TriangleNCT02853331 · OUTCOME
Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Imaging Review
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- Full Range
- Time frame
- Through Database Cutoff Date of 24-Aug-2018 (up to approximately 22 months)
What was measured
DOR was defined as the time from first documented evidence of a Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) per RECIST 1.1 until progressive disease (PD) or death due to any cause, whichever occurred first. PD was defined per RECIST 1.1 as ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. The DOR was calculated using the product-limit (Kaplan-Meier) method for censored data. The DOR for all participants who experienced a CR or PR is presented.
Analysis population: The analysis population consisted of all randomized participants who experienced a CR or PR.
Groups in this outcome
Pembrolizumab + Axitinib
Participants received pembrolizumab 200 mg intravenously every 3 weeks PLUS axitinib 5 mg orally twice daily.
Sunitinib
Participants received sunitinib 50 mg orally once daily for 4 weeks and then were off treatment for 2 weeks.
| Group | Source count |
|---|---|
| Pembrolizumab + Axitinib | 256 |
| Sunitinib | 153 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pembrolizumab + Axitinib | NA | Not reported | 1.4 | NA | Median DOR not reached by the time of the data cutoff (24-Aug-2018). DOR upper limit not calculated due to no progressive disease by the time of last disease assessment. |
| Sunitinib | 15.2 | Not reported | 1.1 | NA | DOR upper limit not calculated due to no progressive disease by the time of last disease assessment. |
Complete source fields
- classes
- categories
- measurements
- comment
- Median DOR not reached by the time of the data cutoff (24-Aug-2018). DOR upper limit not calculated due to no progressive disease by the time of last disease assessment.
- group Id
- OG000
- lower Limit
- 1.4
- upper Limit
- NA
- value
- NA
- comment
- DOR upper limit not calculated due to no progressive disease by the time of last disease assessment.
- group Id
- OG001
- lower Limit
- 1.1
- upper Limit
- NA
- value
- 15.2
- denoms
- counts
- group Id
- OG000
- value
- 256
- group Id
- OG001
- value
- 153
- units
- Participants
- description
- DOR was defined as the time from first documented evidence of a Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) per RECIST 1.1 until progressive disease (PD) or death due to any cause, whichever occurred first. PD was defined per RECIST 1.1 as ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. The DOR was calculated using the product-limit (Kaplan-Meier) method for censored data. The DOR for all participants who experienced a CR or PR is presented.
- dispersion Type
- Full Range
- groups
- description
- Participants received pembrolizumab 200 mg intravenously every 3 weeks PLUS axitinib 5 mg orally twice daily.
- id
- OG000
- title
- Pembrolizumab + Axitinib
- description
- Participants received sunitinib 50 mg orally once daily for 4 weeks and then were off treatment for 2 weeks.
- id
- OG001
- title
- Sunitinib
- param Type
- MEDIAN
- population Description
- The analysis population consisted of all randomized participants who experienced a CR or PR.
- reporting Status
- POSTED
- time Frame
- Through Database Cutoff Date of 24-Aug-2018 (up to approximately 22 months)
- title
- Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Imaging Review
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice