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NCT03597295 · OUTCOME

Cmax of Retifanlimab

A Study of INCMGA00012 in Squamous Carcinoma of the Anal Canal Following Platinum-Based Chemotherapy (POD1UM-202) · Source last updated 2025-08-21

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

Measure
MEAN
Unit
milligrams per Liter (mg/L)
Interval / dispersion
Standard Deviation
Time frame
pre-infusion on Day 1 of Cycles 1, 2, 4, 6, and 7; 10 minutes and 4 hours post-infusion on Day 1 of Cycles 1 and 6

What was measured

Cmax was defined as the maximum observed plasma concentration.

Analysis population: Pharmacokinetic (PK) Evaluable Population: all participants who received at least 1 dose of study drug and provided a Baseline and at least 1 postdose serum sample (1 PK measurement)

Groups in this outcome

Retifanlimab 500 mg

Participants received retifanlimab 500 milligrams (mg) intravenously every 4 weeks (Q4W).

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

Analysis denominator · Participants

GroupSource count
Retifanlimab 500 mg92

Reported measurements

Source class 1
Values in milligrams per Liter (mg/L) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Retifanlimab 500 mg15127.6Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        27.6
        value
        151
denoms
  1. counts
    1. group Id
      OG000
      value
      92
    units
    Participants
description
Cmax was defined as the maximum observed plasma concentration.
dispersion Type
Standard Deviation
groups
  1. description
    Participants received retifanlimab 500 milligrams (mg) intravenously every 4 weeks (Q4W).
    id
    OG000
    title
    Retifanlimab 500 mg
param Type
MEAN
population Description
Pharmacokinetic (PK) Evaluable Population: all participants who received at least 1 dose of study drug and provided a Baseline and at least 1 postdose serum sample (1 PK measurement)
reporting Status
POSTED
time Frame
pre-infusion on Day 1 of Cycles 1, 2, 4, 6, and 7; 10 minutes and 4 hours post-infusion on Day 1 of Cycles 1 and 6
title
Cmax of Retifanlimab
type
SECONDARY
unit Of Measure
milligrams per Liter (mg/L)

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice