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NCT02928224 · OUTCOME

(Phase 3) Change From Baseline in the Participant Global Impression of Change (PGIC) in Triplet Arm vs Control Arm, Doublet Arm vs Control, and Triplet vs Doublet

Study of Encorafenib + Cetuximab Plus or Minus Binimetinib vs. Irinotecan/Cetuximab or Infusional 5-Fluorouracil (5-FU)/Folinic Acid (FA)/Irinotecan (FOLFIRI)/Cetuximab With a Safety Lead-in of Encorafenib + Binimetinib + Cetuximab in Patients With BRAF V600E-mutant Metastatic Colorectal Cancer · Source last updated 2023-12-21

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

Measure: MEAN
Unit: Units on a scale
Interval / dispersion: Standard Deviation
Time frame: Baseline,Cycle (C)1 Day (D)1, C2 D1, C3 D1, C4 D1, C5 D1, C6 D1, C7 D1, C8 D1, C9 D1, C10 D1, C11 D1, C12 D1, C13 D1, C14 D1, C15 D1, C16 D1, C17 D1, C18 D1, C19 D1, C20 D1, C21 D1, C22 D1, C23 D1, End of Treatment, 30 Day Follow Up(each cycle of 28 days)

What was measured

The PGIC is a measure of participant's perceptions of change in their symptoms over time that can be used as an anchoring method to determine the minimal clinically important difference for other participant reported outcome (PROs). For this assessment, participants answered the following question: "Since starting treatment, my colorectal cancer symptoms are: (1) very much improved, (2) much improved, (3) minimally improved, (4) no change, (5) minimally worse, (6) much worse or (7) very much worse."

Analysis population: The FAS for the Phase 3 portion of the study consisted of all randomized Phase 3 participants. Here, 'Number Analyzed' signifies number of participants evaluable for the specified timepoints. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table but may not have evaluable data for every row.

Groups in this outcome

Phase 3: Triplet Arm

Encorafenib + binimetinib + cetuximab. Encorafenib: Orally, once daily. Binimetinib: Orally, twice daily. Cetuximab: Standard of care.

Phase 3:Doublet Arm

Encorafenib + cetuximab. Encorafenib: Orally, once daily. Cetuximab: Standard of care.

Phase 3:Control Arm

Investigator's choice of either irinotecan/cetuximab or FOLFIRI/cetuximab. Cetuximab: Standard of care. Irinotecan: Standard of care. Folinic Acid: Standard of care. 5-Fluorouracil: Standard of care. Following protocol amendment, eligible participants could crossover to receive either triplet or doublet regimen.

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
Phase 3: Triplet Arm	224
Phase 3:Doublet Arm	220
Phase 3:Control Arm	221

Reported measurements

Baseline

Analysis denominator · Participants

Group	Source count
Phase 3: Triplet Arm	153
Phase 3:Doublet Arm	152
Phase 3:Control Arm	149

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 3: Triplet Arm	3.8	1.30	Not reported	Not reported	Not reported
Phase 3:Doublet Arm	3.8	1.30	Not reported	Not reported	Not reported
Phase 3:Control Arm	3.9	1.28	Not reported	Not reported	Not reported

Change at Cycle 1 Day 1

Analysis denominator · Participants

Group	Source count
Phase 3: Triplet Arm	91
Phase 3:Doublet Arm	92
Phase 3:Control Arm	83

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 3: Triplet Arm	-0.1	0.93	Not reported	Not reported	Not reported
Phase 3:Doublet Arm	0.1	1.21	Not reported	Not reported	Not reported
Phase 3:Control Arm	0.0	0.90	Not reported	Not reported	Not reported

Change at Cycle 2 Day 1

Analysis denominator · Participants

Group	Source count
Phase 3: Triplet Arm	127
Phase 3:Doublet Arm	130
Phase 3:Control Arm	90

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 3: Triplet Arm	-0.7	1.44	Not reported	Not reported	Not reported
Phase 3:Doublet Arm	-0.8	1.60	Not reported	Not reported	Not reported
Phase 3:Control Arm	-0.3	1.52	Not reported	Not reported	Not reported

Change at Cycle 3 Day 1

Analysis denominator · Participants

Group	Source count
Phase 3: Triplet Arm	101
Phase 3:Doublet Arm	105
Phase 3:Control Arm	37

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 3: Triplet Arm	-0.9	1.44	Not reported	Not reported	Not reported
Phase 3:Doublet Arm	-1.2	1.53	Not reported	Not reported	Not reported
Phase 3:Control Arm	-0.5	1.56	Not reported	Not reported	Not reported

Change at Cycle 4 Day 1

Analysis denominator · Participants

Group	Source count
Phase 3: Triplet Arm	80
Phase 3:Doublet Arm	79
Phase 3:Control Arm	28

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 3: Triplet Arm	-0.9	1.49	Not reported	Not reported	Not reported
Phase 3:Doublet Arm	-1.1	1.68	Not reported	Not reported	Not reported
Phase 3:Control Arm	-0.5	1.35	Not reported	Not reported	Not reported

Change at Cycle 5 Day 1

Analysis denominator · Participants

Group	Source count
Phase 3: Triplet Arm	66
Phase 3:Doublet Arm	59
Phase 3:Control Arm	19

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 3: Triplet Arm	-0.9	1.61	Not reported	Not reported	Not reported
Phase 3:Doublet Arm	-1.1	1.69	Not reported	Not reported	Not reported
Phase 3:Control Arm	-0.7	1.41	Not reported	Not reported	Not reported

Change at Cycle 6 Day 1

Analysis denominator · Participants

Group	Source count
Phase 3: Triplet Arm	45
Phase 3:Doublet Arm	40
Phase 3:Control Arm	9

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 3: Triplet Arm	-0.8	1.31	Not reported	Not reported	Not reported
Phase 3:Doublet Arm	-1.2	1.70	Not reported	Not reported	Not reported
Phase 3:Control Arm	-0.8	1.39	Not reported	Not reported	Not reported

Change at Cycle 7 Day 1

Analysis denominator · Participants

Group	Source count
Phase 3: Triplet Arm	30
Phase 3:Doublet Arm	36
Phase 3:Control Arm	7

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 3: Triplet Arm	-1.1	1.44	Not reported	Not reported	Not reported
Phase 3:Doublet Arm	-1.0	1.61	Not reported	Not reported	Not reported
Phase 3:Control Arm	-1.1	1.07	Not reported	Not reported	Not reported

Change at Cycle 8 Day 1

Analysis denominator · Participants

Group	Source count
Phase 3: Triplet Arm	23
Phase 3:Doublet Arm	27
Phase 3:Control Arm	5

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 3: Triplet Arm	-1.2	1.56	Not reported	Not reported	Not reported
Phase 3:Doublet Arm	-1.1	1.58	Not reported	Not reported	Not reported
Phase 3:Control Arm	-1.0	0.71	Not reported	Not reported	Not reported

Change at Cycle 9 Day 1

Analysis denominator · Participants

Group	Source count
Phase 3: Triplet Arm	21
Phase 3:Doublet Arm	21
Phase 3:Control Arm	5

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 3: Triplet Arm	-0.8	1.26	Not reported	Not reported	Not reported
Phase 3:Doublet Arm	-0.9	1.37	Not reported	Not reported	Not reported
Phase 3:Control Arm	-1.0	0.71	Not reported	Not reported	Not reported

Change at Cycle 10 Day 1

Analysis denominator · Participants

Group	Source count
Phase 3: Triplet Arm	15
Phase 3:Doublet Arm	17
Phase 3:Control Arm	3

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 3: Triplet Arm	-0.5	1.51	Not reported	Not reported	Not reported
Phase 3:Doublet Arm	-0.6	1.28	Not reported	Not reported	Not reported
Phase 3:Control Arm	-0.3	0.58	Not reported	Not reported	Not reported

Change at Cycle 11 Day 1

Analysis denominator · Participants

Group	Source count
Phase 3: Triplet Arm	13
Phase 3:Doublet Arm	13
Phase 3:Control Arm	2

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 3: Triplet Arm	-0.9	1.38	Not reported	Not reported	Not reported
Phase 3:Doublet Arm	-1.1	1.38	Not reported	Not reported	Not reported
Phase 3:Control Arm	0.0	0.00	Not reported	Not reported	Not reported

Change at Cycle 12 Day 1

Analysis denominator · Participants

Group	Source count
Phase 3: Triplet Arm	11
Phase 3:Doublet Arm	12
Phase 3:Control Arm	2

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 3: Triplet Arm	-0.9	1.45	Not reported	Not reported	Not reported
Phase 3:Doublet Arm	-0.8	1.36	Not reported	Not reported	Not reported
Phase 3:Control Arm	-0.5	0.71	Not reported	Not reported	Not reported

Change at Cycle 13 Day 1

Analysis denominator · Participants

Group	Source count
Phase 3: Triplet Arm	8
Phase 3:Doublet Arm	10
Phase 3:Control Arm	1

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 3: Triplet Arm	-1.3	1.39	Not reported	Not reported	Not reported
Phase 3:Doublet Arm	-0.9	1.52	Not reported	Not reported	Not reported
Phase 3:Control Arm	-1.0	NA	Not reported	Not reported	Number analyzed is 1 so SD is not available.

Change at Cycle 14 Day 1

Analysis denominator · Participants

Group	Source count
Phase 3: Triplet Arm	7
Phase 3:Doublet Arm	6
Phase 3:Control Arm	0

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 3: Triplet Arm	-1.1	1.46	Not reported	Not reported	Not reported
Phase 3:Doublet Arm	-1.5	1.05	Not reported	Not reported	Not reported

Change at Cycle 15 Day 1

Analysis denominator · Participants

Group	Source count
Phase 3: Triplet Arm	6
Phase 3:Doublet Arm	5
Phase 3:Control Arm	0

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 3: Triplet Arm	-1.2	1.47	Not reported	Not reported	Not reported
Phase 3:Doublet Arm	-1.6	0.89	Not reported	Not reported	Not reported

Change at Cycle 16 Day 1

Analysis denominator · Participants

Group	Source count
Phase 3: Triplet Arm	4
Phase 3:Doublet Arm	3
Phase 3:Control Arm	0

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 3: Triplet Arm	-2.0	0.82	Not reported	Not reported	Not reported
Phase 3:Doublet Arm	-0.7	1.53	Not reported	Not reported	Not reported

Change at Cycle 17 Day 1

Analysis denominator · Participants

Group	Source count
Phase 3: Triplet Arm	3
Phase 3:Doublet Arm	3
Phase 3:Control Arm	0

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 3: Triplet Arm	-1.3	1.53	Not reported	Not reported	Not reported
Phase 3:Doublet Arm	-1.0	1.00	Not reported	Not reported	Not reported

Change at Cycle 18 Day 1

Analysis denominator · Participants

Group	Source count
Phase 3: Triplet Arm	1
Phase 3:Doublet Arm	3
Phase 3:Control Arm	0

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 3: Triplet Arm	-2.0	NA	Not reported	Not reported	Number analyzed is 1 so SD is not available.
Phase 3:Doublet Arm	-1.0	1.00	Not reported	Not reported	Not reported

Change at Cycle 19 Day 1

Analysis denominator · Participants

Group	Source count
Phase 3: Triplet Arm	1
Phase 3:Doublet Arm	2
Phase 3:Control Arm	0

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 3: Triplet Arm	-3.0	NA	Not reported	Not reported	Number analyzed is 1 so SD is not available.
Phase 3:Doublet Arm	-0.5	2.12	Not reported	Not reported	Not reported

Change at Cycle 20 Day 1

Analysis denominator · Participants

Group	Source count
Phase 3: Triplet Arm	1
Phase 3:Doublet Arm	1
Phase 3:Control Arm	0

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 3: Triplet Arm	-3.0	NA	Not reported	Not reported	Number analyzed is 1 so SD is not available.
Phase 3:Doublet Arm	-2.0	NA	Not reported	Not reported	Number analyzed is 1 so SD is not available.

Change at Cycle 21 Day 1

Analysis denominator · Participants

Group	Source count
Phase 3: Triplet Arm	1
Phase 3:Doublet Arm	1
Phase 3:Control Arm	0

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 3: Triplet Arm	-3.0	NA	Not reported	Not reported	Number analyzed is 1 so SD is not available.
Phase 3:Doublet Arm	-2.0	NA	Not reported	Not reported	Number analyzed is 1 so SD is not available.

Change at Cycle 22 Day 1

Analysis denominator · Participants

Group	Source count
Phase 3: Triplet Arm	0
Phase 3:Doublet Arm	1
Phase 3:Control Arm	0

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 3:Doublet Arm	-2.0	NA	Not reported	Not reported	Number analyzed is 1 so SD is not available.

Change at Cycle 23 Day 1

Analysis denominator · Participants

Group	Source count
Phase 3: Triplet Arm	0
Phase 3:Doublet Arm	1
Phase 3:Control Arm	0

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 3:Doublet Arm	-2.0	NA	Not reported	Not reported	Number analyzed is 1 so SD is not available.

Change at End of Treatment

Analysis denominator · Participants

Group	Source count
Phase 3: Triplet Arm	52
Phase 3:Doublet Arm	54
Phase 3:Control Arm	63

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 3: Triplet Arm	0.3	1.85	Not reported	Not reported	Not reported
Phase 3:Doublet Arm	0.1	1.82	Not reported	Not reported	Not reported
Phase 3:Control Arm	0.4	1.58	Not reported	Not reported	Not reported

Change at 30 Day Follow Up

Analysis denominator · Participants

Group	Source count
Phase 3: Triplet Arm	18
Phase 3:Doublet Arm	10
Phase 3:Control Arm	19

Values in Units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 3: Triplet Arm	-0.1	2.08	Not reported	Not reported	Not reported
Phase 3:Doublet Arm	0.5	1.43	Not reported	Not reported	Not reported
Phase 3:Control Arm	0.7	1.34	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
1.30
value
3.8
group Id
OG001
spread
1.30
value
3.8
group Id
OG002
spread
1.28
value
3.9
denoms
counts
group Id
OG000
value
153
group Id
OG001
value
152
group Id
OG002
value
149
units
Participants
title
Baseline
categories
measurements
group Id
OG000
spread
0.93
value
-0.1
group Id
OG001
spread
1.21
value
0.1
group Id
OG002
spread
0.90
value
0.0
denoms
counts
group Id
OG000
value
91
group Id
OG001
value
92
group Id
OG002
value
83
units
Participants
title
Change at Cycle 1 Day 1
categories
measurements
group Id
OG000
spread
1.44
value
-0.7
group Id
OG001
spread
1.60
value
-0.8
group Id
OG002
spread
1.52
value
-0.3
denoms
counts
group Id
OG000
value
127
group Id
OG001
value
130
group Id
OG002
value
90
units
Participants
title
Change at Cycle 2 Day 1
categories
measurements
group Id
OG000
spread
1.44
value
-0.9
group Id
OG001
spread
1.53
value
-1.2
group Id
OG002
spread
1.56
value
-0.5
denoms
counts
group Id
OG000
value
101
group Id
OG001
value
105
group Id
OG002
value
37
units
Participants
title
Change at Cycle 3 Day 1
categories
measurements
group Id
OG000
spread
1.49
value
-0.9
group Id
OG001
spread
1.68
value
-1.1
group Id
OG002
spread
1.35
value
-0.5
denoms
counts
group Id
OG000
value
80
group Id
OG001
value
79
group Id
OG002
value
28
units
Participants
title
Change at Cycle 4 Day 1
categories
measurements
group Id
OG000
spread
1.61
value
-0.9
group Id
OG001
spread
1.69
value
-1.1
group Id
OG002
spread
1.41
value
-0.7
denoms
counts
group Id
OG000
value
66
group Id
OG001
value
59
group Id
OG002
value
19
units
Participants
title
Change at Cycle 5 Day 1
categories
measurements
group Id
OG000
spread
1.31
value
-0.8
group Id
OG001
spread
1.70
value
-1.2
group Id
OG002
spread
1.39
value
-0.8
denoms
counts
group Id
OG000
value
45
group Id
OG001
value
40
group Id
OG002
value
9
units
Participants
title
Change at Cycle 6 Day 1
categories
measurements
group Id
OG000
spread
1.44
value
-1.1
group Id
OG001
spread
1.61
value
-1.0
group Id
OG002
spread
1.07
value
-1.1
denoms
counts
group Id
OG000
value
30
group Id
OG001
value
36
group Id
OG002
value
7
units
Participants
title
Change at Cycle 7 Day 1
categories
measurements
group Id
OG000
spread
1.56
value
-1.2
group Id
OG001
spread
1.58
value
-1.1
group Id
OG002
spread
0.71
value
-1.0
denoms
counts
group Id
OG000
value
23
group Id
OG001
value
27
group Id
OG002
value
5
units
Participants
title
Change at Cycle 8 Day 1
categories
measurements
group Id
OG000
spread
1.26
value
-0.8
group Id
OG001
spread
1.37
value
-0.9
group Id
OG002
spread
0.71
value
-1.0
denoms
counts
group Id
OG000
value
21
group Id
OG001
value
21
group Id
OG002
value
5
units
Participants
title
Change at Cycle 9 Day 1
categories
measurements
group Id
OG000
spread
1.51
value
-0.5
group Id
OG001
spread
1.28
value
-0.6
group Id
OG002
spread
0.58
value
-0.3
denoms
counts
group Id
OG000
value
15
group Id
OG001
value
17
group Id
OG002
value
3
units
Participants
title
Change at Cycle 10 Day 1
categories
measurements
group Id
OG000
spread
1.38
value
-0.9
group Id
OG001
spread
1.38
value
-1.1
group Id
OG002
spread
0.00
value
0.0
denoms
counts
group Id
OG000
value
13
group Id
OG001
value
13
group Id
OG002
value
2
units
Participants
title
Change at Cycle 11 Day 1

