TriangleNCT03797326 · OUTCOME
Progression-Free Survival (PFS) Per RECIST 1.1 by Investigator Assessment
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 66 months
What was measured
PFS was defined as the time from date of study treatment to the first documented progressive disease (PD) based on RECIST 1.1, modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. The percentage of participants who experienced PFS per RECIST 1.1 by investigator assessment is presented. Per protocol, only data for Cohorts A and B were presented for this endpoint.
Analysis population: All allocated participants who received at least 1 dose of study intervention.
Groups in this outcome
Cohort A: Triple Negative Breast Cancer (Lenva + Pembro)
Participants received Pembrolizumab (pembro) 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenvatinib (lenva) 20 mg via oral capsule once a day (QD) up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
Cohort B: Ovarian Cancer (Lenva + Pembro)
Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
| Group | Source count |
|---|---|
| Cohort A: Triple Negative Breast Cancer (Lenva + Pembro) | 31 |
| Cohort B: Ovarian Cancer (Lenva + Pembro) | 31 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort A: Triple Negative Breast Cancer (Lenva + Pembro) | 4.2 | Not reported | 1.7 | 6.3 | Not reported |
| Cohort B: Ovarian Cancer (Lenva + Pembro) | 6.1 | Not reported | 4.1 | 9.4 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.7
- upper Limit
- 6.3
- value
- 4.2
- group Id
- OG001
- lower Limit
- 4.1
- upper Limit
- 9.4
- value
- 6.1
- denoms
- counts
- group Id
- OG000
- value
- 31
- group Id
- OG001
- value
- 31
- units
- Participants
- description
- PFS was defined as the time from date of study treatment to the first documented progressive disease (PD) based on RECIST 1.1, modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. The percentage of participants who experienced PFS per RECIST 1.1 by investigator assessment is presented. Per protocol, only data for Cohorts A and B were presented for this endpoint.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received Pembrolizumab (pembro) 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenvatinib (lenva) 20 mg via oral capsule once a day (QD) up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
- id
- OG000
- title
- Cohort A: Triple Negative Breast Cancer (Lenva + Pembro)
- description
- Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
- id
- OG001
- title
- Cohort B: Ovarian Cancer (Lenva + Pembro)
- param Type
- MEDIAN
- population Description
- All allocated participants who received at least 1 dose of study intervention.
- reporting Status
- POSTED
- time Frame
- Up to approximately 66 months
- title
- Progression-Free Survival (PFS) Per RECIST 1.1 by Investigator Assessment
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice