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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)

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ClinicalTrials.gov Identifier: NCT04099251
Recruitment Status : Recruiting
First Posted : September 23, 2019
Last Update Posted : December 6, 2019
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 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 25, 2019
Estimated Primary Completion Date : January 1, 2024
Estimated Study Completion Date : January 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma
Drug Information available for: Nivolumab

Arm Intervention/treatment
Experimental: Nivolumab
specified dose on specified days
Biological: Nivolumab
specified dose on specified days
Other Name: Opdivo

Placebo Comparator: Placebo
placebo equivalent specified dose on specified days
Other: Placebo
Matched placebo specified dose on specified days




Primary Outcome Measures :
  1. Recurrence-Free Survival (RFS) [ Time Frame: approxiatemately 51 months ]
  2. Number of other safety biomarkers [ Time Frame: Up to 5 years ]

Secondary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: Up to 5 years ]
  2. Number of Participants with Serious Adverse Events (SAEs) [ Time Frame: Up to 5 years ]
  3. Number of Participants with Adverse Events (AEs) [ Time Frame: Up to 5 years ]
  4. Distant Metastases-Free Survival (DMFS) [ Time Frame: Up to 5 years ]
  5. Objective Response Rates (ORR) [ Time Frame: Up to 5 years ]
  6. 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 ]
  7. Incidence of change in Vital Signs [ Time Frame: Up to 5 years ]
  8. Incidence of change in Electrocardiograms (ECGs) [ Time Frame: Up to 5 years ]
  9. Incidence of change in biomarkers [ Time Frame: Up to 5 years ]
  10. Incidence of change in clinical laboratory values [ Time Frame: Up to 5 years ]


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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
  • 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

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.

Other protocol defined inclusion/exclusion criteria could apply.


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


Contacts
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Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT # and Site #.

  Show 126 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT04099251     History of Changes
Other Study ID Numbers: CA209-76K
2019-001230-34 ( EudraCT Number )
First Posted: September 23, 2019    Key Record Dates
Last Update Posted: December 6, 2019
Last Verified: December 2019

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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