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

April 15, 2016 updated by: Bristol-Myers Squibb

A Randomized, Open-label, Two-arm Phase II Trial Comparing the Efficacy of Sequential Ipilimumab Versus Best Supportive Care Following First-line Chemotherapy in Subjects With Unresectable Locally Advanced/Metastatic Gastric or Gastro-esophageal Junction Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

143

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier Cedex, France, 34295
        • Local Institution
      • Nice Cedex 03, France, 06202
        • Local Institution
      • Rennes, France, 35042
        • Local Institution
      • Toulouse Cedex 09, France, 31059
        • Local Institution
  • Germany
      • Mainz, Germany, 55131
        • Local Institution
  • Hong Kong
      • Hong Kong, Hong Kong
        • Local Institution
  • Italy
      • Firenze, Italy, 50134
        • Local Institution
      • Milano, Italy, 20133
        • Local Institution
      • Padova, Italy, 35128
        • Local Institution
      • Pisa, Italy, 56126
        • Local Institution
      • Roma, Italy, 00189
        • Local Institution
  • Japan
    • Aichi
      • Nagoya, Aichi, Japan, 4648681
        • Local Institution
    • Nagano
      • Saku-shi, Nagano, Japan, 3840301
        • Local Institution
    • Osaka
      • Osaka-sayama-shi, Osaka, Japan, 5898511
        • Local Institution
    • Saitama
      • Kitaadachi-gun, Saitama, Japan, 3620806
        • Local Institution
  • Korea, Republic of
      • Gyeonggi-do, Korea, Republic of, 463-707
        • Local Institution
      • Gyeonggi-do, Korea, Republic of, 431-796
        • Local Institution
      • Seoul, Korea, Republic of, 135-720
        • Local Institution
      • Seoul, Korea, Republic of, 110-774
        • Local Institution
      • Seoul, Korea, Republic of, 135-705
        • Local Institution
  • Poland
      • Krakow, Poland, 31-501
        • Local Institution
      • Lodz, Poland, 93-513
        • Local Institution
      • Olsztyn, Poland, 10-513
        • Local Institution
    • Ochojec
      • Katowice, Ochojec, Poland, 40-635
        • Local Institution
  • Russian Federation
      • Moscow, Russian Federation, 115 478
        • Local Institution
  • Singapore
      • Singapore, Singapore, 308433
        • Local Institution
      • Singapore, Singapore, 169610
        • Local Institution
  • Spain
      • Barcelona, Spain, 08035
        • Local Institution
      • Madrid, Spain, 28050
        • Local Institution
      • Madrid, Spain, 28040
        • Local Institution
  • Taiwan
      • Taipei, Taiwan, 100
        • Local Institution
      • Taipei, Taiwan, 112
        • Local Institution
  • United States
    • Florida
      • Miami Beach, Florida, United States, 33140
        • Mount Sinai Medical Center
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
      • New York, New York, United States, 10016
        • NYU Clinical Cancer Center
    • Texas
      • Houston, Texas, United States, 77030
        • The University of Texas MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Key Inclusion Criteria:

  • Histologically confirmed, unresectable locally advanced or metastatic adenocarcinoma of the gastric and gastro-esophageal junction
  • Received first-line chemotherapy using fluoropyrimidine and platinum combination without disease progression
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Measurable disease by modified WHO criteria (unless complete response from previous chemotherapy)

Key Exclusion Criteria:

  • Known Human Epidermal growth factor Receptor2 (HER2) positive status
  • Radiological evidence of brain metastases
  • History of severe autoimmune or immune mediated disease requiring prolonged immunosuppressive treatment
  • Inadequate hematologic, renal and hepatic function

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A: Ipilimumab
Ipilimumab 10 mg/kg solution intravenously, 90 minute infusion, once every 3 weeks for 4 doses, then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose)
Biological: Ipilimumab
Other Names:
  • BMS-734016
Other: Arm B: Best Supportive care (BSC)
BSC may include the continuation of the Fluoropyrimidine that was used during the lead-in chemotherapy, but no other systemic anti cancer therapy
Other: Best Supportive care (BSC)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immune-related Progression Free Survival (irPFS) as Per Assessment of a Blinded Independent Review Committee (IRC) According to Immune Related Response Criteria (irRC) Guidelines
Time Frame: Randomization up to 91 irPFS events (Approximately 19 months )
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.
Randomization up to 91 irPFS events (Approximately 19 months )

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival (PFS) Per Modified World Health Organization (mWHO) Criteria
Time Frame: Randomization up to 91 irPFS events (Approximately 19 months )
PFS per mWHO was defined as the time between the randomization date and the time of disease progression per mWHO criteria or death, whichever occurred first and was measured in months. mWHO criteria: New lesions always mean progression; Changes in non-measurable lesions contribute in the definitions of Complete Response (CR), Partial Response (PR), Stable Disease (SD) and Progressive Disease (PD).
Randomization up to 91 irPFS events (Approximately 19 months )
Overall Survival (OS) at Primary Endpoint
Time Frame: Randomization up to 91 irPFS events (Approximately 19 months)
OS was defined as the time from the date of randomization until the date of death. For those participants who have not died, OS was censored on the last date the participant was known to be alive.
Randomization up to 91 irPFS events (Approximately 19 months)
Overall Survival (OS) at Study Completion
Time Frame: Randomization up to end of study, April 2015 (Approximately 28 months)
OS was defined as the time from the date of randomization until the date of death. For those participants who have not died, OS was censored on the last date the participant was known to be alive.
Randomization up to end of study, April 2015 (Approximately 28 months)
Percentage of Participants With Immune-Related Best Overall Response (irBOR)
Time Frame: Randomization up to 91 irPFS events (Approximately 19 months)
IrBOR rate was defined as the number of participants whose Immune-related Best Overall Response (irBOR) criteria was Immune-related Complete Response (irCR) or Immune-related Partial Response (irPR), divided by the total number of participants. The immune-related sum of products of diameters (irSPD) incorporates - in addition to the index lesions - measurable new lesions that may have developed on-study, providing an assessment that includes both index and new lesions. irCR=Complete disappearance of all tumor lesions (both index and non-index lesions with no new measurable/unmeasurable lesions). irPR=A 50% or greater decrease, relative to baseline of the irSPD, (based on irSPD of all index lesions and any measurable new lesions).
Randomization up to 91 irPFS events (Approximately 19 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

April 25, 2012

First Submitted That Met QC Criteria

April 25, 2012

First Posted (Estimate)

April 26, 2012

Study Record Updates

Last Update Posted (Estimate)

May 17, 2016

Last Update Submitted That Met QC Criteria

April 15, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA184-162
  • 2011-000853-22 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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