TriangleNCT01876511 · OUTCOME
Immune-related Objective Response Rate 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
- 28 months
What was measured
For Cohorts A and B: Immune-related Objective Response Rate (irORR) is defined as the percentage of patients achieving a complete response (irCR) or partial response (irPR) based on irRC criteria. 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.
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 | 67 | Not reported | 45 | 84 | Not reported |
| Cohort B: MSI Negative Colorectal Cancer | 0 | Not reported | 0 | 14 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 45
- upper Limit
- 84
- value
- 67
- group Id
- OG001
- lower Limit
- 0
- upper Limit
- 14
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 24
- group Id
- OG001
- value
- 25
- units
- Participants
- description
- For Cohorts A and B: Immune-related Objective Response Rate (irORR) is defined as the percentage of patients achieving a complete response (irCR) or partial response (irPR) based on irRC criteria. 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.
- 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
- 28 months
- title
- Immune-related Objective Response Rate 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