Pharmacokinetics, Safety, and Immunogenicity of Bmab1800 and Keytruda® as Adjuvant Monotherapy in Patients With Melanoma

The purpose of the study is to evaluate the pharmacokinetic (PK) equivalence of Bmab1800 as compared with reference product Keytruda® in a randomized, double-blind, two-arm, parallel comparative, multi-center study in patients with resected melanoma (Stage IIB, or Stage IIC, or Stage III) as an adjuvant treatment. This study also compares the safety and immunogenicity of Bmab1800 and Keytruda.

Trial Details

NCT ID
NCT07581509
Phase
PHASE1
Sponsor
Biocon Biologics UK PLC
Status
RECRUITING
Cancer Type
Melanoma
Interventions
  • Bmab1800
  • US-Licensed Keytruda
Locations (sample)
  • Barretos, São Paulo, Brazil|-20.55722,-48.56778

Key Eligibility Criteria

  • Male or female patients aged ≥18 years (or legal adult age per local regulations)
  • ECOG Performance Status of 0 or 1 at screening and prior to randomization.
  • Histologically confirmed melanoma that is completely surgically resected with negative margins (per local standard), classified as: Stage IIB, IIC,…
  • Patients must have undergone definitive melanoma resection ≥28 days prior to signing informed consent, and randomization must occur within 12 weeks…

For full eligibility, visit ClinicalTrials.gov.

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