denoms

counts
group Id
OG000
value
224
group Id
OG001
value
220
group Id
OG002
value
221
units
Participants

description

The PGIC is a measure of participant's perceptions of change in their symptoms over time that can be used as an anchoring method to determine the minimal clinically important difference for other participant reported outcome (PROs). For this assessment, participants answered the following question: "Since starting treatment, my colorectal cancer symptoms are: (1) very much improved, (2) much improved, (3) minimally improved, (4) no change, (5) minimally worse, (6) much worse or (7) very much worse."

dispersion Type

Standard Deviation

groups

description
Encorafenib + binimetinib + cetuximab. Encorafenib: Orally, once daily. Binimetinib: Orally, twice daily. Cetuximab: Standard of care.
id
OG000
title
Phase 3: Triplet Arm
description
Encorafenib + cetuximab. Encorafenib: Orally, once daily. Cetuximab: Standard of care.
id
OG001
title
Phase 3:Doublet Arm
description
Investigator's choice of either irinotecan/cetuximab or FOLFIRI/cetuximab. Cetuximab: Standard of care. Irinotecan: Standard of care. Folinic Acid: Standard of care. 5-Fluorouracil: Standard of care. Following protocol amendment, eligible participants could crossover to receive either triplet or doublet regimen.
id
OG002
title
Phase 3:Control Arm

param Type

MEAN

population Description

The FAS for the Phase 3 portion of the study consisted of all randomized Phase 3 participants. Here, 'Number Analyzed' signifies number of participants evaluable for the specified timepoints. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table but may not have evaluable data for every row.

reporting Status

POSTED

time Frame

Baseline,Cycle (C)1 Day (D)1, C2 D1, C3 D1, C4 D1, C5 D1, C6 D1, C7 D1, C8 D1, C9 D1, C10 D1, C11 D1, C12 D1, C13 D1, C14 D1, C15 D1, C16 D1, C17 D1, C18 D1, C19 D1, C20 D1, C21 D1, C22 D1, C23 D1, End of Treatment, 30 Day Follow Up(each cycle of 28 days)

title

(Phase 3) Change From Baseline in the Participant Global Impression of Change (PGIC) in Triplet Arm vs Control Arm, Doublet Arm vs Control, and Triplet vs Doublet

type

SECONDARY

unit Of Measure

Units on a scale

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

Preserved source evidence · Independent clinical review pending · Not medical advice