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

NCT07476326 | Not Yet Recruiting Phase 1

• 2 other identifiers: BIO-NIVOLU-1032025-525158-20-00
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Melanoma

Keywords

Neoplasm; Programmed cell death-protein 1(PD-1); Cytotoxic T-lymphocyte-associated protein 4 (CTLA-4); Monoclonal antibody; Immunoglobulins

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• 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)

Study Arms (2)

Bmab1700

EXPERIMENTAL

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

Opdivo

EXPERIMENTAL

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

Interventions

Bmab1700 DRUG

Intravenous infusion.

Bmab1700

Opdivo DRUG

Intravenous infusion.

Opdivo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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 pre randomization clinical or laboratory assessments demonstrate clinically significant hematologic abnormalities, impaired renal function (CrCl or GFR less than or equal to 40 mL/min), or hepatic dysfunction (AST or ALT more than 2.5\*ULN or total bilirubin more than 1.5\*ULN, except for participants with Gilbert syndrome with total bilirubin less than 3\*ULN), as defined by the laboratory cut off values specified in the clinical protocol.
• 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.
• 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.

Sponsors & Collaborators

• Biocon Biologics UK PLC: lead

MeSH Terms

Conditions

Melanoma; Neoplasms; Diabetes Mellitus, Insulin-Dependent, 12

Interventions

Nivolumab

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Dharma Rao Uppada, MD

CONTACT

+91 80 2808 5302; dharmarao.uppada@biocon.com

Rajesh CN

CONTACT

+91 9725466994; rajesh.cn@biocon.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2026
• First Posted: March 17, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): August 16, 2027
• Study Completion (Estimated): February 16, 2028
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share