NCT02488759 · OUTCOME
Metastatic: Investigator-Assessed Duration of Response (DoR)
An Investigational Immuno-therapy Study to Investigate the Safety and Effectiveness of Nivolumab, and Nivolumab Combination Therapy in Virus-associated Tumors · Source last updated 2023-11-13
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 first confirmed response (complete response or partial response) to the date of the initial objectively documented tumor progression or death due to any cause, whichever occurs first (Up to 83 months)
What was measured
Duration of response (DoR) is defined as the time from first confirmed response (complete response or partial response) to the date of the initial objectively documented tumor progression as determined per investigator assessment using RECIST 1.1 criteria or death due to any cause, whichever occurs first. Participants with the following diseases will be assessed:
1. EBV positive related gastric cancer;
2. HPV positive SCCHN;
3. Other anogenital HPV associated cancers;
4. GYN (Cervical, Vaginal, Vulvar) carcinoma;
5. Merkel cell carcinoma (MCC);
6. Nasopharyngeal carcinoma (NPC) NOTE: "Cervical, Randomized" and "Cervical, Pooled" are not mutually exclusive categories.
Analysis population: All complete and partial responders in the metastatic cohorts
Groups in this outcome
Metastatic Monotherapy
Nivolumab IV over 30 minutes at 240 mg every 2 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
Metastatic Combo A
Nivolumab 3 mg/kg IV over 30 minutes every 2 weeks + Ipilimumab 1 mg/kg IV over 30 minutes every 6 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
Metastatic Combo B
Nivolumab 1 mg/kg IV over 30 minutes + Ipilimumab 3 mg/kg IV over 30 minutes every 3 weeks for 4 doses followed by Nivolumab 240 mg IV over 30 minutes every 2 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
Metastatic Combo C
Nivolumab 240 mg IV over 30 minutes + BMS-986016 (Relatlimab) 80 mg IV over 60 minutes administered every 2 weeks for a maximum of 24 months, or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
Metastatic Combo D
Daratumumab 16 mg/kg IV weekly for the first 8 weeks. Starting at Week 3, Nivolumab 240 mg IV over 30 minutes every 2 weeks. Daratumumab 16 mg/kg every 2 weeks from Weeks 9-24. Starting at Week 25, Nivolumab 480 mg IV flat dose over 30 minutes every 4 weeks; daratumumab 16 mg/kg every 4 weeks for a maximum of 24 months or until progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
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 |
|---|
| Metastatic Monotherapy | 30 |
|---|
| Metastatic Combo A | 72 |
|---|
| Metastatic Combo B | 50 |
|---|
| Metastatic Combo C | 0 |
|---|
| Metastatic Combo D | 1 |
|---|
Reported measurements
EBV positive related gastric cancer
Analysis denominator · Participants
| Group | Source count |
|---|
| Metastatic Monotherapy | 2 |
|---|
| Metastatic Combo A | 0 |
|---|
| Metastatic Combo B | 0 |
|---|
| Metastatic Combo C | 0 |
|---|
| Metastatic Combo D | 0 |
|---|
Values in Months · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Metastatic Monotherapy | NA | Not reported | NA | NA | Median not reached as insufficient progression events among responders |
|---|
HPV positive SCCHN
Analysis denominator · Participants
| Group | Source count |
|---|
| Metastatic Monotherapy | 3 |
|---|
| Metastatic Combo A | 13 |
|---|
| Metastatic Combo B | 0 |
|---|
| Metastatic Combo C | 0 |
|---|
| Metastatic Combo D | 0 |
|---|
Values in Months · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Metastatic Monotherapy | 44.25 | Not reported | 24.90 | NA | Upper limit not calculable as upper CI bound does not cross 50% threshold |
|---|
| Metastatic Combo A | 34.46 | Not reported | 10.45 | NA | Upper limit not calculable as upper CI bound does not cross 50% threshold |
|---|
Other anogenital HPV associated cancers
Analysis denominator · Participants
| Group | Source count |
|---|
| Metastatic Monotherapy | 0 |
|---|
| Metastatic Combo A | 8 |
|---|
| Metastatic Combo B | 5 |
|---|
| Metastatic Combo C | 0 |
|---|
| Metastatic Combo D | 0 |
|---|
Values in Months · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Metastatic Combo A | 18.23 | Not reported | 3.68 | 27.93 | Not reported |
|---|
| Metastatic Combo B | 3.71 | Not reported | 3.58 | NA | Upper limit not calculable as upper CI bound does not cross 50% threshold |
|---|
SCCHN I-O naive
Analysis denominator · Participants
| Group | Source count |
|---|
| Metastatic Monotherapy | 0 |
|---|
| Metastatic Combo A | 0 |
|---|
| Metastatic Combo B | 0 |
|---|
| Metastatic Combo C | 0 |
|---|
| Metastatic Combo D | 1 |
|---|
Values in Months · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Metastatic Combo D | NA | Not reported | NA | NA | Median not reached as insufficient progression events among responders |
|---|
Cervical, Randomized
Analysis denominator · Participants
| Group | Source count |
|---|
| Metastatic Monotherapy | 5 |
|---|
| Metastatic Combo A | 14 |
|---|
| Metastatic Combo B | 18 |
|---|
| Metastatic Combo C | 0 |
|---|
| Metastatic Combo D | 0 |
|---|
Values in Months · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Metastatic Monotherapy | NA | Not reported | 35.29 | NA | Median not reached as insufficient progression events among responders and Upper limit not calculable as upper CI bound does not cross 50% threshold |
|---|
| Metastatic Combo A | NA | Not reported | 8.67 | NA | Median not reached as insufficient progression events among responders and Upper limit not calculable as upper CI bound does not cross 50% threshold |
|---|
| Metastatic Combo B | 34.07 | Not reported | 15.28 | NA | Upper limit not calculable as upper CI bound does not cross 50% threshold |
|---|
Cervical, Pooled
Analysis denominator · Participants
| Group | Source count |
|---|
| Metastatic Monotherapy | 0 |
|---|
| Metastatic Combo A | 0 |
|---|
| Metastatic Combo B | 45 |
|---|
| Metastatic Combo C | 0 |
|---|
| Metastatic Combo D | 0 |
|---|
Values in Months · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Metastatic Combo B | 34.07 | Not reported | 15.28 | NA | Upper limit not calculable as upper CI bound does not cross 50% threshold |
|---|
Vaginal/Vulvar
Analysis denominator · Participants
| Group | Source count |
|---|
| Metastatic Monotherapy | 1 |
|---|
| Metastatic Combo A | 0 |
|---|
| Metastatic Combo B | 0 |
|---|
| Metastatic Combo C | 0 |
|---|
| Metastatic Combo D | 0 |
|---|
Values in Months · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Metastatic Monotherapy | 4.96 | Not reported | NA | NA | Lower limit and Upper limit not calculable as upper CI bound does not cross 50% threshold |
|---|
MCC
Analysis denominator · Participants
| Group | Source count |
|---|
| Metastatic Monotherapy | 15 |
|---|
| Metastatic Combo A | 25 |
|---|
| Metastatic Combo B | 0 |
|---|
| Metastatic Combo C | 0 |
|---|
| Metastatic Combo D | 0 |
|---|
Values in Months · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Metastatic Monotherapy | 60.62 | Not reported | 16.72 | NA | Upper limit not calculable as upper CI bound does not cross 50% threshold |
|---|
| Metastatic Combo A | 25.86 | Not reported | 10.38 | NA | Upper limit not calculable as upper CI bound does not cross 50% threshold |
|---|
NPC
Analysis denominator · Participants
| Group | Source count |
|---|
| Metastatic Monotherapy | 4 |
|---|
| Metastatic Combo A | 12 |
|---|
| Metastatic Combo B | 0 |
|---|
| Metastatic Combo C | 0 |
|---|
| Metastatic Combo D | 0 |
|---|
Values in Months · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Metastatic Monotherapy | 9.46 | Not reported | 3.68 | NA | Upper limit not calculable as upper CI bound does not cross 50% threshold |
|---|
| Metastatic Combo A | 19.63 | Not reported | 5.55 | NA | Upper limit not calculable as upper CI bound does not cross 50% threshold |
|---|
Complete source fields
- classes
- categories
- measurements
- comment
- Median not reached as insufficient progression events among responders
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- units
- Participants
- title
- EBV positive related gastric cancer
- categories
- measurements
- comment
- Upper limit not calculable as upper CI bound does not cross 50% threshold
- group Id
- OG000
- lower Limit
- 24.90
- upper Limit
- NA
- value
- 44.25
- comment
- Upper limit not calculable as upper CI bound does not cross 50% threshold
- group Id
- OG001
- lower Limit
- 10.45
- upper Limit
- NA
- value
- 34.46
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 13
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- units
- Participants
- title
- HPV positive SCCHN
- categories
- measurements
- group Id
- OG001
- lower Limit
- 3.68
- upper Limit
- 27.93
- value
- 18.23
- comment
- Upper limit not calculable as upper CI bound does not cross 50% threshold
- group Id
- OG002
- lower Limit
- 3.58
- upper Limit
- NA
- value
- 3.71
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 8
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- units
- Participants
- title
- Other anogenital HPV associated cancers
- categories
- measurements
- comment
- Median not reached as insufficient progression events among responders
- group Id
- OG004
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 1
- units
- Participants
- title
- SCCHN I-O naive
- categories
- measurements
- comment
- Median not reached as insufficient progression events among responders and Upper limit not calculable as upper CI bound does not cross 50% threshold
- group Id
- OG000
- lower Limit
- 35.29
- upper Limit
- NA
- value
- NA
- comment
- Median not reached as insufficient progression events among responders and Upper limit not calculable as upper CI bound does not cross 50% threshold
- group Id
- OG001
- lower Limit
- 8.67
- upper Limit
- NA
- value
- NA
- comment
- Upper limit not calculable as upper CI bound does not cross 50% threshold
- group Id
- OG002
- lower Limit
- 15.28
- upper Limit
- NA
- value
- 34.07
- denoms
- counts
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 14
- group Id
- OG002
- value
- 18
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- units
- Participants
- title
- Cervical, Randomized
- categories
- measurements
- comment
- Upper limit not calculable as upper CI bound does not cross 50% threshold
- group Id
- OG002
- lower Limit
- 15.28
- upper Limit
- NA
- value
- 34.07
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 45
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- units
- Participants
- title
- Cervical, Pooled
- categories
- measurements
- comment
- Lower limit and Upper limit not calculable as upper CI bound does not cross 50% threshold
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- 4.96
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- units
- Participants
- title
- Vaginal/Vulvar
- categories
- measurements
- comment
- Upper limit not calculable as upper CI bound does not cross 50% threshold
- group Id
- OG000
- lower Limit
- 16.72
- upper Limit
- NA
- value
- 60.62
- comment
- Upper limit not calculable as upper CI bound does not cross 50% threshold
- group Id
- OG001
- lower Limit
- 10.38
- upper Limit
- NA
- value
- 25.86
- denoms
- counts
- group Id
- OG000
- value
- 15
- group Id
- OG001
- value
- 25
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- units
- Participants
- title
- MCC
- categories
- measurements
- comment
- Upper limit not calculable as upper CI bound does not cross 50% threshold
- group Id
- OG000
- lower Limit
- 3.68
- upper Limit
- NA
- value
- 9.46
- comment
- Upper limit not calculable as upper CI bound does not cross 50% threshold
- group Id
- OG001
- lower Limit
- 5.55
- upper Limit
- NA
- value
- 19.63
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 12
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- units
- Participants
- title
- NPC
- denoms
- counts
- group Id
- OG000
- value
- 30
- group Id
- OG001
- value
- 72
- group Id
- OG002
- value
- 50
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 1
- units
- Participants
- description
- Duration of response (DoR) is defined as the time from first confirmed response (complete response or partial response) to the date of the initial objectively documented tumor progression as determined per investigator assessment using RECIST 1.1 criteria or death due to any cause, whichever occurs first. Participants with the following diseases will be assessed:
1. EBV positive related gastric cancer;
2. HPV positive SCCHN;
3. Other anogenital HPV associated cancers;
4. GYN (Cervical, Vaginal, Vulvar) carcinoma;
5. Merkel cell carcinoma (MCC);
6. Nasopharyngeal carcinoma (NPC) NOTE: "Cervical, Randomized" and "Cervical, Pooled" are not mutually exclusive categories.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Nivolumab IV over 30 minutes at 240 mg every 2 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
- id
- OG000
- title
- Metastatic Monotherapy
- description
- Nivolumab 3 mg/kg IV over 30 minutes every 2 weeks + Ipilimumab 1 mg/kg IV over 30 minutes every 6 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
- id
- OG001
- title
- Metastatic Combo A
- description
- Nivolumab 1 mg/kg IV over 30 minutes + Ipilimumab 3 mg/kg IV over 30 minutes every 3 weeks for 4 doses followed by Nivolumab 240 mg IV over 30 minutes every 2 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
- id
- OG002
- title
- Metastatic Combo B
- description
- Nivolumab 240 mg IV over 30 minutes + BMS-986016 (Relatlimab) 80 mg IV over 60 minutes administered every 2 weeks for a maximum of 24 months, or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
- id
- OG003
- title
- Metastatic Combo C
- description
- Daratumumab 16 mg/kg IV weekly for the first 8 weeks. Starting at Week 3, Nivolumab 240 mg IV over 30 minutes every 2 weeks. Daratumumab 16 mg/kg every 2 weeks from Weeks 9-24. Starting at Week 25, Nivolumab 480 mg IV flat dose over 30 minutes every 4 weeks; daratumumab 16 mg/kg every 4 weeks for a maximum of 24 months or until progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
- id
- OG004
- title
- Metastatic Combo D
- param Type
- MEDIAN
- population Description
- All complete and partial responders in the metastatic cohorts
- reporting Status
- POSTED
- time Frame
- From first confirmed response (complete response or partial response) to the date of the initial objectively documented tumor progression or death due to any cause, whichever occurs first (Up to 83 months)
- title
- Metastatic: Investigator-Assessed Duration of Response (DoR)
- type
- SECONDARY
- unit Of Measure
- Months
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