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NCT04231981 · OUTCOME

Efficacy Determined by 6-months 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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Baseline up to 6 months

What was measured

6-months PFS rate is defined as the proportion of patients who are alive and progression-free at 6 months from the date of first dose of study treatment based on iRECIST criteria.

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 Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Interventional Arm2Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
denoms
  1. counts
    1. group Id
      OG000
      value
      18
    units
    Participants
description
6-months PFS rate is defined as the proportion of patients who are alive and progression-free at 6 months from the date of first dose of study treatment based on iRECIST criteria.
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
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
Baseline up to 6 months
title
Efficacy Determined by 6-months PFS
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice