What is MB11 studying for advanced melanoma?

MB11 is being studied as a biosimilar to nivolumab to see how it compares with EU- and US-sourced Opdivo in adults with untreated advanced melanoma. Researchers want to understand if MB11 works similarly in terms of drug levels, effectiveness, safety, and immune response. The study is sponsored by mAbxience Research S.L.

Who may be eligible for this advanced melanoma clinical trial?

Adults aged 18 years or older with untreated advanced unresectable or metastatic melanoma may be eligible. Participants must weigh at least 50 kg, have good overall health and organ function, and meet other criteria such as no prior immunotherapy for melanoma. Please review eligibility criteria for more details.

Is there any cost to participate in this advanced melanoma clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly.

Actively Recruiting

Phase 3

Age: 18Years +

All Genders

ID07221734

Randomised, Multicentre, Multinational, Double-Blind Study Comparing MB11 Proposed Nivolumab Biosimilar Versus EU-US-Opdivo in Untreated Advanced Melanoma

Led by mAbxience Research S.L. · Updated on 2026-01-21

632

Participants Needed

Research Sites

96 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating MB11, a proposed biosimilar to nivolumab, compared to EU- and US-sourced Opdivo in adults with untreated advanced unresectable or metastatic melanoma. This phase 3 randomized, double-blind, multinational study aims to compare the pharmacokinetics, efficacy, safety, and immune response of these treatments in this patient population. The trial is sponsored by mAbxience Research S.L. Participants will receive either MB11 or one of two versions of Opdivo through intravenous infusions at a dose of 3 mgkg over 30 minutes every two weeks for the first 12 cycles. From cycle 13 onwards, dosing continues every two weeks with either the same weight-based dose or a flat dose of 240 mg. The study includes multiple treatment groups to assess the biosimilar against the reference products under similar conditions. Throughout the study, participants will undergo regular monitoring, including assessments of drug levels in the blood, tumor response by imaging, safety checks, and immune system evaluations. The primary outcomes focus on pharmacokinetic equivalence and treatment efficacy by week 24, with extended follow-up through week 52 to compare other efficacy and safety measures. The total duration and detailed schedules will be managed to support thorough evaluation of these treatments in advanced melanoma.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Age 18 years or older at time of informed consent
Body weight of at least 50 kg at baseline
Signed informed consent before any study procedures or treatment
ECOG performance status of 0 or 1
Life expectancy of at least 3 months
Untreated, histologically confirmed advanced unresectable Stage III or Stage IV melanoma
At least one measurable disease lesion by CT or MRI per RECIST v1.1
Tumor tissue collected within 90 days prior to randomisation available for PD-L1 testing and classified as positive
Completed any prior palliative radiotherapy at least 2 weeks before study drug administration
Any BRAF mutation status allowed
Adequate organ function demonstrated during screening
Female subjects of childbearing potential and partners must use highly effective contraception during and for 5 months after treatment
Non-fertile females can be included

You will not qualify if you...

Prior systemic therapy for advanced, unresectable, or metastatic melanoma
Prior immunotherapy for melanoma, including anti-PD-1, anti-PD-L1, anti-CTLA-4 therapies, or BRAF-targeted therapy
Participation in another clinical study or investigational treatment within 4 weeks or 5 elimination half-lives before randomisation
Brain or leptomeningeal metastases; negative brain imaging required within 90 days before screening
Peritoneal melanomatosis
Ocular, mucosal, or acral lentiginous melanoma
History or current other malignancies except disease-free for 3 years or certain treated skin/cervical cancers
Active autoimmune disease requiring systemic treatment in last 2 years
Unstable thyroid conditions
Immunodeficiency or recent immunosuppressive therapy within 7 days before first dose
Major surgery less than 28 days before first dose
Organ or bone marrow transplant history
Interstitial lung disease or pneumonitis requiring steroids
Active or recent infections requiring therapy within 30 days
Live virus vaccination within 30 days before first dose
Known active or untreated latent tuberculosis
Positive HIV, hepatitis B or C serology, or untreated Strongyloides infection
Recent substance abuse or regular illicit drug use
Pregnancy, lactation, or planning pregnancy during or up to 5 months after treatment
Immediate family involved in the study site or staff
Inability to comply with protocol or medical conditions increasing risk or interfering with study results

Research Team

Susana Millán, PhD

Camino Huerga

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