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NCT02576990 · OUTCOME

Progression Free Survival (PFS) Based on IWG Response Assessment Criteria by Independent Central Review

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
MEDIAN
Unit
Months
Interval / dispersion
95% Confidence Interval
Time frame
Up to approximately 27 months (Database Cutoff Date: 28MAY2019)

What was measured

PFS was defined as the time from first dose to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. PD is the appearance of any new lesion or increase by ≥ 50% of previously involved site from nadir. Calculated from the product-limit (Kaplan-Meier) method for censored data.

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 Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pembrolizumab: Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL)5.5Not reported2.815.1Not reported
Pembrolizumab: Relapsed or Refractory Richter Syndrome (rrRS)1.6Not reported1.02.1Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.8
        upper Limit
        15.1
        value
        5.5
      2. group Id
        OG001
        lower Limit
        1.0
        upper Limit
        2.1
        value
        1.6
denoms
  1. counts
    1. group Id
      OG000
      value
      53
    2. group Id
      OG001
      value
      23
    units
    Participants
description
PFS was defined as the time from first dose to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. PD is the appearance of any new lesion or increase by ≥ 50% of previously involved site from nadir. Calculated from the product-limit (Kaplan-Meier) method for censored data.
dispersion Type
95% 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
MEDIAN
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
Progression Free Survival (PFS) Based on IWG Response Assessment Criteria by Independent Central Review
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice