TriangleNCT02546986 · OUTCOME
Percentage of Participants Who Achieved a Best Overall Response of Complete Response or Partial Response
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
- 90% Confidence Interval
- Time frame
- Response was assessed every 6 weeks for the first 24 weeks, then every 9 weeks until DP, new anticancer initiation, or withdrawal of consent; maximum treatment exposure for CC-486 + PBZ was 61 weeks and 60 weeks for PBZ + PBO
What was measured
The best overall response is defined as the percentage of participants who achieved an objective confirmed complete response or partial response according to RECIST v1.1, compared with baseline where baseline was the last computed tomography (CT) scan obtained prior to or on day 1 of study treatment. RECIST v1.1 is defined as: - Complete response: disappearance of all target lesions - Partial response: at least a 30% decrease in the sum of diameters of target lesions from baseline - Stable disease: neither sufficient shrinkage to qualify for PR nor sufficient increase of lesions to qualify for progressive disease - Progressive Disease (PD): at least a 20% increase in the sum of diameters of target lesions from nadir or appearance of a new lesion.
Analysis population: The Intent-to-Treat population includes all participants who were randomized.
Groups in this outcome
CC-486 and Pembrolizumab (CC-486 + PBZ)
Participants received CC-486 300 mg tablets by mouth (PO) on Days 1-14 of each 21-day treatment cycle and pembrolizumab (PBZ) 200 mg administered as a 30-minute intravenous (IV) infusion on Day 1 of each 21-day cycle until radiologic disease progression (DP), unacceptable toxicity, initiation of a new anticancer therapy, withdrawal of consent, subject refusal, physician decision, or death.
Placebo and Pembrolizumab (PBO + PBZ)
Participant received placebo tablets (identically matching in appearance to CC-486) administered orally daily on Days 1-14 plus pembrolizumab 200 mg administered as a 30-minute IV infusion on Day 1 of each 21-day cycle until radiologic disease progression, unacceptable toxicity, initiation of a new anticancer therapy, withdrawal of consent, subject refusal, physician decision, or death.
| Group | Source count |
|---|---|
| CC-486 and Pembrolizumab (CC-486 + PBZ) | 51 |
| Placebo and Pembrolizumab (PBO + PBZ) | 49 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| CC-486 and Pembrolizumab (CC-486 + PBZ) | 19.6 | Not reported | 11.0 | 31.0 | Not reported |
| Placebo and Pembrolizumab (PBO + PBZ) | 14.3 | Not reported | 6.9 | 25.2 | Not reported |
Source statistical analyses
- ci Lower Limit
- -11.5
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 90
- ci Upper Limit
- 21.3
- estimate Comment
- The 90% exact unconditional confidence interval was used for ORR difference.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- param Type
- Overall Response Rate (ORR) Difference
- param Value
- 5.3
Complete source fields
- analyses
- ci Lower Limit
- -11.5
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 90
- ci Upper Limit
- 21.3
- estimate Comment
- The 90% exact unconditional confidence interval was used for ORR difference.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- param Type
- Overall Response Rate (ORR) Difference
- param Value
- 5.3
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 11.0
- upper Limit
- 31.0
- value
- 19.6
- group Id
- OG001
- lower Limit
- 6.9
- upper Limit
- 25.2
- value
- 14.3
- denoms
- counts
- group Id
- OG000
- value
- 51
- group Id
- OG001
- value
- 49
- units
- Participants
- description
- The best overall response is defined as the percentage of participants who achieved an objective confirmed complete response or partial response according to RECIST v1.1, compared with baseline where baseline was the last computed tomography (CT) scan obtained prior to or on day 1 of study treatment. RECIST v1.1 is defined as: - Complete response: disappearance of all target lesions - Partial response: at least a 30% decrease in the sum of diameters of target lesions from baseline - Stable disease: neither sufficient shrinkage to qualify for PR nor sufficient increase of lesions to qualify for progressive disease - Progressive Disease (PD): at least a 20% increase in the sum of diameters of target lesions from nadir or appearance of a new lesion.
- dispersion Type
- 90% Confidence Interval
- groups
- description
- Participants received CC-486 300 mg tablets by mouth (PO) on Days 1-14 of each 21-day treatment cycle and pembrolizumab (PBZ) 200 mg administered as a 30-minute intravenous (IV) infusion on Day 1 of each 21-day cycle until radiologic disease progression (DP), unacceptable toxicity, initiation of a new anticancer therapy, withdrawal of consent, subject refusal, physician decision, or death.
- id
- OG000
- title
- CC-486 and Pembrolizumab (CC-486 + PBZ)
- description
- Participant received placebo tablets (identically matching in appearance to CC-486) administered orally daily on Days 1-14 plus pembrolizumab 200 mg administered as a 30-minute IV infusion on Day 1 of each 21-day cycle until radiologic disease progression, unacceptable toxicity, initiation of a new anticancer therapy, withdrawal of consent, subject refusal, physician decision, or death.
- id
- OG001
- title
- Placebo and Pembrolizumab (PBO + PBZ)
- param Type
- NUMBER
- population Description
- The Intent-to-Treat population includes all participants who were randomized.
- reporting Status
- POSTED
- time Frame
- Response was assessed every 6 weeks for the first 24 weeks, then every 9 weeks until DP, new anticancer initiation, or withdrawal of consent; maximum treatment exposure for CC-486 + PBZ was 61 weeks and 60 weeks for PBZ + PBO
- title
- Percentage of Participants Who Achieved a Best Overall Response of Complete Response or Partial Response
- type
- SECONDARY
- unit Of Measure
- Percentage of Participants
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Preserved source evidence · Not medical advice