Sign in

NCT03662659CompletedPhase 2

An Investigational Study of Immunotherapy Combinations With Chemotherapy in Patients With Gastric or Gastroesophageal Junction (GEJ) Cancers

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

Source: ClinicalTrials.gov · Last updated 5 Feb 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
274 (actual)
First submitted
6 Sept 2018
Start date
16 Oct 2018
Primary completion date
27 Aug 2020
Lead sponsor
Bristol-Myers Squibb
NCT number
NCT03662659
EudraCT number
2018-001069-18

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 274
  • From 16 Oct 2018 to the primary completion date, 27 Aug 2020
  • 79 sites in 17 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Uncontrolled or significant cardiovascular disease
    • Other protocol defined inclusion/exclusion criteria could apply

Other

  • Participants with HER2 positive status
  • Participants with known untreated central nervous system (CNS) metastases

Who the study is looking for

  • 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

Criteria the registry did not label

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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (79)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Local Institution - 0009
Coordinator of this site? Confirm its status
Buenos AiresArgentinaUnknown status
Local Institution - 0078
Coordinator of this site? Confirm its status
CABAArgentinaUnknown status
Local Institution - 0010
Coordinator of this site? Confirm its status
Ciudad Autónoma de Buenos AiresArgentinaUnknown status
Local Institution - 0011
Coordinator of this site? Confirm its status
San Miguel de TucumánArgentinaUnknown status
Local Institution - 0090
Coordinator of this site? Confirm its status
GrazAustriaUnknown status
Local Institution - 0089
Coordinator of this site? Confirm its status
ViennaAustriaUnknown status
Local Institution - 0028
Coordinator of this site? Confirm its status
Bedford ParkAustraliaUnknown status
Local Institution - 0003
Coordinator of this site? Confirm its status
HeidelbergAustraliaUnknown status
Local Institution - 0007
Coordinator of this site? Confirm its status
HerstonAustraliaUnknown status
Local Institution - 0029
Coordinator of this site? Confirm its status
MalvernAustraliaUnknown status
Local Institution - 0005
Coordinator of this site? Confirm its status
MurdochAustraliaUnknown status
Local Institution - 0008
Coordinator of this site? Confirm its status
SheppartonAustraliaUnknown status
Local Institution - 0027
Coordinator of this site? Confirm its status
WestmeadAustraliaUnknown status
Local Institution - 0091
Coordinator of this site? Confirm its status
BrusselsBelgiumUnknown status
Local Institution - 0092
Coordinator of this site? Confirm its status
LeuvenBelgiumUnknown status
Local Institution - 0063
Coordinator of this site? Confirm its status
HalifaxCanadaUnknown status
Local Institution - 0024
Coordinator of this site? Confirm its status
KelownaCanadaUnknown status
Local Institution - 0095
Coordinator of this site? Confirm its status
QuébecCanadaUnknown status
Local Institution - 0070
Coordinator of this site? Confirm its status
TorontoCanadaUnknown status
Local Institution - 0055
Coordinator of this site? Confirm its status
Trois-RivièresCanadaUnknown status
Local Institution - 0002
Coordinator of this site? Confirm its status
RancaguaChileUnknown status
Local Institution - 0080
Coordinator of this site? Confirm its status
SantiagoChileUnknown status
Local Institution - 0079
Coordinator of this site? Confirm its status
SantiagoChileUnknown status
Local Institution - 0001
Coordinator of this site? Confirm its status
Viña del MarChileUnknown status
Local Institution - 0031
Coordinator of this site? Confirm its status
BrnoCzechiaUnknown status
Local Institution - 0030
Coordinator of this site? Confirm its status
OlomoucCzechiaUnknown status
Local Institution - 0083
Coordinator of this site? Confirm its status
CologneGermanyUnknown status
Local Institution - 0082
Coordinator of this site? Confirm its status
DresdenGermanyUnknown status
Local Institution - 0017
Coordinator of this site? Confirm its status
EssenGermanyUnknown status
Local Institution - 0081
Coordinator of this site? Confirm its status
EssenGermanyUnknown status
Local Institution - 0014
Coordinator of this site? Confirm its status
FrankfurtGermanyUnknown status
Local Institution - 0018
Coordinator of this site? Confirm its status
HamburgGermanyUnknown status
Local Institution - 0012
Coordinator of this site? Confirm its status
HanoverGermanyUnknown status
Local Institution - 0013
Coordinator of this site? Confirm its status
HeidelbergGermanyUnknown status
Local Institution - 0015
Coordinator of this site? Confirm its status
MannheimGermanyUnknown status
Local Institution - 0016
Coordinator of this site? Confirm its status
MarburgGermanyUnknown status
Local Institution - 0099
Coordinator of this site? Confirm its status
BadajozSpainUnknown status
Local Institution - 0061
Coordinator of this site? Confirm its status
BarcelonaSpainUnknown status
Local Institution - 0098
Coordinator of this site? Confirm its status
BarcelonaSpainUnknown status
Local Institution - 0059
Coordinator of this site? Confirm its status
BilbaoSpainUnknown status
Local Institution - 0058
Coordinator of this site? Confirm its status
MadridSpainUnknown status
Local Institution - 0057
Coordinator of this site? Confirm its status
MadridSpainUnknown status
Local Institution - 0060
Coordinator of this site? Confirm its status
ZaragozaSpainUnknown status
Local Institution - 0047
Coordinator of this site? Confirm its status
AvignonFranceUnknown status
Local Institution - 0073
Coordinator of this site? Confirm its status
BesançonFranceUnknown status
Local Institution - 0045
Coordinator of this site? Confirm its status
DijonFranceUnknown status
Local Institution - 0071
Coordinator of this site? Confirm its status
MontpellierFranceUnknown status
Local Institution - 0043
Coordinator of this site? Confirm its status
ParisFranceUnknown status
Local Institution - 0072
Coordinator of this site? Confirm its status
ParisFranceUnknown status
Local Institution - 0046
Coordinator of this site? Confirm its status
RouenFranceUnknown status
Local Institution - 0032
Coordinator of this site? Confirm its status
CoventryUnited KingdomUnknown status
Local Institution - 0036
Coordinator of this site? Confirm its status
LancasterUnited KingdomUnknown status
Local Institution - 0034
Coordinator of this site? Confirm its status
LondonUnited KingdomUnknown status
Local Institution - 0075
Coordinator of this site? Confirm its status
ManchesterUnited KingdomUnknown status
Local Institution - 0069
Coordinator of this site? Confirm its status
NorthwoodUnited KingdomUnknown status
Local Institution - 0035
Coordinator of this site? Confirm its status
NottinghamUnited KingdomUnknown status
Local Institution - 0033
Coordinator of this site? Confirm its status
SouthamptonUnited KingdomUnknown status
IRCCS Istituto Nazionale Tumori Milano
Coordinator of this site? Confirm its status
MilanItalyUnknown status
Local Institution - 0020
Coordinator of this site? Confirm its status
MilanItalyUnknown status
Local Institution - 0021
Coordinator of this site? Confirm its status
RomaItalyUnknown status
Local Institution - 0088
Coordinator of this site? Confirm its status
BergenNorwayUnknown status
Local Institution - 0086
Coordinator of this site? Confirm its status
OsloNorwayUnknown status
Local Institution - 0087
Coordinator of this site? Confirm its status
TrondheimNorwayUnknown status
Local Institution - 0093
Coordinator of this site? Confirm its status
WarsawPolandUnknown status
Local Institution - 0067
Coordinator of this site? Confirm its status
San JuanPuerto RicoUnknown status
Local Institution - 0038
Coordinator of this site? Confirm its status
SingaporeSingaporeUnknown status
Local Institution - 0056
Coordinator of this site? Confirm its status
AuroraUnited StatesUnknown status
Local Institution - 0049
Coordinator of this site? Confirm its status
ClovisUnited StatesUnknown status
Local Institution - 0054
Coordinator of this site? Confirm its status
DallasUnited StatesUnknown status
Local Institution - 0064
Coordinator of this site? Confirm its status
DuarteUnited StatesUnknown status
Local Institution - 0050
Coordinator of this site? Confirm its status
HackensackUnited StatesUnknown status
Scripps Clinic
Coordinator of this site? Confirm its status
La JollaUnited StatesUnknown status
Local Institution - 0040
Coordinator of this site? Confirm its status
Los AngelesUnited StatesUnknown status
Local Institution - 0062
Coordinator of this site? Confirm its status
New HavenUnited StatesUnknown status
Hoag Memorial Hospital Presbyterian
Coordinator of this site? Confirm its status
Newport BeachUnited StatesUnknown status
Local Institution - 0041
Coordinator of this site? Confirm its status
OrangeUnited StatesUnknown status
Virginia Cancer Institute
Coordinator of this site? Confirm its status
RichmondUnited StatesUnknown status
Local Institution - 0077
Coordinator of this site? Confirm its status
Santa MonicaUnited StatesUnknown status
Local Institution - 0052
Coordinator of this site? Confirm its status
SeattleUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.