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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)

Status and phase

Active, not recruiting
Phase 3

Conditions

Melanoma

Treatments

Other: Placebo
Biological: Nivolumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT04099251
2019-001230-34 (EudraCT Number)
U1111-1229-8927 (Other Identifier)
CA209-76K

Details and patient eligibility

About

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.

Enrollment

790 patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

790 participants in 2 patient groups, including a placebo group

Nivolumab
Experimental group
Treatment:
Biological: Nivolumab
Placebo
Placebo Comparator group
Treatment:
Other: Placebo

Trial contacts and locations

129

There are currently no registered sites for this trial.

Timeline

Last updated: Nov 14, 2023

Start date

Oct 28, 2019 • 5 years ago

End date

Jun 28, 2022 • 2 years ago

Results posted

View

Jul 27, 2023 • 1 year and 5 months ago

Today

Dec 30, 2024

Sponsor of this trial

Data sourced from clinicaltrials.gov