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NCT02335424 · OUTCOME

Programmed Cell Death Ligand 1 (PD-L1) Expression Status

Study of Pembrolizumab (MK-3475) in Participants With Advanced Urothelial Cancer (MK-3475-052/KEYNOTE-052) · Source last updated 2023-03-02

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Day 1

What was measured

PD-L1 expression status was determined as the percent of disease tumor cells, from newly obtained tumor biopsies, demonstrating plasma membrane PD-L1 staining of any intensity using an immunohistochemistry (IHC) assay. The assay uses a Combined Positive Score (CPS) as a measure of PD-L1 positivity. The CPS is calculated as the number of PD-L1-positive cells divided by the number of viable tumor cells analyzed multiplied by 100. A CPS of \<1% = negative; ≥1% = positive; and ≥10% = strongly positive. Per protocol, only data generated during the initial course of treatment contributed to the analysis.

Analysis population: All participants who received at least one dose of study treatment during the initial course of treatment

Groups in this outcome

Pembrolizumab 200 mg

Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 2 years. Eligible participants who stopped the initial course of pembrolizumab due to complete response (CR) or completed initial course of pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to an additional year.

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

Analysis denominator · Participants

GroupSource count
Pembrolizumab 200 mg370

Reported measurements

PD-L1 CPS <1%
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pembrolizumab 200 mg79Not reportedNot reportedNot reportedNot reported
PD-L1 CPS ≥1% to <10%
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pembrolizumab 200 mg172Not reportedNot reportedNot reportedNot reported
PD-L1 CPS ≥10%
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pembrolizumab 200 mg110Not reportedNot reportedNot reportedNot reported
Unknown
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pembrolizumab 200 mg9Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        79
    title
    PD-L1 CPS <1%
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        172
    title
    PD-L1 CPS ≥1% to <10%
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        110
    title
    PD-L1 CPS ≥10%
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        9
    title
    Unknown
denoms
  1. counts
    1. group Id
      OG000
      value
      370
    units
    Participants
description
PD-L1 expression status was determined as the percent of disease tumor cells, from newly obtained tumor biopsies, demonstrating plasma membrane PD-L1 staining of any intensity using an immunohistochemistry (IHC) assay. The assay uses a Combined Positive Score (CPS) as a measure of PD-L1 positivity. The CPS is calculated as the number of PD-L1-positive cells divided by the number of viable tumor cells analyzed multiplied by 100. A CPS of \<1% = negative; ≥1% = positive; and ≥10% = strongly positive. Per protocol, only data generated during the initial course of treatment contributed to the analysis.
groups
  1. description
    Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 2 years. Eligible participants who stopped the initial course of pembrolizumab due to complete response (CR) or completed initial course of pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to an additional year.
    id
    OG000
    title
    Pembrolizumab 200 mg
param Type
COUNT_OF_PARTICIPANTS
population Description
All participants who received at least one dose of study treatment during the initial course of treatment
reporting Status
POSTED
time Frame
Day 1
title
Programmed Cell Death Ligand 1 (PD-L1) Expression Status
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice