Efficacy of INCMGA00012 in Penile Squamous Cell Carcinoma (ORPHEUS)

NCT04231981 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2025-05-29

Study results available
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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

Conditions

  • Penile Cancer

Interventions

DRUG

Retifanlimab

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

Sponsors & Collaborators

  • Incyte Biosciences International Sàrl

    collaborator INDUSTRY
  • MedSIR

    lead OTHER

Principal Investigators

  • Xavier García del Muro · ICO- Hospitalet

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-28
Primary Completion
2022-02-15
Completion
2022-08-26

Countries

  • Italy
  • Spain

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04231981 on ClinicalTrials.gov