TriangleNCT01876511 · OUTCOME
Immune-related Progression Free Survival (irPFS) at 20 Weeks in MSI Positive and Negative Colorectal Adenocarcinoma Participants Using Immune Related Response Criteria (irRC) During Stages 1 and 2
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
- 20 weeks
What was measured
For Cohorts A and B: 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 20 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.
Analysis population: It was a pre-specified objective to complete this objective in Cohort A and B only. Per protocol during stages 1 and 2, the study enrollment goal was 25 for Cohort A and B. However, only 24 subjects were enrolled in Cohort A. Additional subjects for this study were enrolled during the second expansion portion of this protocol.
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
| Group | Source count |
|---|---|
| Cohort A: MSI Positive Colorectal Cancer | 24 |
| Cohort B: MSI Negative Colorectal Cancer | 25 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort A: MSI Positive Colorectal Cancer | 88 | Not reported | 75 | 100 | Not reported |
| Cohort B: MSI Negative Colorectal Cancer | 12 | Not reported | 4 | 36 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 75
- upper Limit
- 100
- value
- 88
- group Id
- OG001
- lower Limit
- 4
- upper Limit
- 36
- value
- 12
- denoms
- counts
- group Id
- OG000
- value
- 24
- group Id
- OG001
- value
- 25
- units
- Participants
- description
- For Cohorts A and B: 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 20 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
- param Type
- NUMBER
- population Description
- It was a pre-specified objective to complete this objective in Cohort A and B only. Per protocol during stages 1 and 2, the study enrollment goal was 25 for Cohort A and B. However, only 24 subjects were enrolled in Cohort A. Additional subjects for this study were enrolled during the second expansion portion of this protocol.
- reporting Status
- POSTED
- time Frame
- 20 weeks
- title
- Immune-related Progression Free Survival (irPFS) at 20 Weeks in MSI Positive and Negative Colorectal Adenocarcinoma Participants Using Immune Related Response Criteria (irRC) During Stages 1 and 2
- type
- PRIMARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Independent clinical review pending · Not medical advice