TriangleNCT04590963 · OUTCOME
Overall Survival in Full Analysis Set (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
- 95% Confidence Interval
- Time frame
- Baseline (-28 to -1) through 17.5 months (maximum observed duration)
What was measured
The OS is defined as time from the date of randomization until death due to any cause regardless of whether the participant withdraws from randomized therapy or receives another anti-cancer therapy (i.e. date of death or censoring - date of randomization + 1). The OS was analyzed using Kaplan-Meier technique. Statistical analysis was performed using P-value from a stratified log-rank test and HR and CIs from a stratified Cox proportional hazards model. Analyses were stratified on HPV status (OPC HPV positive or HPV-unrelated), WHO/ECOG PS (0 or 1) and number of prior lines of therapy in R/M setting (1 or 2).
Analysis population: The FAS included all participants randomized at least 2 months before the DCO 11May2022 (i.e. on or before 11Mar2022).
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 | 175 |
| Placebo Q2W + Cetuximab 400 mg/m^2 | 89 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2 | 8.8 | Not reported | 6.9 | 10.8 | Not reported |
| Placebo Q2W + Cetuximab 400 mg/m^2 | 8.9 | Not reported | 6.0 | 15.1 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.704
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.528
- estimate Comment
- HR and CIs were calculated using a stratified Cox proportional hazards model, adjusted for HPV status, WHO/ECOG PS, and number of lines of prior therapy in R/M setting.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.891
- param Type
- Hazard Ratio (HR)
- param Value
- 1.03
- statistical Comment
- P-value was calculated using stratified log-rank test, adjusted for HPV status, WHO/ECOG PS (0/1) and number of prior lines of therapy in R/M setting.
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.704
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.528
- estimate Comment
- HR and CIs were calculated using a stratified Cox proportional hazards model, adjusted for HPV status, WHO/ECOG PS, and number of lines of prior therapy in R/M setting.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.891
- param Type
- Hazard Ratio (HR)
- param Value
- 1.03
- statistical Comment
- P-value was calculated using stratified log-rank test, adjusted for HPV status, WHO/ECOG PS (0/1) and number of prior lines of therapy in R/M setting.
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 6.9
- upper Limit
- 10.8
- value
- 8.8
- group Id
- OG001
- lower Limit
- 6.0
- upper Limit
- 15.1
- value
- 8.9
- denoms
- counts
- group Id
- OG000
- value
- 175
- group Id
- OG001
- value
- 89
- units
- Participants
- description
- The OS is defined as time from the date of randomization until death due to any cause regardless of whether the participant withdraws from randomized therapy or receives another anti-cancer therapy (i.e. date of death or censoring - date of randomization + 1). The OS was analyzed using Kaplan-Meier technique. Statistical analysis was performed using P-value from a stratified log-rank test and HR and CIs from a stratified Cox proportional hazards model. Analyses were stratified on HPV status (OPC HPV positive or HPV-unrelated), WHO/ECOG PS (0 or 1) and number of prior lines of therapy in R/M setting (1 or 2).
- dispersion Type
- 95% Confidence Interval
- 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).
- reporting Status
- POSTED
- time Frame
- Baseline (-28 to -1) through 17.5 months (maximum observed duration)
- title
- Overall Survival in Full Analysis Set (FAS)
- type
- SECONDARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice