TriangleNCT03615326 · OUTCOME
Objective Response Rate (ORR) Per RECIST 1.1 Assessed by BICR
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
- Up to 63 months
What was measured
ORR is defined as the percentage of participants who have a Complete Response (\[CR\], disappearance of all evidence of disease) or Partial Response (\[PR\], regression of measurable disease and no new sites) per RECIST 1.1 as assessed by blinded independent central review (BICR). ORR was determined for first course pembrolizumab in the Global Cohort. Per statistical analysis plan, participants in the Japan-specific SOX Cohort were not included in the efficacy analysis.
Analysis population: All randomized Global Cohort participants in the Pembrolizumab First Course arm and SOC arm were included in this analysis. Per statistical analysis plan, participants in the Japan-specific SOX Cohort were not included in the efficacy analysis.
Groups in this outcome
Global Pembrolizumab + Standard of Care First Course
Participants received 200 mg pembrolizumab IV every 3 weeks (Q3W) plus trastuzumab (8 mg/kg loading dose, 6 mg/kg maintenance thereafter) IV Q3W in combination with FP or CAPOX chemotherapy.
Global Standard of Care First Course
Participants received matched placebo to pembrolizumab IV Q3W plus trastuzumab (8mg/kg loading dose, 6mg/kg maintenance thereafter) IV Q3W in combination with FP or CAPOX chemotherapy.
| Group | Source count |
|---|---|
| Global Pembrolizumab + Standard of Care First Course | 350 |
| Global Standard of Care First Course | 348 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Global Pembrolizumab + Standard of Care First Course | 72.6 | Not reported | 67.6 | 77.2 | Not reported |
| Global Standard of Care First Course | 60.1 | Not reported | 54.7 | 65.2 | Not reported |
Source statistical analyses
- ci Lower Limit
- 5.6
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 19.4
- group Description
- ORR in all participants of the Global Pembrolizumab + SOC First Course was compared to PFS in all participants of the Global Standard of Care to address the hypothesis (pembrolizumab in combination with trastuzumab plus chemotherapy is superior to trastuzumab plus chemotherapy alone).
- group Ids
- OG000
- OG001
- non Inferiority Comment
- The difference in percentage and its 95% confidence interval (CI) were estimated using the Miettinen \& Nurminen method stratified by geographic region, PD-L1 status (positive vs. negative) at baseline, and chemotherapy regimen (FP or CAPOX).
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.00020
- p Value Comment
- One-sided p-value for testing. H0: difference in % = 0 versus H1: difference in % \> 0.
- param Type
- Difference in Percentage
- param Value
- 12.6
- statistical Method
- Stratified Miettinen and Nurminen Method
Complete source fields
- analyses
- ci Lower Limit
- 5.6
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 19.4
- group Description
- ORR in all participants of the Global Pembrolizumab + SOC First Course was compared to PFS in all participants of the Global Standard of Care to address the hypothesis (pembrolizumab in combination with trastuzumab plus chemotherapy is superior to trastuzumab plus chemotherapy alone).
- group Ids
- OG000
- OG001
- non Inferiority Comment
- The difference in percentage and its 95% confidence interval (CI) were estimated using the Miettinen \& Nurminen method stratified by geographic region, PD-L1 status (positive vs. negative) at baseline, and chemotherapy regimen (FP or CAPOX).
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.00020
- p Value Comment
- One-sided p-value for testing. H0: difference in % = 0 versus H1: difference in % \> 0.
- param Type
- Difference in Percentage
- param Value
- 12.6
- statistical Method
- Stratified Miettinen and Nurminen Method
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 67.6
- upper Limit
- 77.2
- value
- 72.6
- group Id
- OG001
- lower Limit
- 54.7
- upper Limit
- 65.2
- value
- 60.1
- denoms
- counts
- group Id
- OG000
- value
- 350
- group Id
- OG001
- value
- 348
- units
- Participants
- description
- ORR is defined as the percentage of participants who have a Complete Response (\[CR\], disappearance of all evidence of disease) or Partial Response (\[PR\], regression of measurable disease and no new sites) per RECIST 1.1 as assessed by blinded independent central review (BICR). ORR was determined for first course pembrolizumab in the Global Cohort. Per statistical analysis plan, participants in the Japan-specific SOX Cohort were not included in the efficacy analysis.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received 200 mg pembrolizumab IV every 3 weeks (Q3W) plus trastuzumab (8 mg/kg loading dose, 6 mg/kg maintenance thereafter) IV Q3W in combination with FP or CAPOX chemotherapy.
- id
- OG000
- title
- Global Pembrolizumab + Standard of Care First Course
- description
- Participants received matched placebo to pembrolizumab IV Q3W plus trastuzumab (8mg/kg loading dose, 6mg/kg maintenance thereafter) IV Q3W in combination with FP or CAPOX chemotherapy.
- id
- OG001
- title
- Global Standard of Care First Course
- param Type
- NUMBER
- population Description
- All randomized Global Cohort participants in the Pembrolizumab First Course arm and SOC arm were included in this analysis. Per statistical analysis plan, participants in the Japan-specific SOX Cohort were not included in the efficacy analysis.
- reporting Status
- POSTED
- time Frame
- Up to 63 months
- title
- Objective Response Rate (ORR) Per RECIST 1.1 Assessed by BICR
- type
- SECONDARY
- unit Of Measure
- Percentage of Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice