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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01585987
First received: April 25, 2012
Last updated: July 23, 2014
Last verified: April 2014
  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:


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: July 2015
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 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

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Additional Information:
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: July 23, 2014
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
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on August 28, 2014