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 |
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Recruitment Status :
Active, not recruiting
First Posted : September 23, 2019
Last Update Posted : March 13, 2023
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Sponsor:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
- Study Details
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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 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 |
| Actual Primary Completion Date : | June 28, 2022 |
| Estimated Study Completion Date : | June 29, 2027 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Melanoma
MedlinePlus related topics:
Melanoma
Drug Information available for:
Nivolumab
| 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 |
Primary Outcome Measures :
- Recurrence-Free Survival (RFS) [ Time Frame: Approximately 68 months ]
Secondary Outcome Measures :
- 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 ]
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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.
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
Show 135 study locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Additional Information:
| 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: | March 13, 2023 |
| Last Verified: | March 2023 |
| 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 |