TriangleNCT02760498 · OUTCOME
Overall Response Rate (ORR) by Independent Central Review
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 108 weeks
What was measured
ORR was defined as percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR). For participants with metastatic disease, Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 was used to determine BOR. For participants with unresectable locally advanced disease, clinical response criteria were used. RECIST v1.1 Criteria: -CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimeter (mm) \<1 (centimeter (cm). -PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Clinical Response Criteria: -CR: All target and nontarget lesion(s) no longer visible, maintained for at least 4 weeks and no new lesions. -PR: Decrease of at least 50% in the sum the products of perpendicular longest dimensions of target lesion(s), maintained for at least 4 weeks and no new lesions.
Analysis population: The Full Analysis Set (FAS) included all enrolled participants. Only Groups 1, 2, 3, 4, and 6 were planned for this analysis.
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 | 59 |
| Group 2 (Participants With laCSCC): Cemiplimab 3 mg/kg IV Q2W | 78 |
| Group 3 (Participants With mCSCC): Cemiplimab 350 mg IV Q3W | 56 |
| Group 4 (Participants With mCSCC and laCSCC): Cemiplimab 600 mg IV Q4W | 63 |
| Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W | 167 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Group 1 (Participants With mCSCC): Cemiplimab 3 mg/kg IV Q2W | 50.8 | Not reported | 37.5 | 64.1 | Not reported |
| Group 2 (Participants With laCSCC): Cemiplimab 3 mg/kg IV Q2W | 44.9 | Not reported | 33.6 | 56.6 | Not reported |
| Group 3 (Participants With mCSCC): Cemiplimab 350 mg IV Q3W | 46.4 | Not reported | 33.0 | 60.3 | Not reported |
| Group 4 (Participants With mCSCC and laCSCC): Cemiplimab 600 mg IV Q4W | 61.9 | Not reported | 48.8 | 73.9 | Not reported |
| Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W | 47.3 | Not reported | 39.5 | 55.2 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 37.5
- upper Limit
- 64.1
- value
- 50.8
- group Id
- OG001
- lower Limit
- 33.6
- upper Limit
- 56.6
- value
- 44.9
- group Id
- OG002
- lower Limit
- 33.0
- upper Limit
- 60.3
- value
- 46.4
- group Id
- OG003
- lower Limit
- 48.8
- upper Limit
- 73.9
- value
- 61.9
- group Id
- OG004
- lower Limit
- 39.5
- upper Limit
- 55.2
- value
- 47.3
- denoms
- counts
- group Id
- OG000
- value
- 59
- group Id
- OG001
- value
- 78
- group Id
- OG002
- value
- 56
- group Id
- OG003
- value
- 63
- group Id
- OG004
- value
- 167
- units
- Participants
- description
- ORR was defined as percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR). For participants with metastatic disease, Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 was used to determine BOR. For participants with unresectable locally advanced disease, clinical response criteria were used. RECIST v1.1 Criteria: -CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimeter (mm) \<1 (centimeter (cm). -PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Clinical Response Criteria: -CR: All target and nontarget lesion(s) no longer visible, maintained for at least 4 weeks and no new lesions. -PR: Decrease of at least 50% in the sum the products of perpendicular longest dimensions of target lesion(s), maintained for at least 4 weeks and no 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
- NUMBER
- population Description
- The Full Analysis Set (FAS) included all enrolled participants. Only Groups 1, 2, 3, 4, and 6 were planned for this analysis.
- reporting Status
- POSTED
- time Frame
- Up to 108 weeks
- title
- Overall Response Rate (ORR) by Independent Central Review
- type
- PRIMARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice