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NCT02684006 · OUTCOME

Percentage of Participants With OR in PD-L1 Biomarker-Positive and PD-L1 Biomarker-Negative Subgroups

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
NUMBER
Unit
Percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
From date of randomization until PD (maximum up to approximately 26 months)

What was measured

OR was defined as best overall response of CR or PR according to RECIST v1.1 as assessed by BICR recorded from date of randomization until disease progression. CR was defined as complete disappearance of all target and non-target lesions with the exception of nodal disease. All lymph nodes must decrease to normal size (short axis\<10 mm). All target lesions must be assessed. PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. All target lesions must be assessed.

Analysis population: Biomarker positive/negative subset in FAS included participants who had at least one biomarker baseline assessment. Here "Number of Participants Analyzed" signifies participants evaluable for this outcome measure. "Number Analyzed" signifies number of participants evaluable for the specified rows.

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 + Axitinib402
Sunitinib410

Reported measurements

PD-L1 Positive Tumors

Analysis denominator · Participants

GroupSource count
Avelumab + Axitinib270
Sunitinib290
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Avelumab + Axitinib55.2Not reported49.061.2Not reported
Sunitinib25.5Not reported20.630.9Not reported
PD-L1 Negative Tumors

Analysis denominator · Participants

GroupSource count
Avelumab + Axitinib132
Sunitinib120
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Avelumab + Axitinib47.0Not reported38.255.8Not reported
Sunitinib28.3Not reported20.537.3Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        49.0
        upper Limit
        61.2
        value
        55.2
      2. group Id
        OG001
        lower Limit
        20.6
        upper Limit
        30.9
        value
        25.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        270
      2. group Id
        OG001
        value
        290
      units
      Participants
    title
    PD-L1 Positive Tumors
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        38.2
        upper Limit
        55.8
        value
        47.0
      2. group Id
        OG001
        lower Limit
        20.5
        upper Limit
        37.3
        value
        28.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        132
      2. group Id
        OG001
        value
        120
      units
      Participants
    title
    PD-L1 Negative Tumors
denoms
  1. counts
    1. group Id
      OG000
      value
      402
    2. group Id
      OG001
      value
      410
    units
    Participants
description
OR was defined as best overall response of CR or PR according to RECIST v1.1 as assessed by BICR recorded from date of randomization until disease progression. CR was defined as complete disappearance of all target and non-target lesions with the exception of nodal disease. All lymph nodes must decrease to normal size (short axis\<10 mm). All target lesions must be assessed. PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. All target lesions must be assessed.
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
NUMBER
population Description
Biomarker positive/negative subset in FAS included participants who had at least one biomarker baseline assessment. Here "Number of Participants Analyzed" signifies participants evaluable for this outcome measure. "Number Analyzed" signifies number of participants evaluable for the specified rows.
reporting Status
POSTED
time Frame
From date of randomization until PD (maximum up to approximately 26 months)
title
Percentage of Participants With OR in PD-L1 Biomarker-Positive and PD-L1 Biomarker-Negative Subgroups
type
SECONDARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice