Adjuvant Nivolumab Treatment in Stage II (IIA, IIB, IIC) High-risk Melanoma

Exclusion Criteria

• •1. History of primary uveal or mucosal melanoma
• •2. No access to sufficient tumor tissue of primary tumor
• •3. SNB procedure \> 12 weeks before randomization
• •4. Prior active malignancy within the previous 3 years except for locally curable cancers that have been apparently cured, such as: basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the prostate, cervix, or breast. Exception: Participants with a history of non-ulcerated cutaneous/acral primary melanoma \<1 mm in depth with no nodal involvement are allowed in this trial.
• •5. Prior or planned therapy with Interferon alpha, CTLA4 or PD-1 / PD L1 antibodies
• •6. Use of any investigational or non-registered product (drug or vaccine) other than the study treatment
• •7. Administration of live vaccines within 4 weeks before start of study therapy
• •8. Any immunosuppressive therapy given within the past 30 days
• •9. Active psychiatric or addictive disorders that may compromise his/her ability to give informed consent or to comply with the trial procedures
• •10. Active immune deficiencies or significant autoimmune disease
• •11. Serious cardiac, gastrointestinal, hepatic or pulmonary disease which would reduce life expectancy to less than five years
• •12. Serious intercurrent illness, requiring hospitalization
• •13. Other serious illnesses, e.g., serious infections requiring antibiotics or bleeding disorders
• •14. The patient is known to be positive for Human Immunodeficiency Virus (HIV) or other active chronic infections (HBV, HCV) or has another confirmed or suspected immunosuppressive or immunodeficient condition
• •15. Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results.
• •16. Hypersensitivity to the active substance or to any of the excipients
• •17. Participation in another clinical study within the 30 days before registration
• •18. For female patients: Pregnancy or breast-feeding
• •19. For WOCBP and male patients with partners of childbearing potential: Refusal or inability to use effective means of contraception
• •20. Lack of availability for clinical follow-up assessments
• •21. Legal incapacity or limited legal capacity