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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03704077




Registration number
NCT03704077
Ethics application status
Date submitted
9/10/2018
Date registered
12/10/2018

Titles & IDs
Public title
An Investigational Immuno-therapy Study of Relatlimab Plus Nivolumab Compared to Various Standard-of-Care Therapies in Previously Treated Participants With Recurrent, Advanced or Metastatic Gastric Cancer or Gastroesophageal Junction Adenocarcinoma
Scientific title
A Randomized, Active-Controlled, Open-Label, Phase 2 Clinical Trial of BMS-986213, in Combination With Various Standard-of-Care Therapeutic Regimens, in Participants With Recurrent, Locally Advanced, or Metastatic Gastric Cancer (GC) or Gastroesophageal Junction (GEJ) Adenocarcinoma
Secondary ID [1] 0 0
2018-001070-20
Secondary ID [2] 0 0
CA224-061
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
Stomach Cancer 0 0
Gastroesophageal 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 - Relatlimab + Nivolumab
Treatment: Other - Nivolumab
Treatment: Drugs - Paclitaxel
Treatment: Drugs - Ramucirumab

Experimental: Cohort A: relatlimab + nivolumab + paclitaxel -

Experimental: Cohort A: nivolumab + paclitaxel -

Active comparator: Cohort A: ramucirumab + paclitaxel - Standard-of-care

Experimental: Cohort B: relatlimab + nivolumab -

Active comparator: Cohort B: nivolumab - Standard-of-care

Experimental: Cohort C: relatlimab + nivolumab -


Treatment: Other: Relatlimab + Nivolumab
Specified dose on specified days

Treatment: Other: Nivolumab
Specified dose on specified days

Treatment: Drugs: Paclitaxel
Specified dose on specified days

Treatment: Drugs: Ramucirumab
Specified dose on specified days
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
Overall response rate (ORR)
Timepoint [1] 0 0
Approximately 31 months
Secondary outcome [1] 0 0
Incidence of adverse events (AEs)
Timepoint [1] 0 0
Approximately 5 years
Secondary outcome [2] 0 0
Incidence of serious adverse events (SAEs)
Timepoint [2] 0 0
Approximately 5 years
Secondary outcome [3] 0 0
Incidence of AEs leading to discontinuation
Timepoint [3] 0 0
Approximately 5 years
Secondary outcome [4] 0 0
Incidence of deaths
Timepoint [4] 0 0
Approximately 5 years
Secondary outcome [5] 0 0
Incidence of laboratory abnormalities
Timepoint [5] 0 0
Approximately 5 years
Secondary outcome [6] 0 0
ORR
Timepoint [6] 0 0
Approximately 5 years
Secondary outcome [7] 0 0
Duration of response (DOR)
Timepoint [7] 0 0
Approximately 5 years
Secondary outcome [8] 0 0
Progression free survival (PFS)
Timepoint [8] 0 0
Approximately 5 years
Secondary outcome [9] 0 0
Overall survival (OS)
Timepoint [9] 0 0
Approximately 5 years

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



* Histologically or cytologically confirmed locally advanced or recurrent or metastatic GC or GEJ adenocarcinoma that is considered incurable by local therapies such as radiation or surgery
* Evidence of progressive disease (PD) on at least one prior platinum- and fluoropyrimidine-containing chemotherapy regimen
* Available tumor tissue for biomarker analysis
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Must not have squamous cell or undifferentiated GC or GEJ
* Untreated known 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
Withdrawn
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
31/10/2019
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/09/2024
Actual
Sample size
Target
Accrual to date
Final
0
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Local Institution - Westmead
Recruitment hospital [2] 0 0
Local Institution - Heidelberg
Recruitment hospital [3] 0 0
Local Institution - Malvern
Recruitment hospital [4] 0 0
Local Institution - Melbourne
Recruitment hospital [5] 0 0
Local Institution - Bedford Park
Recruitment hospital [6] 0 0
Local Institution - Murdoch
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
3084 - Heidelberg
Recruitment postcode(s) [3] 0 0
3144 - Malvern
Recruitment postcode(s) [4] 0 0
3000 - Melbourne
Recruitment postcode(s) [5] 0 0
5024 - Bedford Park
Recruitment postcode(s) [6] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Massachusetts
Country [7] 0 0
United States of America
State/province [7] 0 0
Missouri
Country [8] 0 0
United States of America
State/province [8] 0 0
New Jersey
Country [9] 0 0
United States of America
State/province [9] 0 0
North Carolina
Country [10] 0 0
United States of America
State/province [10] 0 0
North Dakota
Country [11] 0 0
United States of America
State/province [11] 0 0
Pennsylvania
Country [12] 0 0
United States of America
State/province [12] 0 0
South Dakota
Country [13] 0 0
United States of America
State/province [13] 0 0
Washington
Country [14] 0 0
Argentina
State/province [14] 0 0
RIO Negro
Country [15] 0 0
Argentina
State/province [15] 0 0
Buenos Aires
Country [16] 0 0
Argentina
State/province [16] 0 0
Caba
Country [17] 0 0
Argentina
State/province [17] 0 0
Ciudad Autonoma de Buenos Aires
Country [18] 0 0
Argentina
State/province [18] 0 0
Cordoba
Country [19] 0 0
Brazil
State/province [19] 0 0
Ceara
Country [20] 0 0
Brazil
State/province [20] 0 0
Minas Gerais
Country [21] 0 0
Brazil
State/province [21] 0 0
RIO Grande DO SUL
Country [22] 0 0
Brazil
State/province [22] 0 0
SAO Paulo
Country [23] 0 0
Brazil
State/province [23] 0 0
Rio de Janeiro
Country [24] 0 0
Brazil
State/province [24] 0 0
Sao Paulo
Country [25] 0 0
Canada
State/province [25] 0 0
Nova Scotia
Country [26] 0 0
Canada
State/province [26] 0 0
Ontario
Country [27] 0 0
Canada
State/province [27] 0 0
Quebec
Country [28] 0 0
Chile
State/province [28] 0 0
Metropolitana
Country [29] 0 0
Colombia
State/province [29] 0 0
Medellin
Country [30] 0 0
Germany
State/province [30] 0 0
Berlin
Country [31] 0 0
Germany
State/province [31] 0 0
Cologne
Country [32] 0 0
Germany
State/province [32] 0 0
Erlangen
Country [33] 0 0
Germany
State/province [33] 0 0
Essen
Country [34] 0 0
Germany
State/province [34] 0 0
Frankfurt am Main
Country [35] 0 0
Germany
State/province [35] 0 0
Freiburg
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
Jena
Country [39] 0 0
Germany
State/province [39] 0 0
Mainz
Country [40] 0 0
Germany
State/province [40] 0 0
Mannheim
Country [41] 0 0
Germany
State/province [41] 0 0
Marburg
Country [42] 0 0
Germany
State/province [42] 0 0
Paderborn
Country [43] 0 0
Germany
State/province [43] 0 0
Reutlingen
Country [44] 0 0
Germany
State/province [44] 0 0
Wiesbaden
Country [45] 0 0
Italy
State/province [45] 0 0
Bergamo
Country [46] 0 0
Italy
State/province [46] 0 0
Milano
Country [47] 0 0
Italy
State/province [47] 0 0
Napoli
Country [48] 0 0
Italy
State/province [48] 0 0
Reggio Emilia
Country [49] 0 0
Mexico
State/province [49] 0 0
Chiapas
Country [50] 0 0
Mexico
State/province [50] 0 0
Distrito Federal
Country [51] 0 0
Mexico
State/province [51] 0 0
Guanajuato
Country [52] 0 0
Mexico
State/province [52] 0 0
Yucatan
Country [53] 0 0
Mexico
State/province [53] 0 0
Aguascalientes
Country [54] 0 0
Portugal
State/province [54] 0 0
Lisboa
Country [55] 0 0
Portugal
State/province [55] 0 0
Porto
Country [56] 0 0
Puerto Rico
State/province [56] 0 0
Rio Piedras
Country [57] 0 0
Romania
State/province [57] 0 0
Bucuresti
Country [58] 0 0
Romania
State/province [58] 0 0
Cluj-Napoca
Country [59] 0 0
Romania
State/province [59] 0 0
Craiova
Country [60] 0 0
Romania
State/province [60] 0 0
Floresti
Country [61] 0 0
Spain
State/province [61] 0 0
Badajoz
Country [62] 0 0
Spain
State/province [62] 0 0
Madrid
Country [63] 0 0
Spain
State/province [63] 0 0
Valencia

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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual patient level data from this study may be shared with qualified researchers, upon request, following the timelines and process detailed on https://www.bms.com/researchers-and-partners/independent-research/data-sharing-request-process.html
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03704077