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NCT02853331 · OUTCOME

Overall Survival (OS)

Study to Evaluate the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Axitinib Versus Sunitinib Monotherapy in Participants With Renal Cell Carcinoma (MK-3475-426/KEYNOTE-426) · Source last updated 2026-02-02

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
Through Database Cutoff Date of 24-Aug-2018 (up to approximately 22 months)

What was measured

OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the interim analysis were censored at the date of the last follow up. The OS was calculated using the product-limit (Kaplan-Meier) method for censored data. The OS for participants is presented.

Analysis population: The analysis population consisted of all randomized participants.

Groups in this outcome

Pembrolizumab + Axitinib

Participants received pembrolizumab 200 mg intravenously every 3 weeks PLUS axitinib 5 mg orally twice daily.

Sunitinib

Participants received sunitinib 50 mg orally once daily for 4 weeks and then were off treatment for 2 weeks.

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 + Axitinib432
Sunitinib429

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pembrolizumab + AxitinibNANot reportedNANAOS median, OS lower limit \& OS upper limit were not reached by the time of the data cutoff (24-Aug-2018).
SunitinibNANot reportedNANAOS median, OS lower limit \& OS upper limit were not reached by the time of the data cutoff (24-Aug-2018).

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    0.38
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.74
    estimate Comment
    HR based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by IMDC risk group (favorable vs. intermediate vs. poor) and geographic region (North America vs. Western Europe vs. Rest of World).
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.00005
    param Type
    Hazard Ratio (HR)
    param Value
    0.53
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.38
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.74
    estimate Comment
    HR based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by IMDC risk group (favorable vs. intermediate vs. poor) and geographic region (North America vs. Western Europe vs. Rest of World).
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.00005
    param Type
    Hazard Ratio (HR)
    param Value
    0.53
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. comment
        OS median, OS lower limit \& OS upper limit were not reached by the time of the data cutoff (24-Aug-2018).
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      2. comment
        OS median, OS lower limit \& OS upper limit were not reached by the time of the data cutoff (24-Aug-2018).
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      432
    2. group Id
      OG001
      value
      429
    units
    Participants
description
OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the interim analysis were censored at the date of the last follow up. The OS was calculated using the product-limit (Kaplan-Meier) method for censored data. The OS for participants is presented.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received pembrolizumab 200 mg intravenously every 3 weeks PLUS axitinib 5 mg orally twice daily.
    id
    OG000
    title
    Pembrolizumab + Axitinib
  2. description
    Participants received sunitinib 50 mg orally once daily for 4 weeks and then were off treatment for 2 weeks.
    id
    OG001
    title
    Sunitinib
param Type
MEDIAN
population Description
The analysis population consisted of all randomized participants.
reporting Status
POSTED
time Frame
Through Database Cutoff Date of 24-Aug-2018 (up to approximately 22 months)
title
Overall Survival (OS)
type
PRIMARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice