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Closed (no longer recruiting)Last updated: 7 February 2024

CheckMate76K: This phase III trial will assess an adjuvant immunotherapy in children and adults who have completed surgery for Stage IIB/C melanoma and have a high risk of their cancer coming backA Phase 3, Randomized, Double-Blind Study of Adjuvant Immunotherapy With Nivolumab Versus Placebo After Complete Resection of Stage IIB/C Melanoma

Clinical summary

Summary

Eligible patients will be randomised to receive nivolumab or a placebo-equivalent on specified days in a treatment cycle.

Conditions

This trial is treating patients with melanoma.

Cancer

Skin Cancers Skin

Age

People12+

Phase

III

Trial Acronym

CheckMate76K

More information

Trial Identifiers

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Trial sponsor

Bristol-Myers Squibb (BMS)

Scientific Title

A Phase 3, Randomized, Double-Blind Study of Adjuvant Immunotherapy With Nivolumab Versus Placebo After Complete Resection of Stage IIB/C Melanoma

Eligibility

Inclusion

  • 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

  • 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.

Inclusion

  • Your cancer has not spread to other parts of the body.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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