drugset / Trial / NCT04812535

Non-comparative Study of IFX-1 Alone or IFX-1+Pembrolizumab in Patients With Locally Advanced or Metastatic cSCC.

NCT04812535 ↗

Phase 2 Terminated 30 enrolled InflaRx GmbH Merck Sharp & Dohme LLC · collab
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This is an open-label, "non comparative", non-randomized, Phase II study. Patients will be enrolled in 2 treatment arms

Timeline

Start
2021-03-31
Primary completion
2024-06-04
Completion
2024-06-04

Outcome

Outcome not reported

Stopped: “Sponsor decided to stop the development of vilobelimab in cSCC and early terminated the IFX-1-P2.8 trial due to new alternative treatments for cSCC with high efficacy rates.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Pembrolizumab Monoclonal antibody 400 mg Intravenous
Subject vilobelimab Monoclonal antibody 800 mg Intravenous
Subject vilobelimab Monoclonal antibody 1200 mg Intravenous
Subject vilobelimab Monoclonal antibody 1600 mg Intravenous