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

NCT01585987 | Completed Phase 2 Results

• 2 other identifiers: CA184-1622011-000853-22
• Study Type: interventional
• Target: 143
• Locations: 12 countries
• Sites: 36

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.

Conditions

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

Outcome Measures

Primary Outcomes (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

  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.

  Randomization up to 91 irPFS events (Approximately 19 months )

Secondary Outcomes (4)

• Progression Free Survival (PFS) Per Modified World Health Organization (mWHO) Criteria

  Randomization up to 91 irPFS events (Approximately 19 months )

• Overall Survival (OS) at Primary Endpoint

  Randomization up to 91 irPFS events (Approximately 19 months)

• Overall Survival (OS) at Study Completion

  Randomization up to end of study, April 2015 (Approximately 28 months)

• Percentage of Participants With Immune-Related Best Overall Response (irBOR)

  Randomization up to 91 irPFS events (Approximately 19 months)

Study Arms (2)

Arm A: Ipilimumab

EXPERIMENTAL

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

Arm B: Best Supportive care (BSC)

OTHER

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)

Interventions

Ipilimumab BIOLOGICAL

Also known as: BMS-734016

Arm A: Ipilimumab

Best Supportive care (BSC) OTHER

Arm B: Best Supportive care (BSC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (36)

Mount Sinai Medical Center

Miami Beach, Florida, 33140, United States

Location

Nyu Clinical Cancer Center

New York, New York, 10016, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

The University Of Texas Md Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Local Institution

Montpellier, 34295, France

Location

Local Institution

Nice, 06202, France

Location

Local Institution

Rennes, 35042, France

Location

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Toulouse, 31059, France

Location

Local Institution

Mainz, 55131, Germany

Location

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Hong Kong, Hong Kong

Location

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Florence, 50134, Italy

Location

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Milan, 20133, Italy

Location

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Padua, 35128, Italy

Location

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Pisa, 56126, Italy

Location

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Roma, 00189, Italy

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Nagoya, Aichi-ken, 4648681, Japan

Location

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Saku-shi, Nagano, 3840301, Japan

Location

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Osaka-sayama-shi, Osaka, 5898511, Japan

Location

Local Institution

Kitaadachi-gun, Saitama, 3620806, Japan

Location

Local Institution

Katowice, Ochojec, 40-635, Poland

Location

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Krakow, 31-501, Poland

Location

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Lodz, 93-513, Poland

Location

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Olsztyn, 10-513, Poland

Location

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Moscow, 115 478, Russia

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Singapore, 169610, Singapore

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Singapore, 308433, Singapore

Location

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Gyeonggi-do, 431-796, South Korea

Location

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Gyeonggi-do, 463-707, South Korea

Location

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Seoul, 110-774, South Korea

Location

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Seoul, 135-705, South Korea

Location

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Seoul, 135-720, South Korea

Location

Local Institution

Barcelona, 08035, Spain

Location

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Madrid, 28040, Spain

Location

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Madrid, 28050, Spain

Location

Local Institution

Taipei, 100, Taiwan

Location

Local Institution

Taipei, 112, Taiwan

Location

Related Publications (1)

• Chang X, Ge X, Zhang Y, Xue X. The current management and biomarkers of immunotherapy in advanced gastric cancer. Medicine (Baltimore). 2022 May 27;101(21):e29304. doi: 10.1097/MD.0000000000029304.

  PMID: 35623069 DERIVED

Related Links

• BMS clinical trial educational resource
• Investigator Inquiry form

MeSH Terms

Interventions

Ipilimumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2012
• First Posted: April 26, 2012
• Study Start: July 1, 2012
• Primary Completion: July 1, 2014
• Study Completion: April 1, 2015
• Last Updated: May 17, 2016
• Results First Posted: November 18, 2015

Record last verified: 2016-04

Locations

US (4); HK (1); SG (2); ES (3); JP (4); KR (5); TW (2); DE (1); PL (4); RU (1); IT (5); FR (4)