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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01585987
Recruitment Status : Completed
First Posted : April 26, 2012
Results First Posted : November 18, 2015
Last Update Posted : May 17, 2016
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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Brief 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.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 143 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : July 2012
Actual Primary Completion Date : July 2014
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Ipilimumab

Arms and Interventions
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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 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)


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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.

  3. 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.

  4. 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).


Eligibility Criteria
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Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01585987


Locations
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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
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01585987    
Other Study ID Numbers: CA184-162
2011-000853-22 ( EudraCT Number )
First Posted: April 26, 2012    Key Record Dates
Results First Posted: November 18, 2015
Last Update Posted: May 17, 2016
Last Verified: April 2016
Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
 Ipilimumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action