Clinical Trial

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

Not Yet Recruiting Phase 1
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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.
Protocol Amendment History 2 changes
notable Trial sites expanded: 26 -> 48 locations 2026-08-14
notable Trial sites expanded: 0 -> 26 locations 2026-04-04
Trial Details
NCT Number NCT07476326
Lead Sponsor Biocon Biologics UK PLC
Conditions Melanoma
Enrollment 120 participants
Start Date 2026-08
Primary Completion 2027-08-16 (estimated)
Study Completion 2028-02-16 (estimated)
Updated on ClinicalTrials.gov 2026-08-13