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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03662659
Ethics application status
Date submitted
6/09/2018
Date registered
7/09/2018
Date last updated
13/02/2024

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
Treatment: Other - BMS-986213
Treatment: Other - 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


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

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

Outcomes
Primary outcome [1] 0 0
BICR-Assessed Objective Response Rate (ORR) in Randomized LAG-3 Positive (>=1 %) Participants
Timepoint [1] 0 0
Up to 25 months
Secondary outcome [1] 0 0
Objective Response Rate (ORR)
Timepoint [1] 0 0
Up to 25 months
Secondary outcome [2] 0 0
Duration of Response (DOR)
Timepoint [2] 0 0
Up to 25 months
Secondary outcome [3] 0 0
Overall Survival (OS)
Timepoint [3] 0 0
Up to 25 months
Secondary outcome [4] 0 0
Progression-Free Survival (PFS)
Timepoint [4] 0 0
Up to 25 months
Secondary outcome [5] 0 0
Number of Participants With Adverse Events (AEs)
Timepoint [5] 0 0
From first dose to 30 days post last dose (Up to 23 months)
Secondary outcome [6] 0 0
Number of Deaths
Timepoint [6] 0 0
Up to 25 months
Secondary outcome [7] 0 0
Number of Participants With Laboratory Abnormalities in Specific Liver Tests
Timepoint [7] 0 0
From first dose to up to 30 days post last dose (Up to 23 months)
Secondary outcome [8] 0 0
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
Timepoint [8] 0 0
From first dose to up to 30 days post last dose (Up to 23 months)

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
Sex
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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/10/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
18/01/2024
Sample size
Target
Accrual to date
Final
274
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - 0027 - Westmead
Recruitment hospital [2] 0 0
Local Institution - 0007 - Herston
Recruitment hospital [3] 0 0
Local Institution - 0003 - Heidelberg
Recruitment hospital [4] 0 0
Local Institution - 0029 - Malvern
Recruitment hospital [5] 0 0
Local Institution - 0008 - Shepparton
Recruitment hospital [6] 0 0
Local Institution - 0005 - Murdoch
Recruitment hospital [7] 0 0
Local Institution - 0028 - 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
3630 - Shepparton
Recruitment postcode(s) [6] 0 0
6150 - Murdoch
Recruitment postcode(s) [7] 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
Ciudad Autónoma De Buenos Aires
Country [10] 0 0
Argentina
State/province [10] 0 0
Tucumán
Country [11] 0 0
Argentina
State/province [11] 0 0
Caba
Country [12] 0 0
Austria
State/province [12] 0 0
Graz
Country [13] 0 0
Austria
State/province [13] 0 0
Wien
Country [14] 0 0
Belgium
State/province [14] 0 0
Bruxelles
Country [15] 0 0
Belgium
State/province [15] 0 0
Leuven
Country [16] 0 0
Canada
State/province [16] 0 0
British Columbia
Country [17] 0 0
Canada
State/province [17] 0 0
Nova Scotia
Country [18] 0 0
Canada
State/province [18] 0 0
Ontario
Country [19] 0 0
Canada
State/province [19] 0 0
Quebec
Country [20] 0 0
Chile
State/province [20] 0 0
L.g.bernardoohiggins
Country [21] 0 0
Chile
State/province [21] 0 0
Metropolitana
Country [22] 0 0
Chile
State/province [22] 0 0
Valparaiso
Country [23] 0 0
Chile
State/province [23] 0 0
Santiago
Country [24] 0 0
Czechia
State/province [24] 0 0
Brno
Country [25] 0 0
Czechia
State/province [25] 0 0
Olomouc
Country [26] 0 0
France
State/province [26] 0 0
Avignon Cedex 9
Country [27] 0 0
France
State/province [27] 0 0
Besancon Cedex
Country [28] 0 0
France
State/province [28] 0 0
Dijon
Country [29] 0 0
France
State/province [29] 0 0
Montpellier
Country [30] 0 0
France
State/province [30] 0 0
Paris
Country [31] 0 0
France
State/province [31] 0 0
Rouen Cedex
Country [32] 0 0
Germany
State/province [32] 0 0
Cologne
Country [33] 0 0
Germany
State/province [33] 0 0
Dresden
Country [34] 0 0
Germany
State/province [34] 0 0
Essen
Country [35] 0 0
Germany
State/province [35] 0 0
Frankfurt
Country [36] 0 0
Germany
State/province [36] 0 0
Hamburg
Country [37] 0 0
Germany
State/province [37] 0 0
Hannover
Country [38] 0 0
Germany
State/province [38] 0 0
Heidelberg
Country [39] 0 0
Germany
State/province [39] 0 0
Mannheim
Country [40] 0 0
Germany
State/province [40] 0 0
Marburg
Country [41] 0 0
Italy
State/province [41] 0 0
Milano
Country [42] 0 0
Italy
State/province [42] 0 0
Milan
Country [43] 0 0
Italy
State/province [43] 0 0
Roma
Country [44] 0 0
Norway
State/province [44] 0 0
Bergen
Country [45] 0 0
Norway
State/province [45] 0 0
Oslo
Country [46] 0 0
Norway
State/province [46] 0 0
Trondheim
Country [47] 0 0
Poland
State/province [47] 0 0
Warszawa
Country [48] 0 0
Puerto Rico
State/province [48] 0 0
San Juan
Country [49] 0 0
Singapore
State/province [49] 0 0
Singapore
Country [50] 0 0
Spain
State/province [50] 0 0
M
Country [51] 0 0
Spain
State/province [51] 0 0
Badajoz
Country [52] 0 0
Spain
State/province [52] 0 0
Barcelona
Country [53] 0 0
Spain
State/province [53] 0 0
Bilbao
Country [54] 0 0
Spain
State/province [54] 0 0
Madrid
Country [55] 0 0
Spain
State/province [55] 0 0
Zaragoza
Country [56] 0 0
United Kingdom
State/province [56] 0 0
Greater Manchester
Country [57] 0 0
United Kingdom
State/province [57] 0 0
Nottinghamshire
Country [58] 0 0
United Kingdom
State/province [58] 0 0
West Midlands
Country [59] 0 0
United Kingdom
State/province [59] 0 0
Lancaster
Country [60] 0 0
United Kingdom
State/province [60] 0 0
London
Country [61] 0 0
United Kingdom
State/province [61] 0 0
Northwood
Country [62] 0 0
United Kingdom
State/province [62] 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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT03662659