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NCT03513952 · FLOW

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Atezolizumab and CYT107 in Treating Participants With Locally Advanced, Inoperable, or Metastatic Urothelial Carcinoma · Source last updated 2024-07-26

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

groups
  1. description
    Patients receive CYT107 on days 1, 8, 15, and 22, and atezolizumab on day 8 of cycle 1. Following cycle 1, patients receive atezolizumab on day 1. Cycles with atezolizumab repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Atezolizumab: Given IV Glycosylated Recombinant Human Interleukin-7: Given IM
    id
    FG000
    title
    Group 1 (CYT107, Atezolizumab)
  2. description
    Patients receive atezolizumab on Day 1 of each cycle. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Atezolizumab: Given IV
    id
    FG001
    title
    Group 2 (Atezolizumab)
  3. description
    Patients were not randomized; they were assigned to the experimental arm treatment (atezolizumab + CYT107). Patients receive CYT107 on days 1, 8, 15, and 22, and atezolizumab on day 8 of cycle 1. Following cycle 1, patients receive atezolizumab on day 1. Cycles with atezolizumab repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Atezolizumab: Given IV Glycosylated Recombinant Human Interleukin-7: Given IM
    id
    FG002
    title
    Safety Run in Phase
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        19
      2. group Id
        FG001
        num Subjects
        21
      3. group Id
        FG002
        num Subjects
        7
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      comment
      Completed Study Treatment (up to 2 years)
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        16
      2. group Id
        FG001
        num Subjects
        19
      3. group Id
        FG002
        num Subjects
        7
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
Safety Run-In Phase: If the treatment combination demonstrates an acceptable safety profile (one or fewer patient experiences a protocol-defined Dose Limiting-Toxicity), randomized enrollment will begin.
Complete source fields
groups
  1. description
    Patients receive CYT107 on days 1, 8, 15, and 22, and atezolizumab on day 8 of cycle 1. Following cycle 1, patients receive atezolizumab on day 1. Cycles with atezolizumab repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Atezolizumab: Given IV Glycosylated Recombinant Human Interleukin-7: Given IM
    id
    FG000
    title
    Group 1 (CYT107, Atezolizumab)
  2. description
    Patients receive atezolizumab on Day 1 of each cycle. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Atezolizumab: Given IV
    id
    FG001
    title
    Group 2 (Atezolizumab)
  3. description
    Patients were not randomized; they were assigned to the experimental arm treatment (atezolizumab + CYT107). Patients receive CYT107 on days 1, 8, 15, and 22, and atezolizumab on day 8 of cycle 1. Following cycle 1, patients receive atezolizumab on day 1. Cycles with atezolizumab repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Atezolizumab: Given IV Glycosylated Recombinant Human Interleukin-7: Given IM
    id
    FG002
    title
    Safety Run in Phase
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        19
      2. group Id
        FG001
        num Subjects
        21
      3. group Id
        FG002
        num Subjects
        7
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      comment
      Completed Study Treatment (up to 2 years)
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        16
      2. group Id
        FG001
        num Subjects
        19
      3. group Id
        FG002
        num Subjects
        7
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
Safety Run-In Phase: If the treatment combination demonstrates an acceptable safety profile (one or fewer patient experiences a protocol-defined Dose Limiting-Toxicity), randomized enrollment will begin.

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice