TriangleNCT03924895 · OUTCOME
Pathologic Complete Response (pCR) Rate Between Arm C and Arm B
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 53 monhts
What was measured
Pathologic complete response rate is defined as the percentage of participants having pCR. pCR is defined as absence of viable tumor (pT0N0) in examined tissue from RC and PLND, as assessed by blind independent central review (BICR).
Analysis population: Participants were randomized in two stages. Stage 1 assigned participants 1:1 to Arm A (pembrolizumab plus surgery) or Arm B (surgery alone). Stage 2 added Arm C (enfortumab vedotin plus pembrolizumab and surgery), and participants were randomized 1:1:1 to Arms A, B, and C. The analysis population included all participants randomized in Stage 2 to Arm C or Arm B, regardless of treatment received. Participants were analyzed according to randomized arm.
Groups in this outcome
Arm A: Pembrolizumab + Surgery
Participants receive 3 preoperative cycles of pembrolizumab, followed by standard of care surgery, followed by 14 cycles of postoperative pembrolizumab. Each cycle is 21 days.
Arm B: Surgery Alone
Participants receive standard of care surgery alone.
Arm C: Enfortumab Vedotin + Pembrolizumab + Surgery
Participants receive 3 preoperative cycles of enfortumab vedotin + pembrolizumab, followed by standard of care surgery, followed by 6 cycles of postoperative enfortumab vedotin + pembrolizumab, followed by 8 cycles of pembrolizumab alone. Each cycle is 21 days.
| Group | Source count |
|---|---|
| Arm A: Pembrolizumab + Surgery | 0 |
| Arm B: Surgery Alone | 174 |
| Arm C: Enfortumab Vedotin + Pembrolizumab + Surgery | 170 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm B: Surgery Alone | 8.6 | Not reported | 4.9 | 13.8 | Not reported |
| Arm C: Enfortumab Vedotin + Pembrolizumab + Surgery | 57.1 | Not reported | 49.3 | 64.6 | Not reported |
Source statistical analyses
- ci Lower Limit
- 39.5
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 56.5
- estimate Comment
- Arm C: EV+ Pembrolizumab +Surgery vs Arm B: Surgery Alone
- group Description
- Based on Miettinen \& Nurminen method stratified by cisplatin status (cisplatin-ineligible vs cisplatin-eligible but declined), tumor stage (T2N0 vs T3/T4aN0 vs T1-4aN1), and geographic regions (US vs EU vs MOW) with small strata collapsed
- group Ids
- OG001
- OG002
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.000001
- param Type
- Difference in Percentage
- param Value
- 48.3
- statistical Method
- Miettinen & Nurminen method
Complete source fields
- analyses
- ci Lower Limit
- 39.5
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 56.5
- estimate Comment
- Arm C: EV+ Pembrolizumab +Surgery vs Arm B: Surgery Alone
- group Description
- Based on Miettinen \& Nurminen method stratified by cisplatin status (cisplatin-ineligible vs cisplatin-eligible but declined), tumor stage (T2N0 vs T3/T4aN0 vs T1-4aN1), and geographic regions (US vs EU vs MOW) with small strata collapsed
- group Ids
- OG001
- OG002
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.000001
- param Type
- Difference in Percentage
- param Value
- 48.3
- statistical Method
- Miettinen & Nurminen method
- classes
- categories
- measurements
- group Id
- OG001
- lower Limit
- 4.9
- upper Limit
- 13.8
- value
- 8.6
- group Id
- OG002
- lower Limit
- 49.3
- upper Limit
- 64.6
- value
- 57.1
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 174
- group Id
- OG002
- value
- 170
- units
- Participants
- description
- Pathologic complete response rate is defined as the percentage of participants having pCR. pCR is defined as absence of viable tumor (pT0N0) in examined tissue from RC and PLND, as assessed by blind independent central review (BICR).
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants receive 3 preoperative cycles of pembrolizumab, followed by standard of care surgery, followed by 14 cycles of postoperative pembrolizumab. Each cycle is 21 days.
- id
- OG000
- title
- Arm A: Pembrolizumab + Surgery
- description
- Participants receive standard of care surgery alone.
- id
- OG001
- title
- Arm B: Surgery Alone
- description
- Participants receive 3 preoperative cycles of enfortumab vedotin + pembrolizumab, followed by standard of care surgery, followed by 6 cycles of postoperative enfortumab vedotin + pembrolizumab, followed by 8 cycles of pembrolizumab alone. Each cycle is 21 days.
- id
- OG002
- title
- Arm C: Enfortumab Vedotin + Pembrolizumab + Surgery
- param Type
- NUMBER
- population Description
- Participants were randomized in two stages. Stage 1 assigned participants 1:1 to Arm A (pembrolizumab plus surgery) or Arm B (surgery alone). Stage 2 added Arm C (enfortumab vedotin plus pembrolizumab and surgery), and participants were randomized 1:1:1 to Arms A, B, and C. The analysis population included all participants randomized in Stage 2 to Arm C or Arm B, regardless of treatment received. Participants were analyzed according to randomized arm.
- reporting Status
- POSTED
- time Frame
- Up to approximately 53 monhts
- title
- Pathologic Complete Response (pCR) Rate Between Arm C and Arm B
- type
- SECONDARY
- unit Of Measure
- Percentage of Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice