NCT02928224 · OUTCOME

(Phase 3) Comparison of Time to Response in Triplet Arm vs Control Arm Per BICR

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: MEDIAN
Unit: Months
Interval / dispersion: 95% Confidence Interval
Time frame: From first dose to first radiographic evidence of response (maximum treatment exposure of 277.4 weeks for triplet arm and 108 weeks for control arm)

What was measured

Time to response was defined as the time from first dose to first radiographic evidence of response.

Analysis population: The FAS for the Phase 3 portion of the study consisted of all randomized Phase 3 participants. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

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: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	50
Phase 3:Control Arm	3

Reported measurements

Source class 1

Values in Months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 3: Triplet Arm	1.43	Not reported	1.41	1.51	Not reported
Phase 3:Control Arm	1.45	Not reported	1.41	2.63	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
1.41
upper Limit
1.51
value
1.43
group Id
OG001
lower Limit
1.41
upper Limit
2.63
value
1.45

denoms

counts
group Id
OG000
value
50
group Id
OG001
value
3
units
Participants

description

Time to response was defined as the time from first dose to first radiographic evidence of response.

dispersion Type

95% Confidence Interval

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
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
OG001
title
Phase 3:Control Arm

param Type

MEDIAN

population Description

The FAS for the Phase 3 portion of the study consisted of all randomized Phase 3 participants. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

reporting Status

POSTED

time Frame

From first dose to first radiographic evidence of response (maximum treatment exposure of 277.4 weeks for triplet arm and 108 weeks for control arm)

title

(Phase 3) Comparison of Time to Response in Triplet Arm vs Control Arm Per BICR

type

SECONDARY

unit Of Measure

Months

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

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