Clinical Trials

Inclusion Criteria:

• Male or female patients.
•  (age 18 years or older where local regulations or institutional policies do not allow for patients < 18 years of age to participate).
• Histologically confirmed Stage IIIA (LN metastasis > 1 mm), IIIB/C/D, or IV  (M1a/b/c/d) cutaneous melanoma by AJCC (8th edition) at study entry that has been  completely surgically resected within 12 weeks prior to randomization.  
• Tumor tissue from biopsy or resected disease must be provided to central laboratory  for PD-L1 status analysis. Must have PD-L1 expression classification for  stratification purposes.
• Disease-free status documented by a complete physical examination and imaging studies  within 28 days prior to randomization.  

Exclusion Criteria:

• History of ocular/uveal melanoma or mucosal melanoma.  
• Active, known or suspected autoimmune disease. Patients with Type I diabetes mellitus,  hypothyroidism only requiring hormone replacement, skin disorders not requiring  systemic treatment, or conditions not expected to recur in the absence of an external  trigger are permitted to enroll.
• Conditions requiring systemic treatment with either corticosteroids (> 10 mg daily  prednisone equivalent) or other immunosuppressive medications within 14 days of  randomization. Inhaled or topical steroids, and adrenal replacement steroid doses > 10  mg daily prednisone equivalent, are permitted in the absence of active autoimmune  disease.  
• Prior therapy for melanoma except surgery for the melanoma lesion(s) and/or adjuvant  radiation therapy for central nervous system lesions.  
• Prior therapy with interferon, talimogene laherparepvec (Imylgic®), interleukin-2 (IL-2) directed therapy, anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or  anti-cytotoxic T lymphocyte-associated protein 4 antibody (including ipilimumab or any  other antibody or drug specifically targeting T cell co-stimulation or checkpoint  pathways).
• Prior malignancy active within the previous 3 years except for locally curable cancers  that have been apparently cured.