TriangleNCT04590963 · OUTCOME
Duration of Response Per RECIST 1.1 in FAS
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- Inter-Quartile Range
- Time frame
- Baseline (-28 to -1) through 17.5 months (maximum observed duration)
What was measured
The DoR is defined as the time from the date of first documented confirmed response until date of documented progression or death in the absence of disease progression (i.e. date of PFS event or censoring - date of first response + 1). The CR is defined as disappearance of all target and non-target lesions, no new lesions, and normalization of tumor marker level. The PR is defined as at least a 30% decrease in the SoDs of TLs (compared to baseline) and no new lesions. Confirmation of CR and PR is required by a repeat, consecutive assessment no less than 4 weeks from the date of first documentation. The PD is defined as at least a 20% increase in the SoDs of TLs, taking as reference the smallest previous SoDs (nadir) and the sum must demonstrate an absolute increase of at least 5 mm from nadir or unequivocal progression of existing NTLs or appearance of new lesions. The DoR was analyzed using Kaplan-Meier technique.
Analysis population: The FAS included all participants randomized at least 2 months before the DCO 11May2022 (i.e. on or before 11Mar2022). The DoR is assessed for only those participants who had OR.
Groups in this outcome
Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2
Participants received IV monalizumab 750 mg Q2W and IV cetuximab 400 mg/m\^2 initial dose followed by 250 mg/m\^2 Q1W until disease progression, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
Placebo Q2W + Cetuximab 400 mg/m^2
Participants receieved IV placebo matched to monalizumab Q2W and IV cetuximab 400 mg/m\^2 initial dose followed by 250 mg/m\^2 Q1W until disease progression, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
| Group | Source count |
|---|---|
| Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2 | 23 |
| Placebo Q2W + Cetuximab 400 mg/m^2 | 17 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2 | 5.7 | Not reported | 5.3 | 8.1 | Not reported |
| Placebo Q2W + Cetuximab 400 mg/m^2 | 5.6 | Not reported | 4.4 | NA | The upper limit of 75th percentile was not reached because there were not enough responders who subsequently progressed or died in this treatment group. |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 5.3
- upper Limit
- 8.1
- value
- 5.7
- comment
- The upper limit of 75th percentile was not reached because there were not enough responders who subsequently progressed or died in this treatment group.
- group Id
- OG001
- lower Limit
- 4.4
- upper Limit
- NA
- value
- 5.6
- denoms
- counts
- group Id
- OG000
- value
- 23
- group Id
- OG001
- value
- 17
- units
- Participants
- description
- The DoR is defined as the time from the date of first documented confirmed response until date of documented progression or death in the absence of disease progression (i.e. date of PFS event or censoring - date of first response + 1). The CR is defined as disappearance of all target and non-target lesions, no new lesions, and normalization of tumor marker level. The PR is defined as at least a 30% decrease in the SoDs of TLs (compared to baseline) and no new lesions. Confirmation of CR and PR is required by a repeat, consecutive assessment no less than 4 weeks from the date of first documentation. The PD is defined as at least a 20% increase in the SoDs of TLs, taking as reference the smallest previous SoDs (nadir) and the sum must demonstrate an absolute increase of at least 5 mm from nadir or unequivocal progression of existing NTLs or appearance of new lesions. The DoR was analyzed using Kaplan-Meier technique.
- dispersion Type
- Inter-Quartile Range
- groups
- description
- Participants received IV monalizumab 750 mg Q2W and IV cetuximab 400 mg/m\^2 initial dose followed by 250 mg/m\^2 Q1W until disease progression, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
- id
- OG000
- title
- Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2
- description
- Participants receieved IV placebo matched to monalizumab Q2W and IV cetuximab 400 mg/m\^2 initial dose followed by 250 mg/m\^2 Q1W until disease progression, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
- id
- OG001
- title
- Placebo Q2W + Cetuximab 400 mg/m^2
- param Type
- MEDIAN
- population Description
- The FAS included all participants randomized at least 2 months before the DCO 11May2022 (i.e. on or before 11Mar2022). The DoR is assessed for only those participants who had OR.
- reporting Status
- POSTED
- time Frame
- Baseline (-28 to -1) through 17.5 months (maximum observed duration)
- title
- Duration of Response Per RECIST 1.1 in FAS
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice