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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03662659




Registration number
NCT03662659
Ethics application status
Date submitted
6/09/2018
Date registered
7/09/2018
Date last updated
30/06/2020

Titles & IDs
Public title
An Investigational Study of Immunotherapy Combinations With Chemotherapy in Patients With Gastric or Gastroesophageal Junction (GEJ) Cancers
Scientific 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
Secondary ID [1] 0 0
2018-001069-18
Secondary ID [2] 0 0
CA224-060
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastric Cancer 0 0
Cancer of the Stomach 0 0
Esophagogastric Junction 0 0
Condition category
Condition code
Cancer 0 0 0 0
Stomach

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - BMS-986213
Other interventions - Nivolumab
Treatment: Drugs - XELOX
Treatment: Drugs - FOLFOX
Treatment: Drugs - SOX

Experimental: BMS-986213 + investigator's choice chemotherapy - BMS-986213 + XELOX or BMS-986213 + FOLFOX or BMS-986213 + SOX

Experimental: Nivolumab + investigator's choice chemotherapy - Nivolumab + XELOX or Nivolumab + FOLFOX or Nivolumab + SOX


Other interventions: BMS-986213
Relatlimab + Nivolumab specified dose on specified days

Other interventions: Nivolumab
Specified dose on specified days

Treatment: Drugs: XELOX
Oxaliplatin + capecitabine

Treatment: Drugs: FOLFOX
Oxaliplatin + leucovorin + fluorouracil

Treatment: Drugs: SOX
Oxaliplatin + tegafur/gimeracil/oteracil potassium

Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Objective Response Rate (ORR)
Timepoint [1] 0 0
Up to 22 months
Secondary outcome [1] 0 0
Incidence of Adverse Events (AEs)
Timepoint [1] 0 0
Up to 5 years
Secondary outcome [2] 0 0
Incidence of Serious Adverse Events (SAEs)
Timepoint [2] 0 0
Up to 5 years
Secondary outcome [3] 0 0
Incidence of AEs leading to discontinuation
Timepoint [3] 0 0
Up to 5 years
Secondary outcome [4] 0 0
Incidence of death
Timepoint [4] 0 0
Up to 5 years
Secondary outcome [5] 0 0
Incidence of laboratory abnormalities
Timepoint [5] 0 0
Up to 5 years
Secondary outcome [6] 0 0
Duration of Response (DOR)
Timepoint [6] 0 0
Up to 5 years
Secondary outcome [7] 0 0
Overall survival (OS)
Timepoint [7] 0 0
Up to 5 years
Secondary outcome [8] 0 0
Progression Free Survival (PFS)
Timepoint [8] 0 0
Up to 5 years

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



- 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - Westmead
Recruitment hospital [2] 0 0
Local Institution - Herston
Recruitment hospital [3] 0 0
Local Institution - Heidelberg
Recruitment hospital [4] 0 0
Local Institution - Malvern
Recruitment hospital [5] 0 0
St John of God Murdoch Hospital - Murdoch
Recruitment hospital [6] 0 0
Local Institution - Bedford Park
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
4029 - Herston
Recruitment postcode(s) [3] 0 0
3084 - Heidelberg
Recruitment postcode(s) [4] 0 0
3144 - Malvern
Recruitment postcode(s) [5] 0 0
6150 - Murdoch
Recruitment postcode(s) [6] 0 0
5024 - Bedford Park
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
New Jersey
Country [5] 0 0
United States of America
State/province [5] 0 0
Texas
Country [6] 0 0
United States of America
State/province [6] 0 0
Virginia
Country [7] 0 0
United States of America
State/province [7] 0 0
Washington
Country [8] 0 0
Argentina
State/province [8] 0 0
Buenos Aires
Country [9] 0 0
Argentina
State/province [9] 0 0
Caba
Country [10] 0 0
Argentina
State/province [10] 0 0
Tucuman
Country [11] 0 0
Austria
State/province [11] 0 0
Graz
Country [12] 0 0
Austria
State/province [12] 0 0
Wien
Country [13] 0 0
Belgium
State/province [13] 0 0
Bruxelles
Country [14] 0 0
Belgium
State/province [14] 0 0
Leuven
Country [15] 0 0
Canada
State/province [15] 0 0
British Columbia
Country [16] 0 0
Canada
State/province [16] 0 0
Nova Scotia
Country [17] 0 0
Canada
State/province [17] 0 0
Ontario
Country [18] 0 0
Canada
State/province [18] 0 0
Quebec
Country [19] 0 0
Chile
State/province [19] 0 0
L.g.bernardoohiggins
Country [20] 0 0
Chile
State/province [20] 0 0
Metropolitana
Country [21] 0 0
Chile
State/province [21] 0 0
Valparaiso
Country [22] 0 0
Chile
State/province [22] 0 0
Santiago
Country [23] 0 0
Czechia
State/province [23] 0 0
Brno
Country [24] 0 0
Czechia
State/province [24] 0 0
Olomouc
Country [25] 0 0
France
State/province [25] 0 0
Avignon Cedex 9
Country [26] 0 0
France
State/province [26] 0 0
Besancon Cedex
Country [27] 0 0
France
State/province [27] 0 0
Dijon
Country [28] 0 0
France
State/province [28] 0 0
Montpellier
Country [29] 0 0
France
State/province [29] 0 0
Paris
Country [30] 0 0
France
State/province [30] 0 0
Rouen Cedex
Country [31] 0 0
Germany
State/province [31] 0 0
Cologne
Country [32] 0 0
Germany
State/province [32] 0 0
Dresden
Country [33] 0 0
Germany
State/province [33] 0 0
Essen
Country [34] 0 0
Germany
State/province [34] 0 0
Frankfurt
Country [35] 0 0
Germany
State/province [35] 0 0
Hamburg
Country [36] 0 0
Germany
State/province [36] 0 0
Hannover
Country [37] 0 0
Germany
State/province [37] 0 0
Heidelberg
Country [38] 0 0
Germany
State/province [38] 0 0
Mannheim
Country [39] 0 0
Germany
State/province [39] 0 0
Marburg
Country [40] 0 0
Italy
State/province [40] 0 0
Milano
Country [41] 0 0
Italy
State/province [41] 0 0
Roma
Country [42] 0 0
Norway
State/province [42] 0 0
Bergen
Country [43] 0 0
Norway
State/province [43] 0 0
Oslo
Country [44] 0 0
Norway
State/province [44] 0 0
Trondheim
Country [45] 0 0
Poland
State/province [45] 0 0
Warszawa
Country [46] 0 0
Puerto Rico
State/province [46] 0 0
San Juan
Country [47] 0 0
Singapore
State/province [47] 0 0
Singapore
Country [48] 0 0
Spain
State/province [48] 0 0
Badajoz
Country [49] 0 0
Spain
State/province [49] 0 0
Barcelona
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Spain
State/province [50] 0 0
Bilbao
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Spain
State/province [51] 0 0
Madrid
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Spain
State/province [52] 0 0
Zaragoza
Country [53] 0 0
United Kingdom
State/province [53] 0 0
Greater Manchester
Country [54] 0 0
United Kingdom
State/province [54] 0 0
Nottinghamshire
Country [55] 0 0
United Kingdom
State/province [55] 0 0
WEST Midlands
Country [56] 0 0
United Kingdom
State/province [56] 0 0
Lancaster
Country [57] 0 0
United Kingdom
State/province [57] 0 0
London
Country [58] 0 0
United Kingdom
State/province [58] 0 0
Northwood
Country [59] 0 0
United Kingdom
State/province [59] 0 0
Southampton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT03662659
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications