drugset / Trial / NCT07476326

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

NCT07476326

Phase 1 Not yet recruiting 120 enrolled Biocon Biologics UK Ltd
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2026-06-01
Primary completion
2027-08-16
Completion
2028-02-16

Drugs

EvaluationDrugModalityDoseRoute
Subject Bmab1700 Unknown Intravenous
Subject Nivolumab Monoclonal antibody Intravenous

Indications