Clinical Trials

Inclusion Criteria:

- Has surgically resected and histologically or pathologically confirmed diagnosis of
Stage IIB and IIC (pathological or clinical), III, or IV cutaneous melanoma per the
American Joint Committee on Cancer (AJCC) eighth edition guidelines.
- Has not received any prior systemic therapy for melanoma beyond surgical resection.
- Has had no more than 12 weeks between final surgical resection and randomization.
- Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV
on anti-retroviral therapy (ART).
- Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they
have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have
undetectable HBV viral load before randomization.
- Participants with history of hepatitis C virus (HCV) infection are eligible if HCV
viral load is undetectable at screening.

Exclusion Criteria:

- Has ocular, mucosal, or conjunctival melanoma.
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
(in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of
immunosuppressive therapy within 7 days prior the first dose of study medication.
- Has not adequately recovered from major surgical procedure or has ongoing surgical
complications.
- Has received prior radiotherapy within 2 weeks of start of study intervention or has
had a history of radiation pneumonitis.
- Received a live or live attenuated vaccine within 30 days before the first dose of
study intervention. Administration of killed vaccines is allowed.
- Has received an investigational agent or has used an investigational device within 4
weeks before study intervention administration.
- Has a history of (noninfectious) pneumonitis/interstitial lung disease that required
steroids or has current pneumonitis/interstitial lung disease.
- Has a known additional malignancy that is progressing or has required active treatment
within the past 3 years.
- Has known active central nervous system (CNS) metastases and/or carcinomatous
meningitis.
- Has an active autoimmune disease that has required systemic treatment in past 2 years.
- Has an active infection requiring systemic therapy.
- Has had an allogenic tissue/solid organ transplant.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 1/5/23. Questions regarding updates should be directed to the study team contact.