NCT07476326

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

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Biocon Biologics UK PLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Melanoma

Interventions

Type	Name	Description
DRUG	Bmab1700	Intravenous infusion.
DRUG	Opdivo	Intravenous infusion.

Timeline

• Start date: 2026-06-01
• Primary completion: 2027-08-16
• Completion: 2028-02-16
• First posted: 2026-03-17
• Last updated: 2026-04-03

Locations

26 sites across 6 countries: Georgia, Romania, Serbia, South Africa, Spain, Turkey (Türkiye)