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

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.

Trial Details

NCT ID
NCT07476326
Phase
PHASE1
Sponsor
Biocon Biologics UK PLC
Status
RECRUITING
Cancer Type
Melanoma
Interventions
  • Bmab1700
  • Opdivo
Locations (sample)
  • Bento Gonçalves, Brazil|-29.17139,-51.51917
  • Ijuí, Brazil|-28.38778,-53.91472
  • Pará, Brazil|-22.99509,-47.91472
  • Porto Alegre, Brazil|-30.03283,-51.23019
  • Rio de Janeiro, Brazil|-22.90642,-43.18223

Key Eligibility Criteria

  • Participants greater than or equal to (\>=)18 years of age on the day of signing informed consent (follow local regulatory requirements if the lega…
  • Able to understand and willing to provide consent using the study Informed Consent Form (ICF). The voluntarily signed ICF must be obtained before a…
  • Histologically or cytologically confirmed Stage IIB, Stage IIC, Stage III, or Stage IV melanoma (per American Joint Committee on Cancer, 8th editio…
  • Complete surgical resection of melanoma must have been performed within 12 weeks before randomization.

For full eligibility, visit ClinicalTrials.gov.

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