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NCT02460224 · OUTCOME

Phase 1: Duration of Response (DOR) 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 first documented response (CR or PR) to first documented progression or death due to study indication, assessed up to 4.4 years

What was measured

DOR only applies to subjects for whom best overall response is complete response (CR) or partial response (PR). DOR is defined as the time from the date of first documented response (CR or PR) to the date of first documented progression or death due to study indication. If a patient not had an event, duration was 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.

Analysis population: All patients in phase 1 who received at least one full or partial dose of LAG525 or PDR001 and had a documented response (CR or PR).

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

GroupSource count
Phase 1: LAG525 1 mg/kg Q2W0
Phase 1: LAG525 3 mg/kg Q2W0
Phase 1: LAG525 5 mg/kg Q2W0
Phase 1: LAG525 10 mg/kg Q2W0
Phase 1: LAG525 15 mg/kg Q2W0
Phase 1: LAG525 240 mg Q2W0
Phase 1: LAG525 400 mg Q2W0
Phase 1: LAG525 3 mg/kg Q4W0
Phase 1: LAG525 5 mg/kg Q4W0
Phase 1: LAG525 10 mg/kg Q4W0
Phase 1: LAG525 400 mg Q4W0
Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W2
Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W0
Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W1
Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W0
Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W1
Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W4
Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W2
Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W0
Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W0
Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W0
Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W2
Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W0
Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W0
Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W1
Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W0

Reported measurements

Source class 1
Values in months · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2WNANot reportedNANANot estimable due to insufficient number of participants with events.
Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2WNANot reportedNANANot estimable due to insufficient number of participants with events.
Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W12.2Not reportedNANANot estimable due to insufficient number of participants with events.
Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3WNANot reported7.9NANot estimable due to insufficient number of participants with events.
Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W18.4Not reported2.8NANot estimable due to insufficient number of participants with events.
Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W6.5Not reported5.6NANot estimable due to insufficient number of participants with events.
Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4WNANot reportedNANANot estimable due to insufficient number of participants with events.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Not estimable due to insufficient number of participants with events.
        group Id
        OG011
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      2. comment
        Not estimable due to insufficient number of participants with events.
        group Id
        OG013
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      3. comment
        Not estimable due to insufficient number of participants with events.
        group Id
        OG015
        lower Limit
        NA
        upper Limit
        NA
        value
        12.2
      4. comment
        Not estimable due to insufficient number of participants with events.
        group Id
        OG016
        lower Limit
        7.9
        upper Limit
        NA
        value
        NA
      5. comment
        Not estimable due to insufficient number of participants with events.
        group Id
        OG017
        lower Limit
        2.8
        upper Limit
        NA
        value
        18.4
      6. comment
        Not estimable due to insufficient number of participants with events.
        group Id
        OG021
        lower Limit
        5.6
        upper Limit
        NA
        value
        6.5
      7. comment
        Not estimable due to insufficient number of participants with events.
        group Id
        OG024
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      0
    3. group Id
      OG002
      value
      0
    4. group Id
      OG003
      value
      0
    5. group Id
      OG004
      value
      0
    6. group Id
      OG005
      value
      0
    7. group Id
      OG006
      value
      0
    8. group Id
      OG007
      value
      0
    9. group Id
      OG008
      value
      0
    10. group Id
      OG009
      value
      0
    11. group Id
      OG010
      value
      0
    12. group Id
      OG011
      value
      2
    units
    Participants
description
DOR only applies to subjects for whom best overall response is complete response (CR) or partial response (PR). DOR is defined as the time from the date of first documented response (CR or PR) to the date of first documented progression or death due to study indication. If a patient not had an event, duration was 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.
dispersion Type
90% Confidence Interval
groups
  1. description
    Single-agent LAG525 1 mg/kg Q2W
    id
    OG000
    title
    Phase 1: LAG525 1 mg/kg Q2W
  2. description
    Single-agent LAG525 3 mg/kg Q2W
    id
    OG001
    title
    Phase 1: LAG525 3 mg/kg Q2W
  3. description
    Single-agent LAG525 5 mg/kg Q2W
    id
    OG002
    title
    Phase 1: LAG525 5 mg/kg Q2W
  4. description
    Single-agent LAG525 10 mg/kg Q2W
    id
    OG003
    title
    Phase 1: LAG525 10 mg/kg Q2W
  5. description
    Single-agent LAG525 15 mg/kg Q2W
    id
    OG004
    title
    Phase 1: LAG525 15 mg/kg Q2W
  6. description
    Single-agent LAG525 240 mg Q2W
    id
    OG005
    title
    Phase 1: LAG525 240 mg Q2W
  7. description
    Single-agent LAG525 400 mg Q2W
    id
    OG006
    title
    Phase 1: LAG525 400 mg Q2W
  8. description
    Single-agent LAG525 3 mg/kg Q4W
    id
    OG007
    title
    Phase 1: LAG525 3 mg/kg Q4W
  9. description
    Single-agent LAG525 5 mg/kg Q4W
    id
    OG008
    title
    Phase 1: LAG525 5 mg/kg Q4W
  10. description
    Single-agent LAG525 10 mg/kg Q4W
    id
    OG009
    title
    Phase 1: LAG525 10 mg/kg Q4W
  11. description
    Single-agent LAG525 400 mg Q4W
    id
    OG010
    title
    Phase 1: LAG525 400 mg Q4W
  12. 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
MEDIAN
population Description
All patients in phase 1 who received at least one full or partial dose of LAG525 or PDR001 and had a documented response (CR or PR).
reporting Status
POSTED
time Frame
From first documented response (CR or PR) to first documented progression or death due to study indication, assessed up to 4.4 years
title
Phase 1: Duration of Response (DOR) Per RECIST 1.1
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice