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

Phase 2

Completed

• Conditions: Locally Advanced (Unresectable) or Metastatic Adenocarcinoma of the Gastric and Gastro-esophageal Junction
• Interventions: Other: Best Supportive care (BSC); Biological: Ipilimumab

• Registration Number: NCT01585987
• Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-04-25
• Study First Submitted QC: 2012-04-25
• Study First Posted: 2012-04-26
• Study Start: 2012-07
• Primary Completion: 2014-07
• Study Completion: 2015-04
• Results First Submitted: 2015-07-15
• Results First Submitted QC: 2015-10-19
• Results First Posted: 2015-11-18
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-15
• Last Update Posted: 2016-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 143

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm B: Best Supportive care (BSC)	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
Arm A: Ipilimumab	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)

Primary Outcome Measures

Name	Time	Method
Immune-related Progression Free Survival (irPFS) as Per Assessment of a Blinded Independent Review Committee (IRC) According to Immune Related Response Criteria (irRC) Guidelines	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

Name	Time	Method
Progression Free Survival (PFS) Per Modified World Health Organization (mWHO) Criteria	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).
Overall Survival (OS) at Primary Endpoint	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.
Overall Survival (OS) at Study Completion	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.
Percentage of Participants With Immune-Related Best Overall Response (irBOR)	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).

Trial Locations

Locations (5)

Mount Sinai Medical Center; 🇺🇸 Miami Beach, Florida, United States

Nyu Clinical Cancer Center; 🇺🇸 New York, New York, United States

The University Of Texas Md Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Local Institution; 🇨🇳 Taipei, Taiwan