A New Trial On Board: The ORPHEUS Study

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MedSIR will soon begin the ORPHEUS study“A Multicenter, Open-Label, Single-Arm, Phase II Clinical Trial to Evaluate the Efficacy and Safety of INCMGA00012 in Advanced Penile Squamous Cell Carcinoma”.

This proposal is presented by MedSIR to Incyte Corporation with Dr. Xavier Garcia del Muro from the Catalan Institute of Oncology as Principal Investigator.

The goal of this trial is to explore the benefit of using an immunotherapeutic approach in patients with advanced penile squamous cell carcinoma (PSCC). Previous data showed that other squamous cell carcinomas, such as head and neck and lung cancers, have responded well to immunotherapies. We thereby hypothesize that patients suffering from PSCC will benefit from immunotherapy using the INCMGA00012 drug.

The project aims to explore the efficacy and safety of INCMGA00012 in patients with advanced penile squamous cell carcinoma. The life expectancy of these patients is pretty low due to limited treatment options. Therefore, there is a clear need for novel molecular and immunotherapeutic targets for these patients.

We expect to recruit 18 patients in 3 European countries (Spain, Germany, and Italy) with an estimated accrual period of 12 months. The first regulatory approval in Spain is planned by the beginning of next year.

We believe that this trial represents a great opportunity for a target population with very poor prognosis, significant morbidity and mortality, and where few treatment options currently exist.


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