TriangleNCT01658878 · OUTCOME
Overall Survival (OS) Rate
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percent of Participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- At 6, 12, 24, 48 and 60 months
What was measured
OS rate is defined as the percentage of participants who are still alive at certain time points during the study.
Analysis population: All treated participants for Cohort 1, 2, and 5, and all randomized participants for Cohort 3, 4 and 6. Uninfected HCC, HCV-infected, and HBV-infected participants were pre-specified to be reported together for Cohort 1.
Groups in this outcome
Cohort 1 Uninfected HCC
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 0.1/0.3/1/3/10 mg/kg every 2 weeks
Cohort 1 HCV Infected
Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 0.3/1/3 mg/kg every 2 weeks
Cohort 1 HBV Infected
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 0.1/0.3/1/3 mg/kg every 2 weeks
Cohort 2 Uninfected Sorafenib Naive/Intolerant: Treatment 1
Dose Expansion: Uninfected hepatocellular carcinoma (HCC) participants who are sorafenib naive/intolerant received nivolumab 3 mg/kg every 2 weeks
Cohort 2 Uninfected Sorafenib Progressors: Treatment 2
Dose Expansion: Uninfected hepatocellular carcinoma (HCC) participants who are sorafenib progressors received nivolumab 3 mg/kg every 2 weeks
Cohort 2 HCV Infected: Treatment 3
Dose Expansion: Hepatitis C (HCV)-infected participants received nivolumab 3 mg/kg every 2 weeks
Cohort 2 HBV Infected: Treatment 4
Dose Expansion: Hepatitis B (HBV)-infected participants received nivolumab 3 mg/kg every 2 weeks
Cohort 3: Treatment 1
Arm A: Advance hepatocellular carcinoma (HCC) participants received nivolumab 240 mg every 2 weeks
Cohort 3: Treatment 2
Arm B: Advance hepatocellular carcinoma (HCC) participants received Sorafenib 400 mg twice a day
Cohort 4: Treatment 1
Arm A: Participants received nivolumab 1 mg/kg + ipilimumab 3 mg/kg every 3 weeks
Cohort 4: Treatment 2
Arm B: Participants received nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks
Cohort 4: Treatment 3
Arm C: Participants received nivolumab 3 mg/kg every 2 weeks + ipilimumab 1 mg/kg every 6 weeks
Cohort 5: Treatment 1
Participants received nivolumab 240 mg every 2 weeks
Cohort 6: Treatment 1
Participants received nivolumab 240 mg every 2 weeks + cabozantinib 40 mg once daily
Cohort 6: Treatment 2
Participants received nivolumab 3 mg/kg every 2 weeks + ipilimumab 1 mg/kg every 6 weeks + cabozantinib 40 mg once daily
| Group | Source count |
|---|---|
| Cohort 1 Uninfected HCC | 23 |
| Cohort 1 HCV Infected | 10 |
| Cohort 1 HBV Infected | 15 |
| Cohort 2 Uninfected Sorafenib Naive/Intolerant: Treatment 1 | 56 |
| Cohort 2 Uninfected Sorafenib Progressors: Treatment 2 | 57 |
| Cohort 2 HCV Infected: Treatment 3 | 50 |
| Cohort 2 HBV Infected: Treatment 4 | 51 |
| Cohort 3: Treatment 1 | 61 |
| Cohort 3: Treatment 2 | 66 |
| Cohort 4: Treatment 1 | 50 |
| Cohort 4: Treatment 2 | 49 |
| Cohort 4: Treatment 3 | 49 |
| Cohort 5: Treatment 1 | 49 |
| Cohort 6: Treatment 1 | 36 |
| Cohort 6: Treatment 2 | 35 |
Reported measurements
6 Months
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1 Uninfected HCC | 69.6 | Not reported | 46.6 | 84.2 | Not reported |
| Cohort 1 HCV Infected | 80.0 | Not reported | 40.9 | 94.6 | Not reported |
| Cohort 1 HBV Infected | 53.3 | Not reported | 26.3 | 74.4 | Not reported |
| Cohort 2 Uninfected Sorafenib Naive/Intolerant: Treatment 1 | 89.0 | Not reported | 77.0 | 94.9 | Not reported |
