Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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
Query!
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
Query!
Secondary ID [1]
0
0
2018-001069-18
Query!
Secondary ID [2]
0
0
CA224-060
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Gastric Cancer
0
0
Query!
Cancer of the Stomach
0
0
Query!
Esophagogastric Junction
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Stomach
Query!
Intervention/exposure
Study type
Interventional
Query!
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
Query!
Intervention code [1]
0
0
Other interventions
Query!
Intervention code [2]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
BICR-Assessed Objective Response Rate (ORR) in Randomized LAG-3 Positive (>=1 %) Participants
Query!
Assessment method [1]
0
0
The number of LAG-3 Positive (>=1%) participants with a Best Overall Response (BOR) of confirmed Complete Response (CR) or Partial Response (PR) divided by the number of randomized LAG-3 positive (>=1%) participants in each arm; recorded between randomization date and the date of objectively documented progression [per RECISIT 1.1], death due to any cause, or date of subsequent anticancer therapy, whichever occurs first.
CR= Disappearance of all target lesions PR= At least a 30% decrease in the sum of diameters of target lesions
Query!
Timepoint [1]
0
0
Up to 25 months
Query!
Secondary outcome [1]
0
0
Objective Response Rate (ORR)
Query!
Assessment method [1]
0
0
Objective response rate (ORR) based on Blinded Independent Central Review (BICR) and Investigator assessments is defined as the number of participants with a Best Overall Response (BOR) of confirmed Complete Response (CR) or Partial Response (PR) divided by the number of randomized participants in each arm; recorded between randomization date and the date of objectively documented progression [per RECISIT 1.1], death due to any cause, or date of subsequent anticancer therapy, whichever occurs first.
Query!
Timepoint [1]
0
0
Up to 25 months
Query!
Secondary outcome [2]
0
0
Duration of Response (DOR)
Query!
Assessment method [2]
0
0
Duration of Response (DOR) based on Blinded Independent Central Review (BICR) and investigator is defined as the time between the date of first documented response (complete response or partial response) and the date of the first disease progression, per RECIST 1.1, or death due to any cause, or date of subsequent anticancer therapy, whichever occurs first.
Query!
Timepoint [2]
0
0
Up to 25 months
Query!
Secondary outcome [3]
0
0
Overall Survival (OS)
Query!
Assessment method [3]
0
0
Overall Survival (OS) is defined as the time between the date of randomization and the date of death due to any cause. For those without documentation of death, OS will be censored on the last date the participant was known to be alive.
Query!
Timepoint [3]
0
0
Up to 25 months
Query!
Secondary outcome [4]
0
0
Progression-Free Survival (PFS)
Query!
Assessment method [4]
0
0
Progression-Free Survival (PFS) per Blinded Independent Central Review (BICR) and Investigator is defined as the time between the date of randomization and the first date of documented progression, or death due to any cause, or date of subsequent anticancer therapy, whichever occurs first. Participants who die without a reported prior progression (and die without start of subsequent therapy) will be considered to have progressed on the date of death.
Query!
Timepoint [4]
0
0
Up to 25 months
Query!
Secondary outcome [5]
0
0
Number of Participants With Adverse Events (AEs)
Query!
Assessment method [5]
0
0
Number of participants with any grade adverse events (AEs), serious adverse events (SAE), and adverse events leading to discontinuation using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v 5.0) to assess the overall safety and tolerability of BMS-986213 in combination with chemotherapy vs. Nivolumab in combination with chemotherapy.
Query!
Timepoint [5]
0
0
From first dose to 30 days post last dose (Up to 23 months)
Query!
Secondary outcome [6]
0
0
Number of Deaths
Query!
Assessment method [6]
0
0
Number of deaths in each arm to assess the overall safety and tolerability of BMS-986213 in combination with chemotherapy vs. Nivolumab in combination with chemotherapy.
Query!
Timepoint [6]
0
0
Up to 25 months
Query!
Secondary outcome [7]
0
0
Number of Participants With Laboratory Abnormalities in Specific Liver Tests
Query!
Assessment method [7]
0
0
Number of participants with laboratory abnormalities in specific liver tests based on US conventional units to assess the overall safety and tolerability of BMS-986213 in combination with chemotherapy vs. Nivolumab in combination with chemotherapy. The number of participants with the following laboratory abnormalities from on-treatment evaluations will be summarized:
ALT or AST > 3 x ULN, > 5 x ULN, > 10 x ULN and > 20 x ULN
Total bilirubin > 2 x ULN
ALP > 1.5 x ULN
Concurrent (within 1 day) ALT or AST > 3 x ULN and total bilirubin > 1.5 x ULN
Concurrent (within 30 days) ALT or AST > 3 x ULN and total bilirubin > 1.5 x ULN
Concurrent (within 1 day) ALT or AST > 3 x ULN and total bilirubin > 2 x ULN
Concurrent (within 30 days) ALT or AST > 3 x ULN and total bilirubin > 2 x ULN
Query!
Timepoint [7]
0
0
From first dose to up to 30 days post last dose (Up to 23 months)
Query!
Secondary outcome [8]
0
0
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
Query!
Assessment method [8]
0
0
Number of participants with laboratory abnormalities in specific thyroid tests based on US conventional units. The number of participants with the following laboratory abnormalities from on-treatment evaluations will be summarized:
TSH value > ULN and
with baseline TSH value <= ULN
with at least one FT3/FT4 test value < LLN within 2-week window after the abnormal TSH test
with all FT3/FT4 test values >= LLN within 2-week window after the abnormal TSH test
with FT3/FT4 missing within 2-week window after the abnormal TSH test.
TSH < LLN and
with baseline TSH value >= LLN
with at least one FT3/FT4 test value > ULN within 2-week window after the abnormal TSH test
with all FT3/FT4 test values <= ULN within 2-week window after the abnormal TSH test
with FT3/FT4 missing within 2-week window after the abnormal TSH test
Query!
Timepoint [8]
0
0
From first dose to up to 30 days post last dose (Up to 23 months)
Query!
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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 2
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
16/10/2018
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
18/01/2024
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
274
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Query!
Recruitment hospital [1]
0
0
Local Institution - 0027 - Westmead
Query!
Recruitment hospital [2]
0
0
Local Institution - 0007 - Herston
Query!
Recruitment hospital [3]
0
0
Local Institution - 0003 - Heidelberg
Query!
Recruitment hospital [4]
0
0
Local Institution - 0029 - Malvern
Query!
Recruitment hospital [5]
0
0
Local Institution - 0008 - Shepparton
Query!
Recruitment hospital [6]
0
0
Local Institution - 0005 - Murdoch
Query!
Recruitment hospital [7]
0
0
Local Institution - 0028 - Bedford Park
Query!
Recruitment postcode(s) [1]
0
0
2145 - Westmead
Query!
Recruitment postcode(s) [2]
0
0
4029 - Herston
Query!
Recruitment postcode(s) [3]
0
0
3084 - Heidelberg
Query!
Recruitment postcode(s) [4]
0
0
3144 - Malvern
Query!
Recruitment postcode(s) [5]
0
0
3630 - Shepparton
Query!
Recruitment postcode(s) [6]
0
0
6150 - Murdoch
Query!
Recruitment postcode(s) [7]
0
0
5024 - Bedford Park
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
California
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Colorado
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Connecticut
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
New Jersey
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Texas
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Virginia
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Washington
Query!
Country [8]
0
0
Argentina
Query!
State/province [8]
0
0
Buenos Aires
Query!
Country [9]
0
0
Argentina
Query!
State/province [9]
0
0
Ciudad Autónoma De Buenos Aires
Query!
Country [10]
0
0
Argentina
Query!
State/province [10]
0
0
Tucumán
Query!
Country [11]
0
0
Argentina
Query!
State/province [11]
0
0
Caba
Query!
Country [12]
0
0
Austria
Query!
State/province [12]
0
0
Graz
Query!
Country [13]
0
0
Austria
Query!
State/province [13]
0
0
Wien
Query!
Country [14]
0
0
Belgium
Query!
State/province [14]
0
0
Bruxelles
Query!
Country [15]
0
0
Belgium
Query!
State/province [15]
0
0
Leuven
Query!
Country [16]
0
0
Canada
Query!
State/province [16]
0
0
British Columbia
Query!
Country [17]
0
0
Canada
Query!
State/province [17]
0
0
Nova Scotia
Query!
Country [18]
0
0
Canada
Query!
State/province [18]
0
0
Ontario
Query!
Country [19]
0
0
Canada
Query!
State/province [19]
0
0
Quebec
Query!
Country [20]
0
0
Chile
Query!
State/province [20]
0
0
L.g.bernardoohiggins
Query!
Country [21]
0
0
Chile
Query!
State/province [21]
0
0
Metropolitana
Query!
Country [22]
0
0
Chile
Query!
State/province [22]
0
0
Valparaiso
Query!
Country [23]
0
0
Chile
Query!
State/province [23]
0
0
Santiago
Query!
Country [24]
0
0
Czechia
Query!
State/province [24]
0
0
Brno
Query!
Country [25]
0
0
Czechia
Query!
State/province [25]
0
0
Olomouc
Query!
Country [26]
0
0
France
Query!
State/province [26]
0
0
Avignon Cedex 9
Query!
Country [27]
0
0
France
Query!
State/province [27]
0
0
Besancon Cedex
Query!
Country [28]
0
0
France
Query!
State/province [28]
0
0
Dijon
Query!
Country [29]
0
0
France
Query!
State/province [29]
0
0
Montpellier
Query!
Country [30]
0
0
France
Query!
State/province [30]
0
0
Paris
Query!
Country [31]
0
0
France
Query!
State/province [31]
0
0
Rouen Cedex
Query!
Country [32]
0
0
Germany
Query!
State/province [32]
0
0
Cologne
Query!
Country [33]
0
0
Germany
Query!
State/province [33]
0
0
Dresden
Query!
Country [34]
0
0
Germany
Query!
State/province [34]
0
0
Essen
Query!
Country [35]
0
0
Germany
Query!
State/province [35]
0
0
Frankfurt
Query!
Country [36]
0
0
Germany
Query!
State/province [36]
0
0
Hamburg
Query!
Country [37]
0
0
Germany
Query!
State/province [37]
0
0
Hannover
Query!
Country [38]
0
0
Germany
Query!
State/province [38]
0
0
Heidelberg
Query!
Country [39]
0
0
Germany
Query!
State/province [39]
0
0
Mannheim
Query!
Country [40]
0
0
Germany
Query!
State/province [40]
0
0
Marburg
Query!
Country [41]
0
0
Italy
Query!
State/province [41]
0
0
Milano
Query!
Country [42]
0
0
Italy
Query!
State/province [42]
0
0
Milan
Query!
Country [43]
0
0
Italy
Query!
State/province [43]
0
0
Roma
Query!
Country [44]
0
0
Norway
Query!
State/province [44]
0
0
Bergen
Query!
Country [45]
0
0
Norway
Query!
State/province [45]
0
0
Oslo
Query!
Country [46]
0
0
Norway
Query!
State/province [46]
0
0
Trondheim
Query!
Country [47]
0
0
Poland
Query!
State/province [47]
0
0
Warszawa
Query!
Country [48]
0
0
Puerto Rico
Query!
State/province [48]
0
0
San Juan
Query!
Country [49]
0
0
Singapore
Query!
State/province [49]
0
0
Singapore
Query!
Country [50]
0
0
Spain
Query!
State/province [50]
0
0
M
Query!
Country [51]
0
0
Spain
Query!
State/province [51]
0
0
Badajoz
Query!
Country [52]
0
0
Spain
Query!
State/province [52]
0
0
Barcelona
Query!
Country [53]
0
0
Spain
Query!
State/province [53]
0
0
Bilbao
Query!
Country [54]
0
0
Spain
Query!
State/province [54]
0
0
Madrid
Query!
Country [55]
0
0
Spain
Query!
State/province [55]
0
0
Zaragoza
Query!
Country [56]
0
0
United Kingdom
Query!
State/province [56]
0
0
Greater Manchester
Query!
Country [57]
0
0
United Kingdom
Query!
State/province [57]
0
0
Nottinghamshire
Query!
Country [58]
0
0
United Kingdom
Query!
State/province [58]
0
0
West Midlands
Query!
Country [59]
0
0
United Kingdom
Query!
State/province [59]
0
0
Lancaster
Query!
Country [60]
0
0
United Kingdom
Query!
State/province [60]
0
0
London
Query!
Country [61]
0
0
United Kingdom
Query!
State/province [61]
0
0
Northwood
Query!
Country [62]
0
0
United Kingdom
Query!
State/province [62]
0
0
Southampton
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Bristol-Myers Squibb
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT03662659
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Bristol-Myers Squibb
Query!
Address
0
0
Bristol-Myers Squibb
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03662659
Download to PDF