NCT03409614 · OUTCOME
Part 1: Best Overall Response (BOR) Per IRC
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
- Up to 32 months
What was measured
BOR was defined as the best overall response as determined by the IRC per RECIST 1.1, between the date of randomization and the date of first documented tumor progression or the date of subsequent anti-cancer therapy, whichever occurred earlier.
Analysis population: Part 1 participants only
Groups in this outcome
Part 1: Cemiplimab + Chemotherapy
Participants received cemiplimab plus platinum-based doublet chemotherapy
Part 1: Cemiplimab+AbbrevChemo+Ipilimumab
Participants received cemiplimab plus platinum-based doublet chemotherapy and ipilimumab
Part 1: Chemotherapy
Participants received platinum-based doublet chemotherapy
| Group | Source count |
|---|---|
| Part 1: Cemiplimab + Chemotherapy | 108 |
| Part 1: Cemiplimab+AbbrevChemo+Ipilimumab | 109 |
| Part 1: Chemotherapy | 106 |
Reported measurements
Source class 1
Complete Response (CR)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: Cemiplimab + Chemotherapy | 3 | Not reported | Not reported | Not reported | Not reported |
| Part 1: Cemiplimab+AbbrevChemo+Ipilimumab | 5 | Not reported | Not reported | Not reported | Not reported |
| Part 1: Chemotherapy | 2 | Not reported | Not reported | Not reported | Not reported |
Partial Response (PR)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: Cemiplimab + Chemotherapy | 41 | Not reported | Not reported | Not reported | Not reported |
| Part 1: Cemiplimab+AbbrevChemo+Ipilimumab | 35 | Not reported | Not reported | Not reported | Not reported |
| Part 1: Chemotherapy | 28 | Not reported | Not reported | Not reported | Not reported |
Stable Disease (SD)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: Cemiplimab + Chemotherapy | 41 | Not reported | Not reported | Not reported | Not reported |
| Part 1: Cemiplimab+AbbrevChemo+Ipilimumab | 44 | Not reported | Not reported | Not reported | Not reported |
| Part 1: Chemotherapy | 51 | Not reported | Not reported | Not reported | Not reported |
Progressive Disease (PD)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: Cemiplimab + Chemotherapy | 4 | Not reported | Not reported | Not reported | Not reported |
| Part 1: Cemiplimab+AbbrevChemo+Ipilimumab | 15 | Not reported | Not reported | Not reported | Not reported |
| Part 1: Chemotherapy | 8 | Not reported | Not reported | Not reported | Not reported |
Non-CR / Non-PD
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: Cemiplimab + Chemotherapy | 3 | Not reported | Not reported | Not reported | Not reported |
| Part 1: Cemiplimab+AbbrevChemo+Ipilimumab | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: Chemotherapy | 1 | Not reported | Not reported | Not reported | Not reported |
Not Evaluable (NE)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: Cemiplimab + Chemotherapy | 16 | Not reported | Not reported | Not reported | Not reported |
| Part 1: Cemiplimab+AbbrevChemo+Ipilimumab | 10 | Not reported | Not reported | Not reported | Not reported |
| Part 1: Chemotherapy | 16 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 2
- title
- Complete Response (CR)
- measurements
- group Id
- OG000
- value
- 41
- group Id
- OG001
- value
- 35
- group Id
- OG002
- value
- 28
- title
- Partial Response (PR)
- measurements
- group Id
- OG000
- value
- 41
- group Id
- OG001
- value
- 44
- group Id
- OG002
- value
- 51
- title
- Stable Disease (SD)
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 15
- group Id
- OG002
- value
- 8
- title
- Progressive Disease (PD)
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- title
- Non-CR / Non-PD
- measurements
- group Id
- OG000
- value
- 16
- group Id
- OG001
- value
- 10
- group Id
- OG002
- value
- 16
- title
- Not Evaluable (NE)
- denoms
- counts
- group Id
- OG000
- value
- 108
- group Id
- OG001
- value
- 109
- group Id
- OG002
- value
- 106
- units
- Participants
- description
- BOR was defined as the best overall response as determined by the IRC per RECIST 1.1, between the date of randomization and the date of first documented tumor progression or the date of subsequent anti-cancer therapy, whichever occurred earlier.
- groups
- description
- Participants received cemiplimab plus platinum-based doublet chemotherapy
- id
- OG000
- title
- Part 1: Cemiplimab + Chemotherapy
- description
- Participants received cemiplimab plus platinum-based doublet chemotherapy and ipilimumab
- id
- OG001
- title
- Part 1: Cemiplimab+AbbrevChemo+Ipilimumab
- description
- Participants received platinum-based doublet chemotherapy
- id
- OG002
- title
- Part 1: Chemotherapy
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Part 1 participants only
- reporting Status
- POSTED
- time Frame
- Up to 32 months
- title
- Part 1: Best Overall Response (BOR) Per IRC
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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