TriangleNCT03194867 · OUTCOME
Phase 2: Overall Survival (OS)
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
- From Cycle 1 Day 1 up to primary analysis completion date of 9 Oct 2019 i.e., up to approximately 17 months
What was measured
OS was defined as the time interval from the date of randomization to death from any cause. Participants without death prior to the analysis cut-off date were censored at the last date the participant was known to be alive or the cut-off date, whichever came first. The results provided below corresponds to descriptive OS information at the time of primary analysis completion date of 09 October 2019.
Analysis population: The Randomized population consisted of all participants from Phase 2 who gave their informed consent and were assigned a randomization number by the IRT, regardless of whether participants received any study treatment or received a different study treatment from which they were randomized.
Groups in this outcome
Phase 2: Isatuximab
Participants received isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason.
Phase 2: Isatuximab + CemiplimabQ2W
Participants received isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) and cemiplimab 250 mg IV infusion Q2W (on Days 1 and 15 every cycle of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason.
Phase 2: Isatuximab + CemiplimabQ4W
Participants isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) and cemiplimab 250 mg IV infusion Q4W (on Day 1 every cycle of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason.
| Group | Source count |
|---|---|
| Phase 2: Isatuximab | 34 |
| Phase 2: Isatuximab + CemiplimabQ2W | 36 |
| Phase 2: Isatuximab + CemiplimabQ4W | 36 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2: Isatuximab | NA | Not reported | 7.622 | NA | NA indicates due to the limited follow-up time, most of participants were still alive, so the median OS and upper limit of confidence interval (CI) was not reached. |
| Phase 2: Isatuximab + CemiplimabQ2W | NA | Not reported | 6.801 | NA | NA indicates due to the limited follow-up time, most of participants were still alive, so the median OS and upper limit of CI was not reached. |
| Phase 2: Isatuximab + CemiplimabQ4W | 12.78 | Not reported | 7.392 | NA | NA indicates due to the limited follow-up time, most of participants were still alive, so upper limit of CI was not reached. |
Complete source fields
- classes
- categories
- measurements
- comment
- NA indicates due to the limited follow-up time, most of participants were still alive, so the median OS and upper limit of confidence interval (CI) was not reached.
- group Id
- OG000
- lower Limit
- 7.622
- upper Limit
- NA
- value
- NA
- comment
- NA indicates due to the limited follow-up time, most of participants were still alive, so the median OS and upper limit of CI was not reached.
- group Id
- OG001
- lower Limit
- 6.801
- upper Limit
- NA
- value
- NA
- comment
- NA indicates due to the limited follow-up time, most of participants were still alive, so upper limit of CI was not reached.
- group Id
- OG002
- lower Limit
- 7.392
- upper Limit
- NA
- value
- 12.78
- denoms
- counts
- group Id
- OG000
- value
- 34
- group Id
- OG001
- value
- 36
- group Id
- OG002
- value
- 36
- units
- Participants
- description
- OS was defined as the time interval from the date of randomization to death from any cause. Participants without death prior to the analysis cut-off date were censored at the last date the participant was known to be alive or the cut-off date, whichever came first. The results provided below corresponds to descriptive OS information at the time of primary analysis completion date of 09 October 2019.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason.
- id
- OG000
- title
- Phase 2: Isatuximab
- description
- Participants received isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) and cemiplimab 250 mg IV infusion Q2W (on Days 1 and 15 every cycle of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason.
- id
- OG001
- title
- Phase 2: Isatuximab + CemiplimabQ2W
- description
- Participants isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) and cemiplimab 250 mg IV infusion Q4W (on Day 1 every cycle of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason.
- id
- OG002
- title
- Phase 2: Isatuximab + CemiplimabQ4W
- param Type
- MEDIAN
- population Description
- The Randomized population consisted of all participants from Phase 2 who gave their informed consent and were assigned a randomization number by the IRT, regardless of whether participants received any study treatment or received a different study treatment from which they were randomized.
- reporting Status
- POSTED
- time Frame
- From Cycle 1 Day 1 up to primary analysis completion date of 9 Oct 2019 i.e., up to approximately 17 months
- title
- Phase 2: Overall Survival (OS)
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice