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NCT02684006 · OUTCOME

Number of Participants With Positive Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb) of Avelumab When Used in Combination With Axitinib

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
From start of treatment until 30 days after the end of avelumab treatment (maximum up to approximately 89 months)

Analysis population: Immunogenicity analysis set included all participants who received at least one dose of study drug and who had at least one ADA/nAb sample collected for avelumab in "Avelumab + Axitinib" arm. Here "Number of Participants Analyzed" signifies participants evaluable for this outcome measure. This outcome measure was not planned to be analyzed for ''Sunitinib'' reporting group.

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.

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 + Axitinib433

Reported measurements

ADA Positive
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Avelumab + Axitinib77Not reportedNot reportedNot reportedNot reported
nAb Positive
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Avelumab + Axitinib51Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        77
    title
    ADA Positive
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        51
    title
    nAb Positive
denoms
  1. counts
    1. group Id
      OG000
      value
      433
    units
    Participants
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
param Type
COUNT_OF_PARTICIPANTS
population Description
Immunogenicity analysis set included all participants who received at least one dose of study drug and who had at least one ADA/nAb sample collected for avelumab in "Avelumab + Axitinib" arm. Here "Number of Participants Analyzed" signifies participants evaluable for this outcome measure. This outcome measure was not planned to be analyzed for ''Sunitinib'' reporting group.
reporting Status
POSTED
time Frame
From start of treatment until 30 days after the end of avelumab treatment (maximum up to approximately 89 months)
title
Number of Participants With Positive Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb) of Avelumab When Used in Combination With Axitinib
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice