TriangleNCT04008030 · OUTCOME
Objective Response Rate (ORR) by Blinded Independent Review Center (BICR) - Arm A and Arm B All Lines With dMMR/MSI-H mCRC
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 the date of the initial objectively documented tumor progression, or the date of initiation of subsequent therapy, whichever occurs first (Up to approximately 60 months)
What was measured
Objective Response Rate (ORR) is defined as the percentage of all randomized participants whose best overall response is either confirmed complete response (CR) or confirmed partial response (PR). CR= Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR= At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive disease (PD)=At least a 20% increase in the sum of diameters of target lesions. the sum must also demonstrate an absolute increase of at least 5 mm.
Analysis population: All randomized participants with centrally confirmed DNA mismatch repairdeficient/microsatellite instability-high metastatic colorectal cancer (dMMR/MSI-H mCRC) in Arm A and Arm B only
Groups in this outcome
Arm A - Nivolumab Monotherapy
Nivolumab 240 mg infusion on Day 1 and every two weeks during cycles 1 and 2 for a total of 6 doses. Starting from Cycle 3 Day 1 participants received Nivolumab 480 mg infusion every 4 weeks.
Arm B - Nivolumab + Ipilimumab
Nivolumab 240 mg infusion followed by Ipilimumab 1 mg/kg IV on Day 1 and every three weeks during cycles 1 and 2 for a total of 4 doses. Starting from Cycle 3 Day 1, participants received Nivolumab 480 mg infusion every 4 weeks.
| Group | Source count |
|---|---|
| Arm A - Nivolumab Monotherapy | 286 |
| Arm B - Nivolumab + Ipilimumab | 296 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A - Nivolumab Monotherapy | 57.7 | Not reported | 51.7 | 63.5 | Not reported |
| Arm B - Nivolumab + Ipilimumab | 70.6 | Not reported | 65.1 | 75.7 | Not reported |
Source statistical analyses
- ci Lower Limit
- 1.26
- ci Pct Value
- 95
- ci Upper Limit
- 2.50
- group Ids
- OG000
- OG001
- non Inferiority Comment
- Arm B over Arm A
- non Inferiority Type
- SUPERIORITY
- other Analysis Description
- Stratified by tumor sidedness (left vs. right) and prior lines of therapy (0, 1, \>= 2) as entered into the IRT
- p Value
- 0.0011
- p Value Comment
- Boundary for statistical significance p-value \< 0.006
- param Type
- Odds Ratio (OR)
- param Value
- 1.77
- statistical Comment
- Two-sided p-value from stratified CMH Test.
- statistical Method
- Cochran-Mantel-Haenszel
Complete source fields
- analyses
- ci Lower Limit
- 1.26
- ci Pct Value
- 95
- ci Upper Limit
- 2.50
- group Ids
- OG000
- OG001
- non Inferiority Comment
- Arm B over Arm A
- non Inferiority Type
- SUPERIORITY
- other Analysis Description
- Stratified by tumor sidedness (left vs. right) and prior lines of therapy (0, 1, \>= 2) as entered into the IRT
- p Value
- 0.0011
- p Value Comment
- Boundary for statistical significance p-value \< 0.006
- param Type
- Odds Ratio (OR)
- param Value
- 1.77
- statistical Comment
- Two-sided p-value from stratified CMH Test.
- statistical Method
- Cochran-Mantel-Haenszel
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 51.7
- upper Limit
- 63.5
- value
- 57.7
- group Id
- OG001
- lower Limit
- 65.1
- upper Limit
- 75.7
- value
- 70.6
- denoms
- counts
- group Id
- OG000
- value
- 286
- group Id
- OG001
- value
- 296
- units
- Participants
- description
- Objective Response Rate (ORR) is defined as the percentage of all randomized participants whose best overall response is either confirmed complete response (CR) or confirmed partial response (PR). CR= Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR= At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive disease (PD)=At least a 20% increase in the sum of diameters of target lesions. the sum must also demonstrate an absolute increase of at least 5 mm.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Nivolumab 240 mg infusion on Day 1 and every two weeks during cycles 1 and 2 for a total of 6 doses. Starting from Cycle 3 Day 1 participants received Nivolumab 480 mg infusion every 4 weeks.
- id
- OG000
- title
- Arm A - Nivolumab Monotherapy
- description
- Nivolumab 240 mg infusion followed by Ipilimumab 1 mg/kg IV on Day 1 and every three weeks during cycles 1 and 2 for a total of 4 doses. Starting from Cycle 3 Day 1, participants received Nivolumab 480 mg infusion every 4 weeks.
- id
- OG001
- title
- Arm B - Nivolumab + Ipilimumab
- param Type
- NUMBER
- population Description
- All randomized participants with centrally confirmed DNA mismatch repairdeficient/microsatellite instability-high metastatic colorectal cancer (dMMR/MSI-H mCRC) in Arm A and Arm B only
- reporting Status
- POSTED
- time Frame
- From date of randomization to the date of the initial objectively documented tumor progression, or the date of initiation of subsequent therapy, whichever occurs first (Up to approximately 60 months)
- title
- Objective Response Rate (ORR) by Blinded Independent Review Center (BICR) - Arm A and Arm B All Lines With dMMR/MSI-H mCRC
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Independent clinical review pending · Not medical advice