TriangleNCT01658878 · OUTCOME
Objective Response Rate (ORR) by Investigator for Cohorts 3, 4, 5, and 6
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
- From the date of randomization (Cohort 3, 4, 6) or the date of first dose (Cohort 5) until disease progression, or the date of subsequent anti-cancer therapy, whichever occurs first (Up to approximately 144 months)
What was measured
Objective response rate (ORR) is defined as the percent of all treated participants whose best overall response (BOR) is either complete response (CR) or partial response (PR) by Investigator per Response Evaluation Criteria in Solid Tumors (RECIST v1.1). 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 Cohorts 05, and all randomized participants for Cohorts 03, 04 and 06 only. Pre-specified to be reported for Cohorts 3 through 6.
Groups in this outcome
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 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
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 3: Treatment 1 | 11.5 | Not reported | 4.7 | 22.2 | Not reported |
| Cohort 3: Treatment 2 | 4.5 | Not reported | 0.9 | 12.7 | Not reported |
| Cohort 4: Treatment 1 | 36.0 | Not reported | 22.9 | 50.8 | Not reported |
| Cohort 4: Treatment 2 | 26.5 | Not reported | 14.9 | 41.1 | Not reported |
| Cohort 4: Treatment 3 | 28.6 | Not reported | 16.6 | 43.3 | Not reported |
| Cohort 5: Treatment 1 | 12.2 | Not reported | 4.6 | 24.8 | Not reported |
| Cohort 6: Treatment 1 | 16.7 | Not reported | 6.4 | 32.8 | Not reported |
| Cohort 6: Treatment 2 | 25.7 | Not reported | 12.5 | 43.3 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 4.7
- upper Limit
- 22.2
- value
- 11.5
- group Id
- OG001
- lower Limit
- 0.9
- upper Limit
- 12.7
- value
- 4.5
- group Id
- OG002
- lower Limit
- 22.9
- upper Limit
- 50.8
- value
- 36.0
- group Id
- OG003
- lower Limit
- 14.9
- upper Limit
- 41.1
- value
- 26.5
- group Id
- OG004
- lower Limit
- 16.6
- upper Limit
- 43.3
- value
- 28.6
- group Id
- OG005
- lower Limit
- 4.6
- upper Limit
- 24.8
- value
- 12.2
- group Id
- OG006
- lower Limit
- 6.4
- upper Limit
- 32.8
- value
- 16.7
- group Id
- OG007
- lower Limit
- 12.5
- upper Limit
- 43.3
- value
- 25.7
- denoms
- counts
- group Id
- OG000
- value
- 61
- group Id
- OG001
- value
- 66
- group Id
- OG002
- value
- 50
- group Id
- OG003
- value
- 49
- group Id
- OG004
- value
- 49
- group Id
- OG005
- value
- 49
- group Id
- OG006
- value
- 36
- group Id
- OG007
- value
- 35
- units
- Participants
- description
- Objective response rate (ORR) is defined as the percent of all treated participants whose best overall response (BOR) is either complete response (CR) or partial response (PR) by Investigator per Response Evaluation Criteria in Solid Tumors (RECIST v1.1). 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
- Arm A: Advance hepatocellular carcinoma (HCC) participants received nivolumab 240 mg every 2 weeks
- id
- OG000
- title
- Cohort 3: Treatment 1
- description
- Arm B: Advance hepatocellular carcinoma (HCC) participants received Sorafenib 400 mg twice a day
- id
- OG001
- title
- Cohort 3: Treatment 2
- description
- Arm A: Participants received nivolumab 1 mg/kg + ipilimumab 3 mg/kg every 3 weeks
- id
- OG002
- title
- Cohort 4: Treatment 1
- description
- Arm B: Participants received nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks
- id
- OG003
- 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
- OG004
- title
- Cohort 4: Treatment 3
- description
- Participants received nivolumab 240 mg every 2 weeks
- id
- OG005
- title
- Cohort 5: Treatment 1
- description
- Participants received nivolumab 240 mg every 2 weeks + cabozantinib 40 mg once daily
- id
- OG006
- title
- Cohort 6: Treatment 1
- description
- Participants received nivolumab 3 mg/kg every 2 weeks + ipilimumab 1 mg/kg every 6 weeks + cabozantinib 40 mg once daily
- id
- OG007
- title
- Cohort 6: Treatment 2
- param Type
- NUMBER
- population Description
- All treated participants for Cohorts 05, and all randomized participants for Cohorts 03, 04 and 06 only. Pre-specified to be reported for Cohorts 3 through 6.
- reporting Status
- POSTED
- time Frame
- From the date of randomization (Cohort 3, 4, 6) or the date of first dose (Cohort 5) until disease progression, or the date of subsequent anti-cancer therapy, whichever occurs first (Up to approximately 144 months)
- title
- Objective Response Rate (ORR) by Investigator for Cohorts 3, 4, 5, and 6
- type
- PRIMARY
- unit Of Measure
- Percent of Participants
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Preserved source evidence · Not medical advice