NCT02460224 · OUTCOME

Phase 1: Number of Participants With Anti-PDR001 Antibodies

Safety and Efficacy of LAG525 Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies. · Source last updated 2022-02-10

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: Baseline (pre-infusion on Cycle 1 Day 1) and post-baseline (assessed throughout the treatment up to maximum 4.4 years).

What was measured

Validated immunoassays were used for screening and confirmation of the presence of anti-PDR001 antibodies (ADA, anti-drug antibodies) in serum. Number of participants with ADA in each category is reported in this record.

Analysis population: All patients in phase 1 who received at least one full or partial dose of PDR001 and who had a determinant baseline immunogenicity (IG) sample and at least one determinant post-baseline IG sample. A determinant IG sample is neither ADA-inconclusive nor unevaluable.

Groups in this outcome

Phase 1: LAG525 1 mg/kg Q2W

Single-agent LAG525 1 mg/kg Q2W

Phase 1: LAG525 3 mg/kg Q2W

Single-agent LAG525 3 mg/kg Q2W

Phase 1: LAG525 5 mg/kg Q2W

Single-agent LAG525 5 mg/kg Q2W

Phase 1: LAG525 10 mg/kg Q2W

Single-agent LAG525 10 mg/kg Q2W

Phase 1: LAG525 15 mg/kg Q2W

Single-agent LAG525 15 mg/kg Q2W

Phase 1: LAG525 240 mg Q2W

Single-agent LAG525 240 mg Q2W

Phase 1: LAG525 400 mg Q2W

Single-agent LAG525 400 mg Q2W

Phase 1: LAG525 3 mg/kg Q4W

Single-agent LAG525 3 mg/kg Q4W

Phase 1: LAG525 5 mg/kg Q4W

Single-agent LAG525 5 mg/kg Q4W

Phase 1: LAG525 10 mg/kg Q4W

Single-agent LAG525 10 mg/kg Q4W

Phase 1: LAG525 400 mg Q4W

Single-agent LAG525 400 mg Q4W

Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W

Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)

Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W

Combination LAG525 1 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)

Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W

Combination LAG525 80 mg + PDR001 80 mg (Q2W/Q2W)

Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W

Combination LAG525 80 mg + PDR001 240 mg (Q2W/Q2W)

Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W

Combination LAG525 240 mg + PDR001 240 mg (Q2W/Q2W)

Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W

Combination LAG525 240 mg + PDR001 300 mg (Q3W/Q3W)

Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W

Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W)

Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W

Combination LAG525 600 mg + PDR001 300 mg (Q3W/Q3W)

Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W

Combination LAG525 80 mg + PDR001 240 mg (Q4W/Q4W)

Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W

Combination LAG525 400 mg + PDR001 400 mg (Q4W/Q4W)

Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W

Combination LAG525 800 mg + PDR001 400 mg (Q4W/Q4W)

Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W

Combination LAG525 1000 mg + PDR001 400 mg (Q4W/Q4W)

Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W

Combination LAG525 80 mg + PDR001 400 mg (Q2W/Q4W)

Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W

Combination LAG525 240 mg + PDR001 400 mg (Q2W/Q4W)

Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W

Combination LAG525 300 mg + PDR001 400 mg (Q2W/Q4W)

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
Phase 1: LAG525 1 mg/kg Q2W	0
Phase 1: LAG525 3 mg/kg Q2W	0
Phase 1: LAG525 5 mg/kg Q2W	0
Phase 1: LAG525 10 mg/kg Q2W	0
Phase 1: LAG525 15 mg/kg Q2W	0
Phase 1: LAG525 240 mg Q2W	0
Phase 1: LAG525 400 mg Q2W	0
Phase 1: LAG525 3 mg/kg Q4W	0
Phase 1: LAG525 5 mg/kg Q4W	0
Phase 1: LAG525 10 mg/kg Q4W	0
Phase 1: LAG525 400 mg Q4W	0
Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W	5
Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W	6
Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W	5
Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W	5
Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W	5
Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W	16
Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W	2
Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W	7
Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W	7
Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W	4
Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W	5
Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W	2
Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W	6
Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W	4
Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W	3

Reported measurements

ADA-negative at baseline

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W	5	Not reported	Not reported	Not reported	Not reported
Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W	6	Not reported	Not reported	Not reported	Not reported
Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W	5	Not reported	Not reported	Not reported	Not reported
Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W	4	Not reported	Not reported	Not reported	Not reported
Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W	5	Not reported	Not reported	Not reported	Not reported
Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W	14	Not reported	Not reported	Not reported	Not reported
Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W	2	Not reported	Not reported	Not reported	Not reported
Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W	7	Not reported	Not reported	Not reported	Not reported
Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W	7	Not reported	Not reported	Not reported	Not reported
Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W	4	Not reported	Not reported	Not reported	Not reported
Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W	5	Not reported	Not reported	Not reported	Not reported
Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W	2	Not reported	Not reported	Not reported	Not reported
Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W	6	Not reported	Not reported	Not reported	Not reported
Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W	3	Not reported	Not reported	Not reported	Not reported
Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W	3	Not reported	Not reported	Not reported	Not reported

ADA-positive at post-baseline (i.e. ADA incidence)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W	2	Not reported	Not reported	Not reported	Not reported
Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W	2	Not reported	Not reported	Not reported	Not reported
Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W	2	Not reported	Not reported	Not reported	Not reported
Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W	0	Not reported	Not reported	Not reported	Not reported
Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W	2	Not reported	Not reported	Not reported	Not reported
Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W	2	Not reported	Not reported	Not reported	Not reported
Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W	0	Not reported	Not reported	Not reported	Not reported
Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W	2	Not reported	Not reported	Not reported	Not reported
Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W	1	Not reported	Not reported	Not reported	Not reported
Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W	0	Not reported	Not reported	Not reported	Not reported
Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W	0	Not reported	Not reported	Not reported	Not reported
Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W	0	Not reported	Not reported	Not reported	Not reported
Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W	1	Not reported	Not reported	Not reported	Not reported
Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W	1	Not reported	Not reported	Not reported	Not reported
Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W	0	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG011
value
5
group Id
OG012
value
6
group Id
OG013
value
5
group Id
OG014
value
4
group Id
OG015
value
5
group Id
OG016
value
14
group Id
OG017
value
2
group Id
OG018
value
7
group Id
OG019
value
7
group Id
OG020
value
4
group Id
OG021
value
5
group Id
OG022
value
2
title
ADA-negative at baseline
categories
measurements
group Id
OG011
value
2
group Id
OG012
value
2
group Id
OG013
value
2
group Id
OG014
value
0
group Id
OG015
value
2
group Id
OG016
value
2
group Id
OG017
value
0
group Id
OG018
value
2
group Id
OG019
value
1
group Id
OG020
value
0
group Id
OG021
value
0
group Id
OG022
value
0
title
ADA-positive at post-baseline (i.e. ADA incidence)

denoms

counts
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
group Id
OG005
value
0
group Id
OG006
value
0
group Id
OG007
value
0
group Id
OG008
value
0
group Id
OG009
value
0
group Id
OG010
value
0
group Id
OG011
value
5
units
Participants

description

groups

description
Single-agent LAG525 1 mg/kg Q2W
id
OG000
title
Phase 1: LAG525 1 mg/kg Q2W
description
Single-agent LAG525 3 mg/kg Q2W
id
OG001
title
Phase 1: LAG525 3 mg/kg Q2W
description
Single-agent LAG525 5 mg/kg Q2W
id
OG002
title
Phase 1: LAG525 5 mg/kg Q2W
description
Single-agent LAG525 10 mg/kg Q2W
id
OG003
title
Phase 1: LAG525 10 mg/kg Q2W
description
Single-agent LAG525 15 mg/kg Q2W
id
OG004
title
Phase 1: LAG525 15 mg/kg Q2W
description
Single-agent LAG525 240 mg Q2W
id
OG005
title
Phase 1: LAG525 240 mg Q2W
description
Single-agent LAG525 400 mg Q2W
id
OG006
title
Phase 1: LAG525 400 mg Q2W
description
Single-agent LAG525 3 mg/kg Q4W
id
OG007
title
Phase 1: LAG525 3 mg/kg Q4W
description
Single-agent LAG525 5 mg/kg Q4W
id
OG008
title
Phase 1: LAG525 5 mg/kg Q4W
description
Single-agent LAG525 10 mg/kg Q4W
id
OG009
title
Phase 1: LAG525 10 mg/kg Q4W
description
Single-agent LAG525 400 mg Q4W
id
OG010
title
Phase 1: LAG525 400 mg Q4W
description
Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
id
OG011
title
Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W

param Type

COUNT_OF_PARTICIPANTS

population Description

All patients in phase 1 who received at least one full or partial dose of PDR001 and who had a determinant baseline immunogenicity (IG) sample and at least one determinant post-baseline IG sample. A determinant IG sample is neither ADA-inconclusive nor unevaluable.

reporting Status

POSTED

time Frame

Baseline (pre-infusion on Cycle 1 Day 1) and post-baseline (assessed throughout the treatment up to maximum 4.4 years).

title

Phase 1: Number of Participants With Anti-PDR001 Antibodies

type

SECONDARY

unit Of Measure

Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice