TriangleNCT02760498 · OUTCOME
DOR by Investigator Assessment
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Up to approximately 65 months (treatment period + follow-up including survival follow-up)
What was measured
DOR was measured from the time measurement criteria were first met for CR/PR, as defined in Outcome Measure 1, whichever was recorded first, until the first date of recurrent or Progressive Disease (PD) or death due to any cause in participants with BOR of CR or PR. For participants with metastatic disease, RECIST v1.1 was used to determine BOR. For participants with unresectable locally advanced disease, clinical response criteria were used. RECIST v1.1 Criteria: -PD: At least a 20% increase in the sum of the diameters of target lesions with the sum demonstrating an absolute increase of at least 5 mm (0.5 cm), or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Clinical Response Criteria: -PD: increase of ≥ 25% (World Health Organization (WHO) criteria) in the sum of the products of perpendicular longest dimensions of target lesion(s) and/or the appearance of new lesions.
Analysis population: The FAS included all enrolled participants. Here, 'Overall number of participants analyzed' signifies participants with confirmed CR or PR that are evaluable for this outcome measure. Only Groups 1, 2, 3, 4, and 6 were planned for this outcome measure.
Groups in this outcome
Group 1 (Participants With mCSCC): Cemiplimab 3 mg/kg IV Q2W
Participants received cemiplimab 3 milligrams (mg)/kilogram (kg) intravenously (IV) every 2 weeks (Q2W) during each 8-week treatment cycle, for up to 96 weeks (12 cycles).
Group 2 (Participants With laCSCC): Cemiplimab 3 mg/kg IV Q2W
Participants received cemiplimab 3 mg/kg IV Q2W during each 8-week treatment cycle, for up to 96 weeks (12 cycles).
Group 3 (Participants With mCSCC): Cemiplimab 350 mg IV Q3W
Participants received cemiplimab 350 mg IV every 3 weeks (Q3W) during each 9-week treatment cycle, for up to 54 weeks (6 cycles).
Group 4 (Participants With mCSCC and laCSCC): Cemiplimab 600 mg IV Q4W
Participants received cemiplimab 600 mg IV every 4 weeks (Q4W) during each 8-week treatment cycle, for up to 48 weeks (6 cycles).
Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W
Participants received cemiplimab 350 mg IV Q3W during each 9-week treatment cycle, for up to 108 weeks (12 cycles).
| Group | Source count |
|---|---|
| Group 1 (Participants With mCSCC): Cemiplimab 3 mg/kg IV Q2W | 30 |
| Group 2 (Participants With laCSCC): Cemiplimab 3 mg/kg IV Q2W | 44 |
| Group 3 (Participants With mCSCC): Cemiplimab 350 mg IV Q3W | 31 |
| Group 4 (Participants With mCSCC and laCSCC): Cemiplimab 600 mg IV Q4W | 40 |
| Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W | 88 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Group 1 (Participants With mCSCC): Cemiplimab 3 mg/kg IV Q2W | NA | Not reported | 30.7 | NA | Not reached due to insufficient number of events |
| Group 2 (Participants With laCSCC): Cemiplimab 3 mg/kg IV Q2W | 41.9 | Not reported | NA | NA | Not reached due to insufficient number of events |
| Group 3 (Participants With mCSCC): Cemiplimab 350 mg IV Q3W | 44.2 | Not reported | 25.4 | 44.2 | Not reported |
| Group 4 (Participants With mCSCC and laCSCC): Cemiplimab 600 mg IV Q4W | NA | Not reported | 27.1 | NA | Not reached due to insufficient number of events |
| Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W | NA | Not reported | 29.5 | NA | Not reached due to insufficient number of events |
Complete source fields
- classes
- categories
- measurements
- comment
- Not reached due to insufficient number of events
- group Id
- OG000
- lower Limit
- 30.7
- upper Limit
- NA
- value
- NA
- comment
- Not reached due to insufficient number of events
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- 41.9
- group Id
- OG002
- lower Limit
- 25.4
- upper Limit
- 44.2
- value
- 44.2
- comment
- Not reached due to insufficient number of events
- group Id
- OG003
- lower Limit
- 27.1
- upper Limit
- NA
- value
- NA
- comment
- Not reached due to insufficient number of events
- group Id
- OG004
- lower Limit
- 29.5
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 30
- group Id
- OG001
- value
- 44
- group Id
- OG002
- value
- 31
- group Id
- OG003
- value
- 40
- group Id
- OG004
- value
- 88
- units
- Participants
- description
- DOR was measured from the time measurement criteria were first met for CR/PR, as defined in Outcome Measure 1, whichever was recorded first, until the first date of recurrent or Progressive Disease (PD) or death due to any cause in participants with BOR of CR or PR. For participants with metastatic disease, RECIST v1.1 was used to determine BOR. For participants with unresectable locally advanced disease, clinical response criteria were used. RECIST v1.1 Criteria: -PD: At least a 20% increase in the sum of the diameters of target lesions with the sum demonstrating an absolute increase of at least 5 mm (0.5 cm), or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Clinical Response Criteria: -PD: increase of ≥ 25% (World Health Organization (WHO) criteria) in the sum of the products of perpendicular longest dimensions of target lesion(s) and/or the appearance of new lesions.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received cemiplimab 3 milligrams (mg)/kilogram (kg) intravenously (IV) every 2 weeks (Q2W) during each 8-week treatment cycle, for up to 96 weeks (12 cycles).
- id
- OG000
- title
- Group 1 (Participants With mCSCC): Cemiplimab 3 mg/kg IV Q2W
- description
- Participants received cemiplimab 3 mg/kg IV Q2W during each 8-week treatment cycle, for up to 96 weeks (12 cycles).
- id
- OG001
- title
- Group 2 (Participants With laCSCC): Cemiplimab 3 mg/kg IV Q2W
- description
- Participants received cemiplimab 350 mg IV every 3 weeks (Q3W) during each 9-week treatment cycle, for up to 54 weeks (6 cycles).
- id
- OG002
- title
- Group 3 (Participants With mCSCC): Cemiplimab 350 mg IV Q3W
- description
- Participants received cemiplimab 600 mg IV every 4 weeks (Q4W) during each 8-week treatment cycle, for up to 48 weeks (6 cycles).
- id
- OG003
- title
- Group 4 (Participants With mCSCC and laCSCC): Cemiplimab 600 mg IV Q4W
- description
- Participants received cemiplimab 350 mg IV Q3W during each 9-week treatment cycle, for up to 108 weeks (12 cycles).
- id
- OG004
- title
- Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W
- param Type
- MEDIAN
- population Description
- The FAS included all enrolled participants. Here, 'Overall number of participants analyzed' signifies participants with confirmed CR or PR that are evaluable for this outcome measure. Only Groups 1, 2, 3, 4, and 6 were planned for this outcome measure.
- reporting Status
- POSTED
- time Frame
- Up to approximately 65 months (treatment period + follow-up including survival follow-up)
- title
- DOR by Investigator Assessment
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice