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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

Conditions: Locally Advanced (Unresectable) or Metastatic Adenocarcinoma of the Gastric and Gastro-esophageal Junction

Treatments: Other: Best Supportive care (BSC); Biological: Ipilimumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01585987

CA184-162

2011-000853-22 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 143 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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143 participants in 2 patient groups

Arm A: Ipilimumab

Experimental group

Description:

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)

Treatment:

Biological: Ipilimumab

Arm B: Best Supportive care (BSC)

Other group

Description:

BSC may include the continuation of the Fluoropyrimidine that was used during the lead-in chemotherapy, but no other systemic anti cancer therapy

Treatment:

Other: Best Supportive care (BSC)