TriangleNCT04704219 · OUTCOME
Disease Control Rate (DCR)
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 47 months
What was measured
DCR was defined per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as the percentage of participants who have a Complete Response (CR: Disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) or Stable Disease (SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease \[PD: At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm\]). The appearance of one or more new lesions is also considered PD\]). Disease Control rate 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 | 82.3 | Not reported | 75.4 | 87.9 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 75.4
- upper Limit
- 87.9
- value
- 82.3
- denoms
- counts
- group Id
- OG000
- value
- 158
- units
- Participants
- description
- DCR was defined per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as the percentage of participants who have a Complete Response (CR: Disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) or Stable Disease (SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease \[PD: At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm\]). The appearance of one or more new lesions is also considered PD\]). Disease Control rate 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
- NUMBER
- 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
- Disease Control Rate (DCR)
- type
- SECONDARY
- unit Of Measure
- Percentage of Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice