TriangleNCT01673867 · OUTCOME
Objective Response Rate (ORR) by PD-L1 Expression at Baseline
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 randomization to date of objectively documented progression (up to approximately 110 months)
What was measured
ORR was defined as the percentage of all randomized participants whose Best Overall Response (BOR) was a confirmed Complete Response (CR) or 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. CR+PR, confidence interval based on the Clopper and Pearson method. ORR was reported for all randomized participants grouped by their baseline PD-L1 expression level. PD-L1 expression in participants was defined as the percent of disease tumor cells demonstrating plasma membrane PD-L1 staining of any intensity using an immunohistochemistry (IHC) assay.
Analysis population: All randomized participants who had a tumor biopsy assessed for PD-L1 expression
Groups in this outcome
Nivolumab
Nivolumab 3 mg/kg solution administered intravenously every 2 weeks. Eligible participants transitioned to nivolumab 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.
Docetaxel
Docetaxel 75mg/m\^2 solution administered intravenously every 3 weeks. Eligible participants transitioned to nivolumab 3 mg/kg every 2 weeks or 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.
| Group | Source count |
|---|---|
| Nivolumab | 231 |
| Docetaxel | 224 |
Reported measurements
Participants with baseline PD-L1 expression ≥ 5%
| Group | Source count |
|---|---|
| Nivolumab | 94 |
| Docetaxel | 86 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Nivolumab | 36.2 | Not reported | 26.5 | 46.7 | Not reported |
| Docetaxel | 12.8 | Not reported | 6.6 | 21.7 | Not reported |
Participants with baseline PD-L1 expression < 5%
| Group | Source count |
|---|---|
| Nivolumab | 137 |
| Docetaxel | 138 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Nivolumab | 10.9 | Not reported | 6.3 | 17.4 | Not reported |
| Docetaxel | 14.5 | Not reported | 9.1 | 21.5 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 26.5
- upper Limit
- 46.7
- value
- 36.2
- group Id
- OG001
- lower Limit
- 6.6
- upper Limit
- 21.7
- value
- 12.8
- denoms
- counts
- group Id
- OG000
- value
- 94
- group Id
- OG001
- value
- 86
- units
- Participants
- title
- Participants with baseline PD-L1 expression ≥ 5%
- categories
- measurements
- group Id
- OG000
- lower Limit
- 6.3
- upper Limit
- 17.4
- value
- 10.9
- group Id
- OG001
- lower Limit
- 9.1
- upper Limit
- 21.5
- value
- 14.5
- denoms
- counts
- group Id
- OG000
- value
- 137
- group Id
- OG001
- value
- 138
- units
- Participants
- title
- Participants with baseline PD-L1 expression < 5%
- denoms
- counts
- group Id
- OG000
- value
- 231
- group Id
- OG001
- value
- 224
- units
- Participants
- description
- ORR was defined as the percentage of all randomized participants whose Best Overall Response (BOR) was a confirmed Complete Response (CR) or 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. CR+PR, confidence interval based on the Clopper and Pearson method. ORR was reported for all randomized participants grouped by their baseline PD-L1 expression level. PD-L1 expression in participants was defined as the percent of disease tumor cells demonstrating plasma membrane PD-L1 staining of any intensity using an immunohistochemistry (IHC) assay.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Nivolumab 3 mg/kg solution administered intravenously every 2 weeks. Eligible participants transitioned to nivolumab 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.
- id
- OG000
- title
- Nivolumab
- description
- Docetaxel 75mg/m\^2 solution administered intravenously every 3 weeks. Eligible participants transitioned to nivolumab 3 mg/kg every 2 weeks or 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.
- id
- OG001
- title
- Docetaxel
- param Type
- NUMBER
- population Description
- All randomized participants who had a tumor biopsy assessed for PD-L1 expression
- reporting Status
- POSTED
- time Frame
- From randomization to date of objectively documented progression (up to approximately 110 months)
- title
- Objective Response Rate (ORR) by PD-L1 Expression at Baseline
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
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Preserved source evidence · Not medical advice