TriangleNCT03038100 · OUTCOME
Percentage of Participants With Objective Response (OR) Assessed by Investigator as Per RECIST v1.1 - Primary Tumor-Reductive Surgery Group in ITT Population
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
- Not reported
- Time frame
- From randomization until disease progression or death from any cause (up to approximately 55 months)
What was measured
OR is defined as either a CR or PR as determined by the investigator with the use of RECIST v1.1 for patients with measurable residual disease after primary surgery.
Analysis population: Objective Response Rate (ORR) - evaluable population is defined as primary surgery patients in the ITT population with measurable disease at baseline.
Groups in this outcome
Placebo With Paclitaxel, Carboplatin and Bevacizumab
Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab placebo IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab placebo for a total of 22 cycles of atezolizumab placebo and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and placebo for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and placebo for additional 16 cycles.
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab intravenous (IV) infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab for a total of 22 cycles of atezolizumab and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and atezolizumab for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and atezolizumab for additional 16 cycles.
| Group | Source count |
|---|---|
| Placebo With Paclitaxel, Carboplatin and Bevacizumab | 650 |
| Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab | 651 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo With Paclitaxel, Carboplatin and Bevacizumab | 88.7 | Not reported | Not reported | Not reported | Not reported |
| Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab | 92.8 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 88.7
- group Id
- OG001
- value
- 92.8
- denoms
- counts
- group Id
- OG000
- value
- 650
- group Id
- OG001
- value
- 651
- units
- Participants
- description
- OR is defined as either a CR or PR as determined by the investigator with the use of RECIST v1.1 for patients with measurable residual disease after primary surgery.
- groups
- description
- Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab placebo IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab placebo for a total of 22 cycles of atezolizumab placebo and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and placebo for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and placebo for additional 16 cycles.
- id
- OG000
- title
- Placebo With Paclitaxel, Carboplatin and Bevacizumab
- description
- Participants in the primary tumor-reductive surgery group received paclitaxel, carboplatin, atezolizumab intravenous (IV) infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab for a total of 22 cycles of atezolizumab and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group received paclitaxel, carboplatin and atezolizumab for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants started maintenance therapy of bevacizumab and atezolizumab for additional 16 cycles.
- id
- OG001
- title
- Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
- param Type
- NUMBER
- population Description
- Objective Response Rate (ORR) - evaluable population is defined as primary surgery patients in the ITT population with measurable disease at baseline.
- reporting Status
- POSTED
- time Frame
- From randomization until disease progression or death from any cause (up to approximately 55 months)
- title
- Percentage of Participants With Objective Response (OR) Assessed by Investigator as Per RECIST v1.1 - Primary Tumor-Reductive Surgery Group in ITT Population
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice