NCT03599713 · OUTCOME

First-dose Cmax 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: micrograms per milliliter (μg/mL)
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

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 have provided a Baseline and at least 1 post-dose PK sample

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

Group	Source count
All Participants	102

Reported measurements

Source class 1

Values in micrograms per milliliter (μg/mL) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Participants	144	32.6	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
32.6
value
144

denoms

counts
group Id
OG000
value
102
units
Participants

description

Cmax was defined as the maximum observed plasma concentration.

dispersion Type

Standard Deviation

groups

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

Pharmacokinetic (PK) Evaluable Population: all participants who received at least 1 dose of study drug and have provided a Baseline and at least 1 post-dose PK sample

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 Cmax of Retifanlimab

type

SECONDARY

unit Of Measure

micrograms per milliliter (μg/mL)

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

Preserved source evidence · Not medical advice