A Platform Study of Novel Immunotherapy Products in Participants With Previously Treated Unresectable or Metastatic Cutaneous Melanoma

Exclusion Criteria

• •1. Known hypersensitivity to monoclonal antibodies, any of the IPs, or excipients contained in these products
• •2. Current anti-cancer therapy, other investigational treatment, or any participation in other interventional trials
• •3. Prior exposure to any therapy that targets the same target as the product under investigation, except for PD-1/L1
• •4. Known symptomatic/active untreated central nervous system (CNS) metastasis
• •5. Inadequate recovery from toxicity and/or complications attributable to any previous anti-cancer therapy
• •6. Inadequate recovery from all recent surgeries
• •7. At least 1-week from the time of minor surgery and at least 4 weeks from a major surgery
• •8. Received a live vaccine within 30 days prior to randomization (or planned to receive a live attenuated vaccine during the study)
• •9. History of HIV infection (positive HIV test, not on antiretroviral therapy, detectable viral load)
• •10. Active hepatitis B (positive hepatitis B surface antigen test) or hepatitis C infection (positive hepatitis C antibody)
• •11. Documented history or current diagnosis of clinically significant cardiac disease
• •12. History of or present CNS disease unrelated to cancer, unless adequately treated with standard medical therapy
• •13. Received solid organ or bone marrow transplantation
• •14. History of non-infectious pneumonitis requiring corticosteroid therapy within 1 year prior to enrollment, or current presence of interstitial lung disease
• •15. Active or previously documented autoimmune disease including but not limited to inflammatory bowel disease, diverticulitis, celiac disease, systemic lupus erythematosus, Wegener syndrome, multiple sclerosis, and vasculitis
• •16. Requiring long term systemic corticosteroids, except topical cortical steroids for intranasal inhalation or physiological dose
• •17. Active gastrointestinal (GI) bleeding or GI perforation or fistula
• •18. Serious active infection requiring intravenous (IV) antibiotics and/or hospitalization at study entry
• •19. Pregnant or lactating women or women who intend to get pregnant or lactate during the study and up to 120 days after the end of treatment