TriangleNCT01848834 · OUTCOME
Overall RECIST 1.1 Response Rate Based on Investigator Assessment for Cohorts A, B, C and D
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
- Every 8 weeks until disease progression (Cohorts A, B, D: Up to ~ 35 months; Cohort C: Up to ~ 28 months) - through FA cutoff date 26 Apr 2016 (Cohorts: A, B, D) & 01 Sep 2015 (Cohort C)
What was measured
ORR was defined as the percentage of participants in the analysis population who experienced a CR (disappearance of all target lesions) or a PR (at least a 30% decrease in the sum of diameters of target lesions) and was assessed by Investigator evaluation. The percentage of participants who experienced a CR or PR in Cohorts A, B, C and D based on investigator assessment was presented for the first course of pembrolizumab treatment per protocol. ORR per RECIST 1.1 based on investigator assessment was presented for Cohort B2 in a separate outcome measure.
Analysis population: The population consisted of all Cohort A, B, C and D participants who received ≥1 dose of study treatment.
Groups in this outcome
Cohort A: Triple Negative Breast Cancer
Participants received pembrolizumab, 10 mg/kg, intravenously (IV) once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
Cohort B: Head & Neck Cancer
Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
Cohort C: Urothelial Cancer
Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
Cohort D: Gastric Cancer
Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
| Group | Source count |
|---|---|
| Cohort A: Triple Negative Breast Cancer | 32 |
| Cohort B: Head & Neck Cancer | 60 |
| Cohort C: Urothelial Cancer | 33 |
| Cohort D: Gastric Cancer | 39 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort A: Triple Negative Breast Cancer | 15.6 | Not reported | 5.3 | 32.8 | Not reported |
| Cohort B: Head & Neck Cancer | 16.7 | Not reported | 8.3 | 28.5 | Not reported |
| Cohort C: Urothelial Cancer | 21.2 | Not reported | 9.0 | 38.9 | Not reported |
| Cohort D: Gastric Cancer | 33.3 | Not reported | 19.1 | 50.2 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 5.3
- upper Limit
- 32.8
- value
- 15.6
- group Id
- OG001
- lower Limit
- 8.3
- upper Limit
- 28.5
- value
- 16.7
- group Id
- OG002
- lower Limit
- 9.0
- upper Limit
- 38.9
- value
- 21.2
- group Id
- OG003
- lower Limit
- 19.1
- upper Limit
- 50.2
- value
- 33.3
- denoms
- counts
- group Id
- OG000
- value
- 32
- group Id
- OG001
- value
- 60
- group Id
- OG002
- value
- 33
- group Id
- OG003
- value
- 39
- units
- Participants
- description
- ORR was defined as the percentage of participants in the analysis population who experienced a CR (disappearance of all target lesions) or a PR (at least a 30% decrease in the sum of diameters of target lesions) and was assessed by Investigator evaluation. The percentage of participants who experienced a CR or PR in Cohorts A, B, C and D based on investigator assessment was presented for the first course of pembrolizumab treatment per protocol. ORR per RECIST 1.1 based on investigator assessment was presented for Cohort B2 in a separate outcome measure.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received pembrolizumab, 10 mg/kg, intravenously (IV) once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
- id
- OG000
- title
- Cohort A: Triple Negative Breast Cancer
- description
- Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
- id
- OG001
- title
- Cohort B: Head & Neck Cancer
- description
- Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
- id
- OG002
- title
- Cohort C: Urothelial Cancer
- description
- Participants received pembrolizumab, 10 mg/kg, IV once every 2 weeks, and continued to receive study drug until disease progression, death, withdrawal of consent, Investigator decision, or end of study (up to 2 years). Participants who stopped study treatment without progression (e.g. completed 2 years) may have been eligible for up to 1 year of retreatment upon subsequently experiencing disease progression.
- id
- OG003
- title
- Cohort D: Gastric Cancer
- param Type
- NUMBER
- population Description
- The population consisted of all Cohort A, B, C and D participants who received ≥1 dose of study treatment.
- reporting Status
- POSTED
- time Frame
- Every 8 weeks until disease progression (Cohorts A, B, D: Up to ~ 35 months; Cohort C: Up to ~ 28 months) - through FA cutoff date 26 Apr 2016 (Cohorts: A, B, D) & 01 Sep 2015 (Cohort C)
- title
- Overall RECIST 1.1 Response Rate Based on Investigator Assessment for Cohorts A, B, C and D
- 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