NCT02460224 · OUTCOME
Phase 2: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001 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 From start of treatment until end of treatment, assessed up to 2.6 years. What was measured Number of participants with at least one dose reduction of LAG525, at least one dose interruption of LAG525, at least one dose reduction of PDR001 and at least one dose interruption of PDR001.
The number of participants with dose reductions and dose interruptions of both study drugs is reported for each tumor type.
Analysis population: All patients in phase 2 who received at least one full or partial dose of LAG525 or PDR001.
Groups in this outcome Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients naïve to anti-PD-1/PD-L1
Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W Combination LAG525 600 mg + PDR001 400 mg (Q4W/Q4W) in patients naïve to anti-PD-1/PD-L1
Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients pre-treated with anti-PD-1/PD-L1
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 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W 121 Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W 21 Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W 93
Reported measurements LAG525 dose reduction, NSCLC patients Analysis denominator · Participants
Group Source count Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W 20 Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W 0 Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W 22
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W 0 Not reported Not reported Not reported Not reported Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W 0 Not reported Not reported Not reported Not reported
LAG525 dose interruption, NSCLC patients Analysis denominator · Participants
Group Source count Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W 20 Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W 0 Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W 22
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W 3 Not reported Not reported Not reported Not reported Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W 3 Not reported Not reported Not reported Not reported
PDR001 dose reduction, NSCLC patients Analysis denominator · Participants
Group Source count Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W 20 Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W 0 Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W 22
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W 0 Not reported Not reported Not reported Not reported Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W 0 Not reported Not reported Not reported Not reported
PDR001 dose interruption, NSCLC patients Analysis denominator · Participants
Group Source count Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W 20 Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W 0 Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W 22
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W 3 Not reported Not reported Not reported Not reported Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W 3 Not reported Not reported Not reported Not reported
LAG525 dose reduction, melanoma patients Analysis denominator · Participants
Group Source count Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W 20 Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W 0 Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W 22
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W 0 Not reported Not reported Not reported Not reported Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W 0 Not reported Not reported Not reported Not reported
LAG525 dose interruption, melanoma patients Analysis denominator · Participants
Group Source count Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W 20 Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W 0 Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W 22
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W 4 Not reported Not reported Not reported Not reported Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W 4 Not reported Not reported Not reported Not reported
PDR001 dose reduction, melanoma patients Analysis denominator · Participants
Group Source count Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W 20 Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W 0 Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W 22
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W 0 Not reported Not reported Not reported Not reported Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W 0 Not reported Not reported Not reported Not reported
PDR001 dose interruption, melanoma patients Analysis denominator · Participants
Group Source count Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W 20 Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W 0 Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W 22
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W 4 Not reported Not reported Not reported Not reported Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W 4 Not reported Not reported Not reported Not reported
LAG525 dose reduction, RCC patients Analysis denominator · Participants
Group Source count Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W 19 Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W 0 Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W 19
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W 0 Not reported Not reported Not reported Not reported Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W 0 Not reported Not reported Not reported Not reported
LAG525 dose interruption, RCC patients Analysis denominator · Participants
Group Source count Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W 19 Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W 0 Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W 19
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W 5 Not reported Not reported Not reported Not reported Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W 1 Not reported Not reported Not reported Not reported
PDR001 dose reduction, RCC patients Analysis denominator · Participants
Group Source count Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W 19 Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W 0 Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W 19
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W 0 Not reported Not reported Not reported Not reported Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W 0 Not reported Not reported Not reported Not reported
PDR001 dose interruption, RCC patients Analysis denominator · Participants
Group Source count Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W 19 Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W 0 Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W 19
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W 5 Not reported Not reported Not reported Not reported Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W 1 Not reported Not reported Not reported Not reported
LAG525 dose reduction, mesothelioma patients Analysis denominator · Participants
Group Source count Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W 41 Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W 0 Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W 16
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W 0 Not reported Not reported Not reported Not reported Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W 0 Not reported Not reported Not reported Not reported
LAG525 dose interruption, mesothelioma patients Analysis denominator · Participants
Group Source count Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W 41 Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W 0 Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W 16
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W 8 Not reported Not reported Not reported Not reported Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W 5 Not reported Not reported Not reported Not reported
PDR001 dose reduction, mesothelioma patients Analysis denominator · Participants
Group Source count Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W 41 Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W 0 Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W 16
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W 0 Not reported Not reported Not reported Not reported Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W 0 Not reported Not reported Not reported Not reported
PDR001 dose interruption, mesothelioma patients Analysis denominator · Participants
Group Source count Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W 41 Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W 0 Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W 16
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W 8 Not reported Not reported Not reported Not reported Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W 5 Not reported Not reported Not reported Not reported
LAG525 dose reduction, TNBC patients Analysis denominator · Participants
Group Source count Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W 21 Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W 21 Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W 14
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W 0 Not reported Not reported Not reported Not reported Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W 0 Not reported Not reported Not reported Not reported Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W 0 Not reported Not reported Not reported Not reported
LAG525 dose interruption, TNBC patients Analysis denominator · Participants
Group Source count Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W 21 Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W 21 Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W 14
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W 3 Not reported Not reported Not reported Not reported Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W 0 Not reported Not reported Not reported Not reported Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W 0 Not reported Not reported Not reported Not reported
PDR001 dose reduction, TNBC patients Analysis denominator · Participants
Group Source count Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W 21 Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W 21 Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W 14
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W 0 Not reported Not reported Not reported Not reported Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W 0 Not reported Not reported Not reported Not reported Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W 0 Not reported Not reported Not reported Not reported
PDR001 dose interruption, TNBC patients Analysis denominator · Participants
Group Source count Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W 21 Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W 21 Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W 14
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W 3 Not reported Not reported Not reported Not reported Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W 0 Not reported Not reported Not reported Not reported Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W 0 Not reported Not reported Not reported Not reported
Complete source fields classes categories measurements
group Id OG000
value 0
group Id OG002
value 0 denoms counts
group Id OG000
value 20
group Id OG001
value 0
group Id OG002
value 22
units Participants
title LAG525 dose reduction, NSCLC patients categories measurements
group Id OG000
value 3
group Id OG002
value 3 denoms counts
group Id OG000
value 20
group Id OG001
value 0
group Id OG002
value 22
units Participants
title LAG525 dose interruption, NSCLC patients categories measurements
group Id OG000
value 0
group Id OG002
value 0 denoms counts
group Id OG000
value 20
group Id OG001
value 0
group Id OG002
value 22
units Participants
title PDR001 dose reduction, NSCLC patients categories measurements
group Id OG000
value 3
group Id OG002
value 3 denoms counts
group Id OG000
value 20
group Id OG001
value 0
group Id OG002
value 22
units Participants
title PDR001 dose interruption, NSCLC patients categories measurements
group Id OG000
value 0
group Id OG002
value 0 denoms counts
group Id OG000
value 20
group Id OG001
value 0
group Id OG002
value 22
units Participants
title LAG525 dose reduction, melanoma patients categories measurements
group Id OG000
value 4
group Id OG002
value 4 denoms counts
group Id OG000
value 20
group Id OG001
value 0
group Id OG002
value 22
units Participants
title LAG525 dose interruption, melanoma patients categories measurements
group Id OG000
value 0
group Id OG002
value 0 denoms counts
group Id OG000
value 20
group Id OG001
value 0
group Id OG002
value 22
units Participants
title PDR001 dose reduction, melanoma patients categories measurements
group Id OG000
value 4
group Id OG002
value 4 denoms counts
group Id OG000
value 20
group Id OG001
value 0
group Id OG002
value 22
units Participants
title PDR001 dose interruption, melanoma patients categories measurements
group Id OG000
value 0
group Id OG002
value 0 denoms counts
group Id OG000
value 19
group Id OG001
value 0
group Id OG002
value 19
units Participants
title LAG525 dose reduction, RCC patients categories measurements
group Id OG000
value 5
group Id OG002
value 1 denoms counts
group Id OG000
value 19
group Id OG001
value 0
group Id OG002
value 19
units Participants
title LAG525 dose interruption, RCC patients categories measurements
group Id OG000
value 0
group Id OG002
value 0 denoms counts
group Id OG000
value 19
group Id OG001
value 0
group Id OG002
value 19
units Participants
title PDR001 dose reduction, RCC patients categories measurements
group Id OG000
value 5
group Id OG002
value 1 denoms counts
group Id OG000
value 19
group Id OG001
value 0
group Id OG002
value 19
units Participants
title PDR001 dose interruption, RCC patients Show more (12 of 20) denoms counts
group Id OG000
value 121
group Id OG001
value 21
group Id OG002
value 93
units Participants
description Number of participants with at least one dose reduction of LAG525, at least one dose interruption of LAG525, at least one dose reduction of PDR001 and at least one dose interruption of PDR001.
The number of participants with dose reductions and dose interruptions of both study drugs is reported for each tumor type. groups
description Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients naïve to anti-PD-1/PD-L1
id OG000
title Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W
description Combination LAG525 600 mg + PDR001 400 mg (Q4W/Q4W) in patients naïve to anti-PD-1/PD-L1
id OG001
title Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W
description Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients pre-treated with anti-PD-1/PD-L1
id OG002
title Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W
param Type COUNT_OF_PARTICIPANTS
population Description All patients in phase 2 who received at least one full or partial dose of LAG525 or PDR001.
reporting Status POSTED
time Frame From start of treatment until end of treatment, assessed up to 2.6 years.
title Phase 2: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001
type SECONDARY
unit Of Measure Participants Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
Triangle