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NCT04231981 · OUTCOME

Efficacy Determined by Maximum Tumor Shrinkage

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
MEAN
Unit
percentage of change from baseline
Interval / dispersion
Standard Deviation
Time frame
From baseline until disease progression or treatment discontinuation, up to 10.3 months

What was measured

Maximum tumor shrinkage is defined as the percentage of tumor shrinkage from baseline (obtained from the sum of largest diameters of the target lesions), 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 percentage of change from baseline · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Interventional Arm15.949.1Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        49.1
        value
        15.9
denoms
  1. counts
    1. group Id
      OG000
      value
      18
    units
    Participants
description
Maximum tumor shrinkage is defined as the percentage of tumor shrinkage from baseline (obtained from the sum of largest diameters of the target lesions), based on local investigator's assessment according to RECIST criteria v1.1.
dispersion Type
Standard Deviation
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
MEAN
reporting Status
POSTED
time Frame
From baseline until disease progression or treatment discontinuation, up to 10.3 months
title
Efficacy Determined by Maximum Tumor Shrinkage
type
SECONDARY
unit Of Measure
percentage of change from baseline

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

Preserved source evidence · Not medical advice