NCT01909453 · OUTCOME
Part 1 and Part 2: Number of Participants With Change From Baseline in Eastern Cooperative Oncology Group Performance Status (ECOG PS) 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 COUNT_OF_PARTICIPANTS
Unit Participants
Interval / dispersion Not reported
Time frame Part 1 and Part 2: Baseline, Day 1 of each cycle (Cycle 2 to Cycle 31) What was measured ECOG: participant's performance status was measured on a 6-point scale: 0= fully active/able to carry on all pre-disease activities without restriction; 1= restricted in physically strenuous activity but ambulatory and able to carry out work of a light and sedentary nature; 2= ambulatory and capable of all self-care, but unable to carry out any work activities, up and about more than 50% of waking hours; 3= capable of only limited self-care, confined to bed/chair \>50% of waking hours; 4= completely disabled, cannot carry on any self-care, totally confined to bed/chair: 5= dead.
Analysis population: Safety analysis set included all participants who received at least one dose of study medication and have at least one valid post-baseline safety evaluation. Here, "Number analyzed" signifies participants evaluable for each specified row. It was planned to report combined result data of Part 1 and Part 2 for LGX818 300 mg arm. Data is reported only for categories with non-zero values.
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
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 192 Part 1: LGX818 300 mg 192 Part 1: Vemurafenib 960 mg BID 186 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 257 Part 2: LGX818 300 mg 84 Part 1 + Part 2: LGX818 300 mg 276
Reported measurements Baseline: ECOG score 0 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 192 Part 1: LGX818 300 mg 192 Part 1: Vemurafenib 960 mg BID 186 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 257 Part 2: LGX818 300 mg 84 Part 1 + Part 2: LGX818 300 mg 276
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 136 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 139 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 135 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 189 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 60 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 199 Not reported Not reported Not reported Not reported
Baseline: ECOG score 1 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 192 Part 1: LGX818 300 mg 192 Part 1: Vemurafenib 960 mg BID 186 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 257 Part 2: LGX818 300 mg 84 Part 1 + Part 2: LGX818 300 mg 276
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 56 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 53 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 51 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 68 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 24 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 77 Not reported Not reported Not reported Not reported
Cycle 2 Day 1: ECOG score 0 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 188 Part 1: LGX818 300 mg 182 Part 1: Vemurafenib 960 mg BID 181 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 256 Part 2: LGX818 300 mg 80 Part 1 + Part 2: LGX818 300 mg 262
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 142 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 98 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 113 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 193 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 44 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 142 Not reported Not reported Not reported Not reported
Cycle 2 Day 1: ECOG score 1 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 188 Part 1: LGX818 300 mg 182 Part 1: Vemurafenib 960 mg BID 181 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 256 Part 2: LGX818 300 mg 80 Part 1 + Part 2: LGX818 300 mg 262
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 44 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 79 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 64 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 62 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 32 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 111 Not reported Not reported Not reported Not reported
Cycle 2 Day 1: ECOG score 2 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 188 Part 1: LGX818 300 mg 182 Part 1: Vemurafenib 960 mg BID 181 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 256 Part 2: LGX818 300 mg 80 Part 1 + Part 2: LGX818 300 mg 262
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 1 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 3 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 4 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 1 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 4 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 7 Not reported Not reported Not reported Not reported
Cycle 2 Day 1: ECOG score 3 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 188 Part 1: LGX818 300 mg 182 Part 1: Vemurafenib 960 mg BID 181 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 256 Part 2: LGX818 300 mg 80 Part 1 + Part 2: LGX818 300 mg 262
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 0 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 2 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 0 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 0 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 0 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 2 Not reported Not reported Not reported Not reported
Cycle 2 Day 1: ECOG score 4 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 188 Part 1: LGX818 300 mg 182 Part 1: Vemurafenib 960 mg BID 181 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 256 Part 2: LGX818 300 mg 80 Part 1 + Part 2: LGX818 300 mg 262
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 1 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 0 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 0 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 0 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 0 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 0 Not reported Not reported Not reported Not reported
Cycle 3 Day 1: ECOG score 0 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 185 Part 1: LGX818 300 mg 175 Part 1: Vemurafenib 960 mg BID 176 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 253 Part 2: LGX818 300 mg 74 Part 1 + Part 2: LGX818 300 mg 249
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 131 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 90 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 107 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 197 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 40 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 130 Not reported Not reported Not reported Not reported
Cycle 3 Day 1: ECOG score 1 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 185 Part 1: LGX818 300 mg 175 Part 1: Vemurafenib 960 mg BID 176 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 253 Part 2: LGX818 300 mg 74 Part 1 + Part 2: LGX818 300 mg 249
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 53 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 81 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 64 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 55 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 32 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 113 Not reported Not reported Not reported Not reported
Cycle 3 Day 1: ECOG score 2 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 185 Part 1: LGX818 300 mg 175 Part 1: Vemurafenib 960 mg BID 176 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 253 Part 2: LGX818 300 mg 74 Part 1 + Part 2: LGX818 300 mg 249
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 1 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 4 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 4 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 1 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 2 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 6 Not reported Not reported Not reported Not reported
Cycle 4 Day 1: ECOG score 0 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 179 Part 1: LGX818 300 mg 164 Part 1: Vemurafenib 960 mg BID 158 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 250 Part 2: LGX818 300 mg 68 Part 1 + Part 2: LGX818 300 mg 232
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 128 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 93 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 98 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 189 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 35 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 128 Not reported Not reported Not reported Not reported
Cycle 4 Day 1: ECOG score 1 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 179 Part 1: LGX818 300 mg 164 Part 1: Vemurafenib 960 mg BID 158 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 250 Part 2: LGX818 300 mg 68 Part 1 + Part 2: LGX818 300 mg 232
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 50 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 66 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 52 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 56 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 30 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 96 Not reported Not reported Not reported Not reported
Cycle 4 Day 1: ECOG score 2 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 179 Part 1: LGX818 300 mg 164 Part 1: Vemurafenib 960 mg BID 158 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 250 Part 2: LGX818 300 mg 68 Part 1 + Part 2: LGX818 300 mg 232
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 1 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 4 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 4 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 4 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 3 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 7 Not reported Not reported Not reported Not reported
Cycle 4 Day 1: ECOG score 3 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 179 Part 1: LGX818 300 mg 164 Part 1: Vemurafenib 960 mg BID 158 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 250 Part 2: LGX818 300 mg 68 Part 1 + Part 2: LGX818 300 mg 232
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 0 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 1 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 4 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 1 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 0 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 1 Not reported Not reported Not reported Not reported
Cycle 5 Day 1: ECOG score 0 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 174 Part 1: LGX818 300 mg 158 Part 1: Vemurafenib 960 mg BID 143 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 239 Part 2: LGX818 300 mg 66 Part 1 + Part 2: LGX818 300 mg 224
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 128 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 85 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 82 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 181 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 33 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 118 Not reported Not reported Not reported Not reported
Cycle 5 Day 1: ECOG score 1 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 174 Part 1: LGX818 300 mg 158 Part 1: Vemurafenib 960 mg BID 143 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 239 Part 2: LGX818 300 mg 66 Part 1 + Part 2: LGX818 300 mg 224
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 42 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 69 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 52 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 55 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 31 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 100 Not reported Not reported Not reported Not reported
Cycle 5 Day 1: ECOG score 2 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 174 Part 1: LGX818 300 mg 158 Part 1: Vemurafenib 960 mg BID 143 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 239 Part 2: LGX818 300 mg 66 Part 1 + Part 2: LGX818 300 mg 224
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 3 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 4 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 7 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 2 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 2 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 6 Not reported Not reported Not reported Not reported
Cycle 5 Day 1: ECOG score 3 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 174 Part 1: LGX818 300 mg 158 Part 1: Vemurafenib 960 mg BID 143 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 239 Part 2: LGX818 300 mg 66 Part 1 + Part 2: LGX818 300 mg 224
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 1 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 0 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 1 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 1 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 0 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 0 Not reported Not reported Not reported Not reported
Cycle 5 Day 1: ECOG score 4 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 174 Part 1: LGX818 300 mg 158 Part 1: Vemurafenib 960 mg BID 143 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 239 Part 2: LGX818 300 mg 66 Part 1 + Part 2: LGX818 300 mg 224
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 0 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 0 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 1 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 0 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 0 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 0 Not reported Not reported Not reported Not reported
Cycle 6 Day 1: ECOG score 0 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 169 Part 1: LGX818 300 mg 137 Part 1: Vemurafenib 960 mg BID 126 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 231 Part 2: LGX818 300 mg 58 Part 1 + Part 2: LGX818 300 mg 195
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 124 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 68 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 78 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 168 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 29 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 97 Not reported Not reported Not reported Not reported
Cycle 6 Day 1: ECOG score 1 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 169 Part 1: LGX818 300 mg 137 Part 1: Vemurafenib 960 mg BID 126 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 231 Part 2: LGX818 300 mg 58 Part 1 + Part 2: LGX818 300 mg 195
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 45 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 65 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 46 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 58 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 25 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 90 Not reported Not reported Not reported Not reported
Cycle 6 Day 1: ECOG score 2 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 169 Part 1: LGX818 300 mg 137 Part 1: Vemurafenib 960 mg BID 126 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 231 Part 2: LGX818 300 mg 58 Part 1 + Part 2: LGX818 300 mg 195
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 0 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 3 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 1 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 3 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 3 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 6 Not reported Not reported Not reported Not reported
Cycle 6 Day 1: ECOG score 3 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 169 Part 1: LGX818 300 mg 137 Part 1: Vemurafenib 960 mg BID 126 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 231 Part 2: LGX818 300 mg 58 Part 1 + Part 2: LGX818 300 mg 195
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 0 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 0 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 1 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 1 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 1 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 1 Not reported Not reported Not reported Not reported
Cycle 6 Day 1: ECOG score 4 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 169 Part 1: LGX818 300 mg 137 Part 1: Vemurafenib 960 mg BID 126 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 231 Part 2: LGX818 300 mg 58 Part 1 + Part 2: LGX818 300 mg 195
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 0 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 1 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 0 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 1 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 0 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 1 Not reported Not reported Not reported Not reported
Cycle 7 Day 1: ECOG score 0 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 158 Part 1: LGX818 300 mg 129 Part 1: Vemurafenib 960 mg BID 111 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 218 Part 2: LGX818 300 mg 55 Part 1 + Part 2: LGX818 300 mg 184
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 111 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 68 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 74 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 158 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 27 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 95 Not reported Not reported Not reported Not reported
Cycle 7 Day 1: ECOG score 1 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 158 Part 1: LGX818 300 mg 129 Part 1: Vemurafenib 960 mg BID 111 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 218 Part 2: LGX818 300 mg 55 Part 1 + Part 2: LGX818 300 mg 184
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 46 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 60 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 35 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 58 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 27 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 87 Not reported Not reported Not reported Not reported
Cycle 7 Day 1: ECOG score 2 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 158 Part 1: LGX818 300 mg 129 Part 1: Vemurafenib 960 mg BID 111 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 218 Part 2: LGX818 300 mg 55 Part 1 + Part 2: LGX818 300 mg 184
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 1 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 1 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 2 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 2 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 1 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 2 Not reported Not reported Not reported Not reported
Cycle 8 Day 1: ECOG score 0 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 148 Part 1: LGX818 300 mg 108 Part 1: Vemurafenib 960 mg BID 95 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 200 Part 2: LGX818 300 mg 46 Part 1 + Part 2: LGX818 300 mg 154
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 112 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 55 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 58 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 140 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 22 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 77 Not reported Not reported Not reported Not reported
Cycle 8 Day 1: ECOG score 1 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 148 Part 1: LGX818 300 mg 108 Part 1: Vemurafenib 960 mg BID 95 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 200 Part 2: LGX818 300 mg 46 Part 1 + Part 2: LGX818 300 mg 154
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 33 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 49 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 33 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 58 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 21 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 70 Not reported Not reported Not reported Not reported
Cycle 8 Day 1: ECOG score 2 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 148 Part 1: LGX818 300 mg 108 Part 1: Vemurafenib 960 mg BID 95 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 200 Part 2: LGX818 300 mg 46 Part 1 + Part 2: LGX818 300 mg 154
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 2 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 3 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 4 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 1 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 3 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 6 Not reported Not reported Not reported Not reported
Cycle 8 Day 1: ECOG score 3 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 148 Part 1: LGX818 300 mg 108 Part 1: Vemurafenib 960 mg BID 95 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 200 Part 2: LGX818 300 mg 46 Part 1 + Part 2: LGX818 300 mg 154
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 1 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 1 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 0 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 1 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 0 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 1 Not reported Not reported Not reported Not reported
Cycle 9 Day 1: ECOG score 0 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 144 Part 1: LGX818 300 mg 98 Part 1: Vemurafenib 960 mg BID 90 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 188 Part 2: LGX818 300 mg 43 Part 1 + Part 2: LGX818 300 mg 141
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 102 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 50 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 55 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 135 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 22 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 72 Not reported Not reported Not reported Not reported
Cycle 9 Day 1: ECOG score 1 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 144 Part 1: LGX818 300 mg 98 Part 1: Vemurafenib 960 mg BID 90 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 188 Part 2: LGX818 300 mg 43 Part 1 + Part 2: LGX818 300 mg 141
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 36 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 47 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 30 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 52 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 20 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 67 Not reported Not reported Not reported Not reported
Cycle 9 Day 1: ECOG score 2 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 144 Part 1: LGX818 300 mg 98 Part 1: Vemurafenib 960 mg BID 90 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 188 Part 2: LGX818 300 mg 43 Part 1 + Part 2: LGX818 300 mg 141
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 4 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 1 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 4 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 0 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 0 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 1 Not reported Not reported Not reported Not reported
Cycle 9 Day 1: ECOG score 3 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 144 Part 1: LGX818 300 mg 98 Part 1: Vemurafenib 960 mg BID 90 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 188 Part 2: LGX818 300 mg 43 Part 1 + Part 2: LGX818 300 mg 141
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 0 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 0 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 1 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 0 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 1 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 1 Not reported Not reported Not reported Not reported
Cycle 9 Day 1: ECOG score 4 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 144 Part 1: LGX818 300 mg 98 Part 1: Vemurafenib 960 mg BID 90 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 188 Part 2: LGX818 300 mg 43 Part 1 + Part 2: LGX818 300 mg 141
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 1 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 0 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 0 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 1 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 0 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 0 Not reported Not reported Not reported Not reported
Cycle 9 Day 1: ECOG score 5 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 144 Part 1: LGX818 300 mg 98 Part 1: Vemurafenib 960 mg BID 90 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 188 Part 2: LGX818 300 mg 43 Part 1 + Part 2: LGX818 300 mg 141
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 1 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 0 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 0 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 0 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 0 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 0 Not reported Not reported Not reported Not reported
Cycle 10 Day 1: ECOG score 0 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 129 Part 1: LGX818 300 mg 88 Part 1: Vemurafenib 960 mg BID 72 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 171 Part 2: LGX818 300 mg 37 Part 1 + Part 2: LGX818 300 mg 125
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 94 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 52 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 43 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 121 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 18 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 70 Not reported Not reported Not reported Not reported
Cycle 10 Day 1: ECOG score 1 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 129 Part 1: LGX818 300 mg 88 Part 1: Vemurafenib 960 mg BID 72 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 171 Part 2: LGX818 300 mg 37 Part 1 + Part 2: LGX818 300 mg 125
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 32 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 35 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 26 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 46 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 18 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 53 Not reported Not reported Not reported Not reported
Cycle 10 Day 1: ECOG score 2 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 129 Part 1: LGX818 300 mg 88 Part 1: Vemurafenib 960 mg BID 72 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 171 Part 2: LGX818 300 mg 37 Part 1 + Part 2: LGX818 300 mg 125
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 3 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 1 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 2 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 3 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 1 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 2 Not reported Not reported Not reported Not reported
Cycle 10 Day 1: ECOG score 3 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 129 Part 1: LGX818 300 mg 88 Part 1: Vemurafenib 960 mg BID 72 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 171 Part 2: LGX818 300 mg 37 Part 1 + Part 2: LGX818 300 mg 125
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 0 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 0 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 1 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 1 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 0 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 0 Not reported Not reported Not reported Not reported
Cycle 11 Day 1: ECOG score 0 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 120 Part 1: LGX818 300 mg 85 Part 1: Vemurafenib 960 mg BID 62 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 158 Part 2: LGX818 300 mg 36 Part 1 + Part 2: LGX818 300 mg 121
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 88 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 44 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 39 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 116 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 17 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 61 Not reported Not reported Not reported Not reported
Cycle 11 Day 1: ECOG score 1 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 120 Part 1: LGX818 300 mg 85 Part 1: Vemurafenib 960 mg BID 62 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 158 Part 2: LGX818 300 mg 36 Part 1 + Part 2: LGX818 300 mg 121
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 30 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 40 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 20 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 42 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 16 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 56 Not reported Not reported Not reported Not reported
Cycle 11 Day 1: ECOG score 2 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 120 Part 1: LGX818 300 mg 85 Part 1: Vemurafenib 960 mg BID 62 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 158 Part 2: LGX818 300 mg 36 Part 1 + Part 2: LGX818 300 mg 121
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 2 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 1 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 2 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 0 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 3 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 4 Not reported Not reported Not reported Not reported
Cycle 11 Day 1: ECOG score 3 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 120 Part 1: LGX818 300 mg 85 Part 1: Vemurafenib 960 mg BID 62 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 158 Part 2: LGX818 300 mg 36 Part 1 + Part 2: LGX818 300 mg 121
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 0 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 0 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 1 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 0 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 0 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 0 Not reported Not reported Not reported Not reported
Cycle 12 Day 1: ECOG score 0 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 110 Part 1: LGX818 300 mg 77 Part 1: Vemurafenib 960 mg BID 51 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 152 Part 2: LGX818 300 mg 30 Part 1 + Part 2: LGX818 300 mg 107
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 84 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 44 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 32 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 113 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 11 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 55 Not reported Not reported Not reported Not reported
Cycle 12 Day 1: ECOG score 1 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 110 Part 1: LGX818 300 mg 77 Part 1: Vemurafenib 960 mg BID 51 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 152 Part 2: LGX818 300 mg 30 Part 1 + Part 2: LGX818 300 mg 107
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 25 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 31 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 16 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 38 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 18 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 49 Not reported Not reported Not reported Not reported
Cycle 12 Day 1: ECOG score 2 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 110 Part 1: LGX818 300 mg 77 Part 1: Vemurafenib 960 mg BID 51 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 152 Part 2: LGX818 300 mg 30 Part 1 + Part 2: LGX818 300 mg 107
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 1 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 1 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 2 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 0 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 1 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 2 Not reported Not reported Not reported Not reported
Cycle 12 Day 1: ECOG score 3 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 110 Part 1: LGX818 300 mg 77 Part 1: Vemurafenib 960 mg BID 51 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 152 Part 2: LGX818 300 mg 30 Part 1 + Part 2: LGX818 300 mg 107
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 0 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 1 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 1 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 0 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 0 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 1 Not reported Not reported Not reported Not reported
Cycle 12 Day 1: ECOG score 4 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 110 Part 1: LGX818 300 mg 77 Part 1: Vemurafenib 960 mg BID 51 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 152 Part 2: LGX818 300 mg 30 Part 1 + Part 2: LGX818 300 mg 107
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 0 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 0 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 0 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 1 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 0 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 0 Not reported Not reported Not reported Not reported
Cycle 13 Day 1: ECOG score 0 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 100 Part 1: LGX818 300 mg 73 Part 1: Vemurafenib 960 mg BID 47 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 143 Part 2: LGX818 300 mg 31 Part 1 + Part 2: LGX818 300 mg 104
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 77 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 41 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 27 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 102 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 14 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 55 Not reported Not reported Not reported Not reported
Cycle 13 Day 1: ECOG score 1 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 100 Part 1: LGX818 300 mg 73 Part 1: Vemurafenib 960 mg BID 47 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 143 Part 2: LGX818 300 mg 31 Part 1 + Part 2: LGX818 300 mg 104
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 22 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 31 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 18 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 39 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 15 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 46 Not reported Not reported Not reported Not reported
Cycle 13 Day 1: ECOG score 2 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 100 Part 1: LGX818 300 mg 73 Part 1: Vemurafenib 960 mg BID 47 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 143 Part 2: LGX818 300 mg 31 Part 1 + Part 2: LGX818 300 mg 104
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 1 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 1 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 2 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 1 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 2 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 3 Not reported Not reported Not reported Not reported
Cycle 13 Day 1: ECOG score 4 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 100 Part 1: LGX818 300 mg 73 Part 1: Vemurafenib 960 mg BID 47 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 143 Part 2: LGX818 300 mg 31 Part 1 + Part 2: LGX818 300 mg 104
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 0 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 0 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 0 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 1 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 0 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 0 Not reported Not reported Not reported Not reported
Cycle 14 Day 1: ECOG score 0 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 97 Part 1: LGX818 300 mg 75 Part 1: Vemurafenib 960 mg BID 46 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 136 Part 2: LGX818 300 mg 27 Part 1 + Part 2: LGX818 300 mg 102
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 74 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 47 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 25 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 100 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 15 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 62 Not reported Not reported Not reported Not reported
Cycle 14 Day 1: ECOG score 1 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 97 Part 1: LGX818 300 mg 75 Part 1: Vemurafenib 960 mg BID 46 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 136 Part 2: LGX818 300 mg 27 Part 1 + Part 2: LGX818 300 mg 102
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 23 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 27 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 19 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 33 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 10 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 37 Not reported Not reported Not reported Not reported
Cycle 14 Day 1: ECOG score 2 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 97 Part 1: LGX818 300 mg 75 Part 1: Vemurafenib 960 mg BID 46 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 136 Part 2: LGX818 300 mg 27 Part 1 + Part 2: LGX818 300 mg 102
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 0 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 0 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 2 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 2 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 2 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 2 Not reported Not reported Not reported Not reported
Cycle 14 Day 1: ECOG score 3 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 97 Part 1: LGX818 300 mg 75 Part 1: Vemurafenib 960 mg BID 46 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 136 Part 2: LGX818 300 mg 27 Part 1 + Part 2: LGX818 300 mg 102
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 0 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 0 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 0 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 1 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 0 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 0 Not reported Not reported Not reported Not reported
Cycle 14 Day 1: ECOG score 4 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 97 Part 1: LGX818 300 mg 75 Part 1: Vemurafenib 960 mg BID 46 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 136 Part 2: LGX818 300 mg 27 Part 1 + Part 2: LGX818 300 mg 102
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 0 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 1 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 0 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 0 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 0 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 1 Not reported Not reported Not reported Not reported
Cycle 15 Day 1: ECOG score 0 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 94 Part 1: LGX818 300 mg 72 Part 1: Vemurafenib 960 mg BID 41 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 111 Part 2: LGX818 300 mg 21 Part 1 + Part 2: LGX818 300 mg 93
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 72 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 41 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 22 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 82 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 13 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 54 Not reported Not reported Not reported Not reported
Cycle 15 Day 1: ECOG score 1 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 94 Part 1: LGX818 300 mg 72 Part 1: Vemurafenib 960 mg BID 41 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 111 Part 2: LGX818 300 mg 21 Part 1 + Part 2: LGX818 300 mg 93
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 20 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 30 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 18 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 27 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 7 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 37 Not reported Not reported Not reported Not reported
Cycle 15 Day 1: ECOG score 2 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 94 Part 1: LGX818 300 mg 72 Part 1: Vemurafenib 960 mg BID 41 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 111 Part 2: LGX818 300 mg 21 Part 1 + Part 2: LGX818 300 mg 93
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 1 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 1 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 1 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 1 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 1 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 2 Not reported Not reported Not reported Not reported
Cycle 15 Day 1: ECOG score 3 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 94 Part 1: LGX818 300 mg 72 Part 1: Vemurafenib 960 mg BID 41 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 111 Part 2: LGX818 300 mg 21 Part 1 + Part 2: LGX818 300 mg 93
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 1 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 0 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 0 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 0 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 0 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 0 Not reported Not reported Not reported Not reported
Cycle 15 Day 1: ECOG score 4 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 94 Part 1: LGX818 300 mg 72 Part 1: Vemurafenib 960 mg BID 41 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 111 Part 2: LGX818 300 mg 21 Part 1 + Part 2: LGX818 300 mg 93
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 0 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 0 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 0 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 1 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 0 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 0 Not reported Not reported Not reported Not reported
Cycle 16 Day 1: ECOG score 0 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 89 Part 1: LGX818 300 mg 67 Part 1: Vemurafenib 960 mg BID 35 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 88 Part 2: LGX818 300 mg 19 Part 1 + Part 2: LGX818 300 mg 86
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 64 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 41 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 24 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 64 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 11 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 52 Not reported Not reported Not reported Not reported
Cycle 16 Day 1: ECOG score 1 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 89 Part 1: LGX818 300 mg 67 Part 1: Vemurafenib 960 mg BID 35 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 88 Part 2: LGX818 300 mg 19 Part 1 + Part 2: LGX818 300 mg 86
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 24 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 23 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 10 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 23 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 7 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 30 Not reported Not reported Not reported Not reported
Cycle 16 Day 1: ECOG score 2 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 89 Part 1: LGX818 300 mg 67 Part 1: Vemurafenib 960 mg BID 35 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 88 Part 2: LGX818 300 mg 19 Part 1 + Part 2: LGX818 300 mg 86
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 1 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 3 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 1 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 0 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 1 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 4 Not reported Not reported Not reported Not reported
Cycle 16 Day 1: ECOG score 3 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 89 Part 1: LGX818 300 mg 67 Part 1: Vemurafenib 960 mg BID 35 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 88 Part 2: LGX818 300 mg 19 Part 1 + Part 2: LGX818 300 mg 86
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 0 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 0 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 0 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 1 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 0 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 0 Not reported Not reported Not reported Not reported
Cycle 17 Day 1: ECOG score 0 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 82 Part 1: LGX818 300 mg 67 Part 1: Vemurafenib 960 mg BID 33 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 68 Part 2: LGX818 300 mg 16 Part 1 + Part 2: LGX818 300 mg 83
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 65 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 39 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 21 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 52 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 9 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 48 Not reported Not reported Not reported Not reported
Cycle 17 Day 1: ECOG score 1 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 82 Part 1: LGX818 300 mg 67 Part 1: Vemurafenib 960 mg BID 33 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 68 Part 2: LGX818 300 mg 16 Part 1 + Part 2: LGX818 300 mg 83
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 16 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 27 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 11 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 15 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 6 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 33 Not reported Not reported Not reported Not reported
Cycle 17 Day 1: ECOG score 2 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 82 Part 1: LGX818 300 mg 67 Part 1: Vemurafenib 960 mg BID 33 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 68 Part 2: LGX818 300 mg 16 Part 1 + Part 2: LGX818 300 mg 83
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 1 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 1 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 1 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 1 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 1 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 2 Not reported Not reported Not reported Not reported
Cycle 18 Day 1: ECOG score 0 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 75 Part 1: LGX818 300 mg 60 Part 1: Vemurafenib 960 mg BID 31 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 46 Part 2: LGX818 300 mg 10 Part 1 + Part 2: LGX818 300 mg 70
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 60 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 36 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 18 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 34 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 5 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 41 Not reported Not reported Not reported Not reported
Cycle 18 Day 1: ECOG score 1 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 75 Part 1: LGX818 300 mg 60 Part 1: Vemurafenib 960 mg BID 31 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 46 Part 2: LGX818 300 mg 10 Part 1 + Part 2: LGX818 300 mg 70
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 14 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 24 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 11 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 11 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 5 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 29 Not reported Not reported Not reported Not reported
Cycle 18 Day 1: ECOG score 2 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 75 Part 1: LGX818 300 mg 60 Part 1: Vemurafenib 960 mg BID 31 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 46 Part 2: LGX818 300 mg 10 Part 1 + Part 2: LGX818 300 mg 70
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 1 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 0 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 1 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 1 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 0 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 0 Not reported Not reported Not reported Not reported
Cycle 18 Day 1: ECOG score 3 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 75 Part 1: LGX818 300 mg 60 Part 1: Vemurafenib 960 mg BID 31 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 46 Part 2: LGX818 300 mg 10 Part 1 + Part 2: LGX818 300 mg 70
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 0 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 0 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 1 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 0 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 0 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 0 Not reported Not reported Not reported Not reported
Cycle 19 Day 1: ECOG score 0 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 65 Part 1: LGX818 300 mg 59 Part 1: Vemurafenib 960 mg BID 30 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 30 Part 2: LGX818 300 mg 8 Part 1 + Part 2: LGX818 300 mg 67
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 54 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 38 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 20 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 22 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 2 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 40 Not reported Not reported Not reported Not reported
Cycle 19 Day 1: ECOG score 1 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 65 Part 1: LGX818 300 mg 59 Part 1: Vemurafenib 960 mg BID 30 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 30 Part 2: LGX818 300 mg 8 Part 1 + Part 2: LGX818 300 mg 67
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 9 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 20 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 9 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 7 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 6 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 26 Not reported Not reported Not reported Not reported
Cycle 19 Day 1: ECOG score 2 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 65 Part 1: LGX818 300 mg 59 Part 1: Vemurafenib 960 mg BID 30 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 30 Part 2: LGX818 300 mg 8 Part 1 + Part 2: LGX818 300 mg 67
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 2 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 1 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 1 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 1 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 0 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 1 Not reported Not reported Not reported Not reported
Cycle 20 Day 1: ECOG score 0 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 61 Part 1: LGX818 300 mg 52 Part 1: Vemurafenib 960 mg BID 27 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 20 Part 2: LGX818 300 mg 6 Part 1 + Part 2: LGX818 300 mg 58
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 53 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 31 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 19 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 15 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 3 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 34 Not reported Not reported Not reported Not reported
Cycle 20 Day 1: ECOG score 1 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 61 Part 1: LGX818 300 mg 52 Part 1: Vemurafenib 960 mg BID 27 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 20 Part 2: LGX818 300 mg 6 Part 1 + Part 2: LGX818 300 mg 58
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 7 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 19 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 8 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 5 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 3 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 22 Not reported Not reported Not reported Not reported
Cycle 20 Day 1: ECOG score 2 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 61 Part 1: LGX818 300 mg 52 Part 1: Vemurafenib 960 mg BID 27 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 20 Part 2: LGX818 300 mg 6 Part 1 + Part 2: LGX818 300 mg 58
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 0 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 2 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 0 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 0 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 0 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 2 Not reported Not reported Not reported Not reported
Cycle 20 Day 1: ECOG score 3 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 61 Part 1: LGX818 300 mg 52 Part 1: Vemurafenib 960 mg BID 27 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 20 Part 2: LGX818 300 mg 6 Part 1 + Part 2: LGX818 300 mg 58
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 1 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 0 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 0 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 0 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 0 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 0 Not reported Not reported Not reported Not reported
Cycle 21 Day 1: ECOG score 0 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 46 Part 1: LGX818 300 mg 49 Part 1: Vemurafenib 960 mg BID 23 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 13 Part 2: LGX818 300 mg 3 Part 1 + Part 2: LGX818 300 mg 52
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 36 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 29 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 15 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 11 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 2 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 31 Not reported Not reported Not reported Not reported
Cycle 21 Day 1: ECOG score 1 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 46 Part 1: LGX818 300 mg 49 Part 1: Vemurafenib 960 mg BID 23 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 13 Part 2: LGX818 300 mg 3 Part 1 + Part 2: LGX818 300 mg 52
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 10 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 19 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 8 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 2 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 1 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 20 Not reported Not reported Not reported Not reported
Cycle 21 Day 1: ECOG score 2 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 46 Part 1: LGX818 300 mg 49 Part 1: Vemurafenib 960 mg BID 23 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 13 Part 2: LGX818 300 mg 3 Part 1 + Part 2: LGX818 300 mg 52
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 9 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 1 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 0 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 0 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 0 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 1 Not reported Not reported Not reported Not reported
Cycle 22 Day 1: ECOG score 0 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 37 Part 1: LGX818 300 mg 45 Part 1: Vemurafenib 960 mg BID 17 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 6 Part 2: LGX818 300 mg 0 Part 1 + Part 2: LGX818 300 mg 45
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 29 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 27 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 11 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 4 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 0 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 27 Not reported Not reported Not reported Not reported
Cycle 22 Day 1: ECOG score 1 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 37 Part 1: LGX818 300 mg 45 Part 1: Vemurafenib 960 mg BID 17 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 6 Part 2: LGX818 300 mg 0 Part 1 + Part 2: LGX818 300 mg 45
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 8 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 16 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 6 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 2 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 0 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 16 Not reported Not reported Not reported Not reported
Cycle 22 Day 1: ECOG score 3 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 37 Part 1: LGX818 300 mg 45 Part 1: Vemurafenib 960 mg BID 17 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 6 Part 2: LGX818 300 mg 0 Part 1 + Part 2: LGX818 300 mg 45
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 0 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 1 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 0 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 0 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 0 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 1 Not reported Not reported Not reported Not reported
Cycle 22 Day 1: ECOG score 4 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 37 Part 1: LGX818 300 mg 45 Part 1: Vemurafenib 960 mg BID 17 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 6 Part 2: LGX818 300 mg 0 Part 1 + Part 2: LGX818 300 mg 45
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 0 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 1 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 0 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 0 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 0 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 1 Not reported Not reported Not reported Not reported
Cycle 23 Day 1: ECOG score 0 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 30 Part 1: LGX818 300 mg 38 Part 1: Vemurafenib 960 mg BID 15 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 0 Part 2: LGX818 300 mg 0 Part 1 + Part 2: LGX818 300 mg 38
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 24 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 26 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 10 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 0 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 0 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 26 Not reported Not reported Not reported Not reported
Cycle 23 Day 1: ECOG score 1 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 30 Part 1: LGX818 300 mg 38 Part 1: Vemurafenib 960 mg BID 15 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 0 Part 2: LGX818 300 mg 0 Part 1 + Part 2: LGX818 300 mg 38
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 6 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 12 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 5 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 0 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 0 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 12 Not reported Not reported Not reported Not reported
Cycle 24 Day 1: ECOG score 0 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 28 Part 1: LGX818 300 mg 33 Part 1: Vemurafenib 960 mg BID 14 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 0 Part 2: LGX818 300 mg 0 Part 1 + Part 2: LGX818 300 mg 33
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 21 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 23 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 9 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 0 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 0 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 23 Not reported Not reported Not reported Not reported
Cycle 24 Day 1: ECOG score 1 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 28 Part 1: LGX818 300 mg 33 Part 1: Vemurafenib 960 mg BID 14 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 0 Part 2: LGX818 300 mg 0 Part 1 + Part 2: LGX818 300 mg 33
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 7 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 10 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 5 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 0 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 0 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 10 Not reported Not reported Not reported Not reported
Cycle 25 Day 1: ECOG score 0 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 20 Part 1: LGX818 300 mg 31 Part 1: Vemurafenib 960 mg BID 11 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 0 Part 2: LGX818 300 mg 0 Part 1 + Part 2: LGX818 300 mg 31
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 17 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 23 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 9 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 0 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 0 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 23 Not reported Not reported Not reported Not reported
Cycle 25 Day 1: ECOG score 1 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 20 Part 1: LGX818 300 mg 31 Part 1: Vemurafenib 960 mg BID 11 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 0 Part 2: LGX818 300 mg 0 Part 1 + Part 2: LGX818 300 mg 31
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 3 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 8 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 2 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 0 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 0 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 8 Not reported Not reported Not reported Not reported
Cycle 26 Day 1: ECOG score 0 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 18 Part 1: LGX818 300 mg 29 Part 1: Vemurafenib 960 mg BID 9 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 0 Part 2: LGX818 300 mg 0 Part 1 + Part 2: LGX818 300 mg 29
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 14 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 21 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 7 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 0 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 0 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 21 Not reported Not reported Not reported Not reported
Cycle 26 Day 1: ECOG score 1 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 18 Part 1: LGX818 300 mg 29 Part 1: Vemurafenib 960 mg BID 9 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 0 Part 2: LGX818 300 mg 0 Part 1 + Part 2: LGX818 300 mg 29
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 3 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 8 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 2 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 0 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 0 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 8 Not reported Not reported Not reported Not reported
Cycle 26 Day 1: ECOG score 2 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 18 Part 1: LGX818 300 mg 29 Part 1: Vemurafenib 960 mg BID 9 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 0 Part 2: LGX818 300 mg 0 Part 1 + Part 2: LGX818 300 mg 29
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 1 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 0 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 0 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 0 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 0 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 0 Not reported Not reported Not reported Not reported
Cycle 27 Day 1: ECOG score 0 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 8 Part 1: LGX818 300 mg 26 Part 1: Vemurafenib 960 mg BID 7 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 0 Part 2: LGX818 300 mg 0 Part 1 + Part 2: LGX818 300 mg 26
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 5 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 20 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 3 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 0 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 0 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 20 Not reported Not reported Not reported Not reported
Cycle 27 Day 1: ECOG score 1 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 8 Part 1: LGX818 300 mg 26 Part 1: Vemurafenib 960 mg BID 7 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 0 Part 2: LGX818 300 mg 0 Part 1 + Part 2: LGX818 300 mg 26
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 3 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 6 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 4 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 0 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 0 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 6 Not reported Not reported Not reported Not reported
Cycle 28 Day 1: ECOG score 0 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 8 Part 1: LGX818 300 mg 24 Part 1: Vemurafenib 960 mg BID 5 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 0 Part 2: LGX818 300 mg 0 Part 1 + Part 2: LGX818 300 mg 24
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 5 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 18 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 4 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 0 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 0 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 18 Not reported Not reported Not reported Not reported
Cycle 28 Day 1: ECOG score 1 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 8 Part 1: LGX818 300 mg 24 Part 1: Vemurafenib 960 mg BID 5 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 0 Part 2: LGX818 300 mg 0 Part 1 + Part 2: LGX818 300 mg 24
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 3 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 6 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 1 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 0 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 0 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 6 Not reported Not reported Not reported Not reported
Cycle 29 Day 1: ECOG score 0 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 3 Part 1: LGX818 300 mg 18 Part 1: Vemurafenib 960 mg BID 5 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 0 Part 2: LGX818 300 mg 0 Part 1 + Part 2: LGX818 300 mg 18
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 1 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 13 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 5 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 0 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 0 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 13 Not reported Not reported Not reported Not reported
Cycle 29 Day 1: ECOG score 1 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 3 Part 1: LGX818 300 mg 18 Part 1: Vemurafenib 960 mg BID 5 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 0 Part 2: LGX818 300 mg 0 Part 1 + Part 2: LGX818 300 mg 18
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 2 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 5 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 0 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 0 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 0 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 5 Not reported Not reported Not reported Not reported
Cycle 30 Day 1: ECOG score 0 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 0 Part 1: LGX818 300 mg 12 Part 1: Vemurafenib 960 mg BID 4 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 0 Part 2: LGX818 300 mg 0 Part 1 + Part 2: LGX818 300 mg 12
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 0 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 9 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 4 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 0 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 0 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 9 Not reported Not reported Not reported Not reported
Cycle 30 Day 1: ECOG score 1 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 0 Part 1: LGX818 300 mg 12 Part 1: Vemurafenib 960 mg BID 4 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 0 Part 2: LGX818 300 mg 0 Part 1 + Part 2: LGX818 300 mg 12
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 0 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 3 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 0 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 0 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 0 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 3 Not reported Not reported Not reported Not reported
Cycle 31 Day 1: ECOG score 0 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 0 Part 1: LGX818 300 mg 10 Part 1: Vemurafenib 960 mg BID 2 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 0 Part 2: LGX818 300 mg 0 Part 1 + Part 2: LGX818 300 mg 10
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 0 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 7 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 2 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 0 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 0 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 7 Not reported Not reported Not reported Not reported
Cycle 31 Day 1: ECOG score 1 Analysis denominator · Participants
Group Source count Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 0 Part 1: LGX818 300 mg 10 Part 1: Vemurafenib 960 mg BID 2 Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 0 Part 2: LGX818 300 mg 0 Part 1 + Part 2: LGX818 300 mg 10
Values in Participants · Interval/dispersion: Not reported Group Value Spread Lower Upper Comment Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 0 Not reported Not reported Not reported Not reported Part 1: LGX818 300 mg 3 Not reported Not reported Not reported Not reported Part 1: Vemurafenib 960 mg BID 0 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) 0 Not reported Not reported Not reported Not reported Part 2: LGX818 300 mg 0 Not reported Not reported Not reported Not reported Part 1 + Part 2: LGX818 300 mg 3 Not reported Not reported Not reported Not reported
Complete source fields classes categories measurements
group Id OG000
value 136
group Id OG001
value 139
group Id OG002
value 135
group Id OG003
value 189
group Id OG004
value 60
group Id OG005
value 199 denoms counts
group Id OG000
value 192
group Id OG001
value 192
group Id OG002
value 186
group Id OG003
value 257
group Id OG004
value 84
group Id OG005
value 276
units Participants
title Baseline: ECOG score 0 categories measurements
group Id OG000
value 56
group Id OG001
value 53
group Id OG002
value 51
group Id OG003
value 68
group Id OG004
value 24
group Id OG005
value 77 denoms counts
group Id OG000
value 192
group Id OG001
value 192
group Id OG002
value 186
group Id OG003
value 257
group Id OG004
value 84
group Id OG005
value 276
units Participants
title Baseline: ECOG score 1 categories measurements
group Id OG000
value 142
group Id OG001
value 98
group Id OG002
value 113
group Id OG003
value 193
group Id OG004
value 44
group Id OG005
value 142 denoms counts
group Id OG000
value 188
group Id OG001
value 182
group Id OG002
value 181
group Id OG003
value 256
group Id OG004
value 80
group Id OG005
value 262
units Participants
title Cycle 2 Day 1: ECOG score 0 categories measurements
group Id OG000
value 44
group Id OG001
value 79
group Id OG002
value 64
group Id OG003
value 62
group Id OG004
value 32
group Id OG005
value 111 denoms counts
group Id OG000
value 188
group Id OG001
value 182
group Id OG002
value 181
group Id OG003
value 256
group Id OG004
value 80
group Id OG005
value 262
units Participants
title Cycle 2 Day 1: ECOG score 1 categories measurements
group Id OG000
value 1
group Id OG001
value 3
group Id OG002
value 4
group Id OG003
value 1
group Id OG004
value 4
group Id OG005
value 7 denoms counts
group Id OG000
value 188
group Id OG001
value 182
group Id OG002
value 181
group Id OG003
value 256
group Id OG004
value 80
group Id OG005
value 262
units Participants
title Cycle 2 Day 1: ECOG score 2 categories measurements
group Id OG000
value 0
group Id OG001
value 2
group Id OG002
value 0
group Id OG003
value 0
group Id OG004
value 0
group Id OG005
value 2 denoms counts
group Id OG000
value 188
group Id OG001
value 182
group Id OG002
value 181
group Id OG003
value 256
group Id OG004
value 80
group Id OG005
value 262
units Participants
title Cycle 2 Day 1: ECOG score 3 categories measurements
group Id OG000
value 1
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 denoms counts
group Id OG000
value 188
group Id OG001
value 182
group Id OG002
value 181
group Id OG003
value 256
group Id OG004
value 80
group Id OG005
value 262
units Participants
title Cycle 2 Day 1: ECOG score 4 categories measurements
group Id OG000
value 131
group Id OG001
value 90
group Id OG002
value 107
group Id OG003
value 197
group Id OG004
value 40
group Id OG005
value 130 denoms counts
group Id OG000
value 185
group Id OG001
value 175
group Id OG002
value 176
group Id OG003
value 253
group Id OG004
value 74
group Id OG005
value 249
units Participants
title Cycle 3 Day 1: ECOG score 0 categories measurements
group Id OG000
value 53
group Id OG001
value 81
group Id OG002
value 64
group Id OG003
value 55
group Id OG004
value 32
group Id OG005
value 113 denoms counts
group Id OG000
value 185
group Id OG001
value 175
group Id OG002
value 176
group Id OG003
value 253
group Id OG004
value 74
group Id OG005
value 249
units Participants
title Cycle 3 Day 1: ECOG score 1 categories measurements
group Id OG000
value 1
group Id OG001
value 4
group Id OG002
value 4
group Id OG003
value 1
group Id OG004
value 2
group Id OG005
value 6 denoms counts
group Id OG000
value 185
group Id OG001
value 175
group Id OG002
value 176
group Id OG003
value 253
group Id OG004
value 74
group Id OG005
value 249
units Participants
title Cycle 3 Day 1: ECOG score 2 categories measurements
group Id OG000
value 128
group Id OG001
value 93
group Id OG002
value 98
group Id OG003
value 189
group Id OG004
value 35
group Id OG005
value 128 denoms counts
group Id OG000
value 179
group Id OG001
value 164
group Id OG002
value 158
group Id OG003
value 250
group Id OG004
value 68
group Id OG005
value 232
units Participants
title Cycle 4 Day 1: ECOG score 0 categories measurements
group Id OG000
value 50
group Id OG001
value 66
group Id OG002
value 52
group Id OG003
value 56
group Id OG004
value 30
group Id OG005
value 96 denoms counts
group Id OG000
value 179
group Id OG001
value 164
group Id OG002
value 158
group Id OG003
value 250
group Id OG004
value 68
group Id OG005
value 232
units Participants
title Cycle 4 Day 1: ECOG score 1 Show more (12 of 108) denoms counts
group Id OG000
value 192
group Id OG001
value 192
group Id OG002
value 186
group Id OG003
value 257
group Id OG004
value 84
group Id OG005
value 276
units Participants
description ECOG: participant's performance status was measured on a 6-point scale: 0= fully active/able to carry on all pre-disease activities without restriction; 1= restricted in physically strenuous activity but ambulatory and able to carry out work of a light and sedentary nature; 2= ambulatory and capable of all self-care, but unable to carry out any work activities, up and about more than 50% of waking hours; 3= capable of only limited self-care, confined to bed/chair \>50% of waking hours; 4= completely disabled, cannot carry on any self-care, totally confined to bed/chair: 5= dead. groups
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)
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
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
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)
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
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 COUNT_OF_PARTICIPANTS
population Description Safety analysis set included all participants who received at least one dose of study medication and have at least one valid post-baseline safety evaluation. Here, "Number analyzed" signifies participants evaluable for each specified row. It was planned to report combined result data of Part 1 and Part 2 for LGX818 300 mg arm. Data is reported only for categories with non-zero values.
reporting Status POSTED
time Frame Part 1 and Part 2: Baseline, Day 1 of each cycle (Cycle 2 to Cycle 31)
title Part 1 and Part 2: Number of Participants With Change From Baseline in Eastern Cooperative Oncology Group Performance Status (ECOG PS)
type SECONDARY
unit Of Measure Participants Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
Triangle