At a glance
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A Phase 1 Randomized Clinical Study of Pembrolizumab (MK-3475) to Evaluate the Relative Bioavailability of Subcutaneous Injection Versus Intravenous Infusion in Participants With Advanced Melanoma (KEYNOTE-555)
In Brief
A Phase 1 clinical trial evaluating Pembrolizumab Dose C, Pembrolizumab Dose A, and 2 other interventions for Melanoma. Completed, enrolled 138 participants across 15 sites in 4 countries.
Detailed Summary
The purpose of this study is to characterize the pharmacokinetic (PK) profile of pembrolizumab (MK-3475) following single subcutaneous (SC) injection of pembrolizumab Dose A versus pembrolizumab Dose C in adults with advanced melanoma. Additionally, the safety and tolerability of pembrolizumab SC injections will be assessed. And, finally, the efficacy of pembrolizumab intravenous (IV) infusion administration will be assessed.
Study Details
Timeline
Interventions
165 mg/mL administered to a final dose of 285 mg via subcutaneous injection
130 mg/mL administered to a final dose of 285 mg via subcutaneous injection
200 mg administered via intravenous infusion
400 mg administered via intravenous infusion