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NCT03141177 · OUTCOME

Progression Free Survival (PFS)

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
MEDIAN
Unit
Months
Interval / dispersion
95% Confidence Interval
Time frame
From randomization date to date of first documented tumor progression or death, whichever occurs first (Up to 31 months)

What was measured

PFS is defined as the time from date of randomization to the first documented tumor progression date or death due to any cause, whichever occurs first based on BICR assessment using RECIST v1.1. Participants who die without a reported progression will be considered to have progressed on the date of their death. Participants who did not progress or die will be censored on the date of their last evaluable tumor assessment on or prior to initiation of subsequent anti-cancer therapy. Progressive disease (PD); 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study

Analysis population: All Randomized Participants of treatment A and treatment C

Groups in this outcome

Treatment A

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 C328

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment A16.59Not reported12.4524.94Not reported
Treatment C8.31Not reported6.979.69Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.41
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.64
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Treatment A over Treatment C
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    param Type
    Hazard Ratio (HR)
    param Value
    0.51
    statistical Method
    Stratified Log-Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.41
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.64
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Treatment A over Treatment C
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    param Type
    Hazard Ratio (HR)
    param Value
    0.51
    statistical Method
    Stratified Log-Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        12.45
        upper Limit
        24.94
        value
        16.59
      2. group Id
        OG001
        lower Limit
        6.97
        upper Limit
        9.69
        value
        8.31
denoms
  1. counts
    1. group Id
      OG000
      value
      323
    2. group Id
      OG001
      value
      328
    units
    Participants
description
PFS is defined as the time from date of randomization to the first documented tumor progression date or death due to any cause, whichever occurs first based on BICR assessment using RECIST v1.1. Participants who die without a reported progression will be considered to have progressed on the date of their death. Participants who did not progress or die will be censored on the date of their last evaluable tumor assessment on or prior to initiation of subsequent anti-cancer therapy. Progressive disease (PD); 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study
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
    Sunitinib 50 mg PO QD for 4 weeks, followed by 2 weeks off, per cycle
    id
    OG001
    title
    Treatment C
param Type
MEDIAN
population Description
All Randomized Participants of treatment A and treatment C
reporting Status
POSTED
time Frame
From randomization date to date of first documented tumor progression or death, whichever occurs first (Up to 31 months)
title
Progression Free Survival (PFS)
type
PRIMARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice