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NCT02267603 · OUTCOME

Duration of Response (DOR)

Pembrolizumab in Treating Patients With Advanced Merkel Cell Cancer · Source last updated 2023-07-05

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

Measure
MEDIAN
Unit
months
Interval / dispersion
Full Range
Time frame
Time interval between the date of first response (CR/PR) and the date of progression, assessed up to 3 years

What was measured

Survival curves for DOR will be estimated using the Kaplan-Meier method.

Analysis population: Thirty participants with durable response were assessed by RECIST 1.1.

Groups in this outcome

Treatment (Pembrolizumab)

Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 24 months in the absence of disease progression\* or unacceptable toxicity. \* NOTE: Patients with confirmed disease progression may continue to receive treatment if they are otherwise clinically stable until there is an increase in tumor burden of 25% or more following initial confirmation of progression. Under exceptional circumstances, and with protocol P.I. and CITN P.I. approval, patients may receive treatment beyond 2 years. Laboratory Biomarker Analysis: Ancillary studies Pembrolizumab: Given IV

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

Analysis denominator · Participants

GroupSource count
Treatment (Pembrolizumab)30

Reported measurements

Source class 1
Values in months · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Treatment (Pembrolizumab)NANot reported4.077.4Median was not reached due to insufficient number of events, i.e., (too few participants had reached progression at data cutoff.)
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Median was not reached due to insufficient number of events, i.e., (too few participants had reached progression at data cutoff.)
        group Id
        OG000
        lower Limit
        4.0
        upper Limit
        77.4
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      30
    units
    Participants
description
Survival curves for DOR will be estimated using the Kaplan-Meier method.
dispersion Type
Full Range
groups
  1. description
    Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 24 months in the absence of disease progression\* or unacceptable toxicity. \* NOTE: Patients with confirmed disease progression may continue to receive treatment if they are otherwise clinically stable until there is an increase in tumor burden of 25% or more following initial confirmation of progression. Under exceptional circumstances, and with protocol P.I. and CITN P.I. approval, patients may receive treatment beyond 2 years. Laboratory Biomarker Analysis: Ancillary studies Pembrolizumab: Given IV
    id
    OG000
    title
    Treatment (Pembrolizumab)
param Type
MEDIAN
population Description
Thirty participants with durable response were assessed by RECIST 1.1.
reporting Status
POSTED
time Frame
Time interval between the date of first response (CR/PR) and the date of progression, assessed up to 3 years
title
Duration of Response (DOR)
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice