TriangleNCT02702414 · OUTCOME
Progression-Free Survival (PFS)
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
- Up to approximately 34 months for Cohort 1 and up to approximately 28 months for Cohort 2
What was measured
PFS was defined as the time from the first dose to the first documented progressive disease (PD) or death due to any cause, whichever occurred first, per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by blinded central imaging vendor. PD was at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm, OR unequivocal progression for non-target lesions, OR appearance of one or more new lesions. If there was no disease progression or death, participants were censored at the date of their last disease assessment. The PFS was analyzed using the product-limit (Kaplan-Meier) method for censored data. PFS 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 | 4.9 | Not reported | 3.5 | 6.7 | Not reported |
| Cohort 2: HCC-Systemic Therapy Naïve | 4.3 | Not reported | 2.1 | 7.8 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 3.5
- upper Limit
- 6.7
- value
- 4.9
- group Id
- OG001
- lower Limit
- 2.1
- upper Limit
- 7.8
- value
- 4.3
- denoms
- counts
- group Id
- OG000
- value
- 104
- group Id
- OG001
- value
- 51
- units
- Participants
- description
- PFS was defined as the time from the first dose to the first documented progressive disease (PD) or death due to any cause, whichever occurred first, per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by blinded central imaging vendor. PD was at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm, OR unequivocal progression for non-target lesions, OR appearance of one or more new lesions. If there was no disease progression or death, participants were censored at the date of their last disease assessment. The PFS was analyzed using the product-limit (Kaplan-Meier) method for censored data. PFS 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
- MEDIAN
- 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
- Progression-Free Survival (PFS)
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice