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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02872116
Ethics application status
Date submitted
16/08/2016
Date registered
19/08/2016
Date last updated
12/07/2024

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
Esophageal Adenocarcinoma 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) in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy With PD-L1 CPS = 5
Timepoint [1] 0 0
From the date of randomization up to the date of death, up to approximately 17 months
Primary outcome [2] 0 0
Progression Free Survival (PFS) in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy With PD-L1 CPS = 5
Timepoint [2] 0 0
From randomization to the date of the first documented progressive disease (PD) per BICR or death due to any cause (up to approximately 10 months)
Secondary outcome [1] 0 0
OS in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy
Timepoint [1] 0 0
From the date of randomization up to the date of death, up to approximately 17 months
Secondary outcome [2] 0 0
PFS in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy
Timepoint [2] 0 0
From randomization to the date of the first documented progressive disease (PD) per BICR or death due to any cause (up to approximately 10 months)
Secondary outcome [3] 0 0
Objective Response Rate
Timepoint [3] 0 0
From randomization to the date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first (up to approximately 43 months)
Secondary outcome [4] 0 0
OS in Participants Treated With Nivolumab Plus Ipilimumab vs Chemotherapy
Timepoint [4] 0 0
From the date of randomization up to the date of death, up to approximately 14 months
Secondary outcome [5] 0 0
Time to Symptom Deterioration (TTSD)
Timepoint [5] 0 0
From randomization until a clinically meaningful decline from baseline in GaCS score
Secondary outcome [6] 0 0
PFS in Participants Treated With Nivolumab Plus Ipilimumab vs Chemotherapy
Timepoint [6] 0 0
From randomization to the date of the first documented progressive disease (PD) per BICR or death due to any cause (up to approximately 9 months)

Eligibility
Key inclusion criteria
* 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
Sex
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 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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/10/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
6/06/2024
Sample size
Target
Accrual to date
Final
2031
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - 0202 - Blacktown
Recruitment hospital [2] 0 0
Local Institution - 0100 - Gosford
Recruitment hospital [3] 0 0
Local Institution - 0190 - Southport
Recruitment hospital [4] 0 0
Local Institution - 0101 - Adelaide
Recruitment hospital [5] 0 0
Local Institution - 0103 - Ballarat
Recruitment hospital [6] 0 0
Local Institution - 0102 - Shepparton
Recruitment hospital [7] 0 0
Local Institution - 0214 - St Albans
Recruitment hospital [8] 0 0
Local Institution - 0099 - 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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Texas
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Virginia
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Argentina
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Buenos Aires
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RIO Negro
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Tucuman
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Cordoba
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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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Brazil
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Sao Paulo
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Santiago
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Bogota
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Essen
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Freiburg
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Hamburg
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Muenchen
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Attikí
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Athens
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Ioannina
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Patras
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Jerusalem
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Ramat-gan
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Aichi
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Portugal
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Lisboa
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Porto
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Dolj
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Jud Maramures
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Bucharest
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Cluj-Napoca
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Suceava
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Russian Federation
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Chelyabinsk
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Moscow
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Russian Federation
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St. Petersburg
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Central 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 County
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Turkey
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Ankara
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Turkey
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Antalya
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Turkey
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Diyarbakir
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Turkey
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Edrine
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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/study/NCT02872116
Trial related presentations / publications
Janjigian YY, Shitara K, Moehler M, Garrido M, Salman P, Shen L, Wyrwicz L, Yamaguchi K, Skoczylas T, Campos Bragagnoli A, Liu T, Schenker M, Yanez P, Tehfe M, Kowalyszyn R, Karamouzis MV, Bruges R, Zander T, Pazo-Cid R, Hitre E, Feeney K, Cleary JM, Poulart V, Cullen D, Lei M, Xiao H, Kondo K, Li M, Ajani JA. First-line nivolumab plus chemotherapy versus chemotherapy alone for advanced gastric, gastro-oesophageal junction, and oesophageal adenocarcinoma (CheckMate 649): a randomised, open-label, phase 3 trial. Lancet. 2021 Jul 3;398(10294):27-40. doi: 10.1016/S0140-6736(21)00797-2. Epub 2021 Jun 5.
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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02872116