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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02872116
Registration number
NCT02872116
Ethics application status
Date submitted
16/08/2016
Date registered
19/08/2016
Date last updated
4/12/2023
Titles & IDs
Public title
Efficacy Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Against Chemotherapy in Stomach Cancer or Stomach/Esophagus Junction Cancer
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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
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Secondary ID [1]
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2016-001018-76
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Secondary ID [2]
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CA209-649
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Universal Trial Number (UTN)
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Trial acronym
CheckMate649
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Gastric Cancer
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Gastroesophageal Junction Cancer
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Esophageal Adenocarcinoma
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Overall Survival (OS) in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy With PD-L1 CPS = 5
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Assessment method [1]
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Overall survival (OS), defined as the time from randomization to the time of death, in participants treated with Nivolumab plus Chemotherapy vs Chemotherapy with PD-L1 CPS (combined positive score) = 5. CPS is defined as the number of PD-L1 staining cells (tumor cells, lymphocytes, macrophages) divided by the total number of viable tumor cells, multiplied by 100.
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Timepoint [1]
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From the date of randomization up to the date of death, up to approximately 17 months
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Primary outcome [2]
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Progression Free Survival (PFS) in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy With PD-L1 CPS = 5
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Assessment method [2]
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Progression Free Survival (PFS) is defined as the time from randomization to the date of the first documented PD or death due to any cause. PD is determined by blinded independent committee review (BICR) per RECIST1.1 criteria in participants treated with Nivolumab plus Chemotherapy vs Chemotherapy with PD-L1 CPS = 5. Progressive disease (PD) is defined as at least a 20% increase in the sum of diameters of target lesions, taking in reference the smallest sum on study that also demonstrated an absolute increase of at least 5 mm. CPS is defined as the number of PD-L1 staining cells (tumor cells, lymphocytes, macrophages) divided by the total number of viable tumor cells, multiplied by 100.
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Timepoint [2]
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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)
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Secondary outcome [1]
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OS in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy
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Assessment method [1]
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Overall survival (OS), defined as the time from randomization to the time of death, in participants treated with Nivolumab plus Chemotherapy vs Chemotherapy with PD-L1 CPS = 1, 10, and all randomized participants. CPS is defined as the number of PD-L1 staining cells (tumor cells, lymphocytes, macrophages) divided by the total number of viable tumor cells, multiplied by 100.
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Timepoint [1]
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From the date of randomization up to the date of death, up to approximately 17 months
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Secondary outcome [2]
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PFS in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy
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Assessment method [2]
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Progression free survival (PFS), defined as the time from randomization to the date of the first documented progressive disease (PD) or death due to any cause, in participants treated with Nivolumab plus Chemotherapy vs Chemotherapy by BICR per RECIST1.1 in participants with PD-L1 CPS = 10, 1, or all randomized subjects. Progreessive disease (PD) is defined as at least a 20% increase in the sum of diameters of target lesions, taking in reference the smallest sum on study that also demonstrated an absolute increase of at least 5 mm. CPS is defined as the number of PD-L1 staining cells (tumor cells, lymphocytes, macrophages) divided by the total number of viable tumor cells, multiplied by 100.
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Timepoint [2]
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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)
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Secondary outcome [3]
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Objective Response Rate
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Assessment method [3]
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Objective response rate (ORR) as assessed by BICR in participants with PD-L1 CPS = 10, 5, 1, or all randomized participants. ORR is a percentage of participants determined by the number of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of measurable participants with target lesion at baseline. BOR is defined as the best response designation as determined by the BICR, recorded between the date of randomization and the date of objectively documented progression (per RECIST 1.1 as determined by the BICR) or the date of subsequent anti-cancer therapy, whichever occurs first. CR is defined as the disappearance of all target lesions. PR is define as at 30% decrease in the sum of diameters of target lesions. The 806 chemotherapy treated participants are split into two separate arms (Arm 2a and Arm 2b) to act as comparison groups to the other treatment arms.
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Timepoint [3]
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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)
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Secondary outcome [4]
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OS in Participants Treated With Nivolumab Plus Ipilimumab vs Chemotherapy
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Assessment method [4]
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Overall survival (OS), defined as the time from randomization to the time of death, in participants treated with Nivolumab plus Ipilimumab vs Chemotherapy with PD-L1 CPS (combined positive score) = 1, 5, 10, and all randomized participants. CPS is defined as the number of PD-L1 staining cells (tumor cells, lymphocytes, macrophages) divided by the total number of viable tumor cells, multiplied by 100.
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Timepoint [4]
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From the date of randomization up to the date of death, up to approximately 14 months
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Secondary outcome [5]
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Time to Symptom Deterioration (TTSD)
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Assessment method [5]
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TTSD is defined as the the time from randomization until a clinically meaningful decline from baseline in Gastric Cancer Subscale (GaCS) score. A clinically meaningful deterioration is defined as a reduction of 8.2 points in the GaCS score. Subjects who do not deteriorate will be censored at the time of their last GACS assessment. Subjects without baseline GaCS assessment will be censored on the randomization date. Those with baseline GaCS, who do not have any GaCS assessments after randomization will be censored on the day after randomization.
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Timepoint [5]
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From randomization until a clinically meaningful decline from baseline in GaCS score
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Secondary outcome [6]
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PFS in Participants Treated With Nivolumab Plus Ipilimumab vs Chemotherapy
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Assessment method [6]
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Progression Free Survival (PFS) is defined as the time from randomization to the date of the first documented PD or death due to any cause. PD is determined by blinded independent committee review (BICR) per RECIST1.1 criteria in participants treated with Nivolumab plus Ipilumab vs Chemotherapy with PD-L1 CPS = 10, 5, 1 or all randomized participants. Progressive disease (PD) is defined as at least a 20% increase in the sum of diameters of target lesions, taking in reference the smallest sum on study that also demonstrated an absolute increase of at least 5 mm. CPS is defined as the number of PD-L1 staining cells (tumor cells, lymphocytes, macrophages) divided by the total number of viable tumor cells, multiplied by 100.
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Timepoint [6]
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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)
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
12/10/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/05/2024
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Actual
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Sample size
Target
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Accrual to date
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Final
2031
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Local Institution - 0202 - Blacktown
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Local Institution - 0100 - Gosford
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Local Institution - 0190 - Southport
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Local Institution - 0101 - Adelaide
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Local Institution - 0103 - Ballarat
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Local Institution - 0102 - Shepparton
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Local Institution - 0214 - St Albans
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Local Institution - 0099 - Perth
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2148 - Blacktown
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2250 - Gosford
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4215 - Southport
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5000 - Adelaide
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3350 - Ballarat
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3630 - Shepparton
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3021 - St Albans
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Recruitment postcode(s) [8]
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6150 - Perth
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Recruitment outside Australia
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Poland
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State/province [98]
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Tarnobrzeg
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Country [99]
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Poland
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State/province [99]
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0
Warszawa
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Country [100]
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0
Portugal
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State/province [100]
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Lisboa
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Country [101]
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0
Portugal
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State/province [101]
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0
Porto
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Country [102]
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0
Romania
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State/province [102]
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0
Dolj
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Country [103]
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0
Romania
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State/province [103]
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0
Jud Maramures
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Country [104]
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Romania
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State/province [104]
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Bucharest
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Country [105]
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Romania
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State/province [105]
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Cluj-Napoca
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Country [106]
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Romania
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State/province [106]
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Suceava
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Country [107]
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0
Russian Federation
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State/province [107]
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0
Chelyabinsk
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Country [108]
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Russian Federation
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State/province [108]
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Moscow
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Country [109]
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Russian Federation
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State/province [109]
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St. Petersburg
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Country [110]
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0
Singapore
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State/province [110]
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Central Singapore
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Country [111]
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Singapore
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State/province [111]
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Singapore
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Country [112]
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0
Spain
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State/province [112]
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Badajoz
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Country [113]
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Spain
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State/province [113]
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Badalona-barcelona
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Country [114]
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Spain
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State/province [114]
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Barcelona
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Country [115]
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0
Spain
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State/province [115]
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Pozuelo De Alarcon, Madrid
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Country [116]
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Spain
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State/province [116]
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Valencia
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Country [117]
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Spain
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State/province [117]
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Zaragoza
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Country [118]
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Taiwan
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State/province [118]
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Tainan
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Country [119]
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Taiwan
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State/province [119]
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Taipei
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Country [120]
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Taiwan
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State/province [120]
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Taoyuan County
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Country [121]
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Turkey
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State/province [121]
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Ankara
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Country [122]
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Turkey
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State/province [122]
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Antalya
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Country [123]
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Turkey
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State/province [123]
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0
Diyarbakir
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Country [124]
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Turkey
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State/province [124]
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Edrine
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Country [125]
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United Kingdom
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State/province [125]
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Greater London
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Country [126]
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United Kingdom
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State/province [126]
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Greater Manchester
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Country [127]
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United Kingdom
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State/province [127]
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Nottinghamshire
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Country [128]
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United Kingdom
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State/province [128]
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Surrey
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Country [129]
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United Kingdom
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State/province [129]
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Southampton
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Bristol-Myers Squibb
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Address
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Country
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Other collaborator category [1]
0
0
Commercial sector/Industry
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Name [1]
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Ono Pharmaceutical Co. Ltd
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Address [1]
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0
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Country [1]
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0
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02872116
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Public notes
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Contacts
Principal investigator
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Bristol-Myers Squibb
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Address
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Bristol-Myers Squibb
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02872116
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