TriangleNCT01876511 · OUTCOME
Immune-related Progression Free Survival (irPFS) at 28 Weeks in MSI Positive and Negative Solid Tumor Malignancies Using Immune Related Response Criteria (irRC)
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
- 95% Confidence Interval
- Time frame
- 28 weeks
What was measured
irPFS rate is defined as the percentage of patients with disease progression (irPD or relapse from irCR as assessed using irRC criteria) or death due to any cause at 28 weeks. Per irRC criteria, Complete Response (irCR) is the disappearance of all target lesions, Partial Response (irPR) is a decrease in tumor burden by 50% or greater by a consecutive assessment at least 4 weeks after first documentation, Stable Disease (irSD) is the failure to meet criteria for irCR or irPR (in absence of irPD), Progressive Disease (irPD) is at least 25% increase in tumor burden relative to nadir. Estimation based on the Kaplan-Meier curve.
Groups in this outcome
Cohort A: MSI Positive Colorectal Cancer
MK-3475: MK-3475 10 mg/kg every 14 days
Cohort B: MSI Negative Colorectal Cancer
MK-3475: MK-3475 10 mg/kg every 14 days
Cohort C: MSI Positive Non-Colorectal Cancer
MK-3475: MK-3475 10 mg/kg every 14 days
| Group | Source count |
|---|---|
| Cohort A: MSI Positive Colorectal Cancer | 41 |
| Cohort B: MSI Negative Colorectal Cancer | 25 |
| Cohort C: MSI Positive Non-Colorectal Cancer | 47 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort A: MSI Positive Colorectal Cancer | 70 | Not reported | 58 | 86 | Not reported |
| Cohort B: MSI Negative Colorectal Cancer | 12 | Not reported | 4 | 36 | Not reported |
| Cohort C: MSI Positive Non-Colorectal Cancer | 64 | Not reported | 51 | 80 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 58
- upper Limit
- 86
- value
- 70
- group Id
- OG001
- lower Limit
- 4
- upper Limit
- 36
- value
- 12
- group Id
- OG002
- lower Limit
- 51
- upper Limit
- 80
- value
- 64
- denoms
- counts
- group Id
- OG000
- value
- 41
- group Id
- OG001
- value
- 25
- group Id
- OG002
- value
- 47
- units
- Participants
- description
- irPFS rate is defined as the percentage of patients with disease progression (irPD or relapse from irCR as assessed using irRC criteria) or death due to any cause at 28 weeks. Per irRC criteria, Complete Response (irCR) is the disappearance of all target lesions, Partial Response (irPR) is a decrease in tumor burden by 50% or greater by a consecutive assessment at least 4 weeks after first documentation, Stable Disease (irSD) is the failure to meet criteria for irCR or irPR (in absence of irPD), Progressive Disease (irPD) is at least 25% increase in tumor burden relative to nadir. Estimation based on the Kaplan-Meier curve.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- MK-3475: MK-3475 10 mg/kg every 14 days
- id
- OG000
- title
- Cohort A: MSI Positive Colorectal Cancer
- description
- MK-3475: MK-3475 10 mg/kg every 14 days
- id
- OG001
- title
- Cohort B: MSI Negative Colorectal Cancer
- description
- MK-3475: MK-3475 10 mg/kg every 14 days
- id
- OG002
- title
- Cohort C: MSI Positive Non-Colorectal Cancer
- param Type
- NUMBER
- reporting Status
- POSTED
- time Frame
- 28 weeks
- title
- Immune-related Progression Free Survival (irPFS) at 28 Weeks in MSI Positive and Negative Solid Tumor Malignancies Using Immune Related Response Criteria (irRC)
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Independent clinical review pending · Not medical advice