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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 : September 2, 2022
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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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.

Condition or disease Intervention/treatment Phase
Melanoma Biological: Nivolumab Other: Placebo Phase 3

Expanded Access : An investigational treatment associated with this study has been approved for sale to the public.   More info ...

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 790 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-Blind Study of Adjuvant Immunotherapy With Nivolumab Versus Placebo After Complete Resection of Stage IIB/C Melanoma
Actual Study Start Date : October 28, 2019
Estimated Primary Completion Date : November 11, 2022
Estimated Study Completion Date : December 27, 2025

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma
Drug Information available for: Nivolumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Nivolumab Biological: Nivolumab
Specified dose on specified days
Other Name: Opdivo
Placebo Comparator: Placebo Other: Placebo
Specified dose on specified days


Outcome Measures
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Primary Outcome Measures :
  1. Recurrence-Free Survival (RFS) [ Time Frame: Approximately 68 months ]

Secondary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: Up to 7 years ]
  2. 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 ]
  3. Severity of AEs as defined by NCI CTCAE v5 [ Time Frame: Up to 5 years ]
  4. Distant Metastases-Free Survival (DMFS) [ Time Frame: Up to 7 years ]
  5. 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 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 apply.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04099251


Locations
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Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT04099251    
Other Study ID Numbers: CA209-76K
2019-001230-34 ( EudraCT Number )
U1111-1229-8927 ( Other Identifier: UTN Number )
First Posted: September 23, 2019    Key Record Dates
Last Update Posted: September 2, 2022
Last Verified: September 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
 Nevi and Melanomas
Nivolumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action