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NCT02576990 · OUTCOME

Disease Control Rate (DCR) Based on IWG Response Assessment Criteria by Investigator Assessment

Study of Pembrolizumab (MK-3475) in Participants With Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma or Relapsed or Refractory Richter Syndrome (MK-3475-170/KEYNOTE-170) · Source last updated 2023-07-27

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

Measure
NUMBER
Unit
Percentage of participants
Interval / dispersion
90% Confidence Interval
Time frame
Up to approximately 27 months (Database Cutoff Date: 28MAY2019)

What was measured

The DCR was defined as the percentage of participants in the analysis population who have achieved a CR, PR or SD response prior to PD. CR is the disappearance of all evidence of disease and PR is the regression of measurable disease and no new sites. SD is the failure to attain CR/PR or PD. PD is the appearance any new lesion or increase by ≥ 50% of previously involved site from nadir. Participants with missing data were considered non-responders.

Analysis population: The analysis population included all participants who received at least one dose of study medication (pembrolizumab).

Groups in this outcome

Pembrolizumab: Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL)

Pembrolizumab 200 mg every 3 weeks (Q3W), intravenous infusion (IV) on Day 1 of each 3-week cycle for up to 35 administrations (approximately 2 years).

Pembrolizumab: Relapsed or Refractory Richter Syndrome (rrRS)

Pembrolizumab 200 mg Q3W, IV on Day 1 of each 3-week cycle for up to 35 administrations (approximately 2 years).

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: Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL)53
Pembrolizumab: Relapsed or Refractory Richter Syndrome (rrRS)23

Reported measurements

Source class 1
Values in Percentage of participants · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Pembrolizumab: Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL)52.8Not reported40.764.7Not reported
Pembrolizumab: Relapsed or Refractory Richter Syndrome (rrRS)26.1Not reported12.045.1Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        40.7
        upper Limit
        64.7
        value
        52.8
      2. group Id
        OG001
        lower Limit
        12.0
        upper Limit
        45.1
        value
        26.1
denoms
  1. counts
    1. group Id
      OG000
      value
      53
    2. group Id
      OG001
      value
      23
    units
    Participants
description
The DCR was defined as the percentage of participants in the analysis population who have achieved a CR, PR or SD response prior to PD. CR is the disappearance of all evidence of disease and PR is the regression of measurable disease and no new sites. SD is the failure to attain CR/PR or PD. PD is the appearance any new lesion or increase by ≥ 50% of previously involved site from nadir. Participants with missing data were considered non-responders.
dispersion Type
90% Confidence Interval
groups
  1. description
    Pembrolizumab 200 mg every 3 weeks (Q3W), intravenous infusion (IV) on Day 1 of each 3-week cycle for up to 35 administrations (approximately 2 years).
    id
    OG000
    title
    Pembrolizumab: Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL)
  2. description
    Pembrolizumab 200 mg Q3W, IV on Day 1 of each 3-week cycle for up to 35 administrations (approximately 2 years).
    id
    OG001
    title
    Pembrolizumab: Relapsed or Refractory Richter Syndrome (rrRS)
param Type
NUMBER
population Description
The analysis population included all participants who received at least one dose of study medication (pembrolizumab).
reporting Status
POSTED
time Frame
Up to approximately 27 months (Database Cutoff Date: 28MAY2019)
title
Disease Control Rate (DCR) Based on IWG Response Assessment Criteria by Investigator Assessment
type
SECONDARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice