Dr. Marcus Butler
Key Inclusion Criteria:
1. All patients must be either stage IIB, IIC, III, or stage IV per American Joint
Committee on Cancer (AJCC) 8th edition and have histologically confirmed melanoma
that is completely surgically resected in order to be eligible as defined by the
protocol
2. Complete surgical resection must be performed within 12 weeks prior to
randomization, and enrollment may occur only after satisfactory wound healing from
the surgery
3. All patients must have disease-free status documented by a complete physical
examination and imaging studies within 4 weeks prior to randomization, as described
in the protocol
Key Exclusion Criteria:
1. Uveal melanoma
2. Any evidence of residual disease after surgery by imaging, pathology, or cytology.
3. Ongoing or recent (within 2 years) evidence of clinically significant autoimmune
disease that required treatment
4. Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B virus
(HBV), or hepatitis C (HCV) infection; or diagnosis of immunodeficiency that is
related to, or results in chronic infection, as described in the protocol
5. Another malignancy that is currently progressing or that required active treatment
in the past 5 years, as described in the protocol
6. Participants with a history of myocarditis
7. Adolescent patients (≥12 to
