Efficacy of INCMGA00012 in Penile Squamous Cell Carcinoma (ORPHEUS)

Sponsor
MedSIR
Study ID
NCT04231981
Phase
PHASE2
Status
Completed

Conditions

  • Penile Cancer

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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

Key Dates

Start date
Apr 28, 2020
Status verified
May 2025
Primary completion
Feb 15, 2022
Completion
Aug 26, 2022

Study Design

Enrollment
18 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Interventional arm
    Patients will receive INCMGA00012 500 mg by intravenous infusion on Day1 of each cycle.

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: From baseline until disease progression or treatment discontinuation, up to 10.3 months ]

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