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NCT01909453 · OUTCOME

Part 1 and Part 2: Duration of Response (DOR)

Study Comparing Combination of LGX818 Plus MEK162 Versus Vemurafenib and LGX818 Monotherapy in BRAF Mutant Melanoma · Source last updated 2026-02-27

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEDIAN
Unit
Months
Interval / dispersion
95% Confidence Interval
Time frame
From randomization until disease progression, censoring date or death, whichever occurred first (up to 29 months for Part 1, excluding Part 1: LGX818 300 mg group; up to 35 months for Part 2 and Part 1 LGX 300 mg group)

What was measured

DOR was calculated, as the time from the date of first documented response (CR or PR) to the first documented progression or death due to underlying cancer. DOR was estimated for responders (i.e. participants achieving at least once CR or PR) only using a Kaplan-Meier method. CR was defined as disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. If a participant with a CR or PR had no progression or death due to underlying disease, the participant was censored at the date of last adequate tumor assessment. Results are based on confirmed BIRC response. All collected data up to the pre-specified collection period (i.e., end of study) are reported for this outcome measure.

Analysis population: Analysis population included all the participants who achieved at least once confirmed CR or PR. It was planned to report combined result data of Part 1 and Part 2 for LGX818 300 mg arm.

Groups in this outcome

Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)

Participants received 450 milligram (mg) of LGX818 orally once daily (QD) along with 45 mg of MEK162 twice daily (BID) for each 28 day treatment cycle until progressive disease (PD) as confirmed by Blinded Independent Review Committee (BIRC), withdrawal of consent, intolerable toxicity, study discontinuation, lost to follow-up or death.

Part 1: LGX818 300 mg

Participants received 300 mg of LGX818 orally once daily for each 28 day treatment cycle until PD as confirmed by BIRC, withdrawal of consent, intolerable toxicity, study discontinuation, lost to follow-up or death.

Part 1: Vemurafenib 960 mg BID

Participants received 960 mg of Vemurafenib according to the locally approved prescribing information twice daily for each 28 day treatment cycle until PD as confirmed by BIRC, withdrawal of consent, intolerable toxicity, study discontinuation, lost to follow-up or death.

Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)

Participants received 300 mg of LGX818 orally once daily along with 45 mg of MEK162 twice daily for each 28 day treatment cycle until PD as confirmed by BIRC, withdrawal of consent, intolerable toxicity, study discontinuation, lost to follow-up or death.

Part 2: LGX818 300 mg

Participants received 300 mg of LGX818 orally once daily for each 28 day treatment cycle until PD as confirmed by BIRC, withdrawal of consent, intolerable toxicity, study discontinuation, lost to follow-up or death.

Part 1 + Part 2: LGX818 300 mg

Participants of Part 1 and 2 received 300 mg of LGX818 orally once daily for each 28 day treatment cycle until PD as confirmed by BIRC, withdrawal of consent, intolerable toxicity, and study discontinuation, lost to follow-up or death.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)121
Part 1: LGX818 300 mg98
Part 1: Vemurafenib 960 mg BID77
Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)170
Part 2: LGX818 300 mg43
Part 1 + Part 2: LGX818 300 mg141

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)16.6Not reported12.220.4Not reported
Part 1: LGX818 300 mg15.2Not reported11.1NAUpper limit of 95% CI was not estimable due to low number of participants with events.
Part 1: Vemurafenib 960 mg BID12.3Not reported6.916.9Not reported
Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)12.7Not reported9.315.1Not reported
Part 2: LGX818 300 mg7.5Not reported5.614.0Not reported
Part 1 + Part 2: LGX818 300 mg12.9Not reported8.915.5Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        12.2
        upper Limit
        20.4
        value
        16.6
      2. comment
        Upper limit of 95% CI was not estimable due to low number of participants with events.
        group Id
        OG001
        lower Limit
        11.1
        upper Limit
        NA
        value
        15.2
      3. group Id
        OG002
        lower Limit
        6.9
        upper Limit
        16.9
        value
        12.3
      4. group Id
        OG003
        lower Limit
        9.3
        upper Limit
        15.1
        value
        12.7
      5. group Id
        OG004
        lower Limit
        5.6
        upper Limit
        14.0
        value
        7.5
      6. group Id
        OG005
        lower Limit
        8.9
        upper Limit
        15.5
        value
        12.9
denoms
  1. counts
    1. group Id
      OG000
      value
      121
    2. group Id
      OG001
      value
      98
    3. group Id
      OG002
      value
      77
    4. group Id
      OG003
      value
      170
    5. group Id
      OG004
      value
      43
    6. group Id
      OG005
      value
      141
    units
    Participants
description
DOR was calculated, as the time from the date of first documented response (CR or PR) to the first documented progression or death due to underlying cancer. DOR was estimated for responders (i.e. participants achieving at least once CR or PR) only using a Kaplan-Meier method. CR was defined as disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. If a participant with a CR or PR had no progression or death due to underlying disease, the participant was censored at the date of last adequate tumor assessment. Results are based on confirmed BIRC response. All collected data up to the pre-specified collection period (i.e., end of study) are reported for this outcome measure.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received 450 milligram (mg) of LGX818 orally once daily (QD) along with 45 mg of MEK162 twice daily (BID) for each 28 day treatment cycle until progressive disease (PD) as confirmed by Blinded Independent Review Committee (BIRC), withdrawal of consent, intolerable toxicity, study discontinuation, lost to follow-up or death.
    id
    OG000
    title
    Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)
  2. description
    Participants received 300 mg of LGX818 orally once daily for each 28 day treatment cycle until PD as confirmed by BIRC, withdrawal of consent, intolerable toxicity, study discontinuation, lost to follow-up or death.
    id
    OG001
    title
    Part 1: LGX818 300 mg
  3. description
    Participants received 960 mg of Vemurafenib according to the locally approved prescribing information twice daily for each 28 day treatment cycle until PD as confirmed by BIRC, withdrawal of consent, intolerable toxicity, study discontinuation, lost to follow-up or death.
    id
    OG002
    title
    Part 1: Vemurafenib 960 mg BID
  4. description
    Participants received 300 mg of LGX818 orally once daily along with 45 mg of MEK162 twice daily for each 28 day treatment cycle until PD as confirmed by BIRC, withdrawal of consent, intolerable toxicity, study discontinuation, lost to follow-up or death.
    id
    OG003
    title
    Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)
  5. description
    Participants received 300 mg of LGX818 orally once daily for each 28 day treatment cycle until PD as confirmed by BIRC, withdrawal of consent, intolerable toxicity, study discontinuation, lost to follow-up or death.
    id
    OG004
    title
    Part 2: LGX818 300 mg
  6. description
    Participants of Part 1 and 2 received 300 mg of LGX818 orally once daily for each 28 day treatment cycle until PD as confirmed by BIRC, withdrawal of consent, intolerable toxicity, and study discontinuation, lost to follow-up or death.
    id
    OG005
    title
    Part 1 + Part 2: LGX818 300 mg
param Type
MEDIAN
population Description
Analysis population included all the participants who achieved at least once confirmed CR or PR. It was planned to report combined result data of Part 1 and Part 2 for LGX818 300 mg arm.
reporting Status
POSTED
time Frame
From randomization until disease progression, censoring date or death, whichever occurred first (up to 29 months for Part 1, excluding Part 1: LGX818 300 mg group; up to 35 months for Part 2 and Part 1 LGX 300 mg group)
title
Part 1 and Part 2: Duration of Response (DOR)
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice