TriangleNCT02702414 · OUTCOME
Objective Response Rate (ORR)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Up to approximately 34 months for Cohort 1 and up to approximately 28 months for Cohort 2
What was measured
ORR was defined as the percentage of participants who had a confirmed Complete Response (CR: Disappearance of all target and non-target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target and non-target lesions) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by blinded central imaging vendor. Participants with missing data were considered non-responders. The percentage of participants who experienced a CR or PR per RECIST 1.1 is presented.
Analysis population: All participants who received at least one dose of study treatment during the first course of therapy.
Groups in this outcome
Cohort 1: HCC-Prior Systemic Therapy With Sorafenib
Participants with previously systemically treated HCC received a pembrolizumab 200 mg IV infusion on Day 1 of each 3-week cycle for up to 35 administrations. Participants who stopped pembrolizumab as a result of obtaining a confirmed complete response (CR) or those who stopped after receiving 35 trial treatments were eligible for an additional 17 trial treatments (approximately an additional 1 year of treatment) after progressive disease if they met the criteria for re-treatment.
Cohort 2: HCC-Systemic Therapy Naïve
Participants with HCC who had not received treatment for systemic disease received a pembrolizumab 200 mg IV infusion on Day 1 of each 3-week cycle for up to 35 administrations. Participants who stopped pembrolizumab as a result of obtaining a confirmed complete response (CR) or those who stopped after receiving 35 trial treatments were eligible for an additional 17 trial treatments (approximately an additional 1 year of treatment) after progressive disease if they met the criteria for re-treatment.
| Group | Source count |
|---|---|
| Cohort 1: HCC-Prior Systemic Therapy With Sorafenib | 104 |
| Cohort 2: HCC-Systemic Therapy Naïve | 51 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1: HCC-Prior Systemic Therapy With Sorafenib | 18.3 | Not reported | 11.4 | 27.1 | Not reported |
| Cohort 2: HCC-Systemic Therapy Naïve | 15.7 | Not reported | 7.0 | 28.6 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 11.4
- upper Limit
- 27.1
- value
- 18.3
- group Id
- OG001
- lower Limit
- 7.0
- upper Limit
- 28.6
- value
- 15.7
- denoms
- counts
- group Id
- OG000
- value
- 104
- group Id
- OG001
- value
- 51
- units
- Participants
- description
- ORR was defined as the percentage of participants who had a confirmed Complete Response (CR: Disappearance of all target and non-target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target and non-target lesions) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by blinded central imaging vendor. Participants with missing data were considered non-responders. The percentage of participants who experienced a CR or PR per RECIST 1.1 is presented.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with previously systemically treated HCC received a pembrolizumab 200 mg IV infusion on Day 1 of each 3-week cycle for up to 35 administrations. Participants who stopped pembrolizumab as a result of obtaining a confirmed complete response (CR) or those who stopped after receiving 35 trial treatments were eligible for an additional 17 trial treatments (approximately an additional 1 year of treatment) after progressive disease if they met the criteria for re-treatment.
- id
- OG000
- title
- Cohort 1: HCC-Prior Systemic Therapy With Sorafenib
- description
- Participants with HCC who had not received treatment for systemic disease received a pembrolizumab 200 mg IV infusion on Day 1 of each 3-week cycle for up to 35 administrations. Participants who stopped pembrolizumab as a result of obtaining a confirmed complete response (CR) or those who stopped after receiving 35 trial treatments were eligible for an additional 17 trial treatments (approximately an additional 1 year of treatment) after progressive disease if they met the criteria for re-treatment.
- id
- OG001
- title
- Cohort 2: HCC-Systemic Therapy Naïve
- param Type
- NUMBER
- population Description
- All participants who received at least one dose of study treatment during the first course of therapy.
- reporting Status
- POSTED
- time Frame
- Up to approximately 34 months for Cohort 1 and up to approximately 28 months for Cohort 2
- title
- Objective Response Rate (ORR)
- type
- PRIMARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice