal Junction

Interventions

  • BIOLOGICAL Ipilimumab
  • OTHER Best Supportive care (BSC)

Study Locations (20)

Other

  • Local Institution - Montpellier
  • Local Institution - Nice
  • Local Institution - Rennes
  • Local Institution - Toulouse
  • Local Institution - Mainz
  • Local Institution - Hong Kong
  • Local Institution - Florence
  • Local Institution - Milan
  • Local Institution - Padua
  • Local Institution - Pisa
  • Local Institution - Roma

New York

  • Nyu Clinical Cancer Center - New York
  • Memorial Sloan Kettering Cancer Center - New York

Florida

  • Mount Sinai Medical Center - Miami Beach

Texas

  • The University Of Texas Md Anderson Cancer Center - Houston

Aichi-ken

  • Local Institution - Nagoya

Nagano

  • Local Institution - Saku-shi

Osaka

  • Local Institution - Osaka-sayama-shi

Saitama

  • Local Institution - Kitaadachi-gun

Trial Details

FieldValue
Enrollment Target 143 participants
Start Date 2012-07
Est. Completion 2015-04
Phase Phase 2
Bristol-Myers Squibb

1,025 total trials

What the finished NCT01585987 record still lists

NCT01585987 is an interventional study that assigns participants to a tested intervention. The registered 143 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.

The record links to 1 condition, with Locally Advanced (Unresectable) or Metastatic Adenocarcinoma of the Gastric and Gastro-esophageal Junction appearing as the primary indexed condition, and to 2 interventions - of which Ipilimumab is the first listed.

NCT01585987 names 20 study sites across 9 states, led by Other, New York, Florida.

Frequently Asked Questions

What is clinical trial NCT01585987 about?

NCT01585987 is a clinical study titled "An Efficacy Study in Gastric and Gastroesophageal Junction Cancer Comparing Ipilimumab Versus Standard of Care Immediately Following First Line Chemotherapy". The purpose of the study is to compare the efficacy of Ipilimumab and standard of care as sequential or maintenance treatment immediately after first-line chemotherapy in the treatment of unresectable or metastatic gastric and gastro-esophageal cancer.

What is the current status of trial NCT01585987?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 143 participants. The study started on 2012-07. Estimated completion is 2015-04.

What conditions does trial NCT01585987 study?

This clinical trial studies the following conditions: Locally Advanced (Unresectable) or Metastatic Adenocarcinoma of the Gastric and Gastro-esophageal Junction.

What interventions are being tested in trial NCT01585987?

The interventions under investigation include: Ipilimumab (BIOLOGICAL), Best Supportive care (BSC) (OTHER).

Who is sponsoring clinical trial NCT01585987?

This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01585987 being conducted?

This trial has 20 study locations across Florida, New York, Texas, Aichi-ken, Nagano. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

How this trial's enrollment target compares

Where NCT01585987's enrollment target sits among peer trials

143 507th of 2000 higher than 1,494 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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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Related registry views

Source: ClinicalTrials.gov NCT01585987, the US trial registry maintained by the National Library of Medicine. NCT01585987 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.