NCT02823574 · OUTCOME
Duration of Response (DOR) - Platinum Eligible 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.
Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
Analysis population: All treated participants in the Platinum eligible subgroup with a response
Groups in this outcome
Treatment A - Platinum Eligible Subgroup
Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) who are platinum naive or have recurred 6 months or more after completion of previous platinum-based chemotherapy.
Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W
Treatment B - Platinum Eligible Subgroup
Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) who are platinum naive or have recurred 6 months or more 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 Eligible Subgroup | 25 |
|---|
| Treatment B - Platinum Eligible Subgroup | 18 |
|---|
Reported measurements
TMB: <7
Analysis denominator · Participants
| Group | Source count |
|---|
| Treatment A - Platinum Eligible Subgroup | 6 |
|---|
| Treatment B - Platinum Eligible Subgroup | 8 |
|---|
Values in Months · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Treatment A - Platinum Eligible Subgroup | 10.97 | Not reported | 4.14 | 35.55 | Not reported |
|---|
| Treatment B - Platinum Eligible Subgroup | NA | Not reported | 5.52 | NA | Insufficient number of events to calculate upper limit number and median |
|---|
TMB ≥ 7
Analysis denominator · Participants
| Group | Source count |
|---|
| Treatment A - Platinum Eligible Subgroup | 13 |
|---|
| Treatment B - Platinum Eligible Subgroup | 6 |
|---|
Values in Months · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Treatment A - Platinum Eligible Subgroup | 24.11 | Not reported | 10.97 | NA | Insufficient number of events to calculate upper limit number. |
|---|
| Treatment B - Platinum Eligible Subgroup | 19.32 | Not reported | 5.49 | 24.61 | Not reported |
|---|
TMB: <10
Analysis denominator · Participants
| Group | Source count |
|---|
| Treatment A - Platinum Eligible Subgroup | 14 |
|---|
| Treatment B - Platinum Eligible Subgroup | 10 |
|---|
Values in Months · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Treatment A - Platinum Eligible Subgroup | 13.67 | Not reported | 8.28 | 35.55 | Not reported |
|---|
| Treatment B - Platinum Eligible Subgroup | NA | Not reported | 5.52 | NA | Insufficient number of events to calculate upper limit number and median |
|---|
TMB: ≥ 10
Analysis denominator · Participants
| Group | Source count |
|---|
| Treatment A - Platinum Eligible Subgroup | 5 |
|---|
| Treatment B - Platinum Eligible Subgroup | 4 |
|---|
Values in Months · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Treatment A - Platinum Eligible Subgroup | NA | Not reported | 5.78 | NA | Insufficient number of events to calculate upper limit number and median |
|---|
| Treatment B - Platinum Eligible Subgroup | 19.32 | Not reported | 5.49 | 24.61 | Not reported |
|---|
TMB: Not Reported
Analysis denominator · Participants
| Group | Source count |
|---|
| Treatment A - Platinum Eligible Subgroup | 6 |
|---|
| Treatment B - Platinum Eligible Subgroup | 4 |
|---|
Values in Months · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Treatment A - Platinum Eligible Subgroup | NA | Not reported | 27.04 | NA | Insufficient number of events to calculate upper limit number and median. |
|---|
| Treatment B - Platinum Eligible Subgroup | 48.49 | Not reported | 4.11 | NA | Insufficient number of events to calculate upper limit number. |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 4.14
- upper Limit
- 35.55
- value
- 10.97
- comment
- Insufficient number of events to calculate upper limit number and median
- group Id
- OG001
- lower Limit
- 5.52
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 8
- units
- Participants
- title
- TMB: <7
- categories
- measurements
- comment
- Insufficient number of events to calculate upper limit number.
- group Id
- OG000
- lower Limit
- 10.97
- upper Limit
- NA
- value
- 24.11
- group Id
- OG001
- lower Limit
- 5.49
- upper Limit
- 24.61
- value
- 19.32
- denoms
- counts
- group Id
- OG000
- value
- 13
- group Id
- OG001
- value
- 6
- units
- Participants
- title
- TMB ≥ 7
- categories
- measurements
- group Id
- OG000
- lower Limit
- 8.28
- upper Limit
- 35.55
- value
- 13.67
- comment
- Insufficient number of events to calculate upper limit number and median
- group Id
- OG001
- lower Limit
- 5.52
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 14
- group Id
- OG001
- value
- 10
- units
- Participants
- title
- TMB: <10
- categories
- measurements
- comment
- Insufficient number of events to calculate upper limit number and median
- group Id
- OG000
- lower Limit
- 5.78
- upper Limit
- NA
- value
- NA
- group Id
- OG001
- lower Limit
- 5.49
- upper Limit
- 24.61
- value
- 19.32
- denoms
- counts
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 4
- units
- Participants
- title
- TMB: ≥ 10
- categories
- measurements
- comment
- Insufficient number of events to calculate upper limit number and median.
- group Id
- OG000
- lower Limit
- 27.04
- upper Limit
- NA
- value
- NA
- comment
- Insufficient number of events to calculate upper limit number.
- group Id
- OG001
- lower Limit
- 4.11
- upper Limit
- NA
- value
- 48.49
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 4
- units
- Participants
- title
- TMB: Not Reported
- denoms
- counts
- group Id
- OG000
- value
- 25
- group Id
- OG001
- value
- 18
- 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.
Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) who are platinum naive or have recurred 6 months or more 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 Eligible Subgroup
- description
- Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) who are platinum naive or have recurred 6 months or more after completion of previous platinum-based chemotherapy.
Treated with Nivolumab 3 mg/kg Q2W + Ipilimumab-Placebo Q6W
- id
- OG001
- title
- Treatment B - Platinum Eligible Subgroup
- param Type
- MEDIAN
- population Description
- All treated participants in the Platinum eligible 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 Eligible Subgroup Based on Tumor Mutation Burden (TMB) Status
- type
- SECONDARY
- unit Of Measure
- Months
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