TriangleNCT04704219 · 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 47 months
What was measured
PFS was defined as the time from date of study treatment to the first documented progressive disease (PD) based on Response Evaluation Criteria in Solid Tumors Version 1.1 (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 Blinded Independent Central Review (BICR) is presented.
Analysis population: All allocated participants who received at least 1 dose of study intervention.
Groups in this outcome
Pembrolizumab + Lenvatinib
Participants with non-clear cell Renal Cell Carcinoma (nccRCC) received 400 mg Pembrolizumab (Pembro) intravenously (IV) on Day 1 of a 42-day cycle (every 6 weeks (Q6W)) for approximately 2 years PLUS 20 mg Lenvatinib (Lenva) orally once daily (QD) on Days 1 and 22 of a 42-day cycle (Q6W). Participants continued study intervention until progressive disease or discontinuation.
| Group | Source count |
|---|---|
| Pembrolizumab + Lenvatinib | 158 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pembrolizumab + Lenvatinib | 17.9 | Not reported | 15.0 | 21.1 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 15.0
- upper Limit
- 21.1
- value
- 17.9
- denoms
- counts
- group Id
- OG000
- value
- 158
- units
- Participants
- description
- PFS was defined as the time from date of study treatment to the first documented progressive disease (PD) based on Response Evaluation Criteria in Solid Tumors Version 1.1 (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 Blinded Independent Central Review (BICR) is presented.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with non-clear cell Renal Cell Carcinoma (nccRCC) received 400 mg Pembrolizumab (Pembro) intravenously (IV) on Day 1 of a 42-day cycle (every 6 weeks (Q6W)) for approximately 2 years PLUS 20 mg Lenvatinib (Lenva) orally once daily (QD) on Days 1 and 22 of a 42-day cycle (Q6W). Participants continued study intervention until progressive disease or discontinuation.
- id
- OG000
- title
- Pembrolizumab + Lenvatinib
- 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 47 months
- 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