Study to Compare Pharmacokinetics, Efficacy, Safety, and Immunogenicity of MB11 Versus EU-/US-Opdivo® in Subjects With Previously Untreated Advanced [Unresectable or Metastatic] Melanoma

Exclusion Criteria

• •7. At least 1 measurable disease lesion by CT or MRI per RECIST v1.1 criteria.
• •8. Tumour tissue from an unresectable or metastatic site of disease, collected within 90 days prior to randomisation, must be available and provided for PD-L1 testing. All samples must be classified as PD-L1 positive (≥1% to \<5% or ≥5%). If only the old sample \>90 days is available and there is no possibility of having a new biopsy sample, then the subject will be excluded.
• •9. In the case of prior palliative radiotherapy (on metastatic lesions), this must have been completed at least 2 weeks prior to the study drug administration. No adjuvant radiation therapies are allowed.
• •10. Any BRAF mutation status is allowed (BRAF-mutated, BRAF wild-type or non-mutated, or BRAF status unknown).
• •11. Adequate organ function (bone marrow, hepatic, renal, haematologic, endocrine, and coagulation function) should be demonstrated during the screening period. This is defined as:
• •1. Haematologic function: absolute neutrophil count ≥1.5 × 109/L, platelets 9≥100 × 10 /L, and haemoglobin ≥9 g/dL.
• •\*\* Subjects should not have received RBC transfusion prior to 14 days beforescreening labs.
• •2. Renal function: serum creatinine level ≤1.5 × ULN or calculated CrCl ≥60 mL/min (using the Cockcroft-Gault formula).
• •3. Liver function: total bilirubin level ≤1.5 × ULN (except subjects with Gilbert Syndrome, who can have total bilirubin \<3.0 mg/dL), albumin level ≥LLN, AST/ALT ≤2.5 × ULN (≤5 × ULN for subjects with liver metastases).
• •11. Any major surgery (eg, hip or spine surgery) less than 28 days prior to the first dose of the study drug.
• •12. Having received a solid organ/tissue allogeneic or haematopoietic transplant.
• •13. History and/or current interstitial lung disease or pneumonitis (non-infectious) requiring oral or IV steroids or another immunosuppressive drug.
• •14. Any active or previous infection requiring therapy (oral or systemic) within 30 days prior to the first dose of the study drug.
• •15. Have received or are about to receive a live virus vaccination within 30 days prior to the first dose of the study drug. Seasonal flu and COVID-19 vaccines that do not contain live virus are permitted.
• •16. Known active TB or untreated latent TB.
• •17. Positive serology for human immunodeficiency virus (HIV 1/2), hepatitis B (HBsAg positive and/or HBcAb positive, and HBV DNA positive, refer to Section 8.3.2.1) or hepatitis C (HCVAb positive and HCV RNA positive). In addition, subjects with untreated positive serology for Strongyloides spp will be excluded.
• •18. At the time of signing the informed consent, the subject is a regular user (including "recreational use") of any illicit drug or have a recent history (within the past year) of substance abuse (including alcohol).
• •19. Be pregnant or lactating or expecting to conceive during the study or up to 5 months after the last dose of the study drug.
• •20. Immediate family member who is at the research site or sponsoring staff who is directlyninvolved in this study.
• •21. Inability to comply with protocol procedures and/or any other acute or chronic medical condition that may increase the risk for the subject associated with study participation or study drug administration, that may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the subject inappropriate for entry into this study.