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NCT03599713 · OUTCOME

Overall Survival

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
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
up to 60.4 months

What was measured

Overall survival was defined as the time in months between the first dose date (Day 1) and the date of death due to any cause.

Analysis population: Safety Evaluable Population. Analysis was based on the chemotherapy-naïve subset of the population. Median overall survival time was estimated using the Kaplan-Meier method. CI for median overall survival time was calculated using the method of Brookmeyer and Crowley.

Groups in this outcome

Chemotherapy: Naïve

Participants with recurrent, advanced locoregional disease or distant metastatic disease who did not receive any prior chemotherapy received retifanlimab 500 milligrams (mg), administered by intravenous (IV) infusion over 60 minutes on Day 1 of each 28-day cycle (Q4W).

Chemotherapy: Refractory

Participants with disease not responding to 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
Chemotherapy: Naïve101
Chemotherapy: Refractory0

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Chemotherapy: NaïveNANot reported45.24NAThe median and the upper limit of the confidence interval were not estimable because too few participants died.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        The median and the upper limit of the confidence interval were not estimable because too few participants died.
        group Id
        OG000
        lower Limit
        45.24
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      101
    2. group Id
      OG001
      value
      0
    units
    Participants
description
Overall survival was defined as the time in months between the first dose date (Day 1) and the date of death due to any cause.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants with recurrent, advanced locoregional disease or distant metastatic disease who did not receive any prior chemotherapy received retifanlimab 500 milligrams (mg), administered by intravenous (IV) infusion over 60 minutes on Day 1 of each 28-day cycle (Q4W).
    id
    OG000
    title
    Chemotherapy: Naïve
  2. description
    Participants with disease not responding to prior chemotherapy received retifanlimab 500 mg, administered by IV infusion over 60 minutes on Day 1 Q4W.
    id
    OG001
    title
    Chemotherapy: Refractory
param Type
MEDIAN
population Description
Safety Evaluable Population. Analysis was based on the chemotherapy-naïve subset of the population. Median overall survival time was estimated using the Kaplan-Meier method. CI for median overall survival time was calculated using the method of Brookmeyer and Crowley.
reporting Status
POSTED
time Frame
up to 60.4 months
title
Overall Survival
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice