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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 has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01585987
First received: April 25, 2012
Last updated: April 15, 2016
Last verified: April 2016
Results First Received: July 15, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Locally Advanced (Unresectable) or Metastatic Adenocarcinoma of the Gastric and Gastro-esophageal Junction
Interventions: Biological: Ipilimumab
Other: Best Supportive care (BSC)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Acceptable first-line chemotherapy before randomization to this study for a participant was a regimen containing a fluoropyrimidine agent and a platinum salt. Study initiated July 2012. Primary endpoint July 2014. Study completed April 2015.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
114 enrolled and randomized. 29 enrolled but not randomized to treatment group: 26 no longer met study criteria; 2 withdrew consent, 1 other.

Reporting Groups
  Description
Ipilimumab Ipilimumab 10 milligram per kilogram body weight (mg/kg) solution intravenously (IV), over 90 minutes, once every 3 weeks for 4 doses, then 10 mg/kg every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose). The option of re-introduction, defined as an additional 4 doses of ipilimumab (a dose of 10 mg/kg every 3 weeks) was allowed only at discretion of the investigator if criteria for re-induction were met.
All Best Supportive Care (BSC) All BSC includes both active and non-active BSC. Active BSC includes the continuation of the fluoropyrimidine that was used during the lead-in chemotherapy (prior to randomization to this study), but no other active systemic anti-cancer treatment. In non-active BSC, the fluoropyrimidine used during lead-in chemotherapy was not continued on study and no other chemotherapy or active treatment was used

Participant Flow for 2 periods

Period 1:   Randomized
    Ipilimumab     All Best Supportive Care (BSC)  
STARTED     57     57  
COMPLETED     57     51  
NOT COMPLETED     0     6  
Withdrawal by Subject                 0                 4  
No longer met criteria                 0                 2  

Period 2:   Treated
    Ipilimumab     All Best Supportive Care (BSC)  
STARTED     57     51  
COMPLETED     3     2  
NOT COMPLETED     54     49  
Disease Progression                 39                 36  
Study Drug Toxicity                 9                 5  
Adverse Event                 3                 0  
Withdrawal by Subject                 1                 2  
Death                 1                 0  
Lost to Follow-up                 0                 1  
Maximum Clinical Benefit                 0                 1  
Non-Specified                 1                 2  
Subject Request                 0                 1  
Poor/Non-Compliance                 0                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants randomized to a treatment arm are summarized.

Reporting Groups
  Description
Ipilimumab Ipilimumab 10 milligram per kilogram body weight (mg/kg) solution intravenously (IV), over 90 minutes, once every 3 weeks for 4 doses, then 10 mg/kg every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose). The option of re-introduction, defined as an additional 4 doses of ipilimumab (a dose of 10 mg/kg every 3 weeks) was allowed only at discretion of the investigator if criteria for re-induction were met.
All Best Supportive Care (BSC) BSC may include the continuation of the fluoropyrimidine that was used during the lead-in chemotherapy (prior to randomization to this study), but no other active systemic anti-cancer treatment.
Total Total of all reporting groups

Baseline Measures
    Ipilimumab     All Best Supportive Care (BSC)     Total  
Number of Participants  
[units: participants]
  57     57     114  
Age  
[units: years]
Median (Full Range)
  65.0  
  (34 to 86)  
  62.0  
  (32 to 80)  
  64.0  
  (32 to 86)  
Age, Customized  
[units: participants]
     
Less than (<) 65 years of age     28     35     63  
Greater, equal to (>=) 65 years of age     29     22     51  
Gender  
[units: participants]
     
Female     21     16     37  
Male     36     41     77  
Region of Enrollment  
[units: participants]
     
Russian Federation     1     1     2  
Singapore     1     1     2  
Hong Kong     1     0     1  
United States     8     6     14  
Japan     7     5     12  
Taiwan     1     0     1  
Poland     0     2     2  
Korea, Republic of     21     24     45  
Italy     11     8     19  
France     3     5     8  
Germany     1     0     1  
Spain     2     5     7  



  Outcome Measures
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1.  Primary:   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 ) ]

2.  Secondary:   Progression Free Survival (PFS) Per Modified World Health Organization (mWHO) Criteria   [ Time Frame: Randomization up to 91 irPFS events (Approximately 19 months ) ]

3.  Secondary:   Overall Survival (OS) at Primary Endpoint   [ Time Frame: Randomization up to 91 irPFS events (Approximately 19 months) ]

4.  Secondary:   Overall Survival (OS) at Study Completion   [ Time Frame: Randomization up to end of study, April 2015 (Approximately 28 months) ]

5.  Secondary:   Percentage of Participants With Immune-Related Best Overall Response (irBOR)   [ Time Frame: Randomization up to 91 irPFS events (Approximately 19 months) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Bristol-Myers Squibb Study Director
Organization: Bristol-Myers Squibb
e-mail: Clinical.Trials@bms.com



Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01585987     History of Changes
Other Study ID Numbers: CA184-162
2011-000853-22 ( EudraCT Number )
Study First Received: April 25, 2012
Results First Received: July 15, 2015
Last Updated: April 15, 2016
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