A Study Comparing MB11 and Nivolumab in Adults With Previously Untreated Advanced or Metastatic Melanoma

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What is this study about?

This study is looking at melanoma, which is a type of skin cancer that has spread or cannot be removed by surgery. The study involves people who have not yet received any treatment for their advanced melanoma. The study will compare a new medicine called MB11, which is a proposed similar version of an existing medicine, with the already approved medicine called Opdivo. Both medicines contain the same active ingredient called nivolumab, which works by helping the body’s immune system fight cancer cells. All medicines in this study are given through a drip into a vein, which is called an infusion.

The purpose of this study is to compare how MB11 and Opdivo work in the body, how well they control the cancer, how safe they are, and how the body’s immune system responds to them. The study wants to show that MB11 works in a similar way to Opdivo when used as the first treatment for people with melanoma that cannot be removed by surgery or has spread to other parts of the body.

During the study, participants will be randomly assigned to receive either MB11 or Opdivo. Neither the participants nor the doctors will know which medicine is being given. The treatment will be given regularly over a period of time, and participants will be monitored through regular visits where blood samples will be taken, scans will be performed to check how the cancer is responding, and any side effects will be recorded. The study will also check if the body develops an immune response to the medicine. Participants will continue to be followed for their health and survival even after the treatment period ends.

1 Treatment phase

During the treatment phase, you will receive either MB11 (a proposed similar version of nivolumab) or Opdivo (the reference medicine containing nivolumab). The medicine assigned to you will be determined randomly, and neither you nor your doctor will know which one you are receiving.

The medicine will be given through infusion, which means it will be administered directly into your vein over a period of time.

The treatment will be organized in cycles. Each cycle represents a repeating period during which you receive the medicine and undergo assessments.

You will continue receiving the treatment in cycles until the end of the treatment phase or until your doctor decides to stop the treatment.

2 Cycle 1 and Cycle 2

During Cycle 1 and Cycle 2, blood samples will be collected to measure the amount of medicine in your blood over time. This measurement is called pharmacokinetics and helps to understand how your body processes the medicine.

Specifically, the measurement called AUC0-336 will be calculated. This represents the total amount of medicine in your blood from the start of Cycle 1 through the period between Cycle 1 and Cycle 2.

3 Cycle 8 and Cycle 9

Between Cycle 8 and Cycle 9, additional blood samples will be collected to measure how the medicine levels stabilize in your body over time.

The measurement called AUCss will be calculated during this period. This helps to assess the medicine concentration when it reaches a steady state in your body.

Blood samples will also be taken during Cycle 1 and Cycle 8 to measure the highest concentration of medicine in your blood, which is called Cmax.

Throughout the treatment from Cycle 1 until the end of treatment, blood samples will be collected before each dose to measure the lowest concentration of medicine in your blood, called Ctrough.

4 Disease assessments

Your disease will be assessed regularly using imaging scans such as CT (computed tomography) or MRI (magnetic resonance imaging). These scans allow doctors to see how your melanoma is responding to the treatment.

The assessments will be performed at specific time points: 10 weeks, 16 weeks, 24 weeks, 32 weeks, and 52 weeks after the first day of treatment.

The scans will be reviewed by independent specialists who do not know which treatment you received. They will evaluate whether your tumors have shrunk, stayed the same, or grown, according to standard criteria called RECIST v1.1.

The main goal is to determine your best overall response, which means the best result achieved during treatment. This includes whether you achieved a complete response (all tumors disappeared) or a partial response (tumors significantly shrunk) within 24 weeks after starting treatment.

Other measurements include progression-free survival, which is the time you remain alive without your disease getting worse, assessed at 24 weeks and 52 weeks.

The duration of response will also be measured, which is how long your tumors remain controlled after responding to treatment.

Overall survival, meaning the time you remain alive, will be assessed at 24 weeks and 52 weeks after starting treatment.

5 Safety monitoring

Throughout the study, up to 52 weeks from the first day of treatment and until the end of the study, your safety will be closely monitored.

This includes recording any side effects you experience, including their type, severity, and whether they are serious.

Regular laboratory tests will be performed on your blood and urine to check your blood cell counts, liver function, kidney function, hormone levels, and blood clotting ability.

Your vital signs will be measured regularly, including blood pressure, heart rate, breathing rate, and body temperature.

