Skip to main content
OpenTrials
Completed

NCT Number: NCT01585987

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Local Institution, Montpellier, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ipilimumab

Biological

Other names: BMS-734016

Best Supportive Care (BSC)

Other

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

    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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Apr 26, 2012
Registry last updated
May 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.