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A Randomized, Double-Blind, Multicenter, Pharmacokinetic Equivalence Clinical Trial of Adjuvant FYB206 (Keytruda Biosimilar Candidate) in Comparison With Keytruda (Pembrolizumab) to Demonstrate Pharmacokinetic Similarity in Patients With Completely Resected Stage IIB/IIC or Stage III Melanoma

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Trial Profile

A Randomized, Double-Blind, Multicenter, Pharmacokinetic Equivalence Clinical Trial of Adjuvant FYB206 (Keytruda Biosimilar Candidate) in Comparison With Keytruda (Pembrolizumab) to Demonstrate Pharmacokinetic Similarity in Patients With Completely Resected Stage IIB/IIC or Stage III Melanoma

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 08 May 2025

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At a glance

  • Drugs Pembrolizumab (Primary)
  • Indications Malignant melanoma
  • Focus Pharmacokinetics
  • Acronyms Dahlia
  • Sponsors Formycon

Most Recent Events

  • 17 Feb 2025 According to a Formycon AG media release, the therapeutic comparability of FYB206 with the reference drug Keytruda can be sufficiently demonstrated based on the comprehensive analytical data and the data from the parallel phase I trial (Dahlia) in patients with malignant melanoma (black skin cancer).
  • 13 Jun 2024 According to a Formycon AG media release, first patient was included in this trial. The study design of the "Dahlia" Phase I study was developed in close cooperation with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) and anticipates a treatment period of one year for the patients in the trial.
  • 13 Jun 2024 Status changed from planning to recruiting, according to an Formycon media release.

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