TriangleNCT03948763 · OUTCOME
Objective Response Rate (ORR)
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
- Up to approximately 24 months
What was measured
ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experienced CR or PR as assessed by investigator is reported.
Analysis population: All participants who received at least 1 dose of study treatment. Per protocol, the 1 participant who switched over from Arm 1 Part 1: V941 Monotherapy to Arm 2 Part 1: V941 + Pembrolizumab was excluded from Arm 2 Part 1: V941 + Pembrolizumab for this outcome measure.
Groups in this outcome
Part 1: V941 Monotherapy
V941(mRNA-5671/V941) 1 mg administered intramuscularly (IM) once every 3 weeks (Q3W) for 9 3-week cycles
Part 1: V941 + Pembrolizumab
V941(mRNA-5671/V941) 1 mg administered IM Q3W for 9 3-week cycles and pembrolizumab 200 mg, intravenous (IV) for 35 3-week cycles
Part 2: Expansion Cohort 1 Non-small Cell Lung Cancer (V941 + Pembrolizumab)
V941(mRNA-5671/V941) 1 mg administered IM Q3W for 9 3-week cycles and pembrolizumab 200 mg, IV for 35 3-week cycles
Part 2: Expansion Cohort 2 Colorectal Cancer (V941 + Pembrolizumab)
V941(mRNA-5671/V941) 1 mg administered IM Q3W for 9 3-week cycles and pembrolizumab 200 mg, IV for 35 3-week cycles
Part 2: Expansion Cohort 3 Pancreatic Adenocarcinoma (V941 + Pembrolizumab)
V941(mRNA-5671/V941) 1 mg administered IM Q3W for 9 3-week cycles and pembrolizumab 200 mg, IV for 35 3-week cycles
| Group | Source count |
|---|---|
| Part 1: V941 Monotherapy | 3 |
| Part 1: V941 + Pembrolizumab | 15 |
| Part 2: Expansion Cohort 1 Non-small Cell Lung Cancer (V941 + Pembrolizumab) | 20 |
| Part 2: Expansion Cohort 2 Colorectal Cancer (V941 + Pembrolizumab) | 16 |
| Part 2: Expansion Cohort 3 Pancreatic Adenocarcinoma (V941 + Pembrolizumab) | 16 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: V941 Monotherapy | 0.0 | Not reported | 0.0 | 70.8 | Not reported |
| Part 1: V941 + Pembrolizumab | 6.7 | Not reported | 0.2 | 31.9 | Not reported |
| Part 2: Expansion Cohort 1 Non-small Cell Lung Cancer (V941 + Pembrolizumab) | 5.0 | Not reported | 0.1 | 24.9 | Not reported |
| Part 2: Expansion Cohort 2 Colorectal Cancer (V941 + Pembrolizumab) | 12.5 | Not reported | 1.6 | 38.3 | Not reported |
| Part 2: Expansion Cohort 3 Pancreatic Adenocarcinoma (V941 + Pembrolizumab) | 0.0 | Not reported | 0.0 | 20.6 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.0
- upper Limit
- 70.8
- value
- 0.0
- group Id
- OG001
- lower Limit
- 0.2
- upper Limit
- 31.9
- value
- 6.7
- group Id
- OG002
- lower Limit
- 0.1
- upper Limit
- 24.9
- value
- 5.0
- group Id
- OG003
- lower Limit
- 1.6
- upper Limit
- 38.3
- value
- 12.5
- group Id
- OG004
- lower Limit
- 0.0
- upper Limit
- 20.6
- value
- 0.0
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 15
- group Id
- OG002
- value
- 20
- group Id
- OG003
- value
- 16
- group Id
- OG004
- value
- 16
- units
- Participants
- description
- ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experienced CR or PR as assessed by investigator is reported.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- V941(mRNA-5671/V941) 1 mg administered intramuscularly (IM) once every 3 weeks (Q3W) for 9 3-week cycles
- id
- OG000
- title
- Part 1: V941 Monotherapy
- description
- V941(mRNA-5671/V941) 1 mg administered IM Q3W for 9 3-week cycles and pembrolizumab 200 mg, intravenous (IV) for 35 3-week cycles
- id
- OG001
- title
- Part 1: V941 + Pembrolizumab
- description
- V941(mRNA-5671/V941) 1 mg administered IM Q3W for 9 3-week cycles and pembrolizumab 200 mg, IV for 35 3-week cycles
- id
- OG002
- title
- Part 2: Expansion Cohort 1 Non-small Cell Lung Cancer (V941 + Pembrolizumab)
- description
- V941(mRNA-5671/V941) 1 mg administered IM Q3W for 9 3-week cycles and pembrolizumab 200 mg, IV for 35 3-week cycles
- id
- OG003
- title
- Part 2: Expansion Cohort 2 Colorectal Cancer (V941 + Pembrolizumab)
- description
- V941(mRNA-5671/V941) 1 mg administered IM Q3W for 9 3-week cycles and pembrolizumab 200 mg, IV for 35 3-week cycles
- id
- OG004
- title
- Part 2: Expansion Cohort 3 Pancreatic Adenocarcinoma (V941 + Pembrolizumab)
- param Type
- NUMBER
- population Description
- All participants who received at least 1 dose of study treatment. Per protocol, the 1 participant who switched over from Arm 1 Part 1: V941 Monotherapy to Arm 2 Part 1: V941 + Pembrolizumab was excluded from Arm 2 Part 1: V941 + Pembrolizumab for this outcome measure.
- reporting Status
- POSTED
- time Frame
- Up to approximately 24 months
- title
- Objective Response Rate (ORR)
- type
- SECONDARY
- unit Of Measure
- Percentage of Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice