Clinical trial NCT03662659: An Investigational Study of Immunotherapy Combinations With Chemotherapy in Patients With Gastric or Gastroesophageal Junction (GEJ) Cancers
Official title: A Randomized, Open-label, Phase II Clinical Trial of Relatlimab (Anti-LAG-3) and Nivolumab in Combination With Chemotherapy Versus Nivolumab in Combination With Chemotherapy as First-Line Treatment in Patients With Gastric or Gastroesophageal Junction Adenocarcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gastric Cancer
Cancer of the Stomach
Esophagogastric Junction
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2018-09-07
Enrollment: 274
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 this study is to determine the efficacy and safety of investigational drug relatlimab plus nivolumab in combination with chemotherapy in participants with unresectable, untreated, locally advanced or metastatic gastric or GEJ cancer.


Eligibility criteria: For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
* Histologically- or cytologically-confirmed diagnosis of unresectable and either locally advanced, or metastatic gastric cancer or GEJ adenocarcinoma
* No prior treatment with systemic treatment (including HER 2 inhibitors) given as primary therapy for unresectable and either locally advanced, or metastatic GC or GEJ adenocarcinoma
* Tumor tissue must be provided for biomarker analyses

Exclusion Criteria:

* Participants with HER2 positive status
* Participants with known untreated central nervous system (CNS) metastases
* Uncontrolled or significant cardiovascular disease

Other protocol defined inclusion/exclusion criteria could apply

Primary outcomes:
measure: BICR-Assessed Objective Response Rate (ORR) in Randomized LAG-3 Positive (>=1 %) Participants
timeFrame: Up to 25 months
measure: BICR-Assessed Objective Response Rate (ORR) in Randomized LAG-3 Positive (>=1 %) Participants - Extended Collection
timeFrame: From randomization date to the date of objectively documented progression, death due to any cause, or date of subsequent anticancer therapy, whichever occurs first (Up to 63 months)
Secondary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: From randomization date to the date of objectively documented progression, death due to any cause, or date of subsequent anticancer therapy, whichever occurs first (Up to 63 months)
measure: Duration of Response (DOR)
timeFrame: From the date of first dose to the date of the first disease progression or death due to any cause, or date of subsequent anticancer therapy, whichever occurs first (Up to 63 months)
measure: Overall Survival (OS)
timeFrame: From the date of randomization to the date of death due to any cause (Up to 63 months)
measure: Progression-Free Survival (PFS)
timeFrame: From the date of randomization to the first date of documented progression, or death due to any cause, or date of subsequent anticancer therapy, whichever occurs first (Up to 63 months)
measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: From first dose to 30 days post last dose (Up to 60 months)
measure: Number of Participants Who Died
timeFrame: Up to 60 months
measure: Number of Participants With Laboratory Abnormalities in Specific Liver Tests
timeFrame: From first dose to 30 days post last dose (Up to 60 months)
measure: Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
timeFrame: From first dose to 30 days post last dose (Up to 60 months)
Other outcomes:
Locations:
city: Clovis
country: United States
facility: Local Institution - 0049
state: California
city: Duarte
country: United States
facility: Local Institution - 0064
state: California
city: La Jolla
country: United States
facility: Scripps Clinic
state: California
city: Los Angeles
country: United States
facility: Local Institution - 0040
state: California
city: Newport Beach
country: United States
facility: Hoag Memorial Hospital Presbyterian
state: California
city: Orange
country: United States
facility: Local Institution - 0041
state: California
city: Santa Monica
country: United States
facility: Local Institution - 0077
state: California
city: Aurora
country: United States
facility: Local Institution - 0056
state: Colorado
city: New Haven
country: United States
facility: Local Institution - 0062
state: Connecticut
city: Hackensack
country: United States
facility: Local Institution - 0050
state: New Jersey
city: Dallas
country: United States
facility: Local Institution - 0054
state: Texas
city: Richmond
country: United States
facility: Virginia Cancer Institute
state: Virginia
city: Seattle
country: United States
facility: Local Institution - 0052
state: Washington
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Local Institution - 0010
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Local Institution - 0009
state: Ciudad Autónoma De Buenos Aires
city: San Miguel de Tucumán
country: Argentina
facility: Local Institution - 0011
state: Tucumán
city: Caba
country: Argentina
facility: Local Institution - 0078
city: Westmead
country: Australia
facility: Local Institution - 0027
state: New South Wales
city: Herston
country: Australia
facility: Local Institution - 0007
state: Queensland
city: Heidelberg
country: Australia
facility: Local Institution - 0003
state: Victoria
city: Malvern
country: Australia
facility: Local Institution - 0029
state: Victoria
city: Shepparton
country: Australia
facility: Local Institution - 0008
state: Victoria
city: Murdoch
country: Australia
facility: Local Institution - 0005
state: Western Australia
city: Bedford Park
country: Australia
facility: Local Institution - 0028
city: Graz
country: Austria
facility: Local Institution - 0090
city: Wien
country: Austria
facility: Local Institution - 0089
city: Bruxelles
country: Belgium
facility: Local Institution - 0091
city: Leuven
country: Belgium
facility: Local Institution - 0092
city: Kelowna
country: Canada
facility: Local Institution - 0024
state: British Columbia
city: Halifax
country: Canada
facility: Local Institution - 0063
state: Nova Scotia
city: Toronto
country: Canada
facility: Local Institution - 0070
state: Ontario
city: Trois-Rivieres
country: Canada
facility: Local Institution - 0055
state: Quebec
city: Quebec
country: Canada
facility: Local Institution - 0095
city: Rancagua
country: Chile
facility: Local Institution - 0002
state: L.g.bernardoohiggins
city: Santiago
country: Chile
facility: Local Institution - 0080
state: Metropolitana
city: Vina del Mar
country: Chile
facility: Local Institution - 0001
state: Valparaiso
city: Santiago
country: Chile
facility: Local Institution - 0079
city: Brno
country: Czechia
facility: Local Institution - 0031
city: Olomouc
country: Czechia
facility: Local Institution - 0030
city: Avignon Cedex 9
country: France
facility: Local Institution - 0047
city: Besancon Cedex
country: France
facility: Local Institution - 0073
city: Dijon
country: France
facility: Local Institution - 0045
city: Montpellier
country: France
facility: Local Institution - 0071
city: Paris
country: France
facility: Local Institution - 0043
city: Paris
country: France
facility: Local Institution - 0072
city: Rouen Cedex
country: France
facility: Local Institution - 0046
city: Cologne
country: Germany
facility: Local Institution - 0083
city: Dresden
country: Germany
facility: Local Institution - 0082
city: Essen
country: Germany
facility: Local Institution - 0017
city: Essen
country: Germany
facility: Local Institution - 0081
city: Frankfurt
country: Germany
facility: Local Institution - 0014
city: Hamburg
country: Germany
facility: Local Institution - 0018
city: Hannover
country: Germany
facility: Local Institution - 0012
city: Heidelberg
country: Germany
facility: Local Institution - 0013
city: Mannheim
country: Germany
facility: Local Institution - 0015
city: Marburg
country: Germany
facility: Local Institution - 0016
city: Milano
country: Italy
facility: IRCCS Istituto Nazionale Tumori Milano
city: Milan
country: Italy
facility: Local Institution - 0020
city: Roma
country: Italy
facility: Local Institution - 0021
city: Bergen
country: Norway
facility: Local Institution - 0088
city: Oslo
country: Norway
facility: Local Institution - 0086
city: Trondheim
country: Norway
facility: Local Institution - 0087
city: Warszawa
country: Poland
facility: Local Institution - 0093
city: San Juan
country: Puerto Rico
facility: Local Institution - 0067
city: Singapore
country: Singapore
facility: Local Institution - 0038
city: Madrid
country: Spain
facility: Local Institution - 0058
state: M
city: Badajoz
country: Spain
facility: Local Institution - 0099
city: Barcelona
country: Spain
facility: Local Institution - 0098
city: Barcelona
country: Spain
facility: Local Institution - 0061
city: Bilbao
country: Spain
facility: Local Institution - 0059
city: Madrid
country: Spain
facility: Local Institution - 0057
city: Zaragoza
country: Spain
facility: Local Institution - 0060
city: Manchester
country: United Kingdom
facility: Local Institution - 0075
state: Greater Manchester
city: Nottingham
country: United Kingdom
facility: Local Institution - 0035
state: Nottinghamshire
city: Coventry
country: United Kingdom
facility: Local Institution - 0032
state: West Midlands
city: Lancaster
country: United Kingdom
facility: Local Institution - 0036
city: London
country: United Kingdom
facility: Local Institution - 0034
city: Northwood
country: United Kingdom
facility: Local Institution - 0069
city: Southampton
country: United Kingdom
facility: Local Institution - 0033
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.