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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02872116




Registration number
NCT02872116
Ethics application status
Date submitted
16/08/2016
Date registered
19/08/2016
Date last updated
4/07/2019

Titles & IDs
Public title
Efficacy Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Against Chemotherapy in Stomach Cancer or Stomach/Esophagus Junction Cancer
Scientific title
A Randomized, Multicenter, Open-Label, Phase 3 Study of Nivolumab Plus Ipilimumab or Nivolumab in Combination With Oxaliplatin Plus Fluoropyrimidine Versus Oxaliplatin Plus Fluoropyrimidine in Subjects With Previously Untreated Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer
Secondary ID [1] 0 0
2016-001018-76
Secondary ID [2] 0 0
CA209-649
Universal Trial Number (UTN)
Trial acronym
CheckMate649
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastric Cancer 0 0
Gastroesophageal Junction Cancer 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Nivolumab
Treatment: Drugs - Ipilimumab
Treatment: Drugs - Oxaliplatin
Treatment: Drugs - Capecitabine
Treatment: Drugs - Leucovorin
Treatment: Drugs - Fluorouracil

Experimental: Nivolumab + Ipilimumab - Nivolumab + Ipilimumab for 4 doses, followed by Nivolumab monotherapy
Enrollment is closed for this arm

Active Comparator: XELOX (Oxaliplatin + Capecitabine) -

Active Comparator: FOLFOX (Oxaliplatin + Leucovorin + Fluorouracil) -

Experimental: Nivolumab + XELOX -

Experimental: Nivolumab + FOLFOX -


Treatment: Drugs: Nivolumab
Specified dose on specified days

Treatment: Drugs: Ipilimumab
Specified dose on specified days

Treatment: Drugs: Oxaliplatin
Specified dose on specified days

Treatment: Drugs: Capecitabine
Specified dose on specified days

Treatment: Drugs: Leucovorin
Specified dose on specified days

Treatment: Drugs: Fluorouracil
Specified dose on specified days

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

Outcomes
Primary outcome [1] 0 0
Overall survival (OS) of nivolumab in combination with oxaliplatin + fluoropyrimidine versus oxaliplatin + fluoropyrimidine in programmed cell death ligand 1 (PD-L1) positive participants
Timepoint [1] 0 0
Up to 53 months after the first participant is randomized
Primary outcome [2] 0 0
Progression-free survival (PFS), as assessed by Blinded Independent Central Review (BICR), of nivolumab in combination with oxaliplatin + fluoropyrimidine versus oxaliplatin + fluoropyrimidine in PD-L1 positive participants
Timepoint [2] 0 0
Up to 53 months after the first participant is randomized
Secondary outcome [1] 0 0
OS in all randomized participants
Timepoint [1] 0 0
Up to 53 months after the first participant is randomized
Secondary outcome [2] 0 0
PFS, as assessed by BICR, in all randomized participants
Timepoint [2] 0 0
Up to 53 months after the first participant is randomized
Secondary outcome [3] 0 0
Objective Response Rate (ORR), as assessed by BICR, in all randomized participants
Timepoint [3] 0 0
Up to 53 months after the first participant is randomized
Secondary outcome [4] 0 0
Time to symptom deterioration (TTSD) of nivolumab + ipilimumab vs oxaliplatin + fluoropyrimidine in all randomized participants - Time to Symptom Deterioration assessed with Gastric Cancer Subscale questionnaire
Timepoint [4] 0 0
Up to 53 months after the first participant is randomized

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



- Male or Female at least 18 years of age

- Must have gastric cancer or gastroesophageal junction cancer that cannot be operated
on and that is advanced or has spread out

- Did not receive neoadjuvant or adjuvant treatment (chemotherapy, radiotherapy, or
both) for their disease within the last 6 months

- Must have full activity or, if limited, must be able to walk and carry out light
activities such as light house work or office work

- Must agree to provide tumor tissue sample, either from a previous surgery or biopsy
within 6 months or fresh, prior to the start of treatment in this study
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Presence of tumor cells in the brain or spinal cord that have not been treated

- Active known or suspected autoimmune disease

- Any serious or uncontrolled medical disorder or active infection

- Known history of positive test for human immunodeficiency virus (HIV) or known
acquired immunodeficiency syndrome (AIDS)

- Any positive test result for hepatitis B or C indicating acute or chronic infection

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 3
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,SA,VIC,WA
Recruitment hospital [1] 0 0
Blacktown Hospital - Blacktown
Recruitment hospital [2] 0 0
Gosford Hospital - Gosford
Recruitment hospital [3] 0 0
Tasman Oncology Research Pty Ltd - Southport
Recruitment hospital [4] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [5] 0 0
Ballarat Base Hospital - Ballarat
Recruitment hospital [6] 0 0
Goulburn Valley Health - Shepparton
Recruitment hospital [7] 0 0
Sunshine Hospital - St Albans
Recruitment hospital [8] 0 0
St John of God Murdoch Hospital - Perth
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment postcode(s) [2] 0 0
2250 - Gosford
Recruitment postcode(s) [3] 0 0
4215 - Southport
Recruitment postcode(s) [4] 0 0
5000 - Adelaide
Recruitment postcode(s) [5] 0 0
3350 - Ballarat
Recruitment postcode(s) [6] 0 0
3630 - Shepparton
Recruitment postcode(s) [7] 0 0
3021 - St Albans
Recruitment postcode(s) [8] 0 0
6150 - Perth
Recruitment outside Australia
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United States of America
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California
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Colorado
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District of Columbia
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Maryland
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Massachusetts
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New York
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Oregon
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Pennsylvania
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Tennessee
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Texas
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Virginia
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Argentina
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Buenos Aires
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Argentina
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RIO Negro
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Argentina
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Tucuman
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Argentina
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Caba
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Argentina
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Cordoba
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Argentina
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La Rioja
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Brazil
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Bahia
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Brazil
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SAO Paulo
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Sao Paulo
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Montreal
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Araucania
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Chile
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Chile
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Jilin
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Zhejiang
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Hangzhou
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China
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Tianjin
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Colombia
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Bogota
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Caen
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Lille
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Nantes
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Nice Cedex 2
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Paris
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Plerin
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Essen
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Freiburg
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Hamburg
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Germany
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Mainz
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Germany
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Muenchen
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Greece
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Athens
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Greece
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Ioannina
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Greece
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Nea Kifissia
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Greece
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Patras
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Hong Kong
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Budapest
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Debrecen
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Haifa
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Jerusalem
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Petach Tikva
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Ramat-gan
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Tel Aviv
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Bergamo
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Pisa
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Italy
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Roma
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Italy
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San Giovanni Rotondo
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Japan
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Aichi
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Chiba
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Hokkaido
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Osaka
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Lublin
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Craiova
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Moscow
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Russian Federation
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St. Petersburg
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Singapore
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Singapore
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Spain
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Badajoz
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Spain
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Badalona-barcelona
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Spain
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Barcelona
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Spain
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Pozuelo De Alarcon, Madrid
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Spain
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Valencia
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Spain
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Zaragoza
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Taiwan
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Tainan
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Taiwan
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Taipei
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Taiwan
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Taoyuan
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Turkey
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Ankara
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Antalya
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Turkey
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Diyarbak?r
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Turkey
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Edrine
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Turkey
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Istanbul
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United Kingdom
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Greater London
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United Kingdom
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Greater Manchester
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United Kingdom
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Nottinghamshire
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United Kingdom
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Surrey
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United Kingdom
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Southampton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bristol-Myers Squibb
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Ono Pharmaceutical Co. Ltd
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The main purpose of this study is to compare how long patients with gastric or
gastroesophageal junction cancer live after receiving nivolumab and ipilimumab or nivolumab
and chemotherapy compared with patients receiving chemotherapy alone.
Trial website
https://clinicaltrials.gov/show/NCT02872116
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