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

This study is currently recruiting participants.
Verified March 2013 by Bristol-Myers Squibb
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01585987
First received: April 25, 2012
Last updated: March 28, 2013
Last verified: March 2013
History of Changes
  Purpose

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


Condition Intervention Phase
Locally Advanced (Unresectable) or Metastatic Adenocarcinoma of the Gastric and Gastro-esophageal Junction
 Biological: Ipilimumab
Other: Best Supportive care (BSC)
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Drug Information available for: Ipilimumab
U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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: 91 irPFS events (Approximately 19 months following the first subject randomized) ] [ Designated as safety issue: No ]
    irPFS is defined as the time between the randomization date and the time of disease progression per irRC or death, whichever occurs first


Secondary Outcome Measures:
  • Progression free survival (PFS) per modified WHO criteria [ Time Frame: 91 irPFS events (Approximately 19 months following the first subject randomized) ] [ Designated as safety issue: No ]
    PFS per modified WHO (mWHO) is defined as the time between the randomization date and the time of disease progression per mWHO criteria or death, whichever occurs first

  • Overall survival (OS) [ Time Frame: 91 irPFS events (Approximately 19 months following the first subject randomized) ] [ Designated as safety issue: No ]
    OS is defined as the time from the date of randomization until the date of death. For those subjects who have not died, OS will be censored on the last date the subjects was known to be alive

  • Immune-related best overall response rate (irBORR) [ Time Frame: 91 irPFS events (Approximately 19 months following the first subject randomized) ] [ Designated as safety issue: No ]
    IrBORR is defined as the number of subjects 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 response evaluable subjects


Estimated Enrollment: 114
Study Start Date: July 2012
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A: Ipilimumab
Intravenous (IV) solution, IV, 10 mg/kg, 90 minute infusion, Once every 3 weeks for 4 doses, then every 12 weeks until disease progression
 Biological: Ipilimumab
Other Name: BMS-734016
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 for previous chemotherapy)

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01585987

Contacts
Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email: Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.

  Show 34 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
BMS Clinical Trial Information  This link exits the ClinicalTrials.gov site
BMS clinical trial educational resource  This link exits the ClinicalTrials.gov site
Investigator Inquiry form  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01585987     History of Changes
Other Study ID Numbers: CA184-162, 2011-000853-22
Study First Received: April 25, 2012
Last Updated: March 28, 2013
Health Authority: United States: Food and Drug Administration
Japan: Ministry of Health, Labor and Welfare
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Poland: National Institute of Medicines
Hong Kong: Department of Health
Italy: Ministry of Health
Russia: Ethics Committee
Russia: Ministry of Health of the Russian Federation
Spain: Spanish Agency of Medicines
Singapore: Clinical Trials & Epidemiology Research Unit (CTERU)
South Korea: Korea Food and Drug Administration (KFDA)
United States: Institutional Review Board

Additional relevant MeSH terms:
Adenocarcinoma
Adenocarcinoma, Mucinous
Esophageal Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Cystic, Mucinous, and Serous
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 19, 2013