TriangleNCT01658878 · OUTCOME
Objective Response Rate (ORR) Assessed by Blinded Independent Central Review (BICR) for Cohort 2
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 start of the study treatment 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 BICR 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 Cohort 2 only. Pre-specified to be reported for Cohort 2 only.
Groups in this outcome
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
| Group | Source count |
|---|---|
| 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 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 2 Uninfected Sorafenib Naive/Intolerant: Treatment 1 | 19.6 | Not reported | 10.2 | 32.4 | Not reported |
| Cohort 2 Uninfected Sorafenib Progressors: Treatment 2 | 14.0 | Not reported | 6.3 | 25.8 | Not reported |
| Cohort 2 HCV Infected: Treatment 3 | 20.0 | Not reported | 10.0 | 33.7 | Not reported |
| Cohort 2 HBV Infected: Treatment 4 | 13.7 | Not reported | 5.7 | 26.3 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 10.2
- upper Limit
- 32.4
- value
- 19.6
- group Id
- OG001
- lower Limit
- 6.3
- upper Limit
- 25.8
- value
- 14.0
- group Id
- OG002
- lower Limit
- 10.0
- upper Limit
- 33.7
- value
- 20.0
- group Id
- OG003
- lower Limit
- 5.7
- upper Limit
- 26.3
- value
- 13.7
- denoms
- counts
- group Id
- OG000
- value
- 56
- group Id
- OG001
- value
- 57
- group Id
- OG002
- value
- 50
- group Id
- OG003
- value
- 51
- 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 BICR 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
- Dose Expansion: Uninfected hepatocellular carcinoma (HCC) participants who are sorafenib naive/intolerant received nivolumab 3 mg/kg every 2 weeks
- id
- OG000
- 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
- OG001
- 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
- OG002
- title
- Cohort 2 HCV Infected: Treatment 3
- description
- Dose Expansion: Hepatitis B (HBV)-infected participants received nivolumab 3 mg/kg every 2 weeks
- id
- OG003
- title
- Cohort 2 HBV Infected: Treatment 4
- param Type
- NUMBER
- population Description
- All treated participants for Cohort 2 only. Pre-specified to be reported for Cohort 2 only.
- reporting Status
- POSTED
- time Frame
- From the start of the study treatment until disease progression, or the date of subsequent anti-cancer therapy, whichever occurs first (Up to approximately 144 months)
- title
- Objective Response Rate (ORR) Assessed by Blinded Independent Central Review (BICR) for Cohort 2
- type
- PRIMARY
- unit Of Measure
- Percent of Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice