TriangleNCT01909453 · STUDY IN CONTEXT
Study Comparing Combination of LGX818 Plus MEK162 Versus Vemurafenib and LGX818 Monotherapy in BRAF Mutant Melanoma
Draft scope assessment: unclear. Attached because the study's own record names BRAF and describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
Read the full study record and all posted results →
Linked outcomes
PFS was defined as the time from the date of randomization to the date of the first documented disease progression (PD) or death due to any cause, whichever occurs first. PFS was determined based on tumor assessment (RECIST version 1.1 criteria) as per BIRC/central review and survival information. If a participant did not had an event at the time of the analysis cut-off or at the start of any new anti-cancer therapy, data was censored at the date of last adequate tumor assessment. PD was defined as at least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, the sum must demonstrate an absolute increase of at least 5 square millimeter (mm\^2).
PFS was defined as the time from the date of randomization to the date of the first documented PD or death due to any cause, whichever occurs first. PFS was determined based on tumor assessment (RECIST version 1.1 criteria) as per BIRC and survival information. If a participant did not had an event at the time of the analysis cut-off or at the start of any new anti-cancer therapy, data was censored at the date of last adequate tumor assessment. PD was defined as at least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, the sum must demonstrate an absolute increase of at least 5 mm\^2.
PFS was defined as the time from the date of randomization to the date of the first documented PD or death due to any cause, whichever occurs first. PFS was determined based on tumor assessment (RECIST version 1.1 criteria) as per BIRC and survival information. If a participant did not had an event at the time of the analysis cut-off or at the start of any new anti-cancer therapy, data was censored at the date of last adequate tumor assessment. PD was defined as at least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, the sum must demonstrate an absolute increase of at least 5 mm\^2.
Overall survival was defined as the time from the date of randomization to the date of death due to any cause. If a death was not observed by the date of analysis cutoff, OS was censored at the date of last contact.
An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was any untoward medical occurrence at any dose that resulted in death; was life-threatening; required inpatient hospitalization/prolongation of existing hospitalization; resulted in persistent/significant disability/incapacity; results in congenital anomaly/birth defect or an important medical event. As per NCI-CTCAE version 4.03, severity was graded as Grade 1: asymptomatic/mild symptoms; Grade 2: moderate; Grade 3: severe/medically significant; Grade 4: life-threatening consequence; Grade 5: death. AEs and SAEs of all grades combined were reported.
Laboratory parameters were graded using NCI-CTCAE v4.03 where, Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2: moderate; minimal, local or noninvasive intervention indicated. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated. Grade 4: life-threatening consequences; urgent intervention indicated. Grade 5: death. Clinically notable shift from baseline in laboratory parameter = worsening by at least 2 grades or to \>=grade 3. Only categories with non-zero values for any reporting arm are reported.
Reported safety
Quality of life and patient-reported measures
FACT · Part 1 and Part 2: Time to Definitive 10% Deterioration in the Function Assessment Cancer Therapy-melanoma (FACT-M) Subscale
Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-opdivo-0f1c6ce6
- nct id
- NCT01909453
- qol key
- qol-0023
- source section id
- NCT01909453-om-0023
- source outcome index
- 23
- instrument
- FACT
- instrument basis
- matched 'fact-m' in the study's own wording
- scale title
- Part 1 and Part 2: Time to Definitive 10% Deterioration in the Function Assessment Cancer Therapy-melanoma (FACT-M) Subscale
- measure definition
- FACT-M:melanoma specific questionnaire to assess participant health-related quality of life(QoL).Melanoma specific 16 subscale :signs,symptoms,physical/social activities most relevant to participants with advanced-stage melanoma.Other items :physical,functional and social/family well-being(7 items each),emotional well-being(6 items),surgery specific concerns related to melanoma(8 items,not included in this study).Each item range 0(not at all)to 4(very much),combined to produce subscale scores.Total score range for FACT-M excluding surgery specific items is 0 to172,higher scores:better QoL.Melanoma subscale score range from0(worst)to 64(best response),higher score:better QoL.Time to definitive 10% deterioration:time from date of randomization to date of event with at least 10% relative to baseline worsening of corresponding scale score with no later improvement or death due to any cause.All collected data up to pre-specified collection period(i.e.,end of study)are reported for this OM.
- time frame
- Date of randomization to date of event or death due to any cause, which ever occurred first (up to 29 months for Part 1, excluding Part 1: LGX818 300 mg group; up to 35 months for Part 2 and Part 1 LGX 300 mg group)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- 1
- direction quote
- higher scores:better
- population note
- FAS included all randomized participants. It was planned to report combined result data of Part 1 and Part 2 for LGX818 300 mg arm.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
EORTC QLQ · Part 1 and Part 2: Time to Definitive 10% Deterioration in the Global Health Status Score of the European Organization for Research and Treatment of Cancer's Core Quality of Life Questionnaire (EORTC QLQ-C30)
Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-opdivo-0f1c6ce6
- nct id
- NCT01909453
- qol key
- qol-0024
- source section id
- NCT01909453-om-0024
- source outcome index
- 24
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- Part 1 and Part 2: Time to Definitive 10% Deterioration in the Global Health Status Score of the European Organization for Research and Treatment of Cancer's Core Quality of Life Questionnaire (EORTC QLQ-C30)
- measure definition
- EORTC QLQ-C30 is 30 item questionnaire composed of 5 multi-item functional subscales (physical,role,cognitive,emotional,social functioning), 3 multi-item symptom scales (fatigue,nausea/vomiting, and pain),global health/quality of life (QOL) subscale and 6 single items assessing other cancer related symptoms (dyspnea,sleep disturbance, appetite, diarrhea, constipation and financial impact of cancer). It employed twenty-eight 4 point Likert scales with responses from "not at all" to "very much" and two 7 point Likert scales for global health and overall QOL. Global health status scale score ranged from 0 to 100. Higher score: better level of functioning. Time to definitive 10% deterioration: time from date of randomization to date of event with at least 10% relative to baseline worsening of corresponding scale score with no later improvement or death due to any cause. All collected data up to the pre-specified collection period (i.e., end of study) are reported for this outcome measure.
- time frame
- Date of randomization to date of event or death due to any cause, which ever occurred first (maximum up to 29 months for Part 1, excluding Part 1: LGX818 300 mg group; up to 35 months for Part 2 and Part 1 LGX 300 mg group)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- 1
- direction quote
- Higher score: better
- population note
- FAS included all randomized participants. It was planned to report combined result data of Part 1 and Part 2 for LGX818 300 mg arm.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
FACT · Part 1 and Part 2: Change From Baseline in the FACT-M Subscale at Day 1 of Cycle 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25 and End of Treatment Visit
Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-opdivo-0f1c6ce6
- nct id
- NCT01909453
- qol key
- qol-0025
- source section id
- NCT01909453-om-0025
- source outcome index
- 25
- instrument
- FACT
- instrument basis
- matched 'fact-m' in the study's own wording
- scale title
- Part 1 and Part 2: Change From Baseline in the FACT-M Subscale at Day 1 of Cycle 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25 and End of Treatment Visit
- measure definition
- FACT-M: melanoma specific questionnaire to assess participant health-related quality of life. Melanoma specific subscale consists of 16 items related to signs, symptoms, physical/social activities most relevant to participants with advanced-stage melanoma. Other items include physical, functional and social/family well-being (7 items each), emotional well-being (6 items), surgery specific concerns related to melanoma (8 items, not included in this study). Each item ranged from 0 (not at all) to 4 (very much), combined to produce subscale scores. Total score range for FACT-M excluding surgery specific items is 0 to 172, higher scores represented better quality of life. Melanoma subscale score ranged from 0 (worst response) to 64 (best response), higher score indicated better quality of life.
- time frame
- Baseline (Day 1 of Cycle 1), Day 1 of Cycle 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25 and end of treatment visit (within14 days after the last dose of study drug)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- 1
- direction quote
- higher scores represented better
- population note
- FAS included all randomized participants. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure and "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.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
EQ-5D · Part 1 and Part 2: Change From Baseline in EuroQoL-5 Dimension-5 Level (EQ-5D-5L) Index Score at Day 1 of Cycle 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25 and End of Treatment Visit
Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-opdivo-0f1c6ce6
- nct id
- NCT01909453
- qol key
- qol-0026
- source section id
- NCT01909453-om-0026
- source outcome index
- 26
- instrument
- EQ-5D
- instrument basis
- matched 'eq-5d' in the study's own wording
- scale title
- Part 1 and Part 2: Change From Baseline in EuroQoL-5 Dimension-5 Level (EQ-5D-5L) Index Score at Day 1 of Cycle 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25 and End of Treatment Visit
- measure definition
- EQ-5D-5L is a standardized participant completed questionnaire that measures health status in terms of a single index value or utility score. EQ-5D-5L consisted of two components: a health state profile (descriptive system) and a visual analogue scale (VAS) in which participants rate their overall health status from 0 (worst imaginable) to 100 (best imaginable), where higher scores indicated better health status. EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 response levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. EQ-5D-5L health status index score range between 0 to 1. Higher score indicated better health status.
- time frame
- Baseline (Day 1 of Cycle 1), Day 1 of Cycle 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25 and end of treatment visit (within14 days after the last dose of study drug)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- 1
- direction quote
- higher scores indicated better
- population note
- FAS included all randomized participants. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure and "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.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
EORTC QLQ · Part 1 and Part 2: Change From Baseline in Global Health Status Score of EORTC QLQ-C30 at Day 1 of Cycle 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25 and End of Treatment Visit
Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-opdivo-0f1c6ce6
- nct id
- NCT01909453
- qol key
- qol-0027
- source section id
- NCT01909453-om-0027
- source outcome index
- 27
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- Part 1 and Part 2: Change From Baseline in Global Health Status Score of EORTC QLQ-C30 at Day 1 of Cycle 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25 and End of Treatment Visit
- measure definition
- EORTC QLQ-C30 contains 30 items and is composed of multi-item and single-item measures. These include 5 functional scales (physical, role, emotional, cognitive and social functioning), 3 symptom scales (fatigue, nausea/vomiting, and pain), 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial impact) and a global health status/quality of life (QOL) scale. The questionnaire employs 28 4-point Likert scales with responses from "not at all" to "very much" and two 7-point Likert scales for global health and overall QOL. Responses to all items converted to 0 to 100 scale. For functional and global QOL scales, higher scores represent a better level of functioning/QOL. For symptom-oriented scales, a higher score represents more severe symptoms.
- time frame
- Baseline (Day 1 of Cycle 1), Day 1 of Cycle 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25 and end of treatment visit (within14 days after the last dose of study drug)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- 1
- direction quote
- higher scores represent a better
- population note
- FAS included all randomized participants. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure and "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.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
EORTC QLQ · Part 1 and Part 2: Change From Baseline in Emotional Functioning Scale Score of the EORTC QLQ-C30 at Day 1 of Cycle 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25 and End of Treatment Visit
Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-opdivo-0f1c6ce6
- nct id
- NCT01909453
- qol key
- qol-0028
- source section id
- NCT01909453-om-0028
- source outcome index
- 28
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- Part 1 and Part 2: Change From Baseline in Emotional Functioning Scale Score of the EORTC QLQ-C30 at Day 1 of Cycle 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25 and End of Treatment Visit
- measure definition
- EORTC QLQ-C30 contains 30 items and is composed of multi-item and single-item measures. These include 5 functional scales (physical, role, emotional, cognitive and social functioning), 3 symptom scales (fatigue, nausea/vomiting, and pain), 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial impact) and a global health status/ QOL scale. The questionnaire employs 28 4-point Likert scales with responses from "not at all" to "very much" and two 7-point Likert scales for global health and overall QOL. Responses to all items converted to 0 to 100 scale. For functional and global QOL scales, higher scores represent a better level of functioning/QOL. For symptom-oriented scales, a higher score represented more severe symptoms.
- time frame
- Baseline (Day 1 of Cycle 1), Day 1 of Cycle 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25 and end of treatment visit (within14 days after the last dose of study drug)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- 1
- direction quote
- higher scores represent a better
- population note
- FAS included all randomized participants. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure and "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.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
EORTC QLQ · Part 1 and Part 2: Change From Baseline in Physical Functioning Scale Score of the EORTC QLQ-C30 at Day 1 of Cycle 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25 and End of Treatment Visit
Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-opdivo-0f1c6ce6
- nct id
- NCT01909453
- qol key
- qol-0029
- source section id
- NCT01909453-om-0029
- source outcome index
- 29
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- Part 1 and Part 2: Change From Baseline in Physical Functioning Scale Score of the EORTC QLQ-C30 at Day 1 of Cycle 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25 and End of Treatment Visit
- measure definition
- EORTC QLQ-C30 contains 30 items and is composed of multi-item and single-item measures. These include 5 functional scales (physical, role, emotional, cognitive and social functioning), 3 symptom scales (fatigue, nausea/vomiting, and pain), 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial impact) and a global health status/QOL scale. The questionnaire employs 28 4-point Likert scales with responses from "not at all" to "very much" and two 7-point Likert scales for global health and overall QOL. Responses to all items converted to 0 to 100 scale. For functional and global QOL scales, higher scores represented a better level of functioning/QOL. For symptom-oriented scales, a higher score represented more severe symptoms.
- time frame
- Baseline (Day 1 of Cycle 1), Day 1 of Cycle 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25 and end of treatment visit (within14 days after the last dose of study drug)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- 1
- direction quote
- higher scores represented a better
- population note
- FAS included all randomized participants. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure and "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.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
EORTC QLQ · Part 1 and Part 2: Change From Baseline in Social Functioning Scale Score of the EORTC QLQ-C30 at Day 1 of Cycle 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25 and End of Treatment Visit
Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-opdivo-0f1c6ce6
- nct id
- NCT01909453
- qol key
- qol-0030
- source section id
- NCT01909453-om-0030
- source outcome index
- 30
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- Part 1 and Part 2: Change From Baseline in Social Functioning Scale Score of the EORTC QLQ-C30 at Day 1 of Cycle 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25 and End of Treatment Visit
- measure definition
- EORTC QLQ-C30 contains 30 items and is composed of multi-item and single-item measures. These include 5 functional scales (physical, role, emotional, cognitive and social functioning), 3 symptom scales (fatigue, nausea/vomiting, and pain), 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial impact) and a global health status/QOL scale. The questionnaire employs 28 4-point Likert scales with responses from "not at all" to "very much" and two 7-point Likert scales for global health and overall QOL. Responses to all items converted to 0 to 100 scale. For functional and global QOL scales, higher scores represented a better level of functioning/QOL. For symptom-oriented scales, a higher score represented more severe symptoms.
- time frame
- Baseline (Day 1 of Cycle 1), Day 1 of Cycle 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25 and end of treatment visit (within14 days after the last dose of study drug)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- 1
- direction quote
- higher scores represented a better
- population note
- FAS included all randomized participants. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure and "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.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-opdivo-0f1c6ce6
- nct id
- NCT01909453
- trial label
- Study Comparing Combination of LGX818 Plus MEK162 Versus Vemurafenib and LGX818 Monotherapy in BRAF Mutant Melanoma
- applicability
- unclear
- applicability note
- Attached because the study's own record names BRAF and describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- regulator-cited
- discovery note
- Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
- outcome Count
- 6
- harms Count
- 5
- qol Count
- 8
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-opdivo-0f1c6ce6
- nct id
- NCT01909453
- outcome key
- om-0000
- source section id
- NCT01909453-om-0000
- source outcome index
- 0
- endpoint
- Part 1: Progression Free Survival (PFS) by BIRC in Combo 450 Group as Compared to Vemurafenib Group
- endpoint definition
- PFS was defined as the time from the date of randomization to the date of the first documented disease progression (PD) or death due to any cause, whichever occurs first. PFS was determined based on tumor assessment (RECIST version 1.1 criteria) as per BIRC/central review and survival information. If a participant did not had an event at the time of the analysis cut-off or at the start of any new anti-cancer therapy, data was censored at the date of last adequate tumor assessment. PD was defined as at least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, the sum must demonstrate an absolute increase of at least 5 square millimeter (mm\^2).
- time origin
- From randomization until documented disease progression (PD), initiation of new anti-cancer therapy, censoring date or death, whichever occurred first (up to 29 months)
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- FAS included all randomized participants.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-opdivo-0f1c6ce6
- nct id
- NCT01909453
- outcome key
- om-0001
- source section id
- NCT01909453-om-0001
- source outcome index
- 1
- endpoint
- Part 1: PFS by BIRC in Combo 450 Group as Compared to LGX818 Group
- endpoint definition
- PFS was defined as the time from the date of randomization to the date of the first documented PD or death due to any cause, whichever occurs first. PFS was determined based on tumor assessment (RECIST version 1.1 criteria) as per BIRC and survival information. If a participant did not had an event at the time of the analysis cut-off or at the start of any new anti-cancer therapy, data was censored at the date of last adequate tumor assessment. PD was defined as at least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, the sum must demonstrate an absolute increase of at least 5 mm\^2.
- time origin
- From randomization until documented PD, initiation of new anti-cancer therapy, censoring date or death, whichever occurred first (up to 29 months), excluding Part 1: LGX818 300 mg group; up to 35 months for Part 1: LGX 300 mg group
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- FAS included all randomized participants.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-opdivo-0f1c6ce6
- nct id
- NCT01909453
- outcome key
- om-0002
- source section id
- NCT01909453-om-0002
- source outcome index
- 2
- endpoint
- Part 2: PFS by BIRC in Combo 300 Group as Compared to LGX818 Group
- endpoint definition
- PFS was defined as the time from the date of randomization to the date of the first documented PD or death due to any cause, whichever occurs first. PFS was determined based on tumor assessment (RECIST version 1.1 criteria) as per BIRC and survival information. If a participant did not had an event at the time of the analysis cut-off or at the start of any new anti-cancer therapy, data was censored at the date of last adequate tumor assessment. PD was defined as at least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, the sum must demonstrate an absolute increase of at least 5 mm\^2.
- time origin
- From randomization until documented PD, initiation of new anti-cancer therapy, censoring date or death, whichever occurred first (up to 35 months)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- FAS included all randomized participants. It was planned to report combined result data of Part 1 and Part 2 for LGX818 300 mg arm.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-opdivo-0f1c6ce6
- nct id
- NCT01909453
- outcome key
- om-0003
- source section id
- NCT01909453-om-0003
- source outcome index
- 3
- endpoint
- Part 1: Overall Survival (OS)
- endpoint definition
- Overall survival was defined as the time from the date of randomization to the date of death due to any cause. If a death was not observed by the date of analysis cutoff, OS was censored at the date of last contact.
- time origin
- From randomization until censoring date/death, whichever occurred first (up to 117.8 months [M] of treatment exposure for LGX818 +MEK162; up to 111.4 months of treatment exposure for LGX818; up to 110.5 months of treatment exposure for Vemurafenib)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- FAS included all randomized participants.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-opdivo-0f1c6ce6
- nct id
- NCT01909453
- outcome key
- om-0004
- source section id
- NCT01909453-om-0004
- source outcome index
- 4
- endpoint
- Part 1: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) as Graded by National Cancer Institute Common Terminology Criteria (NCI-CTCAE), Version 4.03
- endpoint definition
- An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was any untoward medical occurrence at any dose that resulted in death; was life-threatening; required inpatient hospitalization/prolongation of existing hospitalization; resulted in persistent/significant disability/incapacity; results in congenital anomaly/birth defect or an important medical event. As per NCI-CTCAE version 4.03, severity was graded as Grade 1: asymptomatic/mild symptoms; Grade 2: moderate; Grade 3: severe/medically significant; Grade 4: life-threatening consequence; Grade 5: death. AEs and SAEs of all grades combined were reported.
- time origin
- Baseline up to 30 days from last dose of study drug (up to 117.8 months of treatment exposure for LGX818+MEK162 45 mg [combo 450]; up to 111.4 months of treatment exposure for LGX818 300 mg; up to 110.5 months of treatment exposure for Vemurafenib 960 mg)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- 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.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-opdivo-0f1c6ce6
- nct id
- NCT01909453
- outcome key
- om-0005
- source section id
- NCT01909453-om-0005
- source outcome index
- 5
- endpoint
- Part 1: Number of Participants With Clinically Notable Shift From Baseline in Laboratory Parameter Values Based on NCI-CTCAE Grade, Version 4.03
- endpoint definition
- Laboratory parameters were graded using NCI-CTCAE v4.03 where, Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2: moderate; minimal, local or noninvasive intervention indicated. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated. Grade 4: life-threatening consequences; urgent intervention indicated. Grade 5: death. Clinically notable shift from baseline in laboratory parameter = worsening by at least 2 grades or to \>=grade 3. Only categories with non-zero values for any reporting arm are reported.
- time origin
- Baseline up to 30 days from last dose of study drug (up to 117.8 months of treatment exposure for LGX818+MEK162 45 mg [combo 450]; up to 111.4 months of treatment exposure for LGX818 300 mg; up to 110.5 months of treatment exposure for Vemurafenib 960 mg)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- 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 number of participants evaluable for specified rows.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-opdivo-0f1c6ce6
- nct id
- NCT01909453
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)
- regimen
- 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.
- analyzed count
- 192
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01909453-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-opdivo-0f1c6ce6
- nct id
- NCT01909453
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Part 1: Vemurafenib 960 mg BID
- regimen
- 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.
- analyzed count
- 191
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01909453-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-opdivo-0f1c6ce6
- nct id
- NCT01909453
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)
- regimen
- 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.
- analyzed count
- 192
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01909453-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-opdivo-0f1c6ce6
- nct id
- NCT01909453
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Part 1: LGX818 300 mg
- regimen
- 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.
- analyzed count
- 194
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01909453-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-opdivo-0f1c6ce6
- nct id
- NCT01909453
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)
- regimen
- 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.
- analyzed count
- 258
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01909453-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-opdivo-0f1c6ce6
- nct id
- NCT01909453
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Part 2: LGX818 300 mg
- regimen
- 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.
- analyzed count
- 86
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01909453-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-opdivo-0f1c6ce6
- nct id
- NCT01909453
- outcome key
- om-0002
- arm key
- OG002
- arm label
- Part 1 + Part 2: LGX818 300 mg
- regimen
- 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.
- analyzed count
- 280
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01909453-om-0002#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-opdivo-0f1c6ce6
- nct id
- NCT01909453
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Part 1: LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)
- regimen
- 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.
- analyzed count
- 192
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01909453-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-opdivo-0f1c6ce6
- nct id
- NCT01909453
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Part 1: LGX818 300 mg
- regimen
- 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.
- analyzed count
- 194
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01909453-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-opdivo-0f1c6ce6
- nct id
- NCT01909453
- outcome key
- om-0003
- arm key
- OG002
- arm label
- Part 1: Vemurafenib 960 mg BID
- regimen
- 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.
- analyzed count
- 191
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01909453-om-0003#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-opdivo-0f1c6ce6
- nct id
- NCT01909453
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)
- regimen
- 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.
- analyzed count
- 192
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01909453-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-opdivo-0f1c6ce6
- nct id
- NCT01909453
- outcome key
- om-0004
- arm key
- OG001
- arm label
- Part 1: LGX818 300 mg
- regimen
- 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.
- analyzed count
- 192
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01909453-om-0004#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-opdivo-0f1c6ce6
- nct id
- NCT01909453
- harm key
- EG000
- source section id
- NCT01909453-ae
- event group key
- EG000
- event group label
- Part 2: LGX818 300 mg QD +MEK162 45 mg BID (Combo 300)
- serious affected
- 98
- serious at risk
- 257
- other affected
- 252
- other at risk
- 257
- frequency threshold
- 5
- collection period
- Baseline up to 30 days from last dose of study drug (P1: up to 117.8 M for LGX818+MEK162 [combo 450]; up to 111.4 M for LGX818 300mg; up to 110.5 M for Vemurafenib 960mg; P2: up to 106.3 M for LGX818+MEK162 45mg [combo 300]; up to 98.4 M for LGX818 300mg)
- event definition
- Same event may appear as non-SAE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-opdivo-0f1c6ce6
- nct id
- NCT01909453
- harm key
- EG001
- source section id
- NCT01909453-ae
- event group key
- EG001
- event group label
- Part 1: LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)
- serious affected
- 84
- serious at risk
- 192
- other affected
- 189
- other at risk
- 192
- frequency threshold
- 5
- collection period
- Baseline up to 30 days from last dose of study drug (P1: up to 117.8 M for LGX818+MEK162 [combo 450]; up to 111.4 M for LGX818 300mg; up to 110.5 M for Vemurafenib 960mg; P2: up to 106.3 M for LGX818+MEK162 45mg [combo 300]; up to 98.4 M for LGX818 300mg)
- event definition
- Same event may appear as non-SAE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-opdivo-0f1c6ce6
- nct id
- NCT01909453
- harm key
- EG002
- source section id
- NCT01909453-ae
- event group key
- EG002
- event group label
- Part 1: LGX818 300 mg
- serious affected
- 71
- serious at risk
- 192
- other affected
- 190
- other at risk
- 192
- frequency threshold
- 5
- collection period
- Baseline up to 30 days from last dose of study drug (P1: up to 117.8 M for LGX818+MEK162 [combo 450]; up to 111.4 M for LGX818 300mg; up to 110.5 M for Vemurafenib 960mg; P2: up to 106.3 M for LGX818+MEK162 45mg [combo 300]; up to 98.4 M for LGX818 300mg)
- event definition
- Same event may appear as non-SAE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-opdivo-0f1c6ce6
- nct id
- NCT01909453
- harm key
- EG003
- source section id
- NCT01909453-ae
- event group key
- EG003
- event group label
- Part 2: LGX818 300 mg
- serious affected
- 31
- serious at risk
- 84
- other affected
- 82
- other at risk
- 84
- frequency threshold
- 5
- collection period
- Baseline up to 30 days from last dose of study drug (P1: up to 117.8 M for LGX818+MEK162 [combo 450]; up to 111.4 M for LGX818 300mg; up to 110.5 M for Vemurafenib 960mg; P2: up to 106.3 M for LGX818+MEK162 45mg [combo 300]; up to 98.4 M for LGX818 300mg)
- event definition
- Same event may appear as non-SAE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-opdivo-0f1c6ce6
- nct id
- NCT01909453
- harm key
- EG004
- source section id
- NCT01909453-ae
- event group key
- EG004
- event group label
- Part 1: Vemurafenib 960 mg BID
- serious affected
- 78
- serious at risk
- 186
- other affected
- 185
- other at risk
- 186
- frequency threshold
- 5
- collection period
- Baseline up to 30 days from last dose of study drug (P1: up to 117.8 M for LGX818+MEK162 [combo 450]; up to 111.4 M for LGX818 300mg; up to 110.5 M for Vemurafenib 960mg; P2: up to 106.3 M for LGX818+MEK162 45mg [combo 300]; up to 98.4 M for LGX818 300mg)
- event definition
- Same event may appear as non-SAE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-opdivo-0f1c6ce6
- nct id
- NCT01909453
- qol key
- qol-0023
- source section id
- NCT01909453-om-0023
- source outcome index
- 23
- instrument
- FACT
- instrument basis
- matched 'fact-m' in the study's own wording
- scale title
- Part 1 and Part 2: Time to Definitive 10% Deterioration in the Function Assessment Cancer Therapy-melanoma (FACT-M) Subscale
- measure definition
- FACT-M:melanoma specific questionnaire to assess participant health-related quality of life(QoL).Melanoma specific 16 subscale :signs,symptoms,physical/social activities most relevant to participants with advanced-stage melanoma.Other items :physical,functional and social/family well-being(7 items each),emotional well-being(6 items),surgery specific concerns related to melanoma(8 items,not included in this study).Each item range 0(not at all)to 4(very much),combined to produce subscale scores.Total score range for FACT-M excluding surgery specific items is 0 to172,higher scores:better QoL.Melanoma subscale score range from0(worst)to 64(best response),higher score:better QoL.Time to definitive 10% deterioration:time from date of randomization to date of event with at least 10% relative to baseline worsening of corresponding scale score with no later improvement or death due to any cause.All collected data up to pre-specified collection period(i.e.,end of study)are reported for this OM.
- time frame
- Date of randomization to date of event or death due to any cause, which ever occurred first (up to 29 months for Part 1, excluding Part 1: LGX818 300 mg group; up to 35 months for Part 2 and Part 1 LGX 300 mg group)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- 1
- direction quote
- higher scores:better
- population note
- FAS included all randomized participants. It was planned to report combined result data of Part 1 and Part 2 for LGX818 300 mg arm.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-opdivo-0f1c6ce6
- nct id
- NCT01909453
- qol key
- qol-0024
- source section id
- NCT01909453-om-0024
- source outcome index
- 24
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- Part 1 and Part 2: Time to Definitive 10% Deterioration in the Global Health Status Score of the European Organization for Research and Treatment of Cancer's Core Quality of Life Questionnaire (EORTC QLQ-C30)
- measure definition
- EORTC QLQ-C30 is 30 item questionnaire composed of 5 multi-item functional subscales (physical,role,cognitive,emotional,social functioning), 3 multi-item symptom scales (fatigue,nausea/vomiting, and pain),global health/quality of life (QOL) subscale and 6 single items assessing other cancer related symptoms (dyspnea,sleep disturbance, appetite, diarrhea, constipation and financial impact of cancer). It employed twenty-eight 4 point Likert scales with responses from "not at all" to "very much" and two 7 point Likert scales for global health and overall QOL. Global health status scale score ranged from 0 to 100. Higher score: better level of functioning. Time to definitive 10% deterioration: time from date of randomization to date of event with at least 10% relative to baseline worsening of corresponding scale score with no later improvement or death due to any cause. All collected data up to the pre-specified collection period (i.e., end of study) are reported for this outcome measure.
- time frame
- Date of randomization to date of event or death due to any cause, which ever occurred first (maximum up to 29 months for Part 1, excluding Part 1: LGX818 300 mg group; up to 35 months for Part 2 and Part 1 LGX 300 mg group)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- 1
- direction quote
- Higher score: better
- population note
- FAS included all randomized participants. It was planned to report combined result data of Part 1 and Part 2 for LGX818 300 mg arm.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-opdivo-0f1c6ce6
- nct id
- NCT01909453
- qol key
- qol-0025
- source section id
- NCT01909453-om-0025
- source outcome index
- 25
- instrument
- FACT
- instrument basis
- matched 'fact-m' in the study's own wording
- scale title
- Part 1 and Part 2: Change From Baseline in the FACT-M Subscale at Day 1 of Cycle 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25 and End of Treatment Visit
- measure definition
- FACT-M: melanoma specific questionnaire to assess participant health-related quality of life. Melanoma specific subscale consists of 16 items related to signs, symptoms, physical/social activities most relevant to participants with advanced-stage melanoma. Other items include physical, functional and social/family well-being (7 items each), emotional well-being (6 items), surgery specific concerns related to melanoma (8 items, not included in this study). Each item ranged from 0 (not at all) to 4 (very much), combined to produce subscale scores. Total score range for FACT-M excluding surgery specific items is 0 to 172, higher scores represented better quality of life. Melanoma subscale score ranged from 0 (worst response) to 64 (best response), higher score indicated better quality of life.
- time frame
- Baseline (Day 1 of Cycle 1), Day 1 of Cycle 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25 and end of treatment visit (within14 days after the last dose of study drug)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- 1
- direction quote
- higher scores represented better
- population note
- FAS included all randomized participants. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure and "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.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-opdivo-0f1c6ce6
- nct id
- NCT01909453
- qol key
- qol-0026
- source section id
- NCT01909453-om-0026
- source outcome index
- 26
- instrument
- EQ-5D
- instrument basis
- matched 'eq-5d' in the study's own wording
- scale title
- Part 1 and Part 2: Change From Baseline in EuroQoL-5 Dimension-5 Level (EQ-5D-5L) Index Score at Day 1 of Cycle 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25 and End of Treatment Visit
- measure definition
- EQ-5D-5L is a standardized participant completed questionnaire that measures health status in terms of a single index value or utility score. EQ-5D-5L consisted of two components: a health state profile (descriptive system) and a visual analogue scale (VAS) in which participants rate their overall health status from 0 (worst imaginable) to 100 (best imaginable), where higher scores indicated better health status. EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 response levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. EQ-5D-5L health status index score range between 0 to 1. Higher score indicated better health status.
- time frame
- Baseline (Day 1 of Cycle 1), Day 1 of Cycle 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25 and end of treatment visit (within14 days after the last dose of study drug)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- 1
- direction quote
- higher scores indicated better
- population note
- FAS included all randomized participants. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure and "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.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-opdivo-0f1c6ce6
- nct id
- NCT01909453
- qol key
- qol-0027
- source section id
- NCT01909453-om-0027
- source outcome index
- 27
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- Part 1 and Part 2: Change From Baseline in Global Health Status Score of EORTC QLQ-C30 at Day 1 of Cycle 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25 and End of Treatment Visit
- measure definition
- EORTC QLQ-C30 contains 30 items and is composed of multi-item and single-item measures. These include 5 functional scales (physical, role, emotional, cognitive and social functioning), 3 symptom scales (fatigue, nausea/vomiting, and pain), 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial impact) and a global health status/quality of life (QOL) scale. The questionnaire employs 28 4-point Likert scales with responses from "not at all" to "very much" and two 7-point Likert scales for global health and overall QOL. Responses to all items converted to 0 to 100 scale. For functional and global QOL scales, higher scores represent a better level of functioning/QOL. For symptom-oriented scales, a higher score represents more severe symptoms.
- time frame
- Baseline (Day 1 of Cycle 1), Day 1 of Cycle 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25 and end of treatment visit (within14 days after the last dose of study drug)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- 1
- direction quote
- higher scores represent a better
- population note
- FAS included all randomized participants. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure and "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.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-opdivo-0f1c6ce6
- nct id
- NCT01909453
- qol key
- qol-0028
- source section id
- NCT01909453-om-0028
- source outcome index
- 28
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- Part 1 and Part 2: Change From Baseline in Emotional Functioning Scale Score of the EORTC QLQ-C30 at Day 1 of Cycle 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25 and End of Treatment Visit
- measure definition
- EORTC QLQ-C30 contains 30 items and is composed of multi-item and single-item measures. These include 5 functional scales (physical, role, emotional, cognitive and social functioning), 3 symptom scales (fatigue, nausea/vomiting, and pain), 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial impact) and a global health status/ QOL scale. The questionnaire employs 28 4-point Likert scales with responses from "not at all" to "very much" and two 7-point Likert scales for global health and overall QOL. Responses to all items converted to 0 to 100 scale. For functional and global QOL scales, higher scores represent a better level of functioning/QOL. For symptom-oriented scales, a higher score represented more severe symptoms.
- time frame
- Baseline (Day 1 of Cycle 1), Day 1 of Cycle 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25 and end of treatment visit (within14 days after the last dose of study drug)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- 1
- direction quote
- higher scores represent a better
- population note
- FAS included all randomized participants. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure and "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.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-opdivo-0f1c6ce6
- nct id
- NCT01909453
- qol key
- qol-0029
- source section id
- NCT01909453-om-0029
- source outcome index
- 29
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- Part 1 and Part 2: Change From Baseline in Physical Functioning Scale Score of the EORTC QLQ-C30 at Day 1 of Cycle 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25 and End of Treatment Visit
- measure definition
- EORTC QLQ-C30 contains 30 items and is composed of multi-item and single-item measures. These include 5 functional scales (physical, role, emotional, cognitive and social functioning), 3 symptom scales (fatigue, nausea/vomiting, and pain), 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial impact) and a global health status/QOL scale. The questionnaire employs 28 4-point Likert scales with responses from "not at all" to "very much" and two 7-point Likert scales for global health and overall QOL. Responses to all items converted to 0 to 100 scale. For functional and global QOL scales, higher scores represented a better level of functioning/QOL. For symptom-oriented scales, a higher score represented more severe symptoms.
- time frame
- Baseline (Day 1 of Cycle 1), Day 1 of Cycle 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25 and end of treatment visit (within14 days after the last dose of study drug)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- 1
- direction quote
- higher scores represented a better
- population note
- FAS included all randomized participants. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure and "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.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-opdivo-0f1c6ce6
- nct id
- NCT01909453
- qol key
- qol-0030
- source section id
- NCT01909453-om-0030
- source outcome index
- 30
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- Part 1 and Part 2: Change From Baseline in Social Functioning Scale Score of the EORTC QLQ-C30 at Day 1 of Cycle 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25 and End of Treatment Visit
- measure definition
- EORTC QLQ-C30 contains 30 items and is composed of multi-item and single-item measures. These include 5 functional scales (physical, role, emotional, cognitive and social functioning), 3 symptom scales (fatigue, nausea/vomiting, and pain), 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial impact) and a global health status/QOL scale. The questionnaire employs 28 4-point Likert scales with responses from "not at all" to "very much" and two 7-point Likert scales for global health and overall QOL. Responses to all items converted to 0 to 100 scale. For functional and global QOL scales, higher scores represented a better level of functioning/QOL. For symptom-oriented scales, a higher score represented more severe symptoms.
- time frame
- Baseline (Day 1 of Cycle 1), Day 1 of Cycle 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25 and end of treatment visit (within14 days after the last dose of study drug)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- 1
- direction quote
- higher scores represented a better
- population note
- FAS included all randomized participants. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure and "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.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- setting source links
Preserved source evidence · Not medical advice