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NCT05010629 · FLOW

Participant flow

9-ING-41 Plus Carboplatin in Salivary Gland Carcinoma · Source last updated 2026-08-07

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups
  1. description
    Participants will receive: 9-ING-41 administered twice per 21-day cycle on Day 1 and Day 4 for up to 1 year. Treatment with 9-ING-41 may continue beyond 1 year in participants with ongoing clinical benefit. Carboplatin administered once per 21-day cycle on Day 1 for up to 1 year.
    id
    FG000
    title
    9-ING-41 + Carboplatin (Part I)
  2. description
    Participants will receive: Pembrolizumab 200 mg IV on Day 1 of each 21-day cycle (±3 days) for Cycles 1 and 2 (lead-in therapy). 9-ING-41 administered twice per 21-day cycle on Day 1 and Day 4 for up to 1 year. Treatment with 9-ING-41 may continue beyond 1 year in participants with ongoing clinical benefit. Carboplatin administered once per 21-day cycle on Day 1 for up to 1 year.
    id
    FG001
    title
    Pembrolizumab + 9-ING-41 + Carboplatin (Part II)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        3
      type
      Physician Decision
    2. reasons
      1. group Id
        FG000
        num Subjects
        9
      2. group Id
        FG001
        num Subjects
        11
      type
      Progressive Disease
    3. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      type
      Adverse Event
    4. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        2
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        16
      2. group Id
        FG001
        num Subjects
        16
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      comment
      Treatment duration is indefinite. All participants are considered "not completed," and reasons for going off treatment are recorded in the "Reason Not Completed" field.
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        16
      2. group Id
        FG001
        num Subjects
        16
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Arms are defined by treatment assignment. Adenoid cystic carcinoma (ACC) and non-ACC represent disease subgroups within each treatment arm and were not assigned to separate treatment arms. Therefore, participants are reported according to treatment assignment rather than histologic subtype.
recruitment Details
Participants were enrolled from 9/17/2021 to 4/12/2024.
Complete source fields
groups
  1. description
    Participants will receive: 9-ING-41 administered twice per 21-day cycle on Day 1 and Day 4 for up to 1 year. Treatment with 9-ING-41 may continue beyond 1 year in participants with ongoing clinical benefit. Carboplatin administered once per 21-day cycle on Day 1 for up to 1 year.
    id
    FG000
    title
    9-ING-41 + Carboplatin (Part I)
  2. description
    Participants will receive: Pembrolizumab 200 mg IV on Day 1 of each 21-day cycle (±3 days) for Cycles 1 and 2 (lead-in therapy). 9-ING-41 administered twice per 21-day cycle on Day 1 and Day 4 for up to 1 year. Treatment with 9-ING-41 may continue beyond 1 year in participants with ongoing clinical benefit. Carboplatin administered once per 21-day cycle on Day 1 for up to 1 year.
    id
    FG001
    title
    Pembrolizumab + 9-ING-41 + Carboplatin (Part II)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        3
      type
      Physician Decision
    2. reasons
      1. group Id
        FG000
        num Subjects
        9
      2. group Id
        FG001
        num Subjects
        11
      type
      Progressive Disease
    3. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      type
      Adverse Event
    4. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        2
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        16
      2. group Id
        FG001
        num Subjects
        16
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      comment
      Treatment duration is indefinite. All participants are considered "not completed," and reasons for going off treatment are recorded in the "Reason Not Completed" field.
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        16
      2. group Id
        FG001
        num Subjects
        16
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Arms are defined by treatment assignment. Adenoid cystic carcinoma (ACC) and non-ACC represent disease subgroups within each treatment arm and were not assigned to separate treatment arms. Therefore, participants are reported according to treatment assignment rather than histologic subtype.
recruitment Details
Participants were enrolled from 9/17/2021 to 4/12/2024.

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Preserved source evidence · Independent clinical review pending · Not medical advice