NCT04231981

Efficacy of INCMGA00012 in Penile Squamous Cell Carcinoma (ORPHEUS)

A Multicenter, Open-Label, Single-Arm, Phase II Clinical Trial to Evaluate the Efficacy and Safety of INCMGA00012 in Advanced Penile Squamous Cell Carcinoma.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: MedSIR · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, open-label, single-arm, phase II clinical trial to evaluate the efficacy and safety of INCMGA00012 in Advanced Penile Squamous Cell Carcinoma

Detailed description

Men age ≥ 18 years with locally advanced unresectable or metastatic PSqCC stage 4 (i.e. T4 or N3 or M1) that are presenting with radiologic progression of disease (PD) following or not standard treatment with chemotherapy. After signing the ICF and confirmed eligibility, patients will receive INCMGA00012 500 mg by intravenous infusion on Day1 of each cycle, once every four weeks for up to 2 years. Patients will receive treatment until disease progression, unacceptable toxicity, death, or discontinuation from the study treatment for any other reason. Patients discontinuing the study treatment period will enter a post-treatment follow-up period during which survival and new anti-cancer therapy information will be collected every 3 months (± 14 days) from the last dose of investigational product until the end of study (EoS).

Conditions

• Penile Cancer

Interventions

Type	Name	Description
DRUG	Retifanlimab	INCMGA00012 500 mg will be administered on Day1 of each cycle (once every four weeks), for up to 2 years.

Timeline

• Start date: 2020-04-28
• Primary completion: 2022-02-15
• Completion: 2022-08-26
• First posted: 2020-01-18
• Last updated: 2025-05-29
• Results posted: 2025-05-29

Locations

13 sites across 2 countries: Italy, Spain