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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Melanoma
• Intervention / Treatment: Drug: Bmab1700; Drug: Opdivo

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.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Dharma Rao Uppada, MD; Phone Number: +91 80 2808 5302; Email: dharmarao.uppada@biocon.com
• Study Contact Backup: Name: Rajesh CN; Phone Number: +91 9725466994; Email: rajesh.cn@biocon.com

Study Locations

• Georgia
  • Batumi, Georgia
    • High Technology Hospital MedCenter
    • Principal Investigator: Tamta Makharadze
  • Kutaisi, Georgia
    • JSC Vian
    • Principal Investigator: Khatuna Bibichadze
  • Tbilisi, Georgia
    • Todua Clinic
    • Principal Investigator: Tamar Melkadze
  • Tbilisi, Georgia
    • LTD New Hospitals
    • Principal Investigator: Davit Giorgadze
  • Tbilisi, Georgia
    • Institute of Clinical Oncology - Lubliana Street
    • Principal Investigator: Vladimer Kuchava
  • Tbilisi, Georgia
    • Israel-Georgian Medical Research Clinic Helsicore
    • Principal Investigator: Ekaterine Arkania
• Romania
  • Craiova, Romania
    • Centrul de Oncologie Sfantu Nectarie
    • Principal Investigator: Michael Schenker
• Serbia
  • Belgrade, Serbia
    • Institute for Oncology and Radiology of Serbia
    • Principal Investigator: Suzana Matkovic
  • Belgrade, Serbia
    • Military Medical Academy
    • Principal Investigator: Tatjana Radevic
  • Kamenitz, Serbia
    • Oncology Institute of Vojvodina
    • Principal Investigator: Borislava Nikolin
  • Kragujevac, Serbia
    • University Clinical Center Kragujevac, Clinic for Oncology
    • Principal Investigator: Marina Petronijevic
  • Niš, Serbia
    • University Clinical Center Nis, Clinic for Oncology/
    • Principal Investigator: Mirjana Balic
• South Africa
  • George, South Africa
    • Excellentis Clinical Trial Consultants
    • Principal Investigator: Martha Bedelu Mekebeb Reuter
  • Johannesburg, South Africa
    • The Medical Oncology Center of Rosebank
    • Principal Investigator: Bernardo Rapoport
  • Johannesburg, South Africa
    • WITS Clinical Research - Wits Donald Gordon Medical Centre
    • Principal Investigator: Georgia Demetriou
  • Port Elizabeth, South Africa
    • Phoenix Pharma Pty Ltd
    • Principal Investigator: Daniel R Malan
• Spain
  • Barcelona, Spain
    • Hospital Universitario Vall d\'Hebron
    • Principal Investigator: Julia Lostes Bardaji
  • Barcelona, Spain
    • Instituto Oncológico Dr. Rosell (IOR) - Hospital Universitari Quirón Dexeus
    • Principal Investigator: Maria Gonzalez Cao
  • Madrid, Spain
    • START Madrid - Hospital Universitario Fundacion Jimenez Diaz
    • Principal Investigator: Manuel Pedregal
  • Murcia, Spain
    • Hospital Virgen de Arrixaca
    • Principal Investigator: Pablo Cerezuela Fuentes
  • Sabadell, Spain
    • Institut d'Investigació iInnovació Parc Taulí
    • Principal Investigator: Marina Sierra Boada
  • Seville, Spain
    • Hospital Universitario Virgen Macarena
    • Principal Investigator: Luis de la Cruz Merino
  • Seville, Spain
    • Hospital Universitario Virgen del Rocío (HUVR)
    • Principal Investigator: Fatima Toscano Murillo
• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye)
    • Universities, 1604. Cadde No 9 Ankara, Ankara 06800 Türkiye, Ankara Billkent Şehir Hastanesi
    • Principal Investigator: Burak Bilgin
  • Bornova, Turkey (Türkiye)
    • Ege University Tulay Aktas Oncology Hospital
    • Principal Investigator: Saziye Karaca
  • Konak, Turkey (Türkiye)
    • Dokuz Eylul University Medical Oncology Hospital Dokuz Eylül Üniverstesi Medikal Onkolji Hastanesi
    • Principal Investigator: Aziz Karaoglu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bmab1700; Participants 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].	Drug: Bmab1700; Intravenous infusion.
Experimental: Opdivo; Participants 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].	Drug: Opdivo; Intravenous infusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	Week 0 through Week 4
Area Under the Concentration-Time Curve Over a Dosing Interval (AUC0-tau) of Bmab 1700 and Opdivo	Week 16 through Week 20

Secondary Outcome Measures

Outcome Measure	Time Frame
Maximum Observed Serum Concentration (Cmax) of Bmab 1700 and Opdivo	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)
Time to Reach the Maximum Serum Concentration (Tmax) of Bmab 1700 and Opdivo	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)
Maximum Observed Plasma Concentration (Cmaxss) of Bmab 1700 and Opdivo at Steady State	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)
Time to Reach the Maximum Serum Concentration (Tmaxss) of Bmab 1700 and Opdivo at Steady State	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)
Serum Observed Concentration Before Next Dosing (Ctrough) of Bmab 1700 and Opdivo	Cycles 2 to 7, Day 1: At predose (each cycle is of 28 days)
Number of Participants with Adverse Events (AEs), serious Adverse Events (SAEs) and Adverse Event of Special Interest (AESIs)	Baseline up to Week 24
Percentage of Participants who Developed Anti-drug Antibodies (ADA) and ADA Titer to Bmab 1700 and Opdivo	Baseline up to Week 24

Collaborators and Investigators

• Sponsor: Biocon Biologics UK PLC

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): August 16, 2027
• Study Completion (Estimated): February 16, 2028

Study Registration Dates

• First Submitted: March 12, 2026
• First Submitted That Met QC Criteria: March 12, 2026
• First Posted (Actual): March 17, 2026

Study Record Updates

• Last Update Posted (Actual): April 3, 2026
• Last Update Submitted That Met QC Criteria: April 2, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Monoclonal antibody; Immunoglobulins; Cytotoxic T-lymphocyte-associated protein 4 (CTLA-4); Neoplasm; Programmed cell death-protein 1(PD-1)
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms by Histologic Type; Skin Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Skin Neoplasms; Skin and Connective Tissue Diseases; Neoplasms; Melanoma; Diabetes Mellitus, Insulin-Dependent, 12; Amino Acids, Peptides, and Proteins; Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Nivolumab
• Other Study ID Numbers: BIO-NIVOLU-103; 2025-525158-20-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No