TriangleNCT04607421 · OUTCOME
Phase 3: Objective Response Rate (ORR) as Assessed by BICR for Arm B vs Arm C - FAS ORR Subset
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From date of randomization to until documented PD by BICR, or start of subsequent anticancer therapy or death, whichever occurred first (maximum up to 24.71 months)
What was measured
ORR was defined as the percentage of participants who achieved best overall response (BOR) of confirmed complete response (CR) or partial response (PR) according to RECIST v 1.1 as assessed by BICR. CR: complete disappearance of all target lesions (with the exception of nodal disease) and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR: \>=30% decrease under baseline of the sum of diameters of all target measurable lesions. PD: 20% increase in sum of diameters of target measurable lesions above smallest sum observed, with minimum absolute increase of 5 mm for target disease or unequivocal progression of pre-existing lesions for non-target disease or any new lesion.
Analysis population: The FAS for Phase 3, ORR included the first 110 participants randomized in each Arm B and Arm C. As pre-specified in protocol of the study, this outcome measure was planned to compare ORR by BICR only between Arm B and Arm C of Phase 3. Hence, Arm A is not reported in this outcome measure.
Groups in this outcome
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 | Source count |
|---|---|
| Phase 3: Arm B [EC + mFOLFOX6] | 110 |
| Phase 3: Arm C [Standard of Care Chemotherapy, Control Arm] | 110 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 3: Arm B [EC + mFOLFOX6] | 60.9 | Not reported | 51.6 | 69.5 | Not reported |
| Phase 3: Arm C [Standard of Care Chemotherapy, Control Arm] | 40.0 | Not reported | 31.3 | 49.3 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.989
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 99.8
- ci Upper Limit
- 6.089
- estimate Comment
- Odds ratio was estimated using stratified Cochran-Mantel-Haenszel method.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- =0.0008
- param Type
- Odds Ratio (OR)
- param Value
- 2.443
- statistical Comment
- 1-sided p-value from stratified Cochran-Mantel-Haenszel (CMH) test.
- statistical Method
- Cochran-Mantel-Haenszel
Complete source fields
- analyses
- ci Lower Limit
- 0.989
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 99.8
- ci Upper Limit
- 6.089
- estimate Comment
- Odds ratio was estimated using stratified Cochran-Mantel-Haenszel method.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- =0.0008
- param Type
- Odds Ratio (OR)
- param Value
- 2.443
- statistical Comment
- 1-sided p-value from stratified Cochran-Mantel-Haenszel (CMH) test.
- statistical Method
- Cochran-Mantel-Haenszel
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 51.6
- upper Limit
- 69.5
- value
- 60.9
- group Id
- OG001
- lower Limit
- 31.3
- upper Limit
- 49.3
- value
- 40.0
- denoms
- counts
- group Id
- OG000
- value
- 110
- group Id
- OG001
- value
- 110
- units
- Participants
- description
- ORR was defined as the percentage of participants who achieved best overall response (BOR) of confirmed complete response (CR) or partial response (PR) according to RECIST v 1.1 as assessed by BICR. CR: complete disappearance of all target lesions (with the exception of nodal disease) and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR: \>=30% decrease under baseline of the sum of diameters of all target measurable lesions. PD: 20% increase in sum of diameters of target measurable lesions above smallest sum observed, with minimum absolute increase of 5 mm for target disease or unequivocal progression of pre-existing lesions for non-target disease or any new lesion.
- dispersion Type
- 95% Confidence Interval
- groups
- 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
- OG000
- 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
- OG001
- title
- Phase 3: Arm C [Standard of Care Chemotherapy, Control Arm]
- param Type
- NUMBER
- population Description
- The FAS for Phase 3, ORR included the first 110 participants randomized in each Arm B and Arm C. As pre-specified in protocol of the study, this outcome measure was planned to compare ORR by BICR only between Arm B and Arm C of Phase 3. Hence, Arm A is not reported in this outcome measure.
- reporting Status
- POSTED
- time Frame
- From date of randomization to until documented PD by BICR, or start of subsequent anticancer therapy or death, whichever occurred first (maximum up to 24.71 months)
- title
- Phase 3: Objective Response Rate (ORR) as Assessed by BICR for Arm B vs Arm C - FAS ORR Subset
- type
- PRIMARY
- unit Of Measure
- Percentage of participants
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