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NCT02684006 · OUTCOME

Progression-Free Survival on Next-line Therapy (PFS2) in Participants Irrespective of PD-L1 Expression

A Study of Avelumab With Axitinib Versus Sunitinib In Advanced Renal Cell Cancer (JAVELIN Renal 101) · Source last updated 2025-07-30

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 date of randomization until PD or death, whichever occurred first (maximum up to approximately 89 months)

What was measured

PFS2 is defined as the time (in months) from randomization to discontinuation of next-line treatment after first objective disease progression by investigator assessment, second objective disease progression by investigator assessment after initiation of next-line treatment, or death from any cause, whichever occurred first. PD was defined as at least a 20% increase in the sum of all the longest diameter of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to relative increase of 20 %, sum must have also demonstrated an absolute \> of at least 5 mm. The appearance of one or more new lesions was also considered progression.

Analysis population: FAS included all randomized participants.

Groups in this outcome

Avelumab + Axitinib

Participants with aRCC received avelumab 10 mg/kg, IV at Q2W in a 6-week cycle plus axitinib 5 mg, orally BID. Each treatment cycle was 42 days.

Sunitinib

Participants with aRCC received sunitinib 50 mg orally, QD on a schedule of 4 weeks on treatment followed by 2 weeks off treatment (schedule 4/2 in 6-week cycles). Each treatment cycle was of 42 days.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Avelumab + Axitinib442
Sunitinib444

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Avelumab + Axitinib30.4Not reported25.834.6Not reported
Sunitinib19.4Not reported17.022.4Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.551
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.754
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    param Type
    Hazard Ratio (HR)
    param Value
    0.64
Complete source fields
analyses
  1. ci Lower Limit
    0.551
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.754
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    param Type
    Hazard Ratio (HR)
    param Value
    0.64
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        25.8
        upper Limit
        34.6
        value
        30.4
      2. group Id
        OG001
        lower Limit
        17.0
        upper Limit
        22.4
        value
        19.4
denoms
  1. counts
    1. group Id
      OG000
      value
      442
    2. group Id
      OG001
      value
      444
    units
    Participants
description
PFS2 is defined as the time (in months) from randomization to discontinuation of next-line treatment after first objective disease progression by investigator assessment, second objective disease progression by investigator assessment after initiation of next-line treatment, or death from any cause, whichever occurred first. PD was defined as at least a 20% increase in the sum of all the longest diameter of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to relative increase of 20 %, sum must have also demonstrated an absolute \> of at least 5 mm. The appearance of one or more new lesions was also considered progression.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants with aRCC received avelumab 10 mg/kg, IV at Q2W in a 6-week cycle plus axitinib 5 mg, orally BID. Each treatment cycle was 42 days.
    id
    OG000
    title
    Avelumab + Axitinib
  2. description
    Participants with aRCC received sunitinib 50 mg orally, QD on a schedule of 4 weeks on treatment followed by 2 weeks off treatment (schedule 4/2 in 6-week cycles). Each treatment cycle was of 42 days.
    id
    OG001
    title
    Sunitinib
param Type
MEDIAN
population Description
FAS included all randomized participants.
reporting Status
POSTED
time Frame
From date of randomization until PD or death, whichever occurred first (maximum up to approximately 89 months)
title
Progression-Free Survival on Next-line Therapy (PFS2) in Participants Irrespective of PD-L1 Expression
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice