TriangleNCT03582475 · OUTCOME
Proportion of Participants With Progression Free Survival at 12 and 24 Months
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Proportion of patients
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- 12 months and 24 months.
What was measured
Progression Free Survival (PFS) defined as the time from the first day of study treatment to first documented disease progression by Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1 as a 20% increase in the sum of the longest diameter of target lesions, a measurable increase in a non-target lesion, or the appearance of new lesion(s).
Analysis population: Proportion of Participants with Progression Free Survival at 12 and 24 Months was measured using sample size of each cohort and incidence of events to provide confidence intervals.
Groups in this outcome
Cohort 1: Metastatic or Locally Advanced Naive Small Cell Bladder Cancer
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
Cohort 2: Small Cell or Neuroendocrine Prostate Cancer
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.
| Group | Source count |
|---|---|
| Cohort 1: Metastatic or Locally Advanced Naive Small Cell Bladder Cancer | 7 |
| Cohort 2: Small Cell or Neuroendocrine Prostate Cancer | 7 |
Reported measurements
12 months
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1: Metastatic or Locally Advanced Naive Small Cell Bladder Cancer | 0.86 | Not reported | 0.63 | 1.00 | Not reported |
| Cohort 2: Small Cell or Neuroendocrine Prostate Cancer | .43 | Not reported | 0.18 | 1.00 | Not reported |
24 months
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1: Metastatic or Locally Advanced Naive Small Cell Bladder Cancer | 0.86 | Not reported | 0.63 | 1.00 | Not reported |
| Cohort 2: Small Cell or Neuroendocrine Prostate Cancer | 0.14 | Not reported | 0.02 | 0.88 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.63
- upper Limit
- 1.00
- value
- 0.86
- group Id
- OG001
- lower Limit
- 0.18
- upper Limit
- 1.00
- value
- .43
- title
- 12 months
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.63
- upper Limit
- 1.00
- value
- 0.86
- group Id
- OG001
- lower Limit
- 0.02
- upper Limit
- 0.88
- value
- 0.14
- title
- 24 months
- denoms
- counts
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 7
- units
- Participants
- description
- Progression Free Survival (PFS) defined as the time from the first day of study treatment to first documented disease progression by Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1 as a 20% increase in the sum of the longest diameter of target lesions, a measurable increase in a non-target lesion, or the appearance of new lesion(s).
- dispersion Type
- 95% Confidence Interval
- 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
- OG000
- 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
- OG001
- title
- Cohort 2: Small Cell or Neuroendocrine Prostate Cancer
- param Type
- NUMBER
- population Description
- Proportion of Participants with Progression Free Survival at 12 and 24 Months was measured using sample size of each cohort and incidence of events to provide confidence intervals.
- reporting Status
- POSTED
- time Frame
- 12 months and 24 months.
- title
- Proportion of Participants With Progression Free Survival at 12 and 24 Months
- type
- PRIMARY
- unit Of Measure
- Proportion of patients
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice