TriangleNCT03284424 · OUTCOME
Duration of Response (DOR)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- Full Range
- Time frame
- Up to approximately 56 months
What was measured
For participants who demonstrated a confirmed CR or PR per RECIST 1.1, DOR was defined as the time from first documented evidence of a CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions as well as an absolute increase of at least a 5 mm in the sum of diameters. The appearance of one or more new lesions was also considered PD. The DOR per RECIST 1.1 as assessed by BICR is presented for all participants who experienced a confirmed CR or PR.
Analysis population: The analysis population consisted of all participants who received ≥1 dose of study treatment and had confirmed complete response or partial response.
Groups in this outcome
Recurrent or Metastatic Cutaneous cSCC Cohort
Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 doses (approximately 24 months).
Locally Advanced Unresectable cSCC Cohort
Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 doses (approximately 24 months).
| Group | Source count |
|---|---|
| Recurrent or Metastatic Cutaneous cSCC Cohort | 37 |
| Locally Advanced Unresectable cSCC Cohort | 28 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Recurrent or Metastatic Cutaneous cSCC Cohort | 1.6 | Not reported | 1.2 | 24.7 | Not reported |
| Locally Advanced Unresectable cSCC Cohort | 2.7 | Not reported | 1.1 | 12.3 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.2
- upper Limit
- 24.7
- value
- 1.6
- group Id
- OG001
- lower Limit
- 1.1
- upper Limit
- 12.3
- value
- 2.7
- denoms
- counts
- group Id
- OG000
- value
- 37
- group Id
- OG001
- value
- 28
- units
- Participants
- description
- For participants who demonstrated a confirmed CR or PR per RECIST 1.1, DOR was defined as the time from first documented evidence of a CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions as well as an absolute increase of at least a 5 mm in the sum of diameters. The appearance of one or more new lesions was also considered PD. The DOR per RECIST 1.1 as assessed by BICR is presented for all participants who experienced a confirmed CR or PR.
- dispersion Type
- Full Range
- groups
- description
- Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 doses (approximately 24 months).
- id
- OG000
- title
- Recurrent or Metastatic Cutaneous cSCC Cohort
- description
- Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 doses (approximately 24 months).
- id
- OG001
- title
- Locally Advanced Unresectable cSCC Cohort
- param Type
- MEDIAN
- population Description
- The analysis population consisted of all participants who received ≥1 dose of study treatment and had confirmed complete response or partial response.
- reporting Status
- POSTED
- time Frame
- Up to approximately 56 months
- title
- Duration of Response (DOR)
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice