TriangleNCT04590963 · OUTCOME
Overall Survival (OS) in Human Papillomavirus (HPV)-Unrelated Analysis Set
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 hazard ratio (HR) and confidence intervals (CIs) from a stratified Cox proportional hazards model. Analyses were stratified on World Health Organization/ Eastern Cooperative Oncology Group performance status (WHO/ECOG PS) (0 or 1) and number of prior lines of therapy in recurrent or metastatic (R/M) setting (1 or 2).
Analysis population: The HPV-unrelated analysis set included all participants who were randomized at least 2 months before the 11May2022 DCO (i.e. on or before 11Mar2022) and were either oropharyngeal cancer (OPC) HPV negative or non OPC regardless of the HPV status.
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 | 145 |
| Placebo Q2W + Cetuximab 400 mg/m^2 | 71 |
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 | 10.4 | Not reported |
| Placebo Q2W + Cetuximab 400 mg/m^2 | 8.6 | Not reported | 6.0 | 14.5 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.660
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.537
- estimate Comment
- HR and CIs were calculated using a stratified Cox proportional hazards model, adjusted for WHO/ECOG PS, and number of lines of prior therapy in R/M setting.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.989
- param Type
- Hazard Ratio (HR)
- param Value
- 1.00
- statistical Comment
- P-value was calculated using stratified log-rank test, adjusted for 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
- 0.660
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.537
- estimate Comment
- HR and CIs were calculated using a stratified Cox proportional hazards model, adjusted for WHO/ECOG PS, and number of lines of prior therapy in R/M setting.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.989
- param Type
- Hazard Ratio (HR)
- param Value
- 1.00
- statistical Comment
- P-value was calculated using stratified log-rank test, adjusted for 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
- 10.4
- value
- 8.8
- group Id
- OG001
- lower Limit
- 6.0
- upper Limit
- 14.5
- value
- 8.6
- denoms
- counts
- group Id
- OG000
- value
- 145
- group Id
- OG001
- value
- 71
- 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 hazard ratio (HR) and confidence intervals (CIs) from a stratified Cox proportional hazards model. Analyses were stratified on World Health Organization/ Eastern Cooperative Oncology Group performance status (WHO/ECOG PS) (0 or 1) and number of prior lines of therapy in recurrent or metastatic (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 HPV-unrelated analysis set included all participants who were randomized at least 2 months before the 11May2022 DCO (i.e. on or before 11Mar2022) and were either oropharyngeal cancer (OPC) HPV negative or non OPC regardless of the HPV status.
- reporting Status
- POSTED
- time Frame
- Baseline (-28 to -1) through 17.5 months (maximum observed duration)
- title
- Overall Survival (OS) in Human Papillomavirus (HPV)-Unrelated Analysis Set
- type
- PRIMARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice