Advanced (Unresectable or Metastatic) MelanomaPhase 3NCT07221734
Study to Compare Pharmacokinetics, Efficacy, Safety, and Immunogenicity of MB11 Versus EU-/US-Opdivo® in Subjects With Previously Untreated Advanced [Unresectable or Metastatic] Melanoma
A Phase 3 study testing MB11 (Proposed Nivolumab Biosimilar), EU-Opdivo® and US- sourced Opdivo® in people with Advanced (Unresectable or Metastatic) Melanoma, run by mAbxience Research S.L. at 86 sites in 13 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced (Unresectable or Metastatic) Melanoma
- What is being tested?
- MB11 (Proposed Nivolumab Biosimilar), EU-Opdivo® and US- sourced Opdivo®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 632 participants
- Where
- 86 sitesin 13 countries
- Study dates
- 29 Dec 2025to Feb 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Untreated, histologically confirmed advanced unresectable Stage III or Stage IV melanoma, as per AJCC 8th Edition staging system. Prior melanoma systemic therapy for earlier stages is allowed for patients who have been disease-free for at least 1 year after end of therapy, except if therapy included use of prohibited medications. Prior use of immune therapies (adjuvant or neoadjuvant) is not allowed as per Exclusion Criteria #2.
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- 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.
Who cannot join
- 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).
- 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)
- Brain metastases or leptomeningeal metastases. A negative brain imaging of less than 90 days prior to screening is required.
- Peritoneal melanomatosis.
- Ocular melanoma, mucosal melanoma and acral lentiginous melanoma.
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- History of another malignancy or a concurrent malignancy. Exceptions include subjects who have been disease-free for 3 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible, for example cervical cancer in situ.
- Active autoimmune disease that has required systemic treatment in the last 2 years (ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin or physiological corticosteroid replacement therapy for pituitary or adrenal insufficiency [daily prednisone at a dose of ≤10 mg or equivalent]) is not considered a form of systemic treatment.
- Subjects with hyperthyroidism or hypothyroidism are excluded but those subjects who are stable on hormone replacement will be allowed.
- Any diagnosis of immunodeficiency, systemic steroid therapy (replacement therapy outlined in Exclusion Criteria #8, inhaled, intranasal, intraocular, or topical steroids are allowed) or any other form of immunosuppressive therapy within 7 days prior to the first dose of the study drug.
- Any major surgery (eg, hip or spine surgery) less than 28 days prior to the first dose of the study drug.
- Having received a solid organ/tissue allogeneic or haematopoietic transplant.
- History and/or current interstitial lung disease or pneumonitis (non-infectious) requiring oral or IV steroids or another immunosuppressive drug.
- Any active or previous infection requiring therapy (oral or systemic) within 30 days prior to the first dose of the study drug.
- Have received or are about to receive a live virus vaccination within 30 days prior to the first dose of the study drug. Seasonal flu and COVID-19 vaccines that do not contain live virus are permitted.
- Known active TB or untreated latent TB.
- Positive serology for human immunodeficiency virus (HIV 1/2), hepatitis B (HBsAg positive and/or HBcAb positive, and HBV DNA positive, refer to Section 8.3.2.1) or hepatitis C (HCVAb positive and HCV RNA positive). In addition, subjects with untreated positive serology for Strongyloides spp will be excluded.
- At the time of signing the informed consent, the subject is a regular user (including "recreational use") of any illicit drug or have a recent history (within the past year) of substance abuse (including alcohol).
- Be pregnant or lactating or expecting to conceive during the study or up to 5 months after the last dose of the study drug.
- Immediate family member who is at the research site or sponsoring staff who is directlyninvolved in this study.
- Inability to comply with protocol procedures and/or any other acute or chronic medical condition that may increase the risk for the subject associated with study participation or study drug administration, that may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the subject inappropriate for entry into this study.
Trial locations and contacts
86 sites in 13 countries. Contact the study team or a site near you to ask about taking part.
86 sites in 13 countries
Ukraine22 sites, 22 recruiting
- Recruiting
Site 117015
Chernivtsi
- Recruiting
Site 117005
Ivano-Frankivsk
- Recruiting
Site 117001
Kyiv
- Recruiting
Site 117002
Kyiv
- Recruiting
Site 117006
Kyiv
- Recruiting
Site 117007
Kyiv
- Recruiting
Site 117008
Kyiv
- Recruiting
Site 117012
Kyiv
- Recruiting
Site 117013
Kyiv
- Recruiting
Site 117014
Kyiv
- Recruiting
Site 117016
Kyiv
- Recruiting
Site 117017
Kyiv
- Recruiting
Site 117018
Kyiv
- Recruiting
Site 117020
Kyiv
- Recruiting
Site 117021
Kyiv
- Recruiting
Site 117022
Lutsk
- Recruiting
Site 117003
Ternopil
- Recruiting
Site 117004
Uzhhorod
- Recruiting
Site 117010
Uzhhorod
- Recruiting
Site 117019
Uzhhorod
- Recruiting
Site 117009
Vinnytsia
- Recruiting
Site 117011
Vinnytsia
Brazil17 sites, 17 recruiting
- Recruiting
Site 103009
Barretos
- Recruiting
Site 103007
Belo Horizonte
- Recruiting
Site 103008
Belo Horizonte
- Recruiting
Site 103002
Bento Gonçalves
- Recruiting
Site 103014
Blumenau
- Recruiting
Site 103012
Caxias do Sul
- Recruiting
Site 103004
Ijuí
- Recruiting
Site 103013
Jaú
- Recruiting
Site 103015
Lajeado
- Recruiting
Site 103010
Natal
- Recruiting
Site 103001
Porto Alegre
- Recruiting
Site 103011
Ribeirão Preto
- Recruiting
Site 103018
Rio de Janeiro
- Recruiting
Site 103017
Santa Cruz do Sul
- Recruiting
Site 103005
São Caetano do Sul
- Recruiting
Site 103016
São Paulo
- Recruiting
Site 103006
Sorocaba
Spain11 sites, 11 recruiting
- Recruiting
Site 115012
Barcelona
- Recruiting
Site 115007
Bilbao
- Recruiting
Site 115005
Huelva
- Recruiting
Site 115009
Lleida
- Recruiting
Site 115003
Madrid
- Recruiting
Site 115004
Madrid
- Recruiting
Site 15001
Madrid
- Recruiting
Site 115002
Málaga
- Recruiting
Site 115010
Sabadell
- Recruiting
Site 115011
Seville
- Recruiting
Site 115008
Torrejón de Ardoz
Turkey (Türkiye)11 sites, 11 recruiting
- Recruiting
116009
Adapazarı
- Recruiting
116013
Ankara
- Recruiting
116015
Ankara
- Recruiting
116017
Ankara
- Recruiting
116002
Çankaya
- Recruiting
116007
Çankaya
- Recruiting
116012
Diyarbakır
- Recruiting
116006
Eskişehir
- Recruiting
116001
Istanbul
- Recruiting
116008
Istanbul
- Recruiting
116005
Yüreğir
Chile5 sites, 5 recruiting
- Recruiting
Site 104002
Independencia
- Recruiting
Site 104004
La Florida
- Recruiting
Site 104003
Providencia
- Recruiting
Site 104005
Providencia
- Recruiting
Site 104001
Viña del Mar
Peru5 sites, 5 recruiting
- Recruiting
109003
Arequipa
- Recruiting
109001
Lima
- Recruiting
109002
Lima
- Recruiting
109004
Lima
- Recruiting
109005
Trujillo
Georgia4 sites, 4 recruiting
- Recruiting
Site 105002
Batumi
- Recruiting
Site 105001
Tbilisi
- Recruiting
Site 105003
Tbilisi
- Recruiting
Site 105004
Tbilisi
Bosnia and Herzegovina3 sites, 3 recruiting
- Recruiting
Site 102002
Banja Luka
- Recruiting
Site 102001
Sarajevo
- Recruiting
Site 102003
Zenica
Portugal3 sites, 3 recruiting
- Recruiting
Site 111003
Funchal
- Recruiting
Site 111001
Lisbon
- Recruiting
Site 111002
Lisbon
Italy2 sites, 2 recruiting
- Recruiting
Site 107002
Catanzaro
- Recruiting
Site 107001
Siena
About this study
Official title: Randomised, Multicentre, Multinational, Double-Blind Integrated Study to Compare the Pharmacokinetics, Efficacy, Safety, and Immunogenicity of MB11 (Proposed Nivolumab Biosimilar) Versus EU-/US-Opdivo® in Subjects With Previously Untreated Advanced (Unresectable or Metastatic) Melanoma (LEON Study)
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
- Being tested
- MB11 (Proposed Nivolumab Biosimilar), EU-Opdivo®, US- sourced Opdivo®
- Medical subject headings
- Neoplasm Metastasis, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
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
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
| Study group | Role | What they receive |
|---|---|---|
| MB11 (Proposed Nivolumab Biosimilar) | Experimental | Not described Receives: Drug: MB11 (Proposed Nivolumab Biosimilar) |
| EU-Opdivo® | Active comparator | Not described Receives: Drug: EU-Opdivo® |
| US- sourced Opdivo® | Active comparator | Not described Receives: Drug: US- sourced Opdivo® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Progression-free survival (PFS)
Measured: Week 1 - Week 52
To compare the efficacy of MB11 with Opdivo based on other efficacy parameters and timepoints over the study period.
Duration of response (DOR)
Measured: Week 1 - Week 52
To compare the efficacy of MB11 with Opdivo based on other efficacy parameters and timepoints over the study period.
Overall survival (OS)
Measured: 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.
Maximum concentration (Cmax), Minimum concentration (Ctrough),
Measured: Week 1 - Week 52
To assess the safety and tolerability of MB11 as compared with Opdivo®
Treatment-emergent adverse events (TEAEs)
Measured: Week 1 - Week 52
To assess the immunogenicity of MB11 as compared with Opdivo®
Anti-drug antibodies (ADAs) and Neutralizing antibodies (NAbs) in ADA-positive samples
Measured: Week 1 - Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2025
- Study start29 Dec 2025
- Primary completionApr 2027 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced (Unresectable or Metastatic) MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 632 participants (estimated)
Sponsor and investigators
- Lead sponsor
- mAbxience Research S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07221734
- Sponsor's protocol ID
- MB11-C-01-25
- Status last verified
- Oct 2026
- First submitted
- 6 Oct 2025
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised, Multicentre, Multinational, Double-Blind Integrated Study to Compare the Pharmacokinetics, Efficacy, Safety, and Immunogenicity of MB11 (Proposed Nivolumab Biosimilar) Versus EU-/US-Opdivo® in Subjects With Previously Untreated Advanced (Unresectable or Metastatic) Melanoma (LEON Study)
- ClinicalTrials.gov ID
- NCT07221734
- Acronym / sponsor ID
- MB11-C-01-25
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 632 participants (estimated)
- Lead sponsor
- mAbxience Research S.L.Industry (pharma, biotech, devices)
- Study start
- 29 Dec 2025 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 28 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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® |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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.
Key exclusion criteria (21 listed)
- 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).
- 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)
- Brain metastases or leptomeningeal metastases. A negative brain imaging of less than 90 days prior to screening is required.
- Peritoneal melanomatosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MB11 (Proposed Nivolumab Biosimilar)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 | Drug | MB11 (Proposed Nivolumab Biosimilar) |
| EU-Opdivo®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 | Drug | EU-Opdivo® |
| US- sourced Opdivo®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 | Drug | US- sourced Opdivo® |
Primary outcome
To demonstrate the Pharmacokinetic (PK) bioequivalence between MB11 and EU/ US-Opdivo.
Time frame: Week 1 - Week 24
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
Time frame: Week 1 - Week 24
Best Overall Response (BOR), prior to permanent treatment discontinuation, prior to use of other anti-cancer therapies and by 24 weeks after Day 1
6 secondary outcomes
To compare the efficacy of MB11 with Opdivo based on other efficacy parameters and timepoints over the study period.
Time frame: Week 1 - Week 52
To compare the efficacy of MB11 with Opdivo based on other efficacy parameters and timepoints over the study period.
Time frame: Week 1 - Week 52
To compare the efficacy of MB11 with Opdivo based on other efficacy parameters and timepoints over the study period.
Time frame: 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.
Time frame: Week 1 - Week 52
To assess the safety and tolerability of MB11 as compared with Opdivo®
Time frame: Week 1 - Week 52
To assess the immunogenicity of MB11 as compared with Opdivo®
Time frame: Week 1 - Week 52
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
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Dabrafenib and Trametinib Followed by Ipilimumab and Nivolumab or Ipilimumab and Nivolumab Followed by Dabrafenib and Trametinib in Treating Patients With Stage III-IV BRAFV600 Melanoma
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
86 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MB11 (Proposed Nivolumab Biosimilar), EU-Opdivo® and US- sourced Opdivo® in people with Advanced (Unresectable or Metastatic) Melanoma, run by mAbxience Research S.L. at 86 sites in 13 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 86 sites in Ukraine, Brazil, Spain, Turkey (Türkiye), Chile and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Susana Millán, PhD (+34917711500, Susana.Millan@mabxience.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To demonstrate the Pharmacokinetic (PK) bioequivalence between MB11 and EU/ US-Opdivo. (time frame: Week 1 - Week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.