Eine randomisierte, doppelblinde Phase-3-Studie zu adjuvanter Immuntherapie mit einer Fixdosiskombination aus Nivolumab plus Relatlimab versus Nivolumab allein nach Komplettresektion von Melanomen des Stadiums III-IV (RELATIVITY-098)

Biological: Nivolumab;Biological: Nivolumab + Relatlimab Fixed Dose Combination

Gender: All
Maximum age: N/A
Minimum age: 12 Years

Inclusion Criteria:

- Must have been diagnosed with either Stage IIIA (> 1 mm tumor in lymph node)/B/C/D or
Stage IV melanoma by American Joint Committee on Cancer (AJCC) v8 and have
histologically confirmed melanoma that is completely surgically resected (free of
disease) with negative margins in order to be eligible

- Participants = 18 years of age must have an Eastern Cooperative Oncology Group (ECOG)
performance status of = 1. Adolescent participants between 12 and < 18 years of age
must have a Lansky/Karnofsky performance score = 80%

- Complete resection must be performed within 90 days prior to randomization

- All participants must have disease-free status documented by a complete physical
examination within 14 days prior to randomization and imaging studies within 35 days
prior to randomization

- Tumor tissue must be provided for biomarker analyses

Exclusion Criteria:

- History of ocular melanoma

- Untreated/unresected CNS metastases or leptomeningeal metastases

- Active, known, or suspected autoimmune disease

- Participants with serious or uncontrolled medical disorder

- Prior immunotherapy treatment for any prior malignancy: No prior immunotherapies are
permitted

- Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 4 weeks
prior to screening

- History of myocarditis, regardless of etiology.

Other protocol-defined inclusion/exclusion criteria apply