TriangleNCT02853305 · OUTCOME
Pembro Combo vs Chemo: Objective Response Rate (ORR) Using RECIST 1.1 as 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 approximately 42 months
What was measured
ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1. based upon BICR. The sponsor allowed a maximum of 10 target lesions in total and 5 per organ on this study. Per protocol, ORR in the pembro combo arm was compared to the chemo arm as a pre-specified secondary analysis of the ITT population. The percentage of participants who experienced CR or PR is reported here as the ORR for all participants in the pembro combo arm and chemo arm. Per protocol, ORR was compared separately between participants of the pembro arm and chemo arm and is presented later in the record.
Analysis population: All participants in the ITT population randomized to the pembro combo arm and chemo arm were included in the analysis. Per protocol, the pembro arm was compared to the chemo arm separately and not included in this analysis.
Groups in this outcome
Pembrolizumab + ST Chemotherapy (Pembro Combo)
Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for a maximum of 35 doses PLUS standard therapy (ST) chemotherapy with EITHER cisplatin 70 mg/m\^2 IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine IV infusion 1,000 mg/m\^2 on Day 1 and Day 8 of each 3-week cycle, OR carboplatin at an area under the curve 5 (AUC 5) (or AUC 4.5 if required per local guidelines) IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine 1,000 mg/m\^2 IV on Day 1 and Day 8 of each 3-week cycle.
Pembrolizumab (Pembro)
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for a maximum of 35 doses.
ST Chemotherapy (Chemo)
Participants received ST chemotherapy with EITHER cisplatin 70 mg/m\^2 IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine IV infusion 1,000 mg/m\^2 on Day 1 and Day 8 of each 3-week cycle OR carboplatin at AUC 5 (or AUC 4.5 if required per local guidelines) IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine 1,000 mg/m\^2 IV on Day 1 and Day 8 of each 3-week cycle.
| Group | Source count |
|---|---|
| Pembrolizumab + ST Chemotherapy (Pembro Combo) | 351 |
| Pembrolizumab (Pembro) | 0 |
| ST Chemotherapy (Chemo) | 352 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pembrolizumab + ST Chemotherapy (Pembro Combo) | 54.7 | Not reported | 49.3 | 60.0 | Not reported |
| ST Chemotherapy (Chemo) | 44.9 | Not reported | 39.6 | 50.2 | Not reported |
Source statistical analyses
- ci Lower Limit
- 2.4
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 17.1
- group Description
- ORR in participants of the pembro combo arm was compared to ORR in participants of the chemo arm. The comparison was based on the Miettinen \& Nurminen method stratified by investigator's choice of chemotherapy (cisplatin or carboplatin) and PD-L1 status (CPS\<10 vs. CPS≥10) at baseline.
- group Ids
- OG000
- OG002
- non Inferiority Type
- OTHER
- p Value Comment
- No formal hypothesis testing was performed.
- param Type
- Difference in Percentage
- param Value
- 9.8
Complete source fields
- analyses
- ci Lower Limit
- 2.4
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 17.1
- group Description
- ORR in participants of the pembro combo arm was compared to ORR in participants of the chemo arm. The comparison was based on the Miettinen \& Nurminen method stratified by investigator's choice of chemotherapy (cisplatin or carboplatin) and PD-L1 status (CPS\<10 vs. CPS≥10) at baseline.
- group Ids
- OG000
- OG002
- non Inferiority Type
- OTHER
- p Value Comment
- No formal hypothesis testing was performed.
- param Type
- Difference in Percentage
- param Value
- 9.8
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 49.3
- upper Limit
- 60.0
- value
- 54.7
- group Id
- OG002
- lower Limit
- 39.6
- upper Limit
- 50.2
- value
- 44.9
- denoms
- counts
- group Id
- OG000
- value
- 351
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 352
- units
- Participants
- description
- ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1. based upon BICR. The sponsor allowed a maximum of 10 target lesions in total and 5 per organ on this study. Per protocol, ORR in the pembro combo arm was compared to the chemo arm as a pre-specified secondary analysis of the ITT population. The percentage of participants who experienced CR or PR is reported here as the ORR for all participants in the pembro combo arm and chemo arm. Per protocol, ORR was compared separately between participants of the pembro arm and chemo arm and is presented later in the record.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for a maximum of 35 doses PLUS standard therapy (ST) chemotherapy with EITHER cisplatin 70 mg/m\^2 IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine IV infusion 1,000 mg/m\^2 on Day 1 and Day 8 of each 3-week cycle, OR carboplatin at an area under the curve 5 (AUC 5) (or AUC 4.5 if required per local guidelines) IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine 1,000 mg/m\^2 IV on Day 1 and Day 8 of each 3-week cycle.
- id
- OG000
- title
- Pembrolizumab + ST Chemotherapy (Pembro Combo)
- description
- Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for a maximum of 35 doses.
- id
- OG001
- title
- Pembrolizumab (Pembro)
- description
- Participants received ST chemotherapy with EITHER cisplatin 70 mg/m\^2 IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine IV infusion 1,000 mg/m\^2 on Day 1 and Day 8 of each 3-week cycle OR carboplatin at AUC 5 (or AUC 4.5 if required per local guidelines) IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine 1,000 mg/m\^2 IV on Day 1 and Day 8 of each 3-week cycle.
- id
- OG002
- title
- ST Chemotherapy (Chemo)
- param Type
- NUMBER
- population Description
- All participants in the ITT population randomized to the pembro combo arm and chemo arm were included in the analysis. Per protocol, the pembro arm was compared to the chemo arm separately and not included in this analysis.
- reporting Status
- POSTED
- time Frame
- Up to approximately 42 months
- title
- Pembro Combo vs Chemo: Objective Response Rate (ORR) Using RECIST 1.1 as Assessed by BICR
- type
- SECONDARY
- unit Of Measure
- Percentage of Participants
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Preserved source evidence · Not medical advice