OncoMatch/Clinical Trials/NCT07221734
Study to Compare Pharmacokinetics, Efficacy, Safety, and Immunogenicity of MB11 Versus EU-/US-Opdivo® in Subjects With Previously Untreated Advanced [Unresectable or Metastatic] Melanoma
Is NCT07221734 recruiting? Yes, currently enrolling (Jun 2026). This Phase 3 trial studies multiple treatments including MB11 (Proposed Nivolumab Biosimilar) and EU-Opdivo® for advanced (unresectable or metastatic) melanoma.
Treatment: MB11 (Proposed Nivolumab Biosimilar) · EU-Opdivo® · US- sourced Opdivo® — 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
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Other
Cancer type
Melanoma
Biomarker criteria
Required: PD-L1 (CD274) positive (≥1% to <5% or ≥5%) (≥1% to <5% or ≥5%)
All samples must be classified as PD-L1 positive (≥1% to <5% or ≥5%)
Allowed: BRAF any status
Any BRAF mutation status is allowed (BRAF-mutated, BRAF wild-type or non-mutated, or BRAF status unknown)
Disease stage
Required: Stage III, IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic therapy
Exception: for advanced, unresectable, or metastatic Stage III or Stage IV melanoma (except for palliative radiotherapy, in accordance with Inclusion Criteria #9)
Subjects receiving any prior systemic therapy for advanced, unresectable, or metastatic Stage III or Stage IV melanoma (except for palliative radiotherapy, in accordance with Inclusion Criteria #9)
Cannot have received: immunotherapy (anti-PD-1 therapy, anti-PD-L1 therapy, anti-PD-L2 therapy, anti-CD137 therapy, anti-LAG therapy, anti-CTLA-4 therapy, ipilimumab, any other antibody or drug that specifically targets costimulation of T-cells or immune checkpoints)
Subjects receiving any prior immunotherapy (regardless of the melanoma stage), such as anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-LAG or anti-CTLA-4 therapy (including ipilimumab or any other antibody or drug that specifically targets costimulation of T-cells or immune checkpoints)
Cannot have received: BRAF-targeted therapy
and/or BRAF-targeted therapy
Lab requirements
Blood counts
absolute neutrophil count ≥1.5 × 10^9/L, platelets ≥100 × 10^9/L, and haemoglobin ≥9 g/dL. Subjects should not have received RBC transfusion prior to 14 days before screening labs.
Kidney function
serum creatinine level ≤1.5 × ULN or calculated CrCl ≥60 mL/min (using the Cockcroft-Gault formula)
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)
Adequate organ function (bone marrow, hepatic, renal, haematologic, endocrine, and coagulation function) should be demonstrated during the screening period. ... See Inclusion Criteria #11 for details.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07221734 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require CD274?
Yes, CD274 positive (≥1% to <5% or ≥5%) is a required biomarker for enrollment.
What disease stage is eligible?
Stage III or IV is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages