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NCT03599713 · OUTCOME

First-dose AUC0-t of Retifanlimab

A Study of INCMGA00012 in Metastatic Merkel Cell Carcinoma (POD1UM-201) · Source last updated 2025-08-05

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

Measure
MEAN
Unit
day*mg/L
Interval / dispersion
Standard Deviation
Time frame
preinfusion, 10 minutes postinfusion (± 10 minutes), and 4 hours postinfusion (± 10 minutes) on Day 1 of Cycle 1

What was measured

AUC0-t was defined as the area under the plasma concentration-time curve from time zero to time t.

Analysis population: PK Evaluable Population

Groups in this outcome

All Participants

Participants with recurrent, advanced locoregional disease or distant metastatic disease who did not receive any prior chemotherapy received retifanlimab 500 mg, administered by IV infusion over 60 minutes on Day 1 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
All Participants102

Reported measurements

Source class 1
Values in day*mg/L · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
All Participants1770549Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        549
        value
        1770
denoms
  1. counts
    1. group Id
      OG000
      value
      102
    units
    Participants
description
AUC0-t was defined as the area under the plasma concentration-time curve from time zero to time t.
dispersion Type
Standard Deviation
groups
  1. description
    Participants with recurrent, advanced locoregional disease or distant metastatic disease who did not receive any prior chemotherapy received retifanlimab 500 mg, administered by IV infusion over 60 minutes on Day 1 Q4W.
    id
    OG000
    title
    All Participants
param Type
MEAN
population Description
PK Evaluable Population
reporting Status
POSTED
time Frame
preinfusion, 10 minutes postinfusion (± 10 minutes), and 4 hours postinfusion (± 10 minutes) on Day 1 of Cycle 1
title
First-dose AUC0-t of Retifanlimab
type
SECONDARY
unit Of Measure
day*mg/L

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

Preserved source evidence · Not medical advice