| Cohort 2 Uninfected Sorafenib Progressors: Treatment 2 | 75.4 | Not reported | 62.1 | 84.7 | Not reported |
| Cohort 2 HCV Infected: Treatment 3 | 83.3 | Not reported | 69.3 | 91.3 | Not reported |
| Cohort 2 HBV Infected: Treatment 4 | 84.3 | Not reported | 71.1 | 91.8 | Not reported |
| Cohort 3: Treatment 1 | 81.3 | Not reported | 68.8 | 89.2 | Not reported |
| Cohort 3: Treatment 2 | 76.7 | Not reported | 63.8 | 85.5 | Not reported |
| Cohort 4: Treatment 1 | 81.7 | Not reported | 67.7 | 90.0 | Not reported |
| Cohort 4: Treatment 2 | 75.0 | Not reported | 60.2 | 85.0 | Not reported |
| Cohort 4: Treatment 3 | 73.5 | Not reported | 58.7 | 83.6 | Not reported |
| Cohort 5: Treatment 1 | 59.2 | Not reported | 44.2 | 71.4 | Not reported |
| Cohort 6: Treatment 1 | 82.4 | Not reported | 64.9 | 91.7 | Not reported |
| Cohort 6: Treatment 2 | 82.4 | Not reported | 65.0 | 91.7 | Not reported |
12 Months
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1 Uninfected HCC | 60.9 | Not reported | 38.3 | 77.4 | Not reported |
| Cohort 1 HCV Infected | 80.0 | Not reported | 40.9 | 94.6 | Not reported |
| Cohort 1 HBV Infected | 46.7 | Not reported | 21.2 | 68.7 | Not reported |
| Cohort 2 Uninfected Sorafenib Naive/Intolerant: Treatment 1 | 76.0 | Not reported | 62.3 | 85.3 | Not reported |
| Cohort 2 Uninfected Sorafenib Progressors: Treatment 2 | 54.4 | Not reported | 40.7 | 66.2 | Not reported |
| Cohort 2 HCV Infected: Treatment 3 | 67.5 | Not reported | 51.9 | 79.0 | Not reported |
| Cohort 2 HBV Infected: Treatment 4 | 58.8 | Not reported | 44.1 | 70.9 | Not reported |
| Cohort 3: Treatment 1 | 57.1 | Not reported | 43.4 | 68.6 | Not reported |
| Cohort 3: Treatment 2 | 57.0 | Not reported | 43.2 | 68.6 | Not reported |
| Cohort 4: Treatment 1 | 60.7 | Not reported | 45.6 | 72.9 | Not reported |
| Cohort 4: Treatment 2 | 56.1 | Not reported | 41.0 | 68.8 | Not reported |
| Cohort 4: Treatment 3 | 50.8 | Not reported | 36.1 | 63.7 | Not reported |
| Cohort 5: Treatment 1 | 34.7 | Not reported | 21.8 | 47.9 | Not reported |
| Cohort 6: Treatment 1 | 70.2 | Not reported | 51.6 | 82.7 | Not reported |
| Cohort 6: Treatment 2 | 70.6 | Not reported | 52.3 | 83.0 | Not reported |
24 Months
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1 Uninfected HCC | 26.1 | Not reported | 10.6 | 44.7 | Not reported |
| Cohort 1 HCV Infected | 60.0 | Not reported | 25.3 | 82.7 | Not reported |
| Cohort 1 HBV Infected | 26.7 | Not reported | 8.3 | 49.6 | Not reported |
| Cohort 2 Uninfected Sorafenib Naive/Intolerant: Treatment 1 | 57.0 | Not reported | 42.7 | 69.0 | Not reported |
| Cohort 2 Uninfected Sorafenib Progressors: Treatment 2 | 26.3 | Not reported | 15.7 | 38.1 | Not reported |
| Cohort 2 HCV Infected: Treatment 3 | 38.9 | Not reported | 24.5 | 53.0 | Not reported |
| Cohort 2 HBV Infected: Treatment 4 | 36.6 | Not reported | 23.6 | 49.7 | Not reported |
| Cohort 3: Treatment 1 | 32.9 | Not reported | 21.3 | 45.0 | Not reported |
| Cohort 3: Treatment 2 | 30.4 | Not reported | 18.8 | 42.8 | Not reported |
| Cohort 4: Treatment 1 | 46.1 | Not reported | 31.7 | 59.3 | Not reported |
| Cohort 4: Treatment 2 | 30.2 | Not reported | 17.9 | 43.5 | Not reported |
| Cohort 4: Treatment 3 | 42.3 | Not reported | 28.3 | 55.7 | Not reported |
| Cohort 5: Treatment 1 | 10.2 | Not reported | 3.7 | 20.5 | Not reported |
| Cohort 6: Treatment 1 | 39.0 | Not reported | 22.6 | 55.2 | Not reported |
| Cohort 6: Treatment 2 | 46.1 | Not reported | 28.7 | 61.8 | Not reported |
48 Months
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1 Uninfected HCC | 17.4 | Not reported | 5.4 | 35.0 | Not reported |
| Cohort 1 HCV Infected | 30.0 | Not reported | 7.1 | 57.8 | Not reported |
| Cohort 1 HBV Infected | 6.7 | Not reported | 0.4 | 26.0 | Not reported |
| Cohort 2 Uninfected Sorafenib Naive/Intolerant: Treatment 1 | 20.9 | Not reported | 11.2 | 32.7 | Not reported |
| Cohort 2 Uninfected Sorafenib Progressors: Treatment 2 | 11.7 | Not reported | 4.9 | 21.7 | Not reported |
| Cohort 2 HCV Infected: Treatment 3 | 14.6 | Not reported | 6.0 | 26.9 | Not reported |
| Cohort 2 HBV Infected: Treatment 4 | 12.2 | Not reported | 5.0 | 22.9 | Not reported |
| Cohort 3: Treatment 1 | 15.6 | Not reported | 7.5 | 26.5 | Not reported |
| Cohort 3: Treatment 2 | 8.4 | Not reported | 2.7 | 18.0 | Not reported |
| Cohort 4: Treatment 1 | 37.0 | Not reported | 23.5 | 50.6 | Not reported |
| Cohort 4: Treatment 2 | 21.6 | Not reported | 11.2 | 34.2 | Not reported |
| Cohort 4: Treatment 3 | 25.4 | Not reported | 14.2 | 38.2 | Not reported |
| Cohort 5: Treatment 1 | 00 | Not reported | 00 | 00 | Not reported |
| Cohort 6: Treatment 1 | 19.0 | Not reported | 7.5 | 34.4 | Not reported |
| Cohort 6: Treatment 2 | 30.7 | Not reported | 16.1 | 46.6 | Not reported |
60 Months
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1 Uninfected HCC | 8.7 | Not reported | 1.5 | 24.2 | Not reported |
| Cohort 1 HCV Infected | 15.0 | Not reported | 1.0 | 45.7 | Not reported |
| Cohort 1 HBV Infected | 6.7 | Not reported | 0.4 | 26.0 | Not reported |
| Cohort 2 Uninfected Sorafenib Naive/Intolerant: Treatment 1 | 15.2 | Not reported | 7.1 | 26.1 | Not reported |
| Cohort 2 Uninfected Sorafenib Progressors: Treatment 2 | 9.7 | Not reported | 3.7 | 19.3 | Not reported |
| Cohort 2 HCV Infected: Treatment 3 | 14.6 | Not reported | 6.0 | 26.9 | Not reported |
| Cohort 2 HBV Infected: Treatment 4 | 12.2 | Not reported | 5.0 | 22.9 | Not reported |
| Cohort 3: Treatment 1 | 8.9 | Not reported | 3.0 | 18.8 | Not reported |
| Cohort 3: Treatment 2 | 5.6 | Not reported | 1.2 | 15.1 | Not reported |
| Cohort 4: Treatment 1 | 29.6 | Not reported | 17.1 | 43.2 | Not reported |
| Cohort 4: Treatment 2 | 19.2 | Not reported | 9.4 | 31.6 | Not reported |
| Cohort 4: Treatment 3 | 21.2 | Not reported | 11.0 | 33.6 | Not reported |
| Cohort 5: Treatment 1 | 00 | Not reported | 00 | 00 | Not reported |
| Cohort 6: Treatment 1 | 15.2 | Not reported | 5.1 | 30.2 | Not reported |
| Cohort 6: Treatment 2 | 24.6 | Not reported | 11.6 | 40.0 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 46.6
- upper Limit
- 84.2
- value
- 69.6
- group Id
- OG001
- lower Limit
- 40.9
- upper Limit
- 94.6
- value
- 80.0
- group Id
- OG002
- lower Limit
- 26.3
- upper Limit
- 74.4
- value
- 53.3
- group Id
- OG003
- lower Limit
- 77.0
- upper Limit
- 94.9
- value
- 89.0
- group Id
- OG004
- lower Limit
- 62.1
- upper Limit
- 84.7
- value
- 75.4
- group Id
- OG005
- lower Limit
- 69.3
- upper Limit
- 91.3
- value
- 83.3
- group Id
- OG006
- lower Limit
- 71.1
- upper Limit
- 91.8
- value
- 84.3
- group Id
- OG007
- lower Limit
- 68.8
- upper Limit
- 89.2
- value
- 81.3
- group Id
- OG008
- lower Limit
- 63.8
- upper Limit
- 85.5
- value
- 76.7
- group Id
- OG009
- lower Limit
- 67.7
- upper Limit
- 90.0
- value
- 81.7
- group Id
- OG010
- lower Limit
- 60.2
- upper Limit
- 85.0
- value
- 75.0
- group Id
- OG011
- lower Limit
- 58.7
- upper Limit
- 83.6
- value
- 73.5
- title
- 6 Months
- categories
- measurements
- group Id
- OG000
- lower Limit
- 38.3
- upper Limit
- 77.4
- value
- 60.9
- group Id
- OG001
- lower Limit
- 40.9
- upper Limit
- 94.6
- value
- 80.0
- group Id
- OG002
- lower Limit
- 21.2
- upper Limit
- 68.7
- value
- 46.7
- group Id
- OG003
- lower Limit
- 62.3
- upper Limit
- 85.3
- value
- 76.0
- group Id
- OG004
- lower Limit
- 40.7
- upper Limit
- 66.2
- value
- 54.4
- group Id
- OG005
- lower Limit
- 51.9
- upper Limit
- 79.0
- value
- 67.5
- group Id
- OG006
- lower Limit
- 44.1
- upper Limit
- 70.9
- value
- 58.8
- group Id
- OG007
- lower Limit
- 43.4
- upper Limit
- 68.6
- value
- 57.1
- group Id
- OG008
- lower Limit
- 43.2
- upper Limit
- 68.6
- value
- 57.0
- group Id
- OG009
- lower Limit
- 45.6
- upper Limit
- 72.9
- value
- 60.7
- group Id
- OG010
- lower Limit
- 41.0
- upper Limit
- 68.8
- value
- 56.1
- group Id
- OG011
- lower Limit
- 36.1
- upper Limit
- 63.7
- value
- 50.8
- title
- 12 Months
- categories
- measurements
- group Id
- OG000
- lower Limit
- 10.6
- upper Limit
- 44.7
- value
- 26.1
- group Id
- OG001
- lower Limit
- 25.3
- upper Limit
- 82.7
- value
- 60.0
- group Id
- OG002
- lower Limit
- 8.3
- upper Limit
- 49.6
- value
- 26.7
- group Id
- OG003
- lower Limit
- 42.7
- upper Limit
- 69.0
- value
- 57.0
- group Id
- OG004
- lower Limit
- 15.7
- upper Limit
- 38.1
- value
- 26.3
- group Id
- OG005
- lower Limit
- 24.5
- upper Limit
- 53.0
- value
- 38.9
- group Id
- OG006
- lower Limit
- 23.6
- upper Limit
- 49.7
- value
- 36.6
- group Id
- OG007
- lower Limit
- 21.3
- upper Limit
- 45.0
- value
- 32.9
- group Id
- OG008
- lower Limit
- 18.8
- upper Limit
- 42.8
- value
- 30.4
- group Id
- OG009
- lower Limit
- 31.7
- upper Limit
- 59.3
- value
- 46.1
- group Id
- OG010
- lower Limit
- 17.9
- upper Limit
- 43.5
- value
- 30.2
- group Id
- OG011
- lower Limit
- 28.3
- upper Limit
- 55.7
- value
- 42.3
- title
- 24 Months
- categories
- measurements
- group Id
- OG000
- lower Limit
- 5.4
- upper Limit
- 35.0
- value
- 17.4
- group Id
- OG001
- lower Limit
- 7.1
- upper Limit
- 57.8
- value
- 30.0
- group Id
- OG002
- lower Limit
- 0.4
- upper Limit
- 26.0
- value
- 6.7
- group Id
- OG003
- lower Limit
- 11.2
- upper Limit
- 32.7
- value
- 20.9
- group Id
- OG004
- lower Limit
- 4.9
- upper Limit
- 21.7
- value
- 11.7
- group Id
- OG005
- lower Limit
- 6.0
- upper Limit
- 26.9
- value
- 14.6
- group Id
- OG006
- lower Limit
- 5.0
- upper Limit
- 22.9
- value
- 12.2
- group Id
- OG007
- lower Limit
- 7.5
- upper Limit
- 26.5
- value
- 15.6
- group Id
- OG008
- lower Limit
- 2.7
- upper Limit
- 18.0
- value
- 8.4
- group Id
- OG009
- lower Limit
- 23.5
- upper Limit
- 50.6
- value
- 37.0
- group Id
- OG010
- lower Limit
- 11.2
- upper Limit
- 34.2
- value
- 21.6
- group Id
- OG011
- lower Limit
- 14.2
- upper Limit
- 38.2
- value
- 25.4
- title
- 48 Months
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.5
- upper Limit
- 24.2
- value
- 8.7
- group Id
- OG001
- lower Limit
- 1.0
- upper Limit
- 45.7
- value
- 15.0
- group Id
- OG002
- lower Limit
- 0.4
- upper Limit
- 26.0
- value
- 6.7
- group Id
- OG003
- lower Limit
- 7.1
- upper Limit
- 26.1
- value
- 15.2
- group Id
- OG004
- lower Limit
- 3.7
- upper Limit
- 19.3
- value
- 9.7
- group Id
- OG005
- lower Limit
- 6.0
- upper Limit
- 26.9
- value
- 14.6
- group Id
- OG006
- lower Limit
- 5.0
- upper Limit
- 22.9
- value
- 12.2
- group Id
- OG007
- lower Limit
- 3.0
- upper Limit
- 18.8
- value
- 8.9
- group Id
- OG008
- lower Limit
- 1.2
- upper Limit
- 15.1
- value
- 5.6
- group Id
- OG009
- lower Limit
- 17.1
- upper Limit
- 43.2
- value
- 29.6
- group Id
- OG010
- lower Limit
- 9.4
- upper Limit
- 31.6
- value
- 19.2
- group Id
- OG011
- lower Limit
- 11.0
- upper Limit
- 33.6
- value
- 21.2
- title
- 60 Months
- denoms
- counts
- group Id
- OG000
- value
- 23
- group Id
- OG001
- value
- 10
- group Id
- OG002
- value
- 15
- group Id
- OG003
- value
- 56
- group Id
- OG004
- value
- 57
- group Id
- OG005
- value
- 50
- group Id
- OG006
- value
- 51
- group Id
- OG007
- value
- 61
- group Id
- OG008
- value
- 66
- group Id
- OG009
- value
- 50
- group Id
- OG010
- value
- 49
- group Id
- OG011
- value
- 49
- units
- Participants
- description
- OS rate is defined as the percentage of participants who are still alive at certain time points during the study.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 0.1/0.3/1/3/10 mg/kg every 2 weeks
- id
- OG000
- title
- Cohort 1 Uninfected HCC
- description
- Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 0.3/1/3 mg/kg every 2 weeks
- id
- OG001
- title
- Cohort 1 HCV Infected
- description
- Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 0.1/0.3/1/3 mg/kg every 2 weeks
- id
- OG002
- title
- Cohort 1 HBV Infected
- description
- Dose Expansion: Uninfected hepatocellular carcinoma (HCC) participants who are sorafenib naive/intolerant received nivolumab 3 mg/kg every 2 weeks
- id
- OG003
- title
- Cohort 2 Uninfected Sorafenib Naive/Intolerant: Treatment 1
- description
- Dose Expansion: Uninfected hepatocellular carcinoma (HCC) participants who are sorafenib progressors received nivolumab 3 mg/kg every 2 weeks
- id
- OG004
- title
- Cohort 2 Uninfected Sorafenib Progressors: Treatment 2
- description
- Dose Expansion: Hepatitis C (HCV)-infected participants received nivolumab 3 mg/kg every 2 weeks
- id
- OG005
- title
- Cohort 2 HCV Infected: Treatment 3
- description
- Dose Expansion: Hepatitis B (HBV)-infected participants received nivolumab 3 mg/kg every 2 weeks
- id
- OG006
- title
- Cohort 2 HBV Infected: Treatment 4
- description
- Arm A: Advance hepatocellular carcinoma (HCC) participants received nivolumab 240 mg every 2 weeks
- id
- OG007
- title
- Cohort 3: Treatment 1
- description
- Arm B: Advance hepatocellular carcinoma (HCC) participants received Sorafenib 400 mg twice a day
- id
- OG008
- title
- Cohort 3: Treatment 2
- description
- Arm A: Participants received nivolumab 1 mg/kg + ipilimumab 3 mg/kg every 3 weeks
- id
- OG009
- title
- Cohort 4: Treatment 1
- description
- Arm B: Participants received nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks
- id
- OG010
- title
- Cohort 4: Treatment 2
- description
- Arm C: Participants received nivolumab 3 mg/kg every 2 weeks + ipilimumab 1 mg/kg every 6 weeks
- id
- OG011
- title
- Cohort 4: Treatment 3
- param Type
- NUMBER
- population Description
- All treated participants for Cohort 1, 2, and 5, and all randomized participants for Cohort 3, 4 and 6. Uninfected HCC, HCV-infected, and HBV-infected participants were pre-specified to be reported together for Cohort 1.
- reporting Status
- POSTED
- time Frame
- At 6, 12, 24, 48 and 60 months
- title
- Overall Survival (OS) Rate
- type
- SECONDARY
- unit Of Measure
- Percent of Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice