TriangleNCT03765918 · OUTCOME
Pathological Complete Response (pCR) Rate
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 ~66 months
What was measured
pCR rate was defined as the percentage of participants having no residual invasive squamous cell carcinoma within the resected primary tumor specimen and all sampled regional lymph nodes. The pCR rate as assessed by BIPR at the time of definitive surgery in all randomized participants was presented.
Analysis population: Efficacy analysis population, which included all randomized participants. Per protocol, two participants in the SOC arm received neoadjuvant treatment in error (protocol deviations) and were included in the SOC arm for efficacy analysis.
Groups in this outcome
Pembrolizumab + Standard of Care (SOC)
Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery. Adjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks).
Standard of Care (SOC)
Adjuvant treatment: Following surgical resection, participants received investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks).
| Group | Source count |
|---|---|
| Pembrolizumab + Standard of Care (SOC) | 363 |
| Standard of Care (SOC) | 351 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pembrolizumab + Standard of Care (SOC) | 3.0 | Not reported | 1.5 | 5.4 | Not reported |
| Standard of Care (SOC) | 0.0 | Not reported | 0.0 | 1.0 | Not reported |
Source statistical analyses
- ci Lower Limit
- 1.5
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 5.3
- group Ids
- OG000
- OG001
- non Inferiority Comment
- Difference in percentage (calculated as % Pembrolizumab + SOC arm - % SOC arm) and 95% CI were based on Miettinen \& Nurminen method stratified by primary tumor site and tumor stage.
- non Inferiority Type
- OTHER
- p Value
- 0.0006
- 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
- 3.0
- statistical Method
- Stratified Miettinen and Nurminen
Complete source fields
- analyses
- ci Lower Limit
- 1.5
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 5.3
- group Ids
- OG000
- OG001
- non Inferiority Comment
- Difference in percentage (calculated as % Pembrolizumab + SOC arm - % SOC arm) and 95% CI were based on Miettinen \& Nurminen method stratified by primary tumor site and tumor stage.
- non Inferiority Type
- OTHER
- p Value
- 0.0006
- 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
- 3.0
- statistical Method
- Stratified Miettinen and Nurminen
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.5
- upper Limit
- 5.4
- value
- 3.0
- group Id
- OG001
- lower Limit
- 0.0
- upper Limit
- 1.0
- value
- 0.0
- denoms
- counts
- group Id
- OG000
- value
- 363
- group Id
- OG001
- value
- 351
- units
- Participants
- description
- pCR rate was defined as the percentage of participants having no residual invasive squamous cell carcinoma within the resected primary tumor specimen and all sampled regional lymph nodes. The pCR rate as assessed by BIPR at the time of definitive surgery in all randomized participants was presented.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery. Adjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks).
- id
- OG000
- title
- Pembrolizumab + Standard of Care (SOC)
- description
- Adjuvant treatment: Following surgical resection, participants received investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks).
- id
- OG001
- title
- Standard of Care (SOC)
- param Type
- NUMBER
- population Description
- Efficacy analysis population, which included all randomized participants. Per protocol, two participants in the SOC arm received neoadjuvant treatment in error (protocol deviations) and were included in the SOC arm for efficacy analysis.
- reporting Status
- POSTED
- time Frame
- Up to ~66 months
- title
- Pathological Complete Response (pCR) Rate
- type
- SECONDARY
- unit Of Measure
- Percentage of Participants
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Preserved source evidence · Not medical advice