Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02460224 · OUTCOME

Phase 2: Progression-free Survival (PFS) Per RECIST 1.1

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
MEDIAN
Unit
months
Interval / dispersion
90% Confidence Interval
Time frame
From start of treatment to first documented progression or death due to any cause, assessed up to 2.6 years

What was measured

PFS is the time from the date of start of treatment to the date of event defined as the first documented progression or death due to any cause. If a patient has not had an event, PFS is censored at the date of last adequate tumor assessment. Tumor response was based on local investigator assessment and the assessment criteria was RECIST 1.1. PFS is reported by 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

GroupSource count
Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W121
Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W21
Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W93

Reported measurements

Non-small cell lung cancer (NSCLC)

Analysis denominator · Participants

GroupSource count
Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W20
Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W0
Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W22
Values in months · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W3.9Not reported1.75.6Not reported
Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W3.5Not reported1.94.9Not reported
Melanoma

Analysis denominator · Participants

GroupSource count
Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W20
Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W0
Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W22
Values in months · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W2.2Not reported1.65.6Not reported
Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W1.9Not reported1.83.7Not reported
Renal cell cancer (RCC)

Analysis denominator · Participants

GroupSource count
Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W19
Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W0
Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W19
Values in months · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W4.4Not reported2.111.1Not reported
Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W3.0Not reported1.63.9Not reported
Mesothelioma

Analysis denominator · Participants

GroupSource count
Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W41
Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W0
Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W16
Values in months · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W5.5Not reported3.56.4Not reported
Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W3.4Not reported1.83.8Not reported
Triple negative breast cancer (TNBC)

Analysis denominator · Participants

GroupSource count
Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W21
Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W21
Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W14
Values in months · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W1.9Not reported1.53.5Not reported
Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W1.8Not reported1.42.6Not reported
Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W1.7Not reported1.33.4Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.7
        upper Limit
        5.6
        value
        3.9
      2. group Id
        OG002
        lower Limit
        1.9
        upper Limit
        4.9
        value
        3.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        20
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        22
      units
      Participants
    title
    Non-small cell lung cancer (NSCLC)
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.6
        upper Limit
        5.6
        value
        2.2
      2. group Id
        OG002
        lower Limit
        1.8
        upper Limit
        3.7
        value
        1.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        20
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        22
      units
      Participants
    title
    Melanoma
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.1
        upper Limit
        11.1
        value
        4.4
      2. group Id
        OG002
        lower Limit
        1.6
        upper Limit
        3.9
        value
        3.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        19
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        19
      units
      Participants
    title
    Renal cell cancer (RCC)
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3.5
        upper Limit
        6.4
        value
        5.5
      2. group Id
        OG002
        lower Limit
        1.8
        upper Limit
        3.8
        value
        3.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        41
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        16
      units
      Participants
    title
    Mesothelioma
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.5
        upper Limit
        3.5
        value
        1.9
      2. group Id
        OG001
        lower Limit
        1.4
        upper Limit
        2.6
        value
        1.8
      3. group Id
        OG002
        lower Limit
        1.3
        upper Limit
        3.4
        value
        1.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        21
      2. group Id
        OG001
        value
        21
      3. group Id
        OG002
        value
        14
      units
      Participants
    title
    Triple negative breast cancer (TNBC)
denoms
  1. counts
    1. group Id
      OG000
      value
      121
    2. group Id
      OG001
      value
      21
    3. group Id
      OG002
      value
      93
    units
    Participants
description
PFS is the time from the date of start of treatment to the date of event defined as the first documented progression or death due to any cause. If a patient has not had an event, PFS is censored at the date of last adequate tumor assessment. Tumor response was based on local investigator assessment and the assessment criteria was RECIST 1.1. PFS is reported by tumor type.
dispersion Type
90% Confidence Interval
groups
  1. 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
  2. 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
  3. 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
MEDIAN
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 to first documented progression or death due to any cause, assessed up to 2.6 years
title
Phase 2: Progression-free Survival (PFS) Per RECIST 1.1
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice