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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04099251
Recruitment Status : Active, not recruiting
First Posted : September 23, 2019
Last Update Posted : December 14, 2021
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE September 20, 2019
First Posted Date  ICMJE September 23, 2019
Last Update Posted Date December 14, 2021
Actual Study Start Date  ICMJE October 28, 2019
Estimated Primary Completion Date July 1, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 23, 2021)
Recurrence-Free Survival (RFS) [ Time Frame: Approximately 68 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 20, 2019)
  • Recurrence-Free Survival (RFS) [ Time Frame: approxiatemately 51 months ]
  • Number of other safety biomarkers [ Time Frame: Up to 5 years ]
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE Effectiveness Study of Nivolumab Compared to Placebo in Prevention of Recurrent Melanoma After Complete Resection of Stage IIB/C Melanoma
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Melanoma
Intervention  ICMJE
  • Biological: Nivolumab
    Specified dose on specified days
    Other Name: Opdivo
  • Other: Placebo
    Specified dose on specified days
Study Arms  ICMJE
  • Experimental: Nivolumab
    Intervention: Biological: Nivolumab
  • Placebo Comparator: Placebo
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: November 12, 2021)
790
Original Estimated Enrollment  ICMJE
 (submitted: September 20, 2019)
1000
Estimated Study Completion Date  ICMJE July 3, 2026
Estimated Primary Completion Date July 1, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Austria,   Belgium,   Canada,   Czechia,   Denmark,   Finland,   France,   Germany,   Greece,   Italy,   Netherlands,   Norway,   Poland,   Romania,   Spain,   Sweden,   Switzerland,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04099251
Other Study ID Numbers  ICMJE 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  ICMJE Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date December 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP