This is a randomised, multicentre, multinational, double-blind, integrated study to sompare the pharmacokinetics, efficacy, safety, and immunogenicity of MB11 versus Opdivo® in subjects with previously untreated advanced (unresectable or Metastatic) Melanoma
Age ≥18 years at the time of signing the informed consent (or adulthood where the legalage of majority in the country is established >18 years).
Body weight ≥50 kg at baseline.
Signed informed consent must be obtained before initiation of any study-specific procedures or treatment.
ECOG performance status of 0 or 1.
At least 1 measurable disease lesion by CT or MRI per RECIST v1.1 criteria.
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.
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.
Any BRAF mutation status is allowed (BRAF-mutated, BRAF wild-type or non-mutated, or BRAF status unknown).
Parallel
MB11 (Proposed Nivolumab Biosimilar)
DrugDuring fist 12 cycles: 3 mg/kg IV infusion, over 30 minutes, Q2W. On Cycle 13 onwards: 3 mg/kg IV infusion, over 30 minutes, Q2W or 240 mg flat dose Q2W dosing
EU-Opdivo®
DrugDuring fist 12 cycles: 3 mg/kg IV infusion, over 30 minutes, Q2W. On Cycle 13 onwards: 3 mg/kg IV infusion, over 30 minutes, Q2W or 240 mg flat dose Q2W dosing
US- sourced Opdivo®
DrugDuring fist 12 cycles: 3 mg/kg IV infusion, over 30 minutes, Q2W. On Cycle 13 onwards: 3 mg/kg IV infusion, over 30 minutes, Q2W or 240 mg flat dose Q2W dosing
To demonstrate the Pharmacokinetic (PK) bioequivalence between MB11 and EU/ US-Opdivo.
Area under the concentration-time curve (AUC) between Cycle 1 and Cycle 2 (AUC from time 0 to 504 hours postdose \[AUC0-336\]. AUC at steady state (AUCss) between Cycle 8 and Cycle 9.
To demonstrate the efficacy equivalence of MB11 and Opdivo® administered as first-line treatment in adult subjects with untreated, unresectable, or metastatic Stage III or Stage IV melanoma
Best Overall Response (BOR), prior to permanent treatment discontinuation, prior to use of other anti-cancer therapies and by 24 weeks after Day 1
To compare the efficacy of MB11 with Opdivo based on other efficacy parameters and timepoints over the study period.
Progression-free survival (PFS)
To compare the efficacy of MB11 with Opdivo based on other efficacy parameters and timepoints over the study period.
Duration of response (DOR)
To compare the efficacy of MB11 with Opdivo based on other efficacy parameters and timepoints over the study period.
Overall survival (OS)
.To compare the PK profile based on other PK parameters and timepoints (not covered by the primary PK endpoints) of MB11 as compared with Opdivo® over the study period.
Maximum concentration (Cmax), Minimum concentration (Ctrough),
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