TriangleNCT04269200 · OUTCOME
Duration of Response (DoR) Based on 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
- Inter-Quartile Range
- Time frame
- At baseline, every 9 wks up to 18 wks, then every 12 wks until objective radiological disease progression. Assessed until 12 Apr 2023 DCO, up to 35 months
What was measured
To determine the efficacy of durvalumab in combination with platinum-based chemotherapy (paclitaxel and carboplatin) followed by maintenance durvalumab or durvalumab with olaparib when compared to platinum-based chemotherapy in newly diagnosed advanced or recurrent endometrial cancer patients by assessment of DoR
Analysis population: All participants with confirmed response were included in the analysis. FAS consisting of all patients randomised as part of global enrolment including patients from China who were randomised before the global recruitment was closed (up to and including 20 Apr 2022). This endpoint was not assessed in the China cohort as it was not prespecified in the statistical analysis plan (SAP).
Groups in this outcome
Global Cohort - SoC
Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with durvalumab placebo (IV) Q3W. Following completion of chemotherapy treatment, participants without objective disease progression received durvalumab placebo (IV) Q4W and olaparib placebo (tablets) twice bd orally as maintenance treatment until disease progression.
Global Cohort - SoC + Durvalumab
Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with 1120 mg durvalumab (IV) Q3W. Following completion of chemotherapy treatment, participants without objective disease progression received 1500 mg durvalumab (IV) Q4W with olaparib placebo (tablets) bd orally as maintenance treatment until disease progression.
Global Cohort - SoC + Durvalumab + Olaparib
Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with 1120 mg durvalumab (IV) Q3W. Following completion of chemotherapy treatment, patients without objective disease progression received 1500 mg durvalumab (IV) Q4W with 300 mg olaparib (tablets) bd orally as maintenance treatment until disease progression.
| Group | Source count |
|---|---|
| Global Cohort - SoC | 109 |
| Global Cohort - SoC + Durvalumab | 125 |
| Global Cohort - SoC + Durvalumab + Olaparib | 117 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Global Cohort - SoC | 7.7 | Not reported | 5.1 | 13.5 | Not reported |
| Global Cohort - SoC + Durvalumab | 13.1 | Not reported | 6.0 | NA | Insufficient DoR events to estimate upper confidence limit. |
| Global Cohort - SoC + Durvalumab + Olaparib | 21.3 | Not reported | 8.1 | 29.9 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 5.1
- upper Limit
- 13.5
- value
- 7.7
- comment
- Insufficient DoR events to estimate upper confidence limit.
- group Id
- OG001
- lower Limit
- 6.0
- upper Limit
- NA
- value
- 13.1
- group Id
- OG002
- lower Limit
- 8.1
- upper Limit
- 29.9
- value
- 21.3
- denoms
- counts
- group Id
- OG000
- value
- 109
- group Id
- OG001
- value
- 125
- group Id
- OG002
- value
- 117
- units
- Participants
- description
- To determine the efficacy of durvalumab in combination with platinum-based chemotherapy (paclitaxel and carboplatin) followed by maintenance durvalumab or durvalumab with olaparib when compared to platinum-based chemotherapy in newly diagnosed advanced or recurrent endometrial cancer patients by assessment of DoR
- dispersion Type
- Inter-Quartile Range
- groups
- description
- Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with durvalumab placebo (IV) Q3W. Following completion of chemotherapy treatment, participants without objective disease progression received durvalumab placebo (IV) Q4W and olaparib placebo (tablets) twice bd orally as maintenance treatment until disease progression.
- id
- OG000
- title
- Global Cohort - SoC
- description
- Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with 1120 mg durvalumab (IV) Q3W. Following completion of chemotherapy treatment, participants without objective disease progression received 1500 mg durvalumab (IV) Q4W with olaparib placebo (tablets) bd orally as maintenance treatment until disease progression.
- id
- OG001
- title
- Global Cohort - SoC + Durvalumab
- description
- Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with 1120 mg durvalumab (IV) Q3W. Following completion of chemotherapy treatment, patients without objective disease progression received 1500 mg durvalumab (IV) Q4W with 300 mg olaparib (tablets) bd orally as maintenance treatment until disease progression.
- id
- OG002
- title
- Global Cohort - SoC + Durvalumab + Olaparib
- param Type
- MEDIAN
- population Description
- All participants with confirmed response were included in the analysis. FAS consisting of all patients randomised as part of global enrolment including patients from China who were randomised before the global recruitment was closed (up to and including 20 Apr 2022). This endpoint was not assessed in the China cohort as it was not prespecified in the statistical analysis plan (SAP).
- reporting Status
- POSTED
- time Frame
- At baseline, every 9 wks up to 18 wks, then every 12 wks until objective radiological disease progression. Assessed until 12 Apr 2023 DCO, up to 35 months
- title
- Duration of Response (DoR) Based on Investigator Assessment
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice