Presence of Mutant Kirsten Rat Sarcoma (KRAS) Specific T Cells
A Study of mRNA-5671/V941 as Monotherapy and in Combination With Pembrolizumab (V941-001) · Source last updated 2025-01-28
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Measure
MEAN
Unit
Log10(IFN-g (SFC per 10^6 PBMC))
Interval / dispersion
Standard Deviation
Time frame
Cycle 1 - Cycle 9 (a cycle is 3 weeks) and at the Discontinuation Visit (at the time of withdrawal or up to 30 weeks, whichever occurs first)
What was measured
The presence of mutant KRAS specific T cells (G12D, G12V, G13D, G12C, and Wild type) in blood was assessed using an enzyme linked immunosorbent spot (ELISpot) assay. ELISpot detects interferon gamma (IFN-g) producing T-cells in a participant's peripheral blood mononuclear cells (PBMC) in response to KRAS specific stimulation. Data are presented as spot forming cells (SFC) per 10\^6 PBMC. The post-treatment ELISpot readout for a cycle is reported. A cycle is 3 weeks.
Analysis population: Participants with centrally-confirmed tumor KRAS mutations, with a baseline scan that demonstrated measurable disease and who received at least 1 dose of study treatment. The number of participants analyzed indicates a pre-treatment ELISpot readout for a cycle and a post-treatment ELISpot readout for a cycle, which are required for a participant's data to be reported for a particular cycle. A cycle is 3 weeks.
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 identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
Group
Source count
Part 1: V941 Monotherapy
2
Part 1: V941 + Pembrolizumab
11
Part 2: Expansion Cohort 1 Non-small Cell Lung Cancer (V941 + Pembrolizumab)
6
Part 2: Expansion Cohort 2 Colorectal Cancer (V941 + Pembrolizumab)
7
Part 2: Expansion Cohort 3 Pancreatic Adenocarcinoma (V941 + Pembrolizumab)
3
Reported measurements
KRAS G12D Cycle 1
Analysis denominator · Participants
Group
Source count
Part 1: V941 Monotherapy
1
Part 1: V941 + Pembrolizumab
3
Part 2: Expansion Cohort 1 Non-small Cell Lung Cancer (V941 + Pembrolizumab)
0
Part 2: Expansion Cohort 2 Colorectal Cancer (V941 + Pembrolizumab)
0
Part 2: Expansion Cohort 3 Pancreatic Adenocarcinoma (V941 + Pembrolizumab)
0
Values in Log10(IFN-g (SFC per 10^6 PBMC)) · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 1: V941 Monotherapy
1.00
NA
Not reported
Not reported
Standard deviation was not calculatable when n\<2.
Part 1: V941 + Pembrolizumab
0.56
0.45
Not reported
Not reported
Not reported
KRAS G12D Cycle 2
Analysis denominator · Participants
Group
Source count
Part 1: V941 Monotherapy
1
Part 1: V941 + Pembrolizumab
6
Part 2: Expansion Cohort 1 Non-small Cell Lung Cancer (V941 + Pembrolizumab)
0
Part 2: Expansion Cohort 2 Colorectal Cancer (V941 + Pembrolizumab)
0
Part 2: Expansion Cohort 3 Pancreatic Adenocarcinoma (V941 + Pembrolizumab)
0
Values in Log10(IFN-g (SFC per 10^6 PBMC)) · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 1: V941 Monotherapy
0.60
NA
Not reported
Not reported
Standard deviation was not calculatable when n\<2.
Part 1: V941 + Pembrolizumab
0.59
0.49
Not reported
Not reported
Not reported
KRAS G12D Cycle 3
Analysis denominator · Participants
Group
Source count
Part 1: V941 Monotherapy
1
Part 1: V941 + Pembrolizumab
3
Part 2: Expansion Cohort 1 Non-small Cell Lung Cancer (V941 + Pembrolizumab)
0
Part 2: Expansion Cohort 2 Colorectal Cancer (V941 + Pembrolizumab)
0
Part 2: Expansion Cohort 3 Pancreatic Adenocarcinoma (V941 + Pembrolizumab)
0
Values in Log10(IFN-g (SFC per 10^6 PBMC)) · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 1: V941 Monotherapy
1.45
NA
Not reported
Not reported
Standard deviation was not calculatable when n\<2.
Part 1: V941 + Pembrolizumab
0.76
0.28
Not reported
Not reported
Not reported
KRAS G12D Cycle 4
Analysis denominator · Participants
Group
Source count
Part 1: V941 Monotherapy
0
Part 1: V941 + Pembrolizumab
2
Part 2: Expansion Cohort 1 Non-small Cell Lung Cancer (V941 + Pembrolizumab)
6
Part 2: Expansion Cohort 2 Colorectal Cancer (V941 + Pembrolizumab)
3
Part 2: Expansion Cohort 3 Pancreatic Adenocarcinoma (V941 + Pembrolizumab)
3
Values in Log10(IFN-g (SFC per 10^6 PBMC)) · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 1: V941 + Pembrolizumab
1.35
0.80
Not reported
Not reported
Not reported
Part 2: Expansion Cohort 1 Non-small Cell Lung Cancer (V941 + Pembrolizumab)
2.08
0.48
Not reported
Not reported
Not reported
Part 2: Expansion Cohort 2 Colorectal Cancer (V941 + Pembrolizumab)
1.70
0.82
Not reported
Not reported
Not reported
Part 2: Expansion Cohort 3 Pancreatic Adenocarcinoma (V941 + Pembrolizumab)
2.14
0.82
Not reported
Not reported
Not reported
KRAS G12D Cycle 6
Analysis denominator · Participants
Group
Source count
Part 1: V941 Monotherapy
0
Part 1: V941 + Pembrolizumab
0
Part 2: Expansion Cohort 1 Non-small Cell Lung Cancer (V941 + Pembrolizumab)
4
Part 2: Expansion Cohort 2 Colorectal Cancer (V941 + Pembrolizumab)
2
Part 2: Expansion Cohort 3 Pancreatic Adenocarcinoma (V941 + Pembrolizumab)
2
Values in Log10(IFN-g (SFC per 10^6 PBMC)) · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 2: Expansion Cohort 1 Non-small Cell Lung Cancer (V941 + Pembrolizumab)
2.34
0.40
Not reported
Not reported
Not reported
Part 2: Expansion Cohort 2 Colorectal Cancer (V941 + Pembrolizumab)
2.30
0.53
Not reported
Not reported
Not reported
Part 2: Expansion Cohort 3 Pancreatic Adenocarcinoma (V941 + Pembrolizumab)
2.34
0.15
Not reported
Not reported
Not reported
KRAS G12D Discontinuation Visit
Analysis denominator · Participants
Group
Source count
Part 1: V941 Monotherapy
2
Part 1: V941 + Pembrolizumab
0
Part 2: Expansion Cohort 1 Non-small Cell Lung Cancer (V941 + Pembrolizumab)
0
Part 2: Expansion Cohort 2 Colorectal Cancer (V941 + Pembrolizumab)
0
Part 2: Expansion Cohort 3 Pancreatic Adenocarcinoma (V941 + Pembrolizumab)
0
Values in Log10(IFN-g (SFC per 10^6 PBMC)) · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 1: V941 Monotherapy
0.54
0.34
Not reported
Not reported
Not reported
KRAS G12V Cycle 1
Analysis denominator · Participants
Group
Source count
Part 1: V941 Monotherapy
0
Part 1: V941 + Pembrolizumab
4
Part 2: Expansion Cohort 1 Non-small Cell Lung Cancer (V941 + Pembrolizumab)
0
Part 2: Expansion Cohort 2 Colorectal Cancer (V941 + Pembrolizumab)
0
Part 2: Expansion Cohort 3 Pancreatic Adenocarcinoma (V941 + Pembrolizumab)
0
Values in Log10(IFN-g (SFC per 10^6 PBMC)) · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 1: V941 + Pembrolizumab
0.59
0.53
Not reported
Not reported
Not reported
KRAS G12V Cycle 2
Analysis denominator · Participants
Group
Source count
Part 1: V941 Monotherapy
1
Part 1: V941 + Pembrolizumab
5
Part 2: Expansion Cohort 1 Non-small Cell Lung Cancer (V941 + Pembrolizumab)
0
Part 2: Expansion Cohort 2 Colorectal Cancer (V941 + Pembrolizumab)
0
Part 2: Expansion Cohort 3 Pancreatic Adenocarcinoma (V941 + Pembrolizumab)
0
Values in Log10(IFN-g (SFC per 10^6 PBMC)) · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 1: V941 Monotherapy
0.90
NA
Not reported
Not reported
Standard deviation was not calculatable when n\<2.
Part 1: V941 + Pembrolizumab
0.12
0.27
Not reported
Not reported
Not reported
KRAS G12V Cycle 3
Analysis denominator · Participants
Group
Source count
Part 1: V941 Monotherapy
0
Part 1: V941 + Pembrolizumab
5
Part 2: Expansion Cohort 1 Non-small Cell Lung Cancer (V941 + Pembrolizumab)
0
Part 2: Expansion Cohort 2 Colorectal Cancer (V941 + Pembrolizumab)
0
Part 2: Expansion Cohort 3 Pancreatic Adenocarcinoma (V941 + Pembrolizumab)
0
Values in Log10(IFN-g (SFC per 10^6 PBMC)) · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 1: V941 + Pembrolizumab
0.88
0.54
Not reported
Not reported
Not reported
KRAS G12V Cycle 4
Analysis denominator · Participants
Group
Source count
Part 1: V941 Monotherapy
0
Part 1: V941 + Pembrolizumab
3
Part 2: Expansion Cohort 1 Non-small Cell Lung Cancer (V941 + Pembrolizumab)
5
Part 2: Expansion Cohort 2 Colorectal Cancer (V941 + Pembrolizumab)
3
Part 2: Expansion Cohort 3 Pancreatic Adenocarcinoma (V941 + Pembrolizumab)
1
Values in Log10(IFN-g (SFC per 10^6 PBMC)) · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 1: V941 + Pembrolizumab
1.84
0.14
Not reported
Not reported
Not reported
Part 2: Expansion Cohort 1 Non-small Cell Lung Cancer (V941 + Pembrolizumab)
2.04
1.17
Not reported
Not reported
Not reported
Part 2: Expansion Cohort 2 Colorectal Cancer (V941 + Pembrolizumab)
1.94
0.67
Not reported
Not reported
Not reported
Part 2: Expansion Cohort 3 Pancreatic Adenocarcinoma (V941 + Pembrolizumab)
2.25
NA
Not reported
Not reported
Standard deviation was not calculatable when n\<2.
KRAS G12V Cycle 6
Analysis denominator · Participants
Group
Source count
Part 1: V941 Monotherapy
0
Part 1: V941 + Pembrolizumab
0
Part 2: Expansion Cohort 1 Non-small Cell Lung Cancer (V941 + Pembrolizumab)
3
Part 2: Expansion Cohort 2 Colorectal Cancer (V941 + Pembrolizumab)
2
Part 2: Expansion Cohort 3 Pancreatic Adenocarcinoma (V941 + Pembrolizumab)
0
Values in Log10(IFN-g (SFC per 10^6 PBMC)) · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 2: Expansion Cohort 1 Non-small Cell Lung Cancer (V941 + Pembrolizumab)
1.64
1.43
Not reported
Not reported
Not reported
Part 2: Expansion Cohort 2 Colorectal Cancer (V941 + Pembrolizumab)
1.77
0.21
Not reported
Not reported
Not reported
KRAS G12V Cycle 7
Analysis denominator · Participants
Group
Source count
Part 1: V941 Monotherapy
0
Part 1: V941 + Pembrolizumab
1
Part 2: Expansion Cohort 1 Non-small Cell Lung Cancer (V941 + Pembrolizumab)
0
Part 2: Expansion Cohort 2 Colorectal Cancer (V941 + Pembrolizumab)
0
Part 2: Expansion Cohort 3 Pancreatic Adenocarcinoma (V941 + Pembrolizumab)
0
Values in Log10(IFN-g (SFC per 10^6 PBMC)) · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 1: V941 + Pembrolizumab
2.20
NA
Not reported
Not reported
Standard deviation was not calculatable when n\<2.
KRAS G12V Cycle 9
Analysis denominator · Participants
Group
Source count
Part 1: V941 Monotherapy
0
Part 1: V941 + Pembrolizumab
1
Part 2: Expansion Cohort 1 Non-small Cell Lung Cancer (V941 + Pembrolizumab)
0
Part 2: Expansion Cohort 2 Colorectal Cancer (V941 + Pembrolizumab)
0
Part 2: Expansion Cohort 3 Pancreatic Adenocarcinoma (V941 + Pembrolizumab)
0
Values in Log10(IFN-g (SFC per 10^6 PBMC)) · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 1: V941 + Pembrolizumab
2.20
NA
Not reported
Not reported
Standard deviation was not calculatable when n\<2.
KRAS G12V Discontinuation Visit
Analysis denominator · Participants
Group
Source count
Part 1: V941 Monotherapy
2
Part 1: V941 + Pembrolizumab
0
Part 2: Expansion Cohort 1 Non-small Cell Lung Cancer (V941 + Pembrolizumab)
0
Part 2: Expansion Cohort 2 Colorectal Cancer (V941 + Pembrolizumab)
0
Part 2: Expansion Cohort 3 Pancreatic Adenocarcinoma (V941 + Pembrolizumab)
0
Values in Log10(IFN-g (SFC per 10^6 PBMC)) · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 1: V941 Monotherapy
1.45
0.04
Not reported
Not reported
Not reported
KRAS G12C Cycle 1
Analysis denominator · Participants
Group
Source count
Part 1: V941 Monotherapy
0
Part 1: V941 + Pembrolizumab
2
Part 2: Expansion Cohort 1 Non-small Cell Lung Cancer (V941 + Pembrolizumab)
0
Part 2: Expansion Cohort 2 Colorectal Cancer (V941 + Pembrolizumab)
0
Part 2: Expansion Cohort 3 Pancreatic Adenocarcinoma (V941 + Pembrolizumab)
0
Values in Log10(IFN-g (SFC per 10^6 PBMC)) · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 1: V941 + Pembrolizumab
0.78
0.67
Not reported
Not reported
Not reported
KRAS G12C Cycle 2
Analysis denominator · Participants
Group
Source count
Part 1: V941 Monotherapy
1
Part 1: V941 + Pembrolizumab
5
Part 2: Expansion Cohort 1 Non-small Cell Lung Cancer (V941 + Pembrolizumab)
0
Part 2: Expansion Cohort 2 Colorectal Cancer (V941 + Pembrolizumab)
0
Part 2: Expansion Cohort 3 Pancreatic Adenocarcinoma (V941 + Pembrolizumab)
0
Values in Log10(IFN-g (SFC per 10^6 PBMC)) · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 1: V941 Monotherapy
0.00
NA
Not reported
Not reported
Standard deviation was not calculatable when n\<2.
Part 1: V941 + Pembrolizumab
0.60
0.85
Not reported
Not reported
Not reported
KRAS G12C Cycle 3
Analysis denominator · Participants
Group
Source count
Part 1: V941 Monotherapy
0
Part 1: V941 + Pembrolizumab
3
Part 2: Expansion Cohort 1 Non-small Cell Lung Cancer (V941 + Pembrolizumab)
0
Part 2: Expansion Cohort 2 Colorectal Cancer (V941 + Pembrolizumab)
0
Part 2: Expansion Cohort 3 Pancreatic Adenocarcinoma (V941 + Pembrolizumab)
0
Values in Log10(IFN-g (SFC per 10^6 PBMC)) · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 1: V941 + Pembrolizumab
1.10
0.70
Not reported
Not reported
Not reported
KRAS G12C Cycle 4
Analysis denominator · Participants
Group
Source count
Part 1: V941 Monotherapy
0
Part 1: V941 + Pembrolizumab
2
Part 2: Expansion Cohort 1 Non-small Cell Lung Cancer (V941 + Pembrolizumab)
5
Part 2: Expansion Cohort 2 Colorectal Cancer (V941 + Pembrolizumab)
4
Part 2: Expansion Cohort 3 Pancreatic Adenocarcinoma (V941 + Pembrolizumab)
1
Values in Log10(IFN-g (SFC per 10^6 PBMC)) · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 1: V941 + Pembrolizumab
1.93
0.72
Not reported
Not reported
Not reported
Part 2: Expansion Cohort 1 Non-small Cell Lung Cancer (V941 + Pembrolizumab)
2.07
1.18
Not reported
Not reported
Not reported
Part 2: Expansion Cohort 2 Colorectal Cancer (V941 + Pembrolizumab)
2.12
0.89
Not reported
Not reported
Not reported
Part 2: Expansion Cohort 3 Pancreatic Adenocarcinoma (V941 + Pembrolizumab)
2.45
NA
Not reported
Not reported
Standard deviation was not calculatable when n\<2.
KRAS G12C Cycle 6
Analysis denominator · Participants
Group
Source count
Part 1: V941 Monotherapy
0
Part 1: V941 + Pembrolizumab
0
Part 2: Expansion Cohort 1 Non-small Cell Lung Cancer (V941 + Pembrolizumab)
4
Part 2: Expansion Cohort 2 Colorectal Cancer (V941 + Pembrolizumab)
3
Part 2: Expansion Cohort 3 Pancreatic Adenocarcinoma (V941 + Pembrolizumab)
0
Values in Log10(IFN-g (SFC per 10^6 PBMC)) · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 2: Expansion Cohort 1 Non-small Cell Lung Cancer (V941 + Pembrolizumab)
1.93
1.29
Not reported
Not reported
Not reported
Part 2: Expansion Cohort 2 Colorectal Cancer (V941 + Pembrolizumab)
2.24
0.68
Not reported
Not reported
Not reported
KRAS G12C Discontinuation Visit
Analysis denominator · Participants
Group
Source count
Part 1: V941 Monotherapy
2
Part 1: V941 + Pembrolizumab
0
Part 2: Expansion Cohort 1 Non-small Cell Lung Cancer (V941 + Pembrolizumab)
0
Part 2: Expansion Cohort 2 Colorectal Cancer (V941 + Pembrolizumab)
0
Part 2: Expansion Cohort 3 Pancreatic Adenocarcinoma (V941 + Pembrolizumab)
0
Values in Log10(IFN-g (SFC per 10^6 PBMC)) · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 1: V941 Monotherapy
1.55
0.35
Not reported
Not reported
Not reported
KRAS G13D Cycle 1
Analysis denominator · Participants
Group
Source count
Part 1: V941 Monotherapy
0
Part 1: V941 + Pembrolizumab
2
Part 2: Expansion Cohort 1 Non-small Cell Lung Cancer (V941 + Pembrolizumab)
0
Part 2: Expansion Cohort 2 Colorectal Cancer (V941 + Pembrolizumab)
0
Part 2: Expansion Cohort 3 Pancreatic Adenocarcinoma (V941 + Pembrolizumab)
0
Values in Log10(IFN-g (SFC per 10^6 PBMC)) · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 1: V941 + Pembrolizumab
0.65
0.49
Not reported
Not reported
Not reported
KRAS G13D Cycle 2
Analysis denominator · Participants
Group
Source count
Part 1: V941 Monotherapy
1
Part 1: V941 + Pembrolizumab
3
Part 2: Expansion Cohort 1 Non-small Cell Lung Cancer (V941 + Pembrolizumab)
0
Part 2: Expansion Cohort 2 Colorectal Cancer (V941 + Pembrolizumab)
0
Part 2: Expansion Cohort 3 Pancreatic Adenocarcinoma (V941 + Pembrolizumab)
0
Values in Log10(IFN-g (SFC per 10^6 PBMC)) · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 1: V941 Monotherapy
0.00
NA
Not reported
Not reported
Standard deviation was not calculatable when n\<2.
Part 1: V941 + Pembrolizumab
0.62
0.56
Not reported
Not reported
Not reported
KRAS G13D Cycle 3
Analysis denominator · Participants
Group
Source count
Part 1: V941 Monotherapy
0
Part 1: V941 + Pembrolizumab
3
Part 2: Expansion Cohort 1 Non-small Cell Lung Cancer (V941 + Pembrolizumab)
0
Part 2: Expansion Cohort 2 Colorectal Cancer (V941 + Pembrolizumab)
0
Part 2: Expansion Cohort 3 Pancreatic Adenocarcinoma (V941 + Pembrolizumab)
0
Values in Log10(IFN-g (SFC per 10^6 PBMC)) · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 1: V941 + Pembrolizumab
0.91
0.87
Not reported
Not reported
Not reported
KRAS G13D Cycle 4
Analysis denominator · Participants
Group
Source count
Part 1: V941 Monotherapy
0
Part 1: V941 + Pembrolizumab
2
Part 2: Expansion Cohort 1 Non-small Cell Lung Cancer (V941 + Pembrolizumab)
5
Part 2: Expansion Cohort 2 Colorectal Cancer (V941 + Pembrolizumab)
3
Part 2: Expansion Cohort 3 Pancreatic Adenocarcinoma (V941 + Pembrolizumab)
1
Values in Log10(IFN-g (SFC per 10^6 PBMC)) · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 1: V941 + Pembrolizumab
1.92
0.71
Not reported
Not reported
Not reported
Part 2: Expansion Cohort 1 Non-small Cell Lung Cancer (V941 + Pembrolizumab)
1.53
1.02
Not reported
Not reported
Not reported
Part 2: Expansion Cohort 2 Colorectal Cancer (V941 + Pembrolizumab)
1.48
0.20
Not reported
Not reported
Not reported
Part 2: Expansion Cohort 3 Pancreatic Adenocarcinoma (V941 + Pembrolizumab)
1.26
NA
Not reported
Not reported
Standard deviation was not calculatable when n\<2.
KRAS G13D Cycle 6
Analysis denominator · Participants
Group
Source count
Part 1: V941 Monotherapy
0
Part 1: V941 + Pembrolizumab
0
Part 2: Expansion Cohort 1 Non-small Cell Lung Cancer (V941 + Pembrolizumab)
4
Part 2: Expansion Cohort 2 Colorectal Cancer (V941 + Pembrolizumab)
2
Part 2: Expansion Cohort 3 Pancreatic Adenocarcinoma (V941 + Pembrolizumab)
0
Values in Log10(IFN-g (SFC per 10^6 PBMC)) · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 2: Expansion Cohort 1 Non-small Cell Lung Cancer (V941 + Pembrolizumab)
1.60
1.12
Not reported
Not reported
Not reported
Part 2: Expansion Cohort 2 Colorectal Cancer (V941 + Pembrolizumab)
1.75
0.05
Not reported
Not reported
Not reported
KRAS G13D Discontinuation Visit
Analysis denominator · Participants
Group
Source count
Part 1: V941 Monotherapy
2
Part 1: V941 + Pembrolizumab
0
Part 2: Expansion Cohort 1 Non-small Cell Lung Cancer (V941 + Pembrolizumab)
0
Part 2: Expansion Cohort 2 Colorectal Cancer (V941 + Pembrolizumab)
0
Part 2: Expansion Cohort 3 Pancreatic Adenocarcinoma (V941 + Pembrolizumab)
0
Values in Log10(IFN-g (SFC per 10^6 PBMC)) · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 1: V941 Monotherapy
0.92
0.87
Not reported
Not reported
Not reported
Wild Type Cycle 1
Analysis denominator · Participants
Group
Source count
Part 1: V941 Monotherapy
1
Part 1: V941 + Pembrolizumab
5
Part 2: Expansion Cohort 1 Non-small Cell Lung Cancer (V941 + Pembrolizumab)
0
Part 2: Expansion Cohort 2 Colorectal Cancer (V941 + Pembrolizumab)
0
Part 2: Expansion Cohort 3 Pancreatic Adenocarcinoma (V941 + Pembrolizumab)
0
Values in Log10(IFN-g (SFC per 10^6 PBMC)) · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 1: V941 Monotherapy
1.08
NA
Not reported
Not reported
Standard deviation was not calculatable when n\<2.
Part 1: V941 + Pembrolizumab
0.24
0.54
Not reported
Not reported
Not reported
Wild Type Cycle 2
Analysis denominator · Participants
Group
Source count
Part 1: V941 Monotherapy
1
Part 1: V941 + Pembrolizumab
10
Part 2: Expansion Cohort 1 Non-small Cell Lung Cancer (V941 + Pembrolizumab)
0
Part 2: Expansion Cohort 2 Colorectal Cancer (V941 + Pembrolizumab)
0
Part 2: Expansion Cohort 3 Pancreatic Adenocarcinoma (V941 + Pembrolizumab)
0
Values in Log10(IFN-g (SFC per 10^6 PBMC)) · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 1: V941 Monotherapy
0.00
NA
Not reported
Not reported
Standard deviation was not calculatable when n\<2.
Part 1: V941 + Pembrolizumab
0.49
0.60
Not reported
Not reported
Not reported
Wild Type Cycle 3
Analysis denominator · Participants
Group
Source count
Part 1: V941 Monotherapy
1
Part 1: V941 + Pembrolizumab
5
Part 2: Expansion Cohort 1 Non-small Cell Lung Cancer (V941 + Pembrolizumab)
0
Part 2: Expansion Cohort 2 Colorectal Cancer (V941 + Pembrolizumab)
0
Part 2: Expansion Cohort 3 Pancreatic Adenocarcinoma (V941 + Pembrolizumab)
0
Values in Log10(IFN-g (SFC per 10^6 PBMC)) · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 1: V941 Monotherapy
1.15
NA
Not reported
Not reported
Standard deviation was not calculatable when n\<2.
Part 1: V941 + Pembrolizumab
0.86
0.60
Not reported
Not reported
Not reported
Wild Type Cycle 4
Analysis denominator · Participants
Group
Source count
Part 1: V941 Monotherapy
0
Part 1: V941 + Pembrolizumab
3
Part 2: Expansion Cohort 1 Non-small Cell Lung Cancer (V941 + Pembrolizumab)
6
Part 2: Expansion Cohort 2 Colorectal Cancer (V941 + Pembrolizumab)
7
Part 2: Expansion Cohort 3 Pancreatic Adenocarcinoma (V941 + Pembrolizumab)
3
Values in Log10(IFN-g (SFC per 10^6 PBMC)) · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 1: V941 + Pembrolizumab
1.79
0.59
Not reported
Not reported
Not reported
Part 2: Expansion Cohort 1 Non-small Cell Lung Cancer (V941 + Pembrolizumab)
1.64
0.59
Not reported
Not reported
Not reported
Part 2: Expansion Cohort 2 Colorectal Cancer (V941 + Pembrolizumab)
1.56
0.47
Not reported
Not reported
Not reported
Part 2: Expansion Cohort 3 Pancreatic Adenocarcinoma (V941 + Pembrolizumab)
1.26
0.59
Not reported
Not reported
Not reported
Wild Type Cycle 6
Analysis denominator · Participants
Group
Source count
Part 1: V941 Monotherapy
0
Part 1: V941 + Pembrolizumab
0
Part 2: Expansion Cohort 1 Non-small Cell Lung Cancer (V941 + Pembrolizumab)
4
Part 2: Expansion Cohort 2 Colorectal Cancer (V941 + Pembrolizumab)
3
Part 2: Expansion Cohort 3 Pancreatic Adenocarcinoma (V941 + Pembrolizumab)
2
Values in Log10(IFN-g (SFC per 10^6 PBMC)) · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 2: Expansion Cohort 1 Non-small Cell Lung Cancer (V941 + Pembrolizumab)
1.38
1.01
Not reported
Not reported
Not reported
Part 2: Expansion Cohort 2 Colorectal Cancer (V941 + Pembrolizumab)
1.88
0.24
Not reported
Not reported
Not reported
Part 2: Expansion Cohort 3 Pancreatic Adenocarcinoma (V941 + Pembrolizumab)
1.59
0.08
Not reported
Not reported
Not reported
Wild Type Cycle 7
Analysis denominator · Participants
Group
Source count
Part 1: V941 Monotherapy
0
Part 1: V941 + Pembrolizumab
1
Part 2: Expansion Cohort 1 Non-small Cell Lung Cancer (V941 + Pembrolizumab)
0
Part 2: Expansion Cohort 2 Colorectal Cancer (V941 + Pembrolizumab)
0
Part 2: Expansion Cohort 3 Pancreatic Adenocarcinoma (V941 + Pembrolizumab)
0
Values in Log10(IFN-g (SFC per 10^6 PBMC)) · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 1: V941 + Pembrolizumab
2.33
NA
Not reported
Not reported
Standard deviation was not calculatable when n\<2.
Wild Type Cycle 9
Analysis denominator · Participants
Group
Source count
Part 1: V941 Monotherapy
0
Part 1: V941 + Pembrolizumab
1
Part 2: Expansion Cohort 1 Non-small Cell Lung Cancer (V941 + Pembrolizumab)
0
Part 2: Expansion Cohort 2 Colorectal Cancer (V941 + Pembrolizumab)
0
Part 2: Expansion Cohort 3 Pancreatic Adenocarcinoma (V941 + Pembrolizumab)
0
Values in Log10(IFN-g (SFC per 10^6 PBMC)) · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 1: V941 + Pembrolizumab
1.95
NA
Not reported
Not reported
Standard deviation was not calculatable when n\<2.
Wild Type Discontinuation Visit
Analysis denominator · Participants
Group
Source count
Part 1: V941 Monotherapy
2
Part 1: V941 + Pembrolizumab
0
Part 2: Expansion Cohort 1 Non-small Cell Lung Cancer (V941 + Pembrolizumab)
0
Part 2: Expansion Cohort 2 Colorectal Cancer (V941 + Pembrolizumab)
0
Part 2: Expansion Cohort 3 Pancreatic Adenocarcinoma (V941 + Pembrolizumab)
0
Values in Log10(IFN-g (SFC per 10^6 PBMC)) · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 1: V941 Monotherapy
0.80
0.71
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
comment
Standard deviation was not calculatable when n\<2.
group Id
OG000
spread
NA
value
1.00
group Id
OG001
spread
0.45
value
0.56
denoms
counts
group Id
OG000
value
1
group Id
OG001
value
3
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
units
Participants
title
KRAS G12D Cycle 1
categories
measurements
comment
Standard deviation was not calculatable when n\<2.
group Id
OG000
spread
NA
value
0.60
group Id
OG001
spread
0.49
value
0.59
denoms
counts
group Id
OG000
value
1
group Id
OG001
value
6
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
units
Participants
title
KRAS G12D Cycle 2
categories
measurements
comment
Standard deviation was not calculatable when n\<2.
group Id
OG000
spread
NA
value
1.45
group Id
OG001
spread
0.28
value
0.76
denoms
counts
group Id
OG000
value
1
group Id
OG001
value
3
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
units
Participants
title
KRAS G12D Cycle 3
categories
measurements
group Id
OG001
spread
0.80
value
1.35
group Id
OG002
spread
0.48
value
2.08
group Id
OG003
spread
0.82
value
1.70
group Id
OG004
spread
0.82
value
2.14
denoms
counts
group Id
OG000
value
0
group Id
OG001
value
2
group Id
OG002
value
6
group Id
OG003
value
3
group Id
OG004
value
3
units
Participants
title
KRAS G12D Cycle 4
categories
measurements
group Id
OG002
spread
0.40
value
2.34
group Id
OG003
spread
0.53
value
2.30
group Id
OG004
spread
0.15
value
2.34
denoms
counts
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
4
group Id
OG003
value
2
group Id
OG004
value
2
units
Participants
title
KRAS G12D Cycle 6
categories
measurements
group Id
OG000
spread
0.34
value
0.54
denoms
counts
group Id
OG000
value
2
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
units
Participants
title
KRAS G12D Discontinuation Visit
categories
measurements
group Id
OG001
spread
0.53
value
0.59
denoms
counts
group Id
OG000
value
0
group Id
OG001
value
4
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
units
Participants
title
KRAS G12V Cycle 1
categories
measurements
comment
Standard deviation was not calculatable when n\<2.
group Id
OG000
spread
NA
value
0.90
group Id
OG001
spread
0.27
value
0.12
denoms
counts
group Id
OG000
value
1
group Id
OG001
value
5
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
units
Participants
title
KRAS G12V Cycle 2
categories
measurements
group Id
OG001
spread
0.54
value
0.88
denoms
counts
group Id
OG000
value
0
group Id
OG001
value
5
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
units
Participants
title
KRAS G12V Cycle 3
categories
measurements
group Id
OG001
spread
0.14
value
1.84
group Id
OG002
spread
1.17
value
2.04
group Id
OG003
spread
0.67
value
1.94
comment
Standard deviation was not calculatable when n\<2.
group Id
OG004
spread
NA
value
2.25
denoms
counts
group Id
OG000
value
0
group Id
OG001
value
3
group Id
OG002
value
5
group Id
OG003
value
3
group Id
OG004
value
1
units
Participants
title
KRAS G12V Cycle 4
categories
measurements
group Id
OG002
spread
1.43
value
1.64
group Id
OG003
spread
0.21
value
1.77
denoms
counts
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
3
group Id
OG003
value
2
group Id
OG004
value
0
units
Participants
title
KRAS G12V Cycle 6
categories
measurements
comment
Standard deviation was not calculatable when n\<2.
group Id
OG001
spread
NA
value
2.20
denoms
counts
group Id
OG000
value
0
group Id
OG001
value
1
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
units
Participants
title
KRAS G12V Cycle 7
denoms
counts
group Id
OG000
value
2
group Id
OG001
value
11
group Id
OG002
value
6
group Id
OG003
value
7
group Id
OG004
value
3
units
Participants
description
The presence of mutant KRAS specific T cells (G12D, G12V, G13D, G12C, and Wild type) in blood was assessed using an enzyme linked immunosorbent spot (ELISpot) assay. ELISpot detects interferon gamma (IFN-g) producing T-cells in a participant's peripheral blood mononuclear cells (PBMC) in response to KRAS specific stimulation. Data are presented as spot forming cells (SFC) per 10\^6 PBMC. The post-treatment ELISpot readout for a cycle is reported. A cycle is 3 weeks.
dispersion Type
Standard Deviation
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
MEAN
population Description
Participants with centrally-confirmed tumor KRAS mutations, with a baseline scan that demonstrated measurable disease and who received at least 1 dose of study treatment. The number of participants analyzed indicates a pre-treatment ELISpot readout for a cycle and a post-treatment ELISpot readout for a cycle, which are required for a participant's data to be reported for a particular cycle. A cycle is 3 weeks.
reporting Status
POSTED
time Frame
Cycle 1 - Cycle 9 (a cycle is 3 weeks) and at the Discontinuation Visit (at the time of withdrawal or up to 30 weeks, whichever occurs first)
title
Presence of Mutant Kirsten Rat Sarcoma (KRAS) Specific T Cells
Triangle