Effectiveness Study of Nivolumab Compared to Placebo in Prevention of Recurrent Melanoma After Complete Resection of Stage IIB/C Melanoma (CheckMate76K)

• ClinicalTrials.gov Identifier: NCT04099251
• Recruitment Status: Active, not recruiting
• First Posted: September 23, 2019
• Last Update Posted: December 14, 2021
• Sponsor: Bristol-Myers Squibb
• Information provided by (Responsible Party): Bristol-Myers Squibb

Tracking Information

• First Submitted Date: September 20, 2019
• First Posted Date: September 23, 2019
• Last Update Posted Date: December 14, 2021
• Actual Study Start Date: October 28, 2019
• Estimated Primary Completion Date: July 1, 2025 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: June 23, 2021): Recurrence-Free Survival (RFS) [ Time Frame: Approximately 68 months ]

Original Primary Outcome Measures (submitted: September 20, 2019)

• Recurrence-Free Survival (RFS) [ Time Frame: approxiatemately 51 months ]
• Number of other safety biomarkers [ Time Frame: Up to 5 years ]

Current Secondary Outcome Measures (submitted: June 23, 2021)

• Overall survival (OS) [ Time Frame: Up to 7 years ]
• Occurrence of Adverse Events (AEs) as defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5 [ Time Frame: Up to 5 years ]
• Severity of AEs as defined by NCI CTCAE v5 [ Time Frame: Up to 5 years ]
• Distant Metastases-Free Survival (DMFS) [ Time Frame: Up to 7 years ]
• Investigator-assessed outcomes on next-line therapies [Objective response rates (if applicable), Duration of treatment on next-line therapies, Progression-Free Survival 2, End-of-next-line-treatment] [ Time Frame: Up to 7 years ]

Original Secondary Outcome Measures (submitted: September 20, 2019)

• Overall survival (OS) [ Time Frame: Up to 5 years ]
• Number of Participants with Serious Adverse Events (SAEs) [ Time Frame: Up to 5 years ]
• Number of Participants with Adverse Events (AEs) [ Time Frame: Up to 5 years ]
• Distant Metastases-Free Survival (DMFS) [ Time Frame: Up to 5 years ]
• Objective Response Rates (ORR) [ Time Frame: Up to 5 years ]
• Outcomes on Next-Line therapies (Objective response rate [if applicable], Duration of treatment on next-line therapies, Progression-Free Survival 2) [ Time Frame: Up to 5 years ]
• Incidence of change in Vital Signs [ Time Frame: Up to 5 years ]
• Incidence of change in Electrocardiograms (ECGs) [ Time Frame: Up to 5 years ]
• Incidence of change in biomarkers [ Time Frame: Up to 5 years ]
• Incidence of change in clinical laboratory values [ Time Frame: Up to 5 years ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effectiveness Study of Nivolumab Compared to Placebo in Prevention of Recurrent Melanoma After Complete Resection of Stage IIB/C Melanoma
• Official Title: A Phase 3, Randomized, Double-Blind Study of Adjuvant Immunotherapy With Nivolumab Versus Placebo After Complete Resection of Stage IIB/C Melanoma
• Brief Summary: The purpose of this study is to determine the effectiveness of nivolumab adjuvant immunotherapy compared to placebo in adults and pediatric participants after complete resection of Stage IIB/C melanoma with no evidence of disease (NED) who are at high risk for recurrence.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment
• Condition: Melanoma

Intervention

• Biological: Nivolumab
  Specified dose on specified days
  Other Name: Opdivo
• Other: Placebo
  Specified dose on specified days

Study Arms

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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: November 12, 2021): 790
• Original Estimated Enrollment (submitted: September 20, 2019): 1000
• Estimated Study Completion Date: July 3, 2026
• Estimated Primary Completion Date: July 1, 2025 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Had a negative sentinel lymph node biopsy
• Participant has not been previously treated for melanoma
• ECOG 0 or 1
• Participants must have been diagnosed with histologically confirmed, Resected, Stage IIB/C cutaneous melanoma

Exclusion Criteria:

• History of ocular or mucosal melanoma.
• Pregnant or nursing women
• Participants with active known or suspected autoimmune disease
• Known history of allergy or hypersensitivity to study drug components
• Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-CTLA-4 antibody, or agents that target IL-2 pathways, T-cell stimulators, or checkpoint pathways

Other protocol defined inclusion/exclusion criteria could apply.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 12 Years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Australia, Austria, Belgium, Canada, Czechia, Denmark, Finland, France, Germany, Greece, Italy, Netherlands, Norway, Poland, Romania, Spain, Sweden, Switzerland, United Kingdom, United States

Administrative Information

• NCT Number: NCT04099251
• Other Study ID Numbers: CA209-76K; 2019-001230-34 ( EudraCT Number ); U1111-1229-8927 ( Other Identifier: UTN 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
• Responsible Party: Bristol-Myers Squibb
• Study Sponsor: Bristol-Myers Squibb
• Collaborators: Not Provided

Investigators

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

• PRS Account: Bristol-Myers Squibb
• Verification Date: December 2021