Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01953692 · OUTCOME

Overall Survival (OS)

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
MEDIAN
Unit
Months
Interval / dispersion
95% Confidence Interval
Time frame
Up to approximately 78.5 months

What was measured

OS was defined as the time from first dose of study treatment to death due to any cause. OS was calculated from product-limit (Kaplan-Meier) method for censored data. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up.

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

Groups in this outcome

Cohort 1: Myelodysplastic Syndrome (MDS)

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

Cohort 2: Relapsed Refractory/Refractory (rR/R) Multiple Myeloma (MM)

Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle OR 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.

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.

Cohort 4A: R/R Primary Mediastinal B-cell Lymphoma (PMBCL)

Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle OR 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.

Cohort 4B: Other Non-Hodgkin Lymphoma: Grey Zone, Splenic Marginal Zone, and Mantle Cell Lymphomas

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

Cohort 4C: R/R Follicular Lymphoma (FL)

Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle.

Cohort 4D: R/R Diffuse Large B-Cell Lymphoma (DLBCL)

Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-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 1: Myelodysplastic Syndrome (MDS)27
Cohort 2: Relapsed Refractory/Refractory (rR/R) Multiple Myeloma (MM)30
Cohort 3: Relapsed/Refractory (R/R) Hodgkin Lymphoma (HL)31
Cohort 4A: R/R Primary Mediastinal B-cell Lymphoma (PMBCL)21
Cohort 4B: Other Non-Hodgkin Lymphoma: Grey Zone, Splenic Marginal Zone, and Mantle Cell Lymphomas4
Cohort 4C: R/R Follicular Lymphoma (FL)20
Cohort 4D: R/R Diffuse Large B-Cell Lymphoma (DLBCL)41

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cohort 1: Myelodysplastic Syndrome (MDS)6.0Not reported3.512.2Not reported
Cohort 2: Relapsed Refractory/Refractory (rR/R) Multiple Myeloma (MM)20.2Not reported14.135.5Not reported
Cohort 3: Relapsed/Refractory (R/R) Hodgkin Lymphoma (HL)NANot reportedNANANA=Median OS and upper and lower limits not reached at time of data cut-off due to insufficient number of participants with an event.
Cohort 4A: R/R Primary Mediastinal B-cell Lymphoma (PMBCL)37.1Not reported4.9NANA=OS upper limit not reached at time of data cut-off due to insufficient number of participants with an event.
Cohort 4B: Other Non-Hodgkin Lymphoma: Grey Zone, Splenic Marginal Zone, and Mantle Cell Lymphomas23.8Not reported0.428.6Not reported
Cohort 4C: R/R Follicular Lymphoma (FL)NANot reported14.7NANA=Median OS and upper limit not reached at time of data cut-off due to insufficient number of participants with an event.
Cohort 4D: R/R Diffuse Large B-Cell Lymphoma (DLBCL)4.9Not reported3.67.8Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3.5
        upper Limit
        12.2
        value
        6.0
      2. group Id
        OG001
        lower Limit
        14.1
        upper Limit
        35.5
        value
        20.2
      3. comment
        NA=Median OS and upper and lower limits not reached at time of data cut-off due to insufficient number of participants with an event.
        group Id
        OG002
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      4. comment
        NA=OS upper limit not reached at time of data cut-off due to insufficient number of participants with an event.
        group Id
        OG003
        lower Limit
        4.9
        upper Limit
        NA
        value
        37.1
      5. group Id
        OG004
        lower Limit
        0.4
        upper Limit
        28.6
        value
        23.8
      6. comment
        NA=Median OS and upper limit not reached at time of data cut-off due to insufficient number of participants with an event.
        group Id
        OG005
        lower Limit
        14.7
        upper Limit
        NA
        value
        NA
      7. group Id
        OG006
        lower Limit
        3.6
        upper Limit
        7.8
        value
        4.9
denoms
  1. counts
    1. group Id
      OG000
      value
      27
    2. group Id
      OG001
      value
      30
    3. group Id
      OG002
      value
      31
    4. group Id
      OG003
      value
      21
    5. group Id
      OG004
      value
      4
    6. group Id
      OG005
      value
      20
    7. group Id
      OG006
      value
      41
    units
    Participants
description
OS was defined as the time from first dose of study treatment to death due to any cause. OS was calculated from product-limit (Kaplan-Meier) method for censored data. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received pembrolizumab 10 mg/kg by intravenous (IV) infusion on Day 1 of each 14-day cycle.
    id
    OG000
    title
    Cohort 1: Myelodysplastic Syndrome (MDS)
  2. description
    Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle OR 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.
    id
    OG001
    title
    Cohort 2: Relapsed Refractory/Refractory (rR/R) Multiple Myeloma (MM)
  3. description
    Participants received pembrolizumab 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.
    id
    OG002
    title
    Cohort 3: Relapsed/Refractory (R/R) Hodgkin Lymphoma (HL)
  4. description
    Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle OR 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.
    id
    OG003
    title
    Cohort 4A: R/R Primary Mediastinal B-cell Lymphoma (PMBCL)
  5. description
    Participants received pembrolizumab 10 mg/kg by intravenous (IV) infusion on Day 1 of each 14-day cycle.
    id
    OG004
    title
    Cohort 4B: Other Non-Hodgkin Lymphoma: Grey Zone, Splenic Marginal Zone, and Mantle Cell Lymphomas
  6. description
    Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle.
    id
    OG005
    title
    Cohort 4C: R/R Follicular Lymphoma (FL)
  7. description
    Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle.
    id
    OG006
    title
    Cohort 4D: R/R Diffuse Large B-Cell Lymphoma (DLBCL)
param Type
MEDIAN
population Description
All participants 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
Overall Survival (OS)
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice