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NCT02155647 · OUTCOME

Part A: Final Analysis: Overall Survival (OS) Time

Avelumab in Participants With Merkel Cell Carcinoma (JAVELIN Merkel 200) · Source last updated 2024-03-13

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

Measure
MEDIAN
Unit
months
Interval / dispersion
Full Range
Time frame
Time from first administration of trial treatment until death (Up to 325 weeks)

What was measured

The OS time was defined as the time from first administration of trial treatment until death. The OS time was analyzed using the Kaplan-Meier method.

Analysis population: Intent-to-Treat analysis set included all participants who received at least 1 dose of study treatment.

Groups in this outcome

Part A: Avelumab

Participants with metastatic Merkel cell carcinoma (MCC) after failing first-line chemotherapy received Avelumab at a dose of 10 milligram per kilogram (mg/kg) as 1-hour intravenous infusion once every 2 weeks until therapeutic failure, significant clinical deterioration, unacceptable toxicity, or any criterion for withdrawal from the trial or investigational medicinal product occurs.

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

Analysis denominator · Participants

GroupSource count
Part A: Avelumab88

Reported measurements

Source class 1
Values in months · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part A: Avelumab12.6Not reported0.471.9Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.4
        upper Limit
        71.9
        value
        12.6
denoms
  1. counts
    1. group Id
      OG000
      value
      88
    units
    Participants
description
The OS time was defined as the time from first administration of trial treatment until death. The OS time was analyzed using the Kaplan-Meier method.
dispersion Type
Full Range
groups
  1. description
    Participants with metastatic Merkel cell carcinoma (MCC) after failing first-line chemotherapy received Avelumab at a dose of 10 milligram per kilogram (mg/kg) as 1-hour intravenous infusion once every 2 weeks until therapeutic failure, significant clinical deterioration, unacceptable toxicity, or any criterion for withdrawal from the trial or investigational medicinal product occurs.
    id
    OG000
    title
    Part A: Avelumab
param Type
MEDIAN
population Description
Intent-to-Treat analysis set included all participants who received at least 1 dose of study treatment.
reporting Status
POSTED
time Frame
Time from first administration of trial treatment until death (Up to 325 weeks)
title
Part A: Final Analysis: Overall Survival (OS) Time
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice