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NCT02231749 · OUTCOME

Objective Response Rate (ORR) in Intermediate/Poor Risk Participants Per Independent Radiology Review Committee (IRRC) Using RECIST v1.1

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
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
From first dose until date of documented disease progression or subsequent therapy, whichever occurs first (assessed up to June 2017, approximately 31 months)

What was measured

ORR was defined as the proportion of randomized subjects who achieved a best response of complete response (CR) or partial response (PR) using the RECIST v1.1 criteria based on Independent Radiology Review Committee (IRRC) assessment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), greater than or equal to 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

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 percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Nivolumab + Ipilimumab41.6Not reported36.946.5Not reported
Sunitinib26.5Not reported22.431.0Not reported

Source statistical analyses

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

  1. ci Lower Limit
    9.8
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    22.2
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    param Type
    Stratified Difference
    param Value
    16.0
    statistical Method
    DerSimonian and Laird Test
Complete source fields
analyses
  1. ci Lower Limit
    9.8
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    22.2
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    param Type
    Stratified Difference
    param Value
    16.0
    statistical Method
    DerSimonian and Laird Test
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        36.9
        upper Limit
        46.5
        value
        41.6
      2. group Id
        OG001
        lower Limit
        22.4
        upper Limit
        31.0
        value
        26.5
denoms
  1. counts
    1. group Id
      OG000
      value
      425
    2. group Id
      OG001
      value
      422
    units
    Participants
description
ORR was defined as the proportion of randomized subjects who achieved a best response of complete response (CR) or partial response (PR) using the RECIST v1.1 criteria based on Independent Radiology Review Committee (IRRC) assessment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), greater than or equal to 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
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
NUMBER
population Description
All Intermediate/Poor-Risk Participants
reporting Status
POSTED
time Frame
From first dose until date of documented disease progression or subsequent therapy, whichever occurs first (assessed up to June 2017, approximately 31 months)
title
Objective Response Rate (ORR) in Intermediate/Poor Risk Participants Per Independent Radiology Review Committee (IRRC) Using RECIST v1.1
type
PRIMARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice