NCT03948763 · BASELINE
Baseline characteristics
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- denoms
- counts
- group Id
- BG000
- value
- 3
- group Id
- BG001
- value
- 15
- group Id
- BG002
- value
- 20
- group Id
- BG003
- value
- 16
- group Id
- BG004
- value
- 16
- group Id
- BG005
- value
- 70
- units
- Participants
- groups
- description
- V941(mRNA-5671/V941) 1 mg administered intramuscularly (IM) once every 3 weeks (Q3W) for 9 3-week cycles
- id
- BG000
- 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
- BG001
- 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
- BG002
- 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
- BG003
- 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
- BG004
- title
- Part 2: Expansion Cohort 3 Pancreatic Adenocarcinoma (V941 + Pembrolizumab)
- description
- Total of all reporting groups
- id
- BG005
- title
- Total
- measures
- classes
- categories
- measurements
- group Id
- BG000
- value
- 2
- group Id
- BG001
- value
- 10
- group Id
- BG002
- value
- 9
- group Id
- BG003
- value
- 12
- group Id
- BG004
- value
- 6
- group Id
- BG005
- value
- 39
- title
- < 65 years
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 5
- group Id
- BG002
- value
- 11
- group Id
- BG003
- value
- 4
- group Id
- BG004
- value
- 10
- group Id
- BG005
- value
- 31
- title
- >= 65 years
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Age, Customized
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 9
- group Id
- BG002
- value
- 13
- group Id
- BG003
- value
- 7
- group Id
- BG004
- value
- 9
- group Id
- BG005
- value
- 39
- title
- Female
- measurements
- group Id
- BG000
- value
- 2
- group Id
- BG001
- value
- 6
- group Id
- BG002
- value
- 7
- group Id
- BG003
- value
- 9
- group Id
- BG004
- value
- 7
- group Id
- BG005
- value
- 31
- title
- Male
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Sex: Female, Male
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 3
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 3
- title
- Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 3
- group Id
- BG001
- value
- 11
- group Id
- BG002
- value
- 19
- group Id
- BG003
- value
- 15
- group Id
- BG004
- value
- 16
- group Id
- BG005
- value
- 64
- title
- Not Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 1
- group Id
- BG003
- value
- 1
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 3
- title
- Unknown or Not Reported
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Ethnicity (NIH/OMB)
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 0
- title
- American Indian or Alaska Native
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 12
- group Id
- BG003
- value
- 9
- group Id
- BG004
- value
- 9
- group Id
- BG005
- value
- 31
- title
- Asian
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 0
- title
- Native Hawaiian or Other Pacific Islander
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 2
- title
- Black or African American
- measurements
- group Id
- BG000
- value
- 2
- group Id
- BG001
- value
- 12
- group Id
- BG002
- value
- 8
- group Id
- BG003
- value
- 6
- group Id
- BG004
- value
- 7
- group Id
- BG005
- value
- 35
- title
- White
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 1
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 1
- title
- More than one race
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 1
- title
- Unknown or Not Reported
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Race (NIH/OMB)
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 2
- group Id
- BG001
- value
- 7
- group Id
- BG002
- value
- 1
- group Id
- BG003
- value
- 7
- group Id
- BG004
- value
- 6
- group Id
- BG005
- value
- 23
- title
- ECOG = 0
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 8
- group Id
- BG002
- value
- 19
- group Id
- BG003
- value
- 9
- group Id
- BG004
- value
- 10
- group Id
- BG005
- value
- 47
- title
- ECOG = 1
- description
- Participants were assessed for ECOG PS where ECOG PS Grade 0 is fully active, able to carry on all pre-disease performance without restriction. Grade 1 is restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature.
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 1
- title
- Adenocarcinoma of the Colon
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 6
- group Id
- BG005
- value
- 7
- title
- Adenocarcinoma of the Pancreas
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 1
- title
- Carcinoma Of Ampulla of Vater
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 1
- title
- Cholangiocarcinoma
- measurements
- group Id
- BG000
- value
- 2
- group Id
- BG001
- value
- 7
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 16
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 25
- title
- Colorectal Cancer, not otherwise specified
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 1
- title
- Lung Cancer, not otherwise specified
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 3
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 10
- group Id
- BG005
- value
- 13
- title
- Pancreatic Cancer (Not Islets)
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 1
- title
- Rectal
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 20
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 20
- title
- Non-Small Cell Lung Cancer, not otherwise specified
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Primary Diagnosis
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 2
- group Id
- BG002
- value
- 5
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 1
- group Id
- BG005
- value
- 9
- title
- First Line
- measurements
- group Id
- BG000
- value
- 2
- group Id
- BG001
- value
- 5
- group Id
- BG002
- value
- 5
- group Id
- BG003
- value
- 4
- group Id
- BG004
- value
- 5
- group Id
- BG005
- value
- 21
- title
- Second Line
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 2
- group Id
- BG002
- value
- 5
- group Id
- BG003
- value
- 6
- group Id
- BG004
- value
- 7
- group Id
- BG005
- value
- 20
- title
- Third Line
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 3
- group Id
- BG002
- value
- 1
- group Id
- BG003
- value
- 2
- group Id
- BG004
- value
- 3
- group Id
- BG005
- value
- 9
- title
- Fourth Line
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 3
- group Id
- BG002
- value
- 4
- group Id
- BG003
- value
- 4
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 11
- title
- Fifth Line or Greater
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Prior Line of Therapy
- unit Of Measure
- Participants
Complete source fields
- denoms
- counts
- group Id
- BG000
- value
- 3
- group Id
- BG001
- value
- 15
- group Id
- BG002
- value
- 20
- group Id
- BG003
- value
- 16
- group Id
- BG004
- value
- 16
- group Id
- BG005
- value
- 70
- units
- Participants
- groups
- description
- V941(mRNA-5671/V941) 1 mg administered intramuscularly (IM) once every 3 weeks (Q3W) for 9 3-week cycles
- id
- BG000
- 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
- BG001
- 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
- BG002
- 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
- BG003
- 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
- BG004
- title
- Part 2: Expansion Cohort 3 Pancreatic Adenocarcinoma (V941 + Pembrolizumab)
- description
- Total of all reporting groups
- id
- BG005
- title
- Total
- measures
- classes
- categories
- measurements
- group Id
- BG000
- value
- 2
- group Id
- BG001
- value
- 10
- group Id
- BG002
- value
- 9
- group Id
- BG003
- value
- 12
- group Id
- BG004
- value
- 6
- group Id
- BG005
- value
- 39
- title
- < 65 years
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 5
- group Id
- BG002
- value
- 11
- group Id
- BG003
- value
- 4
- group Id
- BG004
- value
- 10
- group Id
- BG005
- value
- 31
- title
- >= 65 years
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Age, Customized
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 9
- group Id
- BG002
- value
- 13
- group Id
- BG003
- value
- 7
- group Id
- BG004
- value
- 9
- group Id
- BG005
- value
- 39
- title
- Female
- measurements
- group Id
- BG000
- value
- 2
- group Id
- BG001
- value
- 6
- group Id
- BG002
- value
- 7
- group Id
- BG003
- value
- 9
- group Id
- BG004
- value
- 7
- group Id
- BG005
- value
- 31
- title
- Male
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Sex: Female, Male
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 3
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 3
- title
- Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 3
- group Id
- BG001
- value
- 11
- group Id
- BG002
- value
- 19
- group Id
- BG003
- value
- 15
- group Id
- BG004
- value
- 16
- group Id
- BG005
- value
- 64
- title
- Not Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 1
- group Id
- BG003
- value
- 1
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 3
- title
- Unknown or Not Reported
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Ethnicity (NIH/OMB)
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 0
- title
- American Indian or Alaska Native
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 12
- group Id
- BG003
- value
- 9
- group Id
- BG004
- value
- 9
- group Id
- BG005
- value
- 31
- title
- Asian
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 0
- title
- Native Hawaiian or Other Pacific Islander
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 2
- title
- Black or African American
- measurements
- group Id
- BG000
- value
- 2
- group Id
- BG001
- value
- 12
- group Id
- BG002
- value
- 8
- group Id
- BG003
- value
- 6
- group Id
- BG004
- value
- 7
- group Id
- BG005
- value
- 35
- title
- White
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 1
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 1
- title
- More than one race
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 1
- title
- Unknown or Not Reported
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Race (NIH/OMB)
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 2
- group Id
- BG001
- value
- 7
- group Id
- BG002
- value
- 1
- group Id
- BG003
- value
- 7
- group Id
- BG004
- value
- 6
- group Id
- BG005
- value
- 23
- title
- ECOG = 0
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 8
- group Id
- BG002
- value
- 19
- group Id
- BG003
- value
- 9
- group Id
- BG004
- value
- 10
- group Id
- BG005
- value
- 47
- title
- ECOG = 1
- description
- Participants were assessed for ECOG PS where ECOG PS Grade 0 is fully active, able to carry on all pre-disease performance without restriction. Grade 1 is restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature.
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 1
- title
- Adenocarcinoma of the Colon
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 6
- group Id
- BG005
- value
- 7
- title
- Adenocarcinoma of the Pancreas
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 1
- title
- Carcinoma Of Ampulla of Vater
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 1
- title
- Cholangiocarcinoma
- measurements
- group Id
- BG000
- value
- 2
- group Id
- BG001
- value
- 7
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 16
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 25
- title
- Colorectal Cancer, not otherwise specified
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 1
- title
- Lung Cancer, not otherwise specified
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 3
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 10
- group Id
- BG005
- value
- 13
- title
- Pancreatic Cancer (Not Islets)
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 1
- title
- Rectal
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 20
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 20
- title
- Non-Small Cell Lung Cancer, not otherwise specified
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Primary Diagnosis
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 2
- group Id
- BG002
- value
- 5
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 1
- group Id
- BG005
- value
- 9
- title
- First Line
- measurements
- group Id
- BG000
- value
- 2
- group Id
- BG001
- value
- 5
- group Id
- BG002
- value
- 5
- group Id
- BG003
- value
- 4
- group Id
- BG004
- value
- 5
- group Id
- BG005
- value
- 21
- title
- Second Line
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 2
- group Id
- BG002
- value
- 5
- group Id
- BG003
- value
- 6
- group Id
- BG004
- value
- 7
- group Id
- BG005
- value
- 20
- title
- Third Line
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 3
- group Id
- BG002
- value
- 1
- group Id
- BG003
- value
- 2
- group Id
- BG004
- value
- 3
- group Id
- BG005
- value
- 9
- title
- Fourth Line
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 3
- group Id
- BG002
- value
- 4
- group Id
- BG003
- value
- 4
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 11
- title
- Fifth Line or Greater
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Prior Line of Therapy
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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