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

NCT07221734 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: MB11-C-01-25
• Study Type: interventional
• Target: 632
• Locations: 2 countries
• Sites: 19

Brief Summary

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

Conditions

Advanced (Unresectable or Metastatic) Melanoma

Outcome Measures

Primary Outcomes (2)

• 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.

  Week 1 - Week 24

• 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

  Week 1 - Week 24

Secondary Outcomes (6)

• To compare the efficacy of MB11 with Opdivo based on other efficacy parameters and timepoints over the study period.

  Week 1 - Week 52

• To compare the efficacy of MB11 with Opdivo based on other efficacy parameters and timepoints over the study period.

  Week 1 - Week 52

• To compare the efficacy of MB11 with Opdivo based on other efficacy parameters and timepoints over the study period.

  Week 1 - Week 52

• .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.

  Week 1 - Week 52

• To assess the safety and tolerability of MB11 as compared with Opdivo®

  Week 1 - Week 52

Study Arms (3)

MB11 (Proposed Nivolumab Biosimilar)

EXPERIMENTAL

Drug: MB11 (Proposed Nivolumab Biosimilar)

EU-Opdivo®

ACTIVE COMPARATOR

Drug: EU-Opdivo®

US- sourced Opdivo®

ACTIVE COMPARATOR

Drug: US- sourced Opdivo®

Interventions

MB11 (Proposed Nivolumab Biosimilar) DRUG

During 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

MB11 (Proposed Nivolumab Biosimilar)

EU-Opdivo® DRUG

During 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®

US- sourced Opdivo® DRUG

During 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®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Life expectancy for at least 3 months.

You may not qualify if:

• 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).
• Adequate organ function (bone marrow, hepatic, renal, haematologic, endocrine, and coagulation function) should be demonstrated during the screening period. This is defined as:
• 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.
• Renal 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).
• Endocrine function: TSH within normal limits. If TSH is not within normal limits, the subject may still be eligible if T3 and free T4 are within normal limits.
• Coagulation: INR and aPTT ≤1.5 × ULN unless the subject is receiving anticoagulant therapy. Subjects on anticoagulant therapy must be on a stable anticoagulation regimen and have an INR not above the target therapeutic range for the 14 days preceding the start of the study drug.
• Female subjects of childbearing potential and their partners, as well as male subjects with female partners of childbearing potential and their partners, must agree to adhere to the use of a highly effective method of contraception during the study and for at least 5 months after the last dose of nivolumab. Refer to Appendix 15.1 for contraception guidance.
• Non-fertile females can be included.
• 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) and/or BRAF-targeted therapy.
• Participation in another clinical study or treatment with another investigational agent within 4 weeks or 5 elimination half-lives prior to randomisation (whichever is longer)

Sponsors & Collaborators

• mAbxience Research S.L.: lead

Study Sites (19)

Site 111003

Funchal, Portugal

RECRUITING

Site 117015

Chernivtsi, Ukraine

RECRUITING

Site 117005

Ivano-Frankivsk, Ukraine

RECRUITING

Site 117002

Kyiv, Ukraine

RECRUITING

Site 117006

Kyiv, Ukraine

RECRUITING

Site 117007

Kyiv, Ukraine

RECRUITING

Site 117012

Kyiv, Ukraine

RECRUITING

Site 117013

Kyiv, Ukraine

RECRUITING

Site 117014

Kyiv, Ukraine

RECRUITING

Site 117016

Kyiv, Ukraine

RECRUITING

Site 117017

Kyiv, Ukraine

RECRUITING

Site 117018

Kyiv, Ukraine

RECRUITING

Site 117020

Kyiv, Ukraine

RECRUITING

Site 117021

Kyiv, Ukraine

RECRUITING

Site 117022

Lutsk, Ukraine

RECRUITING

Site 117003

Ternopil, Ukraine

RECRUITING

Site 117004

Uzhhorod, Ukraine

RECRUITING

Site 117010

Uzhhorod, Ukraine

RECRUITING

Site 117019

Uzhhorod, Ukraine

RECRUITING

MeSH Terms

Conditions

Neoplasm Metastasis; Melanoma

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Susana Millán, PhD

CONTACT

+34917711500; Susana.Millan@mabxience.com

Camino Huerga

CONTACT

+34917711500; Camino.Huerga@mabxience.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2025
• First Posted: October 28, 2025
• Study Start: December 29, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): February 1, 2029
• Last Updated: January 21, 2026

Record last verified: 2026-01

Locations

UA (18); PT (1)