Efficacy Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Against Chemotherapy in Stomach Cancer or Stomach/Esophagus Junction Cancer

• Register: ClinicalTrials.gov
• Last refreshed on: 11 December 2023
• Main ID: NCT02872116
• Date of registration: 16/08/2016
• Prospective Registration: Yes
• Primary sponsor: Bristol-Myers Squibb
• Public title: Efficacy Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Against Chemotherapy in Stomach Cancer or Stomach/Esophagus Junction Cancer CheckMate649
• 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
• Date of first enrolment: October 12, 2016
• Target sample size: 2031
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT02872116
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Czech Republic, Czechia, France, Germany, Greece, Hong Kong, Hungary, Israel, Italy, Japan, Korea, Republic of, Mexico, Peru, Poland, Portugal, Romania, Russian Federation, Singapore, Spain, Taiwan, Turkey, United Kingdom, United States

Contacts

• Name: Bristol-Myers Squibb
• Affiliation: Bristol-Myers Squibb

Key inclusion & exclusion criteria

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

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Gastric Cancer

Gastroesophageal Junction Cancer

Esophageal Adenocarcinoma

Intervention(s)

Drug: Capecitabine

Drug: Fluorouracil

Drug: Ipilimumab

Drug: Nivolumab

Drug: Leucovorin

Drug: Oxaliplatin

Primary Outcome(s)

Overall Survival (OS) in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy With PD-L1 CPS = 5 [Time Frame: From the date of randomization up to the date of death, up to approximately 17 months]

Progression Free Survival (PFS) in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy With PD-L1 CPS = 5 [Time Frame: 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(s)

Objective Response Rate [Time Frame: 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)]

PFS in Participants Treated With Nivolumab Plus Ipilimumab vs Chemotherapy [Time Frame: 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)]

OS in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy [Time Frame: From the date of randomization up to the date of death, up to approximately 17 months]

OS in Participants Treated With Nivolumab Plus Ipilimumab vs Chemotherapy [Time Frame: From the date of randomization up to the date of death, up to approximately 14 months]

PFS in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy [Time Frame: 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)]

Time to Symptom Deterioration (TTSD) [Time Frame: From randomization until a clinically meaningful decline from baseline in GaCS score]

Secondary ID(s)

2016-001018-76

CA209-649

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ono Pharmaceutical Co. Ltd

Results

• Results available: Yes
• Date Posted: 28/06/2022
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02872116