Clinical trial NCT01585987: An Efficacy Study in Gastric and Gastroesophageal Junction Cancer Comparing Ipilimumab Versus Standard of Care Immediately Following First Line Chemotherapy
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Locally Advanced (Unresectable) or Metastatic Adenocarcinoma of the Gastric and Gastro-esophageal Junction
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2012-04-26
Enrollment: 143
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Immune-related Progression Free Survival (irPFS) as Per Assessment of a Blinded Independent Review Committee (IRC) According to Immune Related Response Criteria (irRC) Guidelines
timeFrame: Randomization up to 91 irPFS events (Approximately 19 months )
Secondary outcomes:
measure: Progression Free Survival (PFS) Per Modified World Health Organization (mWHO) Criteria
timeFrame: Randomization up to 91 irPFS events (Approximately 19 months )
measure: Overall Survival (OS) at Primary Endpoint
timeFrame: Randomization up to 91 irPFS events (Approximately 19 months)
measure: Overall Survival (OS) at Study Completion
timeFrame: Randomization up to end of study, April 2015 (Approximately 28 months)
measure: Percentage of Participants With Immune-Related Best Overall Response (irBOR)
timeFrame: Randomization up to 91 irPFS events (Approximately 19 months)
Other outcomes:
Locations:
city: Miami Beach
country: United States
facility: Mount Sinai Medical Center
state: Florida
city: New York
country: United States
facility: Nyu Clinical Cancer Center
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Houston
country: United States
facility: The University Of Texas Md Anderson Cancer Center
state: Texas
city: Montpellier Cedex
country: France
facility: Local Institution
city: Nice Cedex 03
country: France
facility: Local Institution
city: Rennes
country: France
facility: Local Institution
city: Toulouse Cedex 09
country: France
facility: Local Institution
city: Mainz
country: Germany
facility: Local Institution
city: Hong Kong
country: Hong Kong
facility: Local Institution
city: Firenze
country: Italy
facility: Local Institution
city: Milano
country: Italy
facility: Local Institution
city: Padova
country: Italy
facility: Local Institution
city: Pisa
country: Italy
facility: Local Institution
city: Roma
country: Italy
facility: Local Institution
city: Nagoya
country: Japan
facility: Local Institution
state: Aichi
city: Saku-shi
country: Japan
facility: Local Institution
state: Nagano
city: Osaka-sayama-shi
country: Japan
facility: Local Institution
state: Osaka
city: Kitaadachi-gun
country: Japan
facility: Local Institution
state: Saitama
city: Gyeonggi-do
country: Korea, Republic of
facility: Local Institution
city: Gyeonggi-do
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Katowice
country: Poland
facility: Local Institution
state: Ochojec
city: Krakow
country: Poland
facility: Local Institution
city: Lodz
country: Poland
facility: Local Institution
city: Olsztyn
country: Poland
facility: Local Institution
city: Moscow
country: Russian Federation
facility: Local Institution
city: Singapore
country: Singapore
facility: Local Institution
city: Singapore
country: Singapore
facility: Local Institution
city: Barcelona
country: Spain
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
city: Taipei
country: Taiwan
facility: Local Institution
city: Taipei
country: Taiwan
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: 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.