ORPHEUS

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Official Title: A Multicenter, Open-Label, Single-ARm, PHase II Clinical Trial to Evaluate the Efficacy and Safety of INCMGA00012 in Advanced Penile SquamoUS Cell Carcinoma – ORPHEUS

ORPHEUS is an international, multicenter, open-label, single-arm, phase II clinical trial in men with locally advanced unresectable or metastatic penile squamous cell carcinoma (PSCC).

The primary goal is to assess the efficacy –as determined by the objective response rate (ORR)– of INCMGA00012 in the study population.

In addition, this study will also evaluate the safety and tolerability of INCMGA00012 in these patients.


TUMOR TYPE PHASE N SITES COUNTRY STATUS
Penile II 18 15 Spain, Italy, Germany Start up