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NCT04231981 · OUTCOME

Efficacy Determined by Progression-free Survival (PFS)

Efficacy of INCMGA00012 in Penile Squamous Cell Carcinoma (ORPHEUS) · Source last updated 2025-05-29

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
From baseline until disease progression or treatment discontinuation, up to 10.3 months

What was measured

PFS is defined as the time from the date of the first dose of study treatment until the first documented PD based on RECIST v1.1. or death due to any cause, whichever occurs first based on local investigator's assessment according to RECIST criteria v1.1.

Groups in this outcome

Interventional Arm

Patients will receive INCMGA00012 500 mg by intravenous infusion on Day1 of each cycle. Retifanlimab: INCMGA00012 500 mg will be administered on Day1 of each cycle (once every four weeks), for up to 2 years.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Interventional Arm18

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Interventional Arm2Not reported1.63.3Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.6
        upper Limit
        3.3
        value
        2
denoms
  1. counts
    1. group Id
      OG000
      value
      18
    units
    Participants
description
PFS is defined as the time from the date of the first dose of study treatment until the first documented PD based on RECIST v1.1. or death due to any cause, whichever occurs first based on local investigator's assessment according to RECIST criteria v1.1.
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients will receive INCMGA00012 500 mg by intravenous infusion on Day1 of each cycle. Retifanlimab: INCMGA00012 500 mg will be administered on Day1 of each cycle (once every four weeks), for up to 2 years.
    id
    OG000
    title
    Interventional Arm
param Type
MEDIAN
reporting Status
POSTED
time Frame
From baseline until disease progression or treatment discontinuation, up to 10.3 months
title
Efficacy Determined by Progression-free Survival (PFS)
type
SECONDARY
unit Of Measure
months

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice