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NCT02231749 · OUTCOME

Overall Survival (OS) in Intermediate/Poor-Risk Participants With Previously Untreated Metastatic Renal Cell Carcinoma (mRCC)

Nivolumab Combined With Ipilimumab Versus Sunitinib in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma (CheckMate 214) · Source last updated 2026-05-27

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
From the date of randomization to the date of death (assessed up to June 2017, approximately 31 months)

What was measured

OS was defined as the time from randomization to the date of death from any cause. Survival time was censored at the date of last contact ("last known alive date") for subjects who were alive.

Analysis population: All Intermediate/Poor-Risk Participants

Groups in this outcome

Nivolumab + Ipilimumab

Nivolumab 3 mg/kg combined with Ipilimumab 1 mg/kg solutions intravenously every 3 weeks for 4 doses then Nivolumab 3 mg/kg solutions intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends

Sunitinib

Sunitinib 50 mg capsules by mouth once daily for 4 weeks then 2 weeks off, continuously until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends After completion of final analysis eligible participants may switch from receiving Sunitinib to receiving Nivolumab 3 mg/kg IV combined with Ipilimumab 1 mg/kg IV every 3 weeks for 4 doses then Nivolumab 240mg flat dose IV every 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
Nivolumab + Ipilimumab425
Sunitinib422

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Nivolumab + IpilimumabNANot reported28.16NAThe median for Overall Survival and Upper Limit have not been reached. There were an insufficient number of participants with events.
Sunitinib25.95Not reported22.08NAThe median for Overall Survival and Upper Limit have not been reached. There were an insufficient number of participants with events.

Source statistical analyses

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

  1. ci Lower Limit
    0.44
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    99.8
    ci Upper Limit
    0.89
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    param Type
    Hazard Ratio (HR)
    param Value
    0.63
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.44
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    99.8
    ci Upper Limit
    0.89
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    param Type
    Hazard Ratio (HR)
    param Value
    0.63
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. comment
        The median for Overall Survival and Upper Limit have not been reached. There were an insufficient number of participants with events.
        group Id
        OG000
        lower Limit
        28.16
        upper Limit
        NA
        value
        NA
      2. comment
        The median for Overall Survival and Upper Limit have not been reached. There were an insufficient number of participants with events.
        group Id
        OG001
        lower Limit
        22.08
        upper Limit
        NA
        value
        25.95
denoms
  1. counts
    1. group Id
      OG000
      value
      425
    2. group Id
      OG001
      value
      422
    units
    Participants
description
OS was defined as the time from randomization to the date of death from any cause. Survival time was censored at the date of last contact ("last known alive date") for subjects who were alive.
dispersion Type
95% Confidence Interval
groups
  1. description
    Nivolumab 3 mg/kg combined with Ipilimumab 1 mg/kg solutions intravenously every 3 weeks for 4 doses then Nivolumab 3 mg/kg solutions intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
    id
    OG000
    title
    Nivolumab + Ipilimumab
  2. description
    Sunitinib 50 mg capsules by mouth once daily for 4 weeks then 2 weeks off, continuously until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends After completion of final analysis eligible participants may switch from receiving Sunitinib to receiving Nivolumab 3 mg/kg IV combined with Ipilimumab 1 mg/kg IV every 3 weeks for 4 doses then Nivolumab 240mg flat dose IV every 2 weeks
    id
    OG001
    title
    Sunitinib
param Type
MEDIAN
population Description
All Intermediate/Poor-Risk Participants
reporting Status
POSTED
time Frame
From the date of randomization to the date of death (assessed up to June 2017, approximately 31 months)
title
Overall Survival (OS) in Intermediate/Poor-Risk Participants With Previously Untreated Metastatic Renal Cell Carcinoma (mRCC)
type
PRIMARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice