Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New biosimilar aims to match opdivo for melanoma

NCT ID NCT07476326

Disease control Sponsor: Biocon Biologics UK PLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 14, 2026 · Updated 2 times

Summary

This study tests whether a new drug called Bmab1700 works the same as the approved immunotherapy Opdivo in people with melanoma who have had their tumors surgically removed. The trial will involve 120 adults with stage IIB to IV melanoma. Researchers will compare how the drugs move through the body, their safety, and how the immune system reacts to them.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Participants greater than or equal to (\>=)18 years of age on the day of signing informed consent (follow local regulatory requirements if the legal age of consent for study participation is \>18 years old). 2. Able to understand and willing to provide consent using the study Informed Consent Form (ICF). The voluntarily signed ICF must be obtained before any study-specific procedures are performed. 3. Histologically or cytologically confirmed Stage IIB, Stage IIC, Stage III, or Stage IV melanoma (per American Joint Committee on Cancer, 8th edition) that was completely surgically resected. Complete surgical resection requires removal of all clinically or radiographically evident regional disease. Completion of lymph node dissection is not required unless clinically indicated. Participants must have been surgically rendered free of disease with negative margins on resected specimens documented by appropriate pathology and surgical reports. 4. Complete surgical resection of melanoma must have been performed within 12 weeks before randomization. 5. All participants must have disease-free status documented by a complete physical examination and imaging studies before randomization. 6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. 7. Participants must have recovered from melanoma related surgery and its complications before randomization, as per investigator. Exclusion Criteria: 1. History of ocular/uveal melanoma. 2. Participants with an active, known, or suspected autoimmune disease are to be excluded from participation. Participants who have received systemic treatment for an autoimmune disease within the past 2 years before randomization (eg, with disease-modifying agents, corticosteroids, or immunosuppressive drugs) are also excluded. 3. History of active malignancy other than melanoma under study within 3 years before randomization, except for locally curable early-stage cancers (carcinoma in situ or Stage I) that have been curatively treated, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast. 4. Participants with a condition requiring systemic treatment with either corticosteroids \>10 mg daily prednisone or equivalent or other immunosuppressive medications within 14 days before randomization. Inhaled or topical steroids, and adrenal replacement steroid doses \<=10 mg daily prednisone or equivalent, are permitted in the absence of active autoimmune disease 5. Female participants who are pregnant or breastfeeding at the screening visit, or who intend to become pregnant or breastfeed at any time during the study and for 150 days after the last dose of study intervention. 6. Use of an investigational agent or an investigational device within 28 days or 5 half-lives (if half-life is known for the investigational agent), whichever is longer, before randomization or have not recovered from AEs associated with such therapies to Grade 1 or below (based on CTCAE Version 6.0). 7. Any antineoplastic therapy after the complete resection of melanoma under study (eg, chemotherapy, radiation therapy, targeted agents, biotherapy, or limb perfusion). 8. Participants who have received a live/attenuated vaccine within 28 days before randomization. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin, and typhoid vaccine. 9. Expected to receive any other form of antineoplastic therapy during the clinical study. 10. Participants who received previous systemic therapy with any of the following: anti-programmed cell death-protein 1 (PD-1), anti programmed cell death-ligand 1 (PD-L1), anti-programmed cell death-ligand 2 (PD-L2), anti-CD137, anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) antibodies (including nivolumab or pembrolizumab or ipilimumab or other CTLA-4 targeting agents), chimeric antigen receptor T-cell therapy cells, or any agents targeting the IL-2 pathway or other T-cell co-stimulation/ checkpoint pathways. 11. Treatment with complementary medications (eg, herbal supplements or traditional medicines) with an antineoplastic intent to treat the melanoma within 2 weeks before randomization. Such medications are permitted if they are used as supportive care. 12. Participants will be excluded if clinical assessment or laboratory investigations before randomization demonstrate any of the following: 1. White blood cells: less than (\<) 2000 per microliter 2. Neutrophils: \<1500 per microliter 3. Platelets: \<100 \*103 per microliter 4. Hemoglobin: \<9.0 gram per deciliter (g/dL) 5. Participants with estimated creatinine clearance (CrCl) (measured or calculated) less than or equal to (\<=) 40 milliliter per minute (mL/min). • CrCl: using the Cockroft-Gault formula: * Female CrCl = \[(140 - age in years) \* weight in kilogram (kg) \* 0.85\] divided by (72 \* serum creatinine in milligram per deciliter \[mg/dL\]) * Male CrCl = \[(140 - age in years) \* weight in kg \* 1.00\] divide by (72 \* serum creatinine in mg/dL) 6. Aspartate aminotransferase: greater than (\>) 2.5 \* upper limit of normal (ULN) 7. Alanine aminotransferase: \>2.5 \* ULN 8. Total bilirubin \>1.5 \* ULN (except participants with Gilbert Syndrome who must have a total bilirubin level of \<3.0 \* ULN) 13. Participants positive for human immune deficiency virus (HIV-1 and HIV-2) tests. Screening for HIV infection must adhere to local regulatory guidelines and confirm the absence of HIV-1 and HIV-2 infection. Note: Participants with documented HIV infection may be enrolled where required by local regulatory or ethics committee guidance, provided all the following criteria are met: * The participant is on stable antiretroviral therapy for at least 12 weeks prior to the first dose of study treatment, and no planned change in antiretroviral therapy regimen during the PK sampling period. * Adequate immune function, defined as: CD4+ T cell count greater than or equal to (\>=) 350 cells per millimeter cube (cells/mm\^3) at screening * No history of uncontrolled or recent Acquired Immunodeficiency Syndrome (AIDS) defining illness, that is \[ie\], no active AIDS defining condition within the past 12 months * Undetectable viral RNA load 14. Participants having positive test result for hepatitis B virus (HBV) or hepatitis C virus (HCV) indicating presence of virus, eg, hepatitis B surface antigen (Australia antigen) positive, or hepatitis C antibody (anti- HCV) positive (except if HCV RNA negative). 15. Participants with history or current evidence of any clinically significant medical condition (including but not limited to physical examination, vital signs, electrocardiogram \[ECG\] findings, laboratory results), or ongoing therapy, that could confound study results, increase participation risk, or are deemed not in the participant's best interest by the treating investigator. 16. Known history of allergy or hypersensitivity to IMP components. 17. Known history of severe hypersensitivity reaction (Grade \>=3) to any monoclonal antibody. 18. Participants who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness. 19. Has documented or known current alcohol/drug abuse that precludes the participant's ability to adhere to the protocol. 20. Prisoners or participants who are involuntarily incarcerated.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Melanoma are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

melanoma neoplasm type 1 diabetes mellitus 12

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Melanoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    48 sites in 10 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Biocon Investigational Site

    Bento Gonçalves, Brazil

  • Biocon Investigational Site

    Ijuí, Brazil

  • Biocon Investigational Site

    Pará, Brazil

  • Biocon Investigational Site

    Porto Alegre, Brazil

  • Biocon Investigational Site

    Rio de Janeiro, Brazil

  • Biocon Investigational Site

    Santa Catarina, Brazil

  • Biocon Investigational Site

    São Paulo, Brazil

  • Biocon Investigational Site

    Providencia, Chile

  • Biocon Investigational Site

    Recoleta, Chile

  • Biocon Investigational Site

    Santiago, Chile

  • Biocon Investigational Site

    Batumi, Georgia

  • Biocon Investigational Site

    Kutaisi, Georgia

  • Biocon Investigational Site

    Tbilisi, Georgia

  • Biocon Investigational Site

    Chisinau, Moldova

  • Biocon Investigational Site

    Bucharest, Romania

  • Biocon Investigational Site

    Craiova, Romania

  • Biocon Investigational Site

    Belgrade, Serbia

  • Biocon Investigational Site

    Kamenitz, Serbia

  • Biocon Investigational Site

    Kragujevac, Serbia

  • Biocon Investigational Site

    Niš, Serbia

  • Biocon Investigational Site

    George, South Africa

  • Biocon Investigational Site

    Johannesburg, South Africa

  • Biocon Investigational Site

    Port Elizabeth, South Africa

  • Biocon Investigational Site

    Barcelona, Spain

  • Biocon Investigational Site

    Madrid, Spain

  • Biocon Investigational Site

    Murcia, Spain

  • Biocon Investigational Site

    Sabadell, Spain

  • Biocon Investigational Site

    Seville, Spain

  • Biocon Investigational Site

    Ankara, Turkey (Türkiye)

  • Biocon Investigational Site

    Bornova, Turkey (Türkiye)

  • Biocon Investigational Site

    Konak, Turkey (Türkiye)

  • Biocon Investigational Site

    Ivano-Frankivsk, Ukraine

  • Biocon Investigational Site

    Kyiv, Ukraine

  • Biocon Investigational Site 1

    Santa Catarina, Brazil

  • Biocon Investigational Site 1

    São Paulo, Brazil

  • Biocon Investigational Site 1

    Santiago, Chile

  • Biocon Investigational Site 1

    Tbilisi, Georgia

  • Biocon Investigational Site 1

    Belgrade, Serbia

  • Biocon Investigational Site 1

    Johannesburg, South Africa

  • Biocon Investigational Site 1

    Barcelona, Spain

  • Biocon Investigational Site 1

    Seville, Spain

  • Biocon Investigational Site 2

    Santa Catarina, Brazil

  • Biocon Investigational Site 2

    São Paulo, Brazil

  • Biocon Investigational Site 2

    Tbilisi, Georgia

  • Biocon Investigational Site 3

    Tbilisi, Georgia

  • Biocon Investigational Site 4

    Tbilisi, Georgia

  • Biocon Investigational Site 5

    Tbilisi, Georgia

  • Site 26

    Cluj-Napoca, Romania

More trials for these conditions

Other studies related to the condition(s) this trial covers.