drugset / Trial / NCT07476326
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bmab1700 | Unknown | — | Intravenous |
| Subject | Nivolumab | Monoclonal antibody | — | Intravenous |