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  3. NCT06586957 – A Randomized, Open Label, Two-Arm, Multicenter Phase 2 Study to Evaluate Efficacy and Safety of PRGN-2009 in Combination with Pembrolizumab Versus Pembrolizumab Monotherapy in Patients with Recurrent or Metastatic Cervical Cancer

NCT06586957 – A Randomized, Open Label, Two-Arm, Multicenter Phase 2 Study to Evaluate Efficacy and Safety of PRGN-2009 in Combination with Pembrolizumab Versus Pembrolizumab Monotherapy in Patients with Recurrent or Metastatic Cervical Cancer

Last modified: August 12, 2025
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  • NCT06586957 – A Randomized, Open Label, Two-Arm, Multicenter Phase 2 Study to Evaluate Efficacy and Safety of PRGN-2009 in Combination with Pembrolizumab Versus Pembrolizumab Monotherapy in Patients with Recurrent or Metastatic Cervical Cancer

The goal of the Dose Escalation phase of the study is to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity to determine the preliminary recommended dose for expansion (RDE) of NKT3964 in adults with advanced or metastatic solid tumors. The goal of the Expansion phase of the study is to evaluate the preliminary anti-tumor activity of NKT3964 at the RDEs based on objective response rate (ORR) and determine the preliminary recommended Phase 2 dose (RP2D).

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