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

Sponsor
Biocon Biologics UK PLC
Study ID
NCT07476326
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bmab1700 — DRUG
    Intravenous infusion.
  • Opdivo — DRUG
    Intravenous infusion.

Study Details

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.

Key Dates

Start date
Jun 1, 2026
Status verified
Apr 2026
Primary completion
Aug 16, 2027
Completion
Feb 16, 2028

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Bmab1700
    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 \[EOT-OL-TP\].
  • Experimental: Opdivo
    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 \[EOT-OL-TP\].

Primary Outcome Measure

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 [ Time Frame: Week 0 through Week 4 ]

Central Contacts

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