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.
This is a randomized, double-blind, two-arm, parallel-group, multicenter Phase 1 study conducted in adult patients with Stage IIB, IIC, or Stage III melanoma following complete surgical resection. Approximately 138 patients will be randomized in 1:1 ratio to receive either Bmab1800 or Keytruda. Study treatment will be administered intravenously at a dose of 200 mg every 3 weeks till Week 21. Post which the patient will continue through Week 21, with continuation through Week 24. At Week 24, following completion of all pre dose assessments, patients who were initially randomized to the pembrolizumab arm and who are eligible to continue treatment will transition to the Bmab1800 arm and receive Bmab1800 during an open label treatment period. These patients will continue to receive Bmab1800 through Week 48 (end of treatment for the open label treatment period \[EOT OL TP\]), with end of study at Week 51 (EOS OL TP), ensuring that all patients receive pembrolizumab equivalent therapy in accordance with recommended treatment guidelines. The primary objective is to demonstrate PK equivalence based on AUC0-21 and AUC over a dosage interval at steady-state (AUCτ during Cycle 7; Week 18 to Week 21) PK parameters. Safety and immunogenicity will be evaluated through Week 24. Additional safety follow-up during an open-label treatment period through Week 51.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
138
* 200 mg Q3W, intravenous infusion, over 24 weeks * Double-blind period through Week 24; eligible patients may continue in open-label period through Week 48
* 200 mg Q3W, intravenous infusion, over 24 weeks * Double-blind period through Week 24
Time Curve from Time 0 to 21 Days (AUC₀-₂₁days)
Assessed to compare pharmacokinetics of Bmab1800 and Keytruda®
Time frame: Week 0 to Week 3
Time Curve Over the Dosing Interval at Steady State (AUCτ)
Cycle 7 (Week 18 to Week 21)
Time frame: Assessed to demonstrate steady-state PK equivalence
Cmax
Time frame: From first dose through Week 24 (DB-TP)
tmax
Time frame: From first dose through Week 24 (DB-TP)
Cmax,ss
Time frame: From first dose through Week 24 (DB-TP)
tmax,ss
Time frame: From first dose through Week 24 (DB-TP)
Ctrough
Time frame: From first dose through Week 24 (DB-TP)
Incidence and severity of adverse events and serious adverse events
Assessed by incidence and severity of adverse events and serious adverse events
Time frame: From first dose through Week 24 (DB-TP)
Immunogenicity
Assessed by incidence of anti-drug antibodies
Time frame: From first dose through Week 24 (DB-TP)
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