An Investigational Immuno-therapy Study of Nivolumab or Placebo in Participants With Resected Esophageal or Gastroesophageal Junction Cancer (CheckMate 577)

• ClinicalTrials.gov Identifier: NCT02743494
• Recruitment Status: Active, not recruiting
• First Posted: April 19, 2016
• Results First Posted: June 22, 2021
• Last Update Posted: September 18, 2023
• Sponsor: Bristol-Myers Squibb
• Collaborator: Ono Pharmaceutical Co. Ltd
• Information provided by (Responsible Party): Bristol-Myers Squibb

Tracking Information

• First Submitted Date: April 15, 2016
• First Posted Date: April 19, 2016
• Results First Submitted Date: May 6, 2021
• Results First Posted Date: June 22, 2021
• Last Update Posted Date: September 18, 2023
• Actual Study Start Date: July 14, 2016
• Actual Primary Completion Date: May 12, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 28, 2021)

Disease-free Survival (DFS) [ Time Frame: From randomization to the date of recurrence or death (up to approximately 46 months) ]

Disease-free survival is defined as the time between randomization date and first date of recurrence or death, whichever occurs first. Recurrence is defined as the appearance of one or more new lesions, which can be local, regional, or distant in location from the primary resected site ( assessed by imaging or pathology). All deaths without prior recurrence are considered as DFS events. For participants who remained alive and without recurrence, DFS was censured on the date of last evaluable disease assessment

Original Primary Outcome Measures (submitted: April 18, 2016)

• Disease-Free Survival of adjuvant nivolumab in subjects with resected esophageal cancer or gastroesophageal junction cancer who have received chemoradiotherapy followed by surgery [ Time Frame: Approximately 29 months after the first subject is randomized ]
• Overall Survival of adjuvant nivolumab in subjects with resected esophageal cancer or gastroesophageal junction cancer who have received chemoradiotherapy followed by surgery [ Time Frame: Approximately 42 months after the first subject is randomized ]

Current Secondary Outcome Measures (submitted: May 28, 2021)

• Overall Survival (OS) [ Time Frame: From randomization to the date of death (up to approximately 46 months) ]
  Overall survival is defined as the time from randomization to the date of death from any cause. For subjects that are alive, their survival time was censored at the date of last contact date (or "last known alive date"). Overall survival was censored at the date of randomization for subjects who were randomized but had no follow-up.
• Overall Survival Rate [ Time Frame: From randomization to 1, 2 and 3 years later ]
  Overall survival rate is defined as the percentage of participants who are alive at 1, 2 and 3 years following randomization

• Original Secondary Outcome Measures (submitted: April 18, 2016): Overall survival rate [ Time Frame: Overall survival rate at 1, 2, and 3 years ]
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: An Investigational Immuno-therapy Study of Nivolumab or Placebo in Participants With Resected Esophageal or Gastroesophageal Junction Cancer
• Official Title: A Randomized, Multicenter, Double Blind, Phase III Study of Adjuvant Nivolumab or Placebo in Subjects With Resected Esophageal, or Gastroesophageal Junction Cancer
• Brief Summary: The primary purpose of this study is to determine whether Nivolumab will improve disease-free survival compared with placebo.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Advanced Cancer

Intervention

• Drug: Nivolumab
  Specified dose on specified days
• Other: Placebo
  Specified dose on specified days

Study Arms

• Experimental: Nivolumab
  Intervention: Drug: Nivolumab
• Placebo Comparator: Placebo
  Intervention: Other: Placebo

• Publications *: Kelly RJ, Ajani JA, Kuzdzal J, Zander T, Van Cutsem E, Piessen G, Mendez G, Feliciano J, Motoyama S, Lievre A, Uronis H, Elimova E, Grootscholten C, Geboes K, Zafar S, Snow S, Ko AH, Feeney K, Schenker M, Kocon P, Zhang J, Zhu L, Lei M, Singh P, Kondo K, Cleary JM, Moehler M; CheckMate 577 Investigators. Adjuvant Nivolumab in Resected Esophageal or Gastroesophageal Junction Cancer. N Engl J Med. 2021 Apr 1;384(13):1191-1203. doi: 10.1056/NEJMoa2032125. Erratum In: N Engl J Med. 2023 Feb 16;388(7):672.

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: April 30, 2021): 794
• Original Estimated Enrollment (submitted: April 18, 2016): 760
• Estimated Study Completion Date: October 11, 2025
• Actual Primary Completion Date: May 12, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Diagnosed with Stage II/III carcinoma of the esophagus or gastroesophageal junction
• Completed pre-operative chemo radiotherapy followed by surgery
• Diagnosed with residual pathologic disease after being surgically rendered free of disease with negative margins following complete resection

Exclusion Criteria:

• Diagnosed with cervical esophageal carcinoma
• Diagnosed with Stage IV resectable disease
• Did not receive concurrent chemoradiotherapy prior to surgery
• Participants who have received a live/attenuated vaccine within 30 days of the first treatment

Other protocol defined Inclusion/exclusion criteria could apply

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Argentina, Australia, Belgium, Brazil, Canada, China, Czechia, Denmark, France, Germany, Hong Kong, Hungary, Ireland, Israel, Italy, Japan, Korea, Republic of, Mexico, Netherlands, Peru, Poland, Puerto Rico, Romania, Russian Federation, Singapore, Spain, Switzerland, Taiwan, Turkey, United Kingdom, United States
• Removed Location Countries: Czech Republic

Administrative Information

• NCT Number: NCT02743494
• Other Study ID Numbers: CA209-577; 2015-005556-10 ( EudraCT Number )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Bristol-Myers Squibb
• Original Responsible Party: Same as current
• Current Study Sponsor: Bristol-Myers Squibb
• Original Study Sponsor: Same as current
• Collaborators: Ono Pharmaceutical Co. Ltd

Investigators

• Study Director: Bristol-Myers Squibb; Bristol-Myers Squibb

• PRS Account: Bristol-Myers Squibb
• Verification Date: September 2023