You will have electrocardiograms (ECGs) performed to check your heart’s electrical activity.

Physical examinations will be conducted to assess your overall health.

6 Immune response monitoring

Blood samples will be collected throughout the study, up to 52 weeks from the first day of treatment, to check whether your body has developed an immune response against the medicine.

These tests will look for anti-drug antibodies (ADAs), which are proteins your immune system may produce in response to the medicine.

If anti-drug antibodies are detected in your blood, additional tests will be performed to measure their levels and to determine if they can block the medicine from working properly. These blocking antibodies are called neutralizing antibodies (NAbs).

7 End of treatment

You will continue receiving treatment until your disease progresses, you experience unacceptable side effects, you decide to withdraw, or your doctor determines it is no longer appropriate to continue.

At the end of treatment, final assessments will be performed, including disease evaluation, safety checks, and collection of blood samples for pharmacokinetics and immune response testing.

8 End of study

After you stop receiving the treatment, you will continue to be followed for safety monitoring and survival assessment.

The study is expected to continue until approximately January 2028, although your individual participation may be shorter depending on your treatment duration and follow-up period.

Who Can Join the Study?

You must be 18 years of age or older at the time of signing the consent form
Your body weight must be at least 50 kilograms
You must sign a consent form before any study procedures begin
Your ECOG performance status must be 0 or 1, which means you are able to carry out normal activities or light work with little or no symptoms
Your life expectancy must be at least 3 months
You must have advanced melanoma that cannot be removed by surgery or has spread to other parts of the body, confirmed by tissue examination, and you have not received treatment for this advanced stage yet
If you received melanoma treatment in the past for earlier stages, you must have been disease-free for at least 1 year after completing that treatment, and it must not have included certain prohibited medications
Previous treatment with immune therapies as additional treatment after surgery or before surgery is not allowed
You must have at least one tumor that can be measured using CT or MRI scans according to specific measurement criteria
A tumor tissue sample from your disease site must be available, collected within 90 days before joining the study, and it must test positive for a protein called PD-L1, which means at least 1 percent of cells show this protein
If you only have an older tissue sample collected more than 90 days ago and cannot provide a new sample, you cannot participate
If you previously received radiation therapy to treat symptoms from tumors that have spread, it must have been completed at least 2 weeks before starting the study drug
Any BRAF mutation status is acceptable, which is a specific genetic change that may or may not be present in your tumor
Your organ function must be adequate, including blood cells, liver, kidneys, hormones, and blood clotting ability, measured during screening
Your blood cell counts must meet minimum levels: white blood cells that fight infection must be at least 1.5 times one billion per liter, platelets that help blood clot must be at least 100 times one billion per liter, and hemoglobin that carries oxygen must be at least 9 grams per deciliter
You should not have received red blood cell transfusions within 14 days before screening blood tests
Your kidney function must be adequate, with creatinine levels no more than 1.5 times the upper normal limit, or your calculated kidney filtration rate must be at least 60 milliliters per minute
Your liver function must be adequate, with bilirubin no more than 1.5 times the upper normal limit, albumin at or above the lower normal limit, and liver enzymes no more than 2.5 times the upper normal limit, or up to 5 times if you have liver tumors
If you have Gilbert Syndrome, a harmless liver condition, your total bilirubin can be less than 3.0 milligrams per deciliter
Your thyroid function must be within normal limits based on TSH levels, or if TSH is abnormal, your T3 and free T4 hormone levels must be normal
Your blood clotting tests must be no more than 1.5 times the upper normal limit unless you are taking blood thinning medication
If you are taking blood thinning medication, your dose must be stable and your clotting test results must be within the target range for at least 14 days before starting the study drug
If you are a woman able to become pregnant or a man with a female partner able to become pregnant, you and your partner must agree to use highly effective birth control during the study and for at least 5 months after the last dose of study medication
Women who cannot become pregnant can participate in the study

Who Cannot Join the Study?

Active autoimmune disease (a condition where the body’s defense system attacks its own healthy cells) that has required treatment with medicines that suppress the immune system within the past 2 years
Known history of testing positive for HIV (Human Immunodeficiency Virus, a virus that weakens the immune system)
Active infection with hepatitis B or hepatitis C (viral infections that affect the liver)
Previous treatment with medicines that work on PD-1, PD-L1, or CTLA-4 pathways (types of cancer treatments that help the immune system fight cancer cells)
Previous treatment for melanoma (a type of skin cancer) that was unresectable (cannot be removed by surgery) or metastatic (has spread to other parts of the body)
Active brain metastases (cancer that has spread to the brain) or leptomeningeal disease (cancer that has spread to the membranes covering the brain and spinal cord)
History of severe allergic reactions to medicines similar to the study drug
Other active cancer within the past 3 years, except for certain skin cancers or early-stage cancers that have been completely removed
Use of medicines that suppress the immune system within 14 days before starting the study
Pregnant or breastfeeding women
Women of childbearing age who are not willing to use effective birth control during the study
Any serious medical condition that could interfere with the study or put the patient at risk

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

No sites found in this category

Other Sites

Site Name	City	Country
F D Roosevelt University General Hospital Of Banska Bystrica	Banska Bystrica	Slovakia
Hospital Ruber Internacional	Madrid	Spain
Hospital Cuf Descobertas S.A.	Lisbon	Portugal
Hospital Universitario Basurto	Bilbao	Spain
Servico de Saude da Regiao Autonoma Da Madeira EPERAM	Funchal	Portugal
Hospital Quironsalud Malaga	Malaga	Spain
Micancer Center S.L.P.	Barcelona	Spain
Centrul De Oncologie SF Nectarie S.R.L.	Craiova	Romania
General Hospital Of Thessaloniki Papageorgiou	Thessaloniki	Greece
Metropolitan General Hospital/Healthcare Facilities Operation And Management Single Member S.A	Cholargos	Greece
Virgen del Rocío University Hospital	Sevilla	Spain
Champalimaud Clinical Centre	Lisbon	Portugal
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida	Lleida	Spain
Pnzj Tndnc Hsmixxsn Uncssnvvpoeh	Sabadell	Spain
Axaicnt Ofexqifjzir Uturstwnojbie Sfaawl	Siena	Italy
Ulegfxqewyjbji Czwlaqo Keazflene	Gdansk	Poland
Ugcdjggtdm Muplq Gdkqqqv Oi Cqolmyhtg	Catanzaro	Italy

Trial status

Country	Status	Recruitment Start
Greece	Recruiting	01.10.2025
Italy	Recruiting	01.10.2025
Poland	Not yet recruiting	01.10.2025
Portugal	Recruiting	01.10.2025
Romania	Recruiting	01.10.2025
Slovakia	Recruiting	01.10.2025
Spain	Recruiting	01.10.2025

Trial locations

Investigated drugs:

Nivolumab

MB11 is a proposed biosimilar medication to nivolumab. A biosimilar is a medication that is highly similar to an already approved biological medicine. This medication is being tested to see if it works the same way as the original nivolumab medication for treating advanced melanoma, which is a serious type of skin cancer that has spread or cannot be removed by surgery.

Opdivo is the brand name for nivolumab, which is an approved medication used to treat various types of cancer, including melanoma. It works by helping the body’s immune system recognize and fight cancer cells. In this study, both the European Union and United States versions of Opdivo are being used as comparison treatments to the proposed biosimilar medication.

Advanced Melanoma – Advanced melanoma refers to a serious form of skin cancer that has progressed beyond its original site and cannot be surgically removed or has spread to distant parts of the body. This condition includes unresectable melanoma, meaning the tumor cannot be completely removed through surgery, and metastatic melanoma, where cancer cells have traveled through the bloodstream or lymphatic system to other organs. The disease is classified as Stage III when it has spread to nearby lymph nodes or skin areas, and Stage IV when it has reached distant organs such as the lungs, liver, brain, or bones. As melanoma advances, it grows deeper into the skin layers and becomes more aggressive in its spread throughout the body. Without treatment, the cancer continues to multiply and form new tumors in various locations. Advanced melanoma represents a progression from earlier stages where the cancer was confined to a smaller area and could potentially be removed surgically.

Trial ID:

2025-521562-95-00

Protocol code:

MB11-C-01-25

Trial Phase:

Therapeutic confirmatory (Phase III)

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A Study Comparing MB11 and Nivolumab in Adults With Previously Untreated Advanced or Metastatic Melanoma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?