TriangleNCT01658878 · OUTCOME
Time to Progression (TTP) Rate Assessed by Blinded Independent Central Review (BICR)
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 and 12 months
What was measured
TTP rate is defined as the percentage of participants without disease progression at select time points (milestones) during the study. Progressive Disease (PD): At least a 20% increase in the sum of the 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 5mm (Note: The appearance of 1or more new lesions is also considered progression).
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 | 28.6 | Not reported | 11.7 | 48.2 | Not reported |
| Cohort 1 HCV Infected | 60.0 | Not reported | 25.3 | 82.7 | Not reported |
| Cohort 1 HBV Infected | 27.9 | Not reported | 7.1 | 54.1 | Not reported |
| Cohort 2 Uninfected Sorafenib Naive/Intolerant: Treatment 1 | 33.9 | Not reported | 21.4 | 46.9 | Not reported |
| Cohort 2 Uninfected Sorafenib Progressors: Treatment 2 | 32.8 | Not reported | 20.2 | 46.0 | Not reported |
| Cohort 2 HCV Infected: Treatment 3 | 41.5 | Not reported | 26.9 | 55.5 | Not reported |
| Cohort 2 HBV Infected: Treatment 4 | 26.0 | Not reported | 14.7 | 38.9 | Not reported |
| Cohort 3: Treatment 1 | 30.1 | Not reported | 17.3 | 44.0 | Not reported |
| Cohort 3: Treatment 2 | 42.5 | Not reported | 27.2 | 56.9 | Not reported |
| Cohort 4: Treatment 1 | 42.5 | Not reported | 28.0 | 56.3 | Not reported |
| Cohort 4: Treatment 2 | 43.6 | Not reported | 28.7 | 57.5 | Not reported |
| Cohort 4: Treatment 3 | 32.4 | Not reported | 19.3 | 46.2 | Not reported |
| Cohort 5: Treatment 1 | 31.6 | Not reported | 16.9 | 47.4 | Not reported |
| Cohort 6: Treatment 1 | 42.8 | Not reported | 25.2 | 59.3 | Not reported |
| Cohort 6: Treatment 2 | 50.0 | Not reported | 30.3 | 66.9 | Not reported |
12 Months
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1 Uninfected HCC | 17.1 | Not reported | 4.6 | 36.5 | Not reported |
| Cohort 1 HCV Infected | 24.0 | Not reported | 3.8 | 53.7 | Not reported |
| Cohort 1 HBV Infected | 18.6 | Not reported | 3.0 | 44.5 | Not reported |
| Cohort 2 Uninfected Sorafenib Naive/Intolerant: Treatment 1 | 21.4 | Not reported | 11.3 | 33.6 | Not reported |
| Cohort 2 Uninfected Sorafenib Progressors: Treatment 2 | 19.3 | Not reported | 9.0 | 32.4 | Not reported |
| Cohort 2 HCV Infected: Treatment 3 | 30.9 | Not reported | 17.7 | 45.1 | Not reported |
| Cohort 2 HBV Infected: Treatment 4 | 13.0 | Not reported | 5.3 | 24.2 | Not reported |
| Cohort 3: Treatment 1 | 12.2 | Not reported | 4.1 | 25.0 | Not reported |
| Cohort 3: Treatment 2 | 35.4 | Not reported | 20.5 | 50.6 | Not reported |
| Cohort 4: Treatment 1 | 33.1 | Not reported | 19.8 | 46.9 | Not reported |
| Cohort 4: Treatment 2 | 35.9 | Not reported | 21.9 | 50.1 | Not reported |
| Cohort 4: Treatment 3 | 27.6 | Not reported | 15.4 | 41.3 | Not reported |
| Cohort 5: Treatment 1 | 14.7 | Not reported | 4.4 | 31.0 | Not reported |
| Cohort 6: Treatment 1 | 32.1 | Not reported | 16.5 | 48.9 | Not reported |
| Cohort 6: Treatment 2 | 45.0 | Not reported | 25.5 | 62.7 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 11.7
- upper Limit
- 48.2
- value
- 28.6
- group Id
- OG001
- lower Limit
- 25.3
- upper Limit
- 82.7
- value
- 60.0
- group Id
- OG002
- lower Limit
- 7.1
- upper Limit
- 54.1
- value
- 27.9
- group Id
- OG003
- lower Limit
- 21.4
- upper Limit
- 46.9
- value
- 33.9
- group Id
- OG004
- lower Limit
- 20.2
- upper Limit
- 46.0
- value
- 32.8
- group Id
- OG005
- lower Limit
- 26.9
- upper Limit
- 55.5
- value
- 41.5
- group Id
- OG006
- lower Limit
- 14.7
- upper Limit
- 38.9
- value
- 26.0
- group Id
- OG007
- lower Limit
- 17.3
- upper Limit
- 44.0
- value
- 30.1
- group Id
- OG008
- lower Limit
- 27.2
- upper Limit
- 56.9
- value
- 42.5
- group Id
- OG009
- lower Limit
- 28.0
- upper Limit
- 56.3
- value
- 42.5
- group Id
- OG010
- lower Limit
- 28.7
- upper Limit
- 57.5
- value
- 43.6
- group Id
- OG011
- lower Limit
- 19.3
- upper Limit
- 46.2
- value
- 32.4
- title
- 6 Months
- categories
- measurements
- group Id
- OG000
- lower Limit
- 4.6
- upper Limit
- 36.5
- value
- 17.1
- group Id
- OG001
- lower Limit
- 3.8
- upper Limit
- 53.7
- value
- 24.0
- group Id
- OG002
- lower Limit
- 3.0
- upper Limit
- 44.5
- value
- 18.6
- group Id
- OG003
- lower Limit
- 11.3
- upper Limit
- 33.6
- value
- 21.4
- group Id
- OG004
- lower Limit
- 9.0
- upper Limit
- 32.4
- value
- 19.3
- group Id
- OG005
- lower Limit
- 17.7
- upper Limit
- 45.1
- value
- 30.9
- group Id
- OG006
- lower Limit
- 5.3
- upper Limit
- 24.2
- value
- 13.0
- group Id
- OG007
- lower Limit
- 4.1
- upper Limit
- 25.0
- value
- 12.2
- group Id
- OG008
- lower Limit
- 20.5
- upper Limit
- 50.6
- value
- 35.4
- group Id
- OG009
- lower Limit
- 19.8
- upper Limit
- 46.9
- value
- 33.1
- group Id
- OG010
- lower Limit
- 21.9
- upper Limit
- 50.1
- value
- 35.9
- group Id
- OG011
- lower Limit
- 15.4
- upper Limit
- 41.3
- value
- 27.6
- title
- 12 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
- TTP rate is defined as the percentage of participants without disease progression at select time points (milestones) during the study. Progressive Disease (PD): At least a 20% increase in the sum of the 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 5mm (Note: The appearance of 1or more new lesions is also considered progression).
- 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 and 12 months
- title
- Time to Progression (TTP) Rate Assessed by Blinded Independent Central Review (BICR)
- type
- SECONDARY
- unit Of Measure
- Percent of Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice