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Study to Compare Pharmacokinetics, Efficacy, Safety, and Immunogenicity of MB11 Versus EU-/US-Opdivo® in Subjects With Previously Untreated Advanced [Unresectable or Metastatic] Melanoma
Led by mAbxience Research S.L. · Updated on 2026-01-21
632
Participants Needed
19
Research Sites
161 weeks
Total Duration
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AI-Summary
What this Trial Is About
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
Official 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
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at the 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, confirmed advanced unresectable Stage III or Stage IV melanoma
- Prior melanoma therapy allowed if disease-free for at least 1 year and no prohibited medications used
- At least one measurable tumor lesion by CT or MRI
- Available tumor tissue collected within 90 days before randomization for PD-L1 testing, classified as PD-L1 positive
- Completed prior palliative radiotherapy at least 2 weeks before study drug administration, no adjuvant radiation allowed
- Any BRAF mutation status accepted
- Adequate organ function including blood counts, liver, kidney, endocrine, and coagulation functions as specified
- Agreement to use effective contraception during the study and for 5 months after last dose for subjects of childbearing potential and their partners
- Non-fertile females can participate
You will not qualify if you...
- Prior systemic therapy for advanced unresectable or metastatic Stage III or IV melanoma
- Prior immunotherapy for melanoma or other treatments targeting immune checkpoints
- Participation in another clinical study or investigational treatment within 4 weeks or 5 elimination half-lives before randomization
- Brain or leptomeningeal metastases; recent negative brain imaging required
- Peritoneal melanomatosis
- Ocular, mucosal, or acral lentiginous melanoma
- History or presence of another malignancy unless disease-free for 3 years or certain treated cancers
- Active autoimmune disease needing systemic treatment in last 2 years
- Unstable thyroid conditions, except stable hormone replacement
- Immunodeficiency or immunosuppressive therapy within 7 days before first dose
- Major surgery within 28 days before first dose
- History of organ or stem cell transplant
- Interstitial lung disease or pneumonitis requiring steroids
- Active or recent infection requiring therapy within 30 days
- Live virus vaccination within 30 days before first dose
- Active or untreated tuberculosis
- Positive HIV, hepatitis B or C serology, or untreated Strongyloides infection
- Current illicit drug use or recent substance abuse
- Pregnancy, lactation, or planning pregnancy during or up to 5 months after study
- Immediate family member involved in the study at the research site
- Inability to comply with study procedures or conditions that increase risk or interfere with results
AI-Screening
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Trial Site Locations
Total: 19 locations
1
Site 111003
Funchal, Portugal
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2
Site 117015
Chernivtsi, Ukraine
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3
Site 117005
Ivano-Frankivsk, Ukraine
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4
Site 117002
Kyiv, Ukraine
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5
Site 117006
Kyiv, Ukraine
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6
Site 117007
Kyiv, Ukraine
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7
Site 117012
Kyiv, Ukraine
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8
Site 117013
Kyiv, Ukraine
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9
Site 117014
Kyiv, Ukraine
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10
Site 117016
Kyiv, Ukraine
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11
Site 117017
Kyiv, Ukraine
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12
Site 117018
Kyiv, Ukraine
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13
Site 117020
Kyiv, Ukraine
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14
Site 117021
Kyiv, Ukraine
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15
Site 117022
Lutsk, Ukraine
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16
Site 117003
Ternopil, Ukraine
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17
Site 117004
Uzhhorod, Ukraine
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18
Site 117010
Uzhhorod, Ukraine
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19
Site 117019
Uzhhorod, Ukraine
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Research Team
S
Susana Millán, PhD
CONTACT
C
Camino Huerga
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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