TriangleNCT02443324 · OUTCOME
Phase 1a and 1b: Duration of Response (DoR)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Up to 24 Months)
What was measured
The duration of response is defined only for responders (patients with a confirmed CR or PR). It is measured from the date of first evidence of a confirmed CR or PR to the date of objective progression or the date of death due to any cause, whichever is earlier. If a responder is not known to have died or have objective progression as of the data inclusion cutoff date, DoR will be censored at the date of the last complete objective progression-free disease assessment (CR or PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause.
Analysis population: All enrolled participants who received at least one dose of the study drug. Per Protocol, Cohort A and B participants \[Gastric-GEJ cancer (Second-Third L)\] were combined and outcome data was analyzed under a single arm (Cohort A and B).
Groups in this outcome
Cohort A and B
Participants with Gastric-GEJ cancer (Second-Third L) received 8 mg/kg ramucirumab given IV on day 1 and 8 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle in Cohort A. Participants with Gastric-GEJ cancer (Second-Third L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle in Cohort B.
Cohort A1
Participants with BTC cancer (Second-Third L) received 8 mg/kg ramucirumab given IV on day 1 and 8 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.
Cohort A2
Participants with Gastric-GEJ cancer (First L) received 8 mg/kg ramucirumab given IV on day 1 and 8 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.
Cohort C
Participants with NSCLC (Second-Fourth L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.
Cohort D
Participants with Urothelial cancer (Second-Fourth L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.
Cohort E
Participants with NSCLC cancer (First L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.
| Group | Source count |
|---|---|
| Cohort A and B | 3 |
| Cohort A1 | 1 |
| Cohort A2 | 7 |
| Cohort C | 8 |
| Cohort D | 3 |
| Cohort E | 11 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort A and B | 6.7 | Not reported | 4.4 | 17.5 | Not reported |
| Cohort A1 | 6.0 | Not reported | NA | NA | Only 1 participant had PR, therefore 95% Confidence Interval was not calculable. |
| Cohort A2 | NA | Not reported | 9.7 | NA | Median and the upper 95% confidence interval was not achieved due to high censoring rate. |
| Cohort C | NA | Not reported | 11.1 | NA | Median and the upper 95% confidence interval was not achieved due to high censoring rate. |
| Cohort D | 8.3 | Not reported | 4.6 | 16.8 | Not reported |
| Cohort E | NA | Not reported | 5.2 | NA | Median and the upper 95% confidence interval was not achieved due to high censoring rate. |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 4.4
- upper Limit
- 17.5
- value
- 6.7
- comment
- Only 1 participant had PR, therefore 95% Confidence Interval was not calculable.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- 6.0
- comment
- Median and the upper 95% confidence interval was not achieved due to high censoring rate.
- group Id
- OG002
- lower Limit
- 9.7
- upper Limit
- NA
- value
- NA
- comment
- Median and the upper 95% confidence interval was not achieved due to high censoring rate.
- group Id
- OG003
- lower Limit
- 11.1
- upper Limit
- NA
- value
- NA
- group Id
- OG004
- lower Limit
- 4.6
- upper Limit
- 16.8
- value
- 8.3
- comment
- Median and the upper 95% confidence interval was not achieved due to high censoring rate.
- group Id
- OG005
- lower Limit
- 5.2
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 7
- group Id
- OG003
- value
- 8
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 11
- units
- Participants
- description
- The duration of response is defined only for responders (patients with a confirmed CR or PR). It is measured from the date of first evidence of a confirmed CR or PR to the date of objective progression or the date of death due to any cause, whichever is earlier. If a responder is not known to have died or have objective progression as of the data inclusion cutoff date, DoR will be censored at the date of the last complete objective progression-free disease assessment (CR or PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with Gastric-GEJ cancer (Second-Third L) received 8 mg/kg ramucirumab given IV on day 1 and 8 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle in Cohort A. Participants with Gastric-GEJ cancer (Second-Third L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle in Cohort B.
- id
- OG000
- title
- Cohort A and B
- description
- Participants with BTC cancer (Second-Third L) received 8 mg/kg ramucirumab given IV on day 1 and 8 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.
- id
- OG001
- title
- Cohort A1
- description
- Participants with Gastric-GEJ cancer (First L) received 8 mg/kg ramucirumab given IV on day 1 and 8 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.
- id
- OG002
- title
- Cohort A2
- description
- Participants with NSCLC (Second-Fourth L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.
- id
- OG003
- title
- Cohort C
- description
- Participants with Urothelial cancer (Second-Fourth L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.
- id
- OG004
- title
- Cohort D
- description
- Participants with NSCLC cancer (First L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.
- id
- OG005
- title
- Cohort E
- param Type
- MEDIAN
- population Description
- All enrolled participants who received at least one dose of the study drug. Per Protocol, Cohort A and B participants \[Gastric-GEJ cancer (Second-Third L)\] were combined and outcome data was analyzed under a single arm (Cohort A and B).
- reporting Status
- POSTED
- time Frame
- Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Up to 24 Months)
- title
- Phase 1a and 1b: Duration of Response (DoR)
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice