TriangleNCT01658878 · OUTCOME
Duration of Response (DOR) 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
- MEDIAN
- Unit
- Months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From first documented response to first documented progression or death, whichever occurs first (Up to approximately 144 months)
What was measured
DOR is defined as the time from the first documented objective response (either complete or partial response) until the date of disease progression or death from any cause, whichever occurs first. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. 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 whose best overall response (BOR) is either complete response (CR) or partial response (PR). 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 | 3 |
| Cohort 1 HCV Infected | 2 |
| Cohort 1 HBV Infected | 2 |
| Cohort 2 Uninfected Sorafenib Naive/Intolerant: Treatment 1 | 11 |
| Cohort 2 Uninfected Sorafenib Progressors: Treatment 2 | 8 |
| Cohort 2 HCV Infected: Treatment 3 | 10 |
| Cohort 2 HBV Infected: Treatment 4 | 7 |
| Cohort 3: Treatment 1 | 8 |
| Cohort 3: Treatment 2 | 4 |
| Cohort 4: Treatment 1 | 16 |
| Cohort 4: Treatment 2 | 16 |
| Cohort 4: Treatment 3 | 15 |
| Cohort 5: Treatment 1 | 3 |
| Cohort 6: Treatment 1 | 5 |
| Cohort 6: Treatment 2 | 10 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1 Uninfected HCC | NA | Not reported | 8.74 | NA | Not estimable due to insufficient number of events |
| Cohort 1 HCV Infected | 12.55 | Not reported | 5.75 | NA | Insufficient number of events to calculate UL |
| Cohort 1 HBV Infected | 6.41 | Not reported | 2.83 | NA | Insufficient number of events to calculate UL |
| Cohort 2 Uninfected Sorafenib Naive/Intolerant: Treatment 1 | 22.57 | Not reported | 5.62 | 31.80 | Not reported |
| Cohort 2 Uninfected Sorafenib Progressors: Treatment 2 | 11.30 | Not reported | 5.55 | NA | Insufficient number of events to calculate UL |
| Cohort 2 HCV Infected: Treatment 3 | NA | Not reported | 3.15 | NA | Not estimable due to insufficient number of events |
| Cohort 2 HBV Infected: Treatment 4 | NA | Not reported | 8.31 | NA | Not estimable due to insufficient number of events |
| Cohort 3: Treatment 1 | 5.21 | Not reported | 2.10 | NA | Insufficient number of events to calculate UL |
| Cohort 3: Treatment 2 | 9.26 | Not reported | 5.45 | NA | Insufficient number of events to calculate UL |
| Cohort 4: Treatment 1 | 17.48 | Not reported | 8.31 | 52.47 | Not reported |
| Cohort 4: Treatment 2 | 22.21 | Not reported | 9.36 | NA | Insufficient number of events to calculate UL |
| Cohort 4: Treatment 3 | 16.59 | Not reported | 4.34 | 48.20 | Not reported |
| Cohort 5: Treatment 1 | 18.40 | Not reported | NA | NA | Insufficient number of events to calculate LL and UL |
| Cohort 6: Treatment 1 | 21.55 | Not reported | 10.84 | NA | Insufficient number of events to calculate UL |
| Cohort 6: Treatment 2 | 49.51 | Not reported | 7.72 | NA | Insufficient number of events to calculate UL |
Complete source fields
- classes
- categories
- measurements
- comment
- Not estimable due to insufficient number of events
- group Id
- OG000
- lower Limit
- 8.74
- upper Limit
- NA
- value
- NA
- comment
- Insufficient number of events to calculate UL
- group Id
- OG001
- lower Limit
- 5.75
- upper Limit
- NA
- value
- 12.55
- comment
- Insufficient number of events to calculate UL
- group Id
- OG002
- lower Limit
- 2.83
- upper Limit
- NA
- value
- 6.41
- group Id
- OG003
- lower Limit
- 5.62
- upper Limit
- 31.80
- value
- 22.57
- comment
- Insufficient number of events to calculate UL
- group Id
- OG004
- lower Limit
- 5.55
- upper Limit
- NA
- value
- 11.30
- comment
- Not estimable due to insufficient number of events
- group Id
- OG005
- lower Limit
- 3.15
- upper Limit
- NA
- value
- NA
- comment
- Not estimable due to insufficient number of events
- group Id
- OG006
- lower Limit
- 8.31
- upper Limit
- NA
- value
- NA
- comment
- Insufficient number of events to calculate UL
- group Id
- OG007
- lower Limit
- 2.10
- upper Limit
- NA
- value
- 5.21
- comment
- Insufficient number of events to calculate UL
- group Id
- OG008
- lower Limit
- 5.45
- upper Limit
- NA
- value
- 9.26
- group Id
- OG009
- lower Limit
- 8.31
- upper Limit
- 52.47
- value
- 17.48
- comment
- Insufficient number of events to calculate UL
- group Id
- OG010
- lower Limit
- 9.36
- upper Limit
- NA
- value
- 22.21
- group Id
- OG011
- lower Limit
- 4.34
- upper Limit
- 48.20
- value
- 16.59
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 11
- group Id
- OG004
- value
- 8
- group Id
- OG005
- value
- 10
- group Id
- OG006
- value
- 7
- group Id
- OG007
- value
- 8
- group Id
- OG008
- value
- 4
- group Id
- OG009
- value
- 16
- group Id
- OG010
- value
- 16
- group Id
- OG011
- value
- 15
- units
- Participants
- description
- DOR is defined as the time from the first documented objective response (either complete or partial response) until the date of disease progression or death from any cause, whichever occurs first. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. 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
- MEDIAN
- population Description
- All treated participants for Cohort 1, 2, and 5, and all randomized participants for Cohort 3, 4 and 6 whose best overall response (BOR) is either complete response (CR) or partial response (PR). Uninfected HCC, HCV-infected, and HBV-infected participants were pre-specified to be reported together for Cohort 1.
- reporting Status
- POSTED
- time Frame
- From first documented response to first documented progression or death, whichever occurs first (Up to approximately 144 months)
- title
- Duration of Response (DOR) Assessed by Blinded Independent Central Review (BICR)
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice