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NCT03948763 · FLOW

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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.

groups
  1. description
    V941(mRNA-5671/V941) 1 mg administered intramuscularly (IM) once every 3 weeks (Q3W) for 9 3-week cycles
    id
    FG000
    title
    Part 1: V941 Monotherapy
  2. 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
    FG001
    title
    Part 1: V941 + Pembrolizumab
  3. 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
    FG002
    title
    Part 2: Expansion Cohort 1 Non-small Cell Lung Cancer (V941 + Pembrolizumab)
  4. 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
    FG003
    title
    Part 2: Expansion Cohort 2 Colorectal Cancer (V941 + Pembrolizumab)
  5. 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
    FG004
    title
    Part 2: Expansion Cohort 3 Pancreatic Adenocarcinoma (V941 + Pembrolizumab)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        6
      4. group Id
        FG003
        num Subjects
        4
      5. group Id
        FG004
        num Subjects
        0
      type
      Sponsor's decision
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      Physician Decision
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        1
      type
      Lost to Follow-up
    4. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        12
      3. group Id
        FG002
        num Subjects
        13
      4. group Id
        FG003
        num Subjects
        10
      5. group Id
        FG004
        num Subjects
        11
      type
      Death
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        2
      5. group Id
        FG004
        num Subjects
        4
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        15
      3. group Id
        FG002
        num Subjects
        20
      4. group Id
        FG003
        num Subjects
        16
      5. group Id
        FG004
        num Subjects
        16
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      Participants Switched Over From V941 Monotherapy to V941 + Pembrolizumab
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        15
      3. group Id
        FG002
        num Subjects
        20
      4. group Id
        FG003
        num Subjects
        16
      5. group Id
        FG004
        num Subjects
        16
      type
      NOT COMPLETED
    title
    Overall Study
Complete source fields
groups
  1. description
    V941(mRNA-5671/V941) 1 mg administered intramuscularly (IM) once every 3 weeks (Q3W) for 9 3-week cycles
    id
    FG000
    title
    Part 1: V941 Monotherapy
  2. 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
    FG001
    title
    Part 1: V941 + Pembrolizumab
  3. 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
    FG002
    title
    Part 2: Expansion Cohort 1 Non-small Cell Lung Cancer (V941 + Pembrolizumab)
  4. 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
    FG003
    title
    Part 2: Expansion Cohort 2 Colorectal Cancer (V941 + Pembrolizumab)
  5. 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
    FG004
    title
    Part 2: Expansion Cohort 3 Pancreatic Adenocarcinoma (V941 + Pembrolizumab)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        6
      4. group Id
        FG003
        num Subjects
        4
      5. group Id
        FG004
        num Subjects
        0
      type
      Sponsor's decision
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      Physician Decision
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        1
      type
      Lost to Follow-up
    4. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        12
      3. group Id
        FG002
        num Subjects
        13
      4. group Id
        FG003
        num Subjects
        10
      5. group Id
        FG004
        num Subjects
        11
      type
      Death
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        2
      5. group Id
        FG004
        num Subjects
        4
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        15
      3. group Id
        FG002
        num Subjects
        20
      4. group Id
        FG003
        num Subjects
        16
      5. group Id
        FG004
        num Subjects
        16
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      Participants Switched Over From V941 Monotherapy to V941 + Pembrolizumab
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        15
      3. group Id
        FG002
        num Subjects
        20
      4. group Id
        FG003
        num Subjects
        16
      5. group Id
        FG004
        num Subjects
        16
      type
      NOT COMPLETED
    title
    Overall Study

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Preserved source evidence · Not medical advice