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MelanomaPhase 1NCT07476326

Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma

A Phase 1 study testing Bmab1700 and Opdivo in people with Melanoma, run by Biocon Biologics UK PLC at 46 sites in 10 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The purpose of this study is to investigate the pharmacokinetics (PK) similarity of Bmab1700 (an intended nivolumab biosimilar), compared with United States (US)-licensed Opdivo, in participants after complete surgical removal of melanoma. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Melanoma
What is being tested?
Bmab1700 and Opdivo
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
46 sitesin 10 countries
Study dates
9 Sep 2026to 16 Feb 2028
Phase
Phase 1
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

  • 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).
  • 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.
  • 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.
  • Complete surgical resection of melanoma must have been performed within 12 weeks before randomization.
  • All participants must have disease-free status documented by a complete physical examination and imaging studies before randomization.
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
  • Participants must have recovered from melanoma related surgery and its complications before randomization, as per investigator.

Who cannot join

  • History of ocular/uveal melanoma.
  • 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.
  • 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.
  • 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
  • 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.
  • 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).
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  • Any antineoplastic therapy after the complete resection of melanoma under study (eg, chemotherapy, radiation therapy, targeted agents, biotherapy, or limb perfusion).
  • 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.
  • Expected to receive any other form of antineoplastic therapy during the clinical study.
  • 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.
  • 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.
  • Participants will be excluded if clinical assessment or laboratory investigations before randomization demonstrate any of the following:
  • White blood cells: less than (<) 2000 per microliter
  • Neutrophils: <1500 per microliter
  • Platelets: <100 *103 per microliter
  • Hemoglobin: <9.0 gram per deciliter (g/dL)
  • 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)
  • Aspartate aminotransferase: greater than (>) 2.5 * upper limit of normal (ULN)
  • Alanine aminotransferase: >2.5 * ULN
  • Total bilirubin >1.5 * ULN (except participants with Gilbert Syndrome who must have a total bilirubin level of <3.0 * ULN)
  • 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
  • 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).
  • 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.
  • Known history of allergy or hypersensitivity to IMP components.
  • Known history of severe hypersensitivity reaction (Grade >=3) to any monoclonal antibody.
  • Participants who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.
  • Has documented or known current alcohol/drug abuse that precludes the participant's ability to adhere to the protocol.
  • Prisoners or participants who are involuntarily incarcerated.

Trial locations and contacts

46 sites in 10 countries. Contact the study team or a site near you to ask about taking part.

Dr. Gursharan Singh, MBBS; PhD Pharm Med; LLM-IP contact

+91 80 2808 2066

gursharan.singh@biocon.com

Rajesh CN contact

+91 9725466994

rajesh.cn@biocon.com

46 sites in 10 countries

Brazil11 sites, 11 recruiting

  • Biocon Investigational Site

    Bento Gonçalves

    Not yet recruiting

  • Biocon Investigational Site

    Ijuí

    Not yet recruiting

  • Biocon Investigational Site

    Pará

    Not yet recruiting

  • Biocon Investigational Site

    Porto Alegre

    Not yet recruiting

  • Biocon Investigational Site

    Rio de Janeiro

    Not yet recruiting

  • Biocon Investigational Site 1

    Santa Catarina

    Not yet recruiting

  • Biocon Investigational Site 2

    Santa Catarina

    Not yet recruiting

  • Biocon Investigational Site

    Santa Catarina

    Not yet recruiting

  • Biocon Investigational Site 1

    São Paulo

    Not yet recruiting

  • Biocon Investigational Site 2

    São Paulo

    Not yet recruiting

  • Biocon Investigational Site

    São Paulo

    Not yet recruiting

Other trials in Brazil

Georgia7 sites, 7 recruiting

  • Biocon Investigational Site

    Batumi

    Not yet recruiting

  • Biocon Investigational Site

    Kutaisi

    Not yet recruiting

  • Biocon Investigational Site 1

    Tbilisi

    Not yet recruiting

  • Biocon Investigational Site 3

    Tbilisi

    Not yet recruiting

  • Biocon Investigational Site 4

    Tbilisi

    Not yet recruiting

  • Biocon Investigational Site 5

    Tbilisi

    Not yet recruiting

  • Biocon Investigational Site

    Tbilisi

    Not yet recruiting

Other trials in Georgia

Spain7 sites, 7 recruiting

  • Biocon Investigational Site 1

    Barcelona

    Not yet recruiting

  • Biocon Investigational Site

    Barcelona

    Not yet recruiting

  • Biocon Investigational Site

    Madrid

    Not yet recruiting

  • Biocon Investigational Site

    Murcia

    Not yet recruiting

  • Biocon Investigational Site

    Sabadell

    Not yet recruiting

  • Biocon Investigational Site 1

    Seville

    Not yet recruiting

  • Biocon Investigational Site

    Seville

    Not yet recruiting

Other trials in Spain

Serbia5 sites, 5 recruiting

  • Biocon Investigational Site 1

    Belgrade

    Recruiting

  • Biocon Investigational Site

    Belgrade

    Recruiting

  • Biocon Investigational Site

    Kamenitz

    Recruiting

  • Biocon Investigational Site

    Kragujevac

    Recruiting

  • Biocon Investigational Site

    Niš

    Recruiting

Other trials in Serbia

Chile4 sites, 4 recruiting

  • Biocon Investigational Site

    Providencia

    Not yet recruiting

  • Biocon Investigational Site

    Recoleta

    Not yet recruiting

  • Biocon Investigational Site 1

    Santiago

    Not yet recruiting

  • Biocon Investigational Site

    Santiago

    Not yet recruiting

Other trials in Chile

Romania3 sites, 3 recruiting

  • Biocon Investigational Site

    Bucharest

    Not yet recruiting

  • Biocon Investigational Site

    Cluj-Napoca

    Not yet recruiting

  • Biocon Investigational Site

    Craiova

    Recruiting

Other trials in Romania

South Africa3 sites, 3 recruiting

  • Biocon Investigational Site

    George

    Not yet recruiting

  • Biocon Investigational Site 1

    Johannesburg

    Not yet recruiting

  • Biocon Investigational Site

    Johannesburg

    Not yet recruiting

Other trials in South Africa

Turkey (Türkiye)3 sites, 3 recruiting

  • Biocon Investigational Site

    Ankara

    Not yet recruiting

  • Biocon Investigational Site

    Bornova

    Not yet recruiting

  • Biocon Investigational Site

    Konak

    Not yet recruiting

Other trials in Turkey (Türkiye)

Ukraine2 sites, 2 recruiting

  • Biocon Investigational Site

    Ivano-Frankivsk

    Not yet recruiting

  • Biocon Investigational Site

    Kyiv

    Not yet recruiting

Other trials in Ukraine

Moldova1 site, 1 recruiting

  • Biocon Investigational Site

    Chisinau

    Not yet recruiting

Other trials in Moldova

About this study

Official title: A Randomized, Double-Blind, Parallel, Multicenter, Two-Arm Study to Compare the Pharmacokinetics, Safety, and Immunogenicity Between Bmab1700 and Opdivo® After Complete Resection of Stage IIB/C, Stage III, or Stage IV Melanoma

The purpose of this study is to investigate the pharmacokinetics (PK) similarity of Bmab1700 (an intended nivolumab biosimilar), compared with United States (US)-licensed Opdivo, in participants after complete surgical removal of melanoma.

Read the detailed description

This study consists of 2 treatment periods: Double-Blind Treatment Period (DB-TP, Week 0 to Week 24 Predose) and Open-Label Treatment Period (OL-TP, From Week 24 Dosing to Week 52). Participants will be randomized in a ratio of 1:1 ratio to receive intravenous infusion of either Bmab1700 (test) or Opdivo (reference) every 4 weeks (Q4W) in DB-TP until disease relapse or recurrence, unacceptable toxicity, or Week 20, whichever occurs earlier. At Week 24, after completing all pre-dose assessments, participants who will remain on study will receive Bmab1700 Q4W until Week 48 end of treatment (EOT) of OL-TP [EOT-OL-TP]. The end-of-study (EOS) for OL-TP (EOS-OL-TP) will then occur at Week 52.

Conditions
Melanoma
Being tested
Bmab1700, Opdivo
Keywords
Neoplasm, Programmed cell death-protein 1(PD-1), Cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), Monoclonal antibody, Immunoglobulins
Medical subject headings
Melanoma, Neoplasms, Diabetes Mellitus, Insulin-Dependent, 12

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bmab1700Drug

    Intravenous infusion.

  • OpdivoDrug

    Intravenous infusion.

Study groups in NCT07476326
Study groupRoleWhat they receive
Bmab1700ExperimentalParticipants will receive intravenous infusion of Bmab1700 every 4 weeks (Q4W) in DB-TP until disease relapse or recurrence, unacceptable toxicity, or Week 20, whichever occurs earlier. At Week 24, after completing all pre-dose assessments, participants who will remain on study will continue to receive Bmab1700 Q4W until Week 48 end of treatment of OL-TP [EOT-OL-TP].
Receives: Drug: Bmab1700
OpdivoExperimentalParticipants will receive intravenous infusion of Opdivo Q4W until disease relapse or recurrence, unacceptable toxicity, or Week 20, whichever occurs earlier. At Week 24, after completing all pre-dose assessments, participants who will remain on study will receive Bmab1700 Q4W until Week 48 end of treatment of OL-TP [EOT-OL-TP].
Receives: Drug: Opdivo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Area Under the Concentration-Time Curve from Time 0 (Day 1) To Day 29 After the First Dose (AUC0-28days) of Bmab 1700 and Opdivo

    Measured: Week 0 through Week 4

  2. Area Under the Concentration-Time Curve Over a Dosing Interval (AUC0-tau) of Bmab 1700 and Opdivo

    Measured: Week 16 through Week 20

Secondary outcomes (7)

  1. Maximum Observed Serum Concentration (Cmax) of Bmab 1700 and Opdivo

    Measured: Cycle 1, Days 1 to 22: Predose, 1, 3, 24, 48, 168, 336 and 504 hours after the end of infusion (each cycle is of 28 days)

  2. Time to Reach the Maximum Serum Concentration (Tmax) of Bmab 1700 and Opdivo

    Measured: Cycle 1, Days 1 to 22: Predose, 1, 3, 24, 48, 168, 336 and 504 hours after the end of infusion (each cycle is of 28 days)

  3. Maximum Observed Plasma Concentration (Cmaxss) of Bmab 1700 and Opdivo at Steady State

    Measured: Cycle 5, Days 1 to 22: Predose, 1, 3, 24, 48, 168, 336 and 504 hours after the end of infusion (each cycle is of 28 days)

  4. Time to Reach the Maximum Serum Concentration (Tmaxss) of Bmab 1700 and Opdivo at Steady State

    Measured: Cycle 5, Days 1 to 22: Predose, 1, 3, 24, 48, 168, 336 and 504 hours after the end of infusion (each cycle is of 28 days)

  5. Serum Observed Concentration Before Next Dosing (Ctrough) of Bmab 1700 and Opdivo

    Measured: Cycles 2 to 7, Day 1: At predose (each cycle is of 28 days)

  6. Number of Participants with Adverse Events (AEs), serious Adverse Events (SAEs) and Adverse Event of Special Interest (AESIs)

    Measured: Baseline up to Week 24

  7. Percentage of Participants who Developed Anti-drug Antibodies (ADA) and ADA Titer to Bmab 1700 and Opdivo

    Measured: Baseline up to Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2026
  2. Study start9 Sep 2026
  3. Primary completion16 Aug 2027 (estimated)
  4. Study completion16 Feb 2028 (estimated)

Resources

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 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07476326
Sponsor's protocol ID
BIO-NIVOLU-103
Other IDs
2025-525158-20-00, 2025
Status last verified
Nov 2026
First submitted
12 Mar 2026
Last updated
6 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Bmab1700 and Opdivo in people with Melanoma, run by Biocon Biologics UK PLC at 46 sites in 10 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 7 inclusion and 36 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 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 46 sites in Brazil, Georgia, Spain, Serbia, Chile and 5 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 Dr. Gursharan Singh, MBBS; PhD Pharm Med; LLM-IP (+91 80 2808 2066, gursharan.singh@biocon.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area Under the Concentration-Time Curve from Time 0 (Day 1) To Day 29 After the First Dose (AUC0-28days) of Bmab 1700 and Opdivo (time frame: Week 0 through Week 4). 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?

On the ClinicalTrials.gov record for NCT07476326.

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 6 Nov 2026.

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