NCT03582475 · 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 IV over 30 minutes on day 1. Courses repeat every 3 weeks for 2 years in the absence of disease progression or unacceptable toxicity. Participants also receive standard of care chemotherapy comprising etoposide IV on days 1-3 and cisplatin IV or carboplatin IV on day 1 (Cohort 1). Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Cisplatin: Given IV Docetaxel: Given IV Etoposide: Given IV Pembrolizumab: Given IV
- id
- FG000
- title
- Cohort 1: Metastatic or Locally Advanced Naive Small Cell Bladder Cancer
- description
- Participants receive pembrolizumab IV over 30 minutes on day 1. Courses repeat every 3 weeks for 2 years in the absence of disease progression or unacceptable toxicity. Participants also receive standard of care chemotherapy comprising etoposide IV on days 1-3, carboplatin IV on day 1, and docetaxel IV on day 1 (Cohort 2). Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
- id
- FG001
- title
- Cohort 2: Small Cell or Neuroendocrine Prostate Cancer
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 1
- type
- Withdrawal by Subject
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 7
- group Id
- FG001
- num Subjects
- 8
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 7
- group Id
- FG001
- num Subjects
- 7
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 1
- type
- NOT COMPLETED
- title
- Treatment Period
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 1
- type
- Withdrawal by Subject
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 7
- group Id
- FG001
- num Subjects
- 8
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 7
- group Id
- FG001
- num Subjects
- 7
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 1
- type
- NOT COMPLETED
- title
- Follow-up Period
- recruitment Details
- This trial was opened for accrual with the first enrollment on January 11, 2019. The study closed to accrual on May 5, 2022.
Complete source fields
- groups
- description
- Participants receive pembrolizumab IV over 30 minutes on day 1. Courses repeat every 3 weeks for 2 years in the absence of disease progression or unacceptable toxicity. Participants also receive standard of care chemotherapy comprising etoposide IV on days 1-3 and cisplatin IV or carboplatin IV on day 1 (Cohort 1). Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Cisplatin: Given IV Docetaxel: Given IV Etoposide: Given IV Pembrolizumab: Given IV
- id
- FG000
- title
- Cohort 1: Metastatic or Locally Advanced Naive Small Cell Bladder Cancer
- description
- Participants receive pembrolizumab IV over 30 minutes on day 1. Courses repeat every 3 weeks for 2 years in the absence of disease progression or unacceptable toxicity. Participants also receive standard of care chemotherapy comprising etoposide IV on days 1-3, carboplatin IV on day 1, and docetaxel IV on day 1 (Cohort 2). Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
- id
- FG001
- title
- Cohort 2: Small Cell or Neuroendocrine Prostate Cancer
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 1
- type
- Withdrawal by Subject
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 7
- group Id
- FG001
- num Subjects
- 8
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 7
- group Id
- FG001
- num Subjects
- 7
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 1
- type
- NOT COMPLETED
- title
- Treatment Period
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 1
- type
- Withdrawal by Subject
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 7
- group Id
- FG001
- num Subjects
- 8
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 7
- group Id
- FG001
- num Subjects
- 7
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 1
- type
- NOT COMPLETED
- title
- Follow-up Period
- recruitment Details
- This trial was opened for accrual with the first enrollment on January 11, 2019. The study closed to accrual on May 5, 2022.
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Preserved source evidence · Not medical advice
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