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NCT01953692 · OUTCOME

Objective Response Rate (ORR) in Cohort 3: Relapsed/Refractory (R/R) Hodgkin Lymphoma (HL)

A Trial of Pembrolizumab (MK-3475) in Participants With Blood Cancers (MK-3475-013/KEYNOTE-013) · Source last updated 2021-08-04

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 78.5 months

What was measured

ORR was defined as the percentage of participants with response (complete response \[CR\] or partial response \[PR\]) according to the revised response criteria for malignant lymphoma per Cheson et al. 2007. CR was demonstrated by disappearance of all evidence of disease in the bone marrow, spleen, liver, and lymph nodes. PR was \>50% decrease in the sum of product diameters (SPD) for ≤6 target masses for lymph nodes and \>50% decrease in SPD for a single nodule in greatest transverse diameter for spleen and liver, and no size increase in the lymph nodes, spleen, or liver. The percentage of participants who experience ORR as assessed by the investigator is presented.

Analysis population: All participants in Cohort 3 with a baseline efficacy evaluation and at least 1 post-baseline efficacy evaluation.

Groups in this outcome

Cohort 3: Relapsed/Refractory (R/R) Hodgkin Lymphoma (HL)

Participants received pembrolizumab 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.

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

Analysis denominator · Participants

GroupSource count
Cohort 3: Relapsed/Refractory (R/R) Hodgkin Lymphoma (HL)31

Reported measurements

Source class 1
Values in Percentage of participants · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Cohort 3: Relapsed/Refractory (R/R) Hodgkin Lymphoma (HL)64.5Not reported48.278.7Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        48.2
        upper Limit
        78.7
        value
        64.5
denoms
  1. counts
    1. group Id
      OG000
      value
      31
    units
    Participants
description
ORR was defined as the percentage of participants with response (complete response \[CR\] or partial response \[PR\]) according to the revised response criteria for malignant lymphoma per Cheson et al. 2007. CR was demonstrated by disappearance of all evidence of disease in the bone marrow, spleen, liver, and lymph nodes. PR was \>50% decrease in the sum of product diameters (SPD) for ≤6 target masses for lymph nodes and \>50% decrease in SPD for a single nodule in greatest transverse diameter for spleen and liver, and no size increase in the lymph nodes, spleen, or liver. The percentage of participants who experience ORR as assessed by the investigator is presented.
dispersion Type
90% Confidence Interval
groups
  1. description
    Participants received pembrolizumab 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.
    id
    OG000
    title
    Cohort 3: Relapsed/Refractory (R/R) Hodgkin Lymphoma (HL)
param Type
NUMBER
population Description
All participants in Cohort 3 with a baseline efficacy evaluation and at least 1 post-baseline efficacy evaluation.
reporting Status
POSTED
time Frame
Up to approximately 78.5 months
title
Objective Response Rate (ORR) in Cohort 3: Relapsed/Refractory (R/R) Hodgkin Lymphoma (HL)
type
SECONDARY
unit Of Measure
Percentage of participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice