NCT04607421 · OUTCOME
Phase 3: Number of Participants According to B-Raf Serine/Threonine-Protein Kinase (BRAF) Valine 600 (V600) Status From ctDNA
A Study of Encorafenib Plus Cetuximab With or Without Chemotherapy in People With Previously Untreated Metastatic Colorectal Cancer · Source last updated 2026-06-11
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
- Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 15, Cycle 7 Day 1 and End of Treatment (anytime till maximum of 37.25 months)
What was measured
BRAF V600 status from ctDNA was classified as follows; measurable: participants with detectable ctDNA had measurable BRAF V600 tumor biomarker alterations and not measurable: participants with detectable ctDNA did not have measurable BRAF V600 biomarker alterations or overall ctDNA was not detectable. The number of participants as per their BRAF V600 status from ctDNA (measurable and not measurable) have been reported in this outcome measure. In this outcome measure, data is presented for participants outside China and Mainland China participants.
Analysis population: The biomarker analysis set included all participants who were in the safety set and who had at least 1 of the pharmacodynamics or biomarkers evaluated at pre and/or post dose. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies participants evaluable for specified rows. All Participants under "Overall Number of Participants Analyzed" contributed data to the table but may not have data evaluable for each row.
Groups in this outcome
Phase 3: Arm A [EC]
Participants received encorafenib 300 mg QD orally and cetuximab 500 mg/m\^2 IV infusion for 120 minutes Q2W. Participants received treatment in 28-day cycles.
Phase 3: Arm B [EC + mFOLFOX6]
Participants received encorafenib 300 mg QD orally and cetuximab 500 mg/m\^2 IV infusion for 120 minutes Q2W along with fluorouracil 400 mg/m\^2 IV bolus then 2400 mg/m\^2 continuous IV infusion over 46-48 hours Q2W; leucovorin 400 mg/m\^2 IV infusion for 120 minutes Q2W and oxaliplatin 85 mg/m\^2 IV infusion for 120 minutes Q2W. Participants received treatment in 28-day cycles.
Phase 3: Arm C [Standard of Care Chemotherapy, Control Arm]
Participants received standard of care (SOC) chemotherapy per Investigator's choice: mFOLFOX6 with or without bevacizumab or FOLFOXIRI with or without bevacizumab or CAPOX with or without bevacizumab. Bevacizumab was optional and it was given per prescribing instructions of treating physician. mFOLFOX6 (28-day Cycle): fluorouracil 400 mg/m\^2 IV bolus then 2400 mg/m\^2 continuous IV infusion over 46-48 hours Q2W; leucovorin 400 mg/m\^2 IV infusion for 120 minutes Q2W and oxaliplatin 85 mg/m\^2 IV infusion for 120 minutes Q2W; FOLFOXIRI (28-day Cycle): fluorouracil 2400 or 3200 mg/m\^2 continuous IV infusion over 46-48 hours Q2W (per local standard of care); leucovorin 400 mg/m\^2 IV infusion for 120 minutes Q2W and oxaliplatin 85 mg/m\^2 IV infusion for 120 minutes Q2W and irinotecan 165 mg/m\^2 as IV infusion for 90 minutes Q2W; CAPOX (21-day Cycle): capecitabine 1000 mg/m\^2 oral tablet twice daily on Days 1-14 and oxaliplatin 130 mg/m\^2 IV infusion for 120 minutes Q3W.
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: Arm A [EC] | 147 |
|---|
| Phase 3: Arm B [EC + mFOLFOX6] | 225 |
|---|
| Phase 3: Arm C [Standard of Care Chemotherapy, Control Arm] | 217 |
|---|
Reported measurements
Outside China: Cycle 1 Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase 3: Arm A [EC] | 123 |
|---|
| Phase 3: Arm B [EC + mFOLFOX6] | 190 |
|---|
| Phase 3: Arm C [Standard of Care Chemotherapy, Control Arm] | 179 |
|---|
Measurable
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 3: Arm A [EC] | 105 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 3: Arm B [EC + mFOLFOX6] | 149 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 3: Arm C [Standard of Care Chemotherapy, Control Arm] | 154 | Not reported | Not reported | Not reported | Not reported |
|---|
Not measurable
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 3: Arm A [EC] | 18 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 3: Arm B [EC + mFOLFOX6] | 41 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 3: Arm C [Standard of Care Chemotherapy, Control Arm] | 25 | Not reported | Not reported | Not reported | Not reported |
|---|
Outside China: Cycle 1 Day 15
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase 3: Arm A [EC] | 106 |
|---|
| Phase 3: Arm B [EC + mFOLFOX6] | 159 |
|---|
| Phase 3: Arm C [Standard of Care Chemotherapy, Control Arm] | 129 |
|---|
Measurable
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 3: Arm A [EC] | 58 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 3: Arm B [EC + mFOLFOX6] | 81 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 3: Arm C [Standard of Care Chemotherapy, Control Arm] | 100 | Not reported | Not reported | Not reported | Not reported |
|---|
Not measurable
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 3: Arm A [EC] | 48 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 3: Arm B [EC + mFOLFOX6] | 78 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 3: Arm C [Standard of Care Chemotherapy, Control Arm] | 29 | Not reported | Not reported | Not reported | Not reported |
|---|
Outside China: Cycle 2 Day 15
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase 3: Arm A [EC] | 103 |
|---|
| Phase 3: Arm B [EC + mFOLFOX6] | 154 |
|---|
| Phase 3: Arm C [Standard of Care Chemotherapy, Control Arm] | 113 |
|---|
Measurable
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 3: Arm A [EC] | 47 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 3: Arm B [EC + mFOLFOX6] | 45 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 3: Arm C [Standard of Care Chemotherapy, Control Arm] | 65 | Not reported | Not reported | Not reported | Not reported |
|---|
Not measurable
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 3: Arm A [EC] | 56 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 3: Arm B [EC + mFOLFOX6] | 109 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 3: Arm C [Standard of Care Chemotherapy, Control Arm] | 48 | Not reported | Not reported | Not reported | Not reported |
|---|
Outside China: Cycle 7 Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase 3: Arm A [EC] | 55 |
|---|
| Phase 3: Arm B [EC + mFOLFOX6] | 111 |
|---|
| Phase 3: Arm C [Standard of Care Chemotherapy, Control Arm] | 63 |
|---|
Measurable
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 3: Arm A [EC] | 25 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 3: Arm B [EC + mFOLFOX6] | 28 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 3: Arm C [Standard of Care Chemotherapy, Control Arm] | 31 | Not reported | Not reported | Not reported | Not reported |
|---|
Not measurable
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 3: Arm A [EC] | 30 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 3: Arm B [EC + mFOLFOX6] | 83 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 3: Arm C [Standard of Care Chemotherapy, Control Arm] | 32 | Not reported | Not reported | Not reported | Not reported |
|---|
Outside China: End of Treatment
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase 3: Arm A [EC] | 75 |
|---|
| Phase 3: Arm B [EC + mFOLFOX6] | 63 |
|---|
| Phase 3: Arm C [Standard of Care Chemotherapy, Control Arm] | 102 |
|---|
Measurable
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 3: Arm A [EC] | 64 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 3: Arm B [EC + mFOLFOX6] | 40 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 3: Arm C [Standard of Care Chemotherapy, Control Arm] | 71 | Not reported | Not reported | Not reported | Not reported |
|---|
Not measurable
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 3: Arm A [EC] | 11 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 3: Arm B [EC + mFOLFOX6] | 23 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 3: Arm C [Standard of Care Chemotherapy, Control Arm] | 31 | Not reported | Not reported | Not reported | Not reported |
|---|
Mainland China: Cycle 1 Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase 3: Arm A [EC] | 24 |
|---|
| Phase 3: Arm B [EC + mFOLFOX6] | 35 |
|---|
| Phase 3: Arm C [Standard of Care Chemotherapy, Control Arm] | 38 |
|---|
Measurable
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 3: Arm A [EC] | 19 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 3: Arm B [EC + mFOLFOX6] | 29 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 3: Arm C [Standard of Care Chemotherapy, Control Arm] | 35 | Not reported | Not reported | Not reported | Not reported |
|---|
Not measurable
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 3: Arm A [EC] | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 3: Arm B [EC + mFOLFOX6] | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 3: Arm C [Standard of Care Chemotherapy, Control Arm] | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
Mainland China: Cycle 1 Day 15
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase 3: Arm A [EC] | 22 |
|---|
| Phase 3: Arm B [EC + mFOLFOX6] | 32 |
|---|
| Phase 3: Arm C [Standard of Care Chemotherapy, Control Arm] | 23 |
|---|
Measurable
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 3: Arm A [EC] | 12 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 3: Arm B [EC + mFOLFOX6] | 13 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 3: Arm C [Standard of Care Chemotherapy, Control Arm] | 22 | Not reported | Not reported | Not reported | Not reported |
|---|
Not measurable
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 3: Arm A [EC] | 10 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 3: Arm B [EC + mFOLFOX6] | 19 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 3: Arm C [Standard of Care Chemotherapy, Control Arm] | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Mainland China: Cycle 2 Day 15
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase 3: Arm A [EC] | 21 |
|---|
| Phase 3: Arm B [EC + mFOLFOX6] | 30 |
|---|
| Phase 3: Arm C [Standard of Care Chemotherapy, Control Arm] | 21 |
|---|
Measurable
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 3: Arm A [EC] | 8 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 3: Arm B [EC + mFOLFOX6] | 7 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 3: Arm C [Standard of Care Chemotherapy, Control Arm] | 11 | Not reported | Not reported | Not reported | Not reported |
|---|
Not measurable
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 3: Arm A [EC] | 13 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 3: Arm B [EC + mFOLFOX6] | 23 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 3: Arm C [Standard of Care Chemotherapy, Control Arm] | 10 | Not reported | Not reported | Not reported | Not reported |
|---|
Mainland China: Cycle 7 Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase 3: Arm A [EC] | 16 |
|---|
| Phase 3: Arm B [EC + mFOLFOX6] | 22 |
|---|
| Phase 3: Arm C [Standard of Care Chemotherapy, Control Arm] | 8 |
|---|
Measurable
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 3: Arm A [EC] | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 3: Arm B [EC + mFOLFOX6] | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 3: Arm C [Standard of Care Chemotherapy, Control Arm] | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
Not measurable
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 3: Arm A [EC] | 10 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 3: Arm B [EC + mFOLFOX6] | 17 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 3: Arm C [Standard of Care Chemotherapy, Control Arm] | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
Mainland China: End of Treatment
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase 3: Arm A [EC] | 11 |
|---|
| Phase 3: Arm B [EC + mFOLFOX6] | 13 |
|---|
| Phase 3: Arm C [Standard of Care Chemotherapy, Control Arm] | 20 |
|---|
Measurable
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 3: Arm A [EC] | 10 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 3: Arm B [EC + mFOLFOX6] | 11 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 3: Arm C [Standard of Care Chemotherapy, Control Arm] | 13 | Not reported | Not reported | Not reported | Not reported |
|---|
Not measurable
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 3: Arm A [EC] | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 3: Arm B [EC + mFOLFOX6] | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 3: Arm C [Standard of Care Chemotherapy, Control Arm] | 7 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 105
- group Id
- OG001
- value
- 149
- group Id
- OG002
- value
- 154
- title
- Measurable
- measurements
- group Id
- OG000
- value
- 18
- group Id
- OG001
- value
- 41
- group Id
- OG002
- value
- 25
- title
- Not measurable
- denoms
- counts
- group Id
- OG000
- value
- 123
- group Id
- OG001
- value
- 190
- group Id
- OG002
- value
- 179
- units
- Participants
- title
- Outside China: Cycle 1 Day 1
- categories
- measurements
- group Id
- OG000
- value
- 58
- group Id
- OG001
- value
- 81
- group Id
- OG002
- value
- 100
- title
- Measurable
- measurements
- group Id
- OG000
- value
- 48
- group Id
- OG001
- value
- 78
- group Id
- OG002
- value
- 29
- title
- Not measurable
- denoms
- counts
- group Id
- OG000
- value
- 106
- group Id
- OG001
- value
- 159
- group Id
- OG002
- value
- 129
- units
- Participants
- title
- Outside China: Cycle 1 Day 15
- categories
- measurements
- group Id
- OG000
- value
- 47
- group Id
- OG001
- value
- 45
- group Id
- OG002
- value
- 65
- title
- Measurable
- measurements
- group Id
- OG000
- value
- 56
- group Id
- OG001
- value
- 109
- group Id
- OG002
- value
- 48
- title
- Not measurable
- denoms
- counts
- group Id
- OG000
- value
- 103
- group Id
- OG001
- value
- 154
- group Id
- OG002
- value
- 113
- units
- Participants
- title
- Outside China: Cycle 2 Day 15
- categories
- measurements
- group Id
- OG000
- value
- 25
- group Id
- OG001
- value
- 28
- group Id
- OG002
- value
- 31
- title
- Measurable
- measurements
- group Id
- OG000
- value
- 30
- group Id
- OG001
- value
- 83
- group Id
- OG002
- value
- 32
- title
- Not measurable
- denoms
- counts
- group Id
- OG000
- value
- 55
- group Id
- OG001
- value
- 111
- group Id
- OG002
- value
- 63
- units
- Participants
- title
- Outside China: Cycle 7 Day 1
- categories
- measurements
- group Id
- OG000
- value
- 64
- group Id
- OG001
- value
- 40
- group Id
- OG002
- value
- 71
- title
- Measurable
- measurements
- group Id
- OG000
- value
- 11
- group Id
- OG001
- value
- 23
- group Id
- OG002
- value
- 31
- title
- Not measurable
- denoms
- counts
- group Id
- OG000
- value
- 75
- group Id
- OG001
- value
- 63
- group Id
- OG002
- value
- 102
- units
- Participants
- title
- Outside China: End of Treatment
- categories
- measurements
- group Id
- OG000
- value
- 19
- group Id
- OG001
- value
- 29
- group Id
- OG002
- value
- 35
- title
- Measurable
- measurements
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 3
- title
- Not measurable
- denoms
- counts
- group Id
- OG000
- value
- 24
- group Id
- OG001
- value
- 35
- group Id
- OG002
- value
- 38
- units
- Participants
- title
- Mainland China: Cycle 1 Day 1
- categories
- measurements
- group Id
- OG000
- value
- 12
- group Id
- OG001
- value
- 13
- group Id
- OG002
- value
- 22
- title
- Measurable
- measurements
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 19
- group Id
- OG002
- value
- 1
- title
- Not measurable
- denoms
- counts
- group Id
- OG000
- value
- 22
- group Id
- OG001
- value
- 32
- group Id
- OG002
- value
- 23
- units
- Participants
- title
- Mainland China: Cycle 1 Day 15
- categories
- measurements
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 11
- title
- Measurable
- measurements
- group Id
- OG000
- value
- 13
- group Id
- OG001
- value
- 23
- group Id
- OG002
- value
- 10
- title
- Not measurable
- denoms
- counts
- group Id
- OG000
- value
- 21
- group Id
- OG001
- value
- 30
- group Id
- OG002
- value
- 21
- units
- Participants
- title
- Mainland China: Cycle 2 Day 15
- categories
- measurements
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 4
- title
- Measurable
- measurements
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 17
- group Id
- OG002
- value
- 4
- title
- Not measurable
- denoms
- counts
- group Id
- OG000
- value
- 16
- group Id
- OG001
- value
- 22
- group Id
- OG002
- value
- 8
- units
- Participants
- title
- Mainland China: Cycle 7 Day 1
- categories
- measurements
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 11
- group Id
- OG002
- value
- 13
- title
- Measurable
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 7
- title
- Not measurable
- denoms
- counts
- group Id
- OG000
- value
- 11
- group Id
- OG001
- value
- 13
- group Id
- OG002
- value
- 20
- units
- Participants
- title
- Mainland China: End of Treatment
- denoms
- counts
- group Id
- OG000
- value
- 147
- group Id
- OG001
- value
- 225
- group Id
- OG002
- value
- 217
- units
- Participants
- description
- BRAF V600 status from ctDNA was classified as follows; measurable: participants with detectable ctDNA had measurable BRAF V600 tumor biomarker alterations and not measurable: participants with detectable ctDNA did not have measurable BRAF V600 biomarker alterations or overall ctDNA was not detectable. The number of participants as per their BRAF V600 status from ctDNA (measurable and not measurable) have been reported in this outcome measure. In this outcome measure, data is presented for participants outside China and Mainland China participants.
- groups
- description
- Participants received encorafenib 300 mg QD orally and cetuximab 500 mg/m\^2 IV infusion for 120 minutes Q2W. Participants received treatment in 28-day cycles.
- id
- OG000
- title
- Phase 3: Arm A [EC]
- description
- Participants received encorafenib 300 mg QD orally and cetuximab 500 mg/m\^2 IV infusion for 120 minutes Q2W along with fluorouracil 400 mg/m\^2 IV bolus then 2400 mg/m\^2 continuous IV infusion over 46-48 hours Q2W; leucovorin 400 mg/m\^2 IV infusion for 120 minutes Q2W and oxaliplatin 85 mg/m\^2 IV infusion for 120 minutes Q2W. Participants received treatment in 28-day cycles.
- id
- OG001
- title
- Phase 3: Arm B [EC + mFOLFOX6]
- description
- Participants received standard of care (SOC) chemotherapy per Investigator's choice: mFOLFOX6 with or without bevacizumab or FOLFOXIRI with or without bevacizumab or CAPOX with or without bevacizumab. Bevacizumab was optional and it was given per prescribing instructions of treating physician. mFOLFOX6 (28-day Cycle): fluorouracil 400 mg/m\^2 IV bolus then 2400 mg/m\^2 continuous IV infusion over 46-48 hours Q2W; leucovorin 400 mg/m\^2 IV infusion for 120 minutes Q2W and oxaliplatin 85 mg/m\^2 IV infusion for 120 minutes Q2W; FOLFOXIRI (28-day Cycle): fluorouracil 2400 or 3200 mg/m\^2 continuous IV infusion over 46-48 hours Q2W (per local standard of care); leucovorin 400 mg/m\^2 IV infusion for 120 minutes Q2W and oxaliplatin 85 mg/m\^2 IV infusion for 120 minutes Q2W and irinotecan 165 mg/m\^2 as IV infusion for 90 minutes Q2W; CAPOX (21-day Cycle): capecitabine 1000 mg/m\^2 oral tablet twice daily on Days 1-14 and oxaliplatin 130 mg/m\^2 IV infusion for 120 minutes Q3W.
- id
- OG002
- title
- Phase 3: Arm C [Standard of Care Chemotherapy, Control Arm]
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- The biomarker analysis set included all participants who were in the safety set and who had at least 1 of the pharmacodynamics or biomarkers evaluated at pre and/or post dose. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies participants evaluable for specified rows. All Participants under "Overall Number of Participants Analyzed" contributed data to the table but may not have data evaluable for each row.
- reporting Status
- POSTED
- time Frame
- Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 15, Cycle 7 Day 1 and End of Treatment (anytime till maximum of 37.25 months)
- title
- Phase 3: Number of Participants According to B-Raf Serine/Threonine-Protein Kinase (BRAF) Valine 600 (V600) Status From ctDNA
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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