NCT02488759 · OUTCOME
Metastatic: Overall Survival (OS)
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 the first dosing date to the date of death (Up to 83 months)
What was measured
Overall survival (OS) is defined as the time from first dosing date to the date of death. A participant who has not died will be censored at last known date alive. 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 treated participants 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 | 113 |
|---|
| Metastatic Combo A | 195 |
|---|
| Metastatic Combo B | 133 |
|---|
| Metastatic Combo C | 8 |
|---|
| Metastatic Combo D | 6 |
|---|
Reported measurements
EBV positive related gastric cancer
Analysis denominator · Participants
| Group | Source count |
|---|
| Metastatic Monotherapy | 14 |
|---|
| 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 | 9.99 | Not reported | 3.09 | 30.13 | Not reported |
|---|
HPV positive SCCHN
Analysis denominator · Participants
| Group | Source count |
|---|
| Metastatic Monotherapy | 26 |
|---|
| Metastatic Combo A | 42 |
|---|
| Metastatic Combo B | 0 |
|---|
| Metastatic Combo C | 8 |
|---|
| Metastatic Combo D | 0 |
|---|
Values in Months · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Metastatic Monotherapy | 20.44 | Not reported | 13.90 | 36.50 | Not reported |
|---|
| Metastatic Combo A | 17.08 | Not reported | 9.49 | 26.78 | Not reported |
|---|
| Metastatic Combo C | 8.84 | Not reported | 2.50 | 35.06 | Not reported |
|---|
Other anogenital HPV associated cancers
Analysis denominator · Participants
| Group | Source count |
|---|
| Metastatic Monotherapy | 0 |
|---|
| Metastatic Combo A | 23 |
|---|
| Metastatic Combo B | 21 |
|---|
| 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 | 12.12 | Not reported | 6.83 | 29.54 | Not reported |
|---|
| Metastatic Combo B | 14.06 | Not reported | 4.37 | 30.59 | Not reported |
|---|
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 | 6 |
|---|
Values in Months · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Metastatic Combo D | 4.21 | Not reported | 1.68 | NA | Upper limit not calculable as upper CI bound does not cross 50% threshold |
|---|
Cervical, Randomized
Analysis denominator · Participants
| Group | Source count |
|---|
| Metastatic Monotherapy | 19 |
|---|
| Metastatic Combo A | 45 |
|---|
| 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 Monotherapy | 21.55 | Not reported | 8.25 | 44.85 | Not reported |
|---|
| Metastatic Combo A | 17.12 | Not reported | 10.22 | 34.79 | Not reported |
|---|
| Metastatic Combo B | 22.74 | Not reported | 14.62 | 32.82 | Not reported |
|---|
Cervical, Pooled
Analysis denominator · Participants
| Group | Source count |
|---|
| Metastatic Monotherapy | 0 |
|---|
| Metastatic Combo A | 0 |
|---|
| Metastatic Combo B | 112 |
|---|
| 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 | 20.93 | Not reported | 14.39 | 29.04 | Not reported |
|---|
Vaginal/Vulvar
Analysis denominator · Participants
| Group | Source count |
|---|
| Metastatic Monotherapy | 5 |
|---|
| 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 | 10.28 | Not reported | 3.88 | 23.72 | Not reported |
|---|
MCC
Analysis denominator · Participants
| Group | Source count |
|---|
| Metastatic Monotherapy | 25 |
|---|
| Metastatic Combo A | 43 |
|---|
| 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 | 80.66 | Not reported | 23.26 | NA | Upper limit not calculable as upper CI bound does not cross 50% threshold |
|---|
| Metastatic Combo A | 29.83 | Not reported | 8.51 | 48.33 | Not reported |
|---|
NPC
Analysis denominator · Participants
| Group | Source count |
|---|
| Metastatic Monotherapy | 24 |
|---|
| Metastatic Combo A | 42 |
|---|
| 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 | 22.74 | Not reported | 12.62 | 35.29 | Not reported |
|---|
| Metastatic Combo A | 23.66 | Not reported | 16.82 | 41.43 | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 3.09
- upper Limit
- 30.13
- value
- 9.99
- denoms
- counts
- group Id
- OG000
- value
- 14
- 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
- group Id
- OG000
- lower Limit
- 13.90
- upper Limit
- 36.50
- value
- 20.44
- group Id
- OG001
- lower Limit
- 9.49
- upper Limit
- 26.78
- value
- 17.08
- group Id
- OG003
- lower Limit
- 2.50
- upper Limit
- 35.06
- value
- 8.84
- denoms
- counts
- group Id
- OG000
- value
- 26
- group Id
- OG001
- value
- 42
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 8
- group Id
- OG004
- value
- 0
- units
- Participants
- title
- HPV positive SCCHN
- categories
- measurements
- group Id
- OG001
- lower Limit
- 6.83
- upper Limit
- 29.54
- value
- 12.12
- group Id
- OG002
- lower Limit
- 4.37
- upper Limit
- 30.59
- value
- 14.06
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 23
- group Id
- OG002
- value
- 21
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- units
- Participants
- title
- Other anogenital HPV associated cancers
- categories
- measurements
- comment
- Upper limit not calculable as upper CI bound does not cross 50% threshold
- group Id
- OG004
- lower Limit
- 1.68
- upper Limit
- NA
- value
- 4.21
- 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
- 6
- units
- Participants
- title
- SCCHN I-O naive
- categories
- measurements
- group Id
- OG000
- lower Limit
- 8.25
- upper Limit
- 44.85
- value
- 21.55
- group Id
- OG001
- lower Limit
- 10.22
- upper Limit
- 34.79
- value
- 17.12
- group Id
- OG002
- lower Limit
- 14.62
- upper Limit
- 32.82
- value
- 22.74
- denoms
- counts
- group Id
- OG000
- value
- 19
- group Id
- OG001
- value
- 45
- group Id
- OG002
- value
- 45
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- units
- Participants
- title
- Cervical, Randomized
- categories
- measurements
- group Id
- OG002
- lower Limit
- 14.39
- upper Limit
- 29.04
- value
- 20.93
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 112
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- units
- Participants
- title
- Cervical, Pooled
- categories
- measurements
- group Id
- OG000
- lower Limit
- 3.88
- upper Limit
- 23.72
- value
- 10.28
- denoms
- counts
- group Id
- OG000
- value
- 5
- 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
- 23.26
- upper Limit
- NA
- value
- 80.66
- group Id
- OG001
- lower Limit
- 8.51
- upper Limit
- 48.33
- value
- 29.83
- denoms
- counts
- group Id
- OG000
- value
- 25
- group Id
- OG001
- value
- 43
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- units
- Participants
- title
- MCC
- categories
- measurements
- group Id
- OG000
- lower Limit
- 12.62
- upper Limit
- 35.29
- value
- 22.74
- group Id
- OG001
- lower Limit
- 16.82
- upper Limit
- 41.43
- value
- 23.66
- denoms
- counts
- group Id
- OG000
- value
- 24
- group Id
- OG001
- value
- 42
- 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
- 113
- group Id
- OG001
- value
- 195
- group Id
- OG002
- value
- 133
- group Id
- OG003
- value
- 8
- group Id
- OG004
- value
- 6
- units
- Participants
- description
- Overall survival (OS) is defined as the time from first dosing date to the date of death. A participant who has not died will be censored at last known date alive. 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 treated participants in the metastatic cohorts
- reporting Status
- POSTED
- time Frame
- From the first dosing date to the date of death (Up to 83 months)
- title
- Metastatic: Overall Survival (OS)
- type
- SECONDARY
- unit Of Measure
- Months
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