NCT02823574 · OUTCOME
Duration of Response (DOR) - Platinum Refractory Subgroup Based on Tumor Mutation Burden (TMB) Status
Study of Nivolumab in Combination With Ipilimumab Versus Nivolumab in Combination With Ipilimumab Placebo in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck · Source last updated 2023-05-03
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
- From randomization to disease progression or death. Approximately 63 Months
What was measured
The time between the date of first confirmed response to the date of the first documented tumor progression, or death due to any cause, whichever occurs first.
Tumor Mutational Burden (TMB) refers to the number of nonsynonymous somatic mutations that exist within a tumor's genome as measured by the Foundation One CDx panel at Foundation Medicine. The analysis was done on subjects with baseline tumor mutation burden by a cutoff of 7 mutations/megabase (mut/Mb) and 10 mut/Mb
Analysis population: All treated participants in the Platinum Refractory subgroup with a response
Groups in this outcome
Treatment A - Platinum Refractory Subgroup
Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy.
Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
Treatment B - Platinum Refractory Subgroup
Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy.
Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab-Placebo Q6W
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Treatment A - Platinum Refractory Subgroup | 21 |
|---|
| Treatment B - Platinum Refractory Subgroup | 15 |
|---|
Reported measurements
TMB: <7
Analysis denominator · Participants
| Group | Source count |
|---|
| Treatment A - Platinum Refractory Subgroup | 6 |
|---|
| Treatment B - Platinum Refractory Subgroup | 8 |
|---|
Values in Months · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Treatment A - Platinum Refractory Subgroup | NA | Not reported | 11.01 | NA | Insufficient number of events to calculate median and upper limit number. |
|---|
| Treatment B - Platinum Refractory Subgroup | 11.14 | Not reported | 2.69 | NA | Insufficient number of events to calculate upper limit number. |
|---|
TMB ≥ 7
Analysis denominator · Participants
| Group | Source count |
|---|
| Treatment A - Platinum Refractory Subgroup | 10 |
|---|
| Treatment B - Platinum Refractory Subgroup | 4 |
|---|
Values in Months · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Treatment A - Platinum Refractory Subgroup | 38.67 | Not reported | 3.06 | 39.43 | Not reported |
|---|
| Treatment B - Platinum Refractory Subgroup | 8.59 | Not reported | 2.79 | NA | Insufficient number of events to calculate upper limit number. |
|---|
TMB: <10
Analysis denominator · Participants
| Group | Source count |
|---|
| Treatment A - Platinum Refractory Subgroup | 10 |
|---|
| Treatment B - Platinum Refractory Subgroup | 11 |
|---|
Values in Months · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Treatment A - Platinum Refractory Subgroup | NA | Not reported | 3.06 | NA | Insufficient number of events to calculate upper limit number and median |
|---|
| Treatment B - Platinum Refractory Subgroup | 11.14 | Not reported | 4.17 | NA | Insufficient number of events to calculate upper limit number. |
|---|
TMB: ≥ 10
Analysis denominator · Participants
| Group | Source count |
|---|
| Treatment A - Platinum Refractory Subgroup | 6 |
|---|
| Treatment B - Platinum Refractory Subgroup | 2 |
|---|
Values in Months · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Treatment A - Platinum Refractory Subgroup | 38.67 | Not reported | 6.87 | 38.67 | Not reported |
|---|
| Treatment B - Platinum Refractory Subgroup | 7.54 | Not reported | 2.79 | 12.29 | Not reported |
|---|
TMB: Not Reported
Analysis denominator · Participants
| Group | Source count |
|---|
| Treatment A - Platinum Refractory Subgroup | 6 |
|---|
| Treatment B - Platinum Refractory Subgroup | 4 |
|---|
Values in Months · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Treatment A - Platinum Refractory Subgroup | 26.71 | Not reported | 6.93 | 26.71 | Not reported |
|---|
| Treatment B - Platinum Refractory Subgroup | 8.21 | Not reported | 4.14 | 14.29 | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- comment
- Insufficient number of events to calculate median and upper limit number.
- group Id
- OG000
- lower Limit
- 11.01
- upper Limit
- NA
- value
- NA
- comment
- Insufficient number of events to calculate upper limit number.
- group Id
- OG001
- lower Limit
- 2.69
- upper Limit
- NA
- value
- 11.14
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 8
- units
- Participants
- title
- TMB: <7
- categories
- measurements
- group Id
- OG000
- lower Limit
- 3.06
- upper Limit
- 39.43
- value
- 38.67
- comment
- Insufficient number of events to calculate upper limit number.
- group Id
- OG001
- lower Limit
- 2.79
- upper Limit
- NA
- value
- 8.59
- denoms
- counts
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 4
- units
- Participants
- title
- TMB ≥ 7
- categories
- measurements
- comment
- Insufficient number of events to calculate upper limit number and median
- group Id
- OG000
- lower Limit
- 3.06
- upper Limit
- NA
- value
- NA
- comment
- Insufficient number of events to calculate upper limit number.
- group Id
- OG001
- lower Limit
- 4.17
- upper Limit
- NA
- value
- 11.14
- denoms
- counts
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 11
- units
- Participants
- title
- TMB: <10
- categories
- measurements
- group Id
- OG000
- lower Limit
- 6.87
- upper Limit
- 38.67
- value
- 38.67
- group Id
- OG001
- lower Limit
- 2.79
- upper Limit
- 12.29
- value
- 7.54
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 2
- units
- Participants
- title
- TMB: ≥ 10
- categories
- measurements
- group Id
- OG000
- lower Limit
- 6.93
- upper Limit
- 26.71
- value
- 26.71
- group Id
- OG001
- lower Limit
- 4.14
- upper Limit
- 14.29
- value
- 8.21
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 4
- units
- Participants
- title
- TMB: Not Reported
- denoms
- counts
- group Id
- OG000
- value
- 21
- group Id
- OG001
- value
- 15
- units
- Participants
- description
- The time between the date of first confirmed response to the date of the first documented tumor progression, or death due to any cause, whichever occurs first.
Tumor Mutational Burden (TMB) refers to the number of nonsynonymous somatic mutations that exist within a tumor's genome as measured by the Foundation One CDx panel at Foundation Medicine. The analysis was done on subjects with baseline tumor mutation burden by a cutoff of 7 mutations/megabase (mut/Mb) and 10 mut/Mb
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy.
Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
- id
- OG000
- title
- Treatment A - Platinum Refractory Subgroup
- description
- Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy.
Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab-Placebo Q6W
- id
- OG001
- title
- Treatment B - Platinum Refractory Subgroup
- param Type
- MEDIAN
- population Description
- All treated participants in the Platinum Refractory subgroup with a response
- reporting Status
- POSTED
- time Frame
- From randomization to disease progression or death. Approximately 63 Months
- title
- Duration of Response (DOR) - Platinum Refractory Subgroup Based on Tumor Mutation Burden (TMB) Status
- type
- SECONDARY
- unit Of Measure
- Months
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