NCT02684006 · OUTCOME

DR 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: MEDIAN
Unit: Months
Interval / dispersion: 95% Confidence Interval
Time frame: From documentation of OR until date of first documentation of PD or death due to any cause, whichever occurred first (maximum up to approximately 26 months)

What was measured

DR: time from first documentation of OR (confirmed CR or PR) to date of first documentation of PD or death due to any cause, whichever occurred first. As per RECIST version 1.1, CR: disappearance of all target and non-target lesions, and sustained for at least 4 weeks. Any pathological lymph nodes (target or non-target) must have reduction in short axis to \<10 mm. PR: at least 30%\< in sum of longest dimensions of target lesions taking as reference baseline sum longest dimensions. PD: defined as at least a 20% \> in sum of diameters of target lesions, taking as reference the smallest sum on study (this included baseline sum if that is smallest on study). In addition to relative increase of 20%, sum must have also demonstrated an absolute increase of at least 5 mm. Appearance of one or more new lesions was also considered progression.

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

Group	Source count
Avelumab + Axitinib	211
Sunitinib	108

Reported measurements

PD-L1 Positive Tumors

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	149
Sunitinib	74

Values in Months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	NA	Not reported	NA	NA	Median and 95% CI was not estimable due to insufficient number of participants with event.
Sunitinib	NA	Not reported	10.9	NA	Median and 95% CI was not estimable due to insufficient number of participants with event.

PD-L1 Negative Tumors

Analysis denominator · Participants

Group	Source count
Avelumab + Axitinib	62
Sunitinib	34

Values in Months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Avelumab + Axitinib	NA	Not reported	11.1	NA	Median and 95% CI was not estimable due to insufficient number of participants with event.
Sunitinib	NA	Not reported	9.0	NA	Median and 95% CI was not estimable due to insufficient number of participants with event.

Complete source fields

classes

categories
measurements
comment
Median and 95% CI was not estimable due to insufficient number of participants with event.
group Id
OG000
lower Limit
NA
upper Limit
NA
value
NA
comment
Median and 95% CI was not estimable due to insufficient number of participants with event.
group Id
OG001
lower Limit
10.9
upper Limit
NA
value
NA
denoms
counts
group Id
OG000
value
149
group Id
OG001
value
74
units
Participants
title
PD-L1 Positive Tumors
categories
measurements
comment
Median and 95% CI was not estimable due to insufficient number of participants with event.
group Id
OG000
lower Limit
11.1
upper Limit
NA
value
NA
comment
Median and 95% CI was not estimable due to insufficient number of participants with event.
group Id
OG001
lower Limit
9.0
upper Limit
NA
value
NA
denoms
counts
group Id
OG000
value
62
group Id
OG001
value
34
units
Participants
title
PD-L1 Negative Tumors

denoms

counts
group Id
OG000
value
211
group Id
OG001
value
108
units
Participants

description

dispersion Type

95% Confidence Interval

groups

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
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

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 documentation of OR until date of first documentation of PD or death due to any cause, whichever occurred first (maximum up to approximately 26 months)

title

DR in PD-L1 Biomarker-Positive and PD-L1 Biomarker-Negative Subgroups

type

SECONDARY

unit Of Measure

Months

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Preserved source evidence · Not medical advice