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NCT02267603 · OUTCOME

Progression-free Survival (PFS) Using RECIST 1.1

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
NUMBER
Unit
% of participants
Interval / dispersion
Not reported
Time frame
Time from start of treatment to time of progression or death, whichever occurs first, assessed up to 16 months

What was measured

Survival curves for PFS will be estimated using the Kaplan-Meier method. Assessed percentage of participants with progression free survival up to 16 months.

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)50

Reported measurements

Source class 1
Values in % of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Pembrolizumab)49.9Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        49.9
denoms
  1. counts
    1. group Id
      OG000
      value
      50
    units
    Participants
description
Survival curves for PFS will be estimated using the Kaplan-Meier method. Assessed percentage of participants with progression free survival up to 16 months.
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
NUMBER
reporting Status
POSTED
time Frame
Time from start of treatment to time of progression or death, whichever occurs first, assessed up to 16 months
title
Progression-free Survival (PFS) Using RECIST 1.1
type
SECONDARY
unit Of Measure
% of participants

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

Preserved source evidence · Not medical advice