TriangleNCT03194867 · OUTCOME
Phase 1 and 2: Number of Participants With ADA to Cemiplimab
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- From Cycle 1 Day 1 up to primary analysis completion date of 9 Oct 2019 i.e., up to approximately 20 months
What was measured
ADA responses were categorized as treatment-induced ADA and treatment boosted ADA. Pre-existing ADA was defined as ADA that were present in samples drawn during the pre-treatment period. Treatment-induced ADA was defined as ADA that developed at any time during the ADA on-study observation period in participants without pre-existing ADA. Treatment boosted ADA was defined as pre-existing ADAs with a significant increase in the ADA titer during the study compared to the Baseline titer.
Analysis population: Analysis was performed on the ADA evaluable population. "Isatuximab + CemiplimabQ2W" arm includes 3 and 36 participants from phase 1 and phase 2, respectively. Same dose of isatuximab was administered to all participants in phase 1 and phase 2 part of study in Isatuximab + Cemiplimab Q2W arms. Hence analysis was combined for phase 1 and phase 2 Isatuximab + Cemiplimab Q2W arms.
Groups in this outcome
Phase 1 and 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 1 and 2: Isatuximab + CemiplimabQ2W | 39 |
| Phase 2: Isatuximab + CemiplimabQ4W | 34 |
Reported measurements
Pre-existing ADA
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1 and 2: Isatuximab + CemiplimabQ2W | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase 2: Isatuximab + CemiplimabQ4W | 0 | Not reported | Not reported | Not reported | Not reported |
Treatment-induced
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1 and 2: Isatuximab + CemiplimabQ2W | 2 | Not reported | Not reported | Not reported | Not reported |
| Phase 2: Isatuximab + CemiplimabQ4W | 0 | Not reported | Not reported | Not reported | Not reported |
Treatment boosted
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1 and 2: Isatuximab + CemiplimabQ2W | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 2: Isatuximab + CemiplimabQ4W | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- calculate Pct
- false
- classes
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- title
- Pre-existing ADA
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 0
- title
- Treatment-induced
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- Treatment boosted
- denoms
- counts
- group Id
- OG000
- value
- 39
- group Id
- OG001
- value
- 34
- units
- Participants
- description
- ADA responses were categorized as treatment-induced ADA and treatment boosted ADA. Pre-existing ADA was defined as ADA that were present in samples drawn during the pre-treatment period. Treatment-induced ADA was defined as ADA that developed at any time during the ADA on-study observation period in participants without pre-existing ADA. Treatment boosted ADA was defined as pre-existing ADAs with a significant increase in the ADA titer during the study compared to the Baseline titer.
- 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) 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
- OG000
- title
- Phase 1 and 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
- OG001
- title
- Phase 2: Isatuximab + CemiplimabQ4W
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Analysis was performed on the ADA evaluable population. "Isatuximab + CemiplimabQ2W" arm includes 3 and 36 participants from phase 1 and phase 2, respectively. Same dose of isatuximab was administered to all participants in phase 1 and phase 2 part of study in Isatuximab + Cemiplimab Q2W arms. Hence analysis was combined for phase 1 and phase 2 Isatuximab + Cemiplimab Q2W arms.
- 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 20 months
- title
- Phase 1 and 2: Number of Participants With ADA to Cemiplimab
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice