TriangleNCT02702414 · OUTCOME
Duration of Response (DOR)
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
DOR was determined in participants who demonstrated a confirmed Complete Response (CR: disappearance of all target and non-target lesions) or Partial Response (PR: ≥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. DOR was defined as the time from first documented evidence of a CR or PR until progressive disease (PD) or death. Participants who had not progressed, started a new anti-cancer therapy, been lost to follow-up, or died at the time of analysis were censored at the date of their last tumor assessment. Per RECIST 1.1, 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. The DOR per RECIST 1.1 for all participants who had a confirmed CR or PR is presented.
Analysis population: All participants who received at least one dose of study treatment and who had a confirmed CR or confirmed PR 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 | 19 |
| Cohort 2: HCC-Systemic Therapy Naïve | 8 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1: HCC-Prior Systemic Therapy With Sorafenib | 21.0 | Not reported | 10.7 | NA | NA=upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse |
| Cohort 2: HCC-Systemic Therapy Naïve | 16.2 | Not reported | 3.1 | NA | NA=upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse |
Complete source fields
- classes
- categories
- measurements
- comment
- NA=upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse
- group Id
- OG000
- lower Limit
- 10.7
- upper Limit
- NA
- value
- 21.0
- comment
- NA=upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse
- group Id
- OG001
- lower Limit
- 3.1
- upper Limit
- NA
- value
- 16.2
- denoms
- counts
- group Id
- OG000
- value
- 19
- group Id
- OG001
- value
- 8
- units
- Participants
- description
- DOR was determined in participants who demonstrated a confirmed Complete Response (CR: disappearance of all target and non-target lesions) or Partial Response (PR: ≥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. DOR was defined as the time from first documented evidence of a CR or PR until progressive disease (PD) or death. Participants who had not progressed, started a new anti-cancer therapy, been lost to follow-up, or died at the time of analysis were censored at the date of their last tumor assessment. Per RECIST 1.1, 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. The DOR per RECIST 1.1 for all participants who had a confirmed CR or PR 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 and who had a confirmed CR or confirmed PR 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
- Duration of Response (DOR)
- type
- SECONDARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice