NCT05116189 · FLOW
Participant flow
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- groups
- description
- Participants receive pembrolizumab 400 mg via intravenous (IV) infusion on Day 1 of each 6-week cycle for up to 18 cycles (approximately 2 years) PLUS paclitaxel 80 mg/m\^2 via IV infusion on Days 1, 8, and 15 of each 3-week cycle until intolerance or disease progression. Participants who experience severe hypersensitivity reaction to paclitaxel or an adverse event requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m\^2 every 3 weeks \[Q3W\]) after Sponsor consultation. Participants may also receive bevacizumab 10 mg/kg via IV infusion of each 2-week cycle until intolerance, disease progression, or at the Investigator's discretion.
- id
- FG000
- title
- Pembrolizumab + Paclitaxel ± Bevacizumab
- description
- Participants receive placebo via IV infusion on Day 1 of each 6-week cycle for up to 18 cycles (approximately 2 years) PLUS paclitaxel 80 mg/m\^2 via IV infusion on Days 1, 8, and 15 of each 3-week cycle until intolerance or disease progression. Participants who experience severe hypersensitivity reaction to paclitaxel or an adverse event requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m\^2 every 3 weeks \[Q3W\]) after Sponsor consultation. Participants may also receive bevacizumab 10 mg/kg via IV infusion of each 2-week cycle until intolerance, disease progression, or at the Investigator's discretion.
- id
- FG001
- title
- Placebo + Paclitaxel ± Bevacizumab
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 6
- group Id
- FG001
- num Subjects
- 8
- type
- Withdrawal by Subject
- reasons
- group Id
- FG000
- num Subjects
- 221
- group Id
- FG001
- num Subjects
- 240
- type
- Death
- reasons
- group Id
- FG000
- num Subjects
- 95
- group Id
- FG001
- num Subjects
- 73
- type
- Ongoing
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 322
- group Id
- FG001
- num Subjects
- 321
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 320
- group Id
- FG001
- num Subjects
- 318
- type
- Treated
- achievements
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 322
- group Id
- FG001
- num Subjects
- 321
- type
- NOT COMPLETED
- title
- Overall Study
Complete source fields
- groups
- description
- Participants receive pembrolizumab 400 mg via intravenous (IV) infusion on Day 1 of each 6-week cycle for up to 18 cycles (approximately 2 years) PLUS paclitaxel 80 mg/m\^2 via IV infusion on Days 1, 8, and 15 of each 3-week cycle until intolerance or disease progression. Participants who experience severe hypersensitivity reaction to paclitaxel or an adverse event requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m\^2 every 3 weeks \[Q3W\]) after Sponsor consultation. Participants may also receive bevacizumab 10 mg/kg via IV infusion of each 2-week cycle until intolerance, disease progression, or at the Investigator's discretion.
- id
- FG000
- title
- Pembrolizumab + Paclitaxel ± Bevacizumab
- description
- Participants receive placebo via IV infusion on Day 1 of each 6-week cycle for up to 18 cycles (approximately 2 years) PLUS paclitaxel 80 mg/m\^2 via IV infusion on Days 1, 8, and 15 of each 3-week cycle until intolerance or disease progression. Participants who experience severe hypersensitivity reaction to paclitaxel or an adverse event requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m\^2 every 3 weeks \[Q3W\]) after Sponsor consultation. Participants may also receive bevacizumab 10 mg/kg via IV infusion of each 2-week cycle until intolerance, disease progression, or at the Investigator's discretion.
- id
- FG001
- title
- Placebo + Paclitaxel ± Bevacizumab
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 6
- group Id
- FG001
- num Subjects
- 8
- type
- Withdrawal by Subject
- reasons
- group Id
- FG000
- num Subjects
- 221
- group Id
- FG001
- num Subjects
- 240
- type
- Death
- reasons
- group Id
- FG000
- num Subjects
- 95
- group Id
- FG001
- num Subjects
- 73
- type
- Ongoing
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 322
- group Id
- FG001
- num Subjects
- 321
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 320
- group Id
- FG001
- num Subjects
- 318
- type
- Treated
- achievements
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 322
- group Id
- FG001
- num Subjects
- 321
- type
- NOT COMPLETED
- title
- Overall Study
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Preserved source evidence · Not medical advice
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