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NCT03141177 · OUTCOME

Objective Response Rate (ORR)

A Study of Nivolumab Combined With Cabozantinib Compared to Sunitinib in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma · Source last updated 2026-08-24

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
Up to 31 Months

What was measured

Objective Response Rate (ORR) is defined as the percentage of randomized participants who achieve a best response of confirmed complete response (CR) or confirmed partial response (PR) based on BICR assessments (using RECIST v1.1 criteria) divided by the number of all randomized participants. Complete response (CR): Disappearance of all target lesions. Partial response (PR): 30% decrease in the sum of diameters of target lesions.

Analysis population: All Randomized Participants

Groups in this outcome

Treatment A

Nivolumab 240 mg flat dose IV Q2W + Cabozantinib 40 mg PO QD

Treatment B

Nivolumab 3 mg/kg IV Q3W (x4 doses) + Cabozantinib 40 mg PO QD + Ipilimumab 1 mg/kg IV Q3W (x4 doses) Then Nivolumab 240 mg flat dose IV Q2W + Cabozantinib 40 mg PO QD

Treatment C

Sunitinib 50 mg PO QD for 4 weeks, followed by 2 weeks off, per 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
Treatment A323
Treatment B50
Treatment C328

Reported measurements

Source class 1
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment A55.7Not reported50.161.2Not reported
Treatment B44.0Not reported30.058.7Not reported
Treatment C27.1Not reported22.432.3Not reported

Source statistical analyses

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

  1. ci Lower Limit
    2.51
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    4.95
    group Ids
    1. OG000
    2. OG002
    non Inferiority Comment
    Treatment A over Treatment C
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    param Type
    Odds Ratio (OR)
    param Value
    3.52
    statistical Method
    Stratified Cochran-Mantel-Haenszel
  2. ci Lower Limit
    21.7
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    35.6
    estimate Comment
    Strata adjusted difference in objective response rate (Nivolumab+Cabozantinib - Sunitinib) based on DerSimonian and Laird.
    group Ids
    1. OG000
    2. OG002
    non Inferiority Comment
    Treatment A - Treatment C
    non Inferiority Type
    OTHER
    param Type
    Difference of Objective Response Rates
    param Value
    28.6
Complete source fields
analyses
  1. ci Lower Limit
    2.51
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    4.95
    group Ids
    1. OG000
    2. OG002
    non Inferiority Comment
    Treatment A over Treatment C
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    param Type
    Odds Ratio (OR)
    param Value
    3.52
    statistical Method
    Stratified Cochran-Mantel-Haenszel
  2. ci Lower Limit
    21.7
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    35.6
    estimate Comment
    Strata adjusted difference in objective response rate (Nivolumab+Cabozantinib - Sunitinib) based on DerSimonian and Laird.
    group Ids
    1. OG000
    2. OG002
    non Inferiority Comment
    Treatment A - Treatment C
    non Inferiority Type
    OTHER
    param Type
    Difference of Objective Response Rates
    param Value
    28.6
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        50.1
        upper Limit
        61.2
        value
        55.7
      2. group Id
        OG001
        lower Limit
        30.0
        upper Limit
        58.7
        value
        44.0
      3. group Id
        OG002
        lower Limit
        22.4
        upper Limit
        32.3
        value
        27.1
denoms
  1. counts
    1. group Id
      OG000
      value
      323
    2. group Id
      OG001
      value
      50
    3. group Id
      OG002
      value
      328
    units
    Participants
description
Objective Response Rate (ORR) is defined as the percentage of randomized participants who achieve a best response of confirmed complete response (CR) or confirmed partial response (PR) based on BICR assessments (using RECIST v1.1 criteria) divided by the number of all randomized participants. Complete response (CR): Disappearance of all target lesions. Partial response (PR): 30% decrease in the sum of diameters of target lesions.
dispersion Type
95% Confidence Interval
groups
  1. description
    Nivolumab 240 mg flat dose IV Q2W + Cabozantinib 40 mg PO QD
    id
    OG000
    title
    Treatment A
  2. description
    Nivolumab 3 mg/kg IV Q3W (x4 doses) + Cabozantinib 40 mg PO QD + Ipilimumab 1 mg/kg IV Q3W (x4 doses) Then Nivolumab 240 mg flat dose IV Q2W + Cabozantinib 40 mg PO QD
    id
    OG001
    title
    Treatment B
  3. description
    Sunitinib 50 mg PO QD for 4 weeks, followed by 2 weeks off, per cycle
    id
    OG002
    title
    Treatment C
param Type
NUMBER
population Description
All Randomized Participants
reporting Status
POSTED
time Frame
Up to 31 Months
title
Objective Response Rate (ORR)
type
SECONDARY
unit Of Measure
Percentage of Participants

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

Preserved source evidence · Not medical advice