NCT04607421 · OUTCOME
Phase 3: Number of Participants According to Circulating Tumor Deoxyribonucleic Acid (ctDNA) Status
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
ctDNA status was classified as follows; detected: overall variant allele frequency (VAF) was greater than zero, not detected: overall VAF equalled zero, and not evaluable: overall VAF could not be calculated. The VAF was defined as percentage of deoxyribonucleic acid (DNA) reads at a specific position that show a genetic variant instead of the normal (reference) sequence. The number of participants as per their ctDNA status (detected, not detected and not evaluable) have been reported in this outcome measure.
Analysis population: The biomarker tumor tissue analysis set was defined as participants from the safety analysis set who had a tumor biomarker assessment at baseline. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies participants evaluable for specified rows.
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] | 123 |
|---|
| Phase 3: Arm B [EC + mFOLFOX6] | 190 |
|---|
| Phase 3: Arm C [Standard of Care Chemotherapy, Control Arm] | 179 |
|---|
Reported measurements
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 |
|---|
Detected
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 3: Arm A [EC] | 116 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 3: Arm B [EC + mFOLFOX6] | 174 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 3: Arm C [Standard of Care Chemotherapy, Control Arm] | 170 | Not reported | Not reported | Not reported | Not reported |
|---|
Not Detected
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 3: Arm A [EC] | 2 | 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] | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Not Evaluable
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] | 14 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 3: Arm C [Standard of Care Chemotherapy, Control Arm] | 9 | Not reported | Not reported | Not reported | Not reported |
|---|
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 |
|---|
Detected
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 3: Arm A [EC] | 85 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 3: Arm B [EC + mFOLFOX6] | 136 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 3: Arm C [Standard of Care Chemotherapy, Control Arm] | 122 | Not reported | Not reported | Not reported | Not reported |
|---|
Not Detected
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 3: Arm A [EC] | 17 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 3: Arm B [EC + mFOLFOX6] | 20 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 3: Arm C [Standard of Care Chemotherapy, Control Arm] | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
Not Evaluable
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 3: Arm A [EC] | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 3: Arm B [EC + mFOLFOX6] | 3 | 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 |
|---|
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 |
|---|
Detected
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 3: Arm A [EC] | 80 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 3: Arm B [EC + mFOLFOX6] | 128 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 3: Arm C [Standard of Care Chemotherapy, Control Arm] | 105 | Not reported | Not reported | Not reported | Not reported |
|---|
Not Detected
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] | 20 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 3: Arm C [Standard of Care Chemotherapy, Control Arm] | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
Not Evaluable
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] | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 3: Arm C [Standard of Care Chemotherapy, Control Arm] | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
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 |
|---|
Detected
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 3: Arm A [EC] | 43 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 3: Arm B [EC + mFOLFOX6] | 102 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 3: Arm C [Standard of Care Chemotherapy, Control Arm] | 59 | Not reported | Not reported | Not reported | Not reported |
|---|
Not Detected
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 3: Arm A [EC] | 9 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 3: Arm B [EC + mFOLFOX6] | 9 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 3: Arm C [Standard of Care Chemotherapy, Control Arm] | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
Not Evaluable
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 3: Arm A [EC] | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 3: Arm B [EC + mFOLFOX6] | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 3: Arm C [Standard of Care Chemotherapy, Control Arm] | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
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 |
|---|
Detected
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 3: Arm A [EC] | 70 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 3: Arm B [EC + mFOLFOX6] | 58 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 3: Arm C [Standard of Care Chemotherapy, Control Arm] | 99 | Not reported | Not reported | Not reported | Not reported |
|---|
Not Detected
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 3: Arm A [EC] | 0 | 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] | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
Not Evaluable
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] | 3 | 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 |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 116
- group Id
- OG001
- value
- 174
- group Id
- OG002
- value
- 170
- title
- Detected
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 0
- title
- Not Detected
- measurements
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 14
- group Id
- OG002
- value
- 9
- title
- Not Evaluable
- denoms
- counts
- group Id
- OG000
- value
- 123
- group Id
- OG001
- value
- 190
- group Id
- OG002
- value
- 179
- units
- Participants
- title
- Cycle 1 Day 1
- categories
- measurements
- group Id
- OG000
- value
- 85
- group Id
- OG001
- value
- 136
- group Id
- OG002
- value
- 122
- title
- Detected
- measurements
- group Id
- OG000
- value
- 17
- group Id
- OG001
- value
- 20
- group Id
- OG002
- value
- 6
- title
- Not Detected
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 1
- title
- Not Evaluable
- denoms
- counts
- group Id
- OG000
- value
- 106
- group Id
- OG001
- value
- 159
- group Id
- OG002
- value
- 129
- units
- Participants
- title
- Cycle 1 Day 15
- categories
- measurements
- group Id
- OG000
- value
- 80
- group Id
- OG001
- value
- 128
- group Id
- OG002
- value
- 105
- title
- Detected
- measurements
- group Id
- OG000
- value
- 11
- group Id
- OG001
- value
- 20
- group Id
- OG002
- value
- 6
- title
- Not Detected
- measurements
- group Id
- OG000
- value
- 12
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 2
- title
- Not Evaluable
- denoms
- counts
- group Id
- OG000
- value
- 103
- group Id
- OG001
- value
- 154
- group Id
- OG002
- value
- 113
- units
- Participants
- title
- Cycle 2 Day 15
- categories
- measurements
- group Id
- OG000
- value
- 43
- group Id
- OG001
- value
- 102
- group Id
- OG002
- value
- 59
- title
- Detected
- measurements
- group Id
- OG000
- value
- 9
- group Id
- OG001
- value
- 9
- group Id
- OG002
- value
- 2
- title
- Not Detected
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 2
- title
- Not Evaluable
- denoms
- counts
- group Id
- OG000
- value
- 55
- group Id
- OG001
- value
- 111
- group Id
- OG002
- value
- 63
- units
- Participants
- title
- Cycle 7 Day 1
- categories
- measurements
- group Id
- OG000
- value
- 70
- group Id
- OG001
- value
- 58
- group Id
- OG002
- value
- 99
- title
- Detected
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 2
- title
- Not Detected
- measurements
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 1
- title
- Not Evaluable
- denoms
- counts
- group Id
- OG000
- value
- 75
- group Id
- OG001
- value
- 63
- group Id
- OG002
- value
- 102
- units
- Participants
- title
- End of Treatment
- denoms
- counts
- group Id
- OG000
- value
- 123
- group Id
- OG001
- value
- 190
- group Id
- OG002
- value
- 179
- units
- Participants
- description
- ctDNA status was classified as follows; detected: overall variant allele frequency (VAF) was greater than zero, not detected: overall VAF equalled zero, and not evaluable: overall VAF could not be calculated. The VAF was defined as percentage of deoxyribonucleic acid (DNA) reads at a specific position that show a genetic variant instead of the normal (reference) sequence. The number of participants as per their ctDNA status (detected, not detected and not evaluable) have been reported in this outcome measure.
- 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 tumor tissue analysis set was defined as participants from the safety analysis set who had a tumor biomarker assessment at baseline. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies participants evaluable for specified rows.
- 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 Circulating Tumor Deoxyribonucleic Acid (ctDNA) Status
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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