Clinical Trial

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

Not Yet Recruiting Phase 1
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Summary
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-05-06.
Trial Details
NCT Number NCT07581509
Lead Sponsor Biocon Biologics UK PLC
Conditions Adult Patients With Stage IIB, IIC, and Stage III Melanoma Following Complete Resection (Adjuvant Settings)
Enrollment 138 participants
Start Date 2026-08-01
Primary Completion 2027-12-15 (estimated)
Study Completion 2028-06-21 (estimated)
Updated on ClinicalTrials.gov 2026-05-14