A Study to Evaluate Efficacy in Subjects With Esophageal Cancer Treated With Nivolumab and Ipilimumab or Nivolumab Combined With Fluorouracil Plus Cisplatin Versus Fluorouracil Plus Cisplatin

• Register: ClinicalTrials.gov
• Last refreshed on: 11 December 2023
• Main ID: NCT03143153
• Date of registration: 04/05/2017
• Prospective Registration: Yes
• Primary sponsor: Bristol-Myers Squibb
• Public title: A Study to Evaluate Efficacy in Subjects With Esophageal Cancer Treated With Nivolumab and Ipilimumab or Nivolumab Combined With Fluorouracil Plus Cisplatin Versus Fluorouracil Plus Cisplatin CheckMate 648
• Scientific title: A Randomized Phase 3 Study of Nivolumab Plus Ipilimumab or Nivolumab Combined With Fluorouracil Plus Cisplatin Versus Fluorouracil Plus Cisplatin in Subjects With Unresectable Advanced, Recurrent or Metastatic Previously Untreated Esophageal Squamous Cell Carcinoma
• Date of first enrolment: June 29, 2017
• Target sample size: 970
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT03143153
• 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, Austria, Brazil, Canada, Chile, China, Colombia, Czechia, Denmark, France, Hong Kong, 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:

- Must have histologically confirmed squamous cell carcinoma or adenosquamous cell
carcinoma of esophagus

- Male or Female at least 18 years of age

- Must have esophageal cancer that cannot be operated on, or treated with definitive
chemoradiation with curative intent, that is advanced, reoccurring or has spread out

- 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 which are symptomatic or require
treatment

- 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
and/or detectable virus

Other protocol defined inclusion/exclusion criteria apply



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

Health Condition(s) or Problem(s) studied

Various Advanced Cancer

Intervention(s)

Biological: Nivolumab

Drug: Fluorouracil

Biological: Ipilimumab

Drug: Cisplatin

Primary Outcome(s)

Overall Survival (OS) in Participants With Tumor Cell PD-L1 [Time Frame: From the date of randomization to up to the date of death (up to approximately 20 months)]

Progression-free Survival (PFS) as Assessed by BICR in Participants With Tumor Cell PD-L1 [Time Frame: From the date of randomization to up to the date of the first documented disease progression or death (up to approximately 9 months)]

Secondary Outcome(s)

Objective Response Rate (ORR) as Assessed by BICR [Time Frame: From the date of randomization to up to the date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first (up to 40 months)]

Progression-free Survival (PFS) in All Randomized Participants as Assessed by BICR [Time Frame: From the date of randomization to up to the date of the first documented disease progression or death (up to approximately 7 months)]

Overall Survival (OS) in All Randomized Participants [Time Frame: From the date of randomization to up to the date of death (up to approximately 16 months)]

Secondary ID(s)

2016-001514-20

CA209-648

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: 02/03/2022
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03143153