NCT02580058 · OUTCOME

Number of Participants With PD-L1 Expression for PFS (Based on BICR Assessment) and for OS

A Study Of Avelumab Alone Or In Combination With Pegylated Liposomal Doxorubicin Versus Pegylated Liposomal Doxorubicin Alone In Patients With Platinum Resistant/Refractory Ovarian Cancer (JAVELIN Ovarian 200) · Source last updated 2023-07-10

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: Biomarkers are measured only at screening.

What was measured

PD-L1 expression was assessed by immunohistochemistry. Participants were considered positive for PD-L1 if their baseline tissue sample demonstrated PD-L1 expression on \>=1% of tumor cells or \>=5% of immune cells.

Analysis population: The biomarker analysis set included participants who had at least 1 screening biomarker assessment. 'Number of Participants Analyzed' is based on number of participants in the biomarker analysis set within each treatment group with reported PD-L1 status.

Groups in this outcome

Avelumab

Avelumab 10 milligram (mg)/kilogram (kg) given as a 1-hour intravenous (IV) infusion every 2 weeks (Q2W) in 4-week cycles.

Avelumab + PLD

Avelumab 10 mg/kg given as a 1-hour IV Q2W in 4-week cycles + pegylated liposomal doxorubicin (PLD) 40 mg/square meter given as a 1-hour IV infusion every 4 weeks (Q4W) in 4-week cycles.

Pegylated Liposomal Doxorubicin (PLD)

PLD 40 mg/square meter given as a 1-hour IV infusion Q4W in 4-week cycles.

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	170
Avelumab + PLD	173
Pegylated Liposomal Doxorubicin (PLD)	165

Reported measurements

Source class 1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Avelumab	100	Not reported	Not reported	Not reported	Not reported
Avelumab + PLD	100	Not reported	Not reported	Not reported	Not reported
Pegylated Liposomal Doxorubicin (PLD)	88	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
100
group Id
OG001
value
100
group Id
OG002
value
88

denoms

counts
group Id
OG000
value
170
group Id
OG001
value
173
group Id
OG002
value
165
units
Participants

description

groups

description
Avelumab 10 milligram (mg)/kilogram (kg) given as a 1-hour intravenous (IV) infusion every 2 weeks (Q2W) in 4-week cycles.
id
OG000
title
Avelumab
description
Avelumab 10 mg/kg given as a 1-hour IV Q2W in 4-week cycles + pegylated liposomal doxorubicin (PLD) 40 mg/square meter given as a 1-hour IV infusion every 4 weeks (Q4W) in 4-week cycles.
id
OG001
title
Avelumab + PLD
description
PLD 40 mg/square meter given as a 1-hour IV infusion Q4W in 4-week cycles.
id
OG002
title
Pegylated Liposomal Doxorubicin (PLD)

param Type

COUNT_OF_PARTICIPANTS

population Description

The biomarker analysis set included participants who had at least 1 screening biomarker assessment. 'Number of Participants Analyzed' is based on number of participants in the biomarker analysis set within each treatment group with reported PD-L1 status.

reporting Status

POSTED

time Frame

Biomarkers are measured only at screening.

title

Number of Participants With PD-L1 Expression for PFS (Based on BICR Assessment) and for OS

type

SECONDARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice