A study comparing immunotherapy combinations with chemotherapy and chemotherapy alone in participants with advanced LAG-3 positive gastric and gastroesophageal junction (GEJ) cancers

A Randomized, Active-Controlled, Blinded, Phase III Clinical Trial of BMS- 986213 (Fixed Dose Combination of Relatlimab [anti-LAG-3] and Nivolumab) in Combination with Chemotherapy versus Placebo in Combination with Chemotherapy as First-Line Treatment in Participants with Unresectable, Locally Advanced or Metastatic LAG-3 Positive Gastric or Gastroesophageal Junction Adenocarcinoma

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-004896-30-IE

Enrollment

2420

Registered

2018-04-06

Start date

2018-07-06

Completion date

Unknown

Last updated

2019-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric or Gastroesophageal Junction Adenocarcinoma MedDRA version: 20.1 Level: PT Classification code 10017758 Term: Gastric cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: LLT Classification code 10056267 Term: Gastroesophageal cancer System Organ C

Interventions

Product Name: Relatlimab/ Nivolumab 1:3 Fixed Dose Combination Product Code: BMS-986213 Pharmaceutical Form: Solution for injection/infusion INN or Prop

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Participants must have histologically- or cytologically-confirmed diagnosis of unresectable, locally advanced, or metastatic gastric or GEJ adenocarcinoma - Available tumor tissue for biomarker analysis; participants must have LAG-3 positive expression - Participants must have at least one measurable lesion or evaluable disease by CT or MRI per RECIST 1.1 criteria Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1694 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 726

Exclusion criteria

Exclusion criteria: - Participants known HER2 positive status - Participants with untreated known CNS metastases - Participants with ascites which cannot be controlled with appropriate interventions

Design outcomes

Primary

Measure	Time frame
Main Objective: - To compare OS of BMS-986213 in combination with chemotherapy with OS of chemotherapy alone in participants with unresectable, untreated, locally advanced or metastatic LAG-3 positive gastric or GEJ adenocarcinoma - To compare PFS of BMS-986213 in combination with chemotherapy with PFS of chemotherapy alone as assessed by Blinded Independent Central Review (BICR) in participants with unresectable, untreated, locally advanced or metastatic LAG-3 positive GC or GEJ adenocarcinoma ; Secondary Objective: - To assess the overall safety and tolerability of BMS-986213 in combination with chemotherapy with chemotherapy alone and in treated participants with advanced or metastatic GC or GEJ cancer tumors; - To compare objective response rate (ORR) of BMS- 986213 in combination with chemotherapy and with ORR of chemotherapy alone in randomized participants with advanced or metastatic GC or GEJ cancer, by BICR and by investigator - To estimate Duration of Response (DOR) of BMS-986213 in combination with chemotherapy and with DOR of chemotherapy alone in randomized participants with advanced or metastatic GC or GEJ cancer, by BICR and by investigator 1) unresectable, untreated, locally advanced or metastatic ; Primary end point(s): 1/ Overall survival (OS) 2/ Progression Free Survival (PFS) ; Timepoint(s) of evaluation of this end point: 1/ Up to 5 years 2/ Up to 5 years	—

Measure

Time frame

Main Objective: - To compare OS of BMS-986213 in combination with chemotherapy with OS of chemotherapy alone in participants with unresectable, untreated, locally advanced or metastatic LAG-3 positive gastric or GEJ adenocarcinoma - To compare PFS of BMS-986213 in combination with chemotherapy with PFS of chemotherapy alone as assessed by Blinded Independent Central Review (BICR) in participants with unresectable, untreated, locally advanced or metastatic LAG-3 positive GC or GEJ adenocarcinoma ; Secondary Objective: - To assess the overall safety and tolerability of BMS-986213 in combination with chemotherapy with chemotherapy alone and in treated participants with advanced or metastatic GC or GEJ cancer tumors; - To compare objective response rate (ORR) of BMS- 986213 in combination with chemotherapy and with ORR of chemotherapy alone in randomized participants with advanced or metastatic GC or GEJ cancer, by BICR and by investigator - To estimate Duration of Response (DOR) of BMS-986213 in combination with chemotherapy and with DOR of chemotherapy alone in randomized participants with advanced or metastatic GC or GEJ cancer, by BICR and by investigator 1) unresectable, untreated, locally advanced or metastatic ; Primary end point(s): 1/ Overall survival (OS) 2/ Progression Free Survival (PFS) ; Timepoint(s) of evaluation of this end point: 1/ Up to 5 years 2/ Up to 5 years

—

Secondary

Measure	Time frame
Secondary end point(s): 1/ Incidence of Adverse Events (AE) 2/ Incidence of Serious Adverse Events (SAEs) 3/ Incidence of AEs leading to discontinuation 4/ Number of deaths 5/ Incidence of laboratory abnormalities 6/ Objective Response Rate (ORR) 7/ Duration of Response (DOR) ; Timepoint(s) of evaluation of this end point: 1/ Up to 5 years 2/ Up to 5 years 3/ Up to 5 years 4/ Up to 5 years 5/ Up to 5 years 6/ Up to 5 years 7/ Up to 5 years	—

Measure

Time frame

Secondary end point(s): 1/ Incidence of Adverse Events (AE) 2/ Incidence of Serious Adverse Events (SAEs) 3/ Incidence of AEs leading to discontinuation 4/ Number of deaths 5/ Incidence of laboratory abnormalities 6/ Objective Response Rate (ORR) 7/ Duration of Response (DOR) ; Timepoint(s) of evaluation of this end point: 1/ Up to 5 years 2/ Up to 5 years 3/ Up to 5 years 4/ Up to 5 years 5/ Up to 5 years 6/ Up to 5 years 7/ Up to 5 years

—

Countries

Argentina, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Finland, France, Germany, Greece, Ireland, Israel, Italy, Japan, Korea, Republic of, Mexico, Netherlands, Norway, Poland, Romania, Russian Federation, Spain, Sweden, Taiwan, United Kingdom

Contacts

Public ContactHead of the GCT-SU

Bristol-Myers Squibb International Corporation

clinical.trials@bms